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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。
OBJECTIVE: To design and optimize the formulation of Vinorelbine intravenous emulsion. Methods: Taking the amount of oil for injection, soybean phospholipid and poloxamer as the investigation factors, the stability parameters of the emulsion and the average particle size of the emulsion were used as indices to describe the indexes and influencing factors by using the multivariate linear equation and the nonlinear quadratic polynomial equation The mathematical relationship between, according to the best mathematical model depicting the effect surface, select the best prescription, and make predictive analysis. Results: According to the nonlinear quadratic polynomial equation, the correlation coefficients between the stability parameters and the average particle size of the emulsion were 0.987 6 and 0.983 7, respectively, with high confidence. Optimized prescription for the injection of oil was 9.0%, soybean phospholipid was 2.2%, poloxamer 1.51%, add water for injection to the full amount. Conclusion: The established model has good predictability.