复方槐米胶囊微生物限度检查法的方法验证

Validation Method Used for Microbial Limit Tests of Compound Huaimi Capsules

目的建立复方槐米胶囊微生物限度检查方法。方法按中国药典2005版有关规定,采用5种阳性对照菌回收率试验进行其方法学验证试验。结果该药有一定程度的抑菌作用,但可通过培养基稀释法消除抑菌作用。结论复方槐米胶囊细菌计数和大肠埃希菌检查采用培养基稀释法进行检测,霉菌、酵母菌计数和沙门菌检查采用常规法即可。

Aim To establish a method for microbial limit tests of compound Huaimi capsules. Methods The 5 control strains recovery test validation method was used as described in the Chinese Pharmacopoeia 2005 edition . Results The medicine has some antimicrobial effect which can be eliminated by the culture medium dilution method. Conclusions The results suggested that culture medium dilution method could be used for counting bacteria and detecting Escherichia coll. while the conventional method could be used common method for counting fungi and for detecting salmonella.