基于HPLC多指标成分定量控制和化学计量学的小儿抗痫胶囊质量评价研究  

Quality evaluation of Xiaoer Kangxian Capsules based on HPLC multi-components quantitative determination and chemometrics analysis

作　　者：耿丽娟 张现娥 张涛 王葆辉 袁宝强 徐丽君 GENG Li-juan;ZHANG Xian’e;ZHANG Tao;WANG Bao-hui;YUAN Bao-qiang;XU Li-jun(Kaifeng Children's Hospital,Kaifeng 475000,China;Affiliated Hospital of Xuzhou Medical University,Xuzhou 221000,China;Henan Provincial Institute of Food and Drug Control,Zhengzhou 450008,China)

机构地区：[1]开封市儿童医院,河南开封475000 [2]徐州医科大学附属医院,江苏徐州221000 [3]河南省食品药品检验所,河南郑州450008

出　　处：《现代药物与临床》2021年第6期1132-1137,共6页Drugs & Clinic

基　　金：河南省医学科技攻关计划项目(2017020716)。

摘　　要：目的建立小儿抗痫胶囊中天麻素、对羟基苯甲醇、洋川芎内酯H、洋川芎内酯I、洋川芎内酯A、柚皮苷、橙皮苷和新橙皮苷的HPLC多指标成分定量控制方法,并采用化学计量学对不同药品生产企业小儿抗痫胶囊质量进行综合评价。方法采用Agilent Eclipse XDB-C18色谱柱(250 mm×4.6 mm,5μm),以乙腈–0.1%磷酸为流动相,梯度洗脱,检测波长分别为220 nm(检测天麻素、对羟基苯甲醇)、280 nm(检测洋川芎内酯H、洋川芎内酯I、洋川芎内酯A、柚皮苷、橙皮苷、新橙皮苷);体积流量0.8 mL/min;柱温25℃;进样量10μL。采用统计软件对小儿抗痫胶囊中8种成分质量分数进行聚类分析和主成分分析。结果天麻素、对羟基苯甲醇、洋川芎内酯H、洋川芎内酯I、洋川芎内酯A、柚皮苷、橙皮苷、新橙皮苷在各自线性范围内均呈良好的线性关系;加样回收率96.89%~100.10%,RSD值0.81%~1.77%;聚类分析和主成分分析结果显示,同一药品生产企业的产品质量较为稳定,不同企业间的样品质量存在一定差异。结论该方法操作简单,结果准确,重现性好,为评价小儿抗痫胶囊的质量提供了参考依据。Objective To establish an HPLC multi-components method for the quantitative determination of gastrodin,4-hydroxbenzyl alcohol,senkyunolide H,senkyunolide I,senkyunolide A,naringin,hesperidin,and neohesperidin in Xiaoer Kangxian Capsules,and chemometrics analysis was used to comprehensive evaluation the quality of samples from different pharmaceutical manufacturing enterprises.Methods The Agilent Eclipse XDB-C18 column(250 mm×4.6 mm,5μm)was used as the chromatographic column with acetonitrile-0.1%phosphoric acid solution as the mobile phase with gradient elution.The detection wavelength were set at 220 nm for gastrodin and 4-hydroxbenzyl alcohol,and 280 nm for senkyunolide H,senkyunolide I,senkyunolide A,naringin,hesperidin,and neohesperidin.The column temperature was 25℃,the flow rate was set at 0.8 mL/min,and the injection volume was 10μL.The cluster analysis and principal component analysis were conducted for the content results of eight constituents in Xiaoer Kangxian Capsules by statistical software.Results Gastrodin,4-hydroxbenzyl alcohol,senkyunolide H,senkyunolide I,senkyunolide A,naringin,hesperidin,and neohesperidin showed good linear relationships within their own ranges,whose average recoveries were 96.89%—100.10%with the RSD values of 0.81%—1.77%.The cluster analysis and principal component analysis showed that there were more consistent among the samples from the same pharmaceutical manufacturing enterprises,and the samples from different pharmaceutical manufacturing enterprises were some differences.Conclusion The method is simple and reproducible which can be used for the quality control of Xiaoer Kangxian Capsules.

关 键 词：小儿抗痫胶囊 天麻素 对羟基苯甲醇 高效液相色谱 聚类分析 主成分分析 

分 类 号：R286.02[医药卫生—中药学]