中国药业2025，Vol.34Issue(11)：82-87,6.DOI:10.3969/j.issn.1006-4931.2025.11.017
咳喘宁高效液相色谱指纹图谱研究与多指标成分含量测定
HPLC Fingerprints of Kechuanning and Content Determination of Multi-Index Components
摘要
Abstract
Objective To establish a high-performance liquid chromatography(HPLC)fingerprint of Kechuangning,and an HPLC method for content determination of seven index components.Methods The chromatographic column was Mercury Ether-Phenyl column(250 mm×4.6 mm,5 μm),and the mobile phase was 0.1%phosphoric acid aqueous solution-acetonitrile(gradient elution),the flow rate was 1.0 mL/min,the detection wavelengths was set at 210 nm for ephedrine hydrochloride,morphine,pseudoephedrine hydrochloride,L-amygdalin,and D-amygdalin,and 237 nm for liquiritin and glycyrrhizic acid,the column temperature was 25℃,and the injection volume was 2 μL.The Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine(Version 2012)was used for similarity evaluation.Results The similarity of HPLC fingerprints of 28 batches of samples was higher than 0.87,with eight common peaks confirmed and seven components identified,which were ephedrine hydrochloride,morphine,pseudoephedrine hydrochloride,L-amygdalin,D-amygdalin,liquiritin,and glycyrrhizic acid.The linear ranges of the above seven components were 3.075-307.5 μg/mL,2.886-288.6 μg/mL,3.033-303.3 μg/mL,2.889-288.9 μg/mL,2.806-280.6 μg/mL,2.870-287.0 μg/mL,and 2.913-291.3 μg/mL(r=0.999 9),respectively.The RSDs of precision,stability,and repeatability tests were all lower than 3.0%(n=6).The average recoveries of the above seven components were 97.15%,93.06%,95.97%,102.02%,96.78%,98.16%,and 100.10%,with RSDs of 0.85%,1.56%,1.93%,1.93%,1.75%,1.67%,and 1.95%(n=6),respectively.The average contents of the above seven components in 28 batches of samples were 2.21,0.34,1.69,2.22,3.67,1.53,and 2.98 mg/g,respectively.Conclusion The established method is simple,accurate,and has good reproducibility,which can be used for the quality evaluation and control of Kechuangning.关键词
咳喘宁/指纹图谱/高效液相色谱法/多指标成分/含量测定Key words
Kechuanning/fingerprints/HPLC/multi-index components/content determination分类
医药卫生引用本文复制引用
田京歌,周娟娟,倪倩,孙彦敏,赵祎涵,庞庆林..咳喘宁高效液相色谱指纹图谱研究与多指标成分含量测定[J].中国药业,2025,34(11):82-87,6.基金项目
江苏省药品监督管理局2023年药品监管科学科研计划项目[202303]. （）
