利伐沙班片经鼻胃管给药方式的体外试验研究

目的：以利伐沙班为例，对临床上需鼻饲管给药的品种，建立体外药学研究的方法，以指导自制制剂与参比制剂在特定给药条件下的药学行为的一致性。方法：模拟临床给药，对影响给药的项目：沉降试验、粒径分析试验和回收试验进行研究。结果：沉降试验、粒径分析试验及回收试验结果可靠，表明本次所选自制制剂与参比制剂经鼻饲管给药过程中，沉降体积一致、粒度分布一致、回收结果一致。结论：所选方法可指导同类品种鼻胃管给药的体外研究。

In Vitro Study of Nasogastric Tube Administration of Rivaroxaban Tablets

Objective: Taking rivaroxaban as an example, to establish an in vitro pharmaceutical study method for the varieties that needing nasogastric tube administration in clinical practice, so as to guide the consistency of pharmaceutical behavior between generic and reference preparations under specific administration conditions. Methods: Experiments including sedimentation test, particle size analysis test and recovery test were used to simulate clinical drug administration. Results and conclusions: The results of sedimentation test, particle size analysis test and recovery test showed that the rivaroxaban tablets produced by our company had the same effect as the reference preparation after nasogastric tube administration. This method is reliable and can be used to guide the in vitro study of nasogastric tube administration of similar drugs.