2010版中国药典英文2012

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2010版中国药典英文

2010版中国药典英文

2.药材的采收与产地加工部分的一般译法为: 药材的采收与产地加工部分的一般译法为: 用The drug作主语,单数。用被动语态,不用主动语态。“采 drug作主语 单数。用被动语态,不用主动语态。 作主语, collected” 不用“ picked” up” 收”用“to be collected”(不用“to be picked”,“to be dug up” 除去杂质” 名词单数) 等 ) 。 “ 除去杂质 ” 等 ( 名词单数 ) 用 “ removed from foreign matter” 洗净” matter”,“洗净”用“washed clean”,“干燥”用“dried”, “晒 clean” 干燥” dried” sun” 干 ” 为 “ dried in the sun” , “ 阴 干 ” 为 “ dried in the shade” 低温干燥” shade”,“低温干燥”为“dried at a lower temperature”。“栽培 temperature” 变种” cultivar” 泥砂” soil” 须根. 细根” 变种 ” 为 “ cultivar” 。 “ 泥砂 ” 为 “ soil” 。 “ 须根 . 细根 ” : root”用于单子叶植物、根茎上的不定根, rootlet” “fibrous root”用于单子叶植物、根茎上的不定根,“rootlet” 用于双子叶植物主根上的细小侧根、支根。 用于双子叶植物主根上的细小侧根、支根。 例1 The drug is collected in autumn, removed from foreign matter, washed clean, and dried in the sun. sun. 例 2 The drug is collected at flowering to fruiting stage, removed from thick stem, cut into section, and dried. dried. ( 注 : 中国药典 2005年版一部英文版药用部位采用名词单数 , 如 中国药典2005 年版一部英文版药用部位采用名词单数 年版一部英文版药用部位采用名词单数, stem, leaf, fibrous root, rootlet等). rootlet等

中国药典2010年版

中国药典2010年版

2010版中国药典中国药典2010年版名称:《中华人民共和国药典》中国药典2010版作者:国家药典委员会出版社:中国医药科技出版社2010年10月出版开本:16开精装册数:全三卷定价:1498 元优惠价:980 元读者服务部→发行部:,内容简介:2010年版药典的鲜明特色:更新与淘汰并举、收载品种大幅增加。

药品检测项目和检测方法增加、标准提高,因而在药品安全性和质量可控性方面有更高、更多、更大提升。

二部中采用高效液相色谱法进行含量测定或用于有关物质检查的品种有近千个,系统适用性要求也更为合理,个别品种采用了分离效能更高的离子色谱法,检测器使用种类也更加多样。

中药标准有突破和创新,尤其在过去比较薄弱的中药材和中药饮片标准的新增和修订方面,如本版《中国药典》一部中动物药蛇类、植物药川贝母等,都采用了PCR检测方法。

新版药典在凡例、品种的标准要求、附录的制剂通则等方面均有较大的变化和进步。

在广泛吸取国内外先进技术和实验方法的基础上,附录内容与目前国际对药品质量控制的方法和技术力求一致,进一步发挥《中国药典》的国际影响力。

新版药典在坚持科学、实用、规范、药品安全性、质量可控性和标准先进性的原则下,力求覆盖国家基本药物目录品种和社会医疗保险报销药品目录品种。

顶尖专家扛鼎之作。

本版《中国药典》是在第九届药典委员会的精心组织下,聘请全国医药行业323位一流专家、投入巨额资金、历时两年编制而成,集中体现了当前我国药品标准工作的最新发展成果。

《中国药典》是国家监督管理药品质量的法定技术标准。

2010年版《中国药典》分为三部出版,一部为中药,二部为化学药,三部为生物制品。

各部内容主要包括凡例、标准正文和附录三部分,其中附录由制剂通则、通用检测方法、指导原则及索引等内容构成。

药典二部收载化学药品、抗生素、生化药品、放射性药品以及药用辅料等。

药典三部收载生物制品。

新版药典在凡例、品种的标准要求、附录的制剂通则和检验方法等方面均有较大的改进和发展,特别是对药品的安全性、有效性和质量可控性方面尤为重视。

最完整最清晰的2010版中国药典(共三部)

最完整最清晰的2010版中国药典(共三部)

最完整、最清晰的2010版中国药典(共三部)费尽千辛万苦,终于弄来了最完整、最清晰的2010版中国药典,效果堪比正版原书。

绝对完整,绝对清晰的2010版中国药典pdf版,共三部,还包括了2010版中国药典勘误表。

内容比较大,三部一共超过440M,大家可以自己去淘宝,下载需要耐心哦。

最完整、最清晰的2010版中国药典(共三部)原文地址:/forum-viewthread-tid-19984-fromuid-5.html主要内容:(1)《中国药典》2010年版1部.pdf(2)《中国药典》2010年版2部.pdf(3)《中国药典》2010年版3部.pdf(4)中国药典2010版1部附录.pdf(5)2010版中国药典一部勘误表.pdf(6)2010版中国药典二部误表.pdf(7)2010版中国药典三部勘误表.pdf2010版中国药典(中药材部分)目录一枝黄花(p3) ................................................................................................... 错误!未定义书签。

丁公藤(p3) ....................................................................................................... 错误!未定义书签。

丁香(p4) ........................................................................................................... 错误!未定义书签。

八角茴香(p4) ................................................................................................... 错误!未定义书签。

2010年药典第三部

2010年药典第三部

2010年药典第三部英文回答:In 2010, the third edition of the Pharmacopoeia was published, which set forth the requirements and standardsfor pharmaceutical substances and preparations. Thisedition aimed to ensure the quality, safety, and efficacyof medicines used in the healthcare industry. It included guidelines for the identification, testing, and control of active pharmaceutical ingredients, as well as theformulation and labeling of finished products.The Pharmacopoeia serves as a vital reference for healthcare professionals, including pharmacists, physicians, and regulatory authorities. It provides them with comprehensive information on the quality and standards of medicines, allowing them to make informed decisions regarding patient care. For example, if a physician prescribes a particular medication, they can consult the Pharmacopoeia to ensure that the product meets the requiredspecifications and is safe for use.One of the key features of the 2010 edition is the inclusion of monographs, which provide detaileddescriptions and specifications for individual drugs ordrug classes. These monographs cover a wide range of topics, including the physical and chemical properties of the drug, the recommended dosage forms and strengths, and the analytical methods for testing its quality. By followingthe monographs, pharmaceutical manufacturers can ensurethat their products are consistent with the established standards.Moreover, the Pharmacopoeia also addresses the issue of impurities in pharmaceutical substances. It sets limits for impurities, such as residual solvents, heavy metals, and microbial contaminants, to ensure that medicines are free from potentially harmful substances. These limits are based on scientific evidence and are designed to protect patient safety. For example, if a medication contains excessive levels of a particular impurity, it may pose a risk to the patient's health. The Pharmacopoeia helps to prevent suchsituations by providing guidelines for testing and controlling impurities.In addition to the standards for pharmaceutical substances, the Pharmacopoeia also includes guidelines for the formulation and labeling of finished products. These guidelines ensure that medicines are formulated in a way that maximizes their stability, efficacy, and safety. For example, the Pharmacopoeia may specify the acceptable range of pH for a particular oral solution to ensure itsstability over time. It may also provide labeling requirements, such as the mandatory inclusion of certain warnings or precautions on the product packaging.中文回答:2010年,第三版药典出版,规定了药物物质和制剂的要求和标准。

2010版药典

2010版药典

2010版药典介绍2010版药典(Pharmacopoeia of the People’s Republic of China, 2010 Edition)是中华人民共和国的一项法定药典,由中国食品药品监督管理局主管,于2010年首次正式发布。

药典是规定和标准化药物质量的权威性文献,对于保证药品的质量和安全至关重要。

每个国家都有自己的药典,以提供关于药物标准、药物检测及质量控制的指导。

药典发展历程自从2000年第一版药典发布以来,每隔十年,中国都会出版一次新版的药典,以适应药物和医疗行业的发展需求。

2010版药典在追求高质量药品的同时,也考虑到了国际药品质量要求的变化。

它包含了中国传统药材和西药等各类药品的质量标准。

药典的内容2010版药典详细描述了每种药品的质量标准,包括药物成分、理化性质、检测方法、用法用量和质量控制等。

药典的目的是确保药物的质量、有效性和安全性,从而保护患者的健康。

药典中还包含了一些药物鉴别和检测的基本原则和指导,以及药品生产和质量控制的规范要求。

药典在保障药品质量中的作用药典是确保药品质量的重要工具。

它为药物生产企业提供了明确的质量标准,帮助企业进行药品质量的控制和管理。

同时,药典还为药物检验机构提供了参考标准和检验方法,确保对药品质量进行准确和有效的检测。

此外,药典还为医疗机构提供了选择合格药品的参考依据,保证患者用药的安全性和有效性。

药典的重要性药典的制定和实施对于维护药品质量、保障患者用药安全具有重要意义。

药典是一个国家药品质量管理体系的重要组成部分,发挥着规范药品生产和流通环节的功能。

它对于推动药品质量的提升、促进药物研发和创新以及保护公众的健康起着至关重要的作用。

结论2010版药典是中华人民共和国发布的一项法定药典,是保障药品质量和保护患者用药安全的重要工具。

药典规定了药品的质量标准,对于药物的生产、检验和使用提供了指导。

药典的制定和实施对于提高药品质量、推动医药行业发展、保护公众健康具有重要意义。

中国药典大全-12-最新2010版药典生化药汇总

中国药典大全-12-最新2010版药典生化药汇总

多糖
15(5) 19(6) 4(1)
26.6%(20%)
脂 总数
2(1)
4(2)
2(1)
159(61) 191(72) 36(12)
100.0%
1
(100.0%)
22.6%(19.6%)5
范围
特点
Generated by Foxit PDF Creator © Foxit Software For evaluation only.
大部分合成,少部分提取、重组产品归 发酵工艺 固:注射用 液:注射液溶液
高分子蛋白
异毒
有关物质
细内
相关蛋白
微生物限度
含量:HPLC
过敏
金属离子:吸收光谱
机体代谢中提供能源、碳 提取、发酵
源,亦是细胞结构主要组 固:片、胶囊、乳膏、软胶囊、注射用
成部分
液:注射液、Nacl、葡萄糖注射液
金属离子:吸收光谱 比活: 比旋度 有机残留 细内
• 尤其对于严重危害人类健康和生命的疾病,如 心脑血管病、癌症、糖尿病和病毒疾患等有其独 特的治疗效果。深受人民的欢迎和重视。
Generated by Foxit PDF Creator © Foxit Software For evaluation only.
2、生化药的发展
Generated by Foxit PDF Creator © Foxit Software For evaluation only.
1、生化药的定义
• 生化药物是我国医药产品的一个大类。
• 生化药主要从动、植物及微生物发酵提取的、 化学合成、生物-化学半合成或用现代生物重组技 术制得的一类药品
有关物质:HPLC 含测:HPLC、GC 过氧化值 *甲氧基胺值 不皂化值

中国药典

中国药典
中文索引(汉语拼音索引)和英文 名称索引。
正文收载药品的格式 中药标准的格式与内容
• (1)品名(包括中文名、汉语拼音、拉丁名) • (2)来源(3)处方(4)制法(5)性状 • (6)鉴别(7)检查(8)浸出物 • (9)含量测定(10)炮制(11)性味与归经 • (12)功能与主治(13)用法与用量 • (14)注意(15)规格(16)贮藏 • (17)制剂等
中国药典(2010年版)分为一部、二 部、三部。
一部:天然药物 二部:化学药物 三部:生物制品
药典的主要内容
药典的内容一般分为凡例、品名目次、 正文、附录和索引五部分。
1、 凡例
是药典的总说明,把一些与标准有关 的、共性的、需要明确的问题,以及采用 的计量单位、符号与专门术语等,用条文 加以规定,以避免在全书中重复说明。
2、品名目次 按中文名称笔画顺序排列,同笔画
数的字按起笔笔形“一丨丿丶乛”的顺 序排列;单方制剂排在原料药的后面。 3、正文品种
是药典的主要内容,为所收载药品 或制剂的质量标准。
4、附录 附录部分记载了制剂通则、生物制
品通则、一般杂质检查方法、一般鉴别 试验、有关物理常数测定法、试剂配制 法以及色谱法、光谱法等内容。 5、索引
中国药典
是一个国家记载药品规格、标准的 法典。由国家组织的药典委员会编写, • 收载范围 必须是医疗必需、疗效肯定、质量可
靠、其质量易控制、检定的品种。
• 中国药典的沿革 建国以来,先后出版了九版药典,
1953、1963、1977、1985、1990、1995、 2000 、 2005和2010年版药典,现行使用 的是中国药典(2010年版)。其英文名称 是 Chinese Pharmacopiea,缩写为ChP。

《中国药典》基本结构与内容

《中国药典》基本结构与内容
化学结构式按世界卫生组织推荐 “药品化学结构式书 写指南”书写。
(2) 检验方法和限度
原料药的含量(%),除另有注明者外,均按重 量计。如规定上限为100%以上时,系指用本药典 规定的分析方法测定时可能达到的数值,为药典 规定的限度或允许偏差,并非真实含有量;如未 规定上限时,系指不超过101.0%。
(3) 标准品、对照品
用途:用于鉴别、检查、含量测定的标准物质。 特点:由国务院药品监督管理部门指定单位制备、标 定和供应。 标准品:用于生物检定、抗生素或生化药品中含量或 效价测定;按效价单位(或μg)计,以国际标准品标定。 对照品: 用于结构确切物质(如化学药)分析。按干燥 品(或无水物)进行计算后使用。
中国药典中国药典20102010年版三部主要内容年版三部主要内容chinesepharmacopoeiachinesepharmacopoeiachinesepharmacopoeiachinesepharmacopoeia中药材中药成方制剂一部化学和生化药品抗生素放射性药品药用辅料二部生化药品三部解释使用药典基本原则规定正文附录共性问题药品质量标准制剂质量标准中文索引英文索引生物制品质量标准通用检测方法指导原则制剂通则2
(4) 精 确 度
精密称定: 称取重量准确至所取重量千分之一; 称定: 称取重量应准确至所取重量的百分之一; 取用量为“约”: 所取量不得超过规定量±10%.
3.正文编排和内容
正文收载药品或制剂的质量标准,按中文药品名称笔 画顺序编排,单方制剂排在原料药后面; 每一品种项含:
⑴品名(包括中文名,汉语拼音名与英文名)⑵有机药物的 结构式;⑶分子式与分子量;⑷来源或有机药物的化学名称; ⑸含量或效价规定;⑹处方;⑺制法;⑻性状;⑼鉴别;⑽检 查;⑾含量或效价测定;⑿类别;⒀规格;⒁贮藏; ⒂制剂

《中国药典》2010版(一部)部分标准商榷

《中国药典》2010版(一部)部分标准商榷

中国药典2010版(一部)部分标准商榷张南平,肖新月(中国药品生物制品检定所,北京100050)Discussion about the problem of Chinese Pharmacopoeia 2010 EditionZHANG Nan-ping,XIAO Xin-yue(The National Institute for the Control of Pharmaceutical and Biological Products 100050 Beijing )2010年版中国药典于2010年10月1日开始正式执行,标准中所有内容的准确性、规范性直接关系到相关药品检验工作的严肃性、公正性和可操作性。

本文作者将研读新版中国药典一部时发现的药材和饮片部分正文及相关附录中的一些问题,依据生物学基本概念和知识,结合多年从事中药材检验与标准研究积累的经验进行了探讨,并提出修订建议,希望有助于中国药典的完善与提高。

具体内容分述如下:1.前言倒数第13行“桃仁、杏仁等新增黄曲霉毒素检测”。

应删去“、杏仁”。

因为正文杏仁项下无黄曲霉毒素检测项目。

2.三白草(第12页)项下载有“【性状】…基出脉5条。

”据《中国植物志》记载,本植物叶片有基出脉5~7条。

故建议改为“【性状】……基出脉5~7条。

”3.大叶紫珠(第18页)项下收载药用部位为干燥叶或带叶嫩枝;拉丁药名为“CALLICARPAE MACROPHYLLAE FOLIUM”。

鉴于拉丁药名构成中缺带叶嫩枝的表述,建议应修正为“CALLICARPAE MACROPHYLLAE RAMULUS ET FOLIUM”。

4.山香圆叶(第28页)项下载有“本品为省沽油科山香圆Turpinia arguta Seem.的干燥叶。

”“【鉴别】(1)本品横切面:…中柱鞘纤维束排列成不连续的环。

”因为叶是没有中柱鞘的,所以也就没有中柱鞘纤维束。

植物学文献将此处称为维管束鞘,一般由厚壁的纤维或薄壁细胞组成,建议改成“【鉴别】(1)本品横切面:…维管束鞘纤维束排列成不连续的环。

2010版GMP英文版

2010版GMP英文版

SDA Order #79Order by Ministry of Health of the People’s Republic of ChinaPublished on February 12, 2011No. 79Good Manufacturing Practice for Pharmaceutical Products (Amended in 2010) has passed by Affairs Meeting on October 19, 2010. This Regulation is now published and shall be effective from March 1, 2011.Director Zhu CHENJanuary 17, 2011Chapter 1 General ProvisionsArticle 1 In order to standardize good manufacturing for pharmaceutical products, this Regulation is enacted in accordance with the “Drug Administration Law of the People’s Republic of China” and “The Regulation on the Implementation of Drug Administration Law of the People’s Republic of China”.Article 2 A p harmaceutical enterprise shall establish pharmaceutical goods’ quality control system. The system shall contain all factors which may affect the quality of pharmaceutical goods, including all organized and planned activities ensuring pharmaceutical goods’ quality in accordance with intending purpose.Article 3 This Regulation is part of quality control system, is basic requirement for manufacturing and quality control of pharmaceutical products. This Regulation aims to reduce the risks in pharmaceutical g oods’ manufacturing process at its maximum, such as pollution,cross pollution and confusion, mistake, ensure for continuous stably manufacturing pharmaceutical goods in accordance with intending purpose and registered requirements.Article 4 The enterprise shall obey this Regulation strictly, insist on honesty and keep faith, prohibit any ostensible and spurious activities.Chapter 2 Quality ControlSection 1 PrincipleArticle 5 The enterprise shall establish quality target in accordance with pharmaceutical goods’ quality control requirements, carry out all requirements related to safety, effective and quality control into the process of pharmaceutical goods’ manufacturing, control and products’ discharging, storag e, delivering, ensure all pharmaceutical goods are produced in accordance with intending purpose and registered requirements.Article 6 Senior administrator in enterprise shall ensure the achievement of intending quality target. Personnel in different levels and provider, dealer shall participate in and take each responsibility.Article 7 The enterprise shall equip adequate personnel, workshop, establishment and equipment in accordance with requirements, and provide essential condition for achieving quality target.Section 2 Quality GuaranteeArticle 8 Quality guarantee is a part of quality control system. The enterprise must establish quality guarantee system, and establish integrate document system at the same time, in order to ensure the system’s e ffective running.Article 9 Quality guarantee system shall ensure the following:I. Represent the requirements of this Regulation in pharmaceutical goods’ design anddevelopment.II. In accordance with the requirements of this Regulation in manufacturing management and quality control activities;III. Specific management responsibility;IV. Exact stocked and used raw material and wrapper;V. Effective control in semi-finished product;VI. Implement of confirmation and validation;VII. Manufacture, examine, inspect and double examined according to rules strictly; VIII. Each batch of products shall only discharge after quality authorizing person’s approval;IX. Applicable measures to ensure pharmaceutical goods’ quality during the process of storage, delivering and all succedent operation process;X. According to self-examine rules, examine and evaluate the validity and applicability of the quality guarantee system quality.Article 10 Basic requirements of pharmaceutical goods’ manufacture quality management: I. Frame manufacturing technique, systemic review and demonstrate it couldcontinuous stably manufacturing products in accordance with requirements;II. Manufacturing technique and its important changes shall be validated;III. Equip all required resources, include, but not limited the following:1. Hold applicable qualification and the eligible trained personnel;2. Adequate workshop and space;3. Applicable equipment and maintain guarantee;4. Accurate raw material, wrapper and label;5. Approved technique rules and operate rules;6. Applicable storage and freight condition.IV. Use accurate and easy understand language to frame operate rules;V. The operate person could accurate operate according to operate rules after training;VI. The whole manufacture process shall be recorded. The windage shall be researched and be recorded;VII. Batch record and delivering record shall be traced back to the whole history of the batch of products, and the records shall be saved appropriately and be easy consult; VIII. Reduce the quality risk during the pharmaceutical goods’ delivering process;IX. Establish pharmaceutical goods’recall system, and ensure any batch delivered and sold products could be recalled;X. Survey the reasons leading to pharmaceutical goods’complaints and quality objections, take measures to prevent similar quality objections.Section 3 Quality ControlArticle 11 Quality control includes corresponding organization, document system and sampling, test and so on, to ensure material or products finish necessary examination before delivering, and to verify its quality is in accordance with the requirements.Article 12 Basic requirements of quality control:I. Equip applicable establishment, equipment, instrument and trained personnel to effective and reliable finish all related quality control activities;II. Have approved operate rules, which used to sampling, examine, inspect raw material, wrapper, semifinished product, bulk product and finished product and products’stability, monitor environment when necessary, to ensure the products is in accordance with the requirements of this Regulation;III. Authorized person shall sampling to raw material, wrapper, semifinished product, bulk product and finished product according to stated methods;IV. Inspect methods shall be confirmed and validated;V. Sampling, check, inspect shall be recorded, the windage shall be researched and be recorded;VI. Material, semifinished product, bulk product and finished product shall be checked and inspected according to quality standard and be recorded;VII. Material and packaged finished product shall have enough reserved samples so that necessary check or inspect shall be taken; except the finished product with too large package container, the reserved sample s’package shall be the same with the final package of the finished product.Section 4 Quality Risk ManagementArticle 13 Quality risk management is evaluate, control, communicate, audit system process to quality risk during the whole product life period, via the manner of foresee or review.Article 14 Quality risk shall evaluate according to science knowledge and experience in order to ensure products’ quality.Article 15 The method, measure, form take during the quality risk management process and the documents formed in the said process shall accommodate to the level of the existent risk.Chapter 3 Organization and PersonnelSection 1 PrincipleArticle 16 An enterprise shall establish management organization which accommodate to the pharmaceutical goods’ product and have its organization framework chart.The enterprise shall set up independent quality management department, which carries out the responsibilities of quality guarantee and quality control. The quality management department could set up quality guarantee department and quality control department respectively.Article 17 Quality management department shall take part in all activities relating to quality, and take responsibility to audit all documents relating to this Regulation. The personnel inquality management department shall not relegate his responsibility to the personnel in other department.Article 18 The enterprise shall be staffed by an appropriate number of management and technical personnel with appropriate qualification (including education background, training and practice experience), and the responsibilities of each department and each station shall be clarified. Station’s responsibility shall not be missed and cross responsibility shall be prescribed specifically. Responsibility taken by each person shall not be overfull.Every person shall clear and understand his own responsibilities, be familiar with the requirements related to his responsibilities, and accept necessary training, including pre-job training and on-job training.Article 19 Generally, one shall not relegate his responsibility to other person. If the responsibilities do need to be relegated, the one should relegate his responsibility to the designated person who has equivalent qualification.Section 2 Important PersonArticle 20 The important person shall be the full-time person of the enterprise, at least including the director of the enterprise, director of manufacturing management, director of quality management and authorized person of quality.Director of quality management and director of manufacturing management shall be independent of each other. Director of quality management and authorized person of quality shall not be independent of each other. Operation proceduress shall be established so that authorized person of quality could take his responsibility independently, with no interference from director of enterprise and other person.Article 21 Director of enterpriseDirector of enterprise is the main responsible person of pharmaceutical goods’ quality, who comprehensive responsible to the daily management of the enterprise. In order to ensure theenterprise complete quality target and manufacture pharmaceutical goods according to this Regulation, the director of enterprise shall take responsible for providing necessary resources, reasonable plan, organize and correspond to ensure the quality management department could take its responsibility independently.Article 22 Director of manufacturing managementI. Qualification:Director of manufacturing management shall at least have pharmacology or related specialty undergraduate education background (or secondary professional technical title or licensed pharmacist qualification), have at least three years’ pharmaceutical goods’ manufacturing and quality management experience, including at least one year’s pharmaceutical goods’manufacturing management experience, have taken part in professional knowledge training related to manufacturing products.II. Main responsibility:1. Manufacture and storage the pharmaceutical goods according to approvedtechnology procedure in order to ensure the quality of the pharmaceutical goods;2. Ensure every operation proceduress related to manufacturing operation areperformed strictly;3. Ensure batch production record and batch package record are audited by designatedperson and submitted to quality management department;4. Ensure the maintenance of workshop and equipment in order to preserve its goodworking condition;5. Ensure all kind of necessary validation work is completed;6. Ensure person related to manufacturing have been trained by pre-job training andon-job training, adjust training content according to actual demands.Article 23 Director of quality managementI. Qualification:Director of quality management shall at least have pharmacology or related specialty undergraduate education background (or secondary professional technical title or licensedpharmacist qualification), have at least five years’ pharmaceutical goods’ manufacturing and quality management experience, including at least one year’s pharmaceutical goods’ quality management experience, have taken part in professional knowledge training related to manufacturing products.II. Main responsibility:1. Ensure the raw material, wrapper, semifinished product, bulk product and finishedproduct are in accordance with the registered approved requirements and quality standard;2. Ensure the products are audited to batch record before delivering;3. Ensure necessary inspection is finished;4. Approve quality standard, sampling method, inspection method and other operationproceduress of quality management;5. Audit and approve all changes related to quality;6. Ensure all important windage and exceed criterion inspection results have beenresearched and been dealt with in time;7. Approve and supervise consigned inspection;8. Supervise the maintenance of workshop and equipment in order to maintain its goodworking condition;9. Ensure to finish every necessary confirmation and validation work, checking andapproving confirmation or validation scheme and report;10. Ensure to finish self-check;11. Evaluate and approve material supplier;12. Ensure all complaints related to product quality have been researched, and have beendealt with in time and accurately;13. Ensure to finish products’persistent stability review plan, provide the data ofpersistent stability review;14. Ensure to finish product quality review analysis;15. Ensure quality control and quality guarantee person have been trained by pre-jobtraining and on-job training, adjust training content according to actual demands.Article 24 Director of manufacturing management and director of quality management often have the following common responsibility:I. Audit and approve the documents of products’technology procedure, operation proceduress;II. Supervise the sanitation condition of factory;III. Ensure the key equipment have been confirmed;IV. Ensure to finish the validation of production technology;V. Ensure all related person in enterprise been trained by pre-job training and on-job training, adjust training content according to actual demands;VI. Approve and supervise consigned manufacture;VII. Ensure and monitor the storage condition of material and goods;VIII. Save the record;IX. Supervise the implement condition of this Regulation;X. Monitor the factors influence the quality of the products.Article 25 Authorized person of qualityI. Qualification:Authorized person of quality shall at least have pharmacology or related specialty undergraduate education background (or secondary professional technical title or licensed pharmacist qualification), have at least five years’ pharmaceutical goods’ manufacturing and quality management experience, have the experience of manufacturing process control and quality check work.Authorized person of quality shall have necessary professional theory knowledge, have taken part in the train about product delivering, and could take his responsibility independently.II. Main responsibility:1. Take part in the establishment of enterprise quality system, interior self-check,exterior quality audit, validate and pharmaceutical goods’bad reaction report, product recall and other quality management activities;2. Take the responsibility of product delivering, to ensure the manufacturing, checkingof every batch of delivered products are all in accordance with corresponding code, pharmaceutical goods’ registered requirements and quality standard;3. Before delivering the products, authorized person of quality must issue productdelivering audit record according to the said item 2 and bring it into batch record.Section 3 TrainingArticle 26 The enterprise shall designate department or person to take responsible for training management work, and shall have the training scheme or plan audited or approved by director of manufacture management or director of quality management. The training record shall be preserved.Article 27 All personnel related to pharmaceutical goods’manufacturing, quality shall be trained, the training content shall accommodate to the post. Except the training of theory and practice of this Regulation, responsibility, skill training about the related code, relevant post shall also be trained, and actual effect shall be periodic evaluated.Article 28 The working person in high risk operating area (such as: manufacture area of high activity, high toxic, infective, high sensitive material) shall take expert training.Section 4 Personnel SanitationArticle 29 All personnel shall take sanitation requirements training, the enterprise shall establish personnel sanitation operation proceduress, so that to reduce the pollution risk to pharmaceutical goods taken by person at its maximum.Article 30 Personnel sanitation operation procedures shall include the content related to health, sanitation practice and personnel dress. Personnel in manufacturing area and quality control area shall correctly understand related personnel sanitation operation procedures. Theenterprise shall take measures to ensure the implement of personnel sanitation operation procedures.Article 31 The enterprise shall manage personnel’s health and establish health file. The manufacture personnel contact pharmaceutical goods directly shall receive physical check, and take at least one physical check per year.Article 32 The enterprise shall take appropriate measure to avoid the person have wound in body surface, have infection disease or other person may pollute pharmaceutical goods to take the manufacture work which directly contact pharmaceutical goods.Article 33 Visiting person and untrained person shall not enter manufacture area and quality control area, if the persons need to enter in special conditions, the items of their individual sanitation, clothes changing and so on shall be instructed.Article 34 Any person enters into manufacturing area shall change clothes according to prescription. The material, style and dressing method of work clothes shall be accommodate to the work engaged and the level of air clean degree.Article 35 The person enters into clean manufacturing area shall not make up and adorn with accouterment.Article 36 Manufacturing area, storage area shall forbid smoking and having meals, forbid to store food, beverage, cigarette and individual pharmaceutical goods and other non-manufacturing goods.Article 37 Operation person shall avoid to touch the surface of pharmaceutical goods, wrapper material contact pharmaceutical goods directly and equipment by hand.Chapter 4 Workshop and EstablishmentSection 1 PrincipleArticle 38 The workshop location’s choice, design, overall arrangement, construct, reconstruct and maintenance must in accordance with the pharmaceutical goods’manufacturing requirements, which may avoid pollution, cross pollution, confusion and mistake at its maximum, and may convenient for clean, operate and maintenance.Article 39 The workshop’s location shall consider according to the workshop and manufacturing safety measures. The environment of the workshop shall reduce the pollution risk to material or products at its maximum.Article 40 The enterprise shall have tidy manufacturing environment. The floor, road surface of the workshop and transport shall not pollute the pharmaceutical goods’manufacturing. The overall arrangement of the manufacturing area, administration area, living area and assistant area shall be reasonable arranged and do not interfere each other. Stream of people and material in factory area and workshop shall reasonable.Article 41 The workshop shall take appropriate maintenance, and ensure the maintenance activity may not influence the quality of pharmaceutical goods. Clean or take necessary sterilization to workshop according to detailed written operation procedures.Article 42 The workshop shall have appropriate illumination, temperature, humidity and aeration, to ensure the quality of produced and reserved products and the performance of related equipment shall not be influenced directly or indirectly.Article 43 The design and installation of workshop, establishment shall effective prevent insect or other animal to enter in. Necessary measures shall be taken to prevent of using raticide, insecticide, smoke fumigant and so on which may pollute equipment, material, goods.Article 44 Necessary measures shall be taken to prevent unauthorized person to enter in. Manufacturing, storage and quality control area shall not be the direct gate for staffs not in this area.Article 45 Complete drawing of constructed or reconstructed workshop, public service, fixed pipeline shall be saved.Section 2 Manufacturing AreaArticle 46 In order to reduce pollution and cross pollution risk, workshop, manufacturing establishment and equipment shall reasonable designed, overall arranged and used according to the characteristic, technique process and corresponding clean level, and in accordance with the following requirements:I. Comprehensive considering the pharmaceutical goods’ characteristic, technique andintending purpose and other factors, to confirm feasibility of using workshop, manufacturing establishment and equipment together, and hing related evaluating report;II. Special and independent workshop, manufacturing establishment and equipment must be used when manufacturing special character pharmaceutical goods, such as high sensitive pharmaceutical goods (i.e. P enicillin) or biologics goods (i.e. bcg vaccine or other pharmaceutical goods prepared by active microorganism). The operating area with large quantity of dust for‎p enicillin species pharmaceutical goods shall keep comparatively negative pressure, the exhaust gas discharged to outdoor shall carry cleanse management and make it be up to the mustard. Air outlet shall be away from air inlet of other air cleanse system;III. Special establishment (i.e. independent air cleanse system) and equipment must be used when manufacturing β-lactam structure species pharmaceutical goods, sexhormone species prophylactic pharmaceutical goods, and shall be detached with other pharmaceutical goods’ manufacturing area strictly;IV. Special establishment (i.e. independent air cleanse system) and equipment shall be used when manufacturing some hormone species, cell toxicity species, high active chemical pharmaceutical goods; under special circumstance, if necessary validation shall be take before taking special protection measures, the above said pharmaceutical goods preparation could use the same establishment and equipment via manufacturing modes in different phases;V. Ventilation of air cleanse system in the above said item II, III, IV shall take cleanse management;VI. Pharmaceutical goods’ m anufacturing workshop shall not used for manufacturing non-officinal used products which may have bad influence to pharmaceutical goods’ quality.Article 47 Manufacturing area and storage area shall have enough space to ensure equipment, material, semifinished product, bulk product and finished product could storage in order, to prevent the confusion, cross pollution of different products or material, to prevent missing or mistake during the operation of manufacturing or quality control.Article 48 Air condition cleanse system shall be equipped according to pharmaceutical goods’variety, manufacturing operation’s requirement and exterior environment condition which let the manufacturing area can effective aeration, and have temperature, humidity control and atmosphere cleanse filtration, to ensure the manufacturing environment of pharmaceutical goods is in accordance with the requirements.The pressure difference between clean area and non-clean area, clean areas in different level shall not lower than 10Pascal. When necessary, appropriate pressure difference grads shall also be kept in different functional areas (operation area) with same clean level.Exposure working procedure area for oral liquid and solid preparation, chamber use pharmaceutical goods (including rectal pharmaceutical goods), surface external use pharmaceutical goods and other non-asepsis preparation manufacturing and exposureworking procedure area for wrapper material directly contact pharmaceutical goods shall equip according to the requirements of “Asepsis Pharmaceutical Goods” D level clean area in Annex. The enterprise could take appropriate microorganism monitor measures according to product s’ standard and characteristic.Article 49 Inner surface of clean area (wall, floor, sunshade) shall be slick, non-crack, narrow joint, non granule fell off, prevent stored dust, convenient for effective clean, and take sterilization when necessary.Article 50 The design and installation of every kind of pipeline, lighting establishment, place with a draught and other public establishment shall prevent having the part of not easy to clean, and shall try best to maintain outside the manufacturing area.Article 51 Sewerage shall have appropriate size and install the device of reversing flow. Try best to prevent drain in clear channel, if it is inevitably, the clear channel shall be flat so that it is convenient to clean and sterilize.Article 52 Quantify of preparation’s raw material often carry on in the metage room special designed.Article 53 Operation rooms which produce dust (such as sampling, metage, mix, package of dry material or products rooms and other operation rooms) shall keep comparatively negative pressure or take special measure, so as to prevent the diffusion of powder dust, avoid cross pollution and easy to keep clean.Article 54 Pharmaceutical goods’packaging workshop or area shall be reasonable designed and arranged, to prevent confusion or cross pollution. If there are several packaging lines in one area, isolation measures shall be taken.Article 55 Manufacturing area shall have appropriate light, the light in contact manufacturing area shall satisfy the operation requirements.Article 56 Manufacturing area could set middle control area. However, middle control operation shall not bring quality risk to pharmaceutical goods.Section 3 Storage AreaArticle 57 Storage area shall have enough space, which ensure the under-examined, qualified, disqualified, withdrew or recalled raw material, wrapper, semifinished product, bulk product and finished product and all kinds of material and products could store in order.Article 58 The design and construct of storage area shall ensure good storage condition, and have aeration and lighting establishment. Storage area shall satisfy material or products’storage condition (such as temperature, humidity, avoid of light) and safety storage requirements, and check and monitor shall be taken.Article 59 High active material or product and printing package material shall storage in safe area.Article 60 Receiving, extending and delivering area shall protect material, product out of influence of weather outside (such as rain, snow). The arrangement and establishment of receiving area shall ensure taking necessary cleaning to the received material’s outside packaging.Article 61 If the under-examined material is stored in separate isolate area, the under-examine area shall have distinct mark, and only authorized person could in and out. Disqualified, withdrew or recalled material or product shall be stored isolated.If other method is used for replacing physics isolation, this method shall have equal security.Article 62 Separate material sampling area is often set up. Air cleaning level of sampling area is the same with the manufacturing requirements. If sample is taken in other area or use other method, pollution or cross pollution shall prevent.Section 4 Quality Control AreaArticle 63 Quality control laboratory is often divided from manufacturing area. Biology examine, microorganism and radioactivity isotope laboratory shall also divided from each other.Article 64 The design of laboratory shall ensure for applying it’s intending purpose, and prevent confusion and cross pollution, enough area shall have for disposing samples, reserved samples and samples for reviewing stability and keeping the records.Article 65 When necessary, set a special instrument room to prevent static, shaking, humid or other outside factors’ disturbance to instrument with high sensitivity.Article 66 The laboratory disposing special goods such as biology samples or radioactivity samples shall in accordance with the related requirements of the country.Article 67 Experiment animal room shall be strictly divided from other area. Its design, construct shall in accordance with the related requirements of the country and have independent air disposing establishment and animal’s special channel.Section 5 Assistant AreaArticle 68 Retiring room shall not take bad influence to manufacturing area, storage area and quality control area.。

2010版中国药典

2010版中国药典

2010版中国药典凡例总则一、《中华人民共和国药典》简称《中国药典》,依据《中华人民共和国药品管理法》组织制定和颁布实施。

《中国药典》一经颁布实施,其同品种的上版标准或其原国家标准即同时停止使用。

《中国药典》由一部、二部、三部及其增补本组成,内容分别包括凡例、正文和附录。

除特别注明版次外,《中国药典》均指现行版《中国药典》。

本部为《中国药典》二部。

二、国家药品标准由凡例与正文及其引用的附录共同构成。

本部药典收载的凡例、附录对药典以外的其他中药国家标准具同等效力。

三、凡例是为正确使用《中国药典》进行药品质量检定的基本原则,是对《中国药典》正文、附录及与质量检定有关的共性问题的统一规定。

四、凡例和附录中采用的“除另有规定外”这一用语,表示存在与凡例或附录有关规定不一致的情况时,则在正文中另作规定,并按此规定执行。

五、正文中引用的药品系指本版药典收载的品种,其质量应符合相应的规定。

六、正文所设各项规定是针对符合《药品生产质量管理规范》(Good Manufacturing Practices, GMP)的产品而言。

任何违反GMP 或有未经批准添加物质所生产的药品,即使符合《中国药典》或按照《中国药典》没有检出其添加物质或相关杂质,亦不能认为其符合规定。

七、《中国药典》的英文名称为Pharmacopoeia of The People’s Republic of China, 英文简称Chinese Pharmacopoeia;英文缩写为Ch.P.。

正文八、正文系根据药物自身的理化与生物学特性,按照批准的处方来源、生产工艺、贮藏运输条件等所制定的、用以检测药品质量是否达到用药要求并衡量其质量是否稳定均一的技术规定。

九、正文项下根据品种和剂型不同,按顺序可分别列有:(1)品名(包括中文名称、汉语拼音与英文名);(2)有机药物的结构式;(3)分子式与分子量;(4)来源或有机药物的化学名称;(5)含量或效价规定;(6)处方;(7)制法;(8)性状;(9)鉴别;(10)检查;(11)含量或效价测定;(12)类别;(13)规格;(14)贮藏;(15)制剂等。

2010版中国药典英文ppt课件

2010版中国药典英文ppt课件
2010版中国药典英文版
1
一、药材来源
1.植(动)物来源的药材的来源部分的一般译法为:
药材英文名称is the 药用部位(名词单数) of 植(动)物拉丁学名 [属名和种(变种)加词为斜体字](科名).
例 : Pummelo Peel is the dried unripe or almost ripe exocarp of Citrus grandis “Tomentosa” or Citrus grandis (L.) Osbeck (Fam. Rutaceae).
含4%醋酸钠的羧甲基纤维素钠溶液为黏合剂的硅胶G薄层 板上...
using silica gel G mixed with sodium carboxymethylcellulose containing 4% solution of sodium acetate as the coating substance.
例1 The drug is collected in autumn, removed from foreign matter, washed clean, and dried in the sun.
例2 The drug is collected at flowering to fruiting stage, removed from thick stem, cut into section, and dried.
本品为芸香科植物化州柚Citrus grandi“Tomentosa”或柚 Citrus grandis(L.)Osbeck的未成熟或近成熟的干燥外层果皮。
2
2.药材的采收与产地加工部分的一般译法为:
用The drug作主语,单数。用被动语态,不用主动语态。“采收” 用“to be collected”(不用“to be picked”,“to be dug up”等)。 “除去杂质”等(名词单数)用“removed from foreign matter”,“洗净” 用“washed clean”,“干燥”用“dried”, “晒干”为“dried in the sun”,“阴干”为“dried in the shade”,“低温干燥”为“dried at a lower temperature” 。 “ 栽 培 变 种 ” 为 “ cultivar” 。 “ 泥 砂 ” 为 “soil”。“须根.细根”:“fibrous root”用于单子叶植物、根茎上的 不定根,“rootlet”用于双子叶植物主根上的细小侧根、支根。

2010版中国药典三部修改

2010版中国药典三部修改

国际药典
《国际药典》的历史可以追溯到1874年, 由于当时需要将术语标准化以及明确药物 的剂量和成分,从而产生了制订一部国际 药典纲要的尝试。
《国际药典》1951年出第一版,
1967年出第二版,
1979年出第三版第一部,其第二、 三、四部分于1981年、1988年和1994年 出版,2003年出第五部。
2006年出第四版。
国际药典
Ph.Int.第四版于2006年出版发行,并同步发 行光盘版(CD—ROM)。Ph.Int第四版将第三版分 散的5卷整合成2卷,并新增抗逆转录病毒药物。其 第1卷的内容包括通则和正文品种(首字母A~O的 原料药);第2卷的内容包括药品标准正文品种(首字 母P至Z的原料药),制剂,放射药品,分析方法, 试剂、试液和滴定液,补充信息和索引。
欧洲药典
《欧洲药典》最大的特点是其各论中只收载原 料药质量标准,不收载制剂质量标准。除此以外, 《欧洲药典》的附录也独具特色,《欧洲药典》 收载的附录,不仅包括各论中通用的检测方法, 而且凡是与药品质量密切相关的项目和内容在附 录中都有规定。另外,在收载的附录中,除了采 用通用的检测方法外,收载的先进技术也比较多, 如原子吸收光谱、原子发射光谱、质谱、核磁共 振谱和拉曼光谱测定法等,对色谱法还专门设立 一项色谱分离技术附录。从整体上看,《欧洲药 典》的附录是至今世界药典中最全面、最完善, 也是最先进的。
Ph.Int第四版共收载原料药418个,制剂67个 (其中片剂47个,注射剂15个,胶囊剂4个,口服补 液盐1个)
欧洲药典
2、欧洲药典(EP)
《欧洲药典》由欧洲药品质量管理局(EDQM)下 属的职能机构欧洲药典委员会(European Pharmacopoeia Commission)出版。欧洲药典 委员会1964年成立。欧洲药典是欧洲药品质量控 制标准。已有多项法律使欧洲药典成为法定标准。

中国gmp2010、附录的英文

中国gmp2010、附录的英文

我国gmp2010GMP是Good Manufacturing Practice的缩写,是指《药品生产质量管理规范》。

与国际上的GMP标准相比,我国GMP2010在一些方面做出了具体的规定,以保证药品的生产和质量管理符合国家的法律法规,并在一定程度上提升药品的生产质量。

我国GMP2010的相关内容在附录中有详细的英文版规定,以下是对我国GMP2010英文附录的解读。

一、 Scope and Application (范围与适用性)我国GMP2010的英文附录中指出了该规范的范围和适用性,适用于所有在我国境内生产药品的企业。

这一规定明确了GMP的适用范围,为国内药品生产企业提供了依据和指导。

二、 Terms and Definitions (术语和定义)对于一些专业术语以及相关的定义,我国GMP2010的英文附录进行了详细的说明。

在药品生产过程中,对术语和定义的清晰理解是非常重要的,可以帮助企业提高对GMP规范的理解和执行。

三、 Personnel (人员)我国GMP2010的英文附录对药品生产企业的人员管理提出了具体的要求,包括对人员的培训、工作记录、合格证书等方面进行了规定。

这些要求可以帮助企业建立健全的人员管理制度,确保生产过程中人员的素质和能力符合相关要求。

四、 Buildings and Facilities (建筑和设施)对于药品生产企业的厂房和设施,我国GMP2010的英文附录也进行了详细的规定。

这些规定涵盖了厂房的选择、设计、维护等方面,为企业提供了在建筑和设施方面遵循的具体标准。

五、 Equipment (设备)在药品生产过程中使用的设备也是关键的一环,我国GMP2010的英文附录对此进行了具体的要求,包括设备的选择、验证、维护等方面的规定。

这些要求有助于确保生产设备的有效性和可靠性,保证药品生产质量的稳定性和可靠性。

六、 Materials (原辅料)对于药品生产中使用的原辅料,我国GMP2010的英文附录也包含了相关的要求。

中国药典中英文对照

中国药典中英文对照

中国药典中英文对照
中国药典中英文对照指的是将中国药典中的中文内容与对应的英文翻译进行对照的工作。

中国药典是由中国药典委员会编制的药物品种、质量标准和检验方法的规范文献,用于指导药品生产、质量控制和药物研发等工作。

由于药品的国际贸易和合作的需要,中国药典中的内容常需要翻译成英文。

以下是中国药典中一些流行的中英文对照实例:
- 中药材 (Herbal Medicine)
- 中药制剂 (Traditional Chinese Medicine Preparations)
- 药用辅料 (Pharmaceutical Excipients)
- 药典规范 (Pharmacopoeial Standards)
- 药用饮片 (Medicinal Crude Bovine)
- 药材质量管理 (Quality Management of Herbal Medicines)
- 药品质量评价 (Evaluation of Drug Quality)
- 药品安全与监管 (Drug Safety and Regulation)
以上只是一些例子,中国药典中英文对照范围广泛,涵盖了各个方面的药物品种、质量标准和检验方法,为药品生产和研发提供了重要的参考和指导。

《中国药典》2010版二部 氧

《中国药典》2010版二部 氧

《中国药典》2010版二部氧拼音名:Yang 英文名:Oxygen书页号:2010年版二部不得少于99.5%(ml/ml)。

本品含O2【性状】本品为无色气体;无臭,无味;有强助燃力。

【鉴别】本品能使炽红的木条突然发火燃烧。

【检查】酸碱度取甲基红指示液与溴麝香草酚蓝指示液各0.3ml,加水400ml,煮沸5分钟,放冷,分取各100ml,置甲、乙、丙3支比色管中,乙管中加盐酸滴定液(0.01mol/L)0.20ml,丙管中加盐酸液(0.01mol/L)0.40ml;再在乙管中通本品2000ml(速度为每小时4000ml),乙管显出的颜色不得较丙管的红色或甲管的绿色更深。

一氧化碳取甲、乙2支比色管,分别加微温的氨制硝酸银试液25ml,甲管中通本品1000ml(速度为每小时4000ml)后,与乙管比较,应同样澄清无色。

二氧化碳取甲、乙2支比色管,分别加5%氢氧化钡溶液100ml,乙管中加0.04%碳酸氢钠溶液1.0ml,甲管中通本品1000ml(速度为每小时4000ml)后,所显浑浊与乙管比较,不得更浓(0.01%)。

其他气态氧化物质取新制的碘化钾淀粉溶液(取碘化钾0.5g,加淀粉指示液100ml溶解,即得)100ml,置比色管中,加醋酸1滴,通本品2000ml(速度为每小时4000ml)后,溶液应无色。

【含量测定】仪器装置如图:A、C为总容量约300ml的吸收器,B为适宜的塞子,D、E及I为细玻璃导管,F为刻度精密至0.1ml、容量为100ml的量气管主体,G为三通活塞,H为气体进出口,J为平衡瓶。

临用前用橡胶管将吸收器与量气管连接,后者再与平衡瓶连接。

测定法先将铜丝节(取直径约0.8mm 的紫铜丝缠成直径约4mm的铜丝卷并剪成长约10mm的小节)装满于吸收器A中,用塞B塞紧,再将氨-氯化铵溶液(取氯化铵150g,加水200ml,随搅随小心加浓氨溶液200ml,混匀)导入,使充满A并部分留于C中,再将饱和氯化钠溶液注入平衡瓶J中,提高平衡瓶,使饱和氯化钠溶液充满F,多余溶液由H流出,转动G接通量气管与吸收器,下降平衡瓶使吸收器中的溶液全部充满导管D、E、I和活塞G的入口,立即关闭活塞,如有气体和部分氨-氯化铵溶液进入量气管时,可提高平衡瓶转动活塞,使由H排出。

2010版中国药典三部修改

2010版中国药典三部修改

欧洲药典
2、欧洲药典(EP)
《欧洲药典》由欧洲药品质量管理局(EDQM)下 属的职能机构欧洲药典委员会(European Pharmacopoeia Commission)出版。欧洲药典委员 会1964年成立。欧洲药典是欧洲药品质量控制标 准。已有多项法律使欧洲药典成为法定标准。 目前采用《欧洲药典》的国家已达28个,除 欧共体成员国和其他欧洲国家外,还有亚洲的土 耳其和塞浦路斯。
国际药典
《国际药典》的历史可以追溯到1874年, 由于当时需要将术语标准化以及明确药物 的剂量和成分,从而产生了制订一部国际 药典纲要的尝试。 《国际药典》1951年出第一版, 1967年出第二版, 1979年出第三版第一部,其第 二、三、四部分于1981年、1988年和1994 年出版,2003年出第五部。 2006年出第四版。
欧洲药典
《欧洲药典》最大的特点是其各论中只收载原 料药质量标准,不收载制剂质量标准。除此以外, 《欧洲药典》的附录也独具特色,《欧洲药典》 收载的附录,不仅包括各论中通用的检测方法, 而且凡是与药品质量密切相关的项目和内容在附 录中都有规定。另外,在收载的附录中,除了采 用通用的检测方法外,收载的先进技术也比较多, 如原子吸收光谱、原子发射光谱、质谱、核磁共 振谱和拉曼光谱测定法等,对色谱法还专门设立 一项色谱分离技术附录。从整体上看,《欧洲药 典》的附录是至今世界药典中最全面、最完善, 也是最先进的。
英国药典
《英国药典》与《欧洲药典》的关系
《英国药典》与《欧洲药典》有密切的关系。 按照惯例,《欧洲药典》中的全部各论与附录都收 录在相应版本的《英国药典》中。这些内容一般不 作任何编辑修改,只在必要的情况下,增加《英国 药典》相应的用法要求。
日本药典

中国2010版GMP英文版译稿

中国2010版GMP英文版译稿

T D V N O N O F F I C I A L T R A N S L A T I O NGMP(Revised in 2010)Order from Ministry of Public Health, PR. ChinaNo. 79"Good Manufacturing Practice (revised in 2010)" was approved by the Ministry of Health on October 19, 2010. It will come into force from 1st, March of 2011.Minister: Chen Zhu17th, Jan, 2011T D V N O N O F F I C I A L T R A N S L A T I O NContents1. General Provisions (4)2. Quality Management (5)2.1 General rules (5)2.2 Quality assurance (5)2.3 Quality control (6)2.4 Quality Risk Management (7)3. Organization and personnel (8)3.1 General rules (8)3.2 Key personnel (8)3.3 Training (11)3.4 Personnel hygiene (11)4. Facility and utilities (13)4.1 General provisions (13)4.2 Production area (13)4.3 Warehousing area (15)4.4 Quality Control Area (16)4.5 Auxiliary area (17)5. Equipment (18)5.1 General rules (18)5.2 Design and installation (18)5.3 Maintenance and repair (18)5.4 Use and cleaning (19)5.5 Calibrations (20)5.6 Water for drug manufacturing (20)6. Materials and products (22)6.1 General rules (22)6.2 Raw materials and excipients (23)6.3 Intermediate products and bulk products (24)6.4 Packaging materials (24)6.5 Final products (25)6.6 Materials and products which need special management (25)6.7 Other (25)7. Validation and qualification (27)T D V N O N O F F I C I A L T R A N S L A T I O N8. Document management (28)8.1 Principles (28)8.2 Quality Standards (30)8.3 Process procedure (31)8.4 Batch production records (32)8.5 Batch Packaging Records (33)8.6 Operating procedures and records (33)9. Production Management (35)9.1 Principle (35)9.2 Prevent contamination and cross contamination in process of production (36)9.3 Production operations (37)9.4 Packaging operations (37)10. Quality control and quality assurance (40)10.1 Quality Control Laboratory Management Section (40)10.2 Release of materials and products (44)10.3 Continued stability study (45)10.4 Change Control (46)10.5 Deviation treatment (47)10.6 Corrective and preventive measures (48)10.7 Evaluation and approval of suppliers (49)10.8 Product quality review and analysis (50)10.9 Complaints and adverse reaction reports (51)11. Contractual production and analysis (53)11.1 Principle (53)11.2 The Company (53)11.3 The Contractor (53)11.4 Contract (54)12. Chapter12 Product shipment and recall (55)12.1 Principle (55)12.2 Delivery and transportation (55)12.3 Recall (55)13. Self-check (57)13.1 Principle (57)13.2 Self-analysis (57)14. Supplementary Provisions (57)T D V N O N O F F I C I A L T R A N S L A T I O N1. General ProvisionsArticle 1 This practice is established according to "Drug Administration Law of PRC" and "Implementation Regulations of the PRC Drug Administration Law" in order to regulate drug production quality control.Article 2 Pharmaceutical companies should establish a drug quality management system. The system should cover all factors that affect drug quality, including all of organized and planned activities that ensure the quality of medicines meet its intended use.Article 3 This practice, as a part of quality management system, acts as the basic requirements for drug production management and quality control with the aim of minimizing contamination, cross-contamination and confusion, error and other risks in the process of drug production to ensure Pharmaceutical companies can constantly produce drugs meeting its intended use and registration requirements.Article 4 Enterprises should strictly enforce the practice; adhere to the honest and trustworthy, and to prohibit any false, deceptive behavior.T D V N O N O F F I C I A L T R A N S L A T I O N2. Quality Management2.1 General rulesArticle 5 Enterprises should establish a quality target that meets pharmaceutical quality management requirements, applying all of requirements on safety, efficacy and quality control related with drug registration to whole process of drug production, control and product release, storage and shipment to ensure that production of pharmaceuticals meet their intended use and registration requirements.Article 6 Top management personnel should ensure implementation of established quality objectives; staff of different levels, suppliers and distributors should work together and assume their responsibilities.Article 7 Enterprises should be equipped with adequate, qualified staff, facilities, facilities and equipment to provide necessary conditions for achievement of quality objectives.2.2 Quality assuranceArticle 8 Quality assurance is part of the quality management system. Enterprises must establish a quality assurance system, while building a complete documentation system to ensure effective operation of the system.Article 9 Quality assurance system should ensure that:1. design and development of drugs reflects requirements of this practice;2. production management and quality control activities are consistent withrequirements of this Code;3. management responsibilities are clearly defined;4. raw materials and packaging materials purchased and used are correct;5. effective control of intermediate products;6. implementation of validation and verification;7. perform production, analysis, analyze and review strictly in accordance withprocedures;8. each batch can only be released with approval of qualified person;9. appropriate measures for drug quality assurance are available in process of storage,shipment and subsequent operation ;10. periodic analysis and evaluation of validity and applicability of quality assurancesystem in accordance with self-analysis operating proceduresArticle 10: The basic requirements for Pharmaceutical production and quality management:T D V N O N O F F I C I A L T R A N S L A T I O N(a) To develop production process, and perform systematic review to certify it can sustainably and stably manufacture qualified products(b) Production technology and major changes need to be validated;(c) Equipped with necessary resources, including at least the following:1. Personnel with appropriate qualifications and qualified by training;2. Adequate premises and facility;3. Proper equipment and maintenance support;4. Right raw materials, packaging materials and labels;5. Approved procedures and operation procedures;6. Appropriate storage conditions.(d) Accurate and understandable language should be used to develop operation procedures;(e) The operators are trained to operate in accordance with proper operating procedures;(f) Production process should be documented; deviations should be investigated and recorded;(g) Batch records and shipping records should allow traceability of complete history of batch products, and should be kept properly for easy reference;(h) Reduce quality risk in process of drug shipment;(i) Establishment of drug recall system should ensure any batch can be recalled after distribution;(j) Investigate complaints and quality defects and take measures to prevent recurrence of similar quality defects.2.3 Quality controlArticle11: Quality control, including related organization, documentation system, and sampling, and analysis to ensure materials or products complete their necessary analysis prior to release and to confirm quality meet requirements.Article 12: The basic requirements of quality control:(a) QC shall be equipped with appropriate facilities, equipment, instruments and trained personnel for effective and reliable completion of all related quality control activities; (b) Operating procedures should be available for sampling, analysis, test of raw materials, packaging materials, intermediate products, packaging and finished products as well as stability analysis of the product, and if necessary, carry out environmental monitoring to ensure compliance with the requirements of this practice;(c) Authorized personnel should sample raw materials, packaging materials, intermediate products, packaging and finished products in accordance with required method;(d) Analysis methods should be validated or confirmed;(e) Sampling, analysis, and check should be recorded, and deviations should be investigated and recorded(f) Materials, intermediate products, packaging and finished products must be checked and analyzed according to quality standards and should be recorded;T D V N O N O F F I C I A L T R A N S L A T I O N(g) Packaging materials and final product should have sufficient retained samples for necessary analysis or check except the final finished packaging container that is too large, retained samples for finished product should be packaged the same as final packaging.2.4 Quality Risk ManagementArticle 13 Quality risk management, a kind of prospective and retrospective method, is a systematic process to evaluate, control, communication, review the quality risk.Article 14 Quality risks should be evaluated on basis of scientific knowledge and experience to ensure product quality.Article 15: The methods, measures, forms and documents formed in the process of quality risk management process should be appropriate to the level of existing risk.T D V N O N O F F I C I A L T R A N S L A T I O N3. Organization and personnel3.1 General rulesArticle 16 Enterprises should establish a management structure appropriate to drug manufacturing and organizational structure chart.Enterprises should establish an independent quality control department to perform quality assurance and quality control responsibilities. Quality assurance department and quality control departments can be established separately within quality management department.Article 17 Quality control department should be involved in all quality related activities, and responsible for reviewing all documents relevant to this practice. Quality management personnel shall not delegate responsibilities to other departments.Article 18 Enterprises should be equipped with adequate and suitably qualified (including education, training and practical experience) management and operations staff; responsibilities of each department and each position should be clearly defined. Responsibilities cannot be missed, and overlapped responsibilities should be clarified. Responsibilities of each person should not be overburden.All personnel should be clear about and understand their responsibilities, familiar with requirements related to their duties and receive proper traiing, including pre-service training and continuing training.Article 19: Normally responsibilities should not be delegated to others. The responsibilities which are in definite need of delegation can be delegated to the qualified and designated personnel.3.2 Key personnelArticle 20 Key personnel should be full-time staff in the enterprise, at least including responsible person, person in charge of production management, quality management and qualified person.Person responsible for quality control and production management shall not serve each other. Person responsible for quality management and quality qualified can serve each other. Operating procedures should be developed to ensure qualified personnel perform their duties independently, free from interference from business leaders and other personnel.Article 21 Owners of enterprisesThe responsible person for enterprise, as the primary responsible person for the enterprise, should cover overall responsibility for daily management of enterprises. TheT D V N O N O F F I C I A L T R A N S L A T I O Nresponsible persons shall be responsible for providing necessary resources, rational planning, organization and coordination to ensure independent performance of responsibilities of quality management department in order to ensure realization of business objectives and production of pharmaceuticals in accordance with the regulatory requirements.Article 22 Person in charge of production managementQualifications:Person in charge of production management should at least have a degree in pharmacy (or intermediate professional titles or Licensed Pharmacist) with at least three years’ engagement in drug production and quality management experience, including at least one year of medicine production management experience, and have been trained on professional knowledge relating to manufactured product.Main responsibilities:1. To ensure drugs are manufactured and stored in accordance with approved process procedures to ensure drug quality;2. To ensure strict implementation of all operation procedures related to the operation and production;3. To ensure batch production and packaging records have been reviewed and sent to quality management department;4. To ensure implementation of facilities and equipment maintenance for good running condition;5. To ensure completion of all necessary validation;6. To ensure personnel related to production receive necessary pre-service training and continuing training, and adjust training contents basing on actual needs.Article 23 Personal in charge of quality managementQualifications: person in charge of quality management should have at least a degree in pharmacy or related (or intermediate professional titles or Licensed Pharmacist) with at least five years’ experience in pharmaceutical production and quality management, including at least one year in medicine Quality management, and have received professional knowledge training relating to manufactured products.Main responsibilities1. To ensure raw materials, packaging materials, intermediate products, packaging and finished products meet requirements and quality standards approval in registration;2. To ensure completion of batch record review before product release;3. To ensure completion of all necessary analysis;4. Approve operation procedures about quality standards, sampling methods, analysis methods and other quality management;5. Review and approve all quality-related changes;6. To ensure all significant deviations and OOS of analysis results have been timely investigated and handled;7. Approve and monitor contractual(entrusted) analysis;T D V N O N O F F I C I A L T R A N S L A T I O N 8. Supervision of facilities and equipment maintenance to ensure it keeps in good running condition;9. To ensure completion of necessary qualification or validation, review and approval of qualification or validation protocols and reports;10. To ensure complete self-analysis;11. Assessment and approval of materials suppliers;12. Ensure all quality-related complaints have been investigated, and timely and correctly treated;13. To ensure completion of quality continual stability study, and provide stability study data;14. To ensure completion of quality review;15. To ensure quality control and quality assurance personnel have received necessary pre-service training and continuing training, and training need to be adjusted according to actual needs.Article 24 Person in charge of production management and quality management normally share following responsibilities:(a) Review and approve products process procedures, operation procedures and other documents;(b) To supervise facilities hygiene status;(c) Ensure key equipment has been qualified;(d) Ensure completion of production process validation;(e) Ensure all related employees have received necessary pre-service training and continuing training, and training need to be adjusted basing on actual need;(f) Approve and supervise contractual production;(g) Identify and monitor the storage conditions of materials and products;(h) Record-keeping;(i)Monitoring implementation of the practice;(j) Monitoring factors that affect product quality.Article 25 Qualified peopleQualifications:The qualified person should have at least bachelor degree in pharmacy or related (or intermediate professional titles or Licensed Pharmacist) with at least five years’ practices in pharmaceutical production and quality management, and have engaged in pharmaceutical production process control and quality analysis.The qualified person shall have necessary professional knowledge, and shall only perform responsibilities after receive training related to product release.(B) Main responsibilities:1. Involving in establishment of the enterprise quality system, internal self-check and external quality audit, validation, and reports of adverse drug reaction, product recalls and other quality management activities;T D V N O N O F F I C I A L T R A N S L A T I O N2. Assume responsibilities of product release to ensure production and analysis for each batch released are in line with relevant laws and regulations, drug registration requirements and quality standards;3. The qualified person should present product release review record in accordance with the second article mentioned above before product release and should incorporate it in the batch record.3.3 TrainingArticle 26 Enterprise shall designate specific department or person responsible for training management; training or plan reviewed or approved by person in charge of production management and quality management should be available. Training records should be preserved.Article 27: All personnel related with pharmaceutical production and quality should be trained, and training should be appropriate to the requirements for corresponding position. In addition to theory and practice training of this practice, responsibilities and skills training about related positions and laws and regulation should be available. And actual result of training should be evaluated.Article 28 Operator engaged in high-risk operation areas (such as: production area for high activity, highly toxic, infectious, and sensitizing materials) should receive specialized training.3.4 Personnel hygieneArticle 29 All personnel should receive training on hygiene requirements; enterprises should establish personal hygiene rules to minimize risk of contamination caused by person.Article 30 Personal hygiene practice should include health, hygiene habits and dressing. Person in production areas and quality control should have proper understanding of personal hygiene practice. Enterprises should take measures to ensure implementation of personnel Hygienic Practice.Article 31 Enterprises should manage personnel health and establish health files. Production personnel in direct contact with drugs shall receive health checks before induction and later health check should be performed at least once a year.Article 32 Enterprises should take appropriate measures to keep person wound surface, infectious diseases or other diseases that may contaminate drug from being engaged in drug production.T D V N O N O F F I C I A L T R A N S L A T I O NArticle 33 Visitors and untrained personnel shall not have access to production and quality control areas. When there is need for access, instruction on personal hygiene, dressing and other matters should be given.Article 34: Any person entering the production area shall change clothes in accordance with provisions. Materials, style and dressing way of clothes should be appropriate to work engaged and air cleanliness level.Article 35 Personnel entering the clean production areas shall not wear make-up accessories.Article 36 There should be no smoking and eating, storage of food, beverages, cigarettes and drugs for personal use and other non-production items in production and storage area.Article 37 Operators should not directly touch drugs, and packaging materials and equipment surface that will be contact with drug with bare hands.T D V N O N O F F I C I A L T R A N S L A T I O N4. Facility and utilities4.1 General provisionsArticle 38 Facilities sites, design, layout, construction, renovation and maintenance must comply with requirements of pharmaceutical production to minimize contamination, cross contamination, confusion and errors and to facilitate cleaning, operation and maintenance.Article 39: The sites for facilities should be selected by taking protective measures for facilities and production into consideration. Facilities should be located in an environment able to minimize risk of contamination on materials and product.Article 40 Enterprises should have a clean production environment; factory floors, roads and transportation should not cause contamination to production of drugs; overall layout of production, administrative, living and support areas should be reasonable and not impede each other; facilities, personnel and materials flow within the facilities should be reasonable.Article 41 Facilities should be properly maintained and maintenance activities will not adversely affect drug quality. Facilities should be cleaned and sanitized according to detailed written operating procedures.Article 42 Facilities should be equipped with proper lighting, temperature, humidity and ventilation to ensure quality of product produced and stored as well as performance of related equipment will not be directly or indirectly affected.Article 43 Facilities and utilities should be designed and installed to prevent entrance of insects or other animals. Necessary measures should be taken to prevent use of rodenticides, pesticides and smoke agent will not cause contamination on equipment, materials, and products.Article 44 Appropriate measures should be taken to prevent access of unauthorized personnel. Production, storage and quality control areas should not be used as access for staff that not belongs to this area.Article 45 Facilities, utilities, fixed pipeline as-built drawings after completion of construction or reconstruction should be reserved.4.2 Production areaT D V N O N O F F I C I A L T R A N S L A T I O NArticle 46 Facilities, production utilities and equipment should be designed and used as required for drug properties, process flow and level of cleanliness in order to reduce risk of contamination and cross-contamination and also meet following requirements :(a) Feasibility of multi-drug facilities, production utilities and equipment should beevaluated by taking drug properties, process and intended use into consideration, and related evaluation report should be available.(b) Drugs with special properties, such as highly sensitizing drugs (e.g. penicillin) or biological products (such as BCG or other use of medicines prepared from microbial activity), must be produced with dedicated and independent facilities, production utilities and equipment. Operation area of penicillin with a large amount of dust should maintain a relatively negative pressure. The exhaust discharged into outdoors should be purified to meet requirements and air vents should be away from other air purification system inlet;(c) Production of β-lactam structure and sex hormone contraceptive drugs must use dedicated utilities (such as a independent air purification systems) and equipment and should be strictly separated from production areas for other drugs;(d) Certain hormones, cytotoxic class, highly active chemicals should be produced with dedicated utilities (such as a separate air purification systems) and equipment; special protective measures, if needed, should be validated. Drugs mentioned above can share same utilities and equipment through divided production.(e) The exhaust fan of air purification system mentioned in above b, c, and d should be purified.(f) Drug production facilities should not be used to produce non-medicinal products that may adversely affect drug quality.Article 47 Production areas and storage areas should be equipped with sufficient space to ensure orderly storage of equipment, materials, intermediate products, packaging and finished products and to avoid confusion of different products or materials, cross contamination, and omission and error caused by production or quality control operations.Article 48 Air purification systems should be installed according to drug variety, operation requirement as well as external environment in order that production area can be ventilated properly, temperature and humidity are controlled, and air is purified and filtered to ensure production environment for drug meet requirement.Pressures difference between clean areas and non-clean areas clean areas, among clean areas of different levels should not be less than 10 psi. When necessary, pressure difference should be maintained among areas with the same level of cleanliness but different functions (operating room).Areas where liquid and solid preparations, cavity medication (including rectal application), topical pharmaceutical skin preparations and other non-sterileT D V N O N O F F I C I A L T R A N S L A T I O Npreparations as well as final processing of packaging materials with direct contact with drug are exposed should be designed in accordance with requirements for D-level in Annex. Company can establish control on microorganism according to product specification and properties.Article 49 Inner surfaces of clean area (walls, floors, ceiling) should be smooth, with tight interface, free from cracks and fall-off particles to avoid dust and permit effective cleaning and if necessary, sanitization.Article 50 Various channels, lighting, air outlets and inlets and other public utilities should be designed and installed to facilitate cleaning. And maintenance should be performed from outside.Article 51 Drainage facilities should be appropriate to installation installed to avoid back-flow. Open drain should be avoided, and be as shallow as possible to facilitate cleaning and sanitization.Article 52 Raw materials and excipients for preparation should be weighed in preparation room specially designed.Article 53: Operation rooms that generate dust (operation rooms such as sampling, weighing, mixing, and packaging of dried material or product) should maintain relatively negative pressure or take special measures to prevent spread of dust, cross-contamination and to facilitate cleaning.Article 54 Facilities or areas used for dug packaging should be properly designed to avoid confusion or cross-contamination. Isolation measures should be taken when there are several packaging lines in the same area.Article 55 Production areas should be equipped with appropriate lighting; lighting in visual check area shall meet requirements.Article 56: In-process control can be located within production area when in-process control operation will not adversely affect product quality.4.3 Warehousing areaArticle 57 Storage areas should be equipped with sufficient space to ensure orderly storage of quarantined, accepted, rejected, return or recalled raw materials and excipients, packaging materials, intermediate products, packaging and finished products and other materials and products.Article 58 Storage areas should be designed and constructed to ensure good storage conditions and equipped with ventilation and lighting utilities. Storage area should be able to meet storage conditions for materials or products (such as temperature andT D V N O N O F F I C I A L T R A N S L A T I O Nhumidity, protection from light) and requirements for safe storage. The storage area needs to be analyzed and monitored.Article 59 Highly reactive materials or products and printed packaging materials should be stored in a secure area.Article 60 Reception, distribution and shipping areas should be able to protect materials, products from being impacted by outside weather (such as rain, snow). Layout and utilities of receiving area should be able to ensure outer packages for materials and product can be cleaned before warehousing.Article 61: If an independent area is used to store quarantine materials, this area should be labeled clearly and only restricted to authorized personnel.Rejected, returned or recalled materials or products should be quarantined.If other means are adopted to replace physical separation, this method should be of equivalent security.Article 62: Usually there should be separate material sampling area. Air cleanliness level in sampling area should be consistent with production requirements. If sampling is performed in other area or by other means, contamination or cross contamination should be avoided.4.4 Quality Control AreaArticle 63 Quality control laboratory should normally be separated from production areas. Biological analysis, microbiological and radioisotope laboratory should also be separated from each other.Article 64 Laboratory should be designed to meet its intended use and to avoid confusion and cross-contamination. And there should be enough area for sample disposal, storage of retained samples and samples for stability study as well as record keeping.Article 65: When necessary, specialized equipment room should be set to keep sensitive equipment from static electricity, vibration, humidity or other external disturbances.Article 66 Laboratory used to treat biological or radioactive samples and other special items should be consistent with relevant national requirements.Article 67 Experimental animal rooms should be strictly separated from other areas; its design and construction shall comply with relevant regulations and equipped with separate air-handling facilities and dedicated channels for animals.。

《中华人民共和国药典》2010年版英文版将正式出版发行

《中华人民共和国药典》2010年版英文版将正式出版发行

《中华人民共和国药典》2010年版英文版将正式出版发行
佚名
【期刊名称】《中国药品标准》
【年(卷),期】2011(12)3
【摘要】《中华人民共和国药典》2010年版英文版(简称2010年版药典英文版)将于2011年6月由中国医药科技出版社正式出版发行。

【总页数】1页(P240-240)
【关键词】《中华人民共和国药典》;出版;英文;发行;中国医药科技
【正文语种】中文
【中图分类】R921.2
【相关文献】
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因版权原因,仅展示原文概要,查看原文内容请购买。

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2010版中国药典英文版
一、药材来源
1.植(动)物来源的药材的来源部分的一般译法为 植 动 物来源的药材的来源部分的一般译法为 物来源的药材的来源部分的一般译法为: 药材英文名称is 药用部位(名词单数 名词单数) 药材英文名称 the 药用部位 名词单数 of 植(动)物拉丁学名 动 物拉丁学名 [属名和种 变种 加词为斜体字 科名 属名和种(变种 加词为斜体字](科名 属名和种 变种)加词为斜体字 科名). 例 : Pummelo Peel is the dried unripe or almost ripe exocarp of Citrus grandis “Tomentosa” or Citrus grandis (L.) Osbeck (Fam. Rutaceae). 本品为芸香科植物化州柚Citrus grandi“Tomentosa”或柚 本品为芸香科植物化州柚 或柚 Citrus grandis(L.)Osbeck的未成熟或近成熟的干燥外层果皮。 的未成熟或近成熟的干燥外层果皮。 的未成熟或近成熟的干燥外层果皮
二、理化鉴别
1.化学鉴别 化学鉴别 Shake 0. 5 g of the powder with 5 ml of ethanol for 5 minutes and filter. Evaporate the filtrate to dryness, add dropwise antimony trichloride saturation solution in chloroform and evaporate again to dryness. A violet-red colour is produced. 取本品粉末0.5g,加乙醇 , 加乙醇5ml,振摇 分 , 滤过 , 滤 分钟, 取本品粉末 , 振摇5分钟 滤过, 液蒸干, 滴加三氯化锑饱和的三氯甲烷溶液, 再蒸干, 液蒸干 , 滴加三氯化锑饱和的三氯甲烷溶液 , 再蒸干 , 即显紫红色。 即显紫红色。
2.药材的采收与产地加工部分的一般译法为 药材的采收与产地加工部分的一般译法为: 药材的采收与产地加工部分的一般译法为 作主语, 用 The drug作主语, 单数 。 用被动语态 , 不用主动语态 。 “ 采收 ” 作主语 单数。用被动语态,不用主动语态。 采收” 不用“ 用“to be collected”(不用“to be picked”,“to be dug up”等)。 不用 , 等。 除去杂质” 名词单数 名词单数)用 洗净” “除去杂质”等(名词单数 用“removed from foreign matter”,“洗净” 洗净 干燥” 用“washed clean”,“干燥”用“dried”, “晒干”为“dried in the 干燥 , 晒干” sun”,“阴干”为“dried in the shade”,“低温干燥”为“dried at a 低温干燥” , 阴干” 低温干燥 lower temperature” 。 “ 栽 培 变 种 ” 为 “ cultivar” 。 “ 泥 砂 ” 为 细根” 用于单子叶植物、 “soil”。“须根 细根”:“fibrous root”用于单子叶植物、根茎上的 。 须根.细根 用于单子叶植物 不定根, 用于双子叶植物主根上的细小侧根、 不定根,“rootlet”用于双子叶植物主根上的细小侧根、支根。 用于双子叶植物主根上的细小侧根 支根。 例 1 The drug is collected in autumn, removed from foreign matter, washed clean, and dried in the sun. 例2 The drug is collected at flowering to fruiting stage, removed from thick stem, cut into section, and dried. (注 :中国药典 注 中国药典 中国药典2005年版一部英文版药用部位采用名词单数 如 stem, 年版一部英文版药用部位采用名词单数,如 年版一部英文版药用部位采用名词单数 leaf, fibrous root, rootlet等). 等
萃取、 萃取、过柱纯化 Extract the filtrate with two 15-ml quantities of nbutanol saturated with water, combine the n-butanol extracts, and evaporate to dryness. Dissolve the residue in 1 ml of dehydrated ethanol, add a quantity of alumina, stir well on a water bath, dry, and apply to a small (10-15mm in diameter) 或 Sepack C18 column packed with neutral alumina (200 mesh, 1g, 10~15mm in diameter ), pre-elute with 30ml of a mixture of ethyl acetate and methanol (3:1). Elute with 30 ml of a mixture of ethyl acetate and methanol (1:1), and collect the eluate. Evaporate to dryness and dissolve the residue in 0.5 ml of ethanol as the test solution.
滤液用水饱和的正丁醇提取二次,合并正丁醇提取液,蒸干, 滤液用水饱和的正丁醇提取二次,合并正丁醇提取液,蒸干,残渣加无水乙 使溶解, 醇1ml使溶解,加适量氧化铝在水浴上拌匀,干燥,装入一预先装填好的中 使溶解 加适量氧化铝在水浴上拌匀,干燥, 性氧化铝小柱( 小柱上, 性氧化铝小柱 ( 200目, 1g,内径 目 , 内径10-15mm)或 C18小柱上, 用乙酸乙酯 ) 小柱上 用乙酸乙酯甲醇( : ) 预洗, 甲醇( : ) 洗脱, 甲醇(3:1)30ml预洗,再用乙酸乙酯 甲醇(1:1)30ml洗脱,收集洗脱 预洗 再用乙酸乙酯-甲醇 洗脱 液,残渣加乙醇0.5ml使溶解,作为供试品溶液。 使溶解, 残渣加乙醇 使溶解 作为供试品溶液。
浸渍、 浸渍、水解 Macerate 0.5 g of the pills in 20 ml of methanol for 1 hour, and filter. Evaporate 5 ml of the filtrate to dryness, dissolve the residue in 10 ml of water, add 1 ml of hydrochloric acid, heat on a water bath for 30 minutes, and cool immediately. 取本品0.5 g,加甲醇 浸泡1 取本品 ,加甲醇20ml浸泡 小时,滤过。取 浸泡 小时,滤过。 5ml滤液蒸干,残渣加10ml水溶解,加1ml盐酸,水浴 滤液蒸干,残渣加 水溶解, 盐酸, 滤液蒸干 水溶解 盐酸 加热30分钟,立即冷却。 加热 分钟,立即冷却。 分钟
2.薄层鉴别 薄层鉴别 (1)经常用到需统一的词汇和短语: )经常用到需统一的词汇和短语: a.超声处理 用ultrasonicate 超声处理 b.提取 用extract 提取 c.温浸 用 warm macerate 温浸 d.水浴加热 用heat on a water bath 水浴加热 对照品名” e.对照品(对照品溶液) 用 “对照品名”加“CRS” 对照品(对照品溶液) 对照品 表示( 表示(reference solution); 对照药材(对照药材 ) 对照药材( 溶液) 溶液) 用reference drug(reference drug ( solution); 供试品溶液 用test solution )
g. 斑点 用spot(s), 条斑 用 band(s) , h. 分别置日光及紫外光灯(365nm)下检视,日光下显…色的斑点; 分别置日光及紫外光灯 下检视,日光下显 色的斑点; 下检视 色的斑点 紫外光灯下显…色的斑点 紫外光灯下显 色的斑点 用 … spot in daylight and … spot under ultraviolet light at 365 nm respectively.
(2)薄层鉴别基本的四个步骤,即供试品溶液制备;对照品溶液制 薄层鉴别基本的四个步骤,即供试品溶液制备; 薄层鉴别基本的四个步骤 备;点样、展开、显色;结果判断。 点样、展开、显色;结果判断。
A. 供试品溶液制备 常见以下几种情况:
超声处理提取 To 9g, cut into pieces, add 20ml of ether, ultrasonicate for 20 minutes, and filter. Evaporate the filtrate to dryness, and dissolve the residue in 0.5ml of n-hexane as the test solution. 取本品 ,切碎,加乙醚 取本品9g,切碎,加乙醚20ml,超声处理 分钟,滤 分钟, ,超声处理20分钟 滤液挥干, 残渣加0.5ml 正己烷溶解 , 作为供试品溶液 。 正己烷溶解, 作为供试品溶液。 过 , 滤液挥干 , 残渣加 艾附暖宫丸) (艾附暖宫丸)
加热回流提取 Heat under reflux 2g, cut into pieces, with 20ml of ethanol for 1 hour, cool and filter, use the filtrate as the test solution. 取本品2g,剪碎,加乙醇20ml,加热回流 小时,放冷,滤过, 取本品 ,剪碎,加乙醇 ,加热回流1 小时,放冷,滤过, 滤液作为供试品溶液。 滤液作为供试品溶液。
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