《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

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。

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

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, respectively. 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 Edition 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 appendix. 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.