中药现代制备工艺对不良反应的影响及相关对策

简述了产生中药不良反应的主要因素，包括药物本身毒性、同物异名药材的混淆、炮制不当、用药剂量不当、用药途径不同、配伍不当和病人个体差异等，并就提取、纯化技术等中药现代制备工艺对药物安全性和有效性的影响进行分析。现代中药制剂工艺与传统工艺相比，前者可能会改变复方的化学成分组成、活性成分用量或药物剂量、药物剂型及给药途径、引入工艺杂质及辅料，对产品安全性造成一定影响。归纳应对上述影响的相关对策，呼吁加强新技术、新工艺在复方中应用的合理性及必要性研究，加强中药物质基础成分的研究，深入开展中药毒理学研究，加强制剂工艺与临床应用的关联研究与分析，加强建立药用辅料质量控制体系与提高辅料安全性，提高企业在不良反应监测体系中的重要性及参与程度，为中药制剂的临床合理用药提供参考。

Effects of Modern Preparation Technology for Chinese Patent Medicine on Adverse Drug Reaction and Related Strategies

This paper briefly introduced main factors of adverse reactions caused by Chinese patent medicine,including drug toxicity,confusable species,improper processing,inappropriate drug dosage,incorrect compatibility and individual difference of patients.Through searching literatures,this article summarized different techniques used in traditional Chinese medicine(TCM) preparation industry,then analysed effects of modern preparation technology on drug safety and adverse reactions.Compared with traditional process,modern preparation technology may change chemical composition of TCM preparation,drug dosage,drug formulation,drug delivery or add processing impurity,which could make passive effect on drug safety.This paper also proposed effective solutions for drug safety and appealed that we should strengthen research on basic chemical constituents of TCM,toxicology of TCM,correlation between preparation process and clinical application,establishment quality control system of pharmaceutical excipients to improve its safety,and improvement of significance participation degree of enterprises in adverse reactions monitoring system,in order to provide a reference for clinical rational drug use of preparations of TCM.