乙酰半胱氨酸微生物限度方法学验证

目的:建立验证乙酰半胱氨酸的微生物限度检测方法。方法:用薄膜过滤法、平皿法验证所采用的方法是否适合该药品微生物限度检查方法。结果:需氧菌检查、控制菌检查采用薄膜过滤法,霉菌和酵母菌数检查采用平皿法,试验菌的回收率均在0.5~2.0范围内。结论:该方法可用于乙酰半胱氨酸的微生物限度检查。

复方碘口服溶液微生物限度检查方法学验证

目的:为建立复方碘口服溶液微生物限度检查法提供依据。方法:采用平皿法、薄膜过滤法、中和法对复方碘口服溶液的微生物限度检查方法进行验证,通过比较回收率确定该品种的检查方法。结果:采用平皿法和薄膜过滤法进行微生物限度检查方法学验证时,均无法消除供试液的抑菌性;采用中和法可完全消除供试液的抑菌性,验证结果符合《中国药典》2010年版要求。结论:以硫代硫酸钠为中和剂的中和法适用于复方碘口服溶液微生物限度的检查。

滋阴宁神合剂微生物限度检查方法学验证

目的建立滋阴宁神合剂微生物限度检查方法。方法采用人工感染五种阳性菌株的方法,对滋阴宁神合剂进行细菌、霉菌及酵母菌的计数检验以及控制菌的检验。结果采用平皿法检查,五种阳性菌株的回收率均不低于70%。控制菌采用平皿法检验呈阳性。结论滋阴宁神合剂微生物限度检查方法可采用平皿法。

Methodology Validation of Microbial Limit Test of Bupi Qiangli Ointment

[Objective] This study was conducted to establish a microbial limit test method for Bupi Qiangli Ointment. [Method] The conventional method and medium dilution method were used for bacterial, mold and yeast counting in sample recovery test. [Result] The medium dilution method （1：10 test solution, 0.5 ml/plate） could effectively eliminate the inhibition effect of the Bupi Qiangli Ointment, and the recovery of Staphylococcus aureus was greater than 70% in the 3 batches of samples; and the conventional method exhibited the recoveries of E. coil, Bacillus subtilis, Candida albicans and Aspergillus greater than 70% in the 3 batches of samples. [Conclusion] Due to Bupi Qiangli Ointment has strongly antibacterial effect on Staphylococcus au- reus, the medium dilution method was used for bacterial counting, and the conventional method was used for mold and yeast counting; and the conventional method was used for controlled bacterium examination of E. coll.