目的 研究不同鱼种来源的硫酸鱼精蛋白原料药的质量情况。方法 对目前在我国上市的硫酸鱼精蛋白原料的鱼种来源采用HPLC进行鉴别和含量测定,对氨基酸组分进行考察,采用电感耦合等离子质谱法检测重金属含量,并考察了不同鱼种来源硫酸鱼精蛋白原料中和肝素的能力。结果 目前我国上市的硫酸鱼精蛋白原料主要为鲑鱼和鲱鱼来源。结论 本实验为建立硫酸鱼精蛋白的HPLC鉴别及含量方法,完善其质量标准提供了理论依据。
Abstract
OBJECTIVE To study the qualities of protamine sulfate raw material from different species of fish. METHODS The identification and determination of protamine sulfate raw material from different fish species were conducted by HPLC, and the composition of amino acids was tested too. Heavy metals was tested by inductively coupled plasma mass spectrometry. The potency of protamine sulfate was measured by biological assay method. RESULTS At present, the sources of protamine sulfate on the market were mainly salmon and herring. CONCLUSION This HPLC method can be applied to effectively identify and determine protamine sulfate raw material in order to improve its quality control.
关键词
硫酸鱼精蛋白 /
鱼精蛋白 /
高效液相色谱法 /
重金属 /
肝素
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Key words
protamine sulfate /
protamine /
HPLC /
heavy metal /
heparin
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中图分类号：
R917
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参考文献
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脚注
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基金
国家“重大新药创制”科技重大专项资助(2015ZX09303001)
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