双黄连吸入溶液UPLC指纹图谱及含量测定研究  

Study on UPLC fingerprint and determination of Shuanghuanglian solution for inhalation

作　　者：尹睿卓 胡杰 王慧阳 周舟 马新称 邓远锋 王雪花 李翠 YIN Ruizhuo;HU Jie;WANG Huiyang;ZHOU Zhou;MA Xincheng;DENG Yuanfeng;WANG Xuehua;LI Cui(Increasepharm(Hengqin)Institute,Zhuhai 519000,China;Beijing Increasepharm Corporation Limited,Beijing 100000,China;Guangdong engineering technology research center of solution for inhalation,Zhuhai 519000,China;Jinan University,Guangzhou 510632,China)

机构地区：[1]盈科瑞(横琴)药物研究院有限公司,广东珠海519000 [2]北京盈科瑞创新医药股份有限公司,北京100000 [3]广东省雾化吸入制剂工程技术研究中心,广东珠海519000 [4]暨南大学,广东广州510632

出　　处：《广东药科大学学报》2021年第3期82-87,共6页Journal of Guangdong Pharmaceutical University

基　　金：国家科技重大专项项目(2017ZX09201002-008);珠海市科技创新局资助项目(ZH22046301200035PWC)。

摘　　要：目的建立双黄连吸入溶液UPLC指纹图谱,并同时测定新绿原酸、绿原酸、隐绿原酸、异绿原酸B、3,5-二-O-咖啡酰奎宁酸、4,5-二-O-咖啡酰奎宁酸、连翘苷7种活性成分的含量。方法采用Agilent 1290超高效液相色谱仪,以黄芩苷为参照物在210 nm波长下建立双黄连吸入溶液指纹图谱;在324 nm波长下对新绿原酸、绿原酸、隐绿原酸、异绿原酸B、3,5-二-O-咖啡酰奎宁酸、4,5-二-O-咖啡酰奎宁酸的含量进行测定,210 nm波长下对连翘苷含量进行测定。结果建立了10批双黄连吸入溶液UPLC指纹图谱,标定了17个共有指纹峰,与对照指纹图谱相似度均在0.90以上;新绿原酸、绿原酸、隐绿原酸、异绿原酸B、3,5-二-O-咖啡酰奎宁酸、4,5-二-O-咖啡酰奎宁酸、连翘苷在相应的浓度范围内线性关系良好,r>0.9995,平均加样回收率分别为97.08%、99.91%、100.9%、102.5%、93.96%、103.4%、100.7%。结论本研究将UPLC指纹图谱定性与多指标成分定量技术相结合,该方法准确、快捷、可行,可为双黄连吸入溶液的质量控制提供实验依据。Objective To establish the UPLC fingerprint of Shuanghuanglian solution for inhalation and determine the contents of seven active ingredients ie.,neochlorogenic acid,chlorogenic acid,cryptochlorogenic acid,isochlorogenic acid B,isochlorogenic acid A,isochlorogenic acid C and forsythin.Methods The fingerprint of Shuanghuanglian solution for inhalation was established by Agilent 1290 Ultra-high performance liquid chromatography with Baicalin as reference at 210 nm.The neochlorogenic acid,chlorogenic acid,cryptochlorogenic acid,isochlorogenic acid B,isochlorogenic acid A and isochlorogenic acid C were determined at 324 nm and forsythin was determined at 210 nm.Results The UPLC fingerprints of 10 batches of Shuanghuanglian solution for inhalation were established,17 common peaks were identified with similarity of more than 0.90.The neochlorogenic acid,chlorogenic acid,cryptochlorogenic acid,isochlorogenic acid B,isochlorogenic acid A,isochlorogenic acid C had a good linear relationship in the corresponding concentration range,r>0.9995,and the average recoveries were 97.08%,99.91%,100.9%,102.5%,93.96%,103.4%and 100.7%.Conclusion The established method is accurate,rapid and accurate,which can provide an experimental basis for the quality control of the Shuanghuanglian solution for inhalation.

关 键 词：双黄连吸入溶液 UPLC法 指纹图谱 双波长测定 含量测定 

分 类 号：R927.2[医药卫生—药学]