中医药导报2025，Vol.31Issue(7)：63-67,5.DOI:10.13862/j.cn43-1446/r.2025.07.010
定喘止嗽丸质量标准研究
Study on Quality Standard of Dingchuan Zhisou Pills(定喘止嗽丸)
摘要
Abstract
Objective:To establish the method of thin layer identification of Yingsuqiao(poppy husk)and Mahuang(ephedra)in Dingchuan Zhisou pills and the content determination of 5 alkaloids in Dingchuan Zhisou pills,to provide the basis for improving the quality standard and strengthening the quality control of preparations.Methods:The Yinsuqiao(poppy husk)and Mahuang(ephedra)in Dingchuan Zhisou pills were identified by thin layer chromatography(TLC).The content of 5 alkaloids in Dingchuan Zhisou pills was determined by high-performance liquid chromatography(HPLC).Chromatographic column was Agilent Zorbax Eclipse Plus C18(4.6 mm×150.0 mm,5.0 μm).Mobile phase was acetonitrile(A)-0.1％triethylamine solution(pH adjusted to 3.0 with phosphoric acid)(B),with gradient elution.Flow rate was 1.0mL/min,with column temperature of 30 ℃.Sample size was 10 μL,and detection wavelength was 210 nm.Results:Yinsuqiao(poppy husk)and Mahuang(ephedra)developed well,with clear spots and obvious bands.The linear concentrations of morphine,ephedrine hydrochloride,pseudoephedrine hydrochloride,codeine phosphate and papaverine hydrochloride ranged from 14.41 to 288.20 μg/mL(r=0.999 7),13.02 to 260.40 μg/mL(r=0.997 4),7.36 to 147.20 μg/mL(r=0.995 7),0.94～18.70 μg/mL(r=0.999 1),and 4.03～80.62 μg/mL(r=0.999 9).Precision,stability,repeatability test RSD＜2.0％(n=6).The average recoveries were 98.3％,97.7％,95.8％,93.4％,98.7％(n=6).Conclusions:The method established in this study is simple,accurate,reproducible and specific,and it can be used for qualitative identification and content determination of Dingchuan Zhisou pills.It can effectively improve the quality control standard of this preparation.关键词
定喘止嗽丸/薄层色谱法/定性鉴别/高效液相色谱法/含量测定/质量标准Key words
Dingchuan Zhisou Pills/thin layer chromatography/identification/high-performance liquid chromatography/content determination/quality standard分类
医药卫生引用本文复制引用
裴璐,姜颖,沈立茹..定喘止嗽丸质量标准研究[J].中医药导报,2025,31(7):63-67,5.基金项目
河北省药品监督管理局科技项目(2023ZC1025) （2023ZC1025）
