构建数字化导向的中药质量标准体系  

Constructing digitally-oriented TCM quality standard system

作　　者：栾永福 郭东晓 汪冰 解盈盈 周广涛 林永强 LUAN Yongfu;GUO Dongxiao;WANG Bing;XIE Yingying;ZHOU Guangtao;LIN Yongqiang(Shandong Institute for Food and Drug Control,NMPA Key Laboratory for Quality Evaluation of Gelatin Products,Shandong Engineering Laboratory for Standard Innovation and Quality Evaluation of TCM,Shandong Engineering Research Center for Generic Technologies of TCM Dispensing Granules,Jinan 250101,China)

机构地区：[1]山东省食品药品检验研究院,国家药品监督管理局胶类产品质量评价重点实验室,山东省中药标准创新与质量评价工程实验室,中药配方颗粒共性技术山东省工程研究中心,山东济南250101

出　　处：《药学研究》2022年第8期516-520,共5页Journal of Pharmaceutical Research

基　　金：山东省重点研发计划(重大科技创新工程项目)(No.2021CXGC010511);山东省重点研发计划(软科学项目)(No.2020RKB24001);山东省人文社会科学课题(No.2021-YYGL-44);山东省食品药品检验研究院平台课题(SDIFDC-KY-1-2021023、SDIFDC-KY-1-2021031)。

摘　　要：目的构建数字化导向的中药质量标准体系,为解决目前中药质量标准体系面临的问题提供可能的解决策略。方法结合日常中药检验工作,通过查阅文献和市场调研,并与相关的专家学者及中药生产企业人员进行研讨,对我国中药质量标准体系现状及问题进行分析,并提出相应的对策。结果目前,中药质量标准存在标准滞后、缺乏整体质量评价方法、偏离中医药理论和临床实践的支撑、工艺可控性差、质量控制指标专属性不够等问题。并且,我国中药质量标准管理和执行中亦存在分类繁多、查询困难、一品种多标准、传统性状鉴别易受主客观因素影响、实物标准物质可及性差等问题。基于此,建议建立健全统一、权威的中药质量标准信息查询平台和中药数字标本馆,并应致力于进行基于数字化的中药质量标准研究。结论构建数字化导向的中药质量标准体系,将有助于中药质量提升和标准科学制订,解决中药质量标准管理和执行中存在的各种问题。Objective To construct digitally-oriented TCM quality standard system to provide possible strategies for solving the current problems of TCM quality standard system.Methods Combined with the routine work of TCM control,the status quo and problems of TCM quality standard system were analysed,and the corresponding countermeasures were put forward,through literature review,market research,and discussion with relevant experts and scholars and personnel of TCM manufacturers.Results At present,there are some problems in the TCM quality standard,such as lagging standards,lack of overall quality evaluation methods,deviation from the support of TCM theory and clinical practice,poor process controllability,and insufficient specificity of quality control indexes.And there are also many problems in the management and implementation of TCM quality standard in China,such as many kinds of classification,difficult query,multiple standards of one variety,traditional character identification being susceptible to subjective and objective factors,and poor accessibility of physical standard substances.Based on this,it is suggested to establish and improve the unified and authoritative TCM quality standard information inquiry platform and TCM digital herbarium,and to devote to the research of TCM quality standard based on digitalization.Conclusion The construction of digitally-oriented TCM quality standard system will contribute to the improvement of TCM quality and the scientific formulation of TCM standard,and could solve various problems existing in the management and implementation of TCM quality standard.

关 键 词：中药质量标准 数字化 标准物质 信息查询平台 数字标本馆 

分 类 号：R286[医药卫生—中药学]