| 引用本文: | 白冰,徐建,高丽娟,祁树贤,赫玉芳,南敏伦,赵昱玮,孙佳明.消炎片的指纹图谱分析及多指标成分含量测定[J].中国现代应用药学,2017,34(2):258-261. |
| BAI Bing,XU Jian,GAO Lijuan,QI Shuxian,HE Yufang,NAN Minlun,ZHAO Yuwei,SUN Jiaming.Fingerprint and Multi-Component Quantification Analysis of Xiaoyan Tablets by HPLC[J].Chin J Mod Appl Pharm(中国现代应用药学),2017,34(2):258-261. |
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| 消炎片的指纹图谱分析及多指标成分含量测定 |
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白冰1,2, 徐建2, 高丽娟1, 祁树贤1, 赫玉芳2,3, 南敏伦3, 赵昱玮3, 孙佳明2
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1.修正药业集团股份有限公司, 吉林 通化 134000;2.吉林修正药业新药开发有限公司, 长春 130012;3.吉林省中医药科学院, 长春 130012
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| 摘要: |
| 目的 采用HPLC建立消炎片的指纹图谱分析方法，并测定秦皮乙素、黄芩苷、蒙花苷、黄芩素、汉黄芩素的含量，为其质量控制提供依据。方法 采用ACE C18色谱柱（4.6 mm×250 mm，5 μm），以乙腈-0.1%甲酸溶液为流动相，梯度洗脱，检测波长为321 nm。运用“中药色谱指纹图谱相似度评价软件”（2004 A版）对11批消炎片进行相似度评价。结果 11批消炎片相似度均>0.90，确定25个共有峰，指定秦皮乙素、黄芩苷、蒙花苷、黄芩素、汉黄芩素为特征峰并测定其含量。结论 该方法建立的消炎片HPLC指纹图谱特征性强、多指标成分含量测定方法重复性好、方法简便、准确，可为产品综合评价和质量控制提供依据。 |
| 关键词: 消炎片 指纹图谱 含量测定 |
| DOI：10.13748/j.cnki.issn1007-7693.2017.02.022 |
| 分类号:R282.5 |
| 基金项目:吉林省科技发展计划项目（20140311061YY） |
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| Fingerprint and Multi-Component Quantification Analysis of Xiaoyan Tablets by HPLC |
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BAI Bing1,2, XU Jian2, GAO Lijuan1, QI Shuxian1, HE Yufang2,3, NAN Minlun3, ZHAO Yuwei3, SUN Jiaming2
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1.Xiuzheng Pharmaceutical Group Co., Ltd., Tonghua 134000, China;2.Jilin Xiuzheng Pharmaceutiacal New Drug Development Co., Ltd., Changchun 130012, China;3.Academy of Chinese Medical Sciences of Jilin Province, Changchun 130012, China
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| Abstract: |
| OBJECTIVE To establish HPLC fingerprint of Xiaoyan tablets and simultaneously determine 5 chemical compositions (aesculetin, baicalin, linarin, baicalein, wogonin), provide evidence for quality control.METHODS The analytical column was ACE C18(4.6 mm×250 mm, 5 μmm). The mobile phase was acetonitrile-water(containing 0.1% formic acid) with gradient elution, and the detection wavelength was set at 321 nm. "Chromatographic fingerprint similarity evaluation software" (version 2004 A) was used to evaluate similarity for the 11 batches Xiaoyan tablets.RESULTS The similarity among the 11 batches was all >0.90, and 25 common peaks were defined in the HPLC fingerprint, and 5 characteristic peaks were earmarked 5 characteristic peaks (aesculetin, baicalin, linarin, baicalein, wogonin) were earmarked and determined.CONCLUSION The HPLC fingerprint method is high characteristics, and the determination of multi-index components is repeatability, accurate and simple, which can be used efficiently in the quality control composite evaluation of Xiaoyan tablets. |
| Key words: Xiaoyan tablets fingerprint determination |
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