摘要
近年来关于何首乌及其制剂致肝损伤的报道逐渐增多,其存在的安全性问题引起社会高度关注。通过整理何首乌及其制剂的安全性研究进展并分析其风险因素,为后续建立系统安全性评价提供研究思路。药材质量方面,从何首乌的基源、种植采收、炮制三个角度分析提出最可能引起安全性问题的因素是基源混用及炮制不当;临床应用方面,分析复方配伍、剂量对何首乌毒性的影响,长期超剂量使用可致肝损伤而配伍是否有影响有待研究;制备工艺方面,不同工艺条件可能使其活性成分产生变化造成不良反应。个体因素也是其导致安全性问题不可忽视的因素。后续系统安全性评价需要着重研究炮制及制备工艺对何首乌及其制剂安全性的影响。
In recent years,the report of liver injury caused by Polygonum multiflorum Thunb and its preparations has gradually increased,and its safety problems have aroused great concern.By arranging the safety research progress of Polygonum multiflorum and its preparation and analyzing its risk factors,it provides the research ideas for the subsequent establishment of system safety evaluation.In terms of quality of herbs,From the source of Polygonum multiflorum,planting and harvesting,concocted three angles to analyze the most likely to cause safety problems is the source of mixed and improper processing;In clinical applications,analysis of the compatibility of the compound,the dose of Polygonum multiflorum toxicity,long-term use of super-dose can cause liver injury and compatibility have to be studied;In the preparation process,Different process conditions may cause changes in the active ingredient to cause adverse reactions.Individual factors are also factors that lead to safety problems that can not be ignored.Subsequent system safety evaluation needs to focus on the effects of processing and preparation on the safety of Polygonum multiflorum and its preparations.
出处
《亚太传统医药》
2018年第1期53-56,共4页
Asia-Pacific Traditional Medicine
基金
2015年国家药品标准提高课题(2015-21)
关键词
何首乌
何首乌制剂
安全性
风险因素
肝损伤
Polygonum Multiflorum
Preparation
Safety
Risk Factors
Liver Injury
作者简介
罗春颖（1990-），女，成都中医药大学硕士研究生，研究方向为中药新制剂、新剂型、新技术。;通讯作者：蒲旭峰（1963-），男，成都市食品药品检验研究院研究员，主任中药师，研究方向为中药分析及中药新药研发。E-mail：pxf68@263．net
