基于血清药物化学的经典名方清金化痰汤关键质量属性研究  

Study on critical quality attributes of Qingjin Huatan Decoction based on serum pharmacochemistry

作　　者：刘建庭 赵鸿鹏 朱强[4] 张洪兵[1] 李翔宇[4] 韩彦琪[1] 王权 许浚[1,2] 张铁军[1,2] LIU Jian-ting;ZHAO Hong-peng;ZHU Qiang;ZHANG Hong-bing;LI Xiang-yu;HAN Yan-qi;WANG Quan;XU Jun;ZHANG Tie-jun(Tianjin Key Laboratory of Quality Marker of Traditional Chinese Medicine,Tianjin Institute of Pharmaceutical Research,Tianjin 300301,China;State Key Laboratory of Drug Release Technology and Pharmacokinetics,Tianjin Institute of Pharmaceutical Research,Tianjin 30301,China;Tianjin University of Traditional Chinese Medicine,Tianjin 301617,China1;Anhui Jiren Pharmaceutical Co.,Ltd.,Bozhou 236800,China)

机构地区：[1]天津药物研究院天津市中药质量标志物重点实验室,天津300301 [2]天津药物研究院释药技术与药代动力学国家重点实验室,天津300301 [3]天津中医药大学,天津301617 [4]安徽济人药业有限公司,安徽亳州236800

出　　处：《中国中药杂志》2022年第5期1392-1402,共11页China Journal of Chinese Materia Medica

基　　金：国家“重大新药创制”科技重大专项(2018ZX09721004-006);国家中医药国际合作专项(0610-2040NF020928);国家自然科学基金项目(81830111)。

摘　　要：清金化痰汤是具有清热润肺、化痰止咳功效的经典名方,为了探究清金化痰汤的关键质量属性,采用超高效液相色谱-四极杆飞行时间质谱法(UPLC-Q-TOF-MS)对清金化痰汤的体内成分进行研究。采用Acquity UPLC BEH C_(18)色谱柱(2.1 mm×100 mm,1.7μm),流动相为0.1%甲酸乙腈(A)-0.1%甲酸水溶液(B),梯度洗脱,流速0.2 mL·min^(-1),柱温30℃,进样量5μL。采用电喷雾离子源,正、负离子模式扫描,毛细管电压正离子模式3 kV,负离子模式2 kV,离子源温度110℃,锥孔电压30 V,锥孔流量50 L·h^(-1),氮气脱气温度350℃,脱气体积流量800 L·h^(-1),扫描范围m/z 50~2000。在大鼠血浆样品中鉴定出66个清金化痰汤相关成分,包括22个原型成分和44个代谢产物。该实验初步揭示了清金化痰汤的体内药效物质基础,为清金化痰汤物质基准研究及新药开发奠定基础。Qingjin Huatan Decoction is a classic prescription with the effects of clearing heat,moistening lung,resolving phlegm,and relieving cough.In order to explore the critical quality attributes of Qingjin Huatan Decoction,we identified the blood components of Qingjin Huatan Decoction by ultra-performance liquid chromatography quadrupole time of flight mass spectrometry(UPLC-Q-TOF-MS)under the following conditions,chromatographic column:Acquity UPLC BEH C_(18) column(2.1 mm×100 mm,1.7μm);mobile phase:0.1%formic acid acetonitrile(A)-0.1%formic acid in water(B);gradient elution;flow rate:0.2 mL·min^(-1);column temperature:30℃;injection volume:5μL.The electrospray ionization(ESI)source was used to collect data in both positive and negative ion modes under the following conditions,capillary voltage:3 kV for the positive ion mode and 2 kV for the negative ion mode;ion source temperature:110℃;cone voltage:30 V;cone gas flow rate:50 L·h^(-1);nitrogen degassing temperature:350℃;degassing volume flow rate:800 L·h^(-1);scanning range:m/z 50-2000.In this experiment,a total of 66 related components of Qingjin Huatan Decoction were identified,including 22 prototype components and 44 metabolites.The results of this study preliminarily revealed the pharmacodynamic material basis of Qingjin Huatan Decoction in vivo,which has provided an experimental basis for the determination of quality markers of Qingjin Huatan Decoction and the development of new drugs.

关 键 词：清金化痰汤 血清药物化学 关键质量属性 

分 类 号：R284[医药卫生—中药学]