CAJ | 학술논문

目的：采用Plackett-Burman设计联用星点设计—效应面法优化双丙戊酸钠缓释片处方。方法以相似因子f2值为指标，运用Plackett-Burman设计评价各影响因素的显著性。以HPMC K100M、HPMC K15M的量和乙醇浓度为自变量，以各指标的总评“归一”值为因变量，通过星点设计—效应面优化法对自变量各水平进行多元线性拟合和二项式拟合，选择最佳模型进行预测分析，比较预测值与实验值的偏差。结果二项式拟合方程相关系数较高，r为0．9620，表明该模型对研制的双丙戊酸钠缓释片预测性良好。最佳处方为HPMC K100M 286．72 mg，HPMC K15M 16．96 mg，乙醇浓度27％。结论该方法用于缓释片处方优化操作简便、预测性好，所制得缓释片效果理想值得进一步扩大应用。
목적：채용Plackett-Burman설계련용성점설계—효응면법우화쌍병무산납완석편처방。방법이상사인자f2치위지표，운용Plackett-Burman설계평개각영향인소적현저성。이HPMC K100M、HPMC K15M적량화을순농도위자변량，이각지표적총평“귀일”치위인변량，통과성점설계—효응면우화법대자변량각수평진행다원선성의합화이항식의합，선택최가모형진행예측분석，비교예측치여실험치적편차。결과이항식의합방정상관계수교고，r위0．9620，표명해모형대연제적쌍병무산납완석편예측성량호。최가처방위HPMC K100M 286．72 mg，HPMC K15M 16．96 mg，을순농도27％。결론해방법용우완석편처방우화조작간편、예측성호，소제득완석편효과이상치득진일보확대응용。
Objective To obtain the optimal formulation of divalproex sodium sustained-release tablets by Plackett-Burman design and central composite design-response surface methodology.Methods With similarity factor method as an index,significant influence fac-tors of divalproex sodium sustained-release tablets were screened by Plackett-Burman design.The amount of HPMC K100M, HPMC K15M and ethanol concentration were chosen as dependent variables and overall desirability method was chosen as independent varia-ble.Central composite design-response surface methodology was used to optimize the formulation by establishing multiple linear regres-sion and second-order quadratic models;deviation was carried out through comparing the observed and predicted values.Results It showed that the coefficient of correlation of second-order quadratic model was high.The related coefficient reached 0.9620.In this ex-periment,the established model could describe the good relation between factors and indexes and the outcome of prediction was good. Optimal formulation of divalproex sodium sustained-release tablets was as follows:HPMC K100M 286.72 mg,HPMC K15M 16.96 mg, ethanol concentration 27%.Conclusion The method of optimized sustained-release formulation is simple with good predictability, which is worthy of application and promotion.