星点设计优化长春瑞滨静脉注射乳剂的处方

目的:星点设计优化长春瑞滨静脉注射乳剂的处方。方法:以注射用油、大豆磷脂和泊洛沙姆的用量为考察因素,以乳剂的稳定性参数和乳剂平均粒径为指标,采用多元线性方程和非线性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:用非线性二次多项式方程描述,稳定性参数和乳剂平均粒径的相关系数分别为0.987 6和0.983 7,具有较高的可信度。优化后的处方为注射用油的用量为9.0%、大豆磷脂的用量为2.2%、泊洛沙姆的用量为1.51%,加注射用水至全量。结论:所建立的模型预测性良好。

Optimized Formulation of Vinorelbine Intravenous Emulsion by a Central Composite Design Methodology

Objective: To optimize the formulations of vinorelbine intravenous emulsion by a central composite design methodology. Method: Independent variables were investigated which included the oil concentration, the soybean phospholipid concentration and the content of poloxamer with the parameter of stability and mean particle size. Linear or nonlinear mathematic models were used to estimate the relationship between independent and dependent variables. Response surfaces were delineated according to best-fit mathematic models, and optimum formulations were selected. Prediction was carried out through comparing the observed and predicted values. Result: Regression coefficients of the parameter of stability and mean particle size were as high as 0.987 6 and 0.983 7 respectively in nonlinear mathematic models. Optimum formulation was proposed to contain oil 9.0%, soybean phospholipid 2.2% and poloxamer 1.51%. Conclusion: The optimum mathematic model established was highly predictive.