达比加群酯胶囊处方工艺研究的一般考虑

General Consideration on Preparation Study of Dabigatran Etexilate Capsules

目的对达比加群酯胶囊处方研究及制备工艺控制要点进行讨论。方法分析了相关文献及专利,在此基础上提出达比加群酯胶囊处方工艺研究的一般考虑。结果与结论达比加群酯是新一代口服直接凝血酶抑制剂,是目前仿制药申报较为热门的品种,其仿制药研发应深入进行处方工艺研究,提出质量控制策略。

OBJECTIVE To discuss the key points of the preparation process control of dabigatran etexilate capsules.METH-ODS Based on the analysis of relevant literatures and patents,the general consideration on preparation study of dabigatran etexilate capsules was proposed.RESULTS AND CONCLUSION Dabigatran etexilate is a new synthetic,rapidly acting oral direct thrombin inhibitor,which is a hot point in application of generic drugs in recent years.Generic drugs should conduct in-depth prescription study and put forward the quality control strategy.