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.
作者
崔小丽
山媛
蒋锋
王莉
张强
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)
出处
《西北药学杂志》
CAS
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)
