摘要
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60g,十二烷基硫酸钠4g,硬脂酸镁1.5g。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。
Objective To screen the optimum formulation technique of tegafur, gimeracil and oteracil capsules. Methods The 1.9（34） orthogonal table and three factors （dissolution, the grain liquidity and appearance as reference factors） were used to select the best formulation 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 formulation was composed of tegafur, gimeracil and oteracil capsules,lactose 60 g,sodium lauryl sulfate 4 g, magnesium stearate 1.5 g. Conclusion The optimum formulation and preparing technique are reliable. The quality of tegafur, gimeracil and oteracil capsules accord with China pharmacopoeia standard. Because the preparing technique is simple and feasible,it is suitable for industrialized production.
出处
《中国药业》
CAS
2006年第11期44-45,共2页
China Pharmaceuticals
关键词
替吉奥胶囊
处方
正交试验设计
溶出度
tegafur, gimeracil and oteracil capsules
formulation
orthogonal experiment design
dissolution
