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一测多评法同时测定玉屏风制剂中8种成分

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建立一测多评法同时测定玉屏风制剂中升麻素苷、毛蕊异黄酮葡萄糖苷、升麻素、5-O-甲基维斯阿米醇、亥茅酚苷、芒柄花素、白术内酯Ⅲ、苍术酮8种成分的含量.以乙腈-水为流动相进行梯度洗脱,柱温为30℃,流量为1.1 mL/min,进样体积为10 μL,检测波长为220 nm.8种成分的色谱峰面积与质量浓度呈良好的线性关系,相关系数均大于0.999.样品加标平均回收率为91.7%~102.1%,测定结果的相对标准偏差为0.57%~1.62%(n=6).以5-O-甲基维斯阿米醇苷为内参照物,计算升麻素苷、毛蕊异黄酮葡萄糖苷、升麻素、亥茅酚苷、芒柄花素、白术内酯Ⅲ、苍术酮的相对校正因子分别为1.009,1.925,2.147,0.822,0.708,1.066,1.425.分别采用外标法与一测多评法测定18批样品,8种成分的测定结果无显著性差异(p>0.05).该方法准确、可靠、便捷,可用于玉屏风制剂中8种成分的同时测定,也可为玉屏风制剂的质量控制及标准提高提供依据.
Simultaneous determination of 8 components in Yupingfeng Preparations by quantitative analysis of multi-components by single marker
A method of quantitative analysis of multi-components by single marker for the determination of 8 components in Yupingfeng Preparations,including prim-O-glucosylcimifugin,calycosin-7-O-β-D-glucoside,cimifugin,5-O-methylvisamminol,sec-O-glucosylhamaudol,formononetin,atractylenolide Ⅲ and atractylon was established.Acetonitrile-water was used as the mobile phase with gradient elution,the flow rate was 1.1 mL/min,the column temperature was 30℃,the detection wavelength was 220 mm,and the injection volume was 10 μL.The mass concentration of 8 components had a good linear relationship with the chromatographic peak area,the correlation coefficients were all more than 0.999.The average recoveries of spiked samples were 91.7%-102.1%,and the relative standard deviations of the measurement results were 0.57%-1.62%(n=6).5-O-methylvisamminol was used as the internal reference,the relative correction factors of prim-O-glucosylcimifugin,calycosin-7-O-β-D-glucoside,cimifugin,sec-O-glucosylhamaudol,formononetin,atractylenolide Ⅲ and atractylon were calculated to be 1.009,1.925,2.147,0.822,0.708,1.066,and 1.425,respectively.18 batches of samples were measured using external standard method and one test multiple evaluation method respectively,there was no significant difference(p>0.05)in the determination results between the two methods.The method is accurate,reliable,convenient,and it can be used for simultaneous determination of 8 components in Yupingfeng preparations,meanwhile,provided a basis for quality control and standard improvement of Yupingfeng preparations.

Yupingfeng preparationsquantitative analysis multi-components by single marker(QAMS)relative correction factorhigh performance liquid chromatography

岳超、徐欣丰、徐普、施贝、毛思浩、周霞、郑成

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浙江省食品药品检验研究院,国家药品监督管理局中成药质量评价重点实验室,国家市场监管重点实验室(功能食品质量与安全领域),浙江省市场局重点实验室(保健食品质量安全重点实验室),杭州 310052

南京医科大学,南京 211166

玉屏风制剂 一测多评法 相对校正因子 高效液相色谱

2025

化学分析计量
中国兵器工业集团第五三研究所(国防科技工业应用化学一级计量站)

化学分析计量

影响因子:0.444
ISSN:1008-6145
年,卷(期):2025.34(1)