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目的:研制吗替麦考酚酯片并考察其体外溶出度。方法:采用中心组合设计法优化处方工艺,以微晶纤维素的用量和羧甲基淀粉钠的用量为考察因素,溶出度为评价指标,分别用线性模型和非线性模型描述溶出度和两个影响因素之间的数学关系,根据最佳数学模型描绘效应面,选择最佳处方,并进行预测分析。结果:溶出度与微晶纤维素的用量和羧甲基淀粉钠的用量的关系不能用线性方程描述,三次多项式是描述指标与因素之间关系的最佳模型,相关系数为0.991 6,具有较高的可信度。优选的最佳条件:微晶纤维素用量29.27 g,羧甲基淀粉钠的用量10.68g。最佳处方溶出度的理论预测值与实测值平均偏差为:-7.47%。结论:所建立的模型预测性良好,优化处方制备的片剂崩散迅速,溶出完全,工艺简单可行。
Objective: To develop mycophenolate mofetil tablets and investigate its in vitro dissolution. Methods: The central composite design method to optimize the formulation process, the amount of microcrystalline cellulose and the amount of sodium carboxymethyl starch as the study factors, the dissolution as an evaluation index, respectively, with a linear model and nonlinear model to describe the dissolution and two Affect the mathematical relationship between factors, according to the best mathematical model depicting the effect surface, select the best prescription, and make predictive analysis. Results: The relationship between dissolution and the amount of microcrystalline cellulose and the amount of sodium carboxymethyl starch can not be described by the linear equation. The third degree polynomial is the best model to describe the relationship between the index and the factor, the correlation coefficient is 0.991 6, High credibility. The optimal conditions: the amount of microcrystalline cellulose 29.27 g, the amount of sodium carboxymethyl starch 10.68g. The average deviation of the theoretical predictive value of the best prescription dissolution and the measured value is: -7.47%. CONCLUSION: The established model has good predictability. The tablet prepared by optimized prescription is rapid, dissolves completely and the process is simple and feasible.