摘要
目的 建立脉络宁颗粒HPLC指纹图谱,同时测定脉络宁颗粒中3,5-二咖啡酰奎尼酸、哈巴俄苷、5-二咖啡酰奎尼酸、咖啡鞣酸、4-二咖啡酰奎宁酸、桂皮酸、异绿原酸B、4,5-二-O-咖啡酰奎宁酸8种成分的含量。方法 Agilent XDB-C18色谱柱(250 mm×4.6 mm,5 μm),乙腈-0.1%磷酸溶液为流动相进行梯度洗脱,流速1.0 mL/min,检测波长0~35 min采用327 nm,35~45 min采用280 nm,45~70 min采用206 nm。利用多波长切换技术,对8个共有峰进行指认。结果 在所选线性范围内8个组分均呈现良好线性,平均加样回收率在99.03%~103.25%之间,精密度和重复性RSD值均小于2%。建立了脉络宁颗粒的HPLC 指纹图谱,计算11批次脉络宁颗粒相似度为0.864~0.999,多个批次的样品具有一致性。结论 该方法稳定可靠、重复性好,可同时测定脉络宁颗粒中的8种组分,指纹图谱特征性及专属性强,可结合含量测定控制脉络宁颗粒的质量。
Objective To establish of HPLC fingerprint of mailuoning granules and determine the HPLC content of 3,5-dicaffeoylquinic acid,habaoside,5-dicaffeoylquinic acid,caffeic acid tannic acid,4-dicaffeoylquinic acid,cinnamic acid,isochlorogenic acid B and 4,5-O-caffeioylquinic acid in mailuoning granules.Methods Agilent XDB-C18 chromatographic column(250 mm×4.6 mm,5μm),gradient elution with acetonitrile and 0.1%phosphoric acid solution,flow rate of 1.0 mL/min,detection wavelength of 0~35 min at 327 nm,35~45 min at 280 nm,and 45~70 min at 206 nm.Using multi-wavelength switching technology,8 common peaks were identified.Results The eight components showed good linearity within the selected linear range,with average recovery rates ranging from 99.03%to 103.25%.The precision and repeatability RSD were both less than 2%,establishing the HPLC fingerprint of mailuoning granules,the similarity of 11 batches of mailuoning granules was calculated,with a value ranging from 0.864 to 0.999,indicating consistency among multiple batches of samples.Conclusion This analysis method is stable,reliable,and has good repeatability.It can simultaneously determine 8 components in mailuoning granules,with strong fingerprint characteristics and specificity.It can be combined with content determination as a standard for controlling the quality of mailuoning granules.
作者
施宝顺
姜军华
余祺瑞
舒经纬
孙盼
SHI Baoshun;JIANG Junhua;YU Qirui;SHU Jingwei;SUN Pan(Jingdezhen Comprehensive Inspection and Testing Center for Market Regulation and Management,Jingdezhen Jiangxi 333000,China;Jiangxi Institute for Drug Control,Nanchang Jiangxi 330029,China)
出处
《药品评价》
2024年第9期1051-1055,共5页
Drug Evaluation
基金
江西省中医药管理局科技计划项目(2020A0369)。
