双标线性校正法联合一测多评法同时测定 清热八味胶囊中9个成分的含量
投稿时间:2024-08-21  修订日期:2024-10-11   点此下载全文
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作者中文名作者英文名单位中文名单位英文名E-Mail
陈玮* Chen Wei 皖北煤电集团总医院药剂科 Department of Pharmacy,Wanbei Coal-electricity Corporation General Hospital 51492050@qq.com 
汪正宇 Wang Zhengyu 安徽省宿州市食品药品检验检测中心 Suzhou food and Drug Control Institute of Anhui Province 122281826@qq.com 
中文摘要:目的: 建立同时测定蒙成药清热八味胶囊中9个组分(胆红素、羟基红花黄色素A、芦丁、胡黄连苷Ⅱ、胡黄连苷Ⅰ、肉桂酸、槲皮素、紫堇灵、山柰素)的一测多评含量测定方法(QAMS)。方法: 采用高效液相色谱法,安捷伦Zorbax Eclipse Plus C18色谱柱(250mm×4.6mm,5μm),以乙腈-0.4%磷酸水溶液为洗脱流动相,进行梯度洗脱,流速1.0mL.min-1,检测波长275、370、403,柱温为35℃。以羟基红花黄色素A和胡黄连苷Ⅰ为双标化合物,使用双标线性校正法(LCTRC)法预测保留时间。以胡黄连苷Ⅱ为内参物,建立与其他8个组分的相对校正因子,并计算9个待测组分的含量,实现一测多评。同时与外标法进行比较,以验证QAMS法的准确性和可行性。结果: 9组分在各自试验浓度范围内的线性关系良好(r≥0.9990),平均加样回收率为93.0%~99.8%(n=6),RSD为0.23%~1.53%;建立QAMS法用于测定清热八味胶囊中9个指标性组分的含量,并对6批清热八味胶囊进行测定,其计算值与测定值的差异较小(P>0.05) 。结论:QAMS法测定清热八味胶囊中9种组分准确且可行,可用于清热八味胶囊的质量控制。
中文关键词:一测多评法  清热八味胶囊  蒙成药  双标线性校正法  含量测定
 
Simultaneous determination of 9 components in Qingre Bawei Capsules by LCTRC and QAMS
Abstract:Objective: To establish a quantitative analysis of multi-components by singlemarker (QAMS) for simultaneous determination of bilirubin,hydroxysafflor yellow A,Rutin, picroside-II,picroside-I,cinnamic acid,quercetin,corynoline and kaempferol in Qingre Bawei Capsules.Methods: The HPLC system considered the agilent Zorbax Eclipse Plus C18 column (250mm×4.6mm, 5 μm) with gradient elution of acetonitrile and 0.4% phosphoric acid as the mobile phase at a flow rate of 1.0mL?min-1, a detection wavelength of 275,370 and 403nm, and a column temperature of 35℃. Both hydroxysafflor yellow A and picroside-I were taken as the two reference substances to forecast the retention time of the other three components by linear calibration with two reference substances (LCTRC). picroside-II was selected as the international reference substance, the relative correction factors between picroside-II and the other 8 onstitutions were established, and the content of these 9 constitutions in samples were calculated to realize QAMS. At the same time, compare with the external standard method to verify the accuracy and feasibility of the QAMS method.Results: All 9 components exhibited good linear relationships are within the respective concentration ranges (r≥0.9990) . The average recoveries (n=6) ranged from 93.0% to 99.8% , with relative standard deviations (RSDS) of 0.23% to 1.53% . The established QAMS was used to determine the 9 Index components in Qingre Bawei Capsules,and totally 6 batches of Qingre Bawei Capsules were determined.There was no significant difference in the calculated values and the determined ones (P>0.05).Conclusion:The QAMS method is feasible and accurate for the determination of the 4 chemical compositions, and which can be used for quality control of Qingre Bawei Capsules.
keywords:Quantitative analysis of multi-components by single marker  Qingre Bawei Capsules  Mongolian medicine  Linear calibration with two reference substances  Content determination
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