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The retention time of test sample major peak complies to reference standard
Almost the same
IR Infrared spectrometry:
The IR spectrum of test sample should comply to reference standard
Almost the same
Melting point
148.0 。C - 152.0。C
148.6.0。C-149.1。C
Loss on drying
≤ 1.0%
0.36%
Residual on ignition
≤ 0.1%
0.04%
Related substance
Any single impurity ≤ 0.1%
Total impurities ≤ 1.0%
Conforms
0.65%
Heavy metals
≤ 20 ppm
< 10 ppm
Assay
99.0% - 102.0%
99.19%
Conclusion
The sample complies with the above specification
Usage
Vildagliptin is a selective, competitive and reversible DPP24 inhibitor. Glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like polypeptide 1 (GLP-1) are important hormones to maintain glucose concentration in the body, and both have incretin effects. The insulin-stimulating effect of GIP in patients with type 2 diabetes is impaired, and only GLP-1 can play the role of insulin-stimulating hormone secretion. GLP-1 also inhibits glucagon secretion and suppresses gastric emptying to increase satiety (suppression of appetite). DPP24 binds to proteins and exists in many tissues, such as kidney, liver, brush border of small intestinal membrane, pancreatic duct, lymphocytes, endothelial cells, and it can rapidly degrade GLP-1 by hydrolyzing the N-terminal 2 alanine of GLP-1. inactivated. This product inhibits the activity of this enzyme by combining with DPP24 to form a DPP24 complex. It increases the concentration of GLP-1 and promotes the production of insulin by islet β cells, while reducing the concentration of glucagon, thereby reducing blood sugar. and had no significant effect on body weight.
Vildagliptin can reduce fasting and postprandial blood glucose levels, postprandial glucagon secretion and improve B cell function, providing a new option for the treatment of type 2 diabetes patients. Safety and effectiveness of this medicine in combination with other medicines.