咽炎片有效成分特征图谱研究  

Study on the Active Component Chromatogram of Yanyan Tablets

作　　者：肖文涛 蒋婷婷 周鹤 XIAO Wentao;JIANG Tingting;ZHOU He(Jiujiang Inspection and Testing Certification Center Food and Drug Sub-center,Jiangxi Province,Jiujiang 332000,China;Department of Anesthesiology,Jiujiang Hospital of Traditional Chinese Medicine,Jiangxi Province,Jiujiang 332000,China)

机构地区：[1]九江市检验检测认证中心食品药品分中心,江西九江332000 [2]九江市中医医院麻醉科,江西九江332000

出　　处：《中国中医药现代远程教育》2024年第24期162-166,共5页Chinese Medicine Modern Distance Education of China

基　　金：江西省药品监督管理局科研项目[No.2023JS15];江西省九江市科技计划项目[No.S2023ZDYFN564]。

摘　　要：目的建立咽炎片的高效液相色谱(HPLC)特征图谱,对56个不同批次的产品进行评价。方法Waters e2695HPLC仪-紫外检测器,色谱柱:Agilent ZORBAX SB-C18(4.6 mm×250 mm,5µm),以乙腈为流动相A,0.1%磷酸溶液为流动相B,进行梯度洗脱。检测波长:0~11 min,280 nm;11~27 min,230 nm,28~94 min,280 nm;柱温:30℃;进样量:10µL。结果通过对56个不同批号的咽炎片进行特征图谱的测定,确定了8个特征峰,分别归属于青果、牡丹皮、款冬花、木蝴蝶、黄芩和玄参6种药材,结果有31个批次样品相似度低于0.85,可能存在投料药材质量有差异、生产工艺不稳定的问题。结论此次研究通过HPLC特征图谱法测定咽炎片中特征成分,方法便捷、灵敏高效,为咽炎片质量评价提供依据。Objective To establish high performance liquid chromatography(HPLC)characterization of Yanyan tablets,and to evaluate 56 different batches of products.Methods Waters e2695-2489 HPLC-ultraviolet detector,Agilent ZORBAX SB-C18(4.6×250 mm,5µm),acetonitrile-0.1%phosphoric acid solution as mobile phase,gradient elution was performed,with the detection wave⁃lengths set at 280 nm for 0 to 11 minutes,230 nm for 11 to 27 minutes,and 280 nm for 28 to 94 minutes.Column temperature was 30℃.Sample size was 10µL.Results Through the characterization of 56 different batches of Yanyan tablets,8 characteristic peaks were identified,which were respectively attributed to six kinds of medicinal materials,fructus chinensis,butterfly,collaria,peony bark,scrophulariae and scutellaria.The results showed that the sample similarity of 31 batches was lower than 0.85,which may have differences in the quality of medicinal materials and unstable production process.Conclusion In this study,HPLC chromatogram was used to determine the characteristic components of Yanyan tablets.The method is convenient,sensitive and efficient,and provides a basis for the quality evaluation of Yanyan tablets.

关 键 词：咽炎片 特征图谱 高效液相色谱 质量评价 

分 类 号：R286.0[医药卫生—中药学]