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A tacrolimus capsule

A technology for tacrolimus and capsules, applied in the field of medicine, can solve the problems of high content uniformity value, difficult to ensure uniform dispersion, low melting point of polyethylene glycol, etc., and achieve smooth production process, rapid drug dissolution, Simple preparation process

Active Publication Date: 2017-06-23
SHANDONG NEWTIME PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In this invention, tacrolimus is added to polyethylene glycol and co-deoxycholic acid molten liquid. Since the liquid is relatively viscous, it is difficult to ensure uniform dispersion, so it is easy to cause high content uniformity values, and due to polyethylene glycol Low melting point, easy sticking during capsule filling

Method used

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  • A tacrolimus capsule
  • A tacrolimus capsule
  • A tacrolimus capsule

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024]

[0025] Preparation Process:

[0026] Dissolve tacrolimus, hydroxypropyl beta cyclodextrin, and deoxycholic acid in absolute ethanol, then granulate the solution with lactose, dry at 40°C, sieve through a 20-mesh sieve, and add stearin to the dry granules Magnesium acid, mixed evenly, and filled into capsules.

Embodiment 2

[0028]

[0029] Preparation Process:

[0030] Dissolve tacrolimus, hydroxypropyl beta cyclodextrin, and deoxycholic acid in absolute ethanol, then granulate the solution with lactose, dry at 40°C, sieve through a 20-mesh sieve, and add stearin to the dry granules Magnesium acid, mixed evenly, and filled into capsules.

Embodiment 3

[0032]

[0033] Preparation Process:

[0034] Dissolve tacrolimus, hydroxypropyl beta cyclodextrin, and deoxycholic acid in absolute ethanol, then use this solution to granulate on mannitol, dry at 40°C, granulate with a 20-mesh sieve, and dry the granules Add magnesium stearate, mix well, and fill capsules.

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Abstract

A tacrolimus capsule is disclosed. Tacrolimus, hydroxypropyl-beta-cyclodextrin and deoxycholic acid are dissolved into absolute ethanol, then the obtained solution is granulated on pharmaceutically acceptable auxiliary materials and dried, and a capsule is filled. Compared with the prior art, the preparing process is simple, medicine dispersion is uniform, a production procedure is smooth and medicine digestion is rapid.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a tacrolimus capsule. Background technique [0002] Tacrolimus, also known as FK506, is a fermentation product isolated from Streptomyces tsukubaensis for the first time in 1984 by the Fujisawa Pharmaceutical Industry Research Institute in Japan. Its chemical structure belongs to 23-membered macrolide antibiotics . It is a powerful new type of immunosuppressant, mainly by inhibiting the release of interleukin-2, and comprehensively inhibits the function of T lymphocytes, which is 100 times stronger than cyclosporine. Tacrolimus was first approved for marketing in Japan on June 7, 1993, under the product name Prograf, and was subsequently marketed in dozens of countries such as the United Kingdom, the United States, and Germany. It is used for acute anti-rejection of liver, kidney, and bone marrow transplantation. Treatment, the development of dosage forms are capsu...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K47/69A61K47/10A61K47/28A61K31/436A61P37/06
CPCA61K9/4858A61K31/436
Inventor 张贵民郝贵周冯中
Owner SHANDONG NEWTIME PHARMA
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