Azathioprine dry suspension and preparation method thereof

A technology of azathioprine and dry suspension is applied in the directions of anti-inflammatory agents, non-central pain relievers, extracellular fluid diseases, etc. Good effect, the effect of improving drug absorption rate

Active Publication Date: 2020-11-17
CHANGSHA RUHONG MEDICINE TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The first object of the present invention is to provide a dry suspension of azathioprine, said dry suspension of azathioprine is poorly water-soluble azathioprine and suitable auxiliary materials into powder or granules, when taken Add water and shake to disperse into a uniform suspension, increase its distribution area in the body, quickly absorb in the digestive tract and transform into a pharmacological structure, achieve the purpose of rapid onset of action, and solve the problem of dysphagia patients, The problem of inconvenient medication for children and elderly patients

Method used

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  • Azathioprine dry suspension and preparation method thereof
  • Azathioprine dry suspension and preparation method thereof
  • Azathioprine dry suspension and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0058] In the azathioprine dry suspension provided in this embodiment, the amounts of each raw material are as follows:

[0059] Azathioprine 50g, sorbitol 400g, polyvinylpyrrolidone 75g, micronized silica gel 3g, cross-linked polyvinylpyrrolidone 50g, 30% ethanol aqueous solution 200g, and aspartame 0.5g.

[0060] The preparation method of azathioprine dry suspension described in this embodiment includes the following steps:

[0061] 1) Take 50 g of azathioprine and 120 g of sorbitol for co-pulverization, and pass through an 80-mesh sieve after pulverization to obtain powder A;

[0062] 2) Take the remaining 280g of sorbitol, 50g of cross-linked polyvinylpyrrolidone, and 3g of micronized silica gel, all pass through a 60-mesh sieve, add powder A, mix well, add 200g of ethanol with a volume fraction of 30% in water to make a soft material;

[0063] 3) The soft material is passed through a 40-mesh sieve to form granules, dried at 60°C, and then passed through a 30-mesh sieve to obtain w...

Embodiment 2

[0066] In the azathioprine dry suspension provided in this embodiment, the amounts of each raw material are as follows:

[0067] Azathioprine 50g, sorbitol 400g, suspending agent 72g, micronized silica gel 3g, cross-linked polyvinylpyrrolidone 55g, 30% ethanol aqueous solution 100g, aspartame 0.5g; wherein, the suspending agent It is a mixture of low-substituted hydroxypropyl cellulose and polyvinylpyrrolidone with a mass ratio of 1:1.2.

[0068] The preparation method of azathioprine dry suspension described in this embodiment includes the following steps:

[0069] 1) Take 50 g of azathioprine and 120 g of sorbitol for co-pulverization, and pass through an 80-mesh sieve after pulverization to obtain powder A;

[0070] 2) Take the remaining 280g of sorbitol, 55g of cross-linked polyvinylpyrrolidone, and 3g of micronized silica gel, all pass through a 60-mesh sieve, add powder A, mix well, add 100g of ethanol with a volume fraction of 30% in water to make a soft material;

[0071] 3) T...

Embodiment 3

[0074] In the azathioprine dry suspension provided in this embodiment, the amounts of each raw material are as follows:

[0075] 50 g of azathioprine, 400 g of sorbitol, 69 g of low-substituted hypromellose, 5 g of talc, 60 g of sodium carboxymethyl starch, 200 g of an aqueous ethanol solution with a volume fraction of 30%, and 0.5 g of aspartame.

[0076] The preparation method of azathioprine dry suspension described in this embodiment includes the following steps:

[0077] 1) Take 50 g of azathioprine and 120 g of sorbitol for co-pulverization, and pass through an 80-mesh sieve after pulverization to obtain powder A;

[0078] 2) Take the remaining 280g of sorbitol, 60g of sodium carboxymethyl starch, and 5g of talc, all pass through a 60-mesh sieve, add powder A, mix well, add 200g of ethanol with a volume fraction of 30% in water to make soft material;

[0079] 3) The soft material is passed through a 40-mesh sieve to form granules, dried at 60°C, and then passed through a 30-mesh ...

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Abstract

The invention relates to the technical field of pharmacy and pharmaceutical production, in particular to an azathioprine dry suspension and a preparation method thereof; the azathioprine dry suspension is made mainly from, by weight, 40-60 parts of azathioprine, 360-440 parts of a filling agent, 65-80 parts of a suspending agent, 3-5 parts of a lubricating agent, 50-60 parts of a disintegrating agent, and 100-200 parts of a humectant. The components, such as the filling agent, the suspending agent, the lubricating agent, the disintegrating agent and the humectant, are coordinated with azathioprine to obtain the azathioprine dry suspension so that the azathioprine dry suspension has good dispersity and suspending property; the homogenous suspension can be made by adding water, shaking and dispersing; the problem that patients with swallowing difficulty, child patients, old patients and other patients feel inconvenient to take medicine is solved.

Description

Technical field [0001] The present invention relates to the technical field of medicine and medicine production, in particular to a dry suspension of azathioprine and a preparation method thereof. Background technique [0002] Azathioprine is an imidazole derivative of 6-mercaptopurine. It is an anti-metabolite with immunosuppressive effect. It can produce alkylation to block SH group, inhibit nucleic acid biosynthesis, prevent cell proliferation, and cause DNA Damage. Clinically, azathioprine is widely used, mainly for acute and chronic leukemia, acquired hemolytic anemia, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, chronic rheumatoid arthritis, chronic active hepatitis, primary Treatment of biliary cirrhosis, hyperthyroidism, myasthenia gravis, chronic nonspecific ulcerative colitis, segmental enteritis, multiple radiculitis, lupus nephritis, proliferative nephritis, Wegener's granulomatosis and other diseases . [0003] As azathioprine is a low-water-so...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/16A61K31/52A61P35/02A61P29/00A61P19/02A61P7/06A61P1/16
CPCA61K9/0095A61K9/1635A61K9/1652A61K31/52
Inventor 卢静荷谭淑珍王述维唐亮
Owner CHANGSHA RUHONG MEDICINE TECH CO LTD
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