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
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摘要
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.
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.
引文
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[11]蔡宛如,钱华,朱渊红,等.芍药甘草汤平喘和抗过敏作用的实验研究[J].中国中西医结合急救杂志,2000,7(6),341-342.
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[15]朱广伟,张贵君,孙奕,等.醋白芍、炙甘草及其配伍载体中药效组分变化规律分析[J].世界中医药,2016,11(1):143-146,150.
[16]高海洋.基于β2-AR色谱的芍药甘草汤抗急性哮喘物质基础研究[D].西安:西北大学,2017.
[2]曾永青,李立新,王洋洋.芍药甘草汤加减联合氟桂利嗪治疗神经性头痛的临床疗效观察[J].世界中医药,2015,10(1):60-62.
[3]崔晨,耿琦,蒋健.蒋健以芍药甘草汤为主古方新用治疗脾胃病[J].世界中医药,2017,12(11):2727-2730.
[4]张思杰,史锁芳.史锁芳教授运用芍药甘草汤治疗哮喘急性发作的经验[J].吉林中医药,2011,31(3):206-207.
[5]李富生,石昕昕,刘新智,等.芍药甘草散治疗哮喘证35例小结[J].国医论坛,1987,8(4):37.
[6]董雷,蔡宛如.芍药甘草汤对哮喘大鼠气道重塑的影响及相关机制研究[J].中药材,2016,39(4),887-890.
[7]何飞,汝触会,沈晓强,等.芍药甘草汤对哮喘大鼠辅助性T细胞17及其细胞因子白细胞介素-17的影响[J].浙江中医药大学学报,2017,41(2),112-116,135.
[8]李泽华,吕卓,肖超妮,等.芍药甘草汤干预过敏性哮喘大鼠的尿液代谢组学研究[J].中华中医药杂志,2017,32(10):4416-4420.
[9]Jeong SJ,Lim HS,Seo CS,et al.Traditional herbal formula Jakyakgamcho-tang(Paeonia lactiflora and Glycyrrhiza uralensis)impairs inflammatory chemokine production by inhibiting activation of STAT1and NF-κB in Ha CaT cells[J].Phytomedicine,2015,22(2):326-332.
[10]王洋,关炜,李韶妮.芍药甘草汤防治支气管哮喘机理研究[J].山西中医,2011,27(9):43-45.
[11]蔡宛如,钱华,朱渊红,等.芍药甘草汤平喘和抗过敏作用的实验研究[J].中国中西医结合急救杂志,2000,7(6),341-342.
[12]于文凯,文姝.肠道菌群与过敏性哮喘[J].中国微生态学杂志,2013,25(10):1217-1221.
[13]阎艳丽,李春花,宋晓宇,等.芍药甘草滴丸的制备与疗效观察[J].中成药,2005,27(6):762-763.
[14]李春花,阎艳丽,宋晓宇,等.芍药甘草滴丸制备研究[J].中国现代应用药学,2004,21(S2):54-55.
[15]朱广伟,张贵君,孙奕,等.醋白芍、炙甘草及其配伍载体中药效组分变化规律分析[J].世界中医药,2016,11(1):143-146,150.
[16]高海洋.基于β2-AR色谱的芍药甘草汤抗急性哮喘物质基础研究[D].西安:西北大学,2017.