运用Minitab软件优化S-1复方胶囊的研究

Study of the formula optimization of S-1 compound capsules By Minitab

目的利用Minitab软件进行S-1复方胶囊剂的处方筛选及优化研究。方法利用Minitab软件的实验设计功能,以奥替拉西钾(OXO)、吉美嘧啶(CDHP)、替加氟(FT)三种有效成分的溶出度为指标,筛选出S-1复方胶囊的关键处方因素为吉美嘧啶粒径、崩解剂用量、乳糖用量;进一步采用效应面法筛选S-1的最佳处方。结果最优处方为X1=28.4μm,X2=5.6 mg,X3=100 mg;DEHP的溶出度为(95.0±0.52)%,OXO的溶出度为(99.1±0.88)%,总混颗粒的休止角为(25.0±1.75)°,与原研产品溶出曲线一致。结论采用Minitab软件进行S-1复方胶囊处方的筛选及优化是有效、可行的。

Objective To study the formula optimization of S-1compound capsules by Minitab.Methods By using the Experiment Design of Minitab,the key prescription factors of S-1compound capsules(Particle size of CDHP,amount of disintegrating agent,amount of lactose)were screened out by evaluating the dissolution rate of Potassium Oxonate(OXO),gimeracil(CDHP)and tegafur(FT),and the optimal formulation of S-1was further screened by response surface method.Results The optimal formulation was X1=28.4μm,X2=5.6mg,X3=100mg;The dissolution of DEHP was(95.0±0.52)%,the dissolution rate of OXO was(99.1±0.88)%,the angle of repose of particles was(25.0±1.75)°,and the product dissolution curve was consistent of the RLD product.Conclusion Using Experiment Design of Minitab to optimize the formula of S-1compound capsules is effective and feasible.