基于HILIC技术的仙灵骨葆胶囊中间体及成品HPLC-ELSD指纹图谱  

HPLC-ELSD Fingerprints of Xianling Gubao Capsules and Its Intermediates Based on HILIC Technology

作　　者：黄春跃[1] 周靖[1] 欧阳丹薇[1] 孙宜春 胡晓[1] HUANG Chunyue;ZHOU Jing;OUYANG Danwei;SU Yichun;HU Xiao(State Key Lab.of New Drug and Pharmaceutical Process,Shanghai Institute of Pharmaceutical Industry,China State Institute of Pharmaceutical Industry,Shanghai 201203;China National Pharmaceutical Group(GuiZhou)Tongjitang Pharmaceutical Co.,Ltd.,Guiyang 550009)

机构地区：[1]中国医药工业研究总院上海医药工业研究院,创新药物与制药工艺国家重点实验室,上海201203 [2]国药集团(贵州)同济堂制药有限公司,贵州贵阳550009

出　　处：《中国医药工业杂志》2020年第1期108-112,共5页Chinese Journal of Pharmaceuticals

基　　金：中药标准化项目(ZYBZH-C-GZ-10)

摘　　要：对15批仙灵骨葆胶囊中间体和20批成品进行HPLC-ELSD指纹图谱分析,采用Welch Ultimate~?HILIC-NH2色谱柱(4.6 mm×250 mm,5μm),乙腈-水为流动相,梯度洗脱,柱温25℃,ELSD为检测器,分别建立了HPLC-ELSD指纹图谱。运用《中药色谱指纹图谱相似度评价系统》,分别确定了8个和9个色谱峰作为仙灵骨葆中间体和成品指纹图谱的共有峰。该方法简便易行,可用于仙灵骨葆胶囊生产控制,为建立更全面的质控标准提供依据。To develop the chromatographic fingerprints for XianlingGubao capsules and its intermediates, especially for water-soluble active components and the highly polar components,the hydrophilic interaction liquid chromatography(HILIC)was used. The HPLC-ELSD fingerprints of XianlingGubao capsules and its intermediates were established. The separation was performed on a Welch Ultimate~? HILIC-NH2 column(4.6 mm×250 mm, 5 μm) with the gradient elution of acetonitrile-water using ELSD detector. The nebulizer was set as cooling mode,the drift tube temperature was set at 60 ℃ and the gas pressure was 30.0 psi. Based on similarity evaluation system for chromatographic fingerprint of traditional Chinese medicine,eight and nine chromatographic peaks were determined as common components for HPLC-ELSD fingerprints of XianlingGubao capsules and its intermediates respectively. The method is simple and practical,which can be used for the identification and quality control for XianlingGubao capsules and its intermediates.

关 键 词：仙灵骨葆胶囊 亲水色谱技术 高效液相色谱-蒸发光散射检测 质量控制 指纹图谱 

分 类 号：O657.7[理学—分析化学]