去氨加压素片及其注射液质量评价

Quality evaluation of desmopressin tablets and injection

目的对去氨加压素片及其注射液上市产品进行质量分析和评价,针对质量现状及存在问题展开探索性研究,为药品质量标准修订提供数据支持,为药品质控和监管提供参考。方法采用法定检验和探索性研究相结合的方式,对20批去氨加压素片和16批去氨加压素注射液进行全项检验,并开展片剂有关物质方法研究、片剂溶出度分析、片剂及注射液稳定性研究等探索性研究工作。结果20批去氨加压素片和16批去氨加压素注射液法定检验合格率为100%。探索性研究对片剂有关物质测定方法进行了优化,消除了辅料聚维酮对检测的干扰;考察了国内外片剂产品溶出度,结果显示溶出行为相似;对片剂及注射液进行了稳定性考察,并对注射液中相关杂质进行了结构确证,主要为5位脱酰胺去氨加压素和光学异构体杂质。结论去氨加压素片及其注射液质量较好,质量标准需进一步完善。

Objective To evaluate the quality of listed products of desmopressin tablets and its injection,and provide data for the revision of drug quality standards and for drug quality control and supervision.Methods Based on statutory inspection and exploratory research,20 batches of desmopressin tablets and 16 batches of desmopressin injection were inspected before exploratory research was carried out,such as methodological research on related substances of tablets,dissolution analysis of tablets,stability of tablets and injections.Results The qualification rate of statutory inspection for 20 batches of desmopressin tablets and 16 batches of desmopressin injection was 100%.The exploratory research optimized the determination methods of related substances in tablets and the interference of the excipient povidone in detection was eliminated.The dissolution of tablets at home and abroad was investigated and the results showed that the dissolution behavior was similar.The stability of the tablets and injection was investigated,and the structure of impurities in the injection was confirmed,which were mainly 5-site deamidation desmopressin and optical isomer impurities.Conclusion The quality of desmopressin tablets and their injections is good,and there are still some problems with the quality standards,which need to be improved.