中国药业2025，Vol.34Issue(8)：86-90,5.DOI:10.3969/j.issn.1006-4931.2025.08.020
妇炎康复片中藏柴胡掺伪检查方法的建立
Establishment of Identification Method for Adulterated Bupleurum marginatum in Fuyan Kangfu Tablets
摘要
Abstract
Objective To establish a detection method for identifying adulterated Bupleurum marginatum in Fuyan Kangfu Tablets.Methods The ultra-high-performance liquid chromatography-triple quadrupole mass spectrometry was used to determine the contents of nepasaikosaponin K in the samples.The chromatography column was the Waters CORTECS® C18 column(150 mm×3.0 mm,2.7 μm),the mobile phase was 0.1%formic acid aqueous solution-0.1%formic acid in acetonitrile solution(70∶30,V/V),the flow rate was 0.25 mL/min,the column temperature was 40℃,and the injection volume was 5 μL.The mass spectrometer was operated in negative ionization mode with multiple reaction monitoring(MRM),with m/z 943.5 → 797.4 as the quantitative ion pair.Results The linear ranges of nepasaikosaponin K was in the range of 0.010-10.026 μg/mL(r=0.999 19).The limit of detection was 0.040 μg/mL and the limit of quantification was 0.12 μg/mL.The RSDs of precision,stability and repeatability tests were all lower than 4.0%.The average recovery rates of the above four components was 84.61%,with RSD of 5.19(n=9).The specification for nepasaikosaponin K was established at 35.0 μg/g as the acceptable threshold.The content of nepasaikosaponin K in 29 market samples were 0.43-242.53 μg/g,non-compliance rate was 3.45%(1/29 batches exceeded the limit).Conlusion The overall quality of commercially available Fuyan Kangfu Tablets is satisfactory,but a few batches were found to contain adulterated Bupleurum marginatum.关键词
妇炎康复片/藏柴胡/尼泊尔柴胡皂苷K/掺伪/超高效液相色谱-三重四极杆质谱法Key words
Fuyan Kangfu Tablet/Bupleurum marginatum/nepasaikosaponin K/adulteration/ultra-high-performance liquid chromatography-triple quadrupole mass spectrometry分类
医药卫生引用本文复制引用
倪芹,来国防..妇炎康复片中藏柴胡掺伪检查方法的建立[J].中国药业,2025,34(8):86-90,5.基金项目
云南省药品评价抽检专项[云药监办[2023]9号]. （）
