利伐沙班片不同来源参比制剂的溶出曲线与渗透速率研究  

Study on dissolution curves and permeation rates of rivaroxabanreference tablets from different sources

作　　者：马玲云[1] 汪璐楠 孟雨馨 张广超 刘倩[1] 牛剑钊[1] 孙会敏[1] MA Ling-yun;WANG Lu-nan;MENG Yu-xin;ZHANG Guang-chao;LIU Qian;NIU Jian-zhao;SUN Hui-min(National Institute for Food and Drug Control,Beijing 100050,China)

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国新药杂志》2025年第8期850-856,共7页Chinese Journal of New Drugs

摘　　要：目的:收集利伐沙班片3种不同规格(10 mg,15 mg,20 mg)共计6个批次的原研进口、未进口原研参比制剂,预测不同参比制剂之间的生物等效性。方法:开展3种溶出介质(pH 4.5醋酸盐缓冲液、pH 6.8磷酸盐缓冲液和水溶液)条件下的溶出曲线的测定,并采用平行人工膜测定其渗透速率。结果:不同来源的参比制剂在3种溶出条件下的溶出曲线相似、在空腹和饱腹条件下渗透速率一致。结论:不同来源利伐沙班片的参比制剂具有质量一致性。Objective:To collect 6 batches of rivaroxaban tablets of 3 different specifications(10,15,20 mg)and predict the bioequivalence of different reference preparations.Methods:The dissolution curves were measured under the conditions of three dissolution media(pH 4.5 acetate buffer,pH 6.8 phosphate buffer,and aqueous solution).Results:The dissolution curves of the reference preparations from different sources were similar under the three dissolution conditions,and the permeation rates were the same under the fasting and satiety conditions.Conclusion:The qualities of rivaroxaban tablets from different sources are consistent.

关 键 词：利伐沙班片 参比制剂 溶出曲线 平行人工膜 渗透速率 

分 类 号：R917[医药卫生—药物分析学]