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Stavudine sustained release tablet

A stavudine and sustained-release tablet technology, applied in antiviral agents, drug delivery, organic active ingredients, etc., can solve the problems of difficult preparation factories, complex manufacturing equipment, and complex processes, and reduce the probability of sudden release" , the effect of improving drug safety

Inactive Publication Date: 2009-10-14
NORTHEAST PHARMA GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The present invention provides a stavudine slow-release tablet that can be prepared by adopting the general tablet equipment of a pharmaceutical factory. problems in terms of

Method used

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  • Stavudine sustained release tablet
  • Stavudine sustained release tablet
  • Stavudine sustained release tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] 1. Tablet core prescription

[0028]

[0029] 2. Tablet core preparation process

[0030] (1) Crush stavudine and pass through a 100-mesh sieve. Lactose, microcrystalline cellulose, magnesium stearate, and hypromellose are directly passed through an 80-mesh sieve for later use.

[0031] (2) The starch is made into 4% starch slurry for subsequent use.

[0032] (3) Weigh the prescribed amount of stavudine, lactose, and microcrystalline cellulose, and place them in a fluidized granulator. Turn on the fan to make the material in a state suitable for fluidization, and spray starch slurry into it for fluidization granulation.

[0033] (4) Add the prescribed amount of hypromellose and magnesium stearate to the dry granules, sieve through a 20-mesh sieve, and compress the granules.

[0034] (5) After passing the core inspection, preheat in an oven at 40°C for 2 hours for later use.

[0035] 3. Coating prescription

[0036] Raw material Feed amount Weight ratio

[0037...

Embodiment 2

[0046] 1. Tablet core prescription

[0047]

[0048] 2. Tablet core preparation process: the specific steps are as in 2 in Example 1.

[0049] 3. Coating prescription

[0050] Raw material Feed amount Weight ratio

[0051] Hypromellose 4.7g 1

[0052] Ethylcellulose 8.46g 1.80

[0053] Dibutyl sebacate 1.64g 0.35

[0054] 85% ethanol 176g 37.4

[0055] 4. Coating process: the specific steps are as in 4 in Example 1.

Embodiment 3

[0057] 1. Tablet core prescription

[0058]

[0059] 2. Tablet core preparation process

[0060] The specific steps are as in 2 in Example 1.

[0061] 3. Coating prescription

[0062] Raw material Feed amount Weight ratio

[0063] Hypromellose 4.7g 1

[0064] Ethylcellulose 10.34g 2.2

[0065] Dibutyl sebacate 1.88g 0.4

[0066] 85% ethanol 188g 40

[0067] 4. Coating process

[0068] The specific steps are as in 4 in Example 1.

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Abstract

The invention relates to a nucleoside reverse transcriptase inhibitor, in particular to a stavudine slow-release tablet and a preparation method thereof. It is characterized in that the ingredients in the outer sustained-release film coat are composed of stavudine and a gel matrix tablet core as a pharmaceutical auxiliary material, and the weight ratio of the stavudine contained therein to the gel matrix tablet core of the pharmaceutical auxiliary material is It is 1:0.68-2.32. The preparation method includes tablet core making, coating, etc.; the purpose of the present invention is to solve the problems existing in the existing stavudine slow-release dosage form manufacturing equipment, complex process, and difficulty in general preparation factories. The manufacturing method of the tablet combines the gel matrix sustained-release technology known in the art and the film-coated sustained-release technology, avoiding the defects of each when used alone, and improving the drug safety of patients.

Description

1. Technical fields; [0001] The invention relates to a nucleoside reverse transcriptase inhibitor, in particular to a stavudine slow-release tablet and a preparation method thereof. 2. Background technology; [0002] Stavudine (D4T) is a nucleoside reverse transcriptase inhibitor that has been approved for marketing in many countries. It is used alone or in combination for the treatment of human immunodeficiency virus (HIV) infection and AIDS or AIDS-related syndromes . Its chemical name and structural formula are as follows: [0003] Chemical name: 2,3-didehydro-3-deoxythymidine, structural formula: [0004] [0005] Molecular formula: C 10 h 12 N 2 o 4 , molecular weight: 224.21. [0006] The common stavudine preparation is a capsule. According to the weight of the patient, the daily dose is 30-100 mg, which is divided into two doses. The more effective method of AIDS treatment at this stage is "cocktail" therapy, that is, the combined use of multiple anti-HIV d...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/7072A61K9/22A61P31/18
Inventor 高洁安晓霞娄威王虹高峦王健颖韩俊雁岳静
Owner NORTHEAST PHARMA GRP
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