基于多种内参物的一测多评法测定金莲清热颗粒中6种成分含量  

Content determination of 6 components in Jinlian qingre granules by QAMS method based on a variety of internal reference substances

作　　者：和敏 毛姗 李琳 倪海峰 都青钰 于永杰 张霞[1,3,4] HE Min;MAO Shan;LI Lin;NI Haifeng;DU Qingyu;YU Yongjie;ZHANG Xia(School of Pharmacy,Ningxia Medical University,Yinchuan 750004,China;Ningxia Qiyuan Pharmaceutical Co.Ltd.,Yinchuan 750011,China;Ningxia Key Laboratory of Drug Development and Generic Drug Research,Yinchuan 750004,China;Key Laboratory of Ningxia Minority Medicine Modernization,Ministry of Education,Yinchuan 750004,China)

机构地区：[1]宁夏医科大学药学院,银川750004 [2]宁夏启元药业有限公司,银川750011 [3]宁夏药物创制与仿制药研究重点实验室,银川750004 [4]宁夏少数民族医药现代化教育部重点实验室,银川750004

出　　处：《中国药房》2023年第17期2069-2073,共5页China Pharmacy

基　　金：国家自然科学基金项目(No.81960711)。

摘　　要：目的建立基于多种内参物的一测多评法测定金莲清热颗粒中芒果苷、荭草素-2″-O-β-L-半乳糖苷、荭草苷、藜芦酸、牡荆苷和哈巴俄苷6个成分的含量。方法以Agilent Eclipse Plus C_(18)为色谱柱,以乙腈-0.1%磷酸溶液为流动相(梯度洗脱),流速为1mL/min,柱温为30℃,检测波长为270 nm。分别以荭草苷、牡荆苷、荭草素-2″-O-β-L-半乳糖苷为内参物,采用一测多评法建立另外5个待测成分与内参物的相对校正因子,然后计算21批金莲清热颗粒样品中6个成分的含量,并与外标法测定结果进行比较。结果一测多评法测得21批金莲清热颗粒样品中芒果苷、荭草素-2″-O-β-L-半乳糖苷、荭草苷、藜芦酸、牡荆苷和哈巴俄苷的含量范围分别为0.234~0.516、1.804~2.270、2.143~2.606、0.190~0.223、0.594~0.782、0.080~0.152 mg/g,外标法测定结果分别为0.235~0.523、1.798~2.265、2.137~2.599、0.190~0.224、0.597~0.786、0.077~0.151 mg/g,2种方法所测结果的差异百分比不大于4.00%。结论建立了基于多种内参物同时测定金莲清热颗粒中6种成分含量的一测多评法,该方法与外标法所得结果无明显差异,可用于金莲清热颗粒的质量控制。OBJECTIVE To establish a quantitative analysis of multi-components by single marker(QAMS) method based on a variety of internal reference substances for the content determination of 6 components in Jinlian qingre granules,such as mangiferin,2″-O-β-L-galactopyranosylorientin,orientin,veratric acid,vitexin,harpagoside.METHODS The determination was performed on Agilent Eclipse Plus C_(18) column with mobile phase consisted of acetonitrile-0.1% phosphoric acid solution(gradient elution) at the flow rate of 1 m L/min.The column temperature was 30 ℃,and the detection wavelength was set at 270 nm.Taking orientin,vitexin and 2″-O-β-L-galactopyranosylorientin as internal references,the relative correction factors(RCF) of the other 5components to be determined and internal substances were determined by QAMS.The contents of 6 components in 21 batches of Jinlian qingre granules were calculated and then compared with the results of the external standard method.RESULTS The contents of mangiferin,2″-O-β-L-galactopyranosylorientin,orientin,veratric acid,vitexin and harpagoside in 21 batches of samples were determined by QAMS in the range of 0.234-0.516,1.804-2.270,2.143-2.606,0.190-0.223,0.594-0.782,0.080-0.152 mg/g;the contents of them determined by external standard method were 0.235-0.523,1.798-2.265,2.137-2.599,0.190-0.224,0.597-0.786,0.077-0.151 mg/g,respectively.The percentage difference between the results measured by the two methods should not exceed 4.00%.CONCLUSIONS QAMS has been constructed for the simultaneous determination of 6 components in Jinlian qingre granules based on a variety of internal reference substances.The results obtained by this method are not significantly different from those obtained by the external standard method,and can be used for the quality control of Jinlian qingre granules.

关 键 词：金莲清热颗粒 一测多评法 芒果苷 荭草素-2″-O-β-L-半乳糖苷 荭草苷 藜芦酸 牡荆苷 哈巴俄苷 含量测定 

分 类 号：R917[医药卫生—药物分析学]