厄贝沙坦片的制备工艺与溶出度一致性研究

Preparation of irbesartan tablets and consistency study of their dissolubility

目的制备厄贝沙坦仿制片并对其进行工艺与溶出度一致性研究。方法以原研药(卡压舒~?)为参比制剂,通过单因素实验考察黏合剂种类、黏合剂用量、片剂硬度、不同含水量和包衣增重对溶出度的影响,确定处方组成。放大制备3批厄贝沙坦仿制片,在4种不同溶出介质中考察3批样品和原研药的溶出一致性,通过相似因子(f_2)法评价自制与参比制剂溶出曲线的相似性。结果 3%HPMC-E5作为黏合剂较5%PVP K30作为黏合剂时稳定,黏合剂用量、硬度和水分在考察的范围内基本不影响,包衣增重2%~3%,3批自制片与原研片在不同溶出介质中f_2均大于50。结论厄贝沙坦片制备工艺稳定且自制制剂与参比制剂在不同溶出介质中的体外溶出行为一致。

Objective To prepare generic irbesartan tablets and to evaluate its consistency of dissolution tests.Methods Using the original drugs （irbesartan） as reference drug,the single factor experiments were applied to investigating the type and amount of adhesive,tablet hardness,water content of tablets,and coating weight.ZRS-8G Dissolution Tester was used to conduct the dissolution tests which were carried on four different dissolution media.Then the similar factor （f2） was adopted to evaluate the similarity of dissolution between the original drug and generic drug.Results As the stabilizer,3% HPMC-E5 was more stable than 5% PVP K30.It had no difference of dissolution between original and generic drugs when the amount of adhesive,tablets hardness and water content were within the range of investigation.And the coating weight was 2% to 3%.Moreover,the f2 values of original drug and generic drug were all greater than 50 in different dissolution media.Conclusion Thef2 results indicate a similarity in the dissolution behavior of reference drug and generic irbesartan tablets prepared by the single factor experiments.And the preparation process of generic irbesartan tablets is stable.