复元胶囊质量标准与药理作用及临床意义  

Quality standard,pharmacological action and clinical significance of Fuyuan capsule

作　　者：周凤盈 王殿奎 张玉 孙琛 耿春辉 Zhou Fengying;Wang Diankui;Zhang Yu;Sun Chen;Geng Chunhui(Hengshui City Comprehensive Inspection and Testing Center,Hebei Province,Hengshui 053000,China;Hengshui City Adverse Drug Reaction Monitoring Center,Hengshui 053000,China)

机构地区：[1]河北省衡水市综合检验检测中心,衡水053000 [2]河北省衡水市药品不良反应监测中心,衡水053000

出　　处：《中国医药》2023年第5期714-719,共6页China Medicine

基　　金：河北省衡水市科技计划(2022014089Z)。

摘　　要：目的探讨复元胶囊部分成分的定性鉴别方法及4种主要活性成分含量测定方法的准确性。方法采用薄层色谱法对复元胶囊中的人参、黄芪、熟地黄、淫羊藿进行定性鉴别。采用高效液相色谱法在同一色谱条件下同时测定复元胶囊中主要活性成分2,3,5,4′-四羟基二苯乙烯-2-O-β-D-葡萄糖苷、3,6′-二芥子酰基蔗糖、淫羊藿苷、丹酚酸B的含量;色谱柱为Waters Symmetry C18柱(250 mm×4.6 mm,5μm),柱温为30℃;流动相为乙腈-0.1%磷酸,梯度洗脱,检测波长为320 nm,进样量为10μl,流速为1.0 ml/min。结果薄层色谱法鉴别人参、黄芪、熟地黄、淫羊藿的特征斑点清晰,分离度好且阴性对照无干扰。含量测定中4个主要活性组分的线性范围分别为:2,3,5,4′-四羟基二苯乙烯-2-O-β-D-葡萄糖苷4.84~48.40μg/ml(r=0.9998)、3,6′-二芥子酰基蔗糖1.11~11.12μg/ml(r=0.9991)、丹酚酸B 1.84~18.36μg/ml(r=0.9992)、淫羊藿苷1.45~14.50μg/ml(r=0.9999),平均加样回收率分别为94.34%、94.70%、95.38%、92.76%,相对标准偏差分别为1.09%、1.03%、0.92%、0.88%(n=6)。检测限分别为0.1530、0.0325、0.0552、0.0433μg/ml;定量限分别为0.509,0.108,0.184,0.144μg/ml;精密度试验、重复性试验、稳定性试验均良好,相对标准偏差均小于2.0%(n=6)。结论采用薄层色谱法可以对复元胶囊组方中人参、黄芪、熟地黄、淫羊藿进行定性鉴别。在检测波长为320 nm的条件下,以乙腈-0.1%磷酸溶液作为流动相进行梯度洗脱,复元胶囊4种主要活性成分检测的方法准确可靠、灵敏度高、稳定性和重复性良好,操作简单。Objective To explore the qualitative identification methods of some components of Fuyuan capsules and the accuracy of the content determination methods of four main active components.Methods Thin⁃layer chromatography(TLC)was used to qualitatively identify ginseng,Astragalus,Rehmannia glutinosa,and Epimedium in Fuyuan capsules.The high⁃performance liquid chromatography was used to simultaneously determine contents of the main active ingredients of 2,3,5,4′⁃tetrahydroxystilbene⁃2⁃O⁃β⁃D⁃glucoside,3,6′⁃dierucanoyl sucrose,icariin and salvianolic acid B in Fuyuan capsules under the same chromatographic conditions.The chromatographic column was Waters Symmetry C18 column(250 mm×4.6 mm,5μm),the column temperature was 30℃,the mobile phase was acetonitrile⁃0.1%phosphoric acid,gradient elution,the detection wavelength was 320 nm,the injection volume was 10μl,and the flow rate was 1.0 ml/min.Results The characteristic spots of ginseng,Astragalus,Rehmannia glutinosa and Epimedium were clear by TLC,with good separation and no interference in negative control.The linear ranges of the four main active components in the content determination were respectively 2,3,5,4′⁃tetrahydroxystilbene⁃2⁃O⁃β⁃D⁃glucoside 4.84⁃48.40μg/ml(r=0.9998),3,6′⁃dierucanoyl sucrose 1.11⁃11.12μg/ml(r=0.9991),salvianolic acid B 1.84⁃18.36μg/ml(r=0.9992),and icariin 1.45⁃14.50μg/ml(r=0.9999).The average recovery rates of sample addition were respectively 94.34%,94.70%,95.38%,and 92.76%,and the relative standard deviations were respectively 1.09%,1.03%,0.92%,and 0.88%(n=6).The limits of detection were 0.1530,0.0325,0.0552,and 0.0433μg/ml,the limits of quantification were 0.509,0.108,0.184,and 0.144μg/ml,the precision test,repeatability test,and stability test were all good,and the relative standard deviations were all less than 2.0%(n=6).Conclusions The TLC can be used to qualitatively identify ginseng,Astragalus,Rehmannia glutinosa,and Epimedium in Fuyuan capsules.At the detection wavelength of

关 键 词：复元胶囊 薄层色谱法 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]