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目的采用星点设计-效应面法优化左乙拉西坦生物黏附缓释片处方。方法以羟丙甲纤维素和卡波姆用量为考察因素,体外释放度和生物黏附力综合评价值为考察指标,采用多元线性回归和多元非线性回归拟合,根据模型绘制效应面图和等高线图,优化处方并进行验证。结果最优处方组成:左乙拉西坦500 mg,HPMC 275 mg,5%HPC-SL水溶液适量,卡波姆84 mg,微粉硅胶0.430 mg,硬脂酸镁0.859 mg,其释放曲线在2~12 h释放符合Weibull方程,12 h的累计释放量为93.54%,实测值与预测值无明显差异。结论采用星点-效应面优化法实现了对处方的优化。
OBJECTIVE To optimize the formulation of levetiracetam bioadhesive sustained-release tablets by the method of star point design-response surface method. Methods Hypromellose and carbomer dosage as the study factors, the in vitro release and bioadhesive force comprehensive evaluation value as the index, using multiple linear regression and multivariate nonlinear regression fitting, according to the model to draw the effect of surface maps and so on High line graph, optimize prescription and verify. Results The optimum formulation consisted of the following: levetiracetam 500 mg, HPMC 275 mg, 5% HPC-SL aqueous solution qs, carbopol 84 mg, silica gel 0.430 mg, magnesium stearate 0.859 mg, The release of 12 h was in line with the Weibull equation. The cumulative release at 12 h was 93.54%. There was no significant difference between the measured and predicted values. Conclusion The optimization of prescriptions is achieved by the star-response surface optimization method.