Box-Behnken响应面法优化中药调脂片薄膜包衣处方

Optimization of Film Coating Formulation of Chinese Medicine Tiaozhi Tablets by Box-Behnken Design and Response Surface Methodology

目的应用Box-Behnken设计-响应面法优化中药调脂片薄膜包衣处方。方法以羟丙基甲基纤维素(HPMC)、聚乙二醇400(PEG 400)、滑石粉3者用量为影响包衣合格率主要考察因素,通过Box-Behnken实验设计,并以薄膜包衣合格率为响应值,应用Design-expert软件对实验数据进行二次多项式模型拟合,绘制响应面图和等高线图,比较各因素交互作用对包衣合格率影响的强弱,得出最优处方,并对其进行验证。结果最佳薄膜包衣处方为HPMC 6.6%(w/w),PEG 400 0.9%(w/w),滑石粉3.3%(w/w),水89.2%(w/w),预测包衣合格率为99.4%,实测值与预测值基本一致,崩解释放良好。结论通过Box-Behnken设计-响应面法建立的模型预测性良好,可用于对中药调脂片薄膜包衣处方的优化。

Objective To optimize the film coating technology for Chinese Medicine Tiaozhi tablets by Box- Behnken design and response surface methodology. Methods The dosage of hydroxypropyl methyl cellulose（HPMC）,polyethylene glycol 400（PEG400） and talc powder was selected as the key factors of influencing coating qualified rate.Box- Behnken design was adopted,and the film coating qualified rate was taken as the response value. Design Expert software was used to establish quadratic multinomial models fitting for experimental data.Response surface and contour overlay plot were delineated for the comparison of the interactions of the key factors on the film coating qualified rate.And then the optimal formulation was screened out and was validated. Results The optimal film coating formulation consisted of 6.6%（w/w） of HPMC,and 0.9 %（w/w） of PEG 400,3.3 %（w/w） of talc powder,and 89.2 %（w/w） of water. The calculated coating qualified rate was 99.4 %, which basically met with the measured value. The disintegration and release of the optimal formulation were qualified. Conclusion The model established by Box- Behnken design and response surface methodology has good predictability,and can be used to optimize the film coating formulation of Chinese Medicine Tiaozhi tablets.