唑来膦酸及其制剂的微生物学检查方法研究

Study on Microbiological Examination Methods of Zoledronic Acid and Zoledronic Acid Injection

关键词:  唑来膦酸  唑来膦酸注射液  微生物限度检查法  无菌检查法  方法适用性试验  薄膜过滤法

Key words:  zoledronic acid  zoledronic acid injection  microbial limit test  sterility test  applicability of method  membrane filtration method

摘要:

目的 建立唑来膦酸的微生物限度检查方法以及唑来膦酸注射液的无菌检查方法。方法 按中国药典2015年版四部要求进行方法适用性试验。结果 唑来膦酸微生物限度检查法采用薄膜过滤法，需氧菌总数、霉菌和酵母菌总数计数方法适用性试验5种试验菌回收率比值均在0.5~2之间；控制菌大肠埃希菌检查试验组可检出大肠埃希菌。唑来膦酸注射液无菌检查方法采用薄膜过滤法，6种试验菌均能检出。结论 唑来膦酸的微生物限度检查方法及唑来膦酸注射液的无菌检查方法均宜采用薄膜过滤法。

Abstract:

OBJECTIVE To establish the method of microbial limit test of zoledronic acid and the method of sterility test of zoledronic acid injection.METHODS The method validation was conducted by microbial limit test from appendixes in Chinese Pharmacopeia (Edition 2015).RESULTS Microbial limit test of zoledronic acid was using membrane filtration method,the recoveries of the total number of aerobic bacteria,molds and yeasts were between 0.5 and 2,Escherichia coli could be detected in the Escherichia coli test group.The sterility test of zoledronic acid injection was using membrane filtration,and the six test bacteria could be detected.CONCLUSION The microbiological examination methods of zoledronic acid and zoledronic acid injection is used membrane filtration method.