国产维生素B1片质量评价  

Quality Evaluation of Domestic Vitamin B1 Tablets

作　　者：张继红 郑露盼 余红 ZHANG Jihong;ZHENG Lupan;YU Hong(Shangrao Inspection and Certification Institute,Shangrao Jiangxi 334000,China)

机构地区：[1]上饶市检验检测认证院,江西上饶334000

出　　处：《药品评价》2024年第8期926-930,共5页Drug Evaluation

基　　金：江西省药品监督管理局科研项目(2023JS22)。

摘　　要：目的对江西省内市售维生素B1片的质量状况进行评价,并初步分析影响产品质量的原因,为生产、监管、贮存提供参考。方法依据省级药品抽检规定,结合探索性研究和法定检验标准,整体评价产品质量及现行质量标准对产品质量的可控性。结果依据法定检验标准,17家生产企业的60批样品全部符合规定;通过探索性研究得出有关物质中杂质主要来自原料药的降解,有7批次杂质超出检出限(0.2%),不合格率为11.7%;建立了HPLC法测定含量均匀度,有1批次不合格,不合格率为1.7%。结论国产维生素B1片质量总体较好,但需关注贮存条件的控制。现行质量标准基本可行,但仍需进一步完善和提升。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.

关 键 词：维生素B1片 有关物质 含量均匀度 质量评价 

分 类 号：R927.1[医药卫生—药学]