《中国药典》2020年版一部收录中成药制法规律分析

Preparation regularity of Chinese patent medicine in Chinese Pharmacopoeia (2020 edition, Vol.Ⅰ)

《中国药典》是我国药品标准的重要组成部分,也是我国药品研制、生产、经营、使用和管理都必须严格遵守的法定依据。《中国药典》一部中收载的中成药制剂明确了其处方、制法、性状、鉴别、检查、含量测定、功能与主治、用法与用量、注意、规格、贮藏等信息,其中“制法”部分将中成药从饮片到成品制剂的制备过程进行了详细的描述,规定了制剂生产的方法和参数,对我国中成药的生产有着很好的指导和规范作用。该文将《中国药典》2020年版一部收载中药成方制剂及单味药制剂的制法按照工艺环节进行了分阶段归纳、总结,分析目前中成药制剂制备中常用制备方法及技术参数等,有助于对我国中成药生产工艺现状的了解,能够为中药新药研制、中成药大品种改造、已上市中药生产工艺变更研究提供参考和借鉴。

Chinese Pharmacopoeia is an important part of drug standards in China, and it is also a legal basis that must be strictly followed in drug development, production, operation, application, and management. The information on prescriptions, preparation methods, properties, identification, inspection, content determination, functions and indications, usage and dosage, precautions, specifications, and storage of Chinese patent medicine preparations included in the Chinese Pharmacopoeia(Vol.Ⅰ) was clarified. The "Preparation Method" section describes the preparation process of Chinese patent medicine from decoction pieces to finished preparations in detail and specifies the preparation production methods and parameters, which has a good guiding and standardizing effect on the production of Chinese patent medicine in China. The present study summarized the preparation methods of Chinese patent medicine preparations and single drug preparations contained in the Chinese Pharmacopoeia(2020 edition, Vol.Ⅰ) in stages and analyzed the common preparation methods and technical parameters of Chinese patent medicine preparations, which is helpful to understand the current situation of Chinese patent medicine production technology in China and can provide references for the development of new Chinese medicine, the transformation of large varieties of Chinese patent medicine, and the optimization of preparation process of Chinese patent medicine in the market.