通宣理肺丸中盐酸麻黄碱含量的方法优化  

Optimization of Content Determination of Ephedrine Hydrochloride in Tongxuan Lifei Pills

作　　者：杨勇帮 施伟兵 许国栋 YANG Yongbang;SHI Weibing;XU Guodong(TCM Pharmacy,Yuxi Food and Drug Inspection Institute,Yuxi Yunnan 653100,China;College of Traditional Chinese Medicine,Yunnan University of Traditional Chinese Medicine,Kunming Yunnan 650500,China)

机构地区：[1]玉溪市食品药品检验所中药室,云南玉溪653100 [2]云南中医药大学中药学院,云南昆明650500

出　　处：《中国卫生标准管理》2021年第16期100-104,共5页China Health Standard Management

基　　金：全国中药特色技术传承人培训项目(国中医药人教教育便函〔2021〕104号)。

摘　　要：目的高效液相测定通宣理肺丸中盐酸麻黄碱含量方法优化。方法采用Agilent ZORBAX SB.C184.6×150 mm 5μm色谱柱,乙腈-0.2%磷酸(含0.2%三乙胺)(3:97)为流动相,UV检测波长是210 nm,1 mL/min流速。结果在2.42~120.96μg/mL浓度范围内线性良好(r=0.99999),经过精密度实验RSD值为0.07%,经重复性实验计算浓度为0.2483 mg/g(n=6),RSD值为4.16%。经过稳定性实验证明盐酸麻黄碱在24小时内处于稳定,平均回收率为95.88%。结论实验选用的样品提取方法相较药典方法更加良好;本方法简便,准确,可行,不使用易制毒试剂,灵敏度高,重复性好,适用于盐酸麻黄碱含量测定。Objective To study the method for determination of ephedrine hydrochloride in Tongxuan Lifei pills by high performance liquid chromatography.Methods Agilent ZORBAX SB.C184.6×150 mm 5 um column was used.Acetonitrile.0.2%phosphoric acid(containing 0.2%triethylamine)(3:97)was used as mobile phase.UV detection wavelength was 210 nm and flow rate was 1 mL/min.Results At 2.42~120.96μg/mL,the linearity was good within the concentration range(r=0.99999),RSD value was 0.07%after precision experiment,RSD value was 0.2483 mg/g(n=6)after repeatability experiment and RSD value was 4.16%.The stability experiment proved that ephedrine hydrochloride was stable within 24 hours,with an average recovery of 95.88%.Conclusion Compared with the Pharmacopoeia method,the sample extraction method selected in the experiment is better.This method is simple,accurate and feasible,does not produce harmful gases,has high sensitivity and good repeatability,and is suitable for the determination of ephedrine hydrochloride.

关 键 词：高效液相 方法优化 药典 盐酸麻黄碱 通宣理肺丸 二氯甲烷 含量测定 

分 类 号：R917[医药卫生—药物分析学]