益肝灵软胶囊微生物限度检查方法学研究

Study on Validation of the Method for Microbial Limit Test of Yiganling soft capsules

目的:建立益肝灵软胶囊的微生物限度检查方法。方法:按《中国药典》2010版一部微生物限度的检查方法,对细菌、霉菌及酵母菌计数方法和控制菌检查法进行验证,通过比较回收率确定适宜的检查方法。结果:益肝灵软胶囊用培养基稀释法(0.5ml/皿)进行细菌计数检查;用平皿法进行霉菌和酵母菌计数检查;按常规法进行控制菌的检查。结论:建立了益肝灵软胶囊微生物限度检查法,方法合理有效,结果可靠。

Objietive：To establish the microbial limit test of Yiganling soft capsules and to validate the method. Methods：According to the method for microbial linit test in appendix of Chinese Pharmacopeia （2010 edition）,the counting method of bacteria,mucedine and saccharomycetes and controlled bacteria tests were validated. Suitable method was confirmed by comparing recovery. Results： Bacteria test was carried out using mediun dilution method, and saccharomycetes and controlled bacteria tests were carried nut using conventional method. Conclusions：With the validation, the microbial limit test of Yiganling soft capsules is established. This method is very simple and suitable for practical application.