克拉霉素缓释片微生物限度的检查方法  

Establishment of method for microbial limit test of clarithromycin in sustained release tablets

作　　者：范震洪[1] 

机构地区：[1]北京天坛医院,北京100050

出　　处：《沈阳药科大学学报》2009年第3期230-233,共4页Journal of Shenyang Pharmaceutical University

摘　　要：目的建立克拉霉素缓释片微生物限度检查方法。方法采用薄膜过滤并在冲洗液中加入增溶剂的方法,去除克拉霉素缓释片的抗菌活性。结果满足《中华人民共和国药典》2005版验证试验的基本要求。5株验证菌株中枯草芽孢杆菌对克拉霉素缓释片最敏感,可作为克拉霉素缓释片微生物限度检查方法的质控菌株。结论该方法可作为克拉霉素缓释片的常规微生物限度检查方法。Objective To establish a method for microbial limit test of clarithromycin in sustained release tablets. Methods The filtration method was used to inhibit the residual antimicrobial activity when the solubilizer was added into the solution. Results The method could pass the validation test of Chinese pharmacopoeia 2005 version. The Bacillus subtilis was the most sensitive strain among the five validation strains, which was recommended as positive control in experiments. Conclusions The method can be used in microbial limit test for clarithromycin in sustained release tablets preparation control.

关 键 词：克拉霉素 缓释片 薄膜过滤 增溶剂 质控菌株 

分 类 号：R914[医药卫生—药物化学] R282.71[医药卫生—药学]