一测多评法测定复方毛冬青片中3种皂苷类成分的含量
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摘要
目的建立复方毛冬青片中3种皂苷类成分一测多评的含量测定方法。方法采用HPLC法,色谱柱:YMC-Pack Pro-C_(18) RS(4.6 mm×250 mm,5μm);流动相:乙腈-0.1%磷酸水溶液,梯度洗脱;流速:1.0mL·min~(-1);检测波长:203 nm;柱温:25℃。以人参皂苷Rb_1为内参物,建立人参皂苷Rb_1与人参皂苷Rg_1及毛冬青皂苷甲的相对校正因子(RCF),并利用RCF计算人参皂苷Rg_1、毛冬青皂苷甲的含量,同时利用外标法测定3种成分的含量,比较两者的差异,验证一测多评法的准确性和科学性。结果不同条件下各成分RCF重现性良好(RSD<5.00%),采用一测多评法计算的含量值与外标法实测值之间无明显差异。结论以一测多评法对复方毛冬青片进行质量控制是稳定、可行的。
Objective To establish a method for simultaneous determination of 3 saponins in Fufang Maodongqing tablets based on the quantitative analysis of multi-components by single marker(QAMS). Methods With the method of HPLC,a YMC-Pack Pro-C_(18) RS(4.6 mm × 250 mm,5 μm) column was adopted. The mobile phase was composed of acetonitrile(A) and 0.1 % phosphoric acid(B) with gradient elution at a flow rate of 1.0 mL·min~(-1);the detection wavelength was at 203 nm;the column temperature was 25 ℃. Ginsenoside Rb_1 was selected as an internal standard to calculate the relative correction factors(RCFs) of ginsenoside Rg_1 and ilexsaponin A1 with reference to ginsenoside Rb_1 respectively. The method was evaluated by comparison of the quantitative results between external standard method and QAMS method. Results The repeatability of RCF of ginsenoside Rg_1 and ilexsaponin A_1 with reference to ginsenoside Rb_1 was good in different experimental conditions and no significant differences was shown between the quantitative results of QAMS method and external standard method. Conclusion It is feasible and accurate to control the quality of Fufang Maodongqing Tablets with QAMS.
Objective To establish a method for simultaneous determination of 3 saponins in Fufang Maodongqing tablets based on the quantitative analysis of multi-components by single marker(QAMS). Methods With the method of HPLC,a YMC-Pack Pro-C_(18) RS(4.6 mm × 250 mm,5 μm) column was adopted. The mobile phase was composed of acetonitrile(A) and 0.1 % phosphoric acid(B) with gradient elution at a flow rate of 1.0 mL·min~(-1);the detection wavelength was at 203 nm;the column temperature was 25 ℃. Ginsenoside Rb_1 was selected as an internal standard to calculate the relative correction factors(RCFs) of ginsenoside Rg_1 and ilexsaponin A1 with reference to ginsenoside Rb_1 respectively. The method was evaluated by comparison of the quantitative results between external standard method and QAMS method. Results The repeatability of RCF of ginsenoside Rg_1 and ilexsaponin A_1 with reference to ginsenoside Rb_1 was good in different experimental conditions and no significant differences was shown between the quantitative results of QAMS method and external standard method. Conclusion It is feasible and accurate to control the quality of Fufang Maodongqing Tablets with QAMS.
引文
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[3]陆继伟,于建,王柯,等.复方丹参片中三七皂苷R1和人参皂苷Rg1、Re、Rb1的HPLC法测定[J].中国医药工业杂志,2012,43(12):1027-1030.
[4]袁旭江,李春阳,张平.一测多评法测定鸡骨草叶中3种黄酮碳苷含量[J].中药新药与临床药理,2014,25(4):493-518.
[5]杨秀梅,王瑾,黄勤挽,等.“一测多评”法测定陈皮中3种黄酮类成分[J].中国实验方剂学杂志,2014,20(11):45-49.
[6]刘潇潇,杨立伟,欧国灯,等.一测多评法在复方丹参片皂苷类成分检测中的应用研究[J].中国新药杂志,2014,23(21):2561-2566.
[7]张诚贤,杨红霞,陈褚建,等.一测多评法同时测定止痢宁片中4个萜类内酯的含量[J].药物分析杂志,2015,35(12):2158-2162.
[8]国家药典委员会.中华人民共和国药典(一部)[M].北京:中国医药科技出版社,2015:153-154.
[9]陈新菊,利家平,袁海铭,等.毛冬青药材中毛冬青皂苷甲和毛冬青皂苷B2的含量测定的研究[J].时珍国医国药,2010,21(8):1880-1881.
[10]秦国伟,陈政雄,徐任生,等.毛冬青化学成分的研究Ⅱ:毛冬青皂苷甲的化学结构[J].化学学报,1987,45(3):249-255.
[11]YAMAHARA J,HIDAKA K,ITO M,et al.A triterpene and saponin from roots of Ilex pubescens[J].Phytochemistry,1987,26(7):2023-2027.
[12]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.