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目的:应用D-最优混料设计优化贝母缓释微丸处方。方法:以总生物碱体外释放度为指标,考察浙贝母浸膏、羟丙基甲基纤维素和乙基纤维素用量,通过拟合最佳数学模型,建立三维曲面图预测最优处方范围,并进行验证。结果:所得优化处方范围内,微丸体外释放度的实验值与预测值十分接近,释药曲线接近零级,r=0.9940。结论:优化贝母缓释微丸处方具有明显缓释作用;采用混D-最优料设计-效应面法优化制剂处方,具有准确的预测性。
Objective: To optimize the formulation of Fritillaria sustained-release pellets by using D-optimal mixture design. Methods: The total alkaloids in vitro release as an indicator to investigate the Fritillaria extract, hydroxypropyl methyl cellulose and ethyl cellulose dosage, by fitting the best mathematical model, the establishment of three-dimensional surface map to predict the optimal prescription range , And verify. Results: In the range of optimized prescription, the in vitro release of the pellets was in good agreement with the predicted value. The release curve approached zero level, r = 0.9940. Conclusion: The optimized Fritillaria sustained-release pellets prescription has a significant sustained release effect; using mixed D-optimal material design - response surface method to optimize the formulation prescription, with accurate predictability.