生精胶囊微生物限度检查方法验证

目的建立生精胶囊的微生物限度检查方法。方法采用2010年版《中国药典》规定的常规法、培养基稀释法,通过验证确认所采用的方法是否适合于该药品的微生物限度检查。结果细菌计数采用培养基稀释法,霉菌及酵母菌计数采用常规法,5种试验菌的回收率均高于70%。控制菌采用常规法检查可以检出,符合规定。结论该方法可用于生精胶囊的微生物限度检查。

Methodological Validation of Microbial Limit Test Method of Shengjing Capsule

Objective To establish a method for the microbial limit test of Shengjing Capsule. Methods The routine method and the dilution method regulated by the Chinese Pharmacopoeia（ 2010 edition） were adopted. Whether the adopted methods suiting for the microbial limit test of Shengjing Capsule was affirmed by the validation. Results The total bacterial count was performed by adopting the medium dilution method and the total molds and yeasts count adopted the conventional plate- count method. The recovery rates of 5 kinds of test organisms were above 70%. The control bacteria were detected by the conventional method, which met the stipulation.Conclusion This method can be used for the microbial limit test of Shengjing Capsule.