苯磺酸左旋氨氯地平微生物限度方法验证  

Validation of method on the microbial limit test for LevamLodipine Besylate

作　　者：翟艳[1] 赵沈娟[1] 石晶萍[1] 焦小丽[1] 

机构地区：[1]扬子江药业集团有限公司,泰州225321

出　　处：《海峡药学》2010年第7期91-92,共2页Strait Pharmaceutical Journal

摘　　要：目的建立苯磺酸左旋氨氯地平的微生物限度检查方法 ,并对方法进行验证。方法采用培养基稀释法、薄膜过滤法。结果验证试验中各类菌的回收率均大于70%。结论该方法有效可行,可用于该品种的微生物检查。OBJECTIVE To provide a method of the microbial limit test for Levamlodipine Besylate and carry out the verification of the method. METHODS Dilution and filtering method was used. RESULTS Test recoveries were over 70 % .CONCLUSION It was proved that the method was and reliable, and it can be used for the microbial limit test for Levamlodipine Besylate.

关 键 词：苯磺酸左旋氨氯地平 微生物限度检查法 方法验证 

分 类 号：R915[医药卫生—微生物与生化药学]