摘要
目的:建立口炎清颗粒的微生物限度检查方法,并对其检验方法进行验证。方法:按照《中华人民共和国药典》2015年版四部通则1105非无菌产品微生物限度检查:微生物计数法、通则1106非无菌产品微生物限度检查:控制菌检查法和通则1107非无菌药品微生物限度标准进行方法适用性试验。结果:采用常规法对样品进行需氧菌总数、霉菌和酵母菌计数方法适用性试验中,试验组与菌液对照组的比值为0. 5～2;采用常规法进行控制菌检查方法适用性试验中,试验组检出阳性试验菌。结论:此方法可作为口炎清颗粒微生物限度的检查方法。
Objective:To establish and validate the microbial limit test methods for Kouyanqing Granule.Methods:According to the general guidelines of 1105,1106,and 1107 in Chinese Pharmacopoeia(edition 2015)for non-sterile drugs carry out suitability of microbial limit test method.Results:The applicability of the general method to count the total number of aerobic bacteria,molds and yeasts in the samples was tested.The ratio between test group and microorganism solution group were between 0.5 and 2.In the control bacteria tests,the control bacteria was found in the test group.Conclusion:Above mentioned method can be used for microbial limit test of the product.
作者
刘荔
刘兴国
白雯静
李天荣
LIU Li;LIU Xing-gou;BAI Wen-jing;LI Tian-rong(Lanzhou Institute for Food and Drug Control,Gansu Lanzhou 730050,China;Lanzhou University,Gansu Lanzhou 730000,China)
出处
《中国药物评价》
2019年第2期101-102,110,共3页
Chinese Journal of Drug Evaluation
