速效止泻胶囊体外溶出度测定方法研究

Determination of Ditro Dissolution of Suxiao Zhixie Capsule

摘要:

目的: 建立速效止泻胶囊体外溶出度测定方法,考察其体外溶出规律。方法: 采用高效液相色谱(HPLC),检测波长256 nm,溶出介质为0.1 mol·L^-1 HCl,转速120 r·min^-1,浆法(沉降蓝)。结果: 速效止泻胶囊溶出率的均一性和重复性良好,以45 min为取样时间,盐酸小檗碱溶出率不少于75%为限度。结论: 方法简单、准确、可靠,可用于速效止泻胶囊溶出度的测定。

Abstract:

Objective: This manuscript presents a method to research the dissolution and external leaching rule of Suxiao Zhixie capsule. Method: By using of HPLC method, the wavelength of the spectrophotometer set at 256 nm. The dissolution medium is 0.1 mol·L^-1 HCl, the rotate speed is 120 r·min^-1(settlement basket method). Result: We get a good uniform and repeatability during assaying the dissolution of Suxiao Zhixie capsule. The sampling time should be 45 min, and the percentage of dissolution should not less than 75%. Conclusion: The method we used to assay the dissolution of Suxiao Zhixie capsule is simple, accuracy and reliable.