摘要
对活性较强、安全性风险较高的雷公藤多苷片的质量控制情况进行研究。探讨进一步加强中药制剂质量控制的关键问题:1)如何提高中药制剂的批间质量一致性;2)如何建立中药制剂临床相关的质量标准(如功效成分、毒性成分的研究和控制)。建议重点关注活性较强、安全性风险较高的中药制剂品种,旨在为建立中药制剂临床相关的质量标准提供参考。
This article studies the quality control of Tripterygium Glycoside Tablets with high activity and high safety risk.The key issues on further strengthening the quality control of traditional Chinese medicine(TCM)preparations are discussed:1)how to improve the quality consistency of TCM preparations between batches;2)how to establish clinically relevant specifications for TCM preparations(such as research and control of active ingredients and toxic ingredients).It is recommended to focus on the TCM preparations with strong activity and high safety risks.This article aims to provide a reference for establishing clinically relevant specifications of TCM preparations.
作者
孙昱
王亚丹
文海若
汪祺
马双成
SUN Yu;WANG Ya-dan;WEN Hai-ruo;WANG Qi;MA Shuang-cheng(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China;National Institutes for Food and Drug Control,Beijing 100050,China)
出处
《中国现代中药》
CAS
2021年第8期1331-1334,共4页
Modern Chinese Medicine
基金
国家自然科学基金项目(81503347,81503068)。
关键词
质量标准
批间一致性
均一化处理
生物活性
specification
batch-to-batch consistency
homogenization
biological activity
