替代对照品法测定复方甘草口服溶液中甘草苷和甘草酸含量  

Content Determination of Liquiritin and Glycyrrhizic Acid in the Compound Glycyrrhiza Oral Solution by Substitute Reference Substance Method

作　　者：曾芳 魏长勇 余敏灵 ZENG Fang;WEI Changyong;YU Minling(Leshan Food and Drug Inspection Center,Leshan,Sichuan,China 614099)

机构地区：[1]四川省乐山市食品药品检验检测中心,四川乐山614099

出　　处：《中国药业》2020年第23期52-55,共4页China Pharmaceuticals

摘　　要：目的建立以橙皮苷为替代对照品测定复方甘草口服溶液中甘草苷和甘草酸含量的高效液相色谱(HPLC)法。方法采用替代对照品法,以橙皮苷为替代对照品,测定甘草酸铵与橙皮苷、甘草苷与橙皮苷的相对校正因子,利用相对校正因子计算复方甘草口服溶液中甘草酸和甘草苷含量。色谱柱采用Welch Ultimate C18柱(250 mm×4.6 mm,5μm),流动相为0.1%三乙胺溶液(用磷酸调pH至2.5)-乙腈(梯度洗脱),检测波长分别为276 nm(甘草苷)、284 nm(橙皮苷)、252 nm(甘草酸铵),柱温为30℃,流速为1.0 m L/min。结果橙皮苷、甘草苷、甘草酸铵的进样量分别在0.033 2~0.498 3μg(r=0.999 5),0.049 3~0.740 2μg(r=0.999 2),0.443 0~6.495 1μg(r=0.999 3)范围内与峰面积线性关系良好;甘草苷和甘草酸铵与橙皮苷的相对校正因子分别为1.081 4和0.449 2;甘草苷和甘草酸的平均回收率分别为98.94%和99.19%(n=6)。结论该方法成本低,试验时间短,仪器噪音小,适用于测定复方甘草口服溶液中甘草苷和甘草酸含量。Objective To establish a high performance liquid chromatography( HPLC) method for the content determination of liquiritin and glycyrrhizic acid in the Compound Glycyrrhiza Oral Solution with hesperidin as a substitute reference substance.Methods The substitute reference substance method was used,and hesperidin was used as the substitute reference substance to measure the relative correction factor( RCF) of ammonium glycyrrhizinate with hesperidin,the RCF of liquiritin with hesperidin.The RCFs were used to calculate the content of glycyrrhizic acid and liquiritin in the Compound Glycyrrhiza Oral Solution.The chromatographic column was Welch Ultimate C18 column( 250 mm × 4.6 mm,5 μm),the mobile phase was 0.1% triethylamine solution( the pH was adjusted to 2.5 with phosphoric acid)-acetonitrile( gradient elution),the detection wavelengths were 276 nm for liquiritin,284 nm for hesperidin and 252 nm for ammonium glycyrrhizinate,the column temperature was 30 ℃,and the flow rate was 1.0 m L/min.Results The linear ranges of hesperidin,liquirtin and ammonium glycyrrhizinate were 0.033 2-0.498 3 μg( r = 0.999 5),0.049 3-0.740 2 μg( r = 0.999 2),0.4430-6.495 1 μg( r = 0.999 3).The RCFs of liquiritin,ammonium glycyrrhizinate and hesperidin were 1.081 4 and 0.449 2,respectively.The average recoveries of liquiritin and glycyrrhizic acid were 98.94% and 99.19%( n = 6),respectively.Conclusion The method has the advantages of low cost,short experimental time and low instrument noise.It is suitable for the content determination of liquiritin and glycyrrhizic acid in Compound Glycyrrhiza Oral Solution.

关 键 词：复方甘草口服溶液 替代对照品法 相对校正因子 甘草苷 甘草酸 橙皮苷 含量 

分 类 号：R927.2[医药卫生—药学] R974