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《Practical Journal of Medicine & Pharmacy》 2018-01
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Establishment of microbial limit test for Compound Zicao Oil

GAO Yuan;LIU Yun-yun;MA Xiao-yu;Institute for Drug and Instrument Control,Jinan Military Region;  
Objective To establish the method for the microbial examination of Compound Zicao Oil.Methods According to the microbial limit test in the four books of Chinese Pharmacopoeia(2015 Edition),the applicability test for Compound Zicao Oil was conducted. The samples were dissolved by sterilized isopropyl myristate,polysorbita 80 or mixed neutralizer. Results Using isopropyl myristate or polysorbita 80 as neutralizer separately to mixed together couldn't get a stable solution,however using sterilized glyceryl monostearate,polysorbita 80 and span 80 as mixed neutralizer could get a stable solution. The recovery ratio of applicability test of total count of aerobic bacteria and total count of molds were in the range of 0.5-2.0. Every positive test microorganism could be detected while negative control one could not grow in the examination of control microorganisms. Conclusion This method could be applied for the microbial limit test of Fufang Zicao Oil.
【Fund】: 军队医疗机构制剂标准提高科研专项课题计划(No.13ZJZ21-1)
【CateGory Index】: R286.0
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