Dipeptidyl peptidase IV inhibitor pharmaceutical composition, use and preparation method thereof

A composition and drug technology, which is applied in the direction of drug combination, pharmaceutical formula, heterocyclic compound active ingredients, etc., can solve the problems such as the stability of linagliptin preparations are not given, and achieve the reduction of types of excipients, good stability, and reduction of cost effect

Active Publication Date: 2016-04-06
CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the patent does not give the effect of the prepared linagliptin preparation, such as the stability

Method used

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  • Dipeptidyl peptidase IV inhibitor pharmaceutical composition, use and preparation method thereof
  • Dipeptidyl peptidase IV inhibitor pharmaceutical composition, use and preparation method thereof
  • Dipeptidyl peptidase IV inhibitor pharmaceutical composition, use and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Example 1: Pharmaceutical composition comprising linagliptin

[0039] Prescription composition (1000 unit dose)

[0040]

[0041] Preparation Process:

[0042] Mix the linagliptin raw material with mannitol, pregelatinized starch, and corn starch in a high-shear mixer, add purified water to granulate, and wet the granules with a 1.6mm-3mm sieve. particles. The wet granules are dried, the temperature of the dried material is 40~60°C, and the moisture content is ≤3.5%. After the dry granules are sized through a 1mm-2mm sieve, magnesium stearate is added and mixed to obtain a pharmaceutical composition containing linagliptin.

Embodiment 2

[0043] Embodiment 2: The pharmaceutical composition comprising linagliptin

[0044] The composition of the prescription is the same as in Example 1, except that the pregelatinized starch is replaced by the pregelatinized starch produced by Huzhou Zhanwang Pharmaceutical Co., Ltd.

[0045] The preparation process is the same as in Example 1.

Embodiment 3

[0046] Embodiment 3: Linagliptin capsules

[0047] The pharmaceutical composition containing linagliptin obtained in Example 1 was packed into a capsule shell to obtain linagliptin capsules.

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Abstract

The invention discloses a pharmaceutical composition containing a dipeptidyl peptidase IV inhibitor linagliptin, use and preparation method thereof. The linagliptin containing pharmaceutical composition provided by the invention consists of linagliptin or a salt thereof serving as the active ingredient, and pharmaceutical excipients mannitol, pregelatinized starch, corn starch and magnesium stearate. The linagliptin containing pharmaceutical composition provided by the invention reduces the types of excipients, increases the stability of the preparation, reduces the cost of raw materials, and solves the hardness and friability problems of linagliptin tablets by controlling the particle size of the key excipient mannitol. The obtained table has all indicators especially the dissolution rate in line with the drug quality standards, and the process is simple, thus being more suitable for large scale production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and specifically relates to a dipeptidyl peptidase IV inhibitor pharmaceutical composition, its use and preparation method, and more particularly relates to a linagliptin pharmaceutical composition, its use and its preparation method. Background technique [0002] Dipeptidyl peptidase IV (DPP-IV) degrades incretin-like polypeptide (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), both of which are involved in the physiology of glucose homeostasis. adjust. DPP-IV inhibitors, which can increase the concentration of active incretin hormones, stimulate insulin release in a glucose-dependent manner, and reduce circulating glucagon levels, are considered to be valuable drugs for the treatment of diabetes. [0003] Linagliptin (Linagliptin, whose structural formula is shown in formula 1), is a dipeptidyl peptidase IV inhibitor, and its chemical name is 1-[(4-methyl-quinazolin-2-...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/522A61K47/26A61K47/36A61P3/10
Inventor 吴欢欢张丹丹赫玉霞生丽丹杨敏杨欣欣
Owner CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD
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