正交设计优化甲磺酸地拉韦啶分散片处方

The formula optimization of delavirdine mesylate dispersible tablets by orthogonal design test

目的:筛选甲磺酸地拉韦啶薄膜衣分散片的处方并进行制备。方法:以崩解时限为指标,采用正交设计实验,对分散片处方进行筛选,并进行体外溶出度考察。结果:按优选处方制备的3批分散片外观光洁,均在3 min内完全崩解并通过710μm筛。结论:研制的甲磺酸地拉韦啶分散片处方合理、工艺可行,符合分散片的质量要求。

Objective： To optimize the formula and prepare delavirdine mesylate dispersible tablets. Methods：The formula of delavirdine mesylate dispersible tablet was optimized in term of disintegrating time by orthogonal design test. The dissolution rates of the principal agent in dispersible tablets were determined. Results ：The optimized dispersible tablets had fine appearance and disintegrated in 3 rain,and the suspension screened through the 710 p^m mesh. The dissolution rates of the dispersible tablets were similar in 3 batches formulation. Conclusion：The prepared delavirdine mesylate dispersible tablet was reasonable in formula, feasible in technology and was accorded with the quality standards.