ABSTRACT
In order to standardize the quality control of traditional Chinese medicine（TCM） dispensing granules， the Chinese Pharmacopoeia Commission has promulgated and implemented 200 national drug standards for TCM dispensing granules， but there are still varieties of TCM dispensing granules without unified standards. Many provinces have actively invested in the formulation of provincial standards for TCM dispensing granules to make up for the gaps in standards for varieties of traditional Chinese medicine dispensing granules other than the national standards. By the end of July 2022， 29 provincial-level administrative regions have successively promulgated and implemented a total of 5 602 provincial standards for TCM dispensing granules， involving more than 400 varieties. In order to better understand the formulation and characteristics of provincial standards， this study took 105 provincial standards that have been promulgated and implemented in Henan province as an example， and comprehensively analyzed the formulation and characteristics through quality control indicators such as dry extract rate of raw materials， contents of index components and their transfer rates， specifications and so on. The formulation and characteristics of the same TCM dispensing granules in the provincial standards of different provinces were further analyzed， in order to provide reference for the formulation of provincial standards of TCM dispensing granules and the implementation of national standards.
ABSTRACT
The paper presents a detailed review of British pharmaceutical standards including British Pharma-copoeia, European Pharmacopoeia, British Approved Names, Reference Standards and Non-Statutory Pharmaceutical Standards. British pharmaceutical standards are established by the British Pharmacopoeia Commission, Expert Advi-sory Groups, Panels of Experts and Working Parties, British Pharmacopoeia Commission Secretariat, British Pharma-copoeia Laboratory, and standard-setting procedures are clear and definite. British Pharmacopoeia standards are le-gally binding, and pharmaceutical products sold in the United Kingdom must comply with pharmacopoeia require-ments. British pharmaceutical standards can serve as an important reference for reforms to China’s pharmaceutical standards, including the scientific management of pharmaceutical standards, the improvement of organizational frame-works in the establishment pharmaceutical standards, the promptness of amendments to pharmacopoeia, and the uni-versality of international exchanges.
