硝酸异山梨酯评价性抽样结果质量分析

目的 评价国产硝酸异山梨酯片的质量现状及存在的问题.方法 按照2010年度国家评价性抽验计划总体要求,采用法定检验方法结合探索性研究进行样品检验,采用HPLC法考察了201批样品的有关物质,另参考了FDA规定的4种溶出介质,考察14个厂家样品在水、0.1 mol·L-1盐酸、pH4.5醋酸盐缓冲液、pH 6.8磷酸盐缓冲液中的体外溶出行为.结果 经按现行中国药典标准对全国201批样品检验,1批次性状不合格,不合格率为0.5％.所有样品均存在已知杂质单硝酸异山梨酯与2-单硝酸异山梨酯,量均＜0.1％,但部分样品其他未知杂质量＞1.5％,单一未知杂质更是高达0.7％.硝酸异山梨酯片在不同溶出介质中溶出较好,但有一定差异.结论 硝酸异山梨酯片的生产工艺有待提高,总体质量情况一般.

Quality assessment on the inspection of isosorbide dinitrate tablets

Objective To evaluate the quality of isosorbide dinitrate tablets produced in China and its existing problem.Methods According to the general regulation of national evaluation sampling,the quality of all samples was inspected by legal inspection method and exploratory research.Related substances of 201 batches of samples were measured by HPLC and the dissolubility of the samples from 14 main manufacturers was tested in 4 media:water,0.1 mol· L-1 HCl,pH 4.5 acetate buffer solution,and pH 6.8 phosphate buffer solution,which were stipulated by FDA.Results Based on the state standards in existence,1 batch was disqualified out of the 201,with the disqualification rate of 0.5%.There were known impurities of isosorbide mononitrate and isosorbide 2-nitrate in all the samples and but the quantity was below 0.1%.In some samples the amount of unknown impurities was more than 1.5%,in which a single unknown impurity was as high as 0.7%.The dissolution of isosorbide dinitrate tablets in the media was good,but there was little difference.Conclusion The overall quality of isosorbide dinitrate tablets is acceptable,and its product process needs improvement.