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目的:优化清开灵注射液的增溶工艺。方法:以清开灵注射液八混液中间体中胆酸的溶解度为指标,通过均匀设计,结合基于遗传算法的BP神经网络(GA-BPNN)建模,对工艺参数进行优化。结果:增溶剂种类和八混液pH影响较大,而增溶剂浓度影响较弱;增溶剂宜选择聚氧乙烯脱水山梨醇单油酸酯(Tween-80),八混液pH一定范围内宜选择较大者,增溶剂浓度虽和溶解度正相关,但因其影响甚弱,故过高的浓度意义不大。结论:均匀设计结合GA-BPNN建模的方法,适合于中药注射液的增溶工艺的优化,具有一定的实际应用价值。
Objective: To optimize the solubilization process of Qingkailing injection. Methods: Based on the solubility of cholic acid in the intermediate of Qingkailing Injection, the process parameters were optimized by uniform design and combined with the genetic algorithm based BP neural network (GA-BPNN) modeling. Results: The type of solubilizer and pH of mixture had a greater effect, but the effect of concentration of solubilizer was weaker. Tween-80 should be chosen as the solubilizer, and the pH of the mixture should be selected within a certain range However, although the concentration of solubilizer is positively correlated with solubility, its concentration is not significant because of its weak influence. Conclusion: The method of uniform design combined with GA-BPNN modeling is suitable for the optimization of solubilization technology of Chinese injection and has certain practical value.