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复方首乌藤合剂微生物限度检查的验证
引用本文:张婷,郑绍忠,刘全芳. 复方首乌藤合剂微生物限度检查的验证[J]. 中国医药导报, 2011, 8(31): 76-78
作者姓名:张婷  郑绍忠  刘全芳
作者单位:解放军第一七五医院,厦门大学附属东南医院,药剂科,福建漳州,363000
摘    要:目的:确定可行的复方首乌藤合剂微生物限度检查法。方法:根据《中国药典》2010年版二部附录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:复方首乌藤合剂无抑菌作用,可用常规法进行微生物限度检查。

关 键 词:复方首乌藤合剂  微生物限度检查  验证

Validation of microbial limit test method of Compound Caulis Polygoni Multiflori Mixture
ZHANG Ting,ZHENG Shaozhong,LIU Quanfang. Validation of microbial limit test method of Compound Caulis Polygoni Multiflori Mixture[J]. China Medical Herald, 2011, 8(31): 76-78
Authors:ZHANG Ting  ZHENG Shaozhong  LIU Quanfang
Affiliation:ZHANG Ting,ZHENG Shaozhong,LIU Quanfang Department of Pharmacy,the 175th Hospital of PLA(the Southeast Hospital Affiliated to Xiamen University),Fujian Province,Zhangzhou 363000,China
Abstract:Objective: To establish a method for the microbial limit test of Compound Caulis Polygoni Muhiflori Mixture. Methods: A validation of microbial limit test method was conducted in accordance with routine method in the appendix of Chinese Pharmacopoeia (2010 edition two parts XI). 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 Compound Caulis Polygoni Muhiflori Mixture has no inhibitory effect, and conventional method can be used in microbial limit test.
Keywords:Compound Caulis Polygoni Multiflori Mixture  Microbial limit test  Validation  
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