摘要
目的研究5种医院制剂的抑菌作用,按照中国药典2015年版对方法进行适用性试验验证研究,建立5种医院制剂的微生物限度检查法和控制菌检查法,比较稀释剂对试验结果的影响。方法按照中国药典2015年版四部通则非无菌产品微生物限度检查:微生物计数法(通则1105)、非无菌产品微生物限度检查:控制菌检查(通则1106)等,以5种医院制剂为研究对象进行方法学建立和验证试验,并比较两种稀释剂对试验结果的影响,以阳性菌回收率对建立的方法进行有效评价。结果五种医院制剂的需氧菌总数、霉菌及酵母菌总数计数均采用平皿法;控制菌检查采用一般方法进行检验。结论两种稀释剂对5种医院制剂的检验结果均没有影响,建立了五种医院制剂的微生物限度检查法。
Objective To study the antibacterial effect of five kinds of hospital preparations,to test and verify the applicability of the method according to the 2015 edition of Chinese Pharmacopoeia,to establish the microbiological limit examination method and control bacteriological examination method of five kinds of hospital preparations,and to compare the effects of diluent on the test results.Methods According to the four general rules of the Chinese Pharmacopoeia of 2015,the microbial limit examination of non-sterile products:the microbial counting method(general rule 1105),the microbial limit inspection of non-sterile products:the control of bacteria examination(general rule 1106),etc.Five kinds of hospital preparations were used to establish and validate the methodology,and the effects of two diluents on the test results were compared.Results The total number of aerobic bacteria,molds and yeasts in five kinds of hospital preparations were counted by the method of flat dish.The general method is used to check the control bacteria.Conclusion The two diluents have no effect on the test results of five kinds of hospital preparations.A method of microbial limit examination of five kinds of hospital preparations was established.
作者
吴宏扬
袁巍
WU Hongyang;YUAN Wei(Microbiology Laboratory,Langfang Institute of Drug Control,Langfang Hebei 065000,China)
出处
《中国卫生标准管理》
2018年第24期70-73,共4页
China Health Standard Management
