论文部分内容阅读
目的采用中心复合设计法优化胰岛素-胆盐与磷脂冻干复合物处方,以获得稳定的胰岛素油溶液。方法分别考察了叔丁醇用量和胆盐与磷脂质量比对冻干复合物的载药量和溶解时所需油相质量等指标的影响。用线性方程和二次多项式描述各指标及总评“归一值”与两个因素之间的数学关系,根据总评“归一值”的最佳数学模型描绘效应面,选择最佳处方,并进行预测分析。结果两个因素和两个评价指标及总评“归一值”之间存在定量关系。优选的最佳处方为叔丁醇0.475 g,胆盐与磷脂质量比2.810。优化处方各指标的预测值和目标值接近。结论所建立的模型预测性良好,可用于优化胰岛素-胆盐与磷脂冻干复合物处方,并获得稳定的胰岛素油溶液。
Objective To optimize the formulation of insulin-bile salts and phospholipid freeze-dried complex by central composite design to obtain a stable insulin oil solution. Methods The effect of the amount of tert-butanol and the ratio of bile salt to phospholipid on the drug loading of lyophilized compound and the quality of oil phase required for dissolution were investigated. Linear equations and quadratic polynomials are used to describe the mathematical relationship between each indicator and general comment “normalized value ” and the two factors, and the effect surface is depicted according to the best mathematical model of “generalized value ” Prescription, and forecast analysis. Results There was a quantitative relationship between the two factors and the two evaluation indexes and the general rating “normalized value ”. The best prescription is 0.475 g of t-butanol, the ratio of bile salt to phospholipid is 2.810. The predicted value and the target value of each index of optimized prescription are close. Conclusion The established model has good predictability and can be used to optimize the insulin-bile salt and phospholipid freeze-dried complex prescription and obtain a stable insulin oil solution.