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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。
OBJECTIVE To establish a method for the determination of zoledronic acid in microorganisms and the sterility test of zoledronic acid injection. Methods According to the requirements of Chinese Pharmacopoeia 2015 edition four methods suitability test. Results The limit of detection of zoledronic acid was determined by the method of membrane filtration, aerobic count, total count of molds and yeasts. The recovery ratios of five kinds of test bacteria were between 0.5 and 2. The control strains Escherichia coli Check the test group can detect E. coli. Zoledronic acid injection sterile test method using membrane filtration method, six kinds of test bacteria can be detected. Conclusion The zoledronic acid microbial limit test method and zoledronic acid injection sterile test methods should adopt the membrane filtration method.