[摘要]微生物的污染以及生长繁殖是影响中药及其制剂质量的重要因素。中药及其制剂在生产过程中，因环境空气、设备用具及操作人员等原因，极易出现染菌现象，影响最终产品质量和临床疗效。中药生产企业药品GMP认证检查明确规定：“中药材、中间产品、成品的灭菌方法以是否不改变质量为原则”、“直接入药的药材粉末，以是否做微生物检查为原则”。因此，选择科学有效的灭菌技术和方法，对产品质量、企业能耗及其效益尤为重要。臭氧是一种安全、环保、高效、无残留的新兴灭菌技术，目前已被广泛应用于医疗卫生及生产生活等各领域。该文通过对臭氧灭菌技术进行系统分析，旨在探讨臭氧灭菌原理、优势、应用现状以及存在的问题等，总结臭氧灭菌管理办法和实施细则，指导中药及其制剂的生产、管理和质量控制等环节的灭菌规范化、合理化、科学化，为臭氧灭菌技术应用于中药及其制剂的适宜性提供理论参考。
[关键词]臭氧灭菌;中药;应用现状;优势;存在问题
Preliminary study on suitability of ozone sterilization in traditional
Chinese medicine and its preparation
HU Yan-jun， WANG Ya-qi*， WU Zhen-feng， LAN Ji-ping， ZHANG Li-guo， YANG Ming*
（Key Laboratory of Modern Preparation of Traditional Chinese Medicine， Ministry of Education，
Jiangxi University of Traditional Chinese Medicine， Nanchang 330004， China）
[Abstract]Microbial contamination， growth and reproduction have a great influence on the quality of traditional Chinese medicine （TCM） and its preparation. TCM may be polluted by microbial in the production process due to ambient air， facilities and appliances and operating personnel， which affects the quality and efficacy of the final product. The GMP certification inspection standard of TCM manufacturing enterprises clearly established： "Sterilization methods of Chinese herbal medicine， intermediate products， finished products should follow the principle whether or not to change its quality "， "TCM powder that used as medicine directly should follow the principle whether to do microbiological examinations". So it′s particularly important for product quality， corporate energy consumption and its efficiency to choose the scientific and effective sterilization techniques and methods. Ozone is a kind of safe， environmentally friendly， efficient and no residue emerging sterilization technology. It has been widely applied in various fields of medical and health care and production and living. This paper mainly analyzed the ozone sterilization technology of TCM， aiming to explore the principle of ozone sterilization， the advantages， application status and existing problems and so on. The management regulations and implementation rules of ozone sterilization were summarized to make sterilization of Chinese medicine in the production， management， quality control and other aspects standardized， reasonable and scientific， and to provide the theoretical reference of the ozone sterilization technology for TCM and its preparation.
[Key words]ozone sterilization; traditional Chinese medicine; application status; advantages; problem analysis