唑来膦酸及其制剂的微生物学检查方法研究-中国现代应用药学.PDF

唑来膦酸及其制剂的微生物学检查方法研究 李冬梅，王钰宁，刘永利，冯丽(河北省药品检验研究院，石家庄 050011) 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。 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 中图分类号：R943 文献标志码：B 文章编号： DOI: 10.13748/ki.issn1007-7693.2017. 引用本文： Research on Microbiological Examination Methods of Zoledronic Acid and Zoledronic Acid Injection LI Dongmei, WANG Yuning, LIU Yongli, FENG Li(Hebei Institute for Drug Control, Shijiazhuang 050011, China) 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 can 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 by Chinese Pharmacopeia(edition 2015) of Zoledronic acid and Zoledronic acid Injection was used membrane filtration method. KEYWORDS: Zoledronic acid; Zoledronic acid Injection; microbial limit test; sterility test; applicability of method; membrane filtration method 唑来膦酸是一种特异性的作用于骨的二磷酸 采用薄膜过滤法更适合。 化合物，能抑制破骨活性增加导致的骨吸收[1] ，其 1 仪器与材料 制剂唑来膦酸注射液(规格为 100 mL ∶5 mg)主要 1.1 仪器设备 用于骨质疏松症、变形性骨炎等[2] 。中国药典2005 IPP 260 培养箱(德国3M 公司) ；KB 240 培养 年版