小儿咳喘灵口服液微生物限度检查方法验证

Validation of Microbial Limit Method of Children Kechuan Oral Liquid

目的:建立小儿咳喘灵口服液微生物限度检查法,并对方法进行验证。方法:将供试品配制1:10的溶液,按常规法进行细菌数、霉菌和酵母菌数检查及控制菌(大肠埃希菌)的检查。结果:在3批样品独立的平行试验中,细菌数、霉菌和酵母菌数检查方法的验证试验,5株试验菌回收率均大于70%;控制菌检查中,检查大肠埃希菌,试验组均可检出试验菌,阴性组均无菌生长,阴性菌对照组均无菌生长。结论:采用常规法对该品种进行细菌数,霉菌和酵母菌计数及控制菌检查,方法有效可行。

Objective： To establish a method for the microbial limit test of Children Kechuan oral liquid. Methods：The sample preparation of 1：10 solution, bacteria, yeast and mold counts the number of inspection and control bacteria by conventional method （Escherichia coli）examination. Results：In the parallel test of Three batches of samples, verification test bacteria, yeast and mold count number check method, 5 strains of tested bacteria recovery rate was more than 70%;The control bacteria examination determination, Escherichia coli, the test group were detected bacteria, negative group are sterile growth, Gram-negative bacteria in the control group had no growth. Concluslon：The number of bacteria by routine method, molds and yeasts count and control bacteria examination,effec-tive and feasible method.