西黄双层片中麝香乳香没药层的处方筛选

目的优化西黄双层片中麝香乳香没药缓释层（MOM—layer）的处方。方法以西黄方活性组分中的麝香酮及醋酸辛酯为指标性成分，通过单因素试验，确定影响麝香酮、醋酸辛酯体外同步释放的主要因素为HPMCK4M和KolliphorHS15的用量；采用星点设计一效应面法，对麝香酮、醋酸辛酯在2、6、10h的累积释放度进行二次多项式方程拟合，通过重叠等高线图确定优化处方。结果优选出MOM—layer处方为：KolliphorHS用量60mg,HPMCK4M30mg。结论制备的MOM—layer有明显的缓释特征，麝香酮、醋酸辛酯之间的正值为73．74，大于50，两种成分在体外能同步释放，达到了预期设计的要求。

Optimization of Formulation of MOM-layer Tablet in Xihuang Double-layer Tablet

Objective To optimize the formulation of MOM-layer tablet in Xihuang double layer tablet. Methods On the basis of single factor experiments, the formulation of MOM layer was optimized by conducting experiments according to central composite design with amounts of HPMC K 4M and Kolliphor HS as factors, respectively, and the cumulative in vitro release amounts of Muscone and octal acetate at 2, 6, 10h as indices, separately. Quadratic model was used to estimate the relationship between the dependent and the independent variables, and the optimal fbrraulation was selected with application of hypothesized in vitro cumulative release in overlay contour plot. Results In the optimum formulation of MOM layer, the amounts of HPMC K4M and Kolliphor HS were to 60 mg and to 30 rag, respectively. Conclusion The MOM-layer showed obviously sustained release characteristics. The f2 value between Muscone and Octyl acetate was 73.74 （ 〉 50）. The result achieves the desired requirement because the two components in vitro released synchronously.