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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
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和 敏 ,毛 姗 ,李 琳 ,倪海峰 ,都青钰 ,于永杰 1, 3, 4 ,张 霞 1, 3, 4 # (1. 宁 夏 医 科 大 学 药 学 院 ,银 川
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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)
中图分类号 R917 文献标志码 A 文章编号 1001-0408(2023)17-2069-05
DOI 10.6039/j.issn.1001-0408.2023.17.04
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 C18为色谱柱,以乙腈-0.1%磷酸溶液为流动相(梯度洗脱),流速为1
mL/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。
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
Content determination of 6 components in Jinlian qingre granules by QAMS method based on a variety of
internal reference substances
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HE Min ,MAO Shan ,LI Lin ,NI Haifeng ,DU Qingyu ,YU Yongjie 1, 3, 4 ,ZHANG Xia 1, 3, 4 (1. School of
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Pharmacy, Ningxia Medical University, Yinchuan 750004, China;2. Ningxia Qiyuan Pharmaceutical Co. Ltd.,
Yinchuan 750011, China;3. Ningxia Key Laboratory of Drug Development and Generic Drug Research,
Yinchuan 750004, China;4. Key Laboratory of Ningxia Minority Medicine Modernization, Ministry of
Education, Yinchuan 750004, China)
ABSTRACT 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 C18 column with mobile phase consisted of acetonitrile-0.1% phosphoric acid solution (gradient
elution) at the flow rate of 1 mL/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 5
components 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.
KEYWORDS Jinlian qingre granules; quantitative analysis
Δ 基金项目 国家自然科学基金项目(No.81960711) of multi-components by single marker; mangiferin; 2″-O-β-L-
*第一作者 硕士研究生。研究方向:药物分析。电话:0951-
galactopyranosylorientin; orientin; veratric acid; vitexin;
6880693。E-mail:hemin981210@163.com
harpagoside; content determination
# 通信作者 正高职高级工程师,硕士生导师,硕士。研究方向:中
药质量控制。电话:0951-6980170。E-mail:ydzhx@126.com
中国药房 2023年第34卷第17期 China Pharmacy 2023 Vol. 34 No. 17 · 2069 ·