更年灵胶囊4种成分的含量测定及HPLC指纹图谱的建立  

Determination of the 4 components and establishment of HPLC fingerprints of Gengnianling Capsules

作　　者：陆游 吴桂凡 李立 罗轶 马双成[2] LU You;WU Guifan;LI Li;LUO Yi;MA Shuangcheng(Institute for Food and Drug Control in Guangxi Zhuang Autonomous Region,NMPA Key Laboratory for Quality Monitoring and Evaluation of Traditional Chinese Medicine,Chinese Materia Medica,Nanning 530021,China;National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]广西壮族自治区食品药品检验所,国家药品监督管理局中药材质量监测与评价重点实验室,南宁530021 [2]中国食品药品检定研究院,北京100050

出　　处：《西北药学杂志》2023年第4期9-15,共7页Northwest Pharmaceutical Journal

基　　金：2021年广西壮族自治区药品监督管理局科研计划项目(编号:桂药监科2021-10直属)。

摘　　要：目的建立HPLC法同时测定更年灵胶囊中女贞子和淫羊藿中特女贞苷、淫羊藿苷、朝藿定B、朝藿定C的含量并建立HPLC指纹图谱,同时进行聚类分析和主成分分析。方法用HPLC法,色谱柱为Capcell pak MGII-C_(18)(250 mm×4.6 mm,5μm),流动相为乙腈-水(梯度洗脱),流速为1.0 mL·min^(-1),检测波长为224 nm,柱温为30℃,进样量为10μL。结果4种成分在各自范围内线性关系良好(r≥0.9999),平均加样回收率为97.10%~102.77%,RSD值为1.24%~1.86%。20批样品的HPLC图谱有11个共有峰,指认了4个峰,分别为特女贞苷、朝藿定B、朝藿定C及淫羊藿苷。结论HPLC指纹图谱准确、可靠,所建立的含量测定方法简便、可行、重复性好,可用于更年灵胶囊的质量控制。Objective To establish an HPLC method for simultaneous determination of specnuezhenide,icariin,epimedin B,and epimedin C in Gengnianling Capsules(Ligustri lucidi Fructus,Epimedium brevicornu),to establish the HPLC fingerprints,and to conduct cluster analysis and principal component analysis.Methods HPLC method was adopted.The determination was carried out on a Capcell pak MGII-C _(18) column(250 mm×4.6 mm,5μm)with mobile phase consisted of acetonitrile-water(gradient elution)at a flow rate of 1.0 mL·min^(-1).The detection wavelength was set at 224 nm,and the column temperature was 30℃.The sample size was 10μL.Results The 4 components showed good linear relationships within their own ranges(r≥0.9999),whose average recoveries were 97.10%-102.77%with the RSDs of 1.24%-1.86%.The HPLC fingerprints of 20 batches of samples showed 11 commons peaks,and 4 of them were identified by comparing with reference substances,namely,specnuezhenide,epimedin B,epimedin C,and icariin.Conclusion The method is reliable,simple and accurate with good reproducibility,and can be used for the quality evaluation of Gengnianling Capsules.

关 键 词：更年灵胶囊 高效液相色谱法 指纹图谱 含量测定 

分 类 号：R284[医药卫生—中药学]