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Stavudine sustained release tablet and its preparing process

A technology for stavudine and sustained-release tablets, which is applied in antiviral agents, pharmaceutical formulations, medical preparations containing active ingredients, etc. The probability of release” and the effect of improving drug safety

Inactive Publication Date: 2005-07-06
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 and its preparing process

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] 1. Tablet core prescription Raw material Feeding amount Weight ratio

[0028] Stavudine 50g 1

[0029]

[0030] Makes 1000 pieces

[0031] 2. Tablet core preparation process

[0032] (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.

[0033] (2) The starch is made into 4% starch slurry for subsequent use.

[0034] (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.

[0035] (4) Add the prescribed amount of hypromellose and magnesium stearate to the dry granules, sieve through a 20-mesh sieve, and compress into tablets.

[0036] (5) After passing the inspection of the ta...

Embodiment 2

[0048] 1. Tablet core prescription Raw material Feeding amount Weight ratio

[0049] Stavudine 50g 1

[0050]

[0051] Makes 1000 pieces

[0052]2. Tablet core preparation process: the specific steps are as in 2 in Example 1.

[0053] 3. Coating prescription

[0054] Raw material Feed amount Weight ratio

[0055] Hypromellose 4.7g 1

[0056] Ethylcellulose 8.46g 1.80

[0057] Dibutyl sebacate 1.64g 0.35

[0058] 85% ethanol 176g 37.4

[0059] 4. Coating process: the specific steps are as in 4 in Example 1.

Embodiment 3

[0061] 1. Tablet core prescription Raw material Feeding amount Weight ratio

[0062] Stavudine 50g 1

[0063]

[0064] Makes 1000 pieces

[0065] 2. Tablet core preparation process

[0066] The specific steps are as in 2 in Example 1.

[0067] 3. Coating prescription

[0068] Raw material Feed amount Weight ratio

[0069] Hypromellose 4.7g 1

[0070] Ethylcellulose 10.34g 2.2

[0071] Dibutyl sebacate 1.88g 0.4

[0072] 85% ethanol 188g 40

[0073] 4. Coating process

[0074] The specific steps are as in 4 in Example 1.

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PUM

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Abstract

The invention relates to stavudine sustained release tablet and its preparing process, wherein the epicuticle comprises Stavudine and gel matrix core as medicinal adjuvant, the weight ratio of the Stavudine and gel matrix core is 1 : 0.68-2.32. The preparing process comprises the steps of making core and dressing.

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 Applications(China)
IPC IPC(8): A61K9/22A61K31/7072A61P31/18
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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