免疫增强剂三七茎叶皂苷口服液的质量控制研究  

Study on Quality Control of Immune Booster of Oral Liquid of Saponins of Stems and Leaves of Panax Notoginseng

作　　者：秦枫[1,2] 王艳 吴植[1] 吴双[1] 王安平[1] 朱善元[1] 李金贵[2] 唐楠楠 陈瑜悦 QIN Feng;WANG Yan;WU Zhi;WU Shuang;WANG Anping;ZHU Shanyuan;LI Jingui;TANG Nannan;CHEN Yuyue(Jiangsu Agri-animal Husbandry Vocational College,Jiangsu Provincial Key Laboratory of Veterinary Bio-pharmaceutical High-tech Research,Taizhou 225300,China;College of Veterinary Medicine,Yangzhou University,Yangzhou 225001,China;Agricultural Comprehensive Law Enforcement Detachment of Zaozhuang City,Shandong Province,Zaozhuang 277800)

机构地区：[1]江苏农牧科技职业学院,江苏省兽用生物制药高技术研究重点实验室,泰州225300 [2]扬州大学兽医学院,扬州225001 [3]山东省枣庄市农业综合执法支队,枣庄277800

出　　处：《中国动物传染病学报》2024年第5期55-64,共10页Chinese Journal of Animal Infectious Diseases

基　　金：江苏现代农业技术体系集成创新中心项目(JATS[2022]389);江苏省2019度高校优秀科技创新团队项目苏教科函[2019]7号;江苏农牧科技职业学院科技创新团队项目(NSF2024TC02)。

摘　　要：本研究从性状、pH、相对密度、装量差异、微生物限度、鉴别、含量测定等方面对三七茎叶皂苷口服液(Oral liquid of saponins of stems and leaves of Panax notoginseng,LSPN)进行质量控制研究。利用薄层色谱(thin layer chromatography,TLC)法,鉴定其主要成分;利用高效液相色谱-蒸发光散射(high-performance liquid chromatography with evaporative light scattering detector,HPLC-ELSD)法,建立LSPN中人参皂苷Rb1和Rb3含量的同步分析方法。HPLC-ELSD的色谱条件:色谱柱为GL,InertSustain C18柱(5μm,250×4.6 mm Column);流动相为乙腈(A)-水(B),采用梯度洗脱;进样量:10 L;人参皂苷Rb1和Rb3保留时间分别为13.264 min和15.415 min。ELSD运行参数:氮气流速为1.64 slpm,气化温度为48℃,蒸发温度为80℃。结果表明,LSPN为黄绿色的澄清液体,味苦,pH、相对密度和微生物限度均符合标准要求。人参皂苷Rb1和Rb3的检出限(limit of detection,LOD)均为10 g/mL,定量限(limit of quantitation,LOQ)均为20 g/mL,均在20~500 g/mL内线性关系良好;回归方程分别为Y=1.58X+1.72(r=0.999904)和Y=1.60X+1.64(r=0.999628)。人参皂苷Rb1和Rb3的平均加样回收率分别为101.25%和100.42%,RSD分别为2.71%和1.12%。该法准确,精密度、重现性好,可用于LSPN中人参皂苷Rb1和Rb3的含量测定。In order to control the quality of LSPN,the quality of LSPN was controlled from the aspects of character,pH,relative density,loading difference,microbial limit,identification and content determination.Thin layer chromatography(TLC)was used to identify the main components of ginsenosides in LSPN.High-performance liquid chromatography with evaporative light scattering detector(HPLC-ELSD)was used to establish a method for simultaneous determination of ginsenosides Rb1 and Rb3 in LSPN.Chromatographic conditions of HPLC-ELSD:GL Column,Inert Sustain C18 Column(5μm,250×4.6 mm Column);The mobile phase consisted of acetonitrile(A)-water(B);The retention time of ginsenoside Rb1 and ginsenoside Rb3 was 13.264 min and 15.415 min,respectively.ELSD parameters:the nitrogen fl ow rate is 1.64 slpm,the gasifi cation temperature is 80ºC,and the evaporation temperature is 80ºC.The results showed that its properties are yellowish-green clarifi ed liquid,bitter taste,pH,relative density,loading diff erence,microbial limit all meet the requirements and the limit of detection(LOD)and limit of quantitation(LOQ)of ginsenoside Rb1 and Rb3 were both 10 g/mL and 20 g/mL.When ginsenoside Rb1 was 20-500 g/mL,the linear relationship was good,and the regression equation was Y=1.58X+1.72(r=0.999904).When ginsenoside Rb3 was 20-500 g/mL,the linear relationship was good,and the regression equation was:Y=1.60+1.64X(r=0.999628).The average recoveries of ginsenoside Rb1 and ginsenoside Rb3 were 101.25%and 100.42%,with RSD of 2.71%and 1.12%,respectively.The method is accurate,precise and reproducible,and can be used for the determination of ginsenoside Rb1 and ginsenoside Rb3 in the oral liquid of Panax notoginseng.

关 键 词：三七茎叶皂苷口服液 薄层色谱 高效液相色谱-蒸发光散射 

分 类 号：S853.73[农业科学—临床兽医学]