【摘要】 目的：研究三味绿矾含漱剂的制备工艺，并进行质量评价。方法：通过单因素筛选提取山矾叶和诃子的温度、时间和加水量；利用正交试验得出含漱剂的最佳溶液配比；最终对制备的含漱剂进行质量评价，包含性能、理化指标以及处方化学成分的研究。结果：药材诃子和山矾叶粉的最佳提取条件为料液比为1∶10(g·m L^-1)，提取温度为60℃，提取时间为4 h；含漱剂的最佳配比为混合药液50%、乙醇15%、甘油7.5%、对羟基苯甲酸乙酯0.02%、亚硫酸氢钠0.5%、吐温-80的加入量1%，最后调p H值至6～7。制备的三味绿矾含漱剂口尝味清凉、嗅觉气芳香、溶液色泽均匀且澄清，其稳定性及p H值等均符合相关行业指标标准。通过液质联用技术推测出处方含有46个化合物，主要涉及到鞣质及酚酸类、黄酮类和三萜类等。结论：将三味绿矾由散剂改为含漱剂，在保证质量的基础上，可大大提高临床患者的方便性，并且确定了三味绿矾制剂中化学物质基础，为今后其规模化工业化生产以及质量控制提供科学依据。更多还原

【Abstract】 Objective:To study the preparation process of three-flavored Lvfan gargle,and evaluate its quality.Methods:The optimal parameters of extraction were obtained by single-factor screening of extraction temperature,extraction time and water addition in extracting Shanfanye and Hezi.Orthogonal test was utilized to obtain the optimal solution ratio of the gargle.Finally,the quality of the prepared gargle was evaluated,including performance,physical and chemical indexes,and prescription chemical composition.Results:The optimal extraction conditions for Hezi and Shanfanye were material-liquid ratio of 1∶10 (g·m L^-1),extraction temperature of 60°C,and extraction time of 4 h.The optimal formulation ratio for the gargle was 50%mixed herbal extract,15%ethanol,7.5%glycerin,0.02%ethylparaben,0.5%sodium bisulfite,1%tween-80,with p H adjusted to 6–7.The prepared three-flavored Lvfan gargle exhibited a cool taste,aromatic odor,uniform and clear solution,and met industry standards for stability and p H.LC-MS/MS analysis identified 46 compounds in the formulation,primarily including tannins,phenolic acids,flavonoids,and triterpenoids.Conclusion:Converting three-flavored Lvfan from a powder to a gargle significantly enhances patient convenience while ensuring quality.This study establishes the chemical basis of Sanwei Lvfan formulations,providing scientific support for future large-scale production and quality control.更多还原