摘要
质量标准研究是药品标准化、现代化研究的核心组成部分,其对新药开发、老药评价、市场监管,特别是在药品生产、临床应用的质量控制中起着极其重要的作用。质量标准研究与制定是中药民族药开发利用的关键共性技术。提高质量标准可为中药民族药的二次开发提供技术保障,通过开展质量再评价,将资源优势转化为产业优势,产品优势转化为市场优势,有助于推动中药民族药产品品质升级换代。本文讨论药品标准概况及制定,分析广西壮、瑶药产业及药材标准研究现状及存在问题,提出关键共性技术以及研究方法和思路,旨在为我区中药民族医药产业发展提供参考。
Quality standard research is a crucial component of the standardization and modernization of pharmaceuticals.It plays an essential role in new drug development,evaluation of existing drugs,market regulation,and particularly in quality control during pharmaceutical production and clinical application.The research and establishment of quality standards represent key and common technologies in the development and utilization of traditional Chinese medicine(TCM)and ethnomedicine.The secondary development of TCM and ethnomedicine,driven by improved quality standards,can provide technical support for quality reevaluation,transforming resource advantages into industrial advantages and product advantages into market competitiveness,thereby promoting comprehensive quality upgrading of TCM and ethnomedicine products.This paper discusses the general framework and formulation of drug standards,analyzes the current status and existing problems of standard research on Zhuang and Yao medicines in Guangxi,and proposes key common technologies,research methods,and approaches,aiming to provide references for the development of the TCM and ethnomedicine industry in the region.
作者
刘布鸣
柴玲
LIU Buming;CHAI Ling(Guangxi Key Laboratory of Traditional Chinese Medicine Quality Standards,Guangxi Institute of Chinese Medicine&Pharmaceutical Science,Nanning 530022,China)
出处
《广西医科大学学报》
2025年第6期787-796,共10页
Journal of Guangxi Medical University
基金
广西科学研究与技术开发计划项目(No.桂科重1355001-4,No.桂科重14124002-11)。
关键词
中药
壮药
瑶药
质量标准
开发应用
产业化
traditional Chinese medicine
Zhuang medicine
Yao medicine
quality standard
development and application
industrialization
