医疗机构应用传统工艺配制中药制剂备案中临床资料问题与思考  

Problems and thoughts on clinical data in the filing of traditional Chinese medicine preparations using traditional techniques in medical institutions

作　　者：李思奇 周梦悦 杨芳芳 张志宇 潘定举 LI Si-qi;ZHOU Meng-yue;YANG Fang-fang;ZHANG Zhi-yu;PAN Ding-ju(Center for Drug Inspection of Guizhou Medical Products Administration,Guiyang 550001,China;The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine,Guiyang 550001,China)

机构地区：[1]贵州省药品监督管理局检查中心,贵阳550001 [2]贵州中医药大学第一附属医院,贵阳550001

出　　处：《中国新药杂志》2025年第4期352-357,共6页Chinese Journal of New Drugs

摘　　要：目的:梳理医疗机构应用传统工艺配制中药制剂备案提交的临床资料中的关键问题,针对问题提供解决方案,以进一步提高医疗机构中药制剂研发质量。方法:通过文献分析和回顾性分析相结合,探讨医疗机构应用传统工艺配制中药制剂备案中的临床资料问题。结果:医疗机构应用传统工艺配制中药制剂备案中,应重点关注固定处方应用、制剂功能主治、用法用量、不良反应等临床支持性证据以及提供的临床资料的可靠性等关键问题,突出的问题应关注中药制剂的临床定位和临床价值。结论:医疗机构应重视应用传统工艺配制中药制剂备案中临床资料的完整性、规范性和科学性,突出中药制剂的临床价值,促进中医药的传承创新发展。Objective:To sort out the key issues in the clinical data submitted by medical institutions using traditional techniques to prepare traditional Chinese medicine(TCM)preparations and provide solutions to the problems to further improve the quality of research and development of TCM preparations in medical institutions.Methods:Through a combination of literature analysis and retrospective analysis,the issues in the clinical data of TCM preparations prepared by medical institutions using traditional techniques were explored.Results:When medical institutions use traditional techniques to prepare TCM preparations for filing,they should focus on key issues such as the application of fixed prescriptions,clinical supporting evidence such as preparation functions and indications,usage and dosage,adverse reactions,and the reliability of the provided clinical data.Special attention should be paid to the clinical positioning and clinical value of TCM preparations.Conclusion:Medical institutions should pay attention to the integrity,standardization and scientificity of the clinical data in the filing of TCM preparations prepared by traditional techniques,highlight the clinical value of TCM preparations,and promote the inheritance,innovation and development of TCM.

关 键 词：传统工艺配制 医疗机构制剂 中药制剂备案 人用经验 

分 类 号：R943[医药卫生—药剂学]