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  

RP-HPLC analysis of scopolamine,atropine andscopoletin in Huashanshen dripping pills

作　　者：周军[1] 赵晨[1] 张洋 张红意 曲佳[1] 王杰[1] 

机构地区：[1]天津市药品检验所,天津300070 [2]天津中新药业集团达仁堂制药厂,天津300457 [3]天津中新药业集团有限公司第六中药厂,天津300401

出　　处：《药物分析杂志》2012年第5期892-894,918,共4页Chinese Journal of Pharmaceutical Analysis

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。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.

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 

分 类 号：R917[医药卫生—药物分析学]