Sitagliptin phosphate tablet and preparation method thereof

Abstract

The invention relates to a sitagliptin phosphate tablet. The tablet or a tablet core comprises an active component sitagliptin phosphate, filling agents, a disintegrating agent and a lubricant, and apreparation process of the sitagliptin phosphate tablet comprises following steps: the active component, the filling agents and the disintegrating agent are uniformly mixed firstly, and then the mixture is mixed with the lubricant for tabletting. According to the invention, microcrystalline cellulose and calcium sulfate are used as the filling agents, the defects of poor fluidity and easy stickingof the active component can be improved, the active component and auxiliary materials do not need to be pretreated in the preparation process, the requirement on the particle size of the material islow, the active component is not easily adsorbed to containers and utensils, and the material utilization rate is high; and when batch amplification is performed to reach 500,000 tablets / batch, no sticking phenomenon is found, the preparation process is simple, the dissolution speed is high, the product quality is excellent, the stability is good, various indexes reach the ideal level of pharmaceutics, and the sitagliptin phosphate tablet is suitable for large-scale commercial production.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a sitagliptin phosphate tablet and a preparation method thereof. Background technique [0002] Diabetes is a group of metabolic diseases characterized by hyperglycemia. Hyperglycemia is caused by defective insulin secretion, impaired biological action, or both. Long-term hyperglycemia leads to chronic damage and dysfunction of various tissues, especially the eyes, kidneys, heart, blood vessels, and nerves. Studies have shown that in 2015, the number of adult diabetic patients in my country reached 109.6 million, ranking first in the world. Worldwide, the prevalence and incidence of diabetes are gradually increasing. In 2040, the number of people with diabetes worldwide will reach 642 million. [0003] In 2006, Merck developed a new type of hypoglycemic drug - sitagliptin phosphate tablets, trade name JANUVIA, which can be used clinically alone or combined with othe...

AI Technical Summary

Problems solved by technology

[0006] The purpose of the present invention is to provide a sitagliptin phosphate tablet on the basis of the prior art, which solves the problem of poor fluidity and easy sticking of the active component sitagliptin phosphate in the preparation process of the tablet, and does not Will lead to the degradation of the main drug or side effects, thereby reducing the quality of the product

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