摘要
目的建立肝复康丸高效液相色谱(HPLC)指纹图谱,结合偏最小二乘判别分析(PLS-DA)法,为其质量标准的提升提供参考。方法色谱柱为Agilent Ecilipse C_(18)柱(250 mm×4.6 mm,5μm),流动相为乙腈-0.05%醋酸溶液(梯度洗脱),流速为0.95 mL/min,检测波长为203 nm(太子参环肽B)、238 nm(车叶草苷和去乙酰车叶草酸酐)、254 nm(五味子醇甲、五味子酯甲、五味子甲素、五味子乙素)、320 nm(阿魏酸和4-香豆酸)及369 nm(槲皮素和山柰素),柱温为30℃,进样量为10μL。采用中药色谱指纹图谱相似度评价系统2012A版建立HPLC指纹图谱。采用PLS-DA法分析4个生产厂家共16批肝复康丸的质量。结果建立了16批肝复康丸的HPLC指纹图谱,确认了26个共有峰;16批肝复康丸相似度为0.894~0.959;通过与对照品比对,共标定11个色谱峰。PLS-DA分析结果显示,4个生产厂家的肝复康丸成分较一致,但26个共有峰含量存在差异,并确定了导致质量差异的5个差异标志物。结论建立的HPLC指纹图谱操作简单、准确、重复性好,与PLS-DA相结合,可为肝复康丸的质量标准提升提供参考。
Objective To establish the high-performance liquid chromatography(HPLC)fingerprint of Ganfukang Pills,and to provide a reference for improving their quality standard combined with the partial least squares-discriminant analysis(PLS-DA)method.Methods The chromatographic column was Agilent Ecilipse C_(18) column(250 mm×4.6 mm,5μm),the mobile phase was acetonitrile-0.05%acetic acid solution(gradient elution),and the flow rate was 0.95 mL/min.The detection wavelengths were203 nm(heterophyllin B),238 nm(asperuloside and deacetylation plantain anhydride),254 nm(schisandrin,schisantherin A,deoxyschizandrin andγ-schisandrin),320 nm(ferulic acid and 4-coumaric acid)and 369 nm(quercetin and kaempferide).The column temperature was 30℃,and the injection volume was 10μL.The HPLC fingerprint was established by the Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine(Version 2012A).The quality of 16 batches of Ganfukang Pills from four manufacturers was analyzed by the PLS-DA method.Results The HPLC fingerprint of 16 batches of Ganfukang Pills were established,and 26 common peaks were identified.The similarity of 16 batches of Ganfukang Pills was in the range of 0.894-0.959.A total of 11 chromatographic peaks were identified by the comparison with the reference.The results of PLS-DA analysis showed that the components of Ganfukang Pills from four manufacturers were relatively consistent,but the contents of 26 common peaks were different,and five different markers leading to the quality differences of Ganfukang Pills from four manufacturers were identified.Conclusion The established HPLC fingerprint is simple,accurate and repeatable,which can provide a reference for improving the quality standard of Ganfukang Pills combined with PLS-DA.
作者
苏若
李桂女
SU Ruo;LI Guinyu(The Second Affiliated Hospital of Hainan Medical University,Haikou,Hainan,China 570102;The First Affiliated Hospital of Hainan Medical University,Haikou,Hainan,China 570100)
出处
《中国药业》
CAS
2022年第23期80-84,共5页
China Pharmaceuticals
