中国中药杂志

2014, v.39(24) 4804-4810

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UPLC用于热毒宁注射液中11种成分测定及其指纹图谱研究
Determination of eleven major components and fingerprint chromatography for Reduning injection by UPLC

吴莎;王雪;吴亚男;刘启安;吴建雄;毕宇安;王振中;萧伟;
WU Sha;WANG Xue;WU Ya-nan;LIU Qi-an;WU Jian-xiong;BI Yu-an;WANG Zhen-zhong;XIAO Wei;Beijing University of Chinese Medicine;Kanion Pharmaceutical Co.,Ltd.;State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process;

摘要(Abstract):

该文建立超高效液相色谱法(UPLC)同时测定热毒宁注射液中新绿原酸,绿原酸,隐绿原酸,异绿原酸B,异绿原酸A,异绿原酸C,山栀苷,京尼平苷酸,京尼平龙胆双糖苷,栀子苷和断氧化马钱子苷共11种有效成分含量,并建立热毒宁注射液UPLC指纹图谱,用于热毒宁注射液质量控制。该方法采用Agilent ZORBAX SB-C18色谱柱(3.0 mm×100 mm,1.8μm),预柱为Agilent UPLC Guard ZORBAX SB-C18(3.0 mm×5 mm),流动相为乙腈(A)-0.1%磷酸溶液(B),梯度洗脱;流速0.4 m L·min-1,进样量2μL,柱温30℃,检测波长324,238 nm用于含量测定,225 nm用于指纹图谱。结果显示新绿原酸,绿原酸,隐绿原酸,异绿原酸B,异绿原酸A,异绿原酸C,山栀苷,京尼平苷酸,京尼平龙胆双糖苷,栀子苷和断氧化马钱子苷11个被测组分达到基线分离;在线性范围内具有良好的线性关系,相关系数均大于0.999;平均回收率分别为103.5%,100.2%,103.3%,102.8%,101.3%,102.8%,97.36%,99.62%,98.16%,102.8%,99.27%。对45批热毒宁注射液进行UPLC指纹图谱研究,以其中的30批生成对照指纹图谱,计算余下15批热毒宁注射液与对照指纹图谱的相似度,相似度值均大于0.99。该方法快速准确灵敏,可为热毒宁注射液多成分含量测定和指纹图谱质量控制提供参考。
A reliable method for simultaneous determinition of eleven representative components(neochlorogenic acid,chlorogenic acid,cryptochlorogenic acid,isochlorogenic acid B,isochlorogenic acid A,isochlorogenic acid C,shanzhiside,geniposidic acid,genipin-1-β-D-gentiobioside,geniposide and secoxyloganin) in combination of chromatographic fingerpint analysis for Reduning injection was developed by ultra high-performance liquid chromatography(UPLC).The method was performed on an Agilent ZORBAX SB-C18 anlytical column(3.0 mm × 100 mm,1.8 μm) with a guard column of Agilent UPLC Guard ZORBAX SB-C18(3.0 mm × 5mm) at the column temperature of 30 ℃.The gradient mobile phase consisted of acetonitrile(A)-0.1% phosphoric acid(B) with a flow rate of 0.4 m L·min-1.The injection volumn was 2 μL.The detection wavelengths were set at 324 nm and 238 nm for quantitative analysis and 225 nm for fingerpint chromatography.Neochlorogenic acid,chlorogenic acid,cryptochlorogenic acid,isochlorogenic acid B,isochlorogenic acid A,isochlorogenic acid C,shanzhiside,geniposidic acid,genipin-1-β-D-gentiobioside,geniposide and secoxyloganin were baseline seperated with good linearity relationships(r > 0.999) between concentration and peak areas over the linear ranges.The average recoverys of the investigated compounds were 103.5%,100.2%,103.3%,102.8%,101.3%,102.8%,97.36%,99.62%,98.16%,102.8%,99.27%,respectively.Reduning injection of forty-five batches was analyzed by UPLC fingerprint chromatography.Thirty batches were selected to generate the reference fringerprint chromatography with fourteen common peaks.The similarity values between the reference fringerprint chromatography and the remaining fifteen batches were higher than 0.99.The developed method was fast,accurate and sensitive.It could be used as a reference for the quality control of multiple components determination and fingerprint chromatography for Reduning injection in future.

关键词(KeyWords): 超高效液相色谱法;热毒宁注射液;多成分含量测定;指纹图谱;质量控制
UPLC;Reduning injection;multiple components determination;fingerprint chromatography;quality control

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基金项目(Foundation): 国家“重大新药创制”科技重大专项(2013ZX09402203)

作者(Author): 吴莎;王雪;吴亚男;刘启安;吴建雄;毕宇安;王振中;萧伟;
WU Sha;WANG Xue;WU Ya-nan;LIU Qi-an;WU Jian-xiong;BI Yu-an;WANG Zhen-zhong;XIAO Wei;Beijing University of Chinese Medicine;Kanion Pharmaceutical Co.,Ltd.;State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process;

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