中药饮片中控制菌的研究及分析

Research and analysis of control bacteria in processed pieces of Chinese materia medica

目的:分析市售10种中药饮片,共计100个批次的控制菌污染状况,并根据实际情况提出合理建议。方法:采用《中国药典》2015年版四部"1106非无菌产品微生物限度检查:控制菌检查法"和国标4789系列方法进行检查。结果:耐胆盐革兰阴性菌的非预培和预培的lg值反映了中药饮片该类污染的4种情况,说明了预培的lg值与非预培的lg值无明显的关系,而与污染微生物受损情况有很大关系;中药饮片中大肠埃希菌、金黄色葡萄球菌和铜绿假单胞菌的检出率较高,沙门菌的检出率较低,志贺氏菌、白色念珠菌和溶血性链球菌的检出率很低。结论:中药饮片污染菌情况复杂,需根据中药饮片的特点制定相应的个性化标准来解决实际质控的难题。

Objective：To investigate the microbial contamination in 100 samples from ten processed pieces of Chinese materia medica（CMM）.Method：Test was carried out according to Microbiological Examination of Nonsterile Products：Tests for specified microorganisms in Chinese Pharmacopeia 2015 Ⅳ1106 and GB 4789.Results：lg value of non-pre-cultured and pre-cultured bile salt resistant Gram-negative bacteria had four types of contaminations in processed pieces of CMM,which indicated that there was no significant relationship between the pre cultured and non-pre-cultured,but related to damage degree of contaminated microorganisms;detection rates of Escherichia coli,Staphylococcus aureus and Pseudomonas aeruginosa were high,Salmonella was low,and Shigella,Candida albicans and hemolytic streptococcus were lower in processed pieces of CMM.Conclusion：The bacteria contaminations are very complicated in processed pieces of CMM.The practical quality control should be stipulated individual standard in accordance with the characteristics of processed pieces of CMM.