| 李俊卿,王金凤,李占芳,宋建建,崔洋洋,安盼盼.基于指纹图谱和多成分含量测定的龙胆泻肝丸(水丸)质量研究[J].中国药事,2021,35(9):1036-1045 |
| 基于指纹图谱和多成分含量测定的龙胆泻肝丸(水丸)质量研究 |
| Quality Study of Longdan Xiegan Pill Based on Fingerprint Analysis and Quantitative Analysis of Multi-components |
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| DOI：10.16153/j.1002-7777.2021.09.011 |
| 中文关键词: 龙胆泻肝丸(水丸) 指纹图谱 含量测定 栀子苷 龙胆苦苷 黄芩苷 汉黄芩苷 黄芩素 甘草酸 汉黄芩素 |
| 英文关键词: Longdan Xiegan pill fingerprint content determination geniposide gentiopicrin baicalin wogonoside baicalein glycyrrhizic acid wogonin |
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| 中文摘要: |
| 目的：建立龙胆泻肝丸(水丸)的HPLC指纹图谱，同时测定龙胆泻肝丸(水丸)中7个成分(栀子苷、龙胆苦苷、黄芩苷、汉黄芩苷、黄芩素、甘草酸、汉黄芩素)的含量，并基于指纹图谱和多成分含量测定结果评价产品质量。方法：采用CAPCELL PAK C18(4.6 mm×250 mm，5 μm)色谱柱，以乙腈 -0.2%磷酸溶液为流动相进行梯度洗脱，流速1.0 mL·min-1，检测波长254 nm，柱温25 ℃。建立龙胆泻肝丸(水丸)指纹图谱并进行相似度分析，同时测定其中7个成分含量。结果：在指纹图谱研究中，以黄芩苷为参照峰，共标定20个共有峰，并指认出7个色谱峰，采用指纹图谱相似度评价系统(2012年版) 进行相似度分析，30批龙胆泻肝丸(水丸)相似度在0.815~1.000。7个化学成分线性关系良好，加样回收在97.7%~104.3%之间，RSD均小于2.0%。30批样品中栀子苷、龙胆苦苷、黄芩苷、汉黄芩苷、黄芩素、甘草酸、汉黄芩素的质量分数依次为2.48~3.59、1.90~6.11、3.51~8.09、0.59~1.70、0.18~1.95、 0.90~1.63、0.10~0.87 mg·g-1。结论：研究建立的HPLC指纹图谱结合多成分同时测定的方法，操作简便，结果准确、稳定，可为龙胆泻肝丸(水丸)的质量评价提供参考。 |
| 英文摘要: |
| Objective: To establish an HPLC fingerprint and to quantitatively analyze seven components (geniposide, gentiopicrin, baicalin, wogonoside, baicalein, glycyrrhizic acid and wogonin) in Longdan Xiegan pill, and the product quality was evaluated based on the fingerprint and multi-component content determination results. Methods: The analysis was performed on an CAPCELL PAK C18 column (4.6 mm × 250 mm, 5 μm), and the mobile phase consisted of acetonitrile-0.2% phosphoric acid with gradient elution at a flow rate of 1.0 mL·min-1 . The detection wavelength was 254 nm and the column temperature was 25 ℃. The HPLC fingerprint of LongdanXiegan pill was established and the similarity analysis was carried out, and seven components were determined simultaneously. Results: In the fingerprint study, baicalin was used as the reference peak, 20 common peaks were marked and 7 peaks were identified. The fingerprint similarity evaluation system (2012 edition) was used for similarity analysis. The similarity of 30 batches of Longdan Xiegan pills (water pills) was between 0.815-1.000. For the quantitive analysis, seven components showed good regression, and the mean recoveries were 97.7%- 104.3% with the RSD less than 2.0%. The mass fractions of geniposide, gentiopicrin, baicalin, wogonoside, baicalein, glycyrrhizic acid and wogonin in 30 batches were 2.48-3.59, 1.90-6.11, 3.51-8.09, 0.59-1.70, 0.18-1.95, 0.90-1.63, 0.10-0.87 mg·g-1, respectively. Conclusion: The established HPLC fingerprint combined with the simultaneous determination of multiple components is simple, accurate and stable, which can provide references for the quality evaluation of Longdan Xiegan pill. |
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