| 李霞,易徐航,杨鑫,等.银翘解毒颗粒多成分含量测定及化学计量学分析[J].安徽医药,2025,29(6):1133-1138. |
| 银翘解毒颗粒多成分含量测定及化学计量学分析 |
| Multi-component content determination and chemometrics analysis of Yinqiao Jiedu Keli |
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| DOI：10.3969/j.issn.1009-6469.2025.06.013 |
| 中文关键词: 化学成分 银翘解毒颗粒 含量测定 化学计量学 色谱法，高压液相 |
| 英文关键词: Chemical composition Yinqiao Jiedu Keli Content determination Chemometric Chromatography, high pressure liquid |
| 基金项目:江西省药品监督管理局科研项目( 2021KY49) |
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| 摘要点击次数: 56 |
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| 中文摘要: |
| 目的建立银翘解毒颗粒中 4个成分的高效液相色谱法( HPLC)含量测定方法，并对测定结果进行化学计量学分析。方法 2022年 4—6月，色谱柱为 Agilent 5TC-C18(2)(250 mm×4.6 mm，5 μm)；流动相为乙腈 -0.3%磷酸溶液梯度洗脱，流速: 1.0 mL/min；检测波长为: 327 nm(绿原酸)、230 nm(甘草苷、连翘苷和牛蒡苷)；柱温: 30 ℃；采用双波长切换法测定 22批银翘解毒颗粒中绿原酸、甘草苷、连翘苷、牛蒡苷的含量，结合雷达图分析、聚类分析和相关性分析对含量测定结果进行综合分析。结绿原酸、甘草苷、连翘苷和牛蒡苷分别在 11.6~231.6 mg/L(r=0.999 7)1.9~37.1 mg/(r=0.999 5)、 2.1~42.8 mg/L(r=0.999 6)、 12果.2~244.4 mg/L(r=0.999 7)范围内线性关系良好；平均加样回收率( n=6别为 98.5%、101.5%、103.1%和 99.0%，相对标准差(RSD)分别为 1.63%、2.21%、1.74%和 2.04%。化学计量学结果表明不同企业不同批次之间产品质量存在一定差异。结论该)分、法灵敏，稳定性强，准确性高，结合化学计量学方法分析，可用于银翘解毒颗粒的质量控制。 |
| 英文摘要: |
| Objective To establish an high performance liquid chromatography (HPLC) method for determining the content of four components in Yinqiao Jiedu Keli and analyze the results using chemometrics.Methods From April to June 2022, analyses were per-formed on an Agilent 5TC-C18(2) column (250 mm×4.6 mm, 5 μm); The mobile phase was a gradient elution of acetonitrile and 0.3%phosphoric acid solution at 1.0 mL/min. Detection wavelengths were 327 nm for chlorogenic acid and 230 nm for liquiritin, forsythin,and arctiin, with the column temperature kept at 30 ℃.The contents of chlorogenic acid, liquiritin, forsythin, and arctiin in 22 batchesof Yinqiao Jiedu Keli were measured using a wavelength -switching method. The results were comprehensively analyzed via radar chart analysis, cluster analysis (CA), and correlation analysis.Results The four components showed good linear relationships within their re-spective ranges. Chlorogenic acid: 11.6-231.6 mg/L (r=0.999 7), liquiritin: 1.9-37.1 mg/L (r=0.999 5), forsythin: 2.1-42.8 mg/L (r=0.999 6), arctiin: 12.2-244.4 mg/L (r=0.999 7). The average recoveries (n=6) were 98.5%, 101.5%, 103.1%, and 99.0%, with RSDs of1.63%, 2.21%, 1.74%, and 2.04%. Chemometric analysis revealed quality differences among products from different batches and enter-prises.Conclusions The method is sensitive, stable and accurate. When combined with chemometrics, it is effective for quality con-trol of Yinqiao Jiedu Keli. |
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