与中药注射剂相关的技术性规范的研究

Study on Technology Standards about TCM Injection

目的:更好的理解与中药注射剂相关的技术性规范内容,提高中药注射剂质量。方法:对《中药、天然药物注射剂基本技术要求》、2010年版《中国药典》、《中药、天然药物处方药说明书格式》、《中药、天然药物处方药说明书内容书写要求》、《中药、天然药物药品说明书撰写指导原则》、《中药注射剂临床使用基本原则》6个规范进行分析和解读。结果与结论:与中药注射剂相关的技术性规范对这一产业的发展起到了促进作用,但仍有很多不足之处有待改进。

OBJECTIVE：To understand the technology standards about TCM injection,and to improve the quality of TCM injection.METHODS：Six technology standards about TCM injection were analyzed and interpreted,i.e.Basic Technology Requirements of TCM and Natural Drug Injection,Chinese Pharmacopeia（2010 edition）,Package Inserts Format for Prescription Drugs of TCM and Natural Drugs,Package Inserts Writing Requirements for Prescription Drugs of TCM and Natural Drugs and General Principle for Clinical Use of TCM Injection.RESULTSCONCLUSION：The technology standards of TCM injection promote the development of this industry in a certain extent,but there are still some shortcomings.