中国中药杂志

2020, v.45(14) 3369-3378

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不同厂家六味地黄浓缩丸组分结构特征与质量控制探究
Structure characteristics and quality control of Liuwei Dihuang Concentrated Pill from different manufacturers

夏昀卿;李如;高松;曹素梅;封亮;贾晓斌;
XIA Yun-qing;LI Ru;GAO Song;CAO Su-mei;FENG Liang;JIA Xiao-bin;School of Traditional Chinese Pharmacy, China Pharmaceutical University;College of Pharmacy, Jiangsu University;Henan Wanxi Pharmaceutical Co., Ltd.;

摘要(Abstract):

该实验将指纹图谱技术和"组分结构"理论联合使用模式对六味地黄浓缩丸的质量进行控制与评价。采用Agilent 5 TC-C_(18)色谱柱(4.6 mm×250 mm, 5μm),以0.1%甲酸水溶液-乙腈为流动相,流速1.0 mL·min~(-1),柱温30℃,检测波长242 nm,进样量10μL,建立了六味地黄浓缩丸HPLC指纹图谱,标定了17个共有峰,相似度为0.550~0.997,表明各批次六味地黄浓缩丸的质量差异比较大。表征了六味地黄浓缩丸中牡丹皮组分结构特征的构成要素,在此基础上,进一步解析六味地黄浓缩丸中牡丹皮的组分结构特征,发现不同厂家生产的六味地黄浓缩丸中牡丹皮组分结构的构成要素的含量以及量比关系差别较大,说明不同批次制剂产品内在质量的差异性。通过以上研究所建立的指纹图谱技术、"组分结构"理论联合使用模式为六味地黄浓缩丸质量评价提供了分析方法和探究基础。
In this paper, we aim to control and evaluate the quality of Liuwei Dihuang Concentrated Pill by using the model of fingerprint technique and "component structure" theory. Agilent 5 TC-C_(18) column(4.6 mm×250 mm,5 μm) was used, with 0.1% formic acid solution-acetonitrile as mobile phase at a flow rate of 1.0 mL·min~(-1). The column temperature was 30 ℃, with detection wavelength of 242 nm and the sample volume of 10 μL. The characteristic fingerprint of Liuwei Dihuang Concentrated Pill was established by high performance liquid chromatography(HPLC) for its quality control. Seventeen common peaks were identified, and the similarity was 0.550-0.997 in 29 batches of samples, indicating that the quality difference among batches of Liuwei Dihuang Concentrated Pills was significant. The structural characteristics of the Moutan Cortex components in Liuwei Dihuang Concentrated Pills were characterized. On this basis, combined with the structural characteristics of genuine components of Moutan Cortex, the structural characteristics of components in Liuwei Dihuang Concentrated Pills were further analyzed. The results showed that there were significant differences in the contents and quantity ratios of 9 representative components(components) of Moutan Cortex in Liuwei Dihuang Concentrated Pills from different manufacturers, indicating internal quality differences among different batches of products. The fingerprint technique and the "component structure" theory established by the above research provide an analytical method and a research foundation for the quality evaluation of Liuwei Dihuang Concentrated Pills.

关键词(KeyWords): 六味地黄浓缩丸;指纹图谱;物质基础;组分结构特征
Liuwei Dihuang Concentrated Pill;fingerprint analysis;pharmacodynamical basis;structural characteristics of components

Abstract:

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基金项目(Foundation): 国家自然科学基金项目(81703775,81973536);; 中国药科大学双一流项目(CPU2018GF07,CPU2018GY11);; 河南宛西制药合作基金项目(8010020204)

作者(Author): 夏昀卿;李如;高松;曹素梅;封亮;贾晓斌;
XIA Yun-qing;LI Ru;GAO Song;CAO Su-mei;FENG Liang;JIA Xiao-bin;School of Traditional Chinese Pharmacy, China Pharmaceutical University;College of Pharmacy, Jiangsu University;Henan Wanxi Pharmaceutical Co., Ltd.;

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