天癸苁盈颗粒质量标准研究  

Research on quality standard of Tiangui Congying Granules

作　　者：王珊珊 张哲 夏忠庭 张敏 胡开永 刘军 李艳英 黄能听 WANG Shanshan;ZHANG Zhe;XIA Zhongting;ZHANG Min;HU Kaiyong;LIU Jun;LI Yanying;HUANG Nengting(Increasepharm(Tianjin)Company Limited,Tianjin 300382,China;Shanghai Dinghui Pharmaceutical Corporation Limited,Shanghai 201400,China;Beijing Increasepharm Corporation Limited,Beijing 102200,China)

机构地区：[1]盈科瑞(天津)创新医药研究有限公司,天津300382 [2]上海鼎辉医药有限公司,上海201400 [3]北京盈科瑞创新医药股份有限公司,北京102200

出　　处：《中国当代医药》2024年第15期18-23,共6页China Modern Medicine

基　　金：天津市“科技助力经济2020”重点专项项目(SQ2020YFF0409431)。

摘　　要：目的建立天癸苁盈颗粒的质量标准。方法采用薄层色谱(TLC)对天癸苁盈颗粒中肉苁蓉、百合、刘寄奴和女贞子进行定性鉴别;应用高效液相色谱-二极管阵列检测器(HPLC-DAD)双波长法,同时测定松果菊苷、特女贞苷的含量;检测波长为330 nm(松果菊苷)、224 nm(特女贞苷),柱温35℃;进样量:10μl。结果TLC鉴别图谱中斑点清晰,分离度良好且阴性色谱无干扰;松果菊苷在0.1040~2.6000μg之间进样量与峰面积线性关系良好(r=0.9999),特女贞苷在0.1226~3.0650μg之间进样量与峰面积线性关系良好(r=1.0000),平均加样回收率分别为97.52%,104.44%,RSD均小于3.0%。结论所建立的质量标准方法专属性强,稳定性好,准确度高且耐用性良好,可用于天癸苁盈颗粒的质量控制。Objective To establish the quality standard of Tiangui Congying Granules.Methods Cistanche deserticola,lily,artemisia anomala and fruit of glossy privet in Tiangui Congying Granules were identified by thin layer chromatography(TLC).High performance liquid chromatography-diode-array detector(HPLC-DAD)was used to simultaneously determine the contents of echinacin and ligustrin.Acetonitrile-0.1%phosphoric acid as mobile phase for gradient elution,and the detection wavelength were 330 nm(echinacea)and 224 nm(ligustrin)respectively.And the column temperature was 35℃.Injection volume was 10μl.Results The spots in TLC identification chromatogram were clear,the resolution was good,and the negative chromatogram had no interference.The linear relationship between the injection volume and the peak area of echinacin was good between 0.1040μg and 2.600μg(r=0.9999).The linear relationship between the injection volume and the peak area of ligustroside was good between 0.1226μg and 3.0650μg(r=1.0000).Echinacin and ligustrin of the average sample recovery were 97.52%and 104.44%respectively,the RSD were less than 3.0%.Conclusion The established quality standard method has strong specificity,good stability,high accuracy and good durability,and it is used for the quality control of Tiangui Congying Granules.

关 键 词：天癸苁盈颗粒 特女贞苷 松果菊苷 薄层色谱 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]