摘要
目的:采用指纹图谱结合多成分含量测定,提升院内制剂连贯抗病毒颗粒质量标准。方法:采用HPLC-UV法,色谱柱为YMC-Pack Pro C_(18)(250 mm×4.6 mm,5μm)色谱柱,流动相为乙腈-0.2%甲酸水溶液,梯度洗脱,流速为1.0 mL·min^(-1),检测波长为280 nm,柱温35℃,进样量为10μL;建立10批次连贯抗病毒颗粒指纹图谱;同时测定了连翘酯苷A、连翘苷和咖啡酸的含量。结果:指纹图谱中,共标定了13个共有峰,指认了其中4个色谱峰,并测定连翘酯苷A、连翘苷及咖啡酸的含量分别为13.22~18.05、2.432~3.540、0.2711~0.3428 mg·g^(-1)。结论:本文通过指纹图谱定性、含量定量方式,多维度提升院内制剂连贯抗病毒颗粒的质量控制水平。
Objective:To establish quality control methods for Lianguan Antiviral granules by HPLC fingerprints and multicomponent determination.Methods:The analysis was developed on a YMC-Pack Pro C_(18)(250 mm×4.6 mm,5μm)column with the mobile phase comprising of acetonitrile-0.2%formic acid in water at 1.0 mL·min^(-1)in a gradient elution and the UV detection at 280 nm.The injection volume was 10μL.The fingerprints were constructed with 10 batches of Lianguan Antiviral granules.In addition,the contents of caffeic acid,forsythoside A and forsythin in Lianguan Antiviral granules were also determined.Results:A total of 13 common peaks were picked in the HPLC fingerprints with 4 peaks identified;and the contents of caffeic acid,forsythoside A and forsythin were in the ranges of 0.2711-0.3428,13.22-18.05 and 2.432-3.540 mg·g^(-1),respectively.Conclusion:The HPLC fingerprints and the contents determination study of Lianguan Antiviral granules will provide a scientific basis for its quality control.
作者
陆杰霖
郭曼曼
殷文娟
钱叶飞
汪怡
LU Jielin;GUO Manman;YIN Wenjuan;QIAN Yefei;WANG Yi(Kunshan Hospital of Chinese Medicine,Kunshan 245347,China;Suzhou Municipal Institute for Drug Control,Suzhou 215104,China)
出处
《药学与临床研究》
2023年第4期317-320,共4页
Pharmaceutical and Clinical Research
基金
昆山市中医医院青年科学基金项目(2020QNJJ12)。
