经典名方质控策略—基于“等位等价”理论和定量指纹一致性的控制技术

The quality control policy for classical prescriptions-the consistency control technology based on both theory of"same quantity to same effect"and the quantitative fingerprints

经典名方已经在中国历史上传承悠久,其临床试验已非常成熟,安全性和疗效也经得起考验,是近年来研究热门之一,相关研究的文献也不断增多。但由于历史悠久,其中药基原、炮制方法、剂量换算等方面与现代标准存在误差,因此经典名方的工艺研究和质量控制方法显得尤为重要。本文针对经典名方研究目标与核心本质、研究价值、研究工艺及质量控制策略与方法等四个主要方面进行综述研究。系统地提出经典名方质控问题—应基于“等位等价”理论和定量指纹一致性的控制策略,对标准汤剂、对照制剂、标准制剂、物质基准、基准样品和质量标准,以及量值传递等概念的含义进行深入研究与控制,找到这些概念的深刻内涵与量值关联关系。最终以物质基准为基础来确定标准制剂的质量标准,按照定量指纹图谱检查实现:a.宏定性相似度S_(m)≥0.90;b.宏定量相似度80%≤P_(m)≤120%来控制经典名方的质量一致性。

Classical prescriptions have been handed down for hundred years in Chinese history,and their clinical trials are well established and their safety and efficacy are well tested.Classical prescriptions have been one of the most popular research topics in recent years,and there is a growing body of literature reporting on research related to it.However,due to their long history,there are errors in their drug base origin,concoction methods and dose conversions from the current standards,making the research process and quality control methods of classical famous prescriptions particularly important.This paper reviews on the four main aspects of classical prescriptions,including research objectives and core essence,research values,research processes and quality control strategies and methods.In this paper,we systematically propose that the essence of classical prescriptions-based on both theory of"same quantity to same effect"and quantitative fingerprint in consistency control strategies-should be studied and controlled in depth for standard decoction,control preparations,standard preparations,substance benchmarks,benchmark samples and quality standards,as well as the meaning of quantitative transfer,in order to find the deep connotation and quantitative value of these concepts.The concept of standard decoction,control preparation,standard formulation,substance reference,reference sample and quality standard,as well as the meaning of quality value transmitting,are investigated and controlled to find the deep connotation and quantitative correlation of these concepts.The final quality standard for the standard formulation is determined on the basis of the substance benchmark,in which the a.S_(m)≥0.90;b.80%≤P_(m)≤120%is achieved according to quantitative fingerprinting checks to control quality consistency.