《中国药典》2010版与2015版微生物限度检查法对四种药物检测结果的比较  

Comparing the Microbial Limit Test Methods of Chinese Pharmacopoeia 2010 Edition and 2015 Edition for Microbes Determination in Four Pharmaceuticals

作　　者：李趣嫦 江艳芳 

机构地区：[1]广东省食品药品检验所,广州510180

出　　处：《中国药品标准》2015年第2期86-90,共5页Drug Standards of China

摘　　要：目的:比较《中国药典》2015年版(通则公示稿)中的微生物限度检查法与《中国药典》2010年版对不同药物的检测结果。方法:以灵芝孢子红景天胶囊、小蓟炭配方颗粒两种中成药和孟鲁司特钠颗粒、双氯芬酸钠贴片两种化学药为研究对象,分别按照《中国药典》2010年版及《中国药典》2015年版(通则公示稿)中所给出的微生物限度检查法进行方法学建立和验证,并对药品中微生物的含量进行检测。结果:两种方法的方法学建立和验证过程不尽相同,但所获的检测结果一致,2015年版拟修订的微生物限度检查法比2010年版更为灵敏。结论:《中国药典》2015年版拟修订的微生物限度检查法比2010年版更为合理,更具优越性。Objective：To compare the two microbial limit test methods proposed by Chinese Pharmacopoeia 2010 Edition appendix and Chinese Pharmacopoeia 2015 Edition （ general rules in public draft ） for microbes determination in various pharmaceuticals .Methods：Two Chinese patent medicines： Spores of Ganoderma LucidumRhodiola Capsules and Herba Cirsii Carbonisatus Granules , and two chemical medicines：Montelukast Sodium Granules and Diclofenac Sodium Patch , were selected as the subjects for investigation .Their microbial limit test methods were established and validated according to Chinese Pharmacopoeia 2010 Edition and 2015 Edition, respec-tively.The established methods were then applied for determination of microbes presented in the investigated pharmaceutical samples . Results：Similar detection results were obtained by using the microbial limit test methods proposed by Chinese Pharmacopoeia 2010 E-dition and 2015 Edition, although their method establishment and validation processes were slightly different .In addition, the method proposed by Chinese Pharmacopoeia 2015 Edition （ general rules in public draft ） was more sensitive than that of 2010 Edition appen-dix.Conclusion：The microbial limit test method proposed by Chinese Pharmacopoeia 2015 Edition （ general rules in public draft ） is more reasonable and superior than that proposed by Chinese Pharmacopoeia 2010 Edition appendix.

关 键 词：微生物限度检查 《中国药典》2015年版 《中国药典》2010年版 比较 

分 类 号：R921.2[医药卫生—药学]