高效毛细管电泳法测定胰岛素气雾剂的含量

丁继军;沈赞聪;张强;魏树礼;

中国药学杂志 ›› 2001, Vol. 36 ›› Issue (08) : 550-552.

中国药学杂志 ›› 2001, Vol. 36 ›› Issue (08) : 550-552.
药品质量及检验

高效毛细管电泳法测定胰岛素气雾剂的含量

  • 丁继军;沈赞聪;张强;魏树礼;
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Determination of insulin in aerosol by highperformance capillary electrophoresis

  • DING Ji-jun;SHEN Zan-cong;ZHANG Qiang;WEI Shu-li;
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摘要

目的 建立以高效毛细管电泳法测定胰岛素气雾剂的含量。方法 采用高效毛细管电泳法,缓冲液系统为硼酸盐(20 mmol·L-1)-Tris(20 mmol·L-1)-Triton X-100 (2%),pH=8.20,检测波长为214 nm。结果 在19.0~228 μg·mL-1间线性良好,相关系数r=0.9991。高、中、低3种浓度的加样回收率在94.7%~106.8%之间,日内和日间RSD低于4%,胰岛素的最低浓度为0.8 μg·mL-1。结论 本方法能简单、快速、经济地测出胰岛素气雾剂的含量,可用于类似药物制剂的质量控制和含量测定。

Abstract

OBJECTIVE To establish a sensitive method to determine insulin in a newly developed aerosol by high-performance capillary electrophoresis (HPCE).METHODS The concentration of insulin was determined by HPCE in the buffer system of borate-Tris-Triton(20 mmol·L-1∶20mmol·L-1∶2% with pH8.20) and was detected at 214 nm.RESULTS The linear range of this method was 19.0~228 μg·mL-1,with a correlation coefficient of 0.9991.The recovery was 94.7%~106.8%,the within-day and between-day precision were both below 4%.The limit of detection of insulin was 0.8 μg·mL-1.CONCLUSION This method appeared to be simple with good reproducibility,and provided a rapid,economic and effective approach for quality control and quantitative analysis of this kind of medicine in similar formulation.

关键词

高效毛细管电泳 / 胰岛素气雾剂 / 含量测定

Key words

high-performance capillary electrophoresis / insulin aerosol / determination

引用本文

导出引用
丁继军;沈赞聪;张强;魏树礼;. 高效毛细管电泳法测定胰岛素气雾剂的含量[J]. 中国药学杂志, 2001, 36(08): 550-552
DING Ji-jun;SHEN Zn-cong;ZHNG Qing;WEI Shu-li;. Determination of insulin in aerosol by highperformance capillary electrophoresis[J]. Chinese Pharmaceutical Journal, 2001, 36(08): 550-552

参考文献

[1]邓尚平,周文碧,熊忠云.胰岛素放射免疫分析实验条件的选择和方法学鉴定[J].四川医学院学报,1982,13(4):345. [2]Lookabaugh M,Biswas M,Krull I.Quantitation of insulin injection by high-performance liquid chromatography and high-performance capillary electrophoresis[J].J Chromatogr,1991,549:357. [3]Yomota C,Matsumoto Y,Okada S,et al.Diserimination limit for purity test of human insulin by capillary electrophoresis[J].J Chromatogr B,1997,703:139. [4]Shihabi ZK,Friedberg M.Insulin stacking for capillary electrophoresis[J].J Chromatogr A,1998,807:129. [5]毛磊.药用气雾剂[M].北京:中国医药科技出版社,1997,3~8.

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天然药物及仿生药物国家重点实验室资助课题

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