含毒性药材的儿科用中成药组方分析

Component Analysis of Chinese Patent Drugs Including Toxicity Components Used in Pediatrics

目的:剖析我国目前儿科用中成药组方中含有毒性药材的现状,分析其相关问题,为我国中成药在儿科的发展提出建议。方法:通过筛选出的264份国家药品标准中收录的儿科用中成药与相关毒性药品目录进行比对,统计、分析其中使用毒性药材的情况。结果:约有1/2的儿科用中成药含有毒性药材,且存在所含毒性药材来源复杂、部分药方中毒性药材的剂量超过限度、治疗病症集中、用量的计法不科学等问题。结论:深入儿科用中成药研究,应加强其标准建设,制定更严格的特殊审批要求,建立全面再评价机制,淘汰临床不适宜品种。

OBJECTIVE： To analyze the situation and the related problems of Chinese patent drugs including toxicity components used in pediatrics, and to provide the suggestion for the development of Chinese patent drugs for pediatrics. METHODS： 264 Chinese patent drugs which were used in pediatrics were collected from national drug standards, and compared with toxicity drug list. The utilization of toxicity drugs were analyzed statistically. RESULTS： About half of Chinese patent drugs for pediatric included toxicity components. Major problems are complex resource of toxicity components, overdose of toxicity components, single disease and pattern, unscientific determination of amount, etc. CONCLUSION： The in-depth study of Chinese patent drugs requires perfecting national drug standards, to developing more rigorous special approval requirements, to establishing the re-evaluation system and to eliminating unsuitable category of Chinese patent drugs.