中药配方颗粒制备工艺、质量评价、与传统汤剂一致性的研究现状分析

Research on Preparation Process and Quality Evaluation of Traditional Chinese Medicine Dispensing Granules and Its Consistency with Traditional Decoction:A Review

中药配方颗粒是随着中医药现代化发展出现的“新型中药饮片”形式,自实际应用以来褒贬不一,2021年,国家多部门发布了《关于结束中药配方颗粒试点工作的公告》,标志着长达28年的中药配方颗粒试点工作的告一段落,符合条件的中药企业经过备案即可生产中药配方颗粒。然而,这并不意味着中药配方颗粒的制备工艺、质量标准、功效研究等已经发展成熟,相反,这其中依然存在一些需要逐步解决、逐步完善的问题。例如,在生产工艺上,存在着制备参数不明晰、不统一、不规范等问题;在质量控制方面,存在着缺少药材的产地规定、品种甄别和炮制规范等问题;在与传统汤剂的一致性评价方面,存在两者化学成分、药理效应关系不明确等问题。因此,针对中药配方颗粒目前存在的一些突出问题,笔者以公开发表的文献为主要数据资料来源,结合2020年版《中华人民共和国药典》《关于中药配方颗粒品种试点统一标准的公示》《中药配方颗粒质量控制与标准制定技术要求》等,对中药配方颗粒的生产工艺、原材料的产地和品种、饮片的加工和炮制、质量控制标准、配方颗粒与传统汤剂的一致性评价等内容,通过文献挖掘、数据分析、列表对比等方式进行梳理并进行可视化分析。根据分析结果提出以下建议:在制备工艺方面应加强工艺参数的完整性与规范性;在质量评价方面应注重药材的道地性、品种、炮制等与品质的关联;在配方颗粒与传统汤剂的一致性评价中应结合结构中药学、中药质量标志物(Q-Marker)理论、理化表征的方式探讨中药配方颗粒与传统汤剂的深层差异及其差异机制,为中药配方颗粒的应用和发展提供参考。

Traditional Chinese medicine dispensing granules(TCMDGs)is the new type of decoction pieces with the development of modernization of TCM,which has received mixed opinions since its practical application.In 2021,the national departments issued Announcement on Ending the Pilot Work of TCMDGs,marking the end of the 28-year pilot work of TCMDGs,and eligible TCM enterprises can produce TCMDGs after filing.However,this does not mean that the preparation process,quality standard and efficacy research of TCMDGs have been developed and matured,on the contrary,there are still some problems that need to be solved and gradually improved.For example,in the production process,there are problems such as unclear,unified and non-standardized preparation parameters.In terms of quality control,there are some problems such as lack of producing area regulation,variety selection and processing specification.In terms of consistency evaluation with traditional decoction,there are problems such as unclear relationship between the chemical constituents and pharmacological effects of the two.Therefore,in view of some prominent problems of TCMDGs at present,this paper takes the published literature as the main data source and combines the specific requirements of the code or technical standards such as the 2020 edition of Chinese Pharmacopoeia,Publicity of the Unified Standard on the Varieties of TCMDGs,Quality Control and Standard Formulation Technical Requirements of TCMDGs.The production process of TCMDGs,the origin and variety of raw materials,the processing of decoction pieces,the quality control standard and the consistency evaluation of formula granules and traditional decoction were sorted out and visualized by literature mining,data analysis and list comparison.Based on the analysis results,the following suggestions were made.In terms of preparation process,the completeness and standardization of process parameters should be strengthened.In terms of quality evaluation,attention should be paid to the relationship between the authenticity,variety,processing and quality of medicinal materials.In the consistency evaluation of formula granules and traditional decoction,the deep difference and mechanism between TCMDGs and traditional decoction were discussed by combining structural Chinese medicine,quality marker(Q-Marker)theory and physicochemical characterization,so as to provide reference for the application and development of TCMDGs.