摘要
本文就我国大毒药材法定标准的质控现状进行了简要汇总和分析,结果显示,51种大毒药材的质量标准中建立了毒性成分含量测定项的有17种(33%),未建立的34种(67%)。药典收载的大毒药材标准的质量可控性较强,而地方药材标准大多未建立与毒性相关的检测方法,标准的可控性较低。建议加强基础研究及多学科合作,明确大毒药材所含毒性成分及中毒剂量;利用相同科属大毒药材所含毒性成分相似的规律,研究建立毒性成分的含量测定方法;建议建立开放的大毒药材标准及检验资料查询平台,提高大毒药材检验水平,避免混用。
The status of specification of highly toxic medicinal materials（ HTMMs） was summarized and analyzed briefly. The result is that specification of 17 kinds of HTMMs includes the content determination of toxic components,while 34 do not. The controllability of specification of HTMMs listed in the Chinese Pharmacopoeia is higher than most of that listed in local specification that haven＇t established method for determination of toxic components. This article puts forward some suggestions to improve inspection level and avoid the misusage of HTMMs：strengthening basic research and interdisciplinary cooperation to discover the kinds and toxic dose of toxic components in HTMMs,establishing method for determination of toxic components according to the rule that different HTMM coming from same family has similar toxic components,and establishing open inquiry platform of specification of HTMMs and inspection dates.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2015年第21期2425-2433,共9页
Chinese Journal of New Drugs
关键词
大毒药材
质量标准
现状
highly toxic medicinal materials
quality specification
status
