利伐沙班片自研制剂和参比制剂鼻饲条件下体外评价

In vitro study of comparing rivaroxaban tablets and reference under nasal feeding conditions

目的评价利伐沙班自研制剂与参比制剂鼻饲条件下的体外一致性。方法采用鼻胃管和胃造口管进行鼻饲实验,以沉降体积、粒度分布和回收率为指标进行利伐沙班自研制剂和参比制剂的体外研究。结果自研制剂在沉降体积、粒度分布和回收率方面均与参比制剂相似。结论自研制剂与参比制剂经鼻胃管给药条件下体外特性一致,消除给药方式所带来的影响。

Objective To evaluate the equivalence of rivaroxaban tablets and reference preperation in vitro under nasal feeding conditions.Methods Nasal feeding conditions were created with nasogastric tube and gastrostomy tube,and in vitro studies of the test and reference preperation were evaluated by sedimentation volume,particle size distribution and recovery studies.Results The similar results appeared between the test and reference preperation in terms of sedimentation volume,particle size distribution and recovery studies.Conclusion The equivalence of the test and reference preperation under nasal feeding conditions in vitro behaviors can effectively eliminate the impacts under different forms administration.