7种医院外用制剂微生物限度检查法的适用性试验

Applicability Test of Microbial Limit Test for 7 Kinds of Hospital Preparations for External Application

目的建立7种医院外用制剂微生物限度检验方法。方法按照《中国药典》2015年版(四部)通则1105~1107的规定,采用平皿法和薄膜过滤法分别对7种医院外用制剂的微生物限度检查方法进行适用性试验。结果本研究所建立的方法能使5种试验菌株的回收比值在0.5~2范围内,控制菌均能检出,阴性对照组未检出控制菌。结论本研究建立的检验方法,操作简便快速,结果准确可靠,能较好的控制7种医院外用制剂的质量。

OBJECTIVE To establish a method of microbial limit test for 7 kinds of hospital preparations for external application.METHODS The routine pour-plate method and membrane-filter procedure method were used in the applicability test referring to the microbial limit test method recorded in the general rules(1105~1107)of Chinese PharmacopoeiaⅣ(2015 edition).RESULTS The method established in this study has a recovery r ate of 0.5-2 for 5 kinds of proven bacterial strains.In the method validations,control bacteria were detected,and no control bacteria were detected out in the negative control group.CONCLUSION The method is simple,rapid,and the results are accurate and reliable.It can better control the quality of the 7 kinds of hospital preparations.