摘要
目的:建立一测多评法(QAMS)同时测定蒙古族成药每粒清热八味胶囊中胆红素、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、山柰素的质量。方法:采用高效液相色谱法,安捷伦Zorbax Eclipse Plus C18色谱柱(250 mm×4.6 mm,5μm),以乙腈-0.4%磷酸水溶液为流动相,梯度洗脱,流速为1.0 m L·min^(–1),检测波长分别为275、370、403 nm,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)预测tR。以胡黄连苷Ⅰ为内参物,建立与其他8个成分的相对校正因子,并计算每粒中9个待测成分的质量,实现一测多评。同时与外标法进行比较,验证QAMS的准确性和可行性。结果:9个成分在各自质量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%,RSD为0.23%~1.53%;建立的QAMS可用于测定每粒清热八味胶囊中9个指标成分的质量,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无统计学意义。结论:QAMS测定清热八味胶囊中9个成分准确且可行,可用于清热八味胶囊的质量控制。
Objective:To establish a method of quantitative analysis of multi-components by single marker(QAMS)for simultaneous determination of bilirubin,hydroxysafflor yellow A,rutin,picrosideⅡ,picrosideⅠ,cinnamic acid,quercetin,corynoline,and kaempferol in Qingre Bawei Capsules.Methods:The high performance liquid chromatography(HPLC)system with the Agilent Zorbax Eclipse Plus C18 column(250 mm×4.6 mm,5μm)was used for gradient elution with acetonitrile-0.4%phosphoric acid as the mobile phase at a flow rate of 1.0 mL·min^(–1),detection wavelengths of 275,370,and 403 nm,and a column temperature of 35℃.Hydroxysafflor yellow A and picrosideⅠwere taken as the two reference substances to forecast the retention time of the other three components by linear calibration with two reference substances(LCTRC).With picrosideⅠas the international reference substance,the relative correction factors between picrosideⅠand the other 8 components were established,and the content of these 9 components in samples was calculated to realize QAMS.The QAMS results were compared with those obtained with the external standard method to verify the accuracy and feasibility of QAMS.Results:All the 9 components exhibited good linear relationships within the respective concentration ranges(r≥0.9990),with the average recovery ranging from 93.0%to 99.8% and the relative standard deviations(RSDs)of 0.23%to 1.53%.The established QAMS method was then used to determine the content of 9 marker components in 6 batches of Qingre Bawei Capsules.There was no significant difference in the calculated values and the determined ones.Conclusion:The QAMS method is feasible and accurate for determining the content of 9 components in Qingre Bawei Capsules,and it can thus be used for the quality control of this formulation.
作者
陈玮
汪正宇
CHEN Wei;WANG Zhengyu(Department of Pharmacy,Wanbei Coal-electricity Group General Hospital,Suzhou 234000,China;Suzhou Food and Drug Inspection and Testing Center of Anhui Province,Suzhou 234000,China)
出处
《中国现代中药》
2025年第4期763-770,共8页
Modern Chinese Medicine
关键词
一测多评法
清热八味胶囊
蒙古族成药
双标线性校正法
含量测定
quantitative analysis of multi-components by single marker(QAMS)
Qingre Bawei Capsules
Mongolian patent medicine
linear calibration with two reference substances
content determination
作者简介
通信作者:陈玮,副主任药师,研究方向:医院药学,Tel:0557-3972308,E-mail:51492050@qq.com。
