摘要
目的:建立利伐沙班片溶出度测定方法,评价自研制剂与原研制剂体外溶出行为的一致性。方法:参考FDA溶出数据库中的条件,在250nm波长处采用紫外-可见分光光度法测定样品吸光度并计算溶出度;考察自研利伐沙班片与原研制剂分别在pH4.5+0.2%SDS醋酸盐缓冲液、pH4.5醋酸盐缓冲液、0.1mol/mL盐酸溶液、pH6.8磷酸盐缓冲液4种溶出介质中的溶出曲线,采用相似因子评价其一致性;并进一步考察不同转速下两种制剂的相似性。结果:自研制剂与原研制剂在4种不同溶出介质中溶出曲线均相似,在不同转速下溶出曲线相似。结论:自研制剂与原研制剂体外溶出行为一致,可开展后续的药品稳定性和BE研究。
Objective: To establish the method for the determination of dissolution of rivaroxaban tablets, and to evaluate the consistency of in vitro dissolution behavior between self-prepared rivaroxaban tablets and original preparation. Methods: According to the dissolution test conditions from FDA database, the absorbance of the sample was determined by UV-visible spectrophotometry at 250 nm and the dissolution was calculated. The self-prepared rivaroxaban tablets and the original preparation were determined in 4 dissolution medium(pH 4.5+0.2% SDS acetate buffer solution, pH 4.5 acetate buffer solution,0.1 mol/mL hydrochloric acid solution, pH 6.8 phosphate buffer solution),the similarity factors were used to evaluate the consistency;and the similarity of the two preparations at different rotation speeds was further investigated. Results: The dissolution curves of the self-prepared rivaroxaban tablets were similar to those of the original preparation in four different dissolution media, and the dissolution curves were similar at different rotation speeds. Conclusion: The self-prepared rivaroxaban tablets is consistent with the in vitro dissolution behavior of the original preparation, and the subsequent drug stability and BE research can be carried out.
作者
张玉莉
孙宇宏
王晓梅
魏小亮
党珍
马超
孙建敏
Zhang Yu-li;Sun Yu-hong;Wang Xiao-mei;Wei Xiao-liang;Dang Zhen;Ma Chao;Sun Jian-min(Shaanxi Institute of International Trade Commerce, Shaanxi Xianyang 712046;Shaanxi Buchang HI-TECH Pharmaceutical Company Limited, Shaanxi Xi'an 710119)
出处
《生物化工》
2019年第4期27-31,共5页
Biological Chemical Engineering
关键词
利伐沙班片
一致性评价
体外溶出行为
相似因子法
Rivaroxaban tablets
Consistency evaluation
In vitro dissolution behavior
Similarity factor method
