中成药说明书安全性相关的项目调查分析

Investigation And Analysis of Safety Related Items in Chinese Patent Medicine Instruction

目的调查分析中成药安全性与其说明书内容的相关性。方法收集310种中成药说明书,按照《中华人民共和国药品管理法》和《药品说明书和标签管理规定》对药品说明书的要求,对其说明书内容进行分析。结果中成药说明书上在成分、功能主治、用法用量方面标注率达到了100%,总体缺项严重的是特殊人群用药、临床试验、药理作用、药物相互作用、不良反应、说明书修改日期、注意事项等。结论中药注射剂说明书存在项目标注不全、语言表述不规范等问题,对其安全使用造成一定影响。

Objectiv To investigate the relationship between the safety of Chinese patent medicine and the contents of its instruction. Methods 310 kinds of Chinese patent medicines were collected, according to the “people＆#39;s Republic of China”and “Drug Administration Law” and “drug instructions and labeling management requirements” to the requirements of the drug, the contents of the manual analysis. Results The labeling rate of the Chinese patent medicine on the composition, function, usage and dosage was 100%, the overall lack of a serious drug, clinical trials, pharmacological effects, drug inter-actions, adverse reactions, manual modification date, notes, etc. Conclusion There are some problems, such as incomplete project labeling, language expression, and so on.