星点设计-效应面法优化杜仲漂浮型脉冲释放片处方的研究  

Optimization on formulation of Eucommia ulmoides floating pulse drug delivery tablets by central composite design-response surface method

作　　者：耿燕娜 常杰 娄婷婷 尹元元 武毅君[2] GENG Yanna;CHANG Jie;LOU Tingting;YIN Yuanyuan;WU Yijun(Department of Pharmacy,Huaihe Hospital of Henan University,Kaifeng,Henan 475000,China;School of Pharmacy,Henan University,Kaifeng,Henan 475000,China)

机构地区：[1]河南大学淮河医院药学部,河南开封475000 [2]河南大学药学院,河南开封475000

出　　处：《安徽医药》2021年第12期2360-2363,I0001,共5页Anhui Medical and Pharmaceutical Journal

基　　金：河南省科技发展计划项目(162102310077)。

摘　　要：目的采用星点设计-效应面法优化杜仲漂浮型脉冲释放片的处方。方法在前期单因素试验的基础上,以包衣层材料中羟丙甲纤维素(HPMC_(K15M))、乳糖、碳酸氢钠的百分含量为考察因素,以释药时滞和起漂时间为考察指标,采用Design-Expert 8.06软件进行试验设计,对指标与因素之间进行多元线性和二次多项式方程拟合,通过效应面法优化最佳处方为:HPMC_(K15M)、乳糖、碳酸氢钠分别占包衣层质量的35%、20%、20%,并对其进行验证。结果各指标与因素之间二次多项式方程拟合良好,相关系数R2分别为0.9655和0.9668,采用优化处方制备的杜仲漂浮型脉冲释放片具有脉冲释药和快速漂浮特性,各指标实测值与预测值偏差+1.94%和−3.77%。结论星点设计-效应面法可用于本制剂处方的优化,所制得的杜仲漂浮型脉冲释放片具有体外定时脉冲释药特性。Objective To optimize the formulation of Eucommia ulmoides floating pulse drug delivery tablets by central composite design-response surface method.Methods On the basis of the previous single factor tests,the percentage of H ydroxypropyl Methycel-lulose(HPMC_(K15M)),lactose and sodium bicarbonate(NaHCO_(3))in the coating material was taken as the investigation factor,the lag time of drug release and the time of floating as the investigation index,and the Design-Expert 8.06 software was applied for central composite design.The data were simulated using multi-linear equation and second-order polynomial equation.The possibly optimal formulation of coating layer was predicted by response surface method:the best ratios of HPMC_(K15),lactoseand sodium bicarbonate were 35%,20%,and 20%,respectively,which was then validated.Results The investigation factor and index agreed well with second-order polynomial equation and R^(2) were 0.9655 and 0.9668.The floating pulse release tablets prepared with the optimized formulation had the characteristics of rapid floating and pulse release.The deviation between the measured values and the predicted values of each index was within+1.94%and−3.77%.Conclusions The central composite design-response surface method can be used to optimize the formulation of this preparation.The prepared floating pulse release tablet of Eucommia ulmoides has the characteristics of in vitro timed pulse release.

关 键 词：杜仲科 药物包装 药物释放 脉冲疗法 药物 工艺学 制药 星点设计-效应面法 漂浮型脉冲释放片 

分 类 号：R943[医药卫生—药剂学]