复方甘草口服溶液中甘草酸和愈创甘油醚的含量考察  

Study on the contents of glycyrrhizic acid and guaifenesin in compound Glycyrrhiza oral solution

作　　者：黄剑英[1] 吴福楷[1] 李玲玲[1] 南楠[2] 

机构地区：[1]厦门市药品检验所,厦门361012 [2]中国食品药品检定研究院,北京100050

出　　处：《药物分析杂志》2012年第3期541-544,549,共5页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:考察复方甘草口服溶液中甘草酸、愈创甘油醚的含量。方法:采用HPLC法,色谱柱为ZORBAX Extent C18(250 mm×4.6 mm,5μm),流动相为50 mmol.L-1磷酸二氢钾溶液-2.5 mmol.L-1庚烷磺酸钠溶液-乙腈(40∶40∶20,用20%氢氧化钠溶液调pH 7.2±0.2),流速1.0 mL.min-1,检测波长260 nm。结果:所测的99批样品中,52批样品含甘草酸≥2.0 mg.mL-1,47批样品含甘草酸<2.0 mg.mL-1;含愈创甘油醚均在4.5～5.5 mg.mL-1之间。结论:复方甘草口服溶液中甘草酸和愈创甘油醚的含量,各企业之间差异较大。Objective： To study the content of glycyrrhizic acid and guaifenesin in compound Glycyrrhiza oral solution.Methods： HPLC method was adopted.The chromatographic separation was performed on a ZORBAX Extent C18（250 mm×4.6 mm,5 μm）column;The mobile phase consisted of 50 mmol·L-1 solution of potassium dihydrogen phosphate-2.5 mmol·L-1 solution of sodium heptanesulfonate-acetonitrile（40∶ 40∶ 20,adjusted to pH 7.2±0.2 with 20% sodium hydroxide sulution）at the flow rate of 1.0 mL·min-1;The detection wavelength was 260 nm.Results：99 batches of samples were measured.The content of glycyrrhizic acid was more than 2.0 mg·mL-1 in 52 batches of samples,while,the content of glycyrrhizic acid was less than 2.0 mg·mL-1 in 47 batches of samples.The content of guaifenesin was 4.5-5.5 mg·mL-1.Conclusion： The content of glycyrrhizic acid and guaifenesin in compound Glycyrrhiza oral solution,large differences between the various enterprises.

关 键 词：甘草 复方甘草口服溶液 甘草酸 愈创甘油醚 含量测定 质量分析 高效液相色谱 

分 类 号：R917[医药卫生—药物分析学]