摘要
目的:建立同仁大活络丸指纹图谱和多指标成分含量测定方法,并应用于10批次同仁大活络丸成品质量检测分析。方法:采用UPLC-DAD多波长分析方法,使用Waters CORTECS T3色谱柱(100 mm×2.1 mm,1.6μm),以乙腈-0.3%磷酸水为流动相,梯度洗脱,流速0.4 mL·min^(-1),柱温38℃,检测波长为195 nm(天麻素、麻黄碱、葛根素、苯甲酸、二苯乙烯苷、黄芩苷、丁香酚)和250 nm(小檗碱、甘草酸)。结果:所建立的指纹图谱和指标性成分含量测定分析方法稳定可行。10批次同仁大活络丸成品指纹图谱相似度均大于0.9,其中9个指标性成分含量测定回收率范围92.7%~104.4%;含量范围:天麻素0.083~0.111 mg·g^(-1),麻黄碱0.080~0.163 mg·g^(-1),葛根素0.271~0.366 mg·g^(-1),苯甲酸1.414~2.070 mg·g^(-1),二苯乙烯苷0.302~0.608 mg·g^(-1),黄芩苷0.782~1.390 mg·g^(-1),小檗碱0.630~0.888 mg·g^(-1),丁香酚0.619~0.846 mg·g^(-1),甘草酸0.354~0.762 mg·g^(-1)。结论:所建立的同仁大活络丸指纹图谱和多指标成分含量测定方法准确、稳定,可用于同仁大活络丸的质量控制。
Objective:To establish the fingerprint and multi-index component determination analysis method of Tongren Dahuoluo pills,and apply it to the quality analysis of 10 batches of Tongren Dahuoluo pills.Methods:UPLC-DAD multi-wavelength analysis method was used,and a Waters CORTECS T;(100 mm×2.1 mm,1.6μm)column was used.The mobile phase was acetonitrile-0.3%phosphoric acid water with gradient elution at a flow rate of 0.4 mL·min^(-1).The column temperature was 38℃,and the detection wavelength was set at 195 nm for gastrodin,ephedrine,puerarin benzoic acid,stilbene glucoside,baicalin and eugenol,and 250 nm for berberine and glycyrrhizic acid.Results:The similarities of fingerprints of 10 batches of TRDHL were all above 0.9,and the adding standard recovery range was 92.7%-104.4%.The content ranges of 9 index components were asfollows:gastrodin 0.083-0.111 mg·g^(-1),ephedrine 0.080-0.163 mg·g^(-1),puerarin 0.271-0.366 mg·g^(-1),benzoic acid 1.414-2.070 mg·g^(-1),stilbene glucoside 0.302-0.608 mg·g^(-1),baicalin 0.782-1.390 mg·g^(-1),berberine 0.630-0.888 mg·g^(-1),eugenol 0.619-0.846 mg·g^(-1)and glycyrrhizic acid 0.354-0.762 mg·g^(-1).Conclusion:The established fingerprint analysis combined with multi-index content determination method is stable and feasible,which can be used for the quality control of Tongren Dahuoluo pills.
作者
彭平
杜菁
王志斌
张蓓
秦晨
易剑平
PENG Ping;DU Jing;WANG Zhi-bin;ZHANG Bei;QIN Chen;YI Jian-ping(Beijing Tongrentang Co.,Ltd.,Beijing 100079,China)
出处
《药物分析杂志》
CAS
CSCD
北大核心
2022年第4期590-597,共8页
Chinese Journal of Pharmaceutical Analysis
基金
国家科学技术部-国家重点研发计划
黄连大品种开发-子课题四(2017YFC1702604)。
关键词
同仁大活络丸
天麻素
麻黄碱
葛根素
黄芩苷
小檗碱
二苯乙烯苷
丁香酚
甘草酸
苯甲酸
指纹图谱
含量测定
Tongren Dahuoluo pills
gastrodin
ephedrine
puerarin benzoic acid
stilbene glucoside
baicalin
berberine
eugenol
glycyrrhizic acid
fingerprint
content determination
