蒲地蓝消炎片微生物限度检查方法的验证(1)
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[摘要] 目的:建立蒲地蓝消炎片微生物限度检查的方法。方法:参照《中国药典》2005版,采用5种阳性对照菌回收率试验测定其是否含抑菌成分。结果:按供试品制备方法,各试验菌样品中的回收率均大于70%。结论:采用培养基稀释法可消除药品的抑菌作用,可有效地检出污染的微生物,使测定结果准确,药品质量安全有效,可用于该药品的微生物限度检查。
[关键词] 蒲地蓝消炎片;微生物限度检查;培养基稀释法;验证
[中图分类号]R927 [文献标识码]A [文章编号]1673-7210(2009)08(a)-076-02
Validation of methods in microbial limit tests for Pudilan Xiaoyan Tablets
XIE Yanli
(The First People's Hospital of Pinjiang, Hu'nan Province, Pinjiang 414500, China)
[Abstract] Objective: To establish a method of microbial limit tests for Pudilan Xiaoyan Tablets. Methods: According to China Pharmacopoeia edition 2005, 5 positive control trains were carried out to determine the recovery rate of antimicrobial effect. Results: According to the results, the recovery rates of sample were over 70% ......
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