| 任莹,吕晓军,李德林,等.一测多评法同时测定保肝丸中 4个指标性成分的含量[J].安徽医药,2020,24(12):2355-2359. |
| 一测多评法同时测定保肝丸中 4个指标性成分的含量 |
| Simultaneous determination of four index components in Baogan pills by a single marker |
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| DOI：10.3969/j.issn.1009?6469.2020.12.006 |
| 中文关键词: 色谱法，高压液相 一测多评 相对校正因子 质量控制 黄芩苷 保肝丸 |
| 英文关键词: Chromatography,high pressure liquid QAMS Relative correction factor Quality control Baicalin Baogan pills |
| 基金项目: |
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| 摘要点击次数: 1994 |
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| 中文摘要: |
| 目的建立一种一测多评法(QAMS)同时测定保肝丸中芍药苷、黄芩苷、五味子醇甲、大黄素 4种指标性成分含量的方法，为其质量控制提供依据。方法采用依利特 Hypersil ODS2色谱柱(4.6 mm×250 mm，5 μm)；以乙腈和 0.01%磷酸水溶液为流动相，梯度洗脱；流速为 1.0 mL/min；柱温为 30 ℃；检测波长分别为 230 nm(芍药苷)、 280 nm(黄芩苷)，254 nm(五味子醇甲、大黄素)；以黄芩苷为内参物，建立其与芍药苷、五味子醇甲、大黄素之间的相对校正因子(fk/m)；采用外标法计算保肝丸中黄芩苷的含量，通过 fk/m计算芍药苷、五味子醇甲、大黄素的量，并将 QAMS测定的结果与外标法测定的结果进行比较分析。结果芍药苷、黄芩苷、五味子醇甲、大黄素在一定范围内浓度与峰面积呈良好的线性关系；精密度、稳定性、重现性等均符合方法学要求；在线性范围内，芍药苷、五味子醇甲、大黄素与黄芩苷之间的 fk/m分别为 1.42、0.344、0.332，且重现性良好； QAMS计算得到的各成分含量与外标法无明显差异，说明实验所得校正因子可信。结论所建立的 QAMS可作为保肝丸的质量控制方法。 |
| 英文摘要: |
| Objective To develop a method for simultaneous determination of paeoniflorin，baicalin，schisandrin，emodin in Baogan pills by one?test?multiple?assessment method(QAMS)to provide a scientific basis for the quality control of Baogan pills.Methods Using Elite Hypersil ODS2 chromatographic column(4.6 mm×250 mm，5 μm)with acetonitrile and 0.01% phosphoric acid aque? ous solution as mobile phase，gradient elution.The mobile phase flow rate was 1.0，mL/min.The temperature was 30 ℃.The detection wavelengths were 230 nm(paeoniflorin)，280 nm(baicalin)，and 254 nm(schisandrin A，emodin)，respectively.With baicalin as an internal reference，the relative correction factors(fk/m)of paeoniflorin，schisandrin，and emodinto baicalinwere calculated，respective? ly.The content of baicalinwas determined by external standard method and the contents of paeoniflorin，schisandrin，and emodin were calculated by fk/m.The results between external standard method(ESM)and quantitative analysis of multi?components by a sin? gle marker(QAMS)methodwerecompared.Results The standard curves of paeoniflorin，baicalin，schisandrin，emodin had good lin? ear relationship in ranges of the tested concentrations.The precision，stability and repeatability complied with the requirements of methodology.Within a certain range，the fk/m of paeoniflorin，schisandrin，and emodinto baicalin were 1.42，0.344，0.332，with good re? peatability in different conditions.The fk/m of the components was accurate and reliable，and there was no significant difference be? tween QAMS and ESM method.Conclusion The QAMS method can be used for quality control of Baogan pills. |
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