泻痢康肠溶胶囊微生物限度检查方法适用性试验研究

Experimental Study on the Applicability of Xie Likang Enteric-coated Capsule Microbial Limit Inspection Method

目的:建立泻痢康肠溶胶囊的微生物限度检查方法。方法:依据《中国药典》2015年版四部通则1105、1106及1107和《中国药品检验标准操作规范》(2010版)收载的微生物限度检查方法对该药品微生物限度检查方法进行适用性试验。结果:需氧菌总数检查时,需要把供试品稀释到10-3;霉菌和酵母菌总数检查时,需要把供试品稀释到10^(-2);大肠埃希菌常规法即可;耐胆盐革兰阴性菌检查时需要增加培养基体积至15 ml;沙门菌检查时需要增加培养基体积至200 ml。结论:需氧菌总数和霉菌和酵母菌总数计数法采用的是供试品溶液稀释法;大肠埃希菌采用的是常规法;耐胆盐革兰阴性菌和沙门菌采用的是增加培养基体积的方法,采用上述方法,回收比值均在0.5~2范围内。

Objective: To establish a microbiological limit inspection method for Xielikang enteric-coated capsules. Methods:The applicability test of the microbiological limit test method for this drug was carried out according to the microbiological limit check method contained in the forth General Rules 1105, 1106, and 1107 of the 2015 edition of the Chinese Pharmacopoeia and the "Chinese Standard Practice for Drug Inspection"(2010 version). Results: When checking the total number of aerobic bacteria, the test sample needs to be diluted to 10-3,when checking the total number of molds and yeasts, the test sample needs to be diluted to 10-2. Escherichia coli routine method can be used. Gall resistance Salt gram-negative bacteria need to increase the volume of medium to 15 ml. Salmonella need to increase the volume of medium to 200 ml. Conclusion: Counting the total aerobic bacteria and the total number of molds and yeasts use the test solution dilution method. Escherichia coli uses the conventional method, the bile-tolerant Gram-negative bacteria and Salmonella use the method of increasing the volume of the medium. Using the above method, the recovery ratio is in the range of 0.5~2.