他克莫司胶囊微生物限度检查法验证的探讨  

Research on the microbial limit verification test of tacrolimus capsules

作　　者：占景华 石鹤坤[1,3] 钟渊福 董智聪 胡永狮[1,2] 

机构地区：[1]中国人民解放军第一七五医院 [2]厦门大学附属东南医院中心实验室,福建363000 [3]厦门大学附属东南医院药学科,福建363000

出　　处：《实用药物与临床》2014年第11期1442-1445,共4页Practical Pharmacy and Clinical Remedies

摘　　要：目的按2010版《中国药典》的要求探讨他克莫司胶囊微生物限度检测方法。方法选取5种具有代表性的微生物菌悬液,用常规法、稀释法、膜过滤法或其相结合的方法分别对他克莫司胶囊进行微生物验证试验。结果细菌总数用膜过滤法稀释1∶10,霉菌和酵母菌用膜过滤法稀释1∶1 000,检测后回收率均能达到70%以上。结论避免采用单一常规法或膜过滤法进行微生物限度检测,使实验科学合理,提高工作效率,更加规范性。Objective To research the microbial limit verification test of tacrolimus capsules according to the requirements of the 2010-edition Chinese Pharmacopoeia. Methods Five types of representative microbial bacterial suspension were selected and then microbial verification tests on tacrolimus capsules through the conventional method, the dilution method, the membrane filtration method or a combination of the above methods respectively were carried out. Results Both of the recovery rates were more than 70% when the total number of bacterial was detected by the membrane filtration method as per 1：10 and when mould and yeast were detected by the membrane filtration method as per 1 ： 1 000. Conclusion Microbial limit test through the single conventional method or membrane filtration method is avoided so as to ensure scientific and reasonable experiment, improve work efficiency and achieve normalization.

关 键 词：微生物方法验证 稀释法 膜过滤法 

分 类 号：R927.1[医药卫生—药学]