喉痛灵颗粒HPLC特征图谱及多指标成分含量测定研究  

Study on HPLC Characteristic Chromatogram and Determination of Multi-index Components of Houtongling Granules

作　　者：刘利辉 卢向红 陆才洋[2] LIU Lihui;LU Xianghong;LU Caiyang(Loudi Institute for Food and Drug Control,Hunan province,Loudi 417100,China;Hunan Provincial Center for Drug Evaluation,Accreditation and Adverse Drug Reaction Monitoring,Changsha 410013,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417100 [2]湖南省药品审评认证与不良反应监测中心,湖南长沙410013

出　　处：《中国民族民间医药》2023年第8期39-44,共6页Chinese Journal of Ethnomedicine and Ethnopharmacy

摘　　要：目的:建立喉痛灵颗粒HPLC特征图谱并测定尿苷、鸟苷(R,S)-告依春、腺苷四个指标性成分的含量,为喉痛灵颗粒的质量控制提供参考。方法:采用Shim-pack VP-ODS(4.6 mm×250 mm,5μm)色谱柱,以甲醇-水为流动相进行梯度洗脱,柱温:30℃;流速:0.9 mL·min^(-1);检测波长:254 nm;进样量10μL;通过相似度评价结合聚类分析对10批喉痛灵颗粒特征图谱进行分析评价,并对其中的4个指标成分进行含量测定研究。结果:建立了喉痛灵颗粒的特征图谱,共标定了10个共有峰,10批样品的指纹图谱相似度在0.810~0.943;尿苷、鸟苷、(R,S)-告依春、腺苷分别在2.78~27.15μg·mL^(-1)、2.25~19.07μg·mL^(-1)、2.93~30.42μg·mL^(-1)、2.02~20.97μg·mL^(-1)内线性关系良好(r≥0.9998),平均加样回收率为95.26%~103.79%,RSD为0.90%~1.72%。通过聚类分析,10批样品聚成二类。结论:建立的喉痛灵颗粒特征图谱及4个指标性成分含量测定方法简便、可靠、重复性好,可为综合评价喉痛灵颗粒的质量提供参考。Objective To establish a method for characteristic chromatogram of Hutongling granules and to detetmine the contents of four index components,uridine,guanosine,(R,S)-goitrin and adenosine,and provide reference its quality control.Methods Shim-pack VP-ODS(4.6mm×250mm,5μm)column was used,the mobile-phase was methanol(A)-water(B)with gradient elution.The flow rate was 0.9mL·min-1,the column temperature was 30 degrers,the detection wavelengths was 254 nm,and the injection volume was 10μL.The similarity evaluation combined with cluster analysis was used to analyze and evaluate the characteristic map of 10 batches of Houtongling granules,and the contents of 4 index components were determined.Results The characteristic spectrum of Houtongling granules was established,and 10 common peaks were calibrated.The similarity of common peaks of 10 batches of samples ranged from 0.810 to 0.943.Uridine,guanosine,(R,S)-goitrin and adenosine had good linear relationship in the ranges of 2.78-27.15μg·mL^(-1),2.25-19.07μg·mL^(-1),2.93-30.42μg·mL^(-1)and 2.02-20.97μg·mL^(-1),respectively.The correlation coefficients were all more than 0.9998.The average recoveries varied from 95.26%to103.79%with the RSDs of 0.90%-1.72%.All the 10 batches of samples could be classified into two clusters.Conclusion The established characteristic chromatograms of Hutongling granule and the method for the determination of 4 index components are simple,reliable and reproducible,which can provide a reference for the comprehensive evaluation of the quality of Hutongling granules.

关 键 词：喉痛灵颗粒 特征图谱 尿苷 鸟苷 (R S)-告依春 腺苷 

分 类 号：R284.1[医药卫生—中药学]