水解蛋白注射液中游离氨基酸含量的测定及分析  

Determination and evaluation of amino acids in protein hydrolysate injection

作　　者：连莹[1] 仲平[1] 

机构地区：[1]河南省食品药品检验所,郑州450003

出　　处：《药物分析杂志》2012年第1期61-66,共6页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立二硝基氟苯(DNFB)柱前衍生化法测定水解蛋白注射液中游离氨基酸含量,并对水解蛋白注射液质量进行分析。方法:采用DNFB为衍生化试剂进行衍生,色谱柱为Diamonsil C18(250 mm×4.6 mm,5μm),流动相为0.05 mol.L-1醋酸钠溶液(含1%N,N-二甲基甲酰胺,调pH为6.4)与50%乙腈水溶液,梯度洗脱,流速1.0 mL.min-1,检测波长360nm。结果:各氨基酸的线性关系良好;平均回收率(n=6)为98.7%～100.8%,RSD为0.46%～3.3%。结论:本研究建立了水解蛋白注射液游离氨基酸测定方法,为质量标准中游离氨基酸含量测定限度的制定提供了依据。Objective： To establish a pro - column derivatization procedure for determination of the content of amino acid in protein hydrolysate injection by RP- HPLC. Methods：DNFB was used as a derivatization reagent and separation of DNP -amino acid derivatives were performed on Diamonsil C18 column（250 mm × 4. 6 mm,5 μm）. The mobile phase was 0. 05 mol · L^-1 sodium acetate solution（containing 1% DMF and adjusted pH 6. 4） and 50% acetonitrile with gradient elution at a flow rate of 1.0 mL · min^- 1, and the signals were detected at 360 nm. Resuits：Under the above condition, all amino acid in the standard solution were separated to baseline; The calibration curves of amino acids were in good linearity; The average recovery of amino acid ranged from 98.7% to 100.8% with RSD of 0. 46% -3.3% （n = 6）. Conclusion：The method is applied to analyzing amino acid composition of protein hydrolysate injection and good results are obtained.

关 键 词：水解蛋白注射液 营养制剂 氨基酸 二硝基氟苯 衍生化 质量分析 

分 类 号：R917[医药卫生—药物分析学]