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Vildagliptin tablets and preparation method thereof

A technology for vildagliptin tablets and tablets, applied in the field of vildagliptin tablets and their preparation, can solve the problems of low dissolution rate, insufficient stability and the like, achieve simple preparation steps, low requirements for equipment and auxiliary materials, and reduce cost effect

Inactive Publication Date: 2018-06-19
PEKING UNIV FOUNDER GRP CO LTD +3
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Currently commercially available vildagliptin tablets include vildagliptin tablets (Jiaweile), but it has the disadvantages of low dissolution rate and insufficient stability

Method used

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  • Vildagliptin tablets and preparation method thereof
  • Vildagliptin tablets and preparation method thereof
  • Vildagliptin tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] The present embodiment provides a kind of vildagliptin tablet, and described vildagliptin tablet is prepared from the following components by weight (calculated as raw materials and auxiliary materials per tablet):

[0031]

[0032] (2) Preparation process

[0033] This embodiment also provides the preparation method of the above-mentioned vildagliptin tablet, the method is specifically:

[0034] Mix vildagliptin with mannitol, then add microcrystalline cellulose and 1 / 2 formula amount of cross-linked polyvinylpyrrolidone, and add formula amount of 3 (w / v)% hydroxypropyl methylcellulose aqueous solution to obtain The soft material is granulated through a 18-mesh sieve, dried at 60°C for 1 hour, granulated through a 18-mesh sieve, added the remaining cross-linked polyvinylpyrrolidone, colloidal silicon dioxide and magnesium stearate, and compressed to obtain tablets. Tablets are coated with Opadry. The dosage of Opadry is 15 mg per tablet to obtain the vildagliptin ...

Embodiment 2

[0036] The present embodiment provides a kind of vildagliptin tablet, and described vildagliptin tablet is prepared from the following components by weight (calculated as raw materials and auxiliary materials per tablet):

[0037]

Embodiment 3

[0039] The present embodiment provides a kind of vildagliptin tablet, and described vildagliptin tablet is prepared from the following components by weight (calculated as raw materials and auxiliary materials per tablet):

[0040]

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PUM

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Abstract

The invention provides vildagliptin tablets and a preparation method thereof. The vildagliptin tablets are prepared from raw materials in parts by weight as follows: 50 parts of an effective componentvildagliptin, 10-30 parts of a disintegrating agent, 200-400 parts of a filling agent, 1-5 parts of a binder, 3-5 parts of a flow aid and 3-5 parts of a lubricating agent. The vildagliptin tablets are prepared through simple steps, the requirement for equipment is lower, dissolution rate of the tablets and stability are good, and the tablets can still keep stable under conditions of high temperature and high humidity.

Description

technical field [0001] The invention relates to a vildagliptin tablet and a preparation method thereof. It belongs to the technical field of pharmaceutical preparations. Background technique [0002] Vildagliptin is a type IV dipeptidyl peptidase (DPP-4) inhibitor, originally developed by Novartis and launched in 2007. The chemical name is 1-[[(3-hydroxyl-adamantyl)amino]acetyl]-2-cyano-(S)-tetrahydropyrrolidine. [0003] Vildagliptin is a selective, competitive and reversible DPP-4 inhibitor. Vildagliptin binds with DPP-4 to form a DPP-4 complex to inhibit the activity of this enzyme, increases the concentration of GLP-1, promotes the production of insulin by pancreatic B cells, and reduces the concentration of glucagon, thereby reducing blood sugar. and had no significant effect on body weight. [0004] Currently commercially available vildagliptin tablets include vildagliptin tablets (Garvile), but it has the disadvantages of low dissolution rate and insufficient stab...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K47/38A61K47/32A61K31/40A61P3/10
CPCA61K9/2054A61K9/2853A61K31/40
Inventor 谢小飞易崇勤姚定丽邹明琛
Owner PEKING UNIV FOUNDER GRP CO LTD
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