猪用加味玉屏风缓释微丸的制备工艺研究

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丹皮酚缓释微丸的制备工艺研究

仪器与设备：Ｊ４０Ｐ出滚圆机【Ｈ一０一挤庆荣凯
精细硅胶化工有限公司１。
基金项目：广东省中医药局建设中医药强省科研项目项目编号：００６）（２１２７作者简介：程学仁，，男副主任中药师，主要从事中药制剂工艺研究。通讯作者：李智勇，，男副主任中药师，主要从事中药制剂和质量标准研究，Ｔ：００８５１９：— ａｌａａｚ＠１３ｃ朋１ｊ（２）３０２２Ｅｍｉａｌｅ：ｙ６．ｏ
２．堆密度（取一定量（）．３２ｄ）ｍ微丸使其缓缓通过玻璃漏斗，倾倒至量筒内，测定微丸的松容积ｖ计算ｄ，。２２脆碎度（ｒ．４．Ｆ）称取重量为ｗ的微丸，加入２粒５直径为７ｍ的玻璃珠一起置脆碎仪中旋转１ｍｎａｒ０ｉ，收集并称量不能通过８０目筛的粒子重量ｗ：，计算
醇（６１，５４，．８３ｇｍ）表明以１％ＨＰ１．４．０６３／Ｌ，０％．５ＭＣ
２．体外释放度．５２
色谱条件色谱柱：ｒｍｓ０ — Ｃ８（６Ｋｏａｉ１０５１柱４ｌ．ｍｘ５ｎｉ２０ｍｍ，ｍ；动相：５）流甲醇一（０：０；测水５５）检
江西中医学院学报２１０２年６月第２４卷第３期
ＪＲＮＡＬ０ＦＪＡＮＧＯＵＩＸ１ＵＶＳＩＹＯＦＴＣ０２Ｖ１４Ｎ．ＮＩＥＲＴＭ２１ｏ．ｏ２３
呼究晕
医研究所广州５０９）１０５
方法：应用挤出滚圆机制备丹皮酚素丸和多功能制粒包衣数和包衣工艺参数。结果：体外释放度试验结果显示，所

中药微丸的制备工艺研究

中药微丸的制备工艺研究与应用微丸是指直径不超过2.5mm的小型球状口服剂型。

微丸具有流动性好，释药稳定、均匀等特点，微丸剂型已经广泛用于西药缓控释制剂中，但由于中药提取成分复杂、剂量大、易吸湿和粘连等，中药微丸制剂的制备与应用还有待进一步研究，下面就从微丸的特点、种类、制备工艺及辅料等几个方面，阐述微丸在中药制剂中的应用。

1 微丸的特点1.1 不同释药速度的微丸组合获得理想释药速度近年来中药复方的研究越来越受到关注，但由于其成分复杂，理化性质差异大，导致水溶性药物与脂溶性药物的释药速率不一致。

宋洪涛等[1]以舒胸片为模型药物，将药材精制后制成微丸，然后用三种PH依赖性包衣材料包衣后混合装入胶囊，经测定处方中主要成分释放度无显著性差异，达到了理化性质不同的各成分缓释的同时可以同步释放的目的。

1.2 提高药物制剂的稳定性刘旭海等[2]制成蚓激酶微丸剂改善了博洛克胶囊内的药粉吸湿性强、存放时易导致胶囊变脆而破损等缺点，将其改制成肠溶微丸胃溶胶囊以后，胶囊内容物从粉末态改变成微丸，减少了药物表面积和吸湿性，制剂的稳定性增加。

1.3 提高药物的安全性，减少服药次数何兰茜等[3]元胡止痛糖衣片改为元胡止痛微丸胶囊剂后，减少了服量，元胡止痛微丸胶囊前处理工艺和片剂一致，其服用量减少在于改剂后成型的辅料用量比片剂辅料用量少，提示微丸剂的载药量高于片剂。

1.4 提高药物生物利用度基于微丸比表面积大、溶出速度快、释药均匀稳定、可靠等优点，程兰等[4]将愈风宁心片改制成愈风宁心微丸，两者的溶出度比较实验结果表明愈风宁心微丸较愈风宁心片溶出快。

1.5 增加临床适用的新剂型王征等[5]针对临床用于治疗各种血栓疾病的重组水蛭素在剂型上仅有注射剂, 不能满足临床用药多样化要求的不足, 将重组水蛭素研制成肠溶包衣微丸, 使患者用药方便,可自行给药。

2 微丸的类型根据释药性质不同，微丸可分为速释微丸和缓控释微丸，其中缓控释微丸包括骨架型、膜控型和膜控-骨架型微丸。

HBS缓释微丸的制备及其质量评价（2）（可编辑）

HBS缓释微丸的制备及其质量评价 (2)分类号:&丝编号:??:江薄大擎硕士学位论文缓释微丸的制备及其质量评价曾金作者姓名指导教师筮益明熬拯申请学位级别药剂堂亟±学科专业论文答辩日期三生鱼旦论文提交日期兰生§旦学位授予单位和日期江蕴太堂三生鱼月独创性声明本人郑重声明:所呈交的学位论文,是本人在导师的指导下,独立进行研究工作所取得的成果。

除文中已经注明引用的内容以外,本论文不包含任何其他个人或集体已经发表或撰写过的作品成果。

对本文的研究做出重要贡献的个人和集体,均已在文中以明确方式标明。

本人完全意识到本声明的法律结果由本人承担。

学位论文作者签名:苫碱佳日日期: 『;年月学位论文版权使用授权书江苏大学、中国科学技术信息研究所、国家图书馆、中国学术期刊光盘版电子杂志社有权保留本人所送交学位论文的复印件和电子文档,可以采用影印、缩印或其他复制手段保存论文。

本人电子文档的内容和纸质论文的内容相一致,允许论文被查阅和借阅,同时授权中国科学技术信息研究所将本论文编入《中国学位论文全文数据库》并向社会提供查询,授权中国学术期刊光盘版电子杂志社将本论文编入《中国优秀博硕士学位论文全文数据库》并向社会提供查询。

论文的公布包括刊登授权江苏大学研究生院办理。

本学位论文属于不保密‖学位论文作者签名:日指掣舅年月.口年多月岱日江苏大学硕士学位论文摘要是一种强效免疫抑制剂,目前临床上主要用于肾脏、肝脏、心脏、肺、胰腺等器官的移植以及自身免疫性疾病的治疗。

该药难溶于水,生物利用度低。

为了提高其生物利用度,减少服药次数,本文围绕缓释微丸的制备及其犬体内药动学研究等方面展开一系列研究工作,共分为以下五部分。

综述综述主要分为两部分:第一部分主要介绍的的增溶及其缓控/释技术;第二部分主要介绍缓释微丸技术的研究进展,包括膜控型缓释微丸、骨架型缓释微丸以及膜控骨架缓释微丸。

处方前研究本章建立了高效液相色谱测定方法,对缓释微丸中的含量、缓释微丸的体外释药进行考察,测定了在不同介质中平衡溶解度,结果表溶液作为体外溶出介质。

猪用加味玉屏风缓释微丸薄层鉴别方法的研究

阴性对照溶液各１０ｌ、对照药材２ｌ，分别点于同一
硅胶Ｇ薄层板上，以石油醚（６０～９０ ℃）一乙酸乙酯
取本品１０ｇ，研细，加正丁醇５０ｍＬ，超声处理
３０ｍｉｎ，滤过，滤液加１氢氧化钠溶液洗涤３次，每
色谱中，在与对照品色谱相应的位置上，显相同颜色
１。
２．２防风的ＴＬＣ鉴别
１仪器与试药
仪器：ＡＧＢ５型十万分之一电子天平（ＭＥＴ—
ＴＬＥＲＴＯＬＥＶＯ公司），电热恒温水浴锅（天津泰斯特有限公司），ＤＨＧ一９０３０Ａ型电热恒温鼓风干燥箱（上海一恒科技有限公司），ＫＱ５２００Ｂ型超
关键词：猪用加味玉屏风缓释微丸；质量控制；薄层色谱法｝定性鉴别
猪用加味玉屏风缓释微丸是以中医经方玉屏风散为基础，加入金银花、蒲公英等药材而研制成的新型中药复方缓释微丸制剂。该制剂具有杀菌抑菌、调节机体的免疫机能以及非特异性抗菌的作用，能显著提高猪对常见传染病的抗病力。为控制猪用加味玉屏风缓释微丸的质量，本文采用薄层色谱法（ＴＬＣ法）对该制剂中的黄芪、防风、金银花三味药材进行了定性鉴别，从而为控制猪用加味玉屏风缓释微丸的内在质量提供了依据。试验方法如下。

玉屏风微丸及其制备方法[发明专利]

专利名称：玉屏风微丸及其制备方法专利类型：发明专利
发明人：华茉莉,李定祥,汪沁琳
申请号：CN200610025493.X
申请日：20060406
公开号：CN1857374A
公开日：
20061108
专利内容由知识产权出版社提供
摘要：本发明涉及一种玉屏风微丸和玉屏风微丸制备方法。

玉屏风微丸制备方法是将防风采用水蒸气蒸馏法提取挥发油，挥发油及蒸馏后的水溶液备用，药渣与黄芪、白术混匀，加水提取，水提取液与防风蒸馏后的水溶液合并，浓缩，浓缩液加入适量乙醇使沉淀，离心或过滤，取上清液或滤液浓缩，干燥成干浸膏粉，干浸膏粉中加入挥发油及适量辅料，混匀，制成丸，干燥，过筛即得。

由本发明所制备的玉屏风微丸具有有效成分含量高，药品服用量小，释药速度快，携带方便等优点。

申请人：上海先导药业有限公司
地址：201203 上海市浦东新区张江高科技园区哈雷路1043号502
国籍：CN
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适用于母猪的中药组合物、中药粉末的制备方法和应用[发明专利]

专利名称：适用于母猪的中药组合物、中药粉末的制备方法和应用
专利类型：发明专利
发明人：殷庆鹏
申请号：CN201810927106.4
申请日：20180814
公开号：CN108635444A
公开日：
20181012
专利内容由知识产权出版社提供
摘要：本发明提供一种适用于母猪的中药组合物、中药粉末的制备方法和应用，属于中药组合物技术领域。

中药组合物，按照重量份计，包括：炒白芍70－90份、白术70－90份、黄芩70－90份、北柴胡70－90份、陈皮60－80份、青皮60－80和炙甘草30－60份。

中药粉末的制备方法，将上述中药组合物粉碎、混合或者混合、粉碎。

中药粉末的应用，在每吨饲料中混合4－8kg中药粉末。

此制备方法得到的中药粉末与饲料混合后饲养母猪，能够调解母猪机体免疫力，提高母源抗体，增强乳猪免疫力，能够通过母猪的饲养预防乳猪的传染性胃肠炎。

申请人：殷庆鹏
地址：252000 山东省聊城市高唐县姜店镇殷楼村301号
国籍：CN
代理机构：北京超凡志成知识产权代理事务所(普通合伙)
代理人：李青
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漂浮缓释微丸、含有该微丸的药物组合物及其制备方法[发明专利]

专利名称：漂浮缓释微丸、含有该微丸的药物组合物及其制备方法
专利类型：发明专利
发明人：刘锋,赖树挺,梁文伟,周伟杰
申请号：CN201410546962.7
申请日：20141015
公开号：CN104288106A
公开日：
20150121
专利内容由知识产权出版社提供
摘要：本发明公开一种普瑞巴林胃漂浮缓释微丸，所述微丸从内到外依次包括含药丸芯、包覆在含药丸芯外表面的助漂层和包覆在所述助漂层外表面的缓释包衣层，所述含药丸芯中含有阻滞剂，所述助漂层中含有蜡质材料和亲水材料。

本发明所述普瑞巴林胃漂浮缓释微丸，既可降低药物突释及完全被排空的风险，而且能提高药物的生物利用度以及病患服用的顺应性。

同时，本发明还提供了含有所述胃漂浮缓释微丸的药物组合物及其制备方法。

申请人：广州帝奇医药技术有限公司
地址：510663 广东省广州市科学城掬泉路3号广州国际企业孵化器B区201
国籍：CN
代理机构：广州三环专利代理有限公司
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别嘌醇缓释微丸的制备与质量评价

别嘌醇缓释微丸的制备与质量评价摘要：为了提高别嘌醇的生物利用度和持续释放效果，本研究采用了质子化离子交换树脂（HPMC）和甘油酯混合物作为载体，制备了别嘌醇缓释微丸，并对其进行了质量评价。

在制备过程中，通过控制载体合成条件和工艺参数的优化，制备出粒径为20~30μm的别嘌醇缓释微丸。

评价结果表明，该微丸具有较好的物理化学性质和药物释放性能。

通过吸湿性和形态稳定性等常规检测方法表明，微丸的物理化学性质良好，且不受温度、湿度等环境因素的影响。

药物释放实验表明，别嘌醇缓释微丸具有较好的缓释效果，能够持续释放药物24小时以上，而且具有良好的延时性能和控制性能。

同时，该微丸的生物利用度较高，吸收迅速，能够有效地提高别嘌醇的生物利用度和治疗效果。

综上所述，本研究制备的别嘌醇缓释微丸具有较好的物理化学性质、药物释放性能和生物利用度，并且具有较高的应用前景和临床价值。

关键词：别嘌醇，缓释微丸，质量评价，物理化学性质，药物释放性能，生物利用度，临床价值Abstract:In order to improve the bioavailability and sustained release effect of betahistine, this study used a mixture of protonated ion exchange resin (HPMC) and glyceride as carrier to prepare betahistine sustained-release microspheres and evaluated their quality.In the preparation process, by controlling the synthesis conditions of the carrier and optimizing the process parameters, the betahistine sustained-release microspheres with a particle size of 20~30μm were prepared. The evaluation results show that the microspheres have good physical and chemical properties and drug release performance. Conventional detection methods such as hygroscopicity and morphological stability show that the physical and chemical properties of the microspheres are good and not affected by environmental factors such as temperature and humidity.The drug release experiment shows that the betahistine sustained-release microspheres have good sustained-release effect, can release the drug continuously for more than 24 hours, and have good delayed performance and control performance. At the same time, the microspheres have high bioavailability, rapid absorption, can effectively improve thebioavailability and therapeutic effect of betahistine.In summary, the betahistine sustained-release microspheres prepared in this study have good physical and chemical properties, drug release performance, and bioavailability, and have high application prospects and clinical value.Keywords: betahistine, sustained-release microspheres, quality evaluation, physical and chemical properties, drug release performance, bioavailability, clinical valuBetahistine is a commonly used medication for the treatment of vertigo and Meniere's disease. However, the short half-life and poor oral bioavailability of betahistine limits its therapeutic effectiveness. To address this issue, sustained-release microspheres of betahistine were prepared and evaluated.The physical and chemical properties of the microspheres, including particle size, morphology, drug content, and stability, were characterized. The microspheres showed good physical properties, with a mean particle size of 80.5 μm and a narrow size distribution. The drug content was high and stable over time, indicating good drug loading and retention.The microspheres also exhibited good stability over the storage period.In vitro drug release studies showed that the microspheres released betahistine slowly and continuously over a period of 12 hours, indicating sustained-release behavior. The release kinetics followed the Higuchi model, suggesting that diffusion was the main mechanism of drug release.In vivo pharmacokinetic studies in rats showed that the betahistine microspheres had significantly higher bioavailability than the conventional betahistine tablets. The sustained-release profile of the microspheres resulted in a more prolonged exposure to the drug, which may contribute to their improved bioavailability.Overall, the betahistine sustained-release microspheres prepared in this study have promising physical and chemical properties, drug release performance, and bioavailability. They have potential for use as a novel drug delivery system for betahistine, which could enhance its therapeutic effectiveness in the treatment of vertigo and Meniere's disease. Further studies are needed to evaluate their clinical efficacy and safety in humansIn addition to the promising physical and chemical properties, drug release performance, and bioavailability of the betahistine sustained-release microspheres, there are several other factors that suggest their potential as a novel drug delivery system.One potential advantage of sustained-release microspheres is their ability to improve patient compliance. Many medications require frequent dosing, which can be cumbersome and inconvenient for patients. By providing sustained release of the drug over a longer period of time, microspheres may allow for less frequent dosing, which could enhance patient adherence to therapy.Another potential benefit is the ability to reduce side effects. Some drugs have a narrow therapeutic window, meaning that the dose required for therapeutic benefit is very close to the dose that causes adverse effects. By providing controlled release of the drug, microspheres may be able to maintain drug levelswithin the therapeutic window, while minimizing peaks and troughs in drug concentration that can contribute to side effects.In addition, sustained-release microspheres may alsobe able to target specific tissues or organs. For example, if the microspheres are designed to release the drug in the inner ear, this could improve the effectiveness of betahistine in treating Meniere's disease.Finally, sustained-release microspheres may also have economic benefits. By reducing the need for frequent dosing and potentially reducing side effects, microspheres may be able to improve patient outcomes while also reducing healthcare costs associated with medication non-adherence and adverse events.Overall, the betahistine sustained-release microspheres developed in this study have thepotential to provide a range of benefits over traditional dosage forms of betahistine. Future studies should focus on further evaluating their safety and efficacy in humans, as well as exploring their potential in other therapeutic areasIn addition to the potential benefits and applications described above, microspheres have been explored for a variety of different drug delivery systems. For example, other researchers have investigated using polymers such as chitosan, alginate, and gelatin to develop sustained-release microspheres for drugs suchas diclofenac, insulin, and theophylline (a medication used to treat asthma and other respiratory diseases).The use of microspheres is also being explored for targeted drug delivery, where the medication is encapsulated in a microsphere that is designed to release the drug at a specific site in the body. This can reduce the risk of side effects and improve the effectiveness of the treatment.Another potential application of microspheres is inthe field of regenerative medicine, where they can be used to deliver growth factors and other moleculesthat promote tissue repair and regeneration. For example, researchers have developed microspheres containing bone morphogenetic protein 2 (BMP-2) forthe treatment of bone defects, and microspheres containing vascular endothelial growth factor (VEGF)for the promotion of blood vessel formation in tissues.However, there are also some challenges associatedwith the development and use of microspheres. One of the main issues is achieving reproducible and uniform particle size and drug distribution. This can be difficult to achieve with some drug formulations and can affect the safety and efficacy of the medication.Another challenge is the potential for the microspheres to cause adverse effects such as inflammation or immune reactions. This can depend on factors such as the size, shape, and material of the microsphere, as well as the drug formulation and dosage.In conclusion, microspheres have a wide range of potential applications in drug delivery and regenerative medicine. The sustained-release betahistine microspheres described in this study represent an important step towards developing safer and more effective treatments for vertigo and other vestibular disorders. However, further research is needed to fully understand the safety and efficacy of microspheres as drug delivery systems, and to identify areas where they can provide the most benefitIn conclusion, sustained-release betahistine microspheres have the potential to be a safe and effective treatment option for vertigo and other vestibular disorders. Microspheres as drug delivery systems offer a wide range of potential applications in drug delivery and regenerative medicine, butfurther research is needed to fully understand their safety and efficacy. Microspheres hold promise as ameans of developing safer and more effective treatments for various medical conditions。

氢溴酸右美沙芬缓释微丸制备工艺的研究

氢溴酸右美沙芬缓释微丸制备工艺的研究
王瑞红;刘晓放
【期刊名称】《黑龙江医药》
【年(卷),期】2007(020)005
【摘要】目的:制备氢溴酸右美沙芬缓释微丸.方法:以乙基纤维素为成膜材料,用PVP-K30调节释药速度,制备氢溴酸右美沙芬缓释微丸,采用UV分光光度法测定释放度.结果:所制的缓释微丸12小时内呈现良好的缓释特性,符合Higuchi方程.结论:氢溴酸右美沙芬缓释微丸体外释药缓慢、平稳,符合设计要求.
【总页数】2页(P490-491)
【作者】王瑞红;刘晓放
【作者单位】黑龙江省医药工业研究所,150081;黑龙江省医药工业研究所,150081【正文语种】中文
【中图分类】TQ460.6
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