ABSTRACT
There are many problems in the use of Bupleurum medicinal materials such as confusion in variety, unclearness in origin and quality problems, e.g., adulteration of authentic Bupleurum and mixing of non-medicinal parts. Therefore, the quality of Chinese patent medicines containing Bupleurum chinense is variable, and it is necessary to establish targeted quality control methods. Based on the quality control methods of Bupleurum and its Chinese patent medicines, combined with the example of Xiaochaihu granules, this paper discussed the quality standard improvement and supplementary test methods of Bupleurum and its Chinese patent medicines, aiming to provide reference for the quality control, quality supervision and standardized production of Chinese patent medicines containing Bupleurum and promote the improvement of its intrinsic quality.
ABSTRACT
OBJECTIVE： To provide reference for the formulation of regulatory policies, revision and improvement of standards with the research and summary of Chinese medicine glues in recent years. METHODS： The quality problems of Chinese medicine glues found in national drug sampling inspection since 2012 were summarized, and based on this, the screening of 41 Chinese medicine glues with large production batches and large market share was carried out, and relevant supplementary inspection methods were established. RESULTS AND CONCLUSION： By summarizing the drug quality notices issued by the state and provincial and municipal drug administrations, from 2012 to 2015, it was found that the cowhide feeding in donkey-hide gelatin was serious. From 2015 to 2017, no cowhide feeding problems were found, but the feeding problems of mule and horse skins were extremely prominent. In view of the market problems, seven units completed the screening of 41 Chinese medicine glues, and established 15 supplementary inspection methods, which effectively strengthened the quality control and standardized the industrial order of Chinese medicine glues.