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姜胆咳喘片微生物限度检查方法的验证
引用本文:陈华龙,王莉蓓,谭莉萍.姜胆咳喘片微生物限度检查方法的验证[J].中国实验方剂学杂志,2010,16(11):67-69.
作者姓名:陈华龙  王莉蓓  谭莉萍
作者单位:1. 韶关市药品检验所,广东,韶关,512028
2. 韶关学院医学院,广东,韶关,512026
摘    要:目的:建立姜胆咳喘片的微生物限度检查方法。方法:参照《中国药典》2005年版,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:该品种对金黄色葡萄球菌和枯草芽孢杆菌有抑菌活性,采用离心沉淀集菌和培养基稀释联用的方法进行细菌数的测定,采用常规法进行霉菌和酵母菌数的测定及控制菌的检查。结论:用该法进行微生物限度检查,可以客观地反映药物中微生物的污染状况,可行性强,能达到检测目的。

关 键 词:姜胆咳喘片  微生物限度检查法  培养基稀释法
收稿时间:2010/3/24 0:00:00

Validation of Method for Microbial Limit Test of Jiangdan Kechuan Tablets
CHEN Hua-long,WANG Li-bei and TAN Li-ping.Validation of Method for Microbial Limit Test of Jiangdan Kechuan Tablets[J].China Journal of Experimental Traditional Medical Formulae,2010,16(11):67-69.
Authors:CHEN Hua-long  WANG Li-bei and TAN Li-ping
Institution:Shaoguan Institute for Drug Control, Shaoguan 512028, China;Shaoguan Institute for Drug Control, Shaoguan 512028, China;Medicine College of Shaoguan University, Shaoguan 512026, China
Abstract:Objective: To establish a method to determine the microbial limit test for Jiangdan Kechuan Tablets. Method: According to China Pharmacopoeia edition 2005, the antimicrobial effect of Jiangdan Kechuan Tablets was determined by recovery rate with 5 control trains. Result: Antibacterial effect was found against Staphyloccocus aureus Rosenbach and Bacillus subtilis Cohn. Centrifuging medium and diluting method were used for counting bacteria. Conclusion: The method is simple, feasible and accurate.
Keywords:Jiangdan Kechuan Tablets  microbial limit test  methodology  dilution method
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