Study On Quality Detection And Stability Of Immunity Nine Peptide

Hyperglycemia is a systemic disease, which make abnormal fat metabolism or operation of the plasma above the normal one or a variety of lipid. Hyperlipidemia is an important risk factor for diabetes to promote high blood pressure and impair glucose tolerance. Search for effective drug treatment of hyperlipidemia is a major topic of current research.The purpose of this paper is to get physical and chemical properties and control quality of the process of their production through experimental research of Immunity nine peptide. According to the guiding principles of drug pharmaceutical research techniques and chemical stability studies on technical guidelines ([H] GPH6-1) and the Chinese Pharmacopoeia (2005 edition), reference materials and design features of nine peptides with immunization experiments, the experiment took a systematic study on quality, nature and detection indicators of the Immunity nine peptide medicine. Through the analysis of the nature of the Immunity nine peptide, made the detection indicators and established the detection way for Immunity nine peptide and finally took quality detection with the peptide according to the former way.First, this study established a detection method for immunity nine peptide with high performance liquid chromatography (RP-HPLC), by the separation of its proprietary experimental and methodological validation, as well as linear and scope of the investigation, The results show that the method used for detection of immune nine peptide, has a good system applicability of the work of linearity, specificity, sensitivity and stability. And then used high performance liquid chromatography (RP-HPLC) to analyze trifluoroacetic acid residues and related substances, and after aseptic testing, we inspected the quality of products. In the last part, the stability studies, which contain the test of impact factors in the condition of the light high temperature (60℃and 40℃), humidity (RH92.5% and RH75%) and others, in addition of accelerated testing and long-stay test and so on, provide the basis for drug production, packaging, storage, transporting and the period of validity to ensure safe and effective clinical treatment.