| 基于化学计量学、灰色关联度、一测多评多组分定量分析的童康片质量控制研究 |
| 投稿时间：2023-12-27 修订日期：2024-04-19 点此下载全文
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| 基金项目:山东省中医药科技发展计划项目（编号：2019-0033） |
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| 中文摘要:目的：建立童康片中13个成分含量测定的方法，并结合化学计量学及灰色关联度分析（GRA）对其质量进行综合评价。方法：采用HPLC-QAMS法，以乙腈-甲醇（9:1）-0.5%磷酸为流动相进行梯度洗脱；检测波长分别为300 nm（检测柚皮芸香苷、橙皮苷）、254nm（检测升麻素苷、升麻素、亥茅酚苷、毛蕊异黄酮葡萄糖苷、芒柄花苷、9,10-二甲氧基紫檀烷-3-O-β-D-葡萄糖苷）、203 nm（检测黄芪甲苷、薯蓣皂苷元）和220 nm（检测尿囊素、白术内酯Ⅲ、白术内酯Ⅰ）；结合化学计量学和GRA对多指标成分含量结果进行差异性分析。结果：方法学验证结果均符合现行中国药典要求。化学计量学分析显示橙皮苷、9,10-二甲氧基紫檀烷-3-O-β-D-葡萄糖苷、升麻素苷、白术内酯Ⅲ和尿囊素是影响童康片产品质量的主要潜在标志物。灰色关联度分析相对关联度0.321 6～0.667 8，同一时期生产的童康片质量差异小。结论:HPLC-QAMS法同时测定童康片中13个成分含量，简便实用，化学计量学和GRA可用于评价童康片的整体质量。 |
| 中文关键词:童康片 高效液相色谱-一测多评评法 化学计量学 灰色关联度分析法 质量评价 |
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| Study on Quality Control of Tongkang Tablets based on Chemometrics, GRA and QAMS Multicomponent Quantitative Analysis |
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| Abstract:Objective: To establish a method for the content determination of 13 components in Tongkang tablets, and to evaluate the quality Tongkang tablets by chemometrics and grey relational analysis (GRA). Method: HPLC-QAMS method was used with acetonitrile-methanol ( 9: 1 ) as mobile phase A and 0.5% phosphate acid solution as mobile phase B in gradient elution mode; the detection wavelength was set at 300 nm fornarirutin and hesperidin, 254 nm for prim-O-glucosylcimifugin, cimifugin, sec-O-glucosylhamaudol, calycosin 7-O-β-D-glucopyranoside, ononin and methylnissolin-3-O-glucoside, 203nm for astragaloside IV and diosgenin, and 220 nm for allantoin, atractylenolide III and atracylenolide I. The chemometric analysis and GRA were used to analyze the differences of the results of multi-index component content. Results: The results of methodological verification of external standard method met the requirements. Chemometric analysis showed that hesperidin, methylnissolin-3-O-glucoside, prim-O-glucosylcimifugin, atractylenolide III and allantoin were the main potential markers affecting the quality of Tongkang tablets. The relative correlation degree of GRA were 0.321 6-0.667 8, and the quality difference of Tongkang tablets produced in the same period was small. Conclusion: The HPLC-QAMS method can simultaneously determine the 13 components in Tongkang tablets, which is simple and practicaland, chemometrics and GRA can be used to evaluate the quality of Tongkang tablets. |
| keywords:Tongkang tablets HPLC-QAMS chemometrics GRA quality evaluation |
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