【摘要】 目的研究替米沙坦氨氯地平片最佳处方和制备工艺,以期得到体外溶出行为与参比制剂一致的复方制剂。方法以自制片和参比制剂在pH 7.5缓冲溶液中溶出曲线的相似因子（f₂）为主要考察指标,采用正交设计试验进行处方优化,优化处方的制剂与参比制剂分别在4种不同溶出介质中进行溶出行为比较,用相似因子法进行评价。结果 4种介质中的f₂值均大于50,说明按优化得到的处方制备的替米沙坦氨氯地平片与参比制剂体外溶出行为相似。结论制备的替米沙坦氨氯地平片处方合理,工艺可行。更多还原

【Abstract】 Objective To study the optimal formulation and preparation technology of Telmisartan and Amlodipine Tablets and obtain a compound preparation with the same dissolution behavior in vitro as the reference preparation.Methods Taking the similarity factor（f₂） as the main index, the dissolution profiles of the tablets and the reference preparation in pH 7.5 buffer solution were compared.The formulation was optimized by orthogonal experiment design.The dissolution behaviors of the optimized preparation and the reference preparation in four different dissolution media were compared respectively, and evaluated by the similarity factor.Results The values of f₂ in the four media were greater than 50,indicating that the in vitro dissolution behavior of telmisartan and amlodipine tablets prepared according to the optimized formulation was similar to that of the reference preparation.Conclusion The formulation composition of Telmisartan and Amlodipine Tablets was rational, and the preparation technology was feasible.更多还原