基于HPLC多指标含量测定及化学计量学的养正消积胶囊质量评价  

Quality evaluation of Yangzheng Xiaoji Capsules based on HPLC multi-index content determination and chemometrics

作　　者：关丽文 高鑫磊 杨天明 GUAN Liwen;GAO Xinlei;YANG Tianming(Department of Clinical Pharmacy,Hainan Cancer Hospital,Haikou 570100,China;the Cancer Center of Hainan,Haikou 570100,China;Department of Quality Management,Haikou Pharmaceutical Limited Company,Haikou 570100,China;College of TCM,Guangdong Food and Drug Vocational College,Guangzhou 510520,China)

机构地区：[1]海南省肿瘤医院临床药学部,海口570100 [2]海南省肿瘤防治中心,海口570100 [3]海口市制药厂有限公司质量管理部,海口570100 [4]广东食品药品职业学院中药学院,广州510520

出　　处：《西北药学杂志》2022年第3期26-33,共8页Northwest Pharmaceutical Journal

基　　金：全国中药特色技术传承人才培训项目(编号:T20194828003)。

摘　　要：目的建立高效液相色谱法(high performance liquid chromatography,HPLC)检测养正消积胶囊中红景天苷、女贞苷、特女贞苷、鸡矢藤次苷甲酯、车叶草苷酸、车叶草苷、绞股蓝皂苷XLIX、绞股蓝皂苷A和绞股蓝皂苷XVII的含量,并结合聚类分析(cluster analysis,CA)和主成分分析(principal component analysis,PCA)对养正消积胶囊进行综合质量评价。方法采用Venusil XBP C_(18)色谱柱;流动相为乙腈-2 mL·L^(-1)磷酸溶液;梯度洗脱;检测波长分别为220 nm(检测红景天苷、女贞苷和特女贞苷)、238 nm(检测鸡矢藤次苷甲酯、车叶草苷酸和车叶草苷)和203 nm(检测绞股蓝皂苷XLIX、绞股蓝皂苷A和绞股蓝皂苷XVII);采用SPSS 26.0统计软件对10批养正消积胶囊进行CA和PCA。结果养正消积胶囊中9种成分的线性范围良好(0.9991≤r≤0.9999);平均加样回收率为96.95%~100.10%(RSD值为0.67%~1.79%);CA和PCA结果一致,10批养正消积胶囊聚为3类,主成分1~2是影响养正消积胶囊质量评价的主要因子。结论建立的HPLC法可用于养正消积胶囊中多指标成分的定量控制和综合质量评价。Objective To establish a high performance liquid chromatography(HPLC)method for the simultaneous determination of salidroside,ligustroflavone,specnuezhenide,feretoside,asperulosidic acid,asperuloside,gypenoside XLXL,gypenoside A and gypenoside XVII in Yangzheng Xiaoji Capsules,and to combine cluster analysis(CA)and principal component analysis(PCA)to comprehensively evaluate the quality of Yangzheng Xiaoji Capsules.Methods The separation was carried out on a Venusil XBP C_(18) column.The mobile phase consisted of acetonitrile-2 mL·L^(-1) phosphoric acid with gradient elution.The detection wavelengths were set at 220 nm for salidroside,ligustroflavone and specnuezhenide,238 nm for feretoside,asperulosidic acid and asperuloside,and 203 nm for gypenoside XLXL,gypenoside A and gypenoside XVII.The CA and PCA of 10 batches of Yangzheng Xiaoji Capsules were performed by using SPSS 26.0 statistical software.Results There was a good linear relationship of 9 components in Yangzheng Xiaoji Capsules(0.9991≤r≤0.9999),with average recoveries of 96.95%-100.10%(RSD 0.67%-1.79%).The results of CA and PCA were consistent.10 batches of samples were clustered into 3 categories,and the principal component 1-2 was the main factor affecting the quality evaluation of Yangzheng Xiaoji Capsules.Conclusion The established HPLC method can be used for the multi-index components quantitative control and comprehensive quality evaluation.

关 键 词：养正消积胶囊 高效液相色谱法(HPLC) 定量控制 化学计量学 聚类分析(CA) 主成分分析(PCA) 

分 类 号：R284[医药卫生—中药学]