恩替卡韦片剂的质量比较研究  

Comparative Study on Quality of Entecavir Tablets

作　　者：丁杨[1] 丁宇[1] 董伦[1] 周建平[1] 

机构地区：[1]中国药科大学天然药物活性组分与药效国家重点实验室,药剂学教研室,南京210009

出　　处：《中国药学杂志》2015年第1期58-62,共5页Chinese Pharmaceutical Journal

基　　金：国家自然科学基金资助项目(81273469);高等学校博士学科点专项科研基金(20110096110005);江苏高校优势学科建设工程资助项目

摘　　要：目的研究恩替卡韦片剂的质量,为临床使用提供参考。方法收集原研、国内3家企业生产的恩替卡韦片剂,通过测定不同企业生产及不同批次的片剂溶出度、有关物质、含量均匀度和初步稳定性试验等数据,比较与评估各制剂的质量。结果国产A片剂的溶出度、有关物质和含量均匀度等指标均优于原研片和片剂C;A片剂在影响因素试验中,各项指标无显著差异,而原研片剂部分指标有波动;A片剂3年期内批间差异小。结论通过对所收集的4种恩替卡韦片剂质量数据分析表明,国产A片剂稳定性好,有延长产品有效期的基础。OBJECTIVE To compare the quality between imported branded and 3 domestic entecavir tablets to provide references for clinical use. METHODS Tests of dissolution, content uniformity, related substances, influencing factor and preliminary stability were carried out between four products in batches, and the quality was compared and assessed. RESULTS Parameters of dissolution, content uniformity and related substances of entieavir tablet A were superior than that of branded product and C. Compared with imported branded tablets in inflencing factor tests, the quality of product A had no significant influence with high-quality during 3-year storage. CONCLUSION The quality of enticavir tablet A is noticebaly superior than branded and other domestic generic agents.

关 键 词：恩替卡韦片剂 原研 仿制 质量 比较研究 

分 类 号：R944[医药卫生—药剂学]