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醒脑再造丸质量标准研究
引用本文:吴庆淼,吴立军,杨志伟.醒脑再造丸质量标准研究[J].中国药品标准,2010,11(1):25-29.
作者姓名:吴庆淼  吴立军  杨志伟
作者单位:1. 沈阳药科大学,沈阳,110016;吉林省松原市食品药品检验所,松原,138000
2. 沈阳药科大学,沈阳,110016
3. 吉林省松原市食品药品检验所,松原,138000
基金项目:《中国药典》2010年版一部标准研究课题 
摘    要:目的:建立醒脑再造丸(黄连、冰片、木香等)的质量标准。方法:采用TLC法鉴别处方中的黄连、冰片和木香;用HPLC—ELSD法测定黄芪中黄芪甲苷的含量,色谱柱PhenomenexGeminiC18(4.6mm×250mm,5μm),流动相:乙腈-水(36:64);流速为1.0mL·min^-1;漂移管温度为105℃;载气流速:2.7L·min^-1。结果:TLC法鉴别色谱特征斑点明显,黄芪甲苷在0.486~2.43μg范围内呈线性关系,r=0.9997;平均回收率为101.7%(n=6),RSD=0.5%。结论:所建立的TLC和HPLC-ELSD方法操作简便,结果准确,重复性好,可用于醒脑再造丸的质量控制。

关 键 词:醒脑再造丸  TLC  HPLC—ELSD  黄连  冰片  木香  黄芪甲苷

Quality Standard of Xingnao Zaizao Pills
Authors:Wu Qing-miao  Wu Li-jun and Yang Zhi-wei
Institution:1. Shenyang Pharmaceutical University, Shenyang 110016 ;2. Songyuan Institute for Food and Drug Control of Jilin Province, Songyuan 138000)
Abstract:Objective: To establish a quality standard of Xingnao Zaizao Pills ( Rhizoma, eoptidis, Borneolum, synthetieum, Radix, auek- landae, etc. ). Methods: Rhizoma coptidis, Borneolum syntheticum, and Radix aueklandae were identified by TLC. HPLC-ELSD Separa- tion was achieved on a Phenomenex Gemini CIS Column(4. 6 mm × 250 mm ,5 μm) and mobile phase composed of acetonitrile-water (36:64) ;Flow rate: 1. 0ml · min^-1 ;Drift tube temperature: 105℃ ;Gas flow rate:2.7 L · min^-1. Results: The developed TLC spots were quite clear. The calibration curve was linear in the range of 0. 486 - 2. 43 μg ( r = 0. 999 7 ) ; The average recovery rate was 101.7% (n = 6), RSD was 0. 5%. Conclusion:The established TLC and HPLC-ELSD methods are simple, accurate and reproducible, thus can be useful in quality control of Xingnao Zaizao Pills.
Keywords:TLC  HPLC-ELSD
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