通络生骨胶囊原粉化学成分鉴定及牡荆苷含量测定  

Identification of chemical components and determination of vitexin in the raw powder of Tongluo Shenggu capsule

作　　者：吴革林 范瑞鑫 梁楚玲 邢冷 谢永建 龚平 周鹏 李博 WU Gelin;FAN Ruixin;LIANG Chuling;XING Leng;XIE Yongjian;GONG Ping;ZHOU Peng;LI Bo(Zhejiang Pralife Pharmaceutical Co.,Ltd.,Taizhou 318000;Hangzhou Zansheng Pharmaceutical Co.,Ltd.,Hangzhou 310052;China Pharmaceutical University Hangzhou Institute of Innovative Pharmaceutics,Hangzhou 310018;School of Pharmacy,China Pharmaceutical University,Nanjing 211198,China)

机构地区：[1]浙江赞生药业有限公司,台州318000 [2]杭州赞生医药有限公司,杭州310052 [3]中国药科大学(杭州)创新药物研究院,杭州310018 [4]中国药科大学药学院,南京211198

出　　处：《中国药科大学学报》2025年第2期166-175,共10页Journal of China Pharmaceutical University

摘　　要：采用UPLC-MS/MS对通络生骨胶囊原粉中的化合物进行分析鉴定,并建立牡荆苷HPLC含量测定方法。通过采用Acquity UPLC■BEH C_(18)(2.1 mm×100 mm,1.7μm)色谱柱,以0.2%甲酸-甲醇为流动相进行梯度洗脱,柱温30℃,流速0.3 mL/min,进样量1μL;通过ESI质谱源,在正、负离子模式下分别采集数据,成功鉴定出通络生骨胶囊原粉中的12个黄酮类和3个芪类化合物。同时,采用XBridge C_(18)(4.6 mm×250 mm,5µm)色谱柱,以0.05%冰醋酸-甲醇为流动相进行梯度洗脱,柱温30℃,流速1.0 mL/min,进样量20µL,建立了牡荆苷的HPLC含量测定方法。该方法在10~40µg/mL范围内线性关系良好(R=1.000),平均回收率为96.7%。这些方法的建立为通络生骨胶囊原粉的质量控制和开发利用提供了科学依据。The present study employed UPLC-MS/MS to analyze and identify compounds in the raw powder of Tongluo Shenggu capsules.An HPLC method for the determination of vitexin content was established.The analysis of this drug was performed on a 30℃ thermostatic Acquity UPLC■BEH C_(18)(2.1 mm×100 mm,1.7μm)column,with the mobile phase comprising 0.2% formic acid-methanol flowing at 0.3 mL/min in a gradient elution manner.Mass spectrometry was detected by ESI sources in both positive and negative ion modes for qualitative identification of chemical constituents.12 flavonoid and 3 stilbenes compounds in the raw powder of Tongluo Shenggu capsules were successfully identified.Additionally,an HPLC method for the determination of vitexin content was established using a XBridge C_(18) column(4.6 mm×250 mm,5μm)with a mobile phase of 0.05% glacial acetic acid in methanol for gradient elution,at a column temperature of 30℃,a flow rate of 1.0 mL/min,and an injection volume of 20μL.The method demonstrated good linearity in the concentration range of 10μg/mL to 40μg/mL(R=1.000)with an average recovery rate of 96.7%.The establishment of these methods provides a scientific basis for the quality control and development of the raw powder of Tongluo Shenggu capsules.

关 键 词：通络生骨胶囊 化学成分 UPLC-MS/MS 牡荆苷 HPLC 

分 类 号：R917[医药卫生—药物分析学]