A kind of compound fructose diphosphate sodium fructose orally disintegrating tablet and preparation method thereof

A technology of sodium fructose diphosphate and orally disintegrating tablets is applied in the directions of pharmaceutical formulations, medical preparations containing active ingredients, drug delivery, etc., which can solve the problems of high production cost, long disintegration time, large equipment investment, etc. Hardness, good clinical effect, friability reduction effect

Active Publication Date: 2019-04-30
SHANGHAI SUNTECH PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Among them, the disadvantages of the freeze-drying method and the solid solution method are that the equipment investment is relatively large, the process is more complicated, the yield rate is low, and the production cost is high; the disadvantage of the wet granulation tablet method is that the disintegration time is relatively long

Method used

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  • A kind of compound fructose diphosphate sodium fructose orally disintegrating tablet and preparation method thereof
  • A kind of compound fructose diphosphate sodium fructose orally disintegrating tablet and preparation method thereof
  • A kind of compound fructose diphosphate sodium fructose orally disintegrating tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Embodiment 1 compound fructose diphosphate sodium fructose orally disintegrating tablet:

[0034]

[0035] Note: The borneol is removed during heating and drying.

[0036] Preparation:

[0037] (1) Separately pulverize sodium fructose diphosphate, fructose and borneol, and pass each through a 60-mesh sieve.

[0038] (2) Weigh 70 g of sucralose, 70 g of colloidal silicon dioxide, 140 g of sodium lauryl sulfate and 300 g of microcrystalline cellulose and mix them.

[0039] (3) Add 2500g of sodium fructose diphosphate, 1250g of fructose, 1830g of microcrystalline cellulose, 800g of crospovidone, and 700g of borneol to the above mixture, mix well, then add 40g of magnesium stearate and mix well, and obtain the total powder before tableting. mixture.

[0040] (4) Put the total mixture into a tablet press, and press into tablets to obtain compound fructose diphosphate sodium fructose tablets (10,000 tablets).

[0041] (5) Coating the above-mentioned tablet in a coating...

Embodiment 2

[0045]

[0046]

[0047] NOTE: The borneol is removed in drying.

[0048] Preparation:

[0049] (1) Separately pulverize sodium fructose diphosphate, fructose and borneol, and pass each through a 60-mesh sieve.

[0050] (2) Weigh 70 g of sucralose, 70 g of colloidal silicon dioxide, 140 g of sodium lauryl sulfate and 300 g of microcrystalline cellulose and mix them.

[0051] (3) Add 2,500 g of sodium fructose diphosphate, 1,250 g of fructose, 1,830 g of microcrystalline cellulose, 800 g of crospovidone, and 1,050 g of borneol to the above mixture, mix well, then add 40 g of magnesium stearate, mix well, and obtain the total powder before tableting. mixture.

[0052] (4) Put the total mixture into a tablet press, and press into tablets to obtain compound fructose diphosphate sodium fructose tablets (10,000 tablets).

[0053] (5) Coating the above tablet in a coating pan to obtain compound fructose diphosphate sodium fructose orally disintegrating tablets.

[0054] The...

Embodiment 3

[0057]

[0058]

[0059] NOTE: The borneol is removed in drying.

[0060] Preparation:

[0061] (1) Separately pulverize sodium fructose diphosphate, fructose and borneol, and pass each through a 60-mesh sieve.

[0062] (2) Weigh 70 g of sucralose, 70 g of colloidal silicon dioxide, 140 g of sodium lauryl sulfate and 300 g of microcrystalline cellulose and mix them.

[0063] (3) Add 2,500 g of sodium fructose diphosphate, 1,250 g of fructose, 1,830 g of microcrystalline cellulose, 800 g of crospovidone, and 1,400 g of borneol to the above mixture, mix well, then add 40 g of magnesium stearate, mix well, and obtain the total powder before tableting. mixture.

[0064] (4) Put the total mixture into a tablet press, and press into tablets to obtain compound fructose diphosphate sodium fructose tablets (10,000 tablets).

[0065] (5) Coating the above tablet in a coating pan to obtain compound fructose diphosphate sodium fructose orally disintegrating tablets.

[0066] The...

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PUM

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Abstract

The invention provides compound sodium fructose diphosphate and fructose orally disintegrating tablets. The compound sodium fructose diphosphate and fructose orally disintegrating tablets are prepared from the following ingredients in percentage by weight: 10-60% of sodium fructose diphosphate, 5-30% of fructose, 5-30% of sublimable substance, 0.5-3% of a surfactant, 4-20% of a disintegrating agent, 0.5-3.0% of a flow aid, 0.5-3.0% of a lubricant, 20.0-58% of a diluent, 0.2-2% of a corrigent, and 3-8% of a coating material. The invention further provides a preparation method of the compound sodium fructose diphosphate and fructose orally disintegrating tablets. The preparation method comprises the following steps: mixing the active ingredients, namely sodium fructose diphosphate and fructose, and pharmaceutical excipients, wherein the sublimable substance is added into the pharmaceutical excipients, tabletting the mixture, coating the obtained semi-finished product tablets, heating the semi-finished product tablets after coating, and drying, thus the sublimable substance sublimates, a plurality of holes are formed in the tablets, and finally, the tablets capable of rapidly disintegrating and with certain strength are obtained. The orally disintegrating tablets can rapidly disintegrate, so that good clinical effects can be obtained; the preparation method is easy and convenient to operate, is suitable for industrial production, and has a large application value.

Description

technical field [0001] The invention relates to pharmaceutical preparations, in particular to a compound fructose diphosphate sodium fructose orally disintegrating tablet and a preparation method thereof. Background technique [0002] Sodium Fructose Diphosphate Compound Fructose is composed of two active ingredients: sodium fructose diphosphate and fructose. Sodium fructose diphosphate is fructose-1,6 diphosphate trisodium salt octahydrate with the chemical formula C 6 h 11 Na 3 o 12 P 2 .8H 2 O, the molecular weight is 550.17, fructose is β-D-fructopyranose, and the chemical formula is C 6 h 12 o 6 , Molecular weight 180.16, Fructose Diphosphate Sodium Tablets currently on the market are common oral tablets, clinical indications are adjuvant treatment of myocardial ischemia, angina pectoris, and cerebral infarction. The latest research shows that compound fructose diphosphate sodium fructose can be used for the treatment of epilepsy. Epilepsy is a common, frequent...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/7024A61K9/36A61P25/08A61K31/7004
Inventor 钱晓明黄献华刘学军陈历胜
Owner SHANGHAI SUNTECH PHARMA
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