摘要
目的:采用HPLC梯度洗脱法同时测定得生胶囊中氧化芍药苷、芍药苷、柴胡皂苷a、柴胡皂苷d、洋川芎内酯H、洋川芎内酯I、洋川芎内酯A和藁本内酯含量,建立得生胶囊多指标成分定量控制模式,并采用化学计量学方法对不同厂家得生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),柱温:30℃;以乙腈-0.1%磷酸为流动相,体积流量:1.0 ml·min^(-1);检测波长分别为230 nm(检测氧化芍药苷和芍药苷)、210 nm(检测柴胡皂苷a和柴胡皂苷d)和280 nm(检测洋川芎内酯H、洋川芎内酯I、洋川芎内酯A和藁本内酯);采用聚类分析和主成分分析方法对8种指标成分定量测定结果进行统计分析,评价不同厂家得生胶囊质量的差异性。结果:氧化芍药苷、芍药苷、柴胡皂苷a、柴胡皂苷d、洋川芎内酯H、洋川芎内酯I、洋川芎内酯A和藁本内酯的线性范围分别为1.47~36.75μg·ml^(-1),14.26~356.50μg·ml^(-1),1.28~32.00μg·ml^(-1),0.97~24.25μg·ml^(-1),0.54~13.50μg·ml^(-1),0.86~21.50μg·ml^(-1),2.65~66.25μg·ml^(-1),3.43~85.75μg·ml^(-1);平均加样回收率分别为98.65%,100.06%,96.90%,98.31%,97.66%,97.89%,99.76%和99.16%,RSD分别为0.90%,0.64%,1.12%,1.63%,1.29%,1.57%,0.84%,0.98%;聚类分析和主成分分析结果显示,10批得生胶囊样品分为3类,主成分1~3是影响得生胶囊质量评价的主要因子,同一厂家得生胶囊样品一致性较好,不同厂家样品一致性较差。结论:所建立的方法操作便捷、结果准确、专属性强,可有效控制得生胶囊的产品质量。
Objective:To establish an HPLC method for the simultaneous content determination of oxypaeoniflorin,paeoniflorin,saikosaponin a,saikosaponin d,senkyunolide H,senkyunolide I,senkyunolide A and ligustilide in Desheng capsules,to establish a multi-index quantitative control mode of Desheng capsules,and to comprehensively evaluate Desheng capsules from different manufacturers by using chemometrics methods of cluster analysis and principal component analysis.Methods:The analysis was performed on an Agilent Eclipse XDB C18 column(250 mm×4.6 mm,5μm),and the mobile phase was a mixture of acetonitrile and water containing 0.1%phosphoric acid solution.The column temperature was set at 30℃,and the flow rate was set at 1.0 ml·min^(-1).The detection wavelengths were set at 230 nm for oxypaeoniflorin and paeoniflorin,210 nm for saikosaponin a and saikosaponin d,and 280 nm for enkyunolide H,senkyunolide I,senkyunolide A and ligustilide.The quantitative results of eight index components were analyzed by cluster analysis and principal component analysis to evaluate the quality differences of Desheng capsules from different manufacturers.Results:The linear ranges were 1.47-36.75μg·ml^(-1)for oxypaeoniflorin,14.26-356.50μg·ml^(-1)for paeoniflorin,1.28-32.00μg·ml^(-1)for saikosaponin a,0.97-24.25μg·ml^(-1)for saikosaponin d,0.54-13.50μg·ml^(-1)for senkyunolide H,0.86-21.50μg·ml^(-1)for senkyunolide I,2.65-66.25μg·ml^(-1)for senkyunolide A and 3.43-85.75μg·ml^(-1)for ligustilide,and the average recoveries were 98.65%,100.06%,96.90%,98.31%,97.66%,97.89%,99.76%and 99.16%with the RSDs of 0.90%,0.64%,1.12%,1.63%,1.29%,1.57%,0.84%and 0.98%,respectively.The results of cluster analysis and principal component analysis showed that 10 batches of Desheng capsules could be roughly divided into three categories.The principal components 1-3 were the main factors affecting the quality evaluation of Desheng capsules.The sample consistency among different batches from the same manufacturer was good,and that among different manuf
作者
陈成
邵艳
俞明义
冯婉红
陈宏远
Chen Cheng;Shao Yan;Yu Mingyi;Feng Wanhong;Chen Hongyuan(Department of Pharmacy,Jiangnan Hospital Affiliated to Binjiang College of Zhejiang Chinese Medical University,Hangzhou 311201,China;Zhejiang Institute for Food and Drug Control)
出处
《中国药师》
CAS
2021年第10期1918-1923,共6页
China Pharmacist
基金
国家中医药管理局全国中药特色技术传承人才培训项目(编号:国中医药人教函[2019]43号)。
关键词
得生胶囊
多指标成分
聚类分析
主成分分析
综合质量评价
化学计量学
Desheng capsules
Multi-index component
Cluster analysis
Principal component analysis
Comprehensive quality evaluation
Chemometrics
