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Pentoxifylline slow-release tablet and preparation method thereof

A technology of theobromine sustained-release tablets and pentoxifylline, which is applied in the direction of pharmaceutical formulas, medical preparations containing no active ingredients, and medical preparations containing active ingredients, etc. Sustained-release tablets have problems such as poor reproducibility of drug release, and achieve good sustained-release effects, good product quality uniformity, and good reproducibility.

Active Publication Date: 2016-11-23
CSPC OUYI PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The inventor found through tests that the pentoxifylline sustained-release tablet prepared according to the method disclosed in this patent has poor drug release reproducibility, and the product is difficult to meet the preparation standard.

Method used

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  • Pentoxifylline slow-release tablet and preparation method thereof
  • Pentoxifylline slow-release tablet and preparation method thereof
  • Pentoxifylline slow-release tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Embodiment 1 The preparation of pentoxifylline sustained-release tablets of the present invention

[0036]

[0037] Preparation Process:

[0038] 1) Add 90 g of pentoxifylline into molten glyceryl behenate, stir to disperse the drug evenly, cool in an ice bath for 6 hours, pulverize, and granulate with a 60-mesh sieve to obtain Granule 1;

[0039]2) Add the remaining pentoxifylline and polyoxyethylene into the granulator and stir at a speed of 100 rpm, and pre-mix for 5 minutes; then add 5% povidone K30 in 95% ethanol solution to make a soft material, and stir at 180 rpm, granulation for 10 minutes, granulation with a 20-mesh sieve, transfer the wet granules to a boiling dryer for drying, and the inlet air temperature is 60°C to obtain granules 2;

[0040] 3) Mix granule 1, granule 2, and magnesium stearate in a mixer for 10 minutes, the rotating speed is 12 rpm, and compressed into tablets (each tablet contains 0.4 g of pentoxifylline), and the tablet core hardness...

Embodiment 2

[0042] Embodiment 2 Preparation of Pentoxifylline Sustained-release Tablets of the Present Invention

[0043]

[0044] Preparation Process:

[0045] 1) Add 70 g of pentoxifylline into molten glyceryl behenate, stir to disperse the drug evenly, cool in an ice bath for 8 hours, pulverize, and sieve with a 60-mesh sieve to obtain Granule 1;

[0046] 2) Add the remaining pentoxifylline and polyoxyethylene into the granulator and stir at a speed of 105 rpm, pre-mix for 4 minutes; then add 5% povidone K30 in 95% ethanol solution to make a soft material, stir at a speed of 185 rpm, granulation for 12 minutes, granulation with a 20-mesh sieve, transfer the wet granules to a boiling dryer for drying, the inlet air temperature is 55°C, and granule 2 is obtained;

[0047] 3) Mix granule 1, granule 2, and magnesium stearate in a mixer for 11 minutes at a speed of 10 rpm, and press into tablets (each tablet contains 0.4 g of pentoxifylline), and the hardness of the tablet core is contr...

Embodiment 3

[0049] Embodiment 3 Preparation of Pentoxifylline Sustained-release Tablets of the Present Invention

[0050]

[0051] Preparation Process:

[0052] 1) Add 110 g of pentoxifylline into molten glyceryl behenate, stir to disperse the drug evenly, cool in an ice bath for 5 hours, pulverize, and granulate with a 60-mesh sieve to obtain Granule 1;

[0053] 2) Add the remaining pentoxifylline and polyoxyethylene into the granulator and stir at a speed of 95 rpm, and pre-mix for 3 minutes; then add 5% povidone K30 in 95% ethanol solution to make a soft material, and stir 190 rpm, granulation for 11 minutes, granulation with a 20-mesh sieve, transfer the wet granules to a boiling dryer for drying, and the inlet air temperature is 50°C to obtain granules 2;

[0054] 3) Mix granule 1, granule 2, and magnesium stearate in a mixer for 15 minutes at a speed of 11 rpm, and press into tablets (each tablet contains 0.4 g of pentoxifylline), and the hardness of the tablet core is controlle...

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Abstract

The invention relates to a pentoxifylline slow-release tablet and a preparation method thereof, and belongs to the technical field of medicine preparations. The pentoxifylline slow-release tablet consists of a tablet core and a coating layer, wherein the tablet core is prepared from the following components of pentoxifylline, slow-release material and the like. The pentoxifylline slow-release tablet has the advantages that the type of auxiliary material is fewer, the formula technology is simple, the slow-release effect is good, the medicine-release reproducibility is good, the product stability is high, and the like.

Description

technical field [0001] The invention relates to a tablet and a preparation method thereof, more specifically to a pentoxifylline sustained-release tablet and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. Background technique [0002] Pentoxifylline is a methylxanthine derivative. It is an alkaloid obtained from theobromine extracted from cocoa beans and then introduced into a pentanone group. It is a white powder or granule; it has a slight odor and a bitter taste; Soluble in chloroform, soluble in water or ethanol, slightly soluble in ether. Molecular formula is C 13 h 18 N 4 o 3 , the chemical name is 3,7-dihydro-3,7-dimethyl-1-(5-oxohexyl)-1H-purine-2,6-dione, and the structural formula is as follows: [0003] [0004] Pentoxifylline is a non-selective phosphodiesterase inhibitor. By inhibiting phosphodiesterase, it increases intracellular adenosine triphosphate, improves the deformability of red blood cells, reduce...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K31/522A61K47/14A61K47/34A61P9/10A61P9/14A61P13/12A61P3/10A61P25/02A61P29/00A61P25/00A61P1/16
CPCA61K9/0007A61K9/2013A61K9/2031A61K9/2866A61K31/522
Inventor 刘磊王唤雨郭倩甘丽倩韩丽霞
Owner CSPC OUYI PHARM CO LTD
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