中国药物警戒 ›› 2012, Vol. 9 ›› Issue (1): 22-24.

• 质量与工艺研究 • 上一篇    下一篇

柱前衍生法测定胸腺中组胺的含量

徐学平,李琳,丁莉芳,张晓敏,吴建中,王亚鹏,王孝功   

  1. 西安迪赛生物药业有限责任公司,陕西西安710016
  • 收稿日期:2012-07-31 修回日期:2016-03-12 出版日期:2013-01-08 发布日期:2016-03-09
  • 通讯作者: 王孝功,男,硕士,工程师,生化药物质量研究。 E-mail：xgwcat@163.com
  • 作者简介:徐学平,男,硕士,工程师,生化药物技术生产。

Determination of Histamine in Raw Thymus by Pre-column Derive

XU Xue-ping ,LI Lin ,DING Li-fang, ZHANG Xiao-min ,WU Jian-zhong, WANG Ya-peng ,WANG Xiao-gong   

  1. Xi’an Disai Biology Pharmaceutical Co.,Ltd., Shanxi Xi’an 710016, China
  • Received:2012-07-31 Revised:2016-03-12 Online:2013-01-08 Published:2016-03-09

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摘要： 目的 建立一种科学、合理的检测胸腺中组胺含量的方法,用于控制胸腺原料的质量。方法采用丹磺酰氯柱前衍生,HPLC-UV 法,C18（4.6mm×250mm,5μm）色谱柱,乙腈- 水为流动相,流速1.0mL·min-1,检测波长254nm,梯度洗脱。结果采用本方法测定组胺标准品,在1.0～50μg·mL-1的范围内,组胺的浓度与峰面积成线性相关,相关系数为0.9979,加样回收率85%~110%,RSD%＜10%。结论采用该方法测定胸腺中痕量组胺的含量,具有简单、快速、准确、灵敏,重复性好的特点,可以用于胸腺原料的质量控制。

关键词: 组胺, 丹磺酰氯柱前衍生法, 胸腺

Abstract: Objective To build a scientific and reasonable way to detect the content of histamine in thymus, in order to control the quality of raw thymus ultimately. Methods We used dansyl chloride pre -column derive, HPLC -UV method, C18 (4.6mm×250mm,5μm) chromatographic column acetonitrile -water asa mobile phase, the flow rate 1.0mL·min -1, wavelength 254nm while the gradient elution method was used to detect histamine. Results In the range of 1.0~50μg·mL-1, the histamine concentration is linear correlation to the peak area, with the correlation coefficient 0.9979. Sample loading recovery is between 85% and 110% , with RSD%约10%. Conclusion Using this way to detect the histamine content in thymus is simple, quick, accurate, sensitive, and easy to repeat. This method can be used as quality control of raw.

Key words: histamine, dansyl chloride pre-column derive, thymus

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