替吉奥胶囊处方优选

目的筛选替吉奥胶囊的最佳处方组成.方法以辅料中的乳糖、十二烷基硫酸钠、硬脂酸镁作为考察因素,每个因素取3个水平,用L9（34）正交表安排试验,以替吉奥胶囊的溶出度为主要考察指标,以颗粒流动性和外观为参照指标,进行正交试验.结果辅料中影响胶囊溶出度的主要因素是十二烷基硫酸钠（P＜0.05）,最佳处方组成为乳糖60 g,十二烷基硫酸钠4 g,硬脂酸镁1.5 g.结论采用该处方及工艺制得的替吉奥胶囊溶出度较高,而且产品质量稳定,制备工艺简单可行,适合工业化大生产.

Study on Formulation and Preparation of Tegafur, Gimeracil and Oteracil Capsules

Objective To screen the optimum formulation technique of tegafur,gimeracil and oteracil capsules.Methods The L9(34)orthogonal table and three factors(dissolution,the grain liquidity and appearance as reference factors)were used to select the best form ulation by taking lactose,with sodium lauryl sulfate and magnesium stearate as the three main factors,and three levels were adopted for each factors.Results The experimental results indicated sodium lauryl sulfate was the chief factor of influencing dissolution of tegafur,gimeracil and oteracil capsules(P <0.05).Lactose and magnesium stearate had no statistic significance.The optimum form ulation was composed of tegafur,gimeracil and oteracil capsules,lactose 60g,sodium lauryl sulfate 4g,magnesium stearate 1.5g.Conclusion The optimum formulation and preparing technique are reliable.The quality of tegafur,gimeracil and oteracil capsules accord with China pharm acopoeia standard.Because the preparing technique is simple and feasible,it is suitable for industrialized production.