| ABSTRACT Objective: To prepare and optimize candesartan cilexetil tablets, and study the stability preliminarily. Methods:The formula was optimized by Box-Behnken experiment design, the ratio of lactose to pregelatinized starch(X1), the amount of disintegrant (X2, %) and the amount of lubricant(X3, %) were selected as the independent variables, and weight difference (Y1, %), friability(Y2, %), disintegration time(Y3, %) and candesartan cilexetil dissolution(Y4, %) were the dependent variables. The release rate of candesartan cilexetil tablets and the reference tablets were compared by similarity factor (f2 value). Preliminary stability was studied by high temperature test, high humidity test and illumination test.Results: The optimal formula of the tablets was as follows: the ratio of lactose to pregelatinized starch was 7∶1, the amount of disintegrant was 5.5%, and the amount of lubricant was 0.5%. The f2 for the candesartan cilexetil tablets and the reference tablets in different dissolution meda was 60.62, 73.34, 66.95 and 68.60, respectively.Conclusion:The formula design is reasonable, the preparation process is feasible and the quality can be controlled. |
