刘利辉 卢向红 陆才洋

【摘 要】 目的：建立喉痛靈颗粒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，5 μm）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10 μL；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2.78～27.15 μg·mL-1、2.25～19.07 μg·mL-1、2.93～30.42 μg·mL-1、2.02～20.97 μg·mL-1内线性关系良好（r≥0.999 8），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。

【关键词】 喉痛灵颗粒；特征图谱；尿苷；鸟苷；（R，S）-告依春；腺苷

【中图分类号】R284.1   【文献标志码】 A    【文章编号】1007-8517（2023）08-0039-06

Abstract：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， 5 μm） 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 10 μL. 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 2.78-27.15 μg·mL-1， 2.25-19.07 μg·mL-1， 2.93-30.42 μg·mL-1 and 2.02-20.97 μg·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.

Key words：Houtongling Granules；Characteristic Chromatograms；Uridine；Guanosine；（R，S）-goitrin；Adenosine

喉痛灵颗粒是回春堂药业股份有限公司的拳头产品，由水牛角浓缩粉、板蓝根、野菊花、荆芥穗四味中药组成，具有清热解毒，消炎利咽止痛的功效，临床上主要用于咽喉炎、急性化脓性扁桃体炎、感冒发热、上呼吸道感染等［1］。水牛角浓缩粉为君药，其有效成分为蛋白质、多肽、生物碱类等，有清热解毒、凉血、定惊等功效［2-3］。板蓝根为臣药且是处方中投料量最大的药物，其主要活性成分为尿苷、鸟苷、腺苷核苷类和表告依春生物碱类，具有抗菌、抗病毒、抗内毒素、增强免疫和解热等药理作用［4］。喉痛灵颗粒现行质量标准为《部颁标准中药成方制剂（第五册WS3-B-1041-91）》，标准中仅有性状和3个理化鉴别项目，无含量测定方法。……