高效液相色谱法同时测定桂芍镇痫片中13种成分的含量  

Simultaneous determination of 13 components in Guishao Zhenxian tablets by HPLC

作　　者：崔小丽[1] 孙宁[1] 赵瑞 蒋锋[1] 张强[1] 贾瑞华 CUI Xiao-li;SUN Ning;ZHAO Rui;JIANG Feng;ZHANG Qiang;JIA Rui-hua(First Department of Neurology,Shaanxi Provincial People’s Hospital,Xi'an 710068)

机构地区：[1]陕西省人民医院神经内一科,西安710068

出　　处：《中南药学》2023年第11期3024-3029,共6页Central South Pharmacy

基　　金：陕西省人民医院2022年科技人才支持计划(No.2022JY-61)。

摘　　要：目的建立HPLC法同时测定桂芍镇痫片中的13种成分的含量,并结合主成分分析与聚类分析对其进行质量评价研究。方法采用Shim-pack Scepter C18(250 mm×4.6 mm,5μm)柱,乙腈-0.1%磷酸溶液为流动相,进行梯度洗脱,流速1.0 mL·min^(-1),检测波长230 nm;柱温30℃,进样量10μL。结果没食子酸、羟基芍药苷、没食子酸甲酯、芍药内酯苷、芍药苷、没食子酰芍药苷、黄芩苷、桂皮酸、汉黄芩苷、苯甲酰芍药苷、黄芩素、甘草酸、汉黄芩素的质量浓度分别在2.36~235.59、4.10~409.64、1.84~184.04、1.41~140.53、2.65~265.19、1.91~191.10、0.85~85.46、1.59~159.05、0.74~74.19、0.83~83.40、1.06~105.64、6.92~691.88、0.98~97.51μg·mL^(-1)与峰面积线性关系良好(r>0.9990);13种成分的平均回收率均在95%~102%,其RSD均<2%。10批样品聚为2类,前3个主成分累计贡献率达89.297%。结论该方法操作简便、稳定可靠、重复性好,可作为桂芍镇痫片质量控制方法,并为其临床应用提供科学依据。Objective To establish an HPLC method for the simultaneous determination of 13 components(gallic acid,hydroxypaeoniflorin,methyl gallate,albiflorin,paeoniflorin,gallic peoniflorin,baicalin,cinnamic acid,wogonoside,benzoyl paeoniflorin,baicalein,glycyrrhizic acid,and wogonin)in Guishao Zhenxian tablets,and to evaluate the quality of the product by principal component analysis and cluster analysis.Methods A Shim-pack Scepter C18 column(250 mm×4.6 mm,5μm)was used for HPLC,with acetonitrile-0.1%phosphoric acid solution as the mobile phase in gradient elution at 1.0 mL·min^(-1).The detection wavelength was 230 nm,the column temperature was 30℃,and the injection volume was 10μL.Results Gallic acid,hydroxypaeoniflorin,methyl gallate,albiflorin,paeoniflorin,gallic peoniflorin,baicalin,cinnamic acid,wogonoside,benzoyl paeoniflorin,baicalein,glycyrrhizic acid,and wogonin showed good linearity at 2.36~235.59,4.10~409.64,1.84~184.04,1.41~140.53,2.65~265.19,1.91~191.10,0.85~85.46,1.59~159.05,0.74~74.19,0.83~83.40,1.06~105.64,6.92~691.88,and 0.98~97.51μg·mL^(-1),respectively(r>0.9990).The average recoveries were at 95%~102%,with the RSD less than 2%.The 10 batches of samples were grouped into two categories,and the cumulative contribution rate of the first three principal components reached 89.297%.Conclusion The method is simple,stable,reliable and reproducible,which can be used for the quality evaluation of Guishao Zhenxian tablets,and provides scientific basis for its clinical application.

关 键 词：桂芍镇痫片 高效液相色谱 活性成分 

分 类 号：R284.1[医药卫生—中药学]