ABSTRACT
Objective:Powders and decocted powders account for about 1/3 in the Catalogue of Ancient Famous Classical Formulas （the First Batch）， and have a very important position. Determination of preparation technology and particle size in the pulverization process is the key step in the research and development of powders and decocted powders following the original methods. However， there are many terms describing the preparation technology and particle size of powders and decocted powders in ancient Chinese medical books， and the parameters are not clear. Due to the lack of unified basis of particle size， the existing research results have not formed a uniform consensus. Based on ancient textual researches and experimental results， this article discusses the particle size of decocted powders and powders. Method:Through textual researches of the preparation technology and particle size of powders and decocted powders and powder classification in the 2020 edition of Chinese Pharmacopoeia， the specifications of pulverized particle size were suggested. In addition， Xiebaisan and Danggui Buxuetang were taken as examples to investigate the influence of different particle sizes （4， 10， 24 mesh） on the preparation process of decocted powders and the obtained decoction. Result:The particle size of 4 mesh was equivalent to that of ancient as big as hemp bean. The contents of index components in Xiebaisan and Danggui Buxuetang with particle size of 4 mesh were higher than that of 10 mesh and 24 mesh， but the particle size of 50 mesh was too fine to be filtered. Conclusion:The suggested particle sizes of powders and decocted powders are recommended as Cumo is the power through 10-mesh sieve， Mo is the power through 24-mesh sieve， Ximo is the power through 80-mesh sieve， as big as hemp bean is the power through 4-mesh sieve and not through 10-mesh sieve.
ABSTRACT
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.