Quality Standard Research Of HYBR-003--A New Drug For Diabetes

HYBR-003 is the new generation of GLP-1 receptor agonist, a class of promising treatments for type 2 diabetes, Its structure has been applied for a patent, and planned to apply for new drugs to the state. The mechanism of the drug is to promote secretion of insulin by combining with the GLP-1 receptor. Currently no listing of these drugs in domestic,but it have been listed abroad and obtained good results. The main product is Lilly Company's Exenatide.According to the preparation technology of HYBR-003 raw materials, and National Center for Drug application requirements, quality standards for raw materials of HYBR-003 has been established, including the research of physical and chemical properties, structure identification, related substances, peptide content, acetic acid content, solvent residue, endotoxin, biological activity. By the research of the stability of raw material medicine, the validity of HYBR-003 raw materials also has been determined.According to the preparation technology of HYBR-003 pharmaceutics,and National Center for Drug application requirements, quality standards for HYBR-003 pharmaceutics has been established, including the research of physical and chemical properties, related substances, peptide content, m-cresol content, sterility, endotoxin, biological activity. By the research of the stability of HYBR-003 pharmaceutics, the validity of HYBR-003 pharmaceutics also has been determined.The structure of HYBR-003 is new, therefore, the quality satndard is obviously innovative and has important practical application.