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Attachment 1 Product Information for Trajenta：为trajenta附件1的产品信息
TRAJENTA(Linagliptin)NAME OF THE MEDICINEActive ingredient:LinagliptinChemical name: 1H-Purine-2,6-dione, 8-[(3R)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-Molecular formula: C25H28N8O2CAS number: 668270-12-0Molecular weight: 472.54Structural formula: DESCRIPTIONLinagliptin is a white to yellowish, not or only slightly hygroscopic solid substance. It is very slightly soluble in water. Linagliptin is soluble in methanol, sparingly soluble in ethanol, very slightly soluble in isopropanol and very slightly soluble in acetone. Dissociation Constants: pKa1?=?8.6; pKa2 = 1.9. Partition Co-efficient: Log P = 1.7 (free base); Log D (pH 7.4) = 0.4.TRAJENTA are film-coated tablets for oral administration containing 5 mg linagliptin.Excipients: Each TRAJENTA tablet also contains starch - pregelatinised maize, starch - maize, mannitol, copovidone, magnesium stearate and the colouring agent Opadry Pink 02F34337.PHARMACOLOGYPharmacotherapeutic group: DPP-4 inhibitor, ATC code: A10BH05PharmacodynamicsLinagliptin is an inhibitor of the enzyme DPP-4 (Dipeptidyl peptidase 4), an enzyme which is involved in the inactivation of the incretin hormones GLP-1 and GIP (glucagon-like peptide-1, glucose-dependent insulinotropic polypeptide). These hormones are rapidly degraded by the enzyme DPP-4. Both incretin hormones are involved in the physiological regulation of glucose homeostasis. Incretins are secreted at a low basal level throughout the day and levels rise immediately after meal intake. GLP-1 and GIP increase insulin biosynthesis and secretion from pancreatic beta cells in the presence of normal and elevated blood glucose levels. Furthermore GLP-1 also reduces glucagon secretion from pancreatic alpha cells, resulting in a reduction in hepatic glucose output. Linagliptin binding to DPP-4 is reversible but long lasting and thus leads to a sustained increase and a prolongation of active incretin levels. In vitro, linagliptin inhibit
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