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苯磺酸左旋氨氯地平微生物限度方法验证
引用本文:翟艳,赵沈娟,石晶萍,焦小丽. 苯磺酸左旋氨氯地平微生物限度方法验证[J]. 海峡药学, 2010, 22(7): 91-92
作者姓名:翟艳  赵沈娟  石晶萍  焦小丽
作者单位:扬子江药业集团有限公司,泰州,225321;扬子江药业集团有限公司,泰州,225321;扬子江药业集团有限公司,泰州,225321;扬子江药业集团有限公司,泰州,225321
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。

关 键 词:苯磺酸左旋氨氯地平  微生物限度检查法  方法验证

Validation of method on the microbial limit test for Levamlodipine Besylate
ZHAI Yan,ZHAO Shen-juan,SHI Jing-ping,JIAO Xiao-li. Validation of method on the microbial limit test for Levamlodipine Besylate[J]. Strait Pharmaceutical Journal, 2010, 22(7): 91-92
Authors:ZHAI Yan  ZHAO Shen-juan  SHI Jing-ping  JIAO Xiao-li
Affiliation:(Yangtza River Pharmaceutical Group Co. Ltd., Taizhou 225321, China)
Abstract:
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.
Keywords:Levamlodipine Besylate  microbial limit test  validation of the method
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