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HPLC法测定华山参滴丸中东莨菪碱、阿托品及东莨菪内酯的含量
引用本文:周军,赵晨,张洋,张红意,曲佳,王杰.HPLC法测定华山参滴丸中东莨菪碱、阿托品及东莨菪内酯的含量[J].药物分析杂志,2012(5):892-894,918.
作者姓名:周军  赵晨  张洋  张红意  曲佳  王杰
作者单位:天津市药品检验所;天津中新药业集团达仁堂制药厂;天津中新药业集团有限公司第六中药厂
摘    要:目的:建立HPLC法测定华山参滴丸中东莨菪碱、阿托品及东莨菪内酯的含量。方法:采用资生堂CAPCELL-PAK C18(4.6 mm×250 mm,5μm)色谱柱,以乙腈-甲醇-磷酸氢二钠缓冲液(15∶4∶81)为流动相,流速1.0 mL·min-1,东莨菪碱、阿托品检测波长210 nm(0~15 min),东莨菪内酯检测波长为344 nm(15.1~30 min),柱温30℃。结果:东莨菪碱、阿托品及东莨菪内酯的线性范围分别为0.04~3.95,0.04~4.10,0.05~0.54μg(r=0.9999);平均回收率(n=6)分别为97.58%(RSD=1.3%),98.65%(RSD=1.3%),98.42%(RSD=1.8%)。结论:本文方法简便、准确,可以用于华山参滴丸中东莨菪碱、阿托品及东莨菪内酯的含量测定。

关 键 词:华山参滴丸  止咳平喘药  托品烷类生物碱  东莨菪碱  阿托品  东莨菪内酯  高效液相色谱法  多成分分析  质量控制  中药制剂  标准提高

RP-HPLC analysis of scopolamine,atropine andscopoletin in Huashanshen dripping pills
ZHOU Jun,ZHAO Chen,ZHANG Yang,ZHANG Hong-yi,QU Jia,WANG Jie.RP-HPLC analysis of scopolamine,atropine andscopoletin in Huashanshen dripping pills[J].Chinese Journal of Pharmaceutical Analysis,2012(5):892-894,918.
Authors:ZHOU Jun  ZHAO Chen  ZHANG Yang  ZHANG Hong-yi  QU Jia  WANG Jie
Institution:1(1.Tianjin Institute of Drug Control,Tianjin 300070,China;2.Tianjin Zhongxin Pharmaceutical Group Corporation LTD,Darentang Traditional Chinese Medicine Factory,Tianjin 300457,China;3.Tianjin Zhongxin Pharmaceutical Group Corporation LTD,No.6 Traditional Chinese Medicine Factory,Tianjin 300401,China)
Abstract:Objective:To establish an HPLC method for determination of scopolamine,atropine and scopoletin in Huashanshen dripping pills.Methods:The analysis was carried out on a CAPCELL-PAK C18(4.6 mm×250 mm,5 μm)column;The mobile phase was composed of acetonitrile-methanol-disodium hydrogen phosphate buffer solution(15∶4∶81)and the flow rate was 1.0 mL·min-1;The detection wavelengths were set at 210 nm for scopolamine and atropine(0-15 min),and 344 nm for scopoletin(15.1-30 min);The column temperature was 30 ℃.Results:The linear ranges of scopolamine,atropine and scopoletin were 0.04-3.95,0.04-4.10,0.05-0.54 μg(r=0.9999),respectively;The average recoveries(n=6)were 97.58%(RSD=1.3%),98.65%(RSD=1.3%),and 98.42%(RSD=1.8%),respectively.Conclusion:This method is simple,and can be used to determine the above three components with satisfactory accuracy and repeatability.
Keywords:Huashanshen dripping pills  antitussive and antiasthmatic drugs  tropane alkaloids  scopolamine  atropine  scopoletin  HPLC  multicomponent assay  quality control  TCM preparation  standard improvement
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