基于UPLC测定桂枝茯苓胶囊中8种活性成分的溶出度

目的:建立桂枝茯苓胶囊溶出度的测定方法,为该制剂的质量评价提供参考。方法:采用UPLC,没食子酸、芍药苷、苯甲酸、苯甲酰芍药苷、丹皮酚、肉桂酸、桂皮醛的流动相为0.02%三氟乙酸水溶液-乙腈梯度洗脱,检测波长分别为230 nm(没食子酸、芍药苷、苯甲酸、苯甲酰芍药苷、丹皮酚)和275 nm(肉桂酸、桂皮醛)。苦杏仁苷的流动相为水-甲醇(80∶20),检测波长218 nm。结果:确定溶出介质为0.1 mol·L~(-1)盐酸,转速50 r·min~(-1),采用转篮法测定溶出度。没食子酸、芍药苷、苯甲酸、苯甲酰芍药苷、丹皮酚、肉桂酸、桂皮醛、苦杏仁苷的线性范围分别为0.097 6~24.389 9,0.097 1~24.275 4,0.052 6~5.262,0.053~5.295 6,0.108 3~27.062 9,0.050 1~5.005,0.052 4~5.236 4,0.096 6~24.139 5 mg·L~(-1),平均加样回收率分别为102.3%,97.3%,99.3%,97.9%,97.8%,95.8%,97.0%,100.4%。样品溶出度均一性良好,45 min内各成分溶出度均能达到80%以上。结论:该方法操作简便、结果准确、重复性较好,可用于桂枝茯苓胶囊溶出度的测定,为中药复方制剂的质量标准评价提供了参考。

Determination of Dissolution of Eight Active Ingredients in Guizhi Fuling Capsules by UPLC

Objective:To establish a method for the determination of dissolution of 8 active ingredients in Guizhi Fuling capsules. Method:UPLC was employed,mobile phase of gallic acid,paeoniflorin,benzoic acid,benzoylpaeoniflorin,paeonol,cinnamic acid and cinnamaldehyde was 0.02% trifluoroacetic acid aqueous solution-acetonitrile for gradient elution,their detection wavelengthes were 230 nm and 275 nm.The mobile phase of amygdalin was water-methanol(80:20) and its detection wavelength was 218 nm. Result:The soluble medium was determined to be 0.1 mol·L^-1 hydrochloric acid,the rotation speed was 50 r·min^-1,the solubility measurement was carried out by the basket method.The linear ranges of gallic acid,paeoniflorin,benzoic acid,benzoylpaeoniflorin,paeonol,cinnamic acid,cinnamaldehyde,amygdalin were 0.097 6-24.389 9, 0.097 1-24.275 4,0.052 6-5.262,0.053-5.295 6,0.108 3-27.062 9,0.050 1-5.005,0.052 4-5.236 4,0.096 6-24.139 5 mg·L^-1,their average recovery rates were 102.3%,97.3%,99.3%,97.9%,97.8%,95.8%,97.0% and 100.4%,respectively.The dissolution rate of samples was good,and the dissolution rate of each component in 45 min could reach >80%. Conclusion:This method is simple,accurate and reproducible,and it can be used for determination of dissolution of Guizhi Fuling capsules.