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【转载】FDA cGMP问答:青霉素药物(自译中英文)  

2012-11-27 19:24:18|  分类: 生物医药产业 |  标签: |举报 |字号 订阅

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Questions and Answers on Good Manufacturing Practices

Good Guidance Practices, Level 2 Guidance

Penicillin Drugs 青霉素药物

1. What is Penicillin? 什么是青霉素?

Penicillin is defined as a group of natural or semi-synthetic antibiotics derived from fungi strains of the genus Penicillium. Generally, all penicillin share a three-carbon, one-nitrogen, and four-member cyclic amide structure, known as the beta-lactam ring. 青霉素是指一些由青霉素类霉菌发酵而成的自然或半合成抗生素。一般来说,所有青霉素都具备相同结构,即三个碳,一个氮,四元环酰氨结构,即通常所说的β-内酰胺环。

 

2. What are the Penicillin drugs? 什么是青霉素药物?

The Manual of Clinical Microbiology, 9th edition, identifies penicillin drugs as follows: 临床微生学手册第九版将青霉素药分类如下

Natural Penicillins: 全发酵青霉素类

              Benzylpenicillin* (commonly known as penicillin G) 苄青霉素(通常也称为青霉素G)

              Benzylpenicilloyl-polylysine (BPP) 苄基青霉素多熔素(BPP)

              Phenoxymethyl penicillin* (commonly known as penicillin V) 苯氧基青霉素(即青霉素V)

 

Semi-synthetic Penicillins: 半合成青霉素类

              Methicillin 甲氧苯青霉素

              Nafcillin 乙氧萘青霉素

              Cloxacillin* 邻氯青霉素

              Dicloxacillin* 双氯青霉素

              Ampicillin* 氨苄青霉素

              Amoxicillin* 阿莫西林

              Bacampicillin 巴氨西林

              Pivampicillin 匹氨西林

              Carbenicillin 羟苄青霉素

              Ticarcillin* 替卡西林

              Azlocillin 阿洛西林

              Mezlocillin 美洛西林

              Piperacillin 哌拉西林

              Hetacillin* 海他西林

 

*Penicillins approved for veterinary use “项为兽用青霉素

Please be aware that penicillin trade names may vary by region and country. Manufacturers, including repackers, are responsible for knowing whether their drug is penicillin. FDA’s “Approved Drug Products with Therapeutic Equivalence Evaluations” (Orange Book) or Drugs@FDA, both of which are located at FDA’s website, enable searching by trade name (i.e., proprietary name) and by active ingredient name (i.e., generic or non-proprietary name). 需要注意的是青霉素的商品名可能因国家和地区差异而不同。生产商,包括分装商有责任知晓他们生产的药品是否青霉素。自FDA官方网站上公布的FDA的“已批准药品及其药学等效性评价”(橙皮书)或Drugs@FDA,可以用商品名(即专利商品名)和活性成分(即仿制或非专利名)进行查阅。

 

3. Is cross-contamination a concern with penicillin drugs? 交叉污染在青霉素药的是否受到重视?

Yes, penicillin can be a sensitizing agent that triggers a hypersensitive exaggerated allergic immune response in some people. Differences in the chemically substituted 6-aminopenicillanic acid side chain can generate allergic reactions ranging from skin rashes to life-threatening anaphylaxis. 是的。青霉素是高致敏药物,有些人可能会出现严重的过敏反应。根据6-氨基青霉素酸侧链不同,可能引发的从皮疹至危及生命的过敏反应。

 

4. Are there special manufacturing requirements for Penicillin drugs? 对青霉素药品的生产有特殊的要求吗?

Yes, all penicillin finished pharmaceutical manufacturers, including repackers, are required by the CGMP regulations to establish a comprehensive control strategy designed to prevent cross-contamination of other drugs with penicillin. These requirements include: 是的。所有青霉素制剂的生产商,包括分装商,应按照CGMP要求建立全面控制策略以防止青霉素与其他药品之间的交叉污染。包括:

              21 CFR 211.42(d): Separation of facility and equipment 设施和设备的隔离

              21 CFR 211.46(d): Separate air handling systems (HVAC) 空调净化系统的隔离

              21 CFR 211.176: Test for traces of penicillin where possible exposure exits. 可能暴露的地方痕量青霉素的检测

 

Penicillin Active Pharmaceutical Ingredients (APIs) are also required to be manufactured under CGMPs in accordance with Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act. FDA has published internationally harmonized guidance on the manufacture of APIs; see International Conference on Harmonization (ICH) Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. Chapter 4, section 4.4 of this guidance describes actions API manufacturers, including those who manufacture or package APIs or penicillin intermediates, are to follow to ensure such material is contained and does not contaminate other drugs.青霉素原料药的生产也要求符合联邦食品药品和化妆品法案501(a)(2)(B)的CGMP要求。FDA已经公布了原料药生产的ICH指南,见ICH Q7A  活性药物成分的GMP,该指南第四章第4.4部分指出了原料药生产商,包括青霉素原料药和中间体的生产和分装商,应采取的措施,以保证包含该物料,且未污染其他药品。

 

References: 参考文献

1. Yao, Joseph D. C., and Robert C. Moellering, Jr. “Antibacterial Agents.” Manual of Clinical Microbiology. 9th ed. Washington D.C., ASM, 2007 “抗生素试剂”临床微生物手册,第9版

2. FDA CGMP regulations (21 C.F.R. Parts 210-211) FDA CGMP法规 (21CFR第210-211部分)

http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm095412.htm  

3. The Federal Food, Drug, & Cosmetic Act 501(a)(2)(B) 联邦食品、药品和化妆品法案501(a)(2)(B)

http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/default.htm     

 

Contact for further information: 更多信息请联络

Edwin Melendez, Consumer Safety Officer

CDER/OC/DMPQ/MAPCB

edwin.melendez@fda.hhs.gov  

Division of Manufacturing and Product Quality (HFD-320): CGMP Subject Contacts

http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm096102.htm

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