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作 者:张青铃 徐益清[2,3] 罗友华 杨辉 许光辉[2] 黄亦琦[2] 戚欢阳[2] 吴珏[2] ZHANG Qing-ling;XU Yi-qing;LUO You-hua;YANG Hui;XU Guang-hui;HUANG Yi-qi;QI Huan-yang;WU Jue(College of Pharmacy,Fujian University of Traditional Chinese Medicine,Fuzhou 350122,China;Xiamen Key Laboratory of Natural Medicine Research and Development,Xiamen Medicine Institute,Xiamen 361008,China;Quanzhou Chinese Medicine Hospital,Quanzhou 362000,China)
机构地区:[1]福建中医药大学药学院,福建福州350122 [2]厦门市医药研究所,厦门市天然药物研究与开发重点实验室,福建厦门361008 [3]泉州市中医院,福建泉州362000
出 处:《海峡药学》2020年第8期52-56,共5页Strait Pharmaceutical Journal
基 金:福建省医学创新课题资助(2016-CXB-16);厦门市卫生和计划生育委员会资助(厦卫科教〔2016〕469号);厦门市科技惠民项目(3502Z20164084)。
摘 要:目的建立HPLC法同步测定复方板蓝根利咽颗粒水煎液特征图谱和6个指标成分含量,为全程评价其制备过程质量提供方法。方法色谱柱为ZORBAX SB-C_(18)(4.6mm×250mm,5μm),流动相为乙腈-0.15%乙酸水溶液,梯度洗脱,多波长切换,进样量10μL,流速1.0mL·min^(-1),柱温35℃。以(R,S)-告依春为参照峰,用中药色谱指纹图谱相似度评价软件(2004A版)分析10批复方板蓝根利咽颗粒水煎液色谱图。结果建立的特征图谱包含19个共有峰,明确了6个峰的化学成分,10批水煎液HPLC图与对照特征图谱的相似度为0.924~0.988。腺苷、甘草苷、(R,S)-告依春、安格洛苷C、甘草酸铵、哈巴俄苷的线性范围分别为0.0014~0.0896、0.0016~0.0505、0.0017~0.1080、0.0011~0.0706、0.0045~0.2910、0.0027~0.1744mg·mL^(-1),平均加样回收率为96.57%~114.28%,水煎液中6个指标成分相当于每克复方饮片含量分别为0.285~0.523、0.142~0.331、0.092~0.282、0.089~0.339、0.264~0.789、0.256~0.409mg·g-1。结论建立的特征图谱及含量HPLC同步测定法稳定可行,为其工艺过程控制奠定基础。OBJECTIVE To establish a HPLC method for simultaneously determinating the specific chromatogram and six index component content of the water decoction of Compound Banlangen-LiYan Granules,and to provide a method for evaluating the quality of its whole preparation process.METHODS The column was ZORBAX SB-C 18(4.6mm×250mm,5μm),with acetonitrile-0.15%acetic acid aqueous solution as the mobile phase for gradient elution,multi-wavelength switching.The column temperature was 35℃at a flow rate of 1.0mL·min-1 and injection amount of 10μL.Taking(R,S)-epigoitrin as the reference peak,the chromatograms of 10 batches of Compound Banlangen-LiYan Granules water decoction were analyzed by the Traditional Chinese Medicine chromatographic fingerprint similarity evaluation software,2004A version.RESULTS The established specific chromatogram contained 19 common peaks and the chemical composition of the six peaks was identified.The similarities of 10 batches water decoction were 0.924~0.988.The linear ranges of adenosine,glycyrrhizin,(R,S)-epigoitrin,angloside C,ammonium glycyrrhizinate,and harpagoside were 0.0014~0.0896,0.0016~0.0505,0.0017~0.1080,and 0.0011~0.0706,0.0045~0.2910,0.0027~0.1744mg·mL-1.The average recovery rate were 96.57%~114.28%.The six components of water decoctionf in compound yinpian content were 0.285~0.523,0.142~0.331,0.092~0.282,0.089~0.339,0.264~0.789,0.256~0.409mg·g-1,respectively.CONCLUSION The established HPLC simultaneous determination method of specific chromatogram and six components of the water decoction is stable and feasible,which lays a foundation for the process control.
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