| Peptide compounds are an important class of biologically active molecules that has been widely used around the world which present in the life sciences and many have been listed as drugs, such as:human insulin, human growth hormone, interferon, interleukin and so on. Mainly are used for clinical anti-tumor, to stimulate the blood, complementary and alternative therapy.The results show that, if T lymphocytes are activated, they will lead to the increasingly release of cytokines, immunoglobulins, chemokines and other inflammatory mediators, which will cause synovial hyperplasia, destruction of cartilage and bone, pathological changes of chronic disabling. Non-T cell binding peptide(NTCP) is an innovative drug researched and developped for this kind of disease. Compared with traditional drugs, non-T cell binding peptides take effect in the pathogenesis of the disease, inhibite the initial part of the immune response. So it is of great significance to develop an optimized method for separation and analysis and to the research on the property of non-T cell binding peptide.The paper consists four parts as follows:(1) Reviewed on the application prospect of non-T cells combination peptide, the source of the impurities, the relation between the target peptide and impurities and the developed methods of separation and analysis of the impurities.(2) The research was done on analysis of physical and chemical properties and structure of non-T cell binding peptide. To provide supplementary information of its structure, amino acid composition was analyzed.We used liquid chromatography-mass spectrometry and amino acid sequencing technologies to confirme the structure of synthetic peptides.(3) The separation research was done on different mechanisms. The reversed phase chromatography method was established to messure the impurities and was validate. The results showed that the separation of the impurities and main-product was efficient and the method had good accuracy, precision and linearity. The content of NTCP was determined by external reference method. The Ultra Performance Liquid Chromatography method was established for the separation of non-T cell binding peptide and its impurities. Preliminary study was done on the stability of non-T cell binding peptide, appropriate storage conditions was analyzed.(4) The impurities of non-T cell binding peptide were studied. The reverse phase high-performance liquid chromatography amplifying system was used to enrich the mixture. The separated impurities were further isolated. The structure was confirmed by HPLC-MASS method. The impurties of non-T cell binding peptide were analyzed via with the corresponding literature and synthetic progress, and the influence of different storage conditions was studied. |