基于标准汤剂(物质基准)的经典名方制备工艺和质量标准研究

Research Strategies for Quality Standards of Famous Classical Formula Based on Standard Decoction(Material Reference)

传承经典名方的传统临床价值是中医药产业发展的一个重要方向。与以往的新药研发最大的不同点,经典名方研究中引入了标准汤剂--(物质基准)的管理要求,以其作为工艺优化和质量控制的基准。经典名方复方制剂的特色还体现在,产业发展之路以精品传承经典为核心理念。如何将上述要求和理念落实到产品研发和工业化生产中,实际研究中还有很多具体的共性问题需要解决,如何有效制备不同剂型的经典名方的物质基准,如何用物质基准指导经典名方复方制剂的工艺优化,如何确定经典名方的日服剂量,如何在原料选择上采取有效措施缩小制剂的质量波动范围?该文就这些生产工艺和质量评价方面的关键问题从如下几个方面进行论述。首先对管理规定和研发指南进行了分析,给出具体落地实施方法;指出《申报资料要求(征求意见稿)》中可能存在的问题,给出相关建议;结合实验室在标准汤剂和经典名方的研究经验,给出实例分析,以其为推进经典名方复方制剂的发展提供借鉴。

The inheritance of traditional clinical value of famous classical formulae is an important direction for the development of traditional Chinese medicine industry.Compared with the previous research and development of new drugs,the management requirement of " material reference" was introduced into the famous classical formulae research,which is used as the reference of process optimization and quality control.The characteristics of compound preparation of famous classical formulae are also reflected in the core concept of " quality inheritance of classics" in the road of industrial development.How to implement the above requirements and concepts into product development and industrial production? There are many specific common problems to be solved in practical research.How to effectively establish the " material reference" of famous classical formulae of different dosage forms? How to use " material reference" to guide the process optimization of compound preparation of famous classical formulae? How to determine the daily dose of famous classical formulae? How to take effective measures in the selection of raw material to reduce quality fluctuation range? This paper discusses the key issues such as production process and quality evaluation from the following aspects.Firstly,the management regulations and research and development guidelines are analyzed,and the specific implementation methods are given.Then,the possible problems in the Requirements for Declaration Documents(Draft for Opinions) are pointed out,and relevant suggestions are given.Finally,based on the research experience of standard decoction and famous classical formulae in the laboratory,an example is given to provide reference for the development of compound preparation of famous classical formulae.