Objective To evaluate the quality of vitamin B1 tablets on the market in Jiangxi Province,and to preliminarily analyze the reasons affecting product quality,so as to provide reference for production,supervision and storage. Methods According to the provincial drug sampling regulations,combined with exploratory research and statutory inspection standards,the overall evaluation of product quality and the controllability of current quality standards on product quality. Results According to the statutory inspection standards,all 60 batches of samples from 17 production enterprises were all qualified;through exploratory research,it was found that the impurities in the relevant substances mainly come from the degradation of raw materials,with 7 batches of impurities exceeding the detection limit (0.2％) and a failure rate of 11.7％;HPLC method was established to determine the uniformity of content,and 1 batch failed with a failure rate of 1.7％. Conclusion The quality of domestic vitamin B1 tablets was generally under good,but attention should be paid to the control of storage conditions. The current quality standards are basically feasible,but further improvement and enhancement are still needed.
万方数据
维普
