摘要
目的 建立痰热清注射液(黄芩、金银花、连翘等)特征图谱,并测定野黄芩苷、黄芩苷、千层纸素-7-O-葡萄糖醛酸苷、白杨素-7-O-葡萄糖醛酸苷含量。方法 该药物的分析采用Diamonsil Plus C_(18)色谱柱(4.6 mm×250 mm,5μm);流动相乙腈-0.1%甲酸,梯度洗脱;体积流量0.8 mL/min;柱温25℃;检测波长280 nm。以黄芩苷为内标,建立其他3种成分的相对校正因子,一测多评法计算其含量。结果 33批样品特征图谱中有12个共有峰,相似度均大于0.97。4种成分在各自范围内线性关系良好(r=1.000 0),平均加样回收率96.2%~102.4%,RSD 0.7%~1.8%。一测多评法所得结果(千层纸素-7-O-葡萄糖醛酸苷、白杨素-7-O-葡萄糖醛酸苷含量)与外标法接近。结论 该方法稳定可靠,可用于痰热清注射液的质量控制。
AIM To establish the characteristic chromatogram for Tanreqing Injection(Scutellariae Radix,Lonicerae japonicae Flos,Forsythiae Fructus,etc.) and to determine the contents of scutellarin,baicalin,oroxylin A-7-O-glucoronide and chrysin-7-O-glucoronide.METHODS The analysis of this drug was performed on a 25 ℃ thermostatic Diamonsil Plus C_(18) column(4.6 mm×250 mm,5 μm),with the mobile phase comprising of acetonitrile-0.1% formic acid flowing at 0.8 mL/min in a gradient elution manner,and the detection wavelength was set at 280 nm.Baicalin was used as an internal standard to calculate the relative correction factors of the other three constituents,after which the content determination was made by quantitative analysis of multi-components by single-marker(QAMS).RESULTS There were twelve common peaks in the characteristic chromatogram of thirty-three batches of samples with the similarities of more than 0.97.Four constituents showed good linear relationships within their own ranges(r=1.000 0),whose average recoveries were 96.2%-102.4% with the RSDs of 0.7%-1.8%.The results(contents of oroxylin A-7-O-glucoronide and chrysin-7-O-glucoronide) obtained by QAMS approximated those obtained by external standard method.CONCLUSION This stable and reliable method can be used for the quality control of Tanreqing Injection.
作者
张静娴
孙健
陈军
吴清臣
毛秀红
胡青
季申
ZHANG Jing-xian;SUN Jian;CHEN Jun;WU Qing-chen;MAO Xiu-hong;HU Qing;JI Shen(NMPA Key Laboratory for Quality Control of Traditional Chinese Medicine,Shanghai Institute for Food and Drug Control,Shanghai 201203,China;Shanghai Kaibao Pharmaceutical Co.,Ltd.,Shanghai 200030,China)
出处
《中成药》
CAS
CSCD
北大核心
2022年第4期1063-1070,共8页
Chinese Traditional Patent Medicine
基金
国家中药标准化项目(ZYBZH-C-SH-48)
国家重点研发计划项目(2017YFC1700800)
上海市科委研发平台专项(18DZ2292200)。
