UPLC/MS/MS法同时测定肾衰宁胶囊中9种成分及一致性分析  

Simultaneous determination of nine constituents in Shenshuining Capsules by UPLC/MS/MS and consistency analysis

作　　者：孙慧珠 王晓蕾 刘永利 SUN Hui-zhu;WANG Xiao-lei;LIU Yong-li(Hebei Provincial Institute for Drug and Medical Device Control,Shijiazhuang 050227,China)

机构地区：[1]河北省药品医疗器械检验研究院,河北石家庄050227

出　　处：《中成药》2023年第1期29-34,共6页Chinese Traditional Patent Medicine

基　　金：国家科技重大专项(2019ZX09201004⁃002);上海市科委科技创新项目(20S21902500);上海市中医药事业发展三年行动计划[ZY(2018⁃2020)⁃CCCX⁃2001⁃04]。

摘　　要：目的建立UPLC/MS/MS法同时测定肾衰宁胶囊中甘草苷、β-蜕皮甾酮、橙皮苷、丹酚酸B、太子参环肽B、人参皂苷Ro、甘草香豆素、甘草次酸、甘草酸的含量,并进行一致性分析。方法该药物90%甲醇(含0.5%甲酸)提取液的分析采用Waters BEH C_(18)色谱柱(1.7μm,2.1 mm×100 mm);流动相乙腈-0.1%甲酸(含5 mmol/L乙酸铵),梯度洗脱;体积流量0.3 mL/min;柱温30℃;电喷雾离子源;负离子检测;多反应监测模式。采用箱式图对29批样品一致性进行评价。结果9种成分在各自范围内线性关系良好(r>0.9900),平均加样回收率92.8%~111.0%,RSD 2.0%~9.2%。不同批次样品中各成分含量稳定。结论该方法准确可靠,可用于肾衰宁胶囊的质量控制。AIM To establish a UPLC/MS/MS method for the simultaneous content determination of glycyrrhizin,β-ecdysterone,hesperidin,salvianolic acid B,heterophyllin B,ginsenoside Ro,glycyrrhizin,glycyrrhetinic acid and glycyrrhizic acid in Shenshuining Capsules and to make consistency analysis.METHODS The analysis of 90%methanol(containing 0.5%formic acid)extract of this drug was performed on a 30℃thermostatic Waters BEH C_(18) column(1.7μm,2.1 mm×100 mm),with the mobile phase comprising of acetonitrile-0.1%formic acid(including 5 mmol/L ammonium acetate)flowing at 0.3 mL/min in a gradient elution manner,and electron spray ionization source was adopted in negative ion detection with multiple reaction monitoring mode.The consistency of twenty-nine batches of samples were evaluated by box plot.RESULTS Nine constituents showed good linear relationships within their own ranges(r>0.9900),whose average recoveries were 92.8%-111.0%with the RSDs of 2.0%-9.2%.Stable contents of various constituents were observable in different batches of samples.CONCLUSION This accurate and reliable method can be used for the quality control of Shenshuaining Capsules.

关 键 词：肾衰宁胶囊 化学成分 UPLC/MS/MS 一致性 

分 类 号：R927.2[医药卫生—药学]