一测多评法测定茵栀黄颗粒中4个黄酮类成分的含量
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摘要
目的建立以黄芩苷为内参物,同时测定茵栀黄颗粒中野黄芩苷、汉黄芩苷、黄芩素和汉黄芩素含量的一测多评法(QAMS)。方法采用Diamonsi C18色谱柱(4.6 mm×250 mm, 5μm),以乙腈-0.1%磷酸为流动相进行梯度洗脱,流速1.0 ml/min,检测波长274 nm,柱温30℃;以黄芩苷为内参物,建立与其他4个黄酮类成分的相对校正因子;分别采用外标法和一测多评法测定4个黄酮类成分的含量,比较两种计算结果的差异。结果在一定线性范围内,黄芩苷与野黄芩苷、汉黄芩苷、黄芩素和汉黄芩素的相对校正因子分别为1.721,0.821,0.601,0.567。建立的校正因子重现性良好;一测多评法计算结果与外标法测得结果无显著差异。结论建立的一测多评法可作为茵栀黄颗粒中4个黄酮类成分的测定方法,为茵栀黄颗粒的质量控制提供参考。
Objective To develop a QAMS method for simultaneous multi-component determination of scutellarin,wogonoside, baicalein and wogonin in Yinzhihuang Granules with baicalin as the internal reference. Mothods Diamonsi C18 column(4.6 mm×250 mm, 5 μm) was adopted. The gradient elution was performed using acetonitrile and 0.1 % phosphoric acidmobile as mobile phase. The flow rate was 1.0 ml/min, the detection wavelength was set at274 nm, and the column temperature was 30 ℃. Baicalin was selected as the internal standard to establish the relative correction factors(RCF) of other flavones. The contents of four flavones were determined by both external standard method and QAMS. The validity of the QAMS method was evaluated by comparison of the quantitative results of both methods. Results Under the de?ned ranges of determination, RCFs of scutellarin, wogonoside, baicalein and wogonin with reference to baicalin, were 1.721, 0.821, 0.601 and 0.567, respectively, and the repeatability was good under different experimental conditions. There were no obvious difference between the quantitative results of the two methods. Conclusion QAMS can be used to determine four flavones in Yinzhihuang Granules, and provide a useful approach for the qualtity control of Yinzhihuang Granules.
Objective To develop a QAMS method for simultaneous multi-component determination of scutellarin,wogonoside, baicalein and wogonin in Yinzhihuang Granules with baicalin as the internal reference. Mothods Diamonsi C18 column(4.6 mm×250 mm, 5 μm) was adopted. The gradient elution was performed using acetonitrile and 0.1 % phosphoric acidmobile as mobile phase. The flow rate was 1.0 ml/min, the detection wavelength was set at274 nm, and the column temperature was 30 ℃. Baicalin was selected as the internal standard to establish the relative correction factors(RCF) of other flavones. The contents of four flavones were determined by both external standard method and QAMS. The validity of the QAMS method was evaluated by comparison of the quantitative results of both methods. Results Under the de?ned ranges of determination, RCFs of scutellarin, wogonoside, baicalein and wogonin with reference to baicalin, were 1.721, 0.821, 0.601 and 0.567, respectively, and the repeatability was good under different experimental conditions. There were no obvious difference between the quantitative results of the two methods. Conclusion QAMS can be used to determine four flavones in Yinzhihuang Granules, and provide a useful approach for the qualtity control of Yinzhihuang Granules.
引文
[1]范建伟,李蔚群,李艳芳,等.茵栀黄制剂处方渊源、剂型沿革与质量控制的研究进展[J].中成药, 2017, 39(11):2365-2368.
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[10]陈永刚,马传学,黄成琼,等.高效液相色谱-波长切换法同时测定茵栀黄颗粒中的7种有效成分[J].中国医院药学杂志, 2012,32(11):894-896.
[11]李春红,梅志强,何兵,等.HPLC同时测定龙胆泻肝制剂中黄芩苷、汉黄芩苷、黄芩素、汉黄芩素的含量[J].生物学通报,2012, 47(4):60-62.
[12]赵亮,王新霞,吕磊,等. HPLC法测定清肝散结颗粒中黄芩苷、汉黄芩苷、野黄芩苷、黄芩素及汉黄芩素[J].中成药, 2014,36(2):313-318.
[13]冯伟红,杨菲,王智民,等.一测多评法与外标法测定双黄连制剂中黄酮类成分含量的比较分析[J].中国药学杂志, 2012,47(20):1665-1669.
[2]国家药典委员会.中华人民共和国药典:2015年版一部[S].北京:中国医药科技出版社, 2015:1154-1156.
[3]陈启冰,陈建东.茵栀黄颗粒治疗新生儿病理性黄疸临床疗效及安全性观察[J].临床合理用药, 2017, 10(8):72-73.
[4]程德勇,丁晓玲,陈浩,等.茵栀黄颗粒治疗新生儿黄疸的临床效果观察[J].中国生化药物杂志, 2017, 37(6):99-101.
[5]蔡红霞,丁武华.茵栀黄颗粒治疗足月新生儿黄疸疗效观察[J].新疆中医药, 2017, 35(4):27-29.
[6]杨菲,冯伟红,王智民,等.一测多评法测定银黄制剂中4种黄酮类成分含量[J].中国药学杂志, 2012, 47(12):984-989.
[7]王智民,高慧敏,付雪涛,等.“一测多评”法中药质量评价模式方法学研究[J].中国中药杂志, 2006, 31(23):1925-1928.
[8]李艳芳,范建伟,刘武占,等.一测多评法测定栀子中4个环烯醚萜苷类成分的含量[J].中药材, 2014, 37(5):822-825.
[9]王智民,钱忠直,张启伟,等.一测多评法建立的技术指南[J].中国中药杂志, 2011, 36(6):657-658.
[10]陈永刚,马传学,黄成琼,等.高效液相色谱-波长切换法同时测定茵栀黄颗粒中的7种有效成分[J].中国医院药学杂志, 2012,32(11):894-896.
[11]李春红,梅志强,何兵,等.HPLC同时测定龙胆泻肝制剂中黄芩苷、汉黄芩苷、黄芩素、汉黄芩素的含量[J].生物学通报,2012, 47(4):60-62.
[12]赵亮,王新霞,吕磊,等. HPLC法测定清肝散结颗粒中黄芩苷、汉黄芩苷、野黄芩苷、黄芩素及汉黄芩素[J].中成药, 2014,36(2):313-318.
[13]冯伟红,杨菲,王智民,等.一测多评法与外标法测定双黄连制剂中黄酮类成分含量的比较分析[J].中国药学杂志, 2012,47(20):1665-1669.