二次回归正交组合设计优化对乙酰氨基酚糖浆处方

目的优化对乙酰氨基酚糖浆处方。方法利用二次回归正交组合设计，以溶解度为指标，得出聚乙二醇400（PEG-400）、1．2-丙二醇、聚维酮K30（PVPK30）3种辅料用量与对乙酰氨基酚溶解度的回归方程；并通过防结晶试验考察各辅料防结晶能力。结果3种辅料均可显著增加药物溶解度，三者混合助溶效果更加显著，其中PVPK30可大大增加溶液防低温结晶的能力。结论通过回归方程可在防止结晶、稳定制剂的前提下进一步降低处方中有机溶剂的用量，从而降低生产成本并提高制剂安全性。

Formula Optimization of Paracetamol Syrup by Quadratic Regression Orthogonal Combination Test

Objective To optimize theformula of Paraeetamol Syrup. Methods By quadratic regression orthogonal combination test, the solubility was used as the index, the regression equation about the dosages of three accessories PEG-400, 1, 2-propylene glycol, PVP K30 and the solubility of paracetamol was gained. By the experiment of preventing crystallization, the anti crystallization ability of the three accessories were investigated. Results The solution power could be enhanced evidently in the three accessories. Mixing the three accessories increased the solubility much more evidently. The ability of preventing low temperature crystallization was markedly enhanced by PVP K30. Conclusion Using the regression equation can further reduce the dosage of organic solvent in formula on the premise of preventing crystallization and stabilizing the preparation, thereby, lower the production cost and enhance the preparation security.