中药与临床2025，Vol.16Issue(6)：13-17,5.
黄马酊的质量标准研究
Quality standard research of Huangma Tincture
摘要
Abstract
Objective:To establish quality standard of the characteristic traditional Chinese medicine formulation HuangmaTincture.Methods:Qualitative identification of Coptidis Rhizoma and Strychni Semen in the formulation was performed using thin-layer chromatog-raphy(TLC).Quantitative analysis of strychnine and berberine hydrochloride were conducted through high-performance liquid chromatog-raphy(HPLC),employing a Phenomenex Luna C18 column(250×4.6 mm,5 μm).The mobile phase consisted of methanol-acetonitrile-0.1 mol·L-1 sodium dihydrogen phosphate solution containing the same volume of 0.025 mol·L-1 sodium dodecyl sulfate solution(50∶25∶25),with a flow rate set at 1.0 mL·min-1.Detection was carried out at a wavelength of 254 nm with column temperature at 25℃ and 10 μL sam-ples injected.Results:The TLC profiles of Coptidis Rhizoma and Strychni Semen showed clear and well-separated spots with no interfer-ence from the negative controls.The HPLC peaks for strychnine and berberine hydrochloride were retained within 10 minutes,demonstrating good separation with no interference from the blank solvent.Precision,repeatability,and stability tests revealed relative standard deviations(RSD)of peak areas for both chemical components to be less than 3%.The sample solutions were stable at room temperature for 24 hours,with spike recoveries of strychnine and berberine hydrochloride at 95.58%and 97.65%,respectively.The mean values of the contents of s strychnine and berberine hydrochloride in 3 batches of Huangma Tincture were 0.888±0.077 mg·mL-1 and 2.231±0.181 mg·mL-1,respec-tively.Conclusion:The methods developed in this study are simple,time-efficient and accurate,making them suitable for quality control of Huangma Tincture.关键词
黄马酊/薄层色谱法/高效液相色谱法/质量控制Key words
Huangma Tincture/TLC/HPLC/quality control分类
医药卫生引用本文复制引用
邱菁,李杰,冷静..黄马酊的质量标准研究[J].中药与临床,2025,16(6):13-17,5.基金项目
重庆市科研机构绩效激励引导专项项目(cstc2021jxjl 10001,cstc2018jxjl 130029) （cstc2021jxjl 10001,cstc2018jxjl 130029）
