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康艾注射液中间产品人参提取液中人参皂苷Rg1和人参皂苷Re的含量测定方法及高效液相指纹图谱研究
引用本文:李建英,李晓彤,翁红,王道新,纪丽岩,祁宇祥,王波,米广明.康艾注射液中间产品人参提取液中人参皂苷Rg1和人参皂苷Re的含量测定方法及高效液相指纹图谱研究[J].人参研究,2020(1):2-5.
作者姓名:李建英  李晓彤  翁红  王道新  纪丽岩  祁宇祥  王波  米广明
作者单位:长白山制药股份有限公司;延边大学
基金项目:国家中医药管理局国家中药标准化项目,项目编号:ZYBZH-C-JL-23。
摘    要:目的建立应用高效液相色谱法同时测定康艾注射液中间产品人参提取液中有效成分人参皂苷Re、Rg1含量的方法与人参提取液的指纹图谱。方法色谱柱为岛津VP-ODS(4.6150 mm,5μm);流动相:乙腈-0.05%磷酸溶液(20∶80);流速:1 mL/min;柱温:30℃;检测波长:203 nm;结果a.人参皂苷Rg1在0.0207~0.6608μg范围内呈良好线性关系,r=0.9998;平均回收率为99.80%,RSD为2.02%;b.人参皂苷Re在0.0204~0.6120μg范围内呈良好线性关系,r=0.9992;平均回收率为102.66%,RSD为1.06%。建立了人参提取液的HPLC指纹图谱,指定了7个共有峰,8批样品相似度均在0.85以上。结论该方法简单、准确并且专属性强。

关 键 词:人参提取液  高效液相色谱法  含量测定  指纹图谱

Study on the Determination of Main Components in Ginseng Extract of Kangai Injection and HPLC Fingerprint
Authors:LI Jian-ying  LI Xiao-tong  WENG Hong  WANG Dao-Xin  Qi Yu-Xiang  WANG Bo  MI Guangming
Institution:(Changbaishan Pharmaceutical co.,ltd jilin jilin 132500;Yanbian University,jilin yanbian 133002)
Abstract:Objective Determination of Ginsenoside IV in astragalus extract of Kangai injection by HPLC and fingerprint of Ginsenoside Re、Rg1 extract.Methods The chromatographic column is Shimadzu VP-ODS(4.6×50mm,5um);mobile phase:(32:68);flow rate:1mL/min;column temperature:30℃;detection wavelength:205nm;Results Astragaloside IV showed a good linear relationship in the range of 0.4024~12.8768ug,r=0.9991;The average recovery was 100.68%,and the RSD was 1.45%.The common mode of HPLC fingerprints of the intermediate product of Astragalus membranaceus extract of Kangai injection was established,and the similarity comparison analysis of the intermediate product of Astragalus membranaceus extract of Kangai injection was performed.Conclusion This method is simple,accurate and specific.It is suitable for the quality control of Kangai injection intermediate products.
Keywords:Ginsenoside Extract  HPLC  Assay  Fingerprint
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