A kind of oral sustained-release solid preparation with vinpocetine as active ingredient

A vinpocetine, slow-release solid technology, applied in the field of medicine, can solve the problems of low patient compliance and frequent drug administration

Inactive Publication Date: 2011-12-21
FUKANGREN BIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] However, the current clinical oral vinpocetine common preparations require frequent administration and low patient compliance, so the development of sustained-release vinpocetine preparations is in line with clinical needs

Method used

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  • A kind of oral sustained-release solid preparation with vinpocetine as active ingredient
  • A kind of oral sustained-release solid preparation with vinpocetine as active ingredient
  • A kind of oral sustained-release solid preparation with vinpocetine as active ingredient

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Embodiment 1 Vinpocetine sustained-release tablet

[0035] Make 1000 Vinpocetine slow-release tablets with the raw materials of following weight ratio

[0036] Extended release partial prescription:

[0037]

[0038] Sustained release part preparation process:

[0039] 1. Pass succinic acid through a 100-mesh sieve, crush vinpocetine, pass through a 100-mesh sieve, and set aside.

[0040] 2. Take carnauba wax, stearic acid, and succinic acid, heat in a water bath at 90°C, stir, and melt, add succinic acid, stir evenly, add vinpocetine, and stir evenly. Stirring was continued, the water bath was removed, and the mass was allowed to cool. A waxy lump was obtained.

[0041] 3. Pulverize the waxy block obtained above, pass through a 60-mesh sieve, add microcrystalline cellulose, pregelatinized starch, and colloidal silicon dioxide, and mix well.

[0042] 4. Add magnesium stearate / SDS (94 / 6) as a lubricant and mix well.

[0043] 5. Prepare 6% Opadry common coating a...

Embodiment 2

[0045] Embodiment 2 Vinpocetine slow-release dry suspension

[0046] Extended release partial prescription:

[0047]

[0048]

[0049] Sustained release part preparation process:

[0050] 1. Pass succinic acid through a 100-mesh sieve, crush vinpocetine, pass through a 100-mesh sieve, and set aside.

[0051] 2. Take carnauba wax, stearic acid, and succinic acid, heat in a water bath at 90°C, stir, and melt, add succinic acid, stir evenly, add vinpocetine, and stir evenly. Stirring was continued, the water bath was removed, and the mass was allowed to cool. A waxy lump was obtained.

[0052] 3. Crush the waxy block obtained above, pass through a 60-mesh sieve, add microcrystalline cellulose, pregelatinized starch, and colloidal silicon dioxide, mix well, add water-based soft materials, extrude and spheronize to make pellets, During the spheronization process, talcum powder is continuously added, and the particle size is 0.5-1.0mm. Sustained-release pellets 1 were obtai...

Embodiment 3

[0069] Embodiment 3: common tablet

[0070] Make 1000 Vinpocetine tablets with the raw materials of following weight ratio

[0071] prescription:

[0072]

[0073] Preparation Process:

[0074] 1. Crush Vinpocetine, pass through a 100-mesh sieve, and set aside.

[0075] 2. Take microcrystalline cellulose and lactose, grind them through a 60-mesh sieve, and set aside.

[0076] 3. Take microcrystalline cellulose, lactose, vinpocetine, and HPMC K4M and mix them uniformly using the method of equal volume increments. Use purified water as a binder to make soft materials, granulate with 24 sieves, dry at 60°C, and control the moisture at 3-5%, granulated with 40 mesh sieve.

[0077] 4. Add magnesium stearate as a lubricant and mix well. Tablet.

[0078] 5. Carry out film coating to above-mentioned plain tablet.

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Abstract

The invention relates to an oral sustained-release solid preparation with vinpocetine as an active ingredient. It is an oral sustained-release solid preparation made from vinpocetine and its salts and pharmaceutically acceptable auxiliary materials through preparation technology. The oral sustained-release solid preparations involved in the present invention include but not limited to tablets, capsules, granules and sustained-release pellets. The quality is stable, controllable, safe and effective.

Description

technical field [0001] The invention relates to an oral sustained-release solid preparation with vinpocetine as the main component. It is a solid preparation made from vinpocetine and pharmaceutically acceptable auxiliary materials through preparation technology. The oral sustained-release solid preparation of the invention is stable in quality, controllable, safe and effective. It belongs to the field of medical technology. Background technique [0002] Vinpocetine (vinpoeetine.VIN) is a derivative of the indole alkaloid vincamine extracted from the vinca flower of the family Apocynaceae. Chemical name: ethyl(13as,13bs)-13a-ethyl-2,3,5,6-13a,13b hexahydro-1H-indole[3,2,1-de]pyridine[3,2,1 -ij][1,5]-naphthyridine-12-carboxylic acid, chemical structural formula: [0003] [0004] Vinpocetine is a brain circulation metabolism improving agent, which can selectively improve brain blood circulation, promote brain energy metabolism, regulate the function of neurotransmitter...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K9/22A61K9/52A61K31/4375A61K47/44A61K47/38A61K47/36A61K47/34A61K47/32A61P9/00A61P25/00
Inventor 不公告发明人
Owner FUKANGREN BIO PHARMA
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