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Abstract
Pharmaceutical Care and Research: 2018; 18(4):300-303
DOI: 10.5428/pcar20180418
Study on the applicability of microbial limit tests for six kinds of traditional Chinese patent medicines
1. WANG ZhiJun(Department of Pharmacy,Changhai Hospital,Second Military Medical University,Shanghai 200433,China wl19521957@126.com)
2. MEI LiQian(Department of Pharmacy,Changhai Hospital,Second Military Medical University,Shanghai 200433,China meibbs@hotmail.com)
3. WANG XiaoJun(Department of Pharmacy,Changhai Hospital,Second Military Medical University,Shanghai 200433,China )
4. GAO HongBin(Department of Pharmacy,Changhai Hospital,Second Military Medical University,Shanghai 200433,China )
5. HU YeShuai(Department of Pharmacy,Changhai Hospital,Second Military Medical University,Shanghai 200433,China )
6. SONG HongJie(Department of Pharmacy,Changhai Hospital,Second Military Medical University,Shanghai 200433,China h_jsong@126.com)
ABSTRACT  Objective: To establish applicable methods of microbial limit tests for six kinds of traditional Chinese patent medicines.Methods and results:According to the requirements of Pharmacopoeia of the People’s Republic of China(2015 ed),the applicability of microbial limit tests for six kinds of traditional Chinese patent medicines, such as Danmaining tablets,Ganfu capsules,Yuchang granules,Qinmei granules,Weiweiling granules and Compound Chuipencao capsules were validated.(1)Validation of microbial counting methods:the microorganisms of Danmaining tablets and Ganfu capsules could be counted by the plate method and antibacterial activity could be eliminated with the 1∶100(ww) dilution.The microorganisms of Qinmei granules,Yuchang granules,Weiweiling granules and Compound Chuipencao capsules could be counted by the membrane filtration method due to their strong antibacterial effect.The microbial count recovery rate of the six preparations ranged from 0.5 to 2.(2) Validation of specified bacteria tests:Danmaining tablets and Ganfu capsules were tested by conventional inspection method.Qinmei granules,Yuchang granules,Weiweiling granules and Compound Chuipencao capsules were tested by membrane filtration method.The results of specified bacteria tests were all positive.Conclusion:The established methods could be used for routine microbial limit tests of these preparations.
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Please cite this article as:
WANG ZhiJun,MEI LiQian,WANG XiaoJun,GAO HongBin,HU YeShuai,SONG HongJie,. Study on the applicability of microbial limit tests for six kinds of traditional Chinese patent medicines[J]. Pharmaceutical Care and Research / yao xue fu wu yu yan jiu. 2018; 18(4): 300-303.
References:
1. State Pharmacopoeia Committee.Pharmacopoeia of the People’s Republic of China.2015 ed.Volume 4[S]. Beijing:Chinese Medical Science Press, 2015:136-151.In Chinese.
2. ZHAO HuiLan.Method validation of microbial limit test of 15 kinds of traditional Chinese patent medicines[J].China Licens Pharm, 2014,11(5):17-20.In Chinese with English abstract.
3. LI YaNa, TAO QingChun. Research status and thinking on the antibacterial activity of traditional Chinese materia medica[J].Int J Lab Med,2014,35(2):198-200.In Chinese.
4. LIN Yan.Exploration of microbial limit tests of Chinese patent medicine containing antibacterial components[J].Prim J Chin Mat Medica,2002,16(6):39,46.In Chinese.
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