芍药甘草滴丸的制备及其芍药苷、甘草苷和甘草酸的HPLC含量测定

Preparation of Shaoyao Gancao Dripping Pills and Determination of Its Main Contents of Paeoniflorin,Liquiritin and Glycyrrhizic Acid by HPLC Method

目的:制备芍药甘草滴丸(SGDP),测定其主要成分芍药苷、甘草苷、甘草酸的含量,以及其他与质量控制相关的指标,为有效控制其质量提供重要指标和参数。方法:采用水煎煮提取,乙醇沉淀、HP-20大孔树脂纯化后,选择合适的基质和冷却剂,制备SGDP;采用HPLC-DAD法测定SGDP中芍药苷(230 nm)、甘草苷(276 nm)、甘草酸(250 nm)的含量。并按照《中华人民共和国药典》2015版的方法对其外观、重量差异、溶散时限进行检查。结果:成功制备了SGDP,HPLC法可同时测定SGDP中芍药苷、甘草苷、甘草酸铵盐的含量,分别是(32. 66±0. 46) mg/g、(9. 23±0. 23) mg/g、(17. 48±0. 86)mg/g;平均回收率分别是111. 23%、96. 04%、104. 43%。外观、重量差异、溶散时限均符合药典要求。结论:SGDP的制备工艺合理可行。HPLC法灵敏、准确可靠,重复性好,可用于同时检测SGDP中芍药苷、甘草苷、甘草酸的含量,为其质量控制提供参考依据。

Objective:To prepare Shaoyao Gancao Dripping Pills(SGDP)and determine its main contents of paeoniflorin,liquiritin and glycyrrhizic acid by HPLC Method,and to provide important reference and parameters for the effective quality control of SGDP.Methods:SGDP was prepared by water decoction,ethanol precipitation and purification of HP-20 macroporous resin.The main contents paeoniflorin,liquiritin and glycyrrhizic acid of SGDP were determined by HPLC-DAD methods at 230 nm,276 nm and 250 nm,respectively.The appearance,weight difference and solution time were determined according to Chinese Pharmacopoeia(2015).Results:SGDP was successfully prepared and the main contents of paeoniflorin,liquiritin and glycyrrhizic acid ammonium salt of SGDP were(32.66±0.46)mg/g,(9.23±0.23)mg/g,and(17.48±0.86)mg/g,respectively,and could be detected simultaneously by HPLC method with mean recovery rate of 111.23%,96.04%and 104.43%,respectively.The indexes of appearance,weight difference and solution time were consistent with the standards of the pharmacopoeia.Conclusion:The preparation techniques of SGDP was rational and practicable.HPLC method was sensitive,accurate,and reproducible.It could be used to determine paeoniflorin,liquiritin and glycyrrhizic acid of SGDP simultaneously and provide important reference for the quality control of SGDP.