2种医院制剂微生物限度检查方法学适用性研究

目的：建立微生物限度检查方法，保证微生物限度检查结果的准确性。方法：依据《中国药典》2015年版四部通则1105及1106对制剂中需氧菌总数、霉菌和酵母菌总数计数法及控制菌检查方法进行适用性验证。结果：宣肺止嗽丸需氧菌总数计数检查采用培养基稀释法，霉菌和酵母菌总数计数及控制菌检查采用常规法。消炎栓需氧菌、霉菌和酵母菌总数计数及控制菌检查均需采用供试液稀释法。结论：医院制剂微生物检验方法应该按照药典规定进行升级，完成方法学验证后进行检验。

On Methodological Applicability of Microbial Limit Test for Two Hospital Preparations

Objective:To establish the method of microbial limit test to ensure the accuracy of microbial limit test results. Methods:According to the general rules of 1105 and 1106 in the Chinese Pharmacopoeia of 2015 edition, Volume IV, the counting methods of bacteria, molds and yeasts and the controlling bacteria checking methods were validated for applicability. Results:The total number of aerobic bacteria in Xuanfei Zhisu pills was determined by culture medium dilution method, while the total number of molds and yeasts and the control bacteria was determined by the routine method. The total number of aerobic bacteria, molds, yeasts and the control bacteria was determined by the dilution method. Conclusion:Microbiological test methods for hospital preparations should be upgraded in accordance with the provisions of the Pharmacopoeia and tested after the completion of methodological validation.