中药及其制剂辐照灭菌技术应用现状分析  

Analysis of the Application Status of Radiation Sterilization in Traditional Chinese Medicine and its Preparation

作　　者：王宝才[1] 李俊江[1] WANG Baocai;LI Junjiang(Gansu Provincial Hospital of TCM,Lanzhou Gansu 730050,China)

机构地区：[1]甘肃省中医院,甘肃兰州730050

出　　处：《甘肃科技纵横》2024年第1期64-70,共7页Scientific & Technical Information of Gansu

摘　　要：制药卫生是药品生产质量管理规范(GMP)的一项重要内容,也是药品生产最基本的要求之一。药品生产过程中涉及到人、机、料、环等因素均是微生物污染的来源,而微生物的污染和滋生会严重影响中药及其制剂的质量和临床疗效。因此,针对污染源选择适宜的灭菌方式关系到临床用药的有效性和安全性。辐照灭菌技术具有快捷、彻底、绿色环保、无污染、无残留、节能的特点,该技术已广泛应用于药品、医疗器械、食品等领域。文章主要对辐照灭菌技术的原理、特点、应用现状、工艺存在的问题、研究方向与思路进行了全面分析,期望能为辐照灭菌技术合理地应用于中药科研与生产提供参考。Pharmaceutical hygiene is an important content of GMP and one of the most basic requirements of drug production.The human,machine,material,environment and other factors involved in the drug production pro-cess are the sources of microbial pollution,and microbial pollution and breeding will seriously affect the quality and clinical efficacy of traditional Chinese medicine and its preparations.Therefore,the selection of appropriate steril-ization method is related to the effectiveness and safety of clinical medication.Irradiation sterilization technology has the characteristics of fast,thorough,green,no pollution,no residue and energy saving.It has been widely used in medicine,medical products,food and other fields.This paper mainly analyzes the principle,characteristics,ap-plication status and problems of equipment and technology of irradiation sterilization technology,hoping to provide reference for the application of irradiation sterilization technology in scientific research and production of traditional Chinese medicine.

关 键 词：中药 辐照灭菌 应用现状 检测标准 

分 类 号：R288[医药卫生—中药学]