摘要
上市经典名方产品的二次开发,是对已上市中成药围绕药品质量与临床用药存在问题进行深入研究的过程,从而达到以高品质传承中成药的目的。通过回顾小柴胡颗粒质量研究进展,对比中日两国药典对小柴胡颗粒质量控制标准,旨在发现小柴胡颗粒目前存在的问题,并在此基础上提出小柴胡颗粒精品化发展策略,为实现高品质传承提供研究思路。精品化发展策略主要包括4个方面:1)建立小柴胡颗粒全产业链质量追溯系统;2)以质量源于设计(QbD)理念优化小柴胡颗粒生产工艺,打造智能制造模式;3)建立临床评价与不良反应监测系统;4)基于整合药理学策略阐释小柴胡颗粒作用机制。
The redevelopment of the listed classical prescription products is a process of in-depth research on the problems existing in the drug quality and clinical use of the Chinese patent medicines.The aim of secondary development of listed classical prescription is to achieve the purpose of inheriting the Chinese patent medicines with high quality.This paper mainly reviews the research progress of the quality of Xiaochaihu Granules,compares the quality control standards of Xiaochaihu Granules in Pharmacopoeia of China and Japan,and compares the daily dosage and price of different manufacturers,in order to find the existing problems of Xiaochaihu Granules.Then a development strategy of high-quality Xiaochaihu Granules was provided.It includes four aspects:tablishing the quality tracing system of the whole industry chain of Xiaochaihu Granules,optimizing the production process with QbD and intelligent manufacturing of Xiaochaihu Granules,clinical evaluation and adverse reaction monitoring of Xiaochaihu Granules,and explaining the treatment mechanism of Xiaochaihu Granules based on the integrative pharmacology.
作者
张雪
吴宏伟
林丽娜
刘晖晖
杨洪军
ZHANG Xue;WU Hong-wei;LIN Li-na;LIU Hui-hui;YANG Hong-jun(Institute of Chinese Materia Medica,China Academy of Chinese Medical Sciences,Beijing 100700,China;China Resources Sanjiu Medical & Pharmaceutical Co.,Ltd.,Shenzhen 518000,China;Experimental research center, China Academy of Chinese Medical Sciences, Beijing 100700, China)
出处
《中国现代中药》
CAS
2021年第4期605-610,共6页
Modern Chinese Medicine
基金
国家科技重大专项(2019ZX09201005)。
关键词
小柴胡颗粒
经典名方
质量源于设计
全产业链
质量追溯
二次开发
整合药理学
Xiaochaihu Granules
classical prescription
QbD
whole industry chain
quality traceability
secondary development
integrative pharmacology
