中药注射剂说明书安全性信息报告调查分析

通过文献检索与实地收集相结合的方式,获取《国家基本医疗保险、工伤保险和生育保险目录》(2017年版)中涉及的中药注射剂品种(包括所有生产企业)的说明书。按照国家药品监督管理局发布的《中药、天然药物处方药说明书撰写指导原则》等相关管理条例的要求,对纳入的中药注射剂说明书中涉及到的安全性信息,包括成分、警示语、不良反应、禁忌报告、注意事项、特殊人群用药提示、药物相互作用、临床试验及药理毒理报告等项目的标注情况逐一进行统计分析。并对中药注射剂安全性研究和中药注射剂说明书安全性信息的完善提出思考及建议,为进一步完善药品说明书提供依据,也为中药安全性研究提供参考。

Investigation and Analysis on Safety Information in Chinese Medicine Injection Instructions

Comprehensive instructions were collected by field collection or literature retrieval.In this paper,the safety information of instructions(all enterprises)contained in National Medical Insurance Drug Catalogue(2017 edition)were analyzed.The safety information includes ingredients,warnings,adverse reactions,contraindication reports,precautions,medication tips for special groups,drug interactions,clinical trials and pharmacology,and so on.The evaluation criterion is the requirements of the relevant regulations issued by National Medical Products Administration,such as the guiding principles for the preparation of instructions of traditional Chinese medicine and natural drugs.Some reflections and suggestions are proposed about the studies on the safety of traditional Chinese medicine injection and improvement of safety information in the instructions of traditional Chinese medicine injection.This study provides a basis of improvement of drug instructions and a reference for the safety research.