口服水解蛋白的质量评价研究

Quality Evaluation of Oral Protein Hydrolysate

目的:评价口服水解蛋白的质量,并对质量标准进行完善。方法:对23批次口服水解蛋白按法定标准进行检验,通过分子排阻色谱法对口服水解蛋白的分子量分布进行测定,建立基于ICP-AES法的钙锌铁含量检测方法,采用茚三酮柱后衍生法对口服水解蛋白中的氨基酸的含量进行了测定和考察。结果:口服水解蛋白的分子量在240 Da左右;口服水解蛋白中钙含量范围为3293~5841μg·g^(-1)、锌含量范围为32~74μg·g^(-1)、铁含量范围为13~34μg·g^(-1);口服水解蛋白中含有18种氨基酸,游离氨基酸总量为40.3%~49.3%;肽含量为15.4%~34.7%。结论:口服水解蛋白质量总体良好,建议相关企业关注原料质量,质量标准中增加微生物限度检查项和游离氨基酸含量测定项,增加对肽限度的规定,以确保生产工艺的稳定及标准可控。

Objective:To evaluate the quality of oral protein hydrolysate,and improve the quality standard.Methods:23 batches of oral protein hydrolysate were tested according to the legal standard.The molecular weight distribution of oral protein hydrolysate was determined by size exclusion chromatography.An ICP-AES method was established for the determination of calcium,zinc and iron.The content of amino acids in oral protein hydrolysate was determined by ion exchange chromatography with ninhydrin post-column derivatization.Results:The results showed the molecular weight of oral protein hydrolysate is about 240 Da.The calcium content of oral protein hydrolysate ranged in 3293-5841μg·g^(-1) and the zinc content ranged in 32-74μg·g^(-1) and the iron content ranged in 13-34μg·g^(-1).It contained 18 kinds of amino acids,the total amount of free amino acids ranged in 40.3%-49.3%.The peptide content ranged in 15.4%-34.7%.Conclusion:The quality of oral protein hydrolysate is generally good.It is suggested that relevant enterprises pay attention to the quality of raw materials,and that microbial limit test and free amino acid content determination should be added to the quality standards,as well as the regulation of peptide limit,so as to ensure the stability of the production process and the standard can be controlled.