中药饮片中需氧菌、霉菌和酵母菌污染情况的研究及分析

Contamination and limits for aerobic bacteria,mold and yeast in processed pieces of chinese materia medica

目的:分析市售10种中药饮片,共计100个批次中的需氧菌、霉菌和酵母菌的污染状况,并对其检查和限度标准提出合理建议。方法:采用《中国药典》2015年版四部"1105非无菌产品微生物限度检查:微生物计数法"进行检查。结果:中药饮片的需氧菌、霉菌和酵母菌污染程度较高,并与其来源、形态和炮制处理方法有一定的关联性。结论:建议初期根据中药饮片的来源、形态、炮制方法,并结合实际用途来制定相应的微生物限度标准,同时要求生产厂家改进工艺,最终实现中药饮片、中药提取物、中药制剂等微生物限度标准的统一。

Objective：To investigate the microbial contamination in ten processed pieces of 100 samples from Chinese materia medica（CMM）and to put some rational suggestioins for test methods and for microbial limit to mold and yeast.Method：Test was carried out according to Microbiological Examination of Nonsterile Products：Microbial Enumeration Tests in Chinese Pharmacopeia 2015 Ⅳ 〈1105〉.Results：The contamination degree of the aerobic bacteria,mold and yeast in processed pieces of CMM was high,which might be related to their sources,form and processing methods.Conclusion：For processed pieces of CMM,microbial limit should be varied according to their sources,form and processing methods combined with their actual applications.It is required to improve the existing processing methods to follow an identical microbial limit for all the processed pieces of CMM,extracts and preparations of Traditional Chinese Medicine.