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作 者:谭友莉[1] 王强[1] 巨少华[1] 高必兴 王明建[1] 程真真 TAN Youli;Wang qiang;JU Shaohua;GAO Bixing;WANG Mingjian;Cheng zhenzhen(Affiliated Sport Hospital of CDSU,Chengdu 610041,China;Sichuan Institute for Drug Control/NMPA Key Laboratory for Quality Evaluation of Traditional Chinese Medicine,Chengdu 610045,China)
机构地区:[1]成都体育学院附属体育医院,四川成都610041 [2]四川省药品检验研究院/国家药品监督管理局中成药质量评价重点实验室,四川成都610045
出 处:《基层中医药》2023年第9期95-102,共8页Basic Traditional Chinese Medicine
基 金:四川省中医药管理局科学技术研究专项课题(2023MS271);成都体育学院附属体育医院临床创新课题(LCCX22B02);成都体育学院附属体育医院中药协定方剂项目(ZYXD20B02)。
摘 要:目的 建立新伤二号汤的高效液相色谱法(HPLC)指纹图谱及其5种指标性成分含量测定方法,为新伤二号汤的质量控制提供参考。方法 通过HPLC建立新伤二号汤的指纹图谱,采用HPLC法对新伤二号汤样品多指标成分进行含量测定。结果 建立了新伤二号汤的指纹图谱,测定10批新伤二号汤样品,相似度均大于0.9;在指纹图谱上共标定13个共有峰,指认出5个共有峰(阿魏酸、甘草苷、盐酸小檗碱、肉桂酸及甘草酸铵)。阿魏酸、甘草苷、盐酸小檗碱、肉桂酸及甘草酸铵含量分别为:0.029~0.040 mg/m L、 0.327~0.516 mg/m L、 0.069~0.163mg/m L、0.031~0.069 mg/m L、 0.192~0.545 mg/m L。结论 建立的新伤二号汤HPLC指纹图谱特征性强,结合多指标成分含量测定能较好地控制新伤二号汤质量,方法简便可靠,重复性好,可为其后期制剂开发和质量控制提供参考。Objective To establish the HPLC fingerprint of Xinshang Erhaotang(XSEHT)and determine the content of five index components,so as to provide a basis for the quality control of XSEHT.Methods The high performance liquid chromatography(HPLC)was employed to establish the fingerprint of XSEHT and determine the content of index components.Results The fingerprints of 10 batches of XSEHT samples showed the similarity greater than 0.9.Thirteen common peaks were identified on the fingerprint,among which 5 common peaks were identified as ferulic acid,liquiritin,berberine chloride,cinnamic acid,and ammonium glycyrrhetate.The content of ferulic acid,glycyrrhizin,berberine hydrochloride,cinnamic acid,and ammonium glycyrrhetate was 0.029-0.040,0.327-0.516,0.069-0.163,0.031-0.069,and 0.192-0.545 mg/mL,respectively.Conclusion The established HPLC fingerprint of XSEHT has strong characteristics,which,combined with the content of index components,can well control the quality of XSEHT.This method,with simple operation,reliable results,and high repeatability,can provide a reference for the preparation development and quality control of XSEHT.
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