孕康糖浆微生物限度检查方法学验证研究

Study on the Yunkang Syrup microbial limit inspection method

目的建立孕康糖浆微生物限度检查法。方法采用2010年版《中国药典》规定方法。结果细菌检查采用培养基稀释法(0.2mL/皿)以及霉菌和酵母菌采用平皿法,对5种阳性菌株的回收率均大于70%;采用常规法对控制菌进行检查。结论用该法进行微生物限度检查,可以客观地反映药物中微生物的污染状况,能达到检测目的。该方法有效可行,可用于该品种的微生物限度检查。

Objective To establish a microbial limits inspection method for Yunkang Syrup. Methods The 2010 edition of the Chinese Pharmacopoeia method was used. Results The culture medium diluted method （0.2 mL/dish） and culture dish method were used. The recovery rate five kinds of positive strains were greater than 70 %. Conclusion The method used to check microbial limits, can objectively reflect the drug of microbial in pollution conditions. This method is effective and feasible,and can be used for this type of microbial limit inspection.