复方甘草口服溶液微生物限度检查法验证实验
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[摘要] 目的：建立复方甘草口服溶液的微生物限度检查法。方法：根据《中国药典》2005版二部附录ⅪJ微生物限度检查法常规法进行验证试验。结果：试验组的菌回收率均大于70%，控制菌常规法验证检出阳性菌，阴性菌未检出。结论：复方甘草口服溶液微生物限度检查法符合《中国药典》的验证规定。
[关键词] 复方甘草口服溶液；微生物限度检查；验证
[中图分类号]R927.1 [文献标识码]A [文章编号]1673-7210(2008)07(a)-30-02
Validation of microbial limit test method of Compound Glycyrrhiza Oral Solution
GAO Jie
(Affiliated Hospital of Nantong University, Nantong 226001,China)
[Abstract] Objective: To establish a method for the microbial limit test of Compound Glycyrrhiza Oral Solution.Methods:A validation of microbial limit test method was conducted in accordance with routine method stated in the Appendix of Chinese Pharmacopoeia(2005 edition).Results:The recoveries of test organisms by routine method were more than 70%, the test organisms were detected in the control bacteria test and were not detected in the negative control bacteria test. Conclusion:The method for the microbial limit test of Compound Glycyrrhiza Oral Solution was validated ......
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