嘉法狮口服solid dosage form_201110Shenyang

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盐酸坦洛新缓释胶囊英国药典2011.doc

英国药典2011Prolonged-release Tamsulosin CapsulesGeneral NoticesProlonged-release Tamsulosin Capsules from different manufacturers, whilst complying with the requirements of the monograph, are not interchangeable unless otherwise justified and authorised.DEFINITIONProlonged-release Tamsulosin Capsules contain Tamsulosin Hydrochloride. They are formulated so that the medicament is released over a period of several hours.PRODUCTIONA suitable dissolution test is carried out to demonstrate the appropriate release of Tamsulosin Hydrochloride. The dissolution profile reflects the in vivo performance which in turn is compatible with the dosage schedule recommended by the manufacturer.The capsules comply with the requirements stated under Capsules and with the following requirements.Content of tamsulosin hydrochloride, C20H28N2O5S,HCl95.0 to 105.0% of the stated amount.IDENTIFICATIONA. In the Assay, the principal peak in the chromatogram obtained with solution (1) has the same retention time as that in the chromatogram obtained with solution (2).B. The light absorption of solution (1) obtained in the Assay, Appendix II B in the range 210 to 400 nm, exhibits a single maximum at 225 nm.TESTSRelated substance sCarry out the method for liquid chromatography, Appendix III D, using the following solutions.(1) Mix for at least 15 minutes with the aid of ultrasound and with intermittent shaking a quantity of the capsules containing 0.8 mg of Tamsulosin Hydrochloride with 10 ml of 1M methanolic hydrochloric acid and filter through a 0.7-µm glass fibre filter, to 1 volume of the filtrate add 4 volumes of 1M methanolic hydrochloric acid and filter through a 0.7-µm glass fibre filter.(2) Dilute 1 volume of solution (1) to 500 volumes with mobile phase.(3) 0.00032% w/v of tamsulosin hydrochloride impurity standard BPCRS in the mobile phase.(4) Dilute 1 volume of solution (2) to 4 volumes with mobile phase.CHROMATOGRAPHIC CONDITIONS(a) Use a stainless steel column (15 cm × 4.6 mm) packed with octadecylsilyl silica gel for chromatography (5 µm) (Nucleosil C18 100Å is suitable).(b) Use isocratic elution and the mobile phase described below.(c) Use a flow rate of 1.5 ml per minute.(d) Use a column temperature of 40°.(e) Use a detection wavelength of 225 nm.(f) Inject 20 µl of each solution.(g) Allow the chromatography to proceed for 40 minutes.MOBILE PHASE300 volumes of acetonitrile mixed with 700 volumes of water containing 0.44% v/v perchloric acid and 0.15% w/v sodium hydroxide previously adjusted to pH 2.0 with 1M sodium hydroxide.SYSTEM SUITABILITYThe test is not valid unless the chromatogram obtained with solution (3) closely resembles the chromatogramsupplied with tamsulosin hydrochloride impurity standard BPCRS.LIMITSIn the chromatogram obtained with solution (1):the area of any peak corresponding to (2R)-N-[2-(2-ethoxyphenoxy)ethyl]-1-(4- methoxyphenyl)propan-2-amine is not greater than 2.5 times the area of the principal peak in the chromatogram obtained with solution (2) (0.5%);the area of any other secondary peak is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.2%);the sum of the areas of all secondary peaks is not greater than 7.5 times the area of the principal peak in the chromatogram obtained with solution (2) (1.5%).Disregard any peak with an area less than the area of the principal peak in the chromatogram obtained with solution (4) (0.05%).Uniformity of contentCapsules containing less than 2 mg and/or less than 2% w/w of Tamsulosin Hydrochloride comply with the requirements stated under Capsules using the following method of analysis.Carry out the method for liquid chromatography, Appendix III D, using the following solutions.(1) Mix the contents of 1 capsule with 10 ml of 1M methanolic hydrochloric acid for at least 15 minutes with the aid of ultrasound and with intermittent shaking, filter through a 0.7-µm glass fibre filter, dilute 1 volume of the filtrate to 10 volumes with 1M methanolic hydrochloric acid and filter through a 0.7-µm glass fibre filter.(2) Prepare a 0.040% w/v solution of tamsulosin hydrochloride BPCRS in methanol with the aid of ultrasound, cool and dilute 1 volume to 100 volumes with 1M methanolic hydrochloric acid . CHROMATOGRAPHIC CONDITIONSThe chromatographic conditions described under Related substances may be used.DE TERMINATION OF CONTENTCalculate the content of C20H28N2O5S,HCl in each capsule from the declared content of C20H28N2O5S,HCl in tamsulosin hydrochloride BPCRS.ASSAYCarry out the method for liquid chromatography, Appendix III D, using the following freshly prepared solutions.(1) To a quantity of the powdered mixed contents of 20 capsules containing 1.6 mg of Tamsulosin Hydrochloride add 50 ml of 1M methanolic hydrochloric acid , mix for at least 15 minutes with the aid of ultrasound, cool and add sufficient 1M methanolic hydrochloric acid to produce 100 ml. Filter using a 0.7-µm glass fibre filter and dilute 1 volume of the filtrate to 4 volumes with 0.1M methanolic hydrochloric acid .(2) Prepare a 0.040% w/v solution of tamsulosin hydrochloride BPCRS in methanol with the aid of ultrasound, cool and dilute 1 volume to 100 volumes with 1M methanolic hydrochloric acid . CHROMATOGRAPHIC CONDITIONSThe chromatographic conditions described under Related substances may be used.DE TERMINATION OF CONTENTCalculate the content of C20H28N2O5S,HCl in the capsules from the declared content of C20H28N2O5S,HCl in tamsulosin hydrochloride BPCRS.STORAGEProlonged-release Tamsulosin Capsules should be protected from moisture.IMPURITIESThe impurities limited by the requirements of this monograph include impurit ies B, E, F and H listed under the Tamsulosin Hydrochloride monograph.。

Farxiga(dapagliflozin,达格列净片)说明书

(8.1)（2）哺乳母亲：终止FARXIGA或终止哺乳. (8.3)（3）老年人：与减低血管内容量相关不良反应发生率较高。

(5.1，8.5)（4）肾受损：与减低血管内容量和肾功能相关不良反应发生率较高。

(5.2，6.1，8.6)完整处方资料1 适应证和用途FARXIGA(dapagliflozin)适用作为辅助在成人中对饮食和运动改善血糖控制有2型糖尿病[见临床研究(1 4)]。

1.1 使用限制建议FARXIGA不为1型糖尿病患者或为糖尿病酮症酸中毒治疗。

2 剂量和给药方法2.1 推荐给药FARXIGA的推荐起始剂量是5 mg每天1次，早晨服用，有或无食物。

在耐受FARXIGA 5 mg每天1次患者需要另外血糖控制时，剂量可增加至10 mg每天1次。

在有血容量不足患者中，建议在开始FARXIGA前纠正这种情况[见警告和注意事项(5.1)，在特殊人群中使用(8.5，8.6)，和患者咨询资料(17)]。

2.2 有肾受损患者建议开始FARXIGA治疗前和其后定期地评估肾功能。

在eGFR低于60 mL/min/1.73 m2患者中不应开始FARXIGA。

在有轻度肾受损患者(eGFR为60 mL/min/1.73 m2或更高)无需剂量调整。

当eGFR持续地低于60 mL/min/1.73 m2时应终止FARXIGA[见警告和注意事项(5.2)和在特殊人群中使用(8.6)]。

3 剂型和规格● FARXIGA 5 mg片是黄色，双凸，圆，薄膜包衣片在一侧刻有“5”和另一侧“1427”。

● FARXIGA 10 mg片是黄色，双凸，菱形，薄膜包衣片一侧刻有“10“和另一侧“1428”。

4 禁忌证● 对FARXIGA严重超敏反应史[见不良反应(6.1)]。

● 严重肾受损，肾病终末期(ESRD)，或用透析患者[见在特殊人群中使用(8.6)]。

5 警告和注意事项5.1 低血压FARXIGA致血管内容积收缩。

开始FARXIGA后可能发生症状性低血压[见不良反应(6.1)]特别是在有肾功能受损患者中(eGFR低于60 mL/min/1.73 m2)，老年患者，或用袢利尿剂的患者。

嘉法狮用于直肠阴道给药的脂质辅料

STANDARD grades : N line
标准型：N型
o
“direct esterification” of selected fatty acids with glycerol
甘油同选定的脂肪酸直接酯化反应得到的基质
OH
Hydroxyl group
Fatty acids Glycerol
MAG
特殊型号derivedfromstandardsuppocirerange由suppocire标准系列衍生得到的specificphysicochemicalcharacteristicsperformancefeatures特殊的物理化学特性和性能higherproportionsomecontainadditivesincludingphospholipidsbeeswaxpolyoxylethylenepoesorbitanesters单甘脂和一些添加剂包括磷脂蜂蜡聚氧乙烯山梨醇酯的比例较高highloadingmonoglyceridescontentadditiveingredient含有一定量范围的单甘脂或添加剂成分morehydrophilicbehavior更亲水apisincreasingsuppositorymass适合能提高栓剂基质熔点的活性物fastreleaseapi药物快速释放nonionicemulsifyingbase含有非离子型乳化添加剂aqueoussolutions适合水溶液的配方preventexudationsolution适合用于阻止水溶液的活性物从栓剂中渗出suppocirespecialtygradessuppocire
o + o
Ester 1
o
o o
Ester 2

转发：发改委通知【2011】440

序号定价序号药品名称剂型规格零售单位企业名称最高零售价格备注12青霉素V片剂40万单位*12盒(瓶)华北制药股份有限公司7.1* 22青霉素V片剂40万单位*15盒(瓶)华北制药股份有限公司8.832青霉素V片剂40万单位*24盒(瓶)华北制药股份有限公司13.942青霉素V片剂40万单位*30盒(瓶)华北制药股份有限公司17.252青霉素V片剂80万单位*9盒(瓶)华北制药股份有限公司9.262青霉素V片剂40万单位*12盒(瓶)东药集团沈阳施德药业有限公司7.9*72青霉素V片剂40万单位*24盒(瓶)东药集团沈阳施德药业有限公司15.582青霉素V片剂40万单位*24盒(瓶)山德士（中国）制药有限公司20.2*92青霉素V片剂40万单位*12盒(瓶)山德士（中国）制药有限公司10.4107阿莫西林颗粒剂125mg*12盒(瓶)珠海联邦制药股份有限公司中山分公司，联邦制药厂有限公司（香港）8.4*117阿莫西林颗粒剂125mg*24盒(瓶)珠海联邦制药股份有限公司中山分公司，联邦制药厂有限公司（香港）16.4127阿莫西林颗粒剂125mg*18盒(瓶)先声药业有限公司12.5*137阿莫西林干混悬剂125mg*10盒(瓶)昆明贝克诺顿制药有限公司7.6*147阿莫西林注射剂1g(溶媒结晶)支（瓶）哈药集团制药总厂8.1*157阿莫西林注射剂500mg(溶媒结晶)支（瓶）哈药集团制药总厂 4.8167阿莫西林注射剂2g(溶媒结晶)支（瓶）哈药集团制药总厂13.8178氨苄西林胶囊250mg*24盒(瓶)珠海联邦制药股份有限公司中山分公司，联邦制药厂有限公司（香港）14.0*188氨苄西林胶囊250mg*12盒(瓶)珠海联邦制药股份有限公司中山分公司，联邦制药厂有限公司（香港）7.2附件一:单独定价药品最高零售价格金额单位：元序号定价序号药品名称剂型规格零售单位企业名称最高零售价格备注191808培哚普利片剂8mg*15盒(瓶)施维雅（天津）制药有限公司102192808培哚普利片剂8mg*30盒(瓶)施维雅（天津）制药有限公司199193810厄贝沙坦片剂150mg*7盒(瓶)赛诺菲安万特(杭州)制药有限公司37.4*194810厄贝沙坦片剂300mg*7盒(瓶)赛诺菲安万特(杭州)制药有限公司63.5195811坎地沙坦片剂8mg*7盒(瓶)天津武田药品有限公司42.0* 196811坎地沙坦片剂4mg*7盒(瓶)天津武田药品有限公司24.7197812氯沙坦钾片剂50mg*7盒(瓶)杭州默沙东制药有限公司47.2* 198812氯沙坦钾片剂50mg*14盒(瓶)杭州默沙东制药有限公司92.1199812氯沙坦钾片剂50mg*28盒(瓶)杭州默沙东制药有限公司180200812氯沙坦钾片剂100mg*7盒(瓶)杭州默沙东制药有限公司60.9* 201812氯沙坦钾片剂100mg*14盒(瓶)杭州默沙东制药有限公司119202812氯沙坦钾片剂100mg*28盒(瓶)杭州默沙东制药有限公司232203813替米沙坦片剂80mg*7盒(瓶)上海勃林格殷格翰药业有限公司45.6*204814缬沙坦胶囊80mg*7盒(瓶)诺华公司45.8* 205830米多君片剂 2.5mg*20盒(瓶)奈科明公司61.2* 206833阿托伐他汀片剂10mg*7盒(瓶)辉瑞公司53.9* 207833阿托伐他汀片剂20mg*7盒(瓶)辉瑞公司76.3○208833阿托伐他汀片剂40mg*7盒(瓶)辉瑞公司130209834氟伐他汀胶囊40mg*7盒(瓶)诺华公司34.8* 210834氟伐他汀缓释片80mg*7盒(瓶)诺华公司42.3*211836普伐他汀片剂10mg*7盒(瓶)第一三共制药（上海）有限公司29.1*212836普伐他汀片剂20mg*7盒(瓶)第一三共制药（上海）有限公司49.4213836普伐他汀片剂10mg*7盒(瓶)中美上海施贵宝制药有限公司43.1*214836普伐他汀片剂20mg*5盒(瓶)中美上海施贵宝制药有限公司44.1○215838阿昔莫司胶囊250mg*30盒(瓶)辉瑞公司138*216840非诺贝特胶囊200mg*10(微粒化制剂）盒(瓶)法国利博福尼制药公司43.6*217847辅酶Q10片剂10mg*30盒(瓶)卫材（中国）药业有限公司31.6*。

法南公司生产的马胶类产品说明书

EPA REG. No. 270-251 EPA Est. No. 2724-TX-1Manufactured for:Farnam COmPanIES, InC. 1501 East Woodfield Road 200WSchaumburg, IL 60173 • Product Code: 3002221 • RM#: 300518057 15-20018©2008, 2009, 2015 Farnam Companies, Inc. Endure, RepeLock, Farnam with design and Your Partner in Horse Care are trademarks of Farnam Companies, Inc.PrECaUTIOnarY STaTEmEnTSHaZarDS TO HUmanS anD DOmESTIC anImaLSCaUTIOnHUmanS: Harmful if inhaled. Avoid breathing spray mist. Causes moderate eye irritation. Avoid contact with skin, eyes, or clothing. Prolonged or frequently repeated skin contact may cause allergic reactions in some individuals. Wear long-sleeved shirt and long pants, socks and shoes, and chemical-resistant gloves made of any waterproof material.HOrSES: Do not allow product to contact animal’s eyes, nose, mouth, or sores during application. Do not use on foals under 12 weeks. Use only in well-ventilated Er SaFETY rECOmmEnDaTIOnS:• Users should wash hands before eating, drinking, chewing gum, using tobacco, or using the toilet.• Users should remove clothing/PPE immediately if pesticide gets inside. Then wash thoroughly and put on clean clothing.• Users should remove PPE immediately after handling this product. Wash the outside of gloves before removing. As soon as possible, wash thoroughly and change into clean clothing.FIrST aID If inhaled• Move person to fresh air.• If person is not breathing, call 911 or an ambulance, then give artificial respiration, preferably by mouth-to-mouth, if possible.• Call a poison control center or doctor for further treatment advice.If in eyes• Hold eye open and rinse slowly and gently with water for 15-20 minutes.• Remove contact lenses, if present, after the first 5 minutes, then continue rinsing eye.• Call a poison control center or doctor for treatment advice.If on skin or clothing • Take off contaminated clothing.• Rinse skin immediately with plenty of water for 15-20 minutes.• Call a poison control center or doctor immediately for treatment advice.If swallowed• Call a poison control center or doctor immediately for treatment advice.• Have person sip a glass of water if able to swallow.• Do not induce vomiting unless told to do so by the poison control center or doctor.• Do not give anything by mouth to an unconscious person.In case of medical emergencies or health and safety inquiries or in case of fire, leaking or damaged containers, or for product use information, call 800-234-2269.Have the product container or label with you when calling a poison control center or doctor, or going for treatment.ENVIRONMENTAL HAZARDSThis product is extremely toxic to fish and aquatic vertebrates. To protect the environment, d o not allow pesticide to enter or run off into storm drains, drainage ditches, gutters or surface waters. Applying this product in calm weather when rain is not predicted for the next 24 hours will help to ensure that wind or rain does not blow or wash pesticide off the treatment area.FOr USE On HOrSES anD POnIESReady-to-use ENDURE ®SWEAT-RESISTANT FLY SPRAY FOR HORSES insecticide/r epellent/sunscreen formula provides repellency, quick knock-down & long lasting protection from flies, gnats, and mosquitoes. Unique formulation stays active and eeps work ing even in wet conditions and when the horse sweats. The special sunscreening agent in this product protects against both forms of the sun’s harmful ultra-violet rays.Rinsing application equipment over the treated area will help avoid run off to water bodies or drainage systems. This product is highly toxic to bees exposed to direct treatment on blooming crops or weeds. Do not apply this product or allow it to drift to blooming crops or weeds while bees are actively visiting the treatment area.DIRECTIONS FOR USEIt is a violation of Federal Law to use this product in a manner inconsistent with its labeling.Do not use in outdoor residential misting systems. Do not allow adults, children, or pets to enter the treated area or contact treated surfaces until sprays have dried. Do not apply this product in a way that will contact any person or pet, either directly or through drift. Keep people and pets out of the area during application. Exit area immediately and remain outside the treated area until sprays have dried. Use only in well-ventilated areas.Not for use on horses or foals intended for slaughter. Shake well before using. To protect horses from horse flies, house flies, stable flies, face flies, horn flies, deer flies, gnats, mosquitoes, lice, ticks and deer ticks that may transmit Lyme disease. Thoroughly brush the horse’s coat prior to application to remove loose dirt and debris. For dirty horses, shampoo and rinse thoroughly. Wait until the coat is completely dry before applying ENDURE ® SWEAT-RESISTANT FLY SPRAY FOR HORSES . Its unique water-resistant formula contains a special conditioner that binds to the hair shaft so it keeps working even in moist conditions or when the horse sweats. Do not use more than 11 oz per animal. Do not spray product when food is present.This product may be applied either as a spray or as a wipe. For horse’s face, always apply as a wipe using a piece of clean, absorbent cloth toweling or sponge. Wear rubber glove or mitt when applying as a wipe. Spray or wipe horse’s entire body while brushing against the lay of the coat to insure adequate coverage. Avoid getting spray into horse’s eyes, nose, or mouth.Application should be liberal for best results. Reapply every 5 to 7 days under normal conditions for initial applications. As protection builds, reapply every 10 to 14 days as needed. Also, reapply each time animal is washed or exposed to heavy rain.STOraGE anD DISPOSaLDo not contaminate water, food or feed by storage or disposal. PESTICIDE STOraGE: Store in original container in a dry place inaccessible to children and pets. If a leaky container must be contained within another, mark the outer container to identify the contents. Store pesticides away from food, pet food, seed, fertilizers, and veterinary supplies. PESTICIDE DISPOSaL anD COnTaInEr HanDLInG: Nonrefillable container. Do not reuse or refill this container. If empty: Place in trash or offer for recycling if available. If partly filled: Call your local solid waste agency for disposal instructions. Never place unused product down any indoor or outdoor drain.Buyer assumes all risk of use, storage or handling of this product not in strict accordance with directions given herein.Your Partner in Horse Care ™。

越南卫生部药品注册规定0416

越南药品注册规定（越南卫生部第3121/2001/QD-BYT号决定) 为便于对药品的生产和流通实施统一的国家管理，保障药品的安全、有效和质量可控性，越南卫生部（MOH）决定颁布关于人用防病、治病、补养药品注册的规定（简称为《药品注册规定》）.解读：越南的药品注册归口越南卫生部管理。

总则第一条在越南生产和流通的人用防病、治病、补养药品必须进行注册并由卫生部给予注册编号。

在特殊场合下（用于防疫、抗灾的药品及孤儿药),卫生部将依据实际情况允许流通未给予注册编号的药品。

解读：各类药品均须注册，由卫生部颁给注册编号，类似于我国的批准文号。

非常情况下，没有注册编号的药品亦可流通。

第二条调整范围及适用对象2.1 调整范围－——国内外具备生产条件的药品生产企业生产的药品在越南上市前均必须注册。

－--科研院所研制的新药，在待技术转让期间，若本单位充分具备生产条件,可申请注册在本单位内生产销售。

解读:与我国不同，具备生产条件的科研院所研制成功的新药在转让前可以生产。

－—-授权生产（under-license)的药品只能在越境内符合药品生产质量管理规范（GMP）的药品生产企业进行生产.解读：貌似我国的委托生产。

－——医疗机构依照诊治病处方配制/生产的服务于本单位诊治疾病的药品，不能在市场上流通。

医疗机构的领导必须对药品的配方、生产规程、质量标准及药品的安全有效性负责。

解读:貌似我国的院内制剂,医院领导负责制。

2.2 适用对象以下各单位可以进行药品注册，在越南进行药品生产和流通：－——越南国内各药品生产企业；－-—从事药品贸易的国内企业，获准在药品领域内活动的外国公司。

解读：越南国内的药品生产和经营企业，以及有权限的外国公司均可申请药品注册.这里没有提及科研院所,但从前面条款中不难看出，科研院所、医院等是可以注册药品的。

第三条在本规定内，一些术语做如下理解：3。

1 药品是指用于人防病、治病、减轻病情、诊断疾病或调整机体生理职能的产品。

一种以依地酸铁钠为活性成分的口服液体制剂[发明专利]

专利名称：一种以依地酸铁钠为活性成分的口服液体制剂专利类型：发明专利
发明人：不公告发明人
申请号：CN201010246606.5
申请日：20100806
公开号：CN102342906A
公开日：
20120208
专利内容由知识产权出版社提供
摘要：本发明涉及一种以依地酸铁钠为活性成分的口服液体制剂。

它是以依地酸铁钠或其纯化水合物为药用活性成分，与药学上可接受的辅料制成的口服液体制剂。

剂型包括口服溶液剂和糖浆剂。

申请人：北京润德康医药技术有限公司
地址：100070 北京市丰台区富丰路4号A1604
国籍：CN
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嘉法狮产品目录

随意使用胶凝剂。形成精美和非常均一的分散液。具有触变流动性，改善铺展性（提高 SPF 值）和使用时的舒服感。与油、pH 和特殊活性原料（锌衍生物，DHA……）具有宽广相容性。完美呈现相矛盾的
发用品、彩妆、皮肤护理品、日晒用品
厚实、霜状外观和轻质感官。可配制不含凝胶的无机粉体配方。
Cetyl Alcohol(and) Glyceryl Stearate(and)PEG-75 O/W 乳化剂，适用于膏霜。与大多数化妆品用油、难乳化原料成分（如
彩妆、皮肤护理品、日晒用品、盥洗品
不含 PEG，W/O 乳化剂，能单独使用(膏霜)或与 PLUROL OLEIQUE 或 PLUROL ISOSTEARIQUE 配合使用(乳液)。可与无机颜料配伍，具有天然抗水性。冷热流程均可。推荐使用油相增稠剂，以便增强与油的兼容性。保
护皮脂膜。干性/敏感性和婴儿皮肤用品的最佳选择。
彩妆、皮肤护理品、日晒用品、
2
上海浦恩生化科技有限公司 021-52357600;52357606;52359098
- 嘉法狮原料目录 -
PLUROL STERAIQUE SEDEFOS 75
TEFOSE HC TEFOSE 1500
块状
Polyglyceryl-6 Distearate 聚甘油-6 双硬酯酸酯
其基质和活性物包括:
基质：
1 特色乳化剂(Emulium 系列质感型乳化剂): 丰厚质感、溶化质感、真实的质感、粉状质感 2 双凝胶制造者（Emulfree 系列）：不含表面活性剂，无刺激而有特殊轻盈的肤感，介于乳液和精华之间的开创性双凝胶 3 特色油脂（Cocoate BG，compritol 888，ISIS，Transcutol CG，Hydrocire S）：