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Orally disintegrated sodium ferulate tablet and its prepn process

The technology of oral disintegrating tablet and sodium ferulate is applied in the field of sodium ferulate oral disintegrating tablet and its preparation field, which can solve the problems such as the research report of sodium ferulate oral disintegrating tablet which has not been seen, and is suitable for industrialization. Large-scale production, simple preparation method and fast onset effect

Inactive Publication Date: 2005-12-14
SECOND MILITARY MEDICAL UNIV OF THE PEOPLES LIBERATION ARMY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But at present, there is no research report about sodium ferulate orally disintegrating tablets

Method used

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  • Orally disintegrated sodium ferulate tablet and its prepn process
  • Orally disintegrated sodium ferulate tablet and its prepn process

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Embodiment 1 freeze-drying method prepares sodium ferulate orally disintegrating tablet

[0021] Components and ratio (w / w%)

[0022] Sodium Ferulate 40

[0023] Sodium carboxymethyl starch 5

[0024] Microcrystalline Cellulose 10

[0025] Lactose 23

[0026] Sucrose 20

[0027] Aspartame 1.5

[0028] Orange flavor 0.5

[0029] Preparation:

[0030] Suspend sodium ferulate, sodium carboxymethyl starch, microcrystalline cellulose, lactose, sucrose, aspartame, and orange essence in appropriate amount of water, stir for 1 hour to make a suspension, and pour it into the tablet mold , carry out freeze-drying, freeze-drying and forming, pressing and sealing, and packaging.

[0031] The resulting freeze-dried product has a loose structure, suitable acidity and sweetness on the tongue, no gritty feeling, a disintegration time of 5 seconds, and a 100% dissolution time of 4 minutes.

Embodiment 2

[0032] Embodiment 2 freeze-drying method prepares sodium ferulate orally disintegrating tablet

[0033] Components and ratio (w / w%)

[0034] Sodium Ferulate 15

[0035] Low-substituted hydroxypropyl cellulose 10

[0036] Microcrystalline Cellulose 20

[0037] Lactose 33.8

[0038] pregelatinized starch 20

[0039] Cyclamate 1

[0040] Cherry essence 0.2

[0041] Preparation:

[0042] Suspend sodium ferulate, low-substituted hydroxypropyl cellulose, microcrystalline cellulose, lactose, pregelatinized starch, cyclamate, and cherry essence in appropriate amount of water, stir for 1 hour to make a suspension, and pour it into In the tablet mold, freeze-drying is carried out, and after freeze-drying and molding, it is compressed and sealed, and packed.

[0043] The resulting freeze-dried product has a loose structure, suitable acidity and sweetness on the tongue, no gritty feeling, a disintegration time of 5 seconds, and a 100% dissolution time of 4 minutes.

Embodiment 3

[0044] Embodiment 3 powder direct compression method prepares sodium ferulate orally disintegrating tablet

[0045] Components and ratio (w / w%)

[0046] Sodium Ferulate 25

[0047] Crospovidone 8

[0048] Microcrystalline Cellulose 20

[0049] Lactose 19

[0050] Mannitol 23.5

[0051] Micronized silica gel 2

[0052] Magnesium Stearate 1

[0053] aspartame 1

[0054] Orange flavor 0.5

[0055] Preparation:

[0056]Pass sodium ferulate, crospovidone, microcrystalline cellulose, lactose, and mannitol through an 80-mesh sieve, and mix them with micropowder silica gel, magnesium stearate, aspartame, and orange essence in equal amounts, and directly Tablet forming, packaging.

[0057] The obtained orally disintegrating tablet has a cooling sensation on the tongue, suitable acidity and sweetness, and no gritty feeling. The disintegration time is 47 seconds, and the 100% dissolution time is 10 minutes, all of which meet the requirements of the Pharmacopoeia.

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Abstract

The present invention relates to medicine preparation technology, and is one kind of orally disintegrated sodium ferulate tablet for treating coronary heart disease, cerebral vascular diseases, angeitis and other diseases and its preparation process. The orally disintegrated sodium ferulate tablet consists of sodium ferulate as active component in 10-50 wt% and pharmaceutically acceptable supplementary material including disintegrating agent, stuffing, adhesive, lubricant and corrective in 50-90 wt%. It may be prepared through freeze drying process, direct powder tabletting process or wet tabletting process with different supplementary material being selected. The orally disintegrated sodium ferulate tablet has fast leaching, easy swallowing and other advantages, and is especially suitable for old patients with dysphagia.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, and relates to a sodium ferulate orally disintegrating tablet and a preparation method thereof. Background technique [0002] Sodium ferulate (sodium ferulate) is the sodium salt of ferulic acid, the main component of traditional Chinese medicine extracts such as angelica and chuanxiong. disease treatment. The curative effect is definite, and its marketed oral dosage form is common tablet. However, sodium ferulate tablets are insoluble in the stomach. According to the dissolution test of sodium ferulate tablets in the 2005 edition of "Chinese Pharmacopoeia", it is found that commercially available sodium ferulate tablets (Chengdu Hengda Pharmaceutical Co., Ltd., batch number 040804) Only 10% of the drug dose is dissolved in the artificial gastric juice in 45 minutes, which affects the absorption of the drug in the body, and the drug takes effect slowl...

Claims

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Application Information

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IPC IPC(8): A61K31/192
Inventor 胡晋红张立超
Owner SECOND MILITARY MEDICAL UNIV OF THE PEOPLES LIBERATION ARMY
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