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目的:应用Box-Behnken设计-效应面法优化淫羊藿总黄酮微孔渗透泵片处方。方法:以渗透压活性物质用量(乳糖)、增塑剂用量(邻苯二甲酸二丁酯)、包衣增重量为影响片剂释放的主要因素,以12h的药物累积释药量和释放曲线拟合度为效应值,应用Design Expert进行处方优化,并对优化处方进行验证。结果:成功找到了最优释药区域;优化后处方呈零级释放特性。结论:淫羊藿总黄酮微孔渗透泵片的最佳赋形剂配方是0.18g乳糖,邻苯二甲酸二丁酯与醋酸纤维素之比是0.26,片剂增量为7.7%。
OBJECTIVE: To optimize the formulation of epimedium pubescens total flavone microporous osmotic pump tablet by using Box-Behnken design-response surface method. Methods: The main factors influencing the release of tablets were the dosage of osmotic pressure (lactose), dosage of plasticizer (dibutyl phthalate) and the weight of coating, the cumulative drug release and release curve The fitting degree is the effect value, the formulation optimization is carried out by using Design Expert, and the optimization prescription is verified. Results: The optimal drug release area was found successfully. The optimal prescription was zero-order release. CONCLUSION: The best excipient formulation of Epimedium pubescens microporous osmotic pump tablets was 0.18 g lactose with a ratio of dibutylphthalate to cellulose acetate of 0.26 and an increment of 7.7% tablets.