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目的采用星点设计-效应面法优化异长春花碱脂质体的处方。方法以磷脂/药(质量比)、胆固醇/磷脂(摩尔比)、水化温度为考察因素,以脂质体的包封率和脂质体的平均粒径为指标,采用二次多项式方程描述考察指标和影响因素之间的数学关系,根据此数学模型描绘效应面,选择最佳处方,并进行预测分析。结果所建立的考察指标和影响因素之间的数学模型具有较高的可信度。以优化后的处方制备样品,各指标实测值与预测值偏差较小。结论所建立的模型预测性良好,制备的脂质体符合设计要求。
OBJECTIVE: To optimize the formulation of vincristine liposomes by the method of star point design-response surface methodology. Methods Taking phospholipid / drug (mass ratio), cholesterol / phospholipid (molar ratio) and hydration temperature as the investigation factors, the encapsulation efficiency of liposomes and the average particle size of liposomes The mathematical relationship between the index and the influencing factors was investigated. According to the mathematical model, the effect surface was drawn, the best prescription was selected, and the predictive analysis was carried out. Results The mathematical model established between the inspection index and the influencing factors has high credibility. Samples were prepared with the optimized prescription, and the deviation between measured and predicted values of each index was small. Conclusion The established model has good predictability and the prepared liposomes meet the design requirements.