脑得生片中10种成分的定量研究  

Quantitative study on 10 components in Naodesheng Tablets

作　　者：崔小丽[1] 山媛[1] 蒋锋[1] 王莉[1] 张强[1] 赵瑞 CUI Xiaoli;SHAN Yuan;JIANG Feng;WANG Li;ZHANG Qiang;ZHAO Rui(Department of Neurology,Shaanxi Provincial People′s Hospital,Xi′an 710068,China)

机构地区：[1]陕西省人民医院神经内一科,西安710068

出　　处：《西北药学杂志》2019年第3期317-322,共6页Northwest Pharmaceutical Journal

基　　金：陕西省社会发展科技攻关项目(编号:2015SF209)

摘　　要：目的建立HPLC法,对脑得生片中3′-羟基葛根素、葛根素、葛根素芹菜糖苷、3′-甲氧基葛根素、大豆苷、染料木苷、三七皂苷Rb_1、人参皂苷Rg_1、大豆苷元和人参皂苷Rb_1 10种有效成分进行定量分析。方法色谱条件:色谱柱为Kromasil C_(18)柱(250 mm×4.6 mm,5μm);流动相为乙腈-2.0 g·L^(-1)磷酸水溶液,梯度洗脱;流速为0.8 mL·min^(-1);检测波长为250和203 nm;柱温为35℃。结果 10个成分的峰具有良好的分离度;3′-羟基葛根素、葛根素、葛根素芹菜糖苷、3′-甲氧基葛根素、大豆苷、染料木苷、三七皂苷Rb_1、人参皂苷Rg_1、大豆苷元和人参皂苷Rb_1的线性范围分别为14.99～299.88,15.00～300.03,8.26～165.13,10.24～204.82,10.01～200.13,6.40～128.00,15.75～314.93,21.00～419.97,7.01～140.14和17.50～349.97μg·mL^(-1),相关系数分别为0.999 5,0.999 8,0.999 9,0.999 5,0.999 6,0.999 5,0.999 6,0.999 8,0.999 6和0.999 6;精密度、稳定性与重复性实验的RSD值均小于1.60%;10个对照品的加样回收率均在97.10%～98.48%之间,RSD值均在0.76%～1.56%之间;10批制剂中3′-羟基葛根素、葛根素、葛根素芹菜糖苷、3′-甲氧基葛根素、大豆苷、染料木苷、三七皂苷Rb_1、人参皂苷Rg_1、大豆苷元和人参皂苷Rb_1的平均含量分别为7.43,13.33,8.29,10.64,9.35,1.04,2.21,8.44,1.73和2.97 mg·g^(-1),RSD值分别为1.23%,0.82%,1.11%,1.24%,1.07%,1.58%,1.28%,0.86%,1.45%和1.28%。结论脑得生片中10种主要有效成分的含量检测方法操作简便、准确、可靠、稳定且重复性好,为该制剂的质量控制提供了有效的评价方法。Objective To establish an HPLC method for the quantitative analysis of10 functional ingredients,including 3′- hydroxy puerarin,puerarin,puerarin apioside,3′-methoxy puerarin, daidzin,genistin,notoginsenoside Rb1,ginsenoside Rg1,isoflavoues aglycone and ginsenoside Rb1 in Naodesheng Tablets. Methods The Kromasil C18 column(250 mm×4.6 mm,5 μm) was used,and the column temperature was maintained at 35 ℃.The detection wavelength was at 250 and 203 nm.A gradient elution of acetonitrile-2.0 g·L^-1 phosphoric acid was adopted at a flow rate of 0.8 mL·min -1 . Results Good resolution was achieved among the10 active components.The linear ranges and RSDs of 3′-hydroxy puerarin, puerarin,puerarin apioside,3′-methoxy puerarin,daidzin,genistin ,notoginsenoside Rb1,ginsenoside Rg1,isoflavoues aglycone and ginsenoside Rb1,respectively,were14.99-299.88 ( r1 =0.999 5), 15.00-300.03 ( r 2 =0.999 8),8.26-165.13 ( r 3 =0.999 9),10.24- 204.82 ( r 4 =0.999 5),10.01-200.13 ( r 5 =0.999 6), 6.40-128.00 ( r 6 =0.999 5),15.75-314.93 ( r 7 =0.999 6),21.00-419.97 ( r 8 =0.999 8),7.01-140.14 ( r 9 =0.999 6) and17.50-349.97 μg·mL -1 ( r10 =0.999 6).Precision stability and repeatability tests′ RSD values were less than1.60%;the average recoveries were between 97.10% and 98.48%,and RSDs were between 0.76% and1.56%,respectively.The contents of 3′-hydroxypuerarin,puerarin,puerarin apioside,3′- methoxy puerarin,daidzin,genistin,notoginsenoside Rb1,ginsenoside Rg 1,isoflavoues aglycone and ginsenoside Rb1 in10 batches of the preparation were 7.43,13.33,8.29,10.64,9.35,1.04,2.21,8.44,1.73 and 2.97 mg·g -1 ,and their RSD values were 1.23%,0.82%,1.11%,1.24%,1.07%,1.58%,1.28%,0.86%,1.45% and1.28%, respectively. Conclusion The method is exact,simple,reliable, stable and repeatable for the10 main medicinal ingredients content determination in Naodesheng Tablets,and can be used as the Naodesheng Tablets quality evaluation method.

关 键 词：脑得生片 葛根素 三七皂苷Rb1 大豆苷 人参皂苷RB1 HPLC法 

分 类 号：R927.2[医药卫生—药学]