扶正合剂质量标准提高研究  

Improvement of Quality Standard of Fuzheng Mixture

作　　者：卢向红 贺敏才 汪霞 LU Xianghong;HE Mincai;WANG Xia(Loudi Institute for Food and Drug Inspection&Testing,Loudi 417000,China)

机构地区：[1]湖南省娄底市食品药品检验检测所,湖南娄底417000

出　　处：《中国民族民间医药》2022年第2期55-59,共5页Chinese Journal of Ethnomedicine and Ethnopharmacy

摘　　要：目的:建立高效液相色谱法测定扶正合剂中黄芪甲苷、补骨脂素和异补骨脂素含量的方法。方法:黄芪甲苷采用多因素考察样品前处理方法,优化样品前处理。色谱柱:Waters SunFire C18(4.6 mm×250 mm,5μm),柱温:30℃,流动相:乙腈-水(34∶66),流速:1.0mL·min^(-1),蒸发光散射检测器(漂移管温度:80.0℃,气体压力:30 psi)。补骨脂素和异补骨脂素采用高效液相色谱法,色谱柱:Shim-Pack VP-ODS(4.6 mm×250 mm,5μm),柱温:30℃,流动相:乙腈-0.1%磷酸溶液(30∶70),流速:1.0 mL·min^(-1),二极管阵列检测器,检测波长:245 nm。结果:此方法黄芪甲苷在3.426~10.279μg范围内线性关系良好,r=0.9995,方法的平均回收率为102.25%,RSD为1.20%(n=9)。补骨脂素在0.04367~0.2183μg范围内线性关系良好,r=1.000,方法的平均回收率为99.41%,RSD为1.48%(n=9)。异补骨脂素在0.05274~0.2637μg范围内线性关系良好,r=1.000,方法的平均回收率为95.98%,RSD为1.85%(n=9)。结论:本法建立扶正合剂中黄芪甲苷、补骨脂素和异补骨脂素含量测定方法,该方法测定操作简便,结果准确,重复性好,能更好地控制扶正合剂的质量,确保产品质量稳定和可靠。Objective To establish a method for determination of astragaloside IV,psoralen and isopsoralen in Fuzheng mixture by high-performance liquid chromatography.MethodAstragaloside IV was used to optimize the sample pretreatment by multi-factor investigation.Waters SunFire C18 column(4.6 mm×250 mm,5μm),column temperature of 30℃,a mobile phase composed of acetonitrile-water(34∶66)were adopted.Flow rate:1.00 mL·min^(-1).The detecer was an evaporative light scattering detector(ELSD),the drift tube temperature was set at 80.0℃,and the gas pressure was 30 psi.Psoralen and isopsoralen were detected by High-performance liquid chromatography,Shim-Pack VP-ODS(4.6 mm×250 mm,5μm),column temperature:30℃,mobile phase:Acetonitrile-0.1%phosphoric acid solution(30∶70),flow rate:1.0 ml min^(-1),detection wavelength:245 nm.Result The linear range of astragaloside IV was at 3.426~10.279μg,r=0.9995.The recovery of paeoniflorin was 102.25%with RSD=1.20%(n=9).The linear range of psoralen was 0.04367~0.2183μg,r=1.000.The average recovery was 99.41%,RSD was1.48%(n=9).The linear range of isopsoralen was 0.05274μg~0.2637μg,r=1.000.The average recovery was 95.98%,RSD was 1.85%(n=9).ConclusionA method for the determination of astragaloside IV,psoralen and isopsoralen in Fuzheng mixture was established.The method is simple,accurate,reproducible and can be used to control the quality of Fuzheng mixture,ensure product quality is stable and reliable.

关 键 词：扶正合剂 黄芪甲苷 补骨脂素 异补骨脂素 高效液相色谱法 质量标准提高 

分 类 号：R917[医药卫生—药物分析学]