消炎灵胶囊微生物限度检查适用性方法探索研究  

Study on the Applicability of Microbial Limit Test for XiaoYanLing Capsules

作　　者：周映佑 薛咏兰 黄婕[1] 滕钰 肖丹 ZHOU Ying-you;XUE Yong-lan;HUANG Jie;TEN Yu;XIAO Dan(Guizhou Institute for Food and Drug Control,Guiyang 550004,China;Guizhou Provincial Institute of Food Inspection and Testing,Guiyang 550004,China)

机构地区：[1]贵州省食品药品检验所,贵州贵阳550004 [2]贵州省食品检验检测院,贵州贵阳550004

出　　处：《海峡药学》2022年第6期44-48,共5页Strait Pharmaceutical Journal

摘　　要：目的建立消炎灵胶囊的微生物限度检查适用性方法,并对不同省份3个企业48批样品进行微生物限度检查及结果分析。方法按《中国药典》2020年版四部通则非无菌产品微生物限度检查方法(1105、1106和1107)进行方法探索研究。结果本品对金黄色葡萄球菌和铜绿假单胞菌有一定的抑菌活性,需氧菌总数采用供试液稀释法(1∶50,每皿1 mL)、霉菌和酵母菌总数采用常规法计数回收率均能达到0.5~2要求;大肠埃希菌、耐胆盐革兰氏阴性菌和沙门菌采用常规法,阳性菌均能生长良好。结论统一了消炎灵胶囊的微生物限度检查适用性方法,且方法可行;48批样品的微生物限度检查结果均符合规定。OBJECTIVE Establishment of microbial limit test for XiaoYanLing Capsule was established,and the microbial limit test and result analysis were carried out on 48 batches of samples from 3 enterprises in different provinces.METHODS According to the method of microbial limit inspection of four non-aseptic products(general rules 1105,1106 and 1107)in Chinese Pharmacopoeia 2020.RESULTS It had antibacterial activity against on Staphylococcus aureus and Pseudomonas aeruginosa,the total number of aerobic bacteria using the dilution method(1∶50,1 mL per dish),the total number of mold and yeast using the conventional method to count recovery rate could reach 0.5~2;The Escherichia coli,Bile-tolerant gram-negative bacteria and Salmonella could grow well by conventional method.CONCLUSION The method of microbial limit test for XiaoYanLing capsule was unified and feasible;The results of microbial limit test for 48 batches of products were all in accordance with the regulations.

关 键 词：消炎灵胶囊 微生物限度检查 《中国药典》2020年版 供试液稀释法 

分 类 号：R927[医药卫生—药学]