• 中国核心期刊(遴选)数据库收录期刊
  • 中文科技期刊数据库收录期刊
  • 中国期刊全文数据库收录期刊
  • 中国学术期刊综合评价数据库统计源期刊等

快速检索引用检索图表检索高级检索

中国医药导刊 ›› 2022, Vol. 24 ›› Issue (5): 498-503.

• 检验检测 • 上一篇    下一篇

HPLC法同时测定恒古骨伤愈合剂中东莨菪碱和硫酸阿托品限量的研究

王飘1,3, 朱志坤1,3, 郭媛媛1,3, 杨唯1,3, 易志恒2, 陈凌云1,3*   

  1. 1.云南中医药大学, 云南 昆明 650500; 2.赛灵药业科技集团股份有限公司, 云南 玉溪 653100;  3.云南省高校外用给药系统与制剂技术研究重点实验室, 云南 昆明 650500
  • 收稿日期:2022-02-25 修回日期:2022-04-14 出版日期:2022-05-28 发布日期:2022-05-28
  • 基金资助:
    云南省重大科技专项(项目编号:202102AA310029;项目名称:中药大品种“恒古骨伤愈合剂”质量标准提升)

Study on Simultaneous Determination of Scopolamine and Atropine Sulfate Limits of OsteoKing by HPLC

  1. 1.Yunnan University of Traditional Chinese Medicine,Yunnan Kunming 650500, China;  2. Sailing Pharmaceutical Technology Group Co., Ltd, Yunnan Yuxi 653100, China; 3.Key Laboratory of External Drug Delivery System and Preparation Technology Research in Universities of Yunnan Province,Yunnan Kunming 650500, China
  • Received:2022-02-25 Revised:2022-04-14 Online:2022-05-28 Published:2022-05-28
  • Contact: chen lingyun E-mail:498507628@qq.com

摘要: 目的:同时测定恒古骨伤愈合剂中东莨菪碱和硫酸阿托品的含量,建立其限量检查方法,旨在为有效控制恒古骨伤愈合剂的质量及安全性提供可靠依据。方法:采用高效液相色谱(HPLC)法进行测定,色谱条件为固定相采用色谱柱Diamonsil C18(250 mm×4.6 mm,5 μm),流动相为乙腈∶0.07 mol·L-1磷酸钠溶液(用磷酸调节pH值至4.5)(11∶89),柱温:30 ℃,检测波长:205 nm,流速:1 mL·min-1。结果:东莨菪碱和硫酸阿托品分别在0.003 7~0.118 0 mg·mL-1、0.002 4~0.077 4 mg·mL-1浓度范围内与峰面积呈良好的线性关系;平均回收率分别为97.25%、97.61%,RSD值分别为2.32%、2.44%(n=9)。结论:该方法合理可行、准确可靠,可用于恒古骨伤愈合剂中东莨菪碱和硫酸阿托品的限量检查。

关键词: font-size:medium, ">东莨菪碱;硫酸阿托品;洋金花;恒古骨伤愈合剂;限量检查

Abstract: Objective:To simultaneously determine the contents of scopolamine and atropine sulfate in OsteoKing, and to establish the method for limit test,so as to provide a reliable basis for effectively controlling the quality and safety of OsteoKing.Methods:High performance liquid chromatography (HPLC) method was used. The chromatographic conditions were that the stationary phase was Diamonsil C18 (250 mm×4.6 mm, 5μm), the mobile phase was acetonitrile was 0.07 mol·L-1 sodium phosphate solution (pH was adjusted to 4.5 with phosphoric acid) (11∶89). The column temperature was 30 ℃. Detection wavelength: 205 nm. Flow rate: 1 mL·min-1.Results:Scopolamine and atropine sulfate in the concentration range of 0.003 7-0.118 0 mg·mL-1,0.002 4-0.077 4 mg·mL-1 respectively have a good linear relationship with the peak area. The average recovery rates were 97.25%,97.61%respectively, and the RSD values were 2.32%,2.44%(n=9) respectively.Conclusion: The method is reasonable, feasible, accurate and reliable, and it can be used for the limit test of scopolamine and atropine sulfate.

Key words: Scopolamine, Atropine sulfate, Flos daturae, OsteoKing, Limited inspection

中图分类号: