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Early determination of quality fluctuation of herbal injection by chromatographic coupled with biothermodynamic fingerprinting

Early determination of quality fluctuation of herbal injecti...

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第十一届全国青年药学工作者最新科研成果交流会

作者： Dan Yan a,Yong-shen Ren a,b,Ping Zhang a,c,Jia-bo Wang a,Xiao-xi Du d,Xiao-he Xiao a a Military Institute of Chinese Materia Medica,302th Military Hospital of China,Beijing 100039,China b College of Pharmacy,Chengdu University of Traditional Chinese Medicine,Chengdu 610075,China c Postgraduate Team,Military Medical Postgraduate School of China,Beijing 100853,China d Center for Drug Reevaluation,State Food and Drug Administration,Beijing 100045,China

herbal injection is one of the most powerful preparations of modern Traditional Chinese Medicine;however the quality control of it is fairly difficult for their complicated ***,chromatographic fingerprint（CF） has been recommended as a potential strategy for the quality control of herbal injection,nevertheless there are still various substances absent from the inspection of chromatographic method for no spectrum absorption,which might cause grievous drug-induced *** establish a comprehensive and early prediction security control process,biothermodynamic fingerprint（BF） was adopted as a complement for CF to detection the quality fluctuation of herbal injection from both chemical and bioactive *** this work,Yinzhihuang injection（YZHI） was selected as a representative of herbal injection,10 batches of normal samples and 6 batches of artificial abnormal samples were collected,high performance liquid chromatography and Thermal Active Monitor were applied to develop their CF and BF *** results showed that the CF and BF of normal samples were similar with good stability and consistence;however the abnormal samples deviated from *** abnormal samples could be correctly distinguished when coupled CF with BF,the recognition ratio was higher than CF and BF respectively,and the key factors of quality fluctuation extent could be ordered as bacterial contamination,high temperature,lighting and sterilizing *** established method could be used for early prediction adverse drug events,which would be potentially helpful to improve the safety level of herbal injection in clinical application.

关键词： herbal injection Yinzhihuang injection quality fluctuation chromatographic fingerprinting biothermodynamic fingerprinting

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