Quality Analysis and Research on Bupleurum Chinense Formula Granules Based on Drug Sampling Inspection in Shandong Province
Objective To evaluate the quality of Bupleurum Chinese Formula Granules based on drug sampling inspection in Shandong province.Methods A total of 54 batches of samples were tested according to the statutory standard combined with exploratory research,in order to comprehensively evaluate the quality status of Bupleurum Chinese Formula Granules.Results The qualified rate was 100％determined according to the statutory standard,however,the qualified rate determined according to methods of the exploratory research was 90.7％.The main reason for the failure of 5 batches of samples was that the total amount of saikosaponin was lower than the proposed limit.Exploratory research found that some batches of samples had the risk of heavy metal pollution.Some batches of samples may have problems such as poor quality of raw materials and incorrect feeding.Conclusion It is suggested that enterprises should strengthen the control of raw materials,optimize the process and strictly control the quality,so as to better ensure the safety and effectiveness of the drug products.
Bupleurum Chinese Formula Granulesstatutory standardexploratory researchsaikosaponinquality analysis
万方数据
维普
