中药饮片由中药材炮制加工而成,而中药材一般来源有动物药、植物药及矿物药等,其本身带有一定微生物,生产加工过程也会引入微生物。饮片中的微生物生长繁殖影响饮片质量,甚至部分有害微生物通过口服进入人体,影响患者健康和生命安全。因此,对中药饮片进行灭菌处理及控制其微生物限度具有十分重要的意义。总结了中药饮片微生物控制的研究现状及生产过程中常用的灭菌方法及适用范围等,对中药饮片的灭菌问题进行了探讨,提出特别注重“原形饮片”的灭菌、制定其微生物限度等思路,旨在提高中药饮片质量标准,保证中药饮片的用药安全。

Decoction pieces of Chinese herbal medicine (CHM) was processed by Chinese medicinal materials, and generally the sources of medicinal materials were from animals, botanical, mineral drugs, etc., with itself microorganisms which could be introduced in the production process too. The microbial growth and reproduction in pieces will affect the quality of the pieces, even some of the harmful microorganisms affect the health and safety of patients through the oral administration. Therefore, it is important to sterilize the pieces under the controlled microbial limits. This article summarizes the microbial control of CHM research status and commonly sterilization methods in the production process, considers and discusses the problems on sterilization issues of CHM, and puts forward the suggestion on the thoughts of a special focus on “prototype pieces” sterilization, the establishment of its microbial limit, which could improve the quality standard of CHM so as to ensure the safely and effecacy of CHM pieces.

国家“十二五”科技支撑计划项目(2012BAI29B11)