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金芪降糖胶囊多成分含量研究

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金芪降糖胶囊(JQJTC)临床上常用于2型糖尿病的预防与治疗,但其中主要的化学成分含量尚不清楚。本研究首先建立JQJTC中新绿原酸、绿原酸、隐绿原酸、芒柄花素、芒柄花苷、毛蕊异黄酮、毛蕊异黄酮苷、黄芪甲苷、小檗碱、表小檗碱、小檗红碱、黄连碱、药根碱、巴马汀、木兰花碱的超高效液相-串联质谱联用的含量测定方法,再采用所建立的方法测定JQJTC中15种成分的含量,并考察辅料对JQJTC多成分含量的影响。使用ACQUITYUPLC BEH C18(100 mm × 2。1 mm,1。7 μm)色谱柱,流动相为0。1%乙酸-5 mmol·L-1乙酸铵水溶液(A)-乙腈(B),流速0。3 mL·min-1,柱温40 ℃,采用电喷雾离子源,在正离子模式下进行检测。结果显示建立的方法符合中国药典含量测定方法学的要求;所检测的15种成分在JQJTC中含量高低不等,含量前5位依次是小檗碱、绿原酸、巴马汀、黄连碱、隐绿原酸,共占87。31%;未含辅料全方提取物中黄连生物碱类(小檗碱、表小檗碱、小檗红碱、黄连碱、药根碱、巴马汀、木兰花碱)和金银花有机酸类(新绿原酸、绿原酸、隐绿原酸)成分含量显著低于胶囊内容物含量,这10种成分含量占测定成分总含量的99。20%。本研究建立了准确、灵敏和高效的JQJTC多成分超高效液相色谱-串联质谱测定方法,稳定可靠地检测了胶囊中15种成分含量,可为更全面的质量分析提供基础;并发现辅料可使测定的生物碱类和有机酸类成分含量增加,这可能有利于胶囊整体药效的发挥。
Study on multi-component contents of Jinqi Jiangtang Capsule
Jinqi Jiangtang Capsule(JQJTC)is clinically used for the prevention and treatment of type 2 diabetes,but the contents of its main chemical components are not yet clear.In this study,an ultra-high-performance liquid chromatography-tandem mass spectrometry(UHPLC-MS/MS)method was established for the determination of 15 components in JQJTC,including new chlorogenic acid,chlorogenic acid,cryptochlorogenic acid,formononetin,ononin,calycosin,calycosin-7-glucoside,astragaloside IV,berberine,epiberberine,berberrubine,coptisine,jatror-rhizine,palmatine and magnoflorine.The method was used to determine the contents of 15 components in the capsule and then to investigate the influence of excipients on the contents of the components in JQJTC.The separa-tion was performed on a ACQUITY UPLC BEH C18 column(100 mm × 2.1 mm,1.7 μm)with a mobile phase consisting of 0.1%acetic acid and 5 mmol·L-1 ammonium acetate(A)and acetonitrile(B)with gradient elution at a flow rate of 0.3 mL·min-1 and a column temperature at 40 ℃.Electron spray ionization was used for mass spec-trometry in positive ion mode.The established method meets the requirements of methodology of content determi-nation in Chinese pharmacopoeia.The contents of 15 components in JQJTC varied from high to low.The top 5 contents were berberine,chlorogenic acid,magnoflorine,coptisine,and cryptochlorogenic acid,accounting for 87.31%of the total content.The contents of 10 components,including the alkaloids of coptidis rhizoma(berberine,epiberberine,berberrubine,coptisine,jatrorrhizine,palmatine and magnoflorine)and the organic acids of honey-suckle(new chlorogenic acid,chlorogenic acid,and cryptochlorogenic acid)in the whole formula extract without excipients was significantly lower than that in the capsule.These components accounted for 99.20%of the deter-mined component contents.In this experiment,an accurate,sensitive and efficient UHPLC-MS/MS method for the determination of multi-components in JQJTC was established,which stably and reliably detected the contents of 15 components in the capsule and could provide the basis for more comprehensive quality analysis.It was also found that excipients had an increasing effect on the contents of detected alkaloid and organic acid components,which may be beneficial to the effectiveness of the capsules.

Jinqi Jiangtang Capsulemulti-component contentexcipientultra performance liquid chroma-tography-tandem mass spectrometry

田甜、石荣、吴家胜、王天明、李建国、夏国凤、李安宁、李园园、马越鸣

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上海中医药大学中药学院,上海 201203

上海中医药大学科技实验中心,上海 201203

吉林敖东延边药业股份有限公司,吉林延边 133700

金芪降糖胶囊 多成分含量 辅料 超高效液相色谱-串联质谱

上海中医药大学基金会项目

202301003

2024

药学学报
中国药学会 中国医学科学院药物研究所

药学学报

CSTPCD北大核心
影响因子:1.274
ISSN:0513-4870
年,卷(期):2024.59(10)