CAJ | 학술논문

目的：优化益节健片的处方。方法采用星点设计法考察预胶化淀粉用量、二氧化硅用量、压片厚度等因素对益节健片崩解时间、脆碎度的影响，对试验数据分别进行多元线性和二次多项式方程拟合，结合效应面法，优选最佳处方。结果二次多项式模型相关系数优于多元线性模型，优化处方中预胶化淀粉用量为38．9mg，二氧化硅用量为31．7mg，压片厚度为1．77mm，预测值和测定值非常接近。结论星点设计－效应面法可用于益节健片处方优化，所建立的模型预测性良好。
목적：우화익절건편적처방。방법채용성점설계법고찰예효화정분용량、이양화규용량、압편후도등인소대익절건편붕해시간、취쇄도적영향，대시험수거분별진행다원선성화이차다항식방정의합，결합효응면법，우선최가처방。결과이차다항식모형상관계수우우다원선성모형，우화처방중예효화정분용량위38．9mg，이양화규용량위31．7mg，압편후도위1．77mm，예측치화측정치비상접근。결론성점설계－효응면법가용우익절건편처방우화，소건립적모형예측성량호。
OBJECTIVE To optimize Yijiejian Tablets Formulation.METHODS Central composite design was used in the experimental design to explore the impacts of Nitrogen ketone、Oleic acid and Propylene glycol on the disintegration time and friability of Yijiejian Tablets.Experimental data was fitted by multiple linear and quadratic polynomial equations,response surface methodology was adopted to determine optimum formulation.RESULTS The multiple correlation coefficient of quadratic polynomial models was better than multiple linear models,Optimal formu-lation was proposed to contain pregelatinized starch 38.9mg,silicon dioxide 31.7mg,the disintegration time and fria-bility of optimum formulation was close between predicted value and observed value.CONCLUSION The central composite design-response surface method are useful for the optimization of Yijiejian Tablets.the established model had good prediction.