胡军华;苏倩倩;李婷婷;李家春;萧伟;
HU Jun-hua;SU Qian-qian;LI Ting-ting;LI Jia-chun;XIAO Wei;Jiangsu Kanion Pharmaceutical Co. ,Ltd.;State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process;

• 1:江苏康缘药业股份有限公司
• 2:中药制药过程新技术国家重点实验室

摘要(Abstract)：

该研究建立了金振口服液HPLC指纹图谱测定方法,为金振口服液的质量控制提供新方法。采用RP-HPLC,phenomenex Luna C18(4.6 mm×250 mm,5μm)色谱柱,以0.1%磷酸水溶液和乙腈为流动相,梯度洗脱,检测波长为280 nm,建立了金振口服液的指纹图谱,确立了金振口服液中17个共有峰,10批成品指纹图谱相似度在0.90以上。该研究建立的HPLC指纹图谱有较好的精密度、重复性和稳定性,适用于金振口服液的质量控制。
The HPLC fingerprint determination method of Jinzhen oral solution was established to provide a new method for quality control of Jinzhen oral solution. RP-HPLC was used for phenomenex Luna C18( 4. 6 mm × 250 mm,5 μm) chromatographic column,with 0. 1% H3PO4 water solution and acetonitrile as the mobile phase for gradient elution. The detection wavelength was 280 nm.HPLC fingerprint of Jinzhen oral solution was established to identify 17 common peaks in Jinzhen oral solution. The similarity of fingerprints of 10 batches of finished products was more than 0. 90. The established HPLC fingerprint has a better precision,reproducibility and stability,and can be applied in quality control of Jinzhen oral solution.

关键词(KeyWords)： 金振口服液;高效液相色谱法;指纹图谱;相似度
Jinzhen oral solution;HPLC;fingerprint;similarity

Abstract:

Keywords:

基金项目(Foundation):

作者(Author): 胡军华;苏倩倩;李婷婷;李家春;萧伟;
HU Jun-hua;SU Qian-qian;LI Ting-ting;LI Jia-chun;XIAO Wei;Jiangsu Kanion Pharmaceutical Co. ,Ltd.;State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process;

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DOI:

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