文章摘要
张昊天,王璐,高远,尹燕杰.薄芝糖肽注射液多肽含量测定的研究[J].中国药品标准,2018,19(1):21-27
薄芝糖肽注射液多肽含量测定的研究
Research of the method for the content determination of polypeptide in BoZhi glycopeptide for injection
投稿时间:2017-08-02  修订日期:2018-02-08
DOI:
中文关键词: 薄芝糖肽注射液  多肽
英文关键词: BoZhi glycopeptide  Polypeptide
基金项目:
作者单位E-mail
张昊天* 哈尔滨市食品药品检验检测中心 abc232291@163.com 
王璐 哈尔滨医科大学药学院  
高远 哈尔滨市食品药品检验检测中心  
尹燕杰 哈尔滨市食品药品检验检测中心  
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中文摘要:
      目的:薄芝糖肽等动植物提取物广泛应用于临床领域,而由于这些提取物的药物化学与药理学方面的研究仍属于正在探索的领域,所以这类药品在生产工艺与质量检验水平方面也还需要有很多的改进和提升,本研究旨在将薄芝糖肽的多肽含量测定方法进行改进,从而给薄芝糖肽注射液中含量测定方法带来新思路,加强对多肽含量的控制。方法:采用碱水解方法分离糖肽键,并利用D1010大孔吸附树脂对多糖与多肽进行分离,再采用福林酚反应标准曲线法对多肽进行含量测定,同时利用高效液相色谱法及多糖-蒽酮反应标准曲线法对分离产物进行鉴定与分析,再利用凯氏定氮的方法测定分离的多肽的收率。结果:对薄芝糖肽进行72h的碱水解效果较好;运用D101大孔吸附树脂,分别以水和80%乙醇进行洗脱可以将多糖和多肽进行有效分离;经过分离后的多肽采用定氮法测定收率为95%,效果良好。结论:应用碱水解的方法可以实现糖肽键断裂,用大孔吸附树脂实现了多糖多肽的基本分离,多肽收率较高,并可以对分离产物进行定量。
英文摘要:
      Objective:It is reported that macromolecular substances such as BoZhi glycopeptides are widely used in the field of clinical. And because these extracts of the drug chemistry and pharmacology research is still being explored in the field, so these drugs in the production process and quality inspection level also need to have a lot of improvement and promotion. The aim of this study was to improve the method of determination of the content of polypeptide in BoZhi glycopeptide, and to provide new ideas for the determination of the content of the injection and to control the content of the polypeptide. Methods: The glycopeptide bond was separated by alkaline hydrolysis method and the polysaccharide and polypeptide were separated by D1010 macroporous adsorption resin. The content of the peptides was determined by the standard curve method of pectin reaction. The separation products were identified and analyzed by high performance liquid chromatography and polysaccharide- anthrone reaction standard curve method. Results: Alkaline hydrolysis of BoZhi glycopeptide for 72h effect is better. D101 macroporous adsorption resin, with water and 80% alcohol as the mobile phase polysaccharides and peptides can be extracted from BoZhi glycopeptide. After separation, the polypeptide was determined by the method of nitrogen fixation. The yield was 95%, and the effect was good. Conclusion: The hydrolysis of glycopeptide bonds can be achieved by alkaline hydrolysis. The macroporous adsorption resin can realize the basic separation of polysaccharide polypeptide and obtain the main part of the polypeptide. The yield of the polypeptide is high, and the separation product can be quantified.
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