山西医科大学学报2025，Vol.56Issue(2)：182-187,6.DOI:10.13753/j.issn.1007-6611.2025.02.010
疏风再造丸中马兜铃酸Ⅰ的测定及风险评估
Determination and risk assessment of aristolochic acid Ⅰ in Shufeng Zaizao Wan
摘要
Abstract
Objective To establish a method for the determination of aristolochic acid Ⅰ in Shufeng Zaizao Was and provide theoretical basis for quality control of Shufeng Zaizao Wan.Methods The experiment was performed on CAPCELL PAK C18 column(2.1 mm×100 mm,2 μm),with methanol(A)-0.1％formic acid(containing 5 mmol/L ammonium acetate)(B)as mobile phase for gradient elution at a flow rate of 0.3 mL/min.The content of aristolochic acid Ⅰ in Shufeng Zaizao Wan was detected by liquid chromatography-mass spectrometry,and its methodology was investigated.Results The standard curve of aristolochic acid Ⅰ showed good linearity in the range of 2.12-52.96 ng/mL(R2=0.999 0,n=6).RSDs of precision,repeatability and stability of the method were respectively 0.85％,1.3％,1.8％.The detection limit was 1.06 ng/mL.The average recovery rate was 84.72％.The content of aristolochic acid Ⅰ was 11.9-34.0 ng/g in all 38 batches of samples.Conclusion The established method can be used to determine the content of aristolochic acid Ⅰ in Shufeng Zaizao Wan and effectively control the quality of the preparation.关键词
疏风再造丸/马兜铃酸Ⅰ/含量测定/液相色谱-质谱联用/质量控制Key words
Shufeng Zaizao Wan/aristolochic acid Ⅰ/content determination/liquid-mass combination/quality control分类
药学引用本文复制引用
郝娟,连云岚,李转梅..疏风再造丸中马兜铃酸Ⅰ的测定及风险评估[J].山西医科大学学报,2025,56(2):182-187,6.基金项目
国家药品监督管理局药品监管科学体系建设重点项目(RS2024Z006) （RS2024Z006）
食品药品安全防控山西省重点实验室基金项目(202204010931006) （202204010931006）
