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Fructo-oligosaccharide tablet excipient, medicine tablet and preparation method of medicine tablet

A technology of fructooligosaccharides and excipients, which is applied in the field of medicine, can solve the problems of being unable to be pressed into tablets and high fragility, and achieve the effects of good molding degree, high hydrophilicity, and stable volume

Inactive Publication Date: 2013-07-10
安吉东来药用辅料有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In Example 8, ordinary microcrystalline cellulose was used as an excipient to carry out tablet compression of disodium clometris phosphate tablet. When the tablet compression speed reached 30,000 tablets / hour, the friability was as high as 38%. When reaching 50000 tablets / hour, then can not be compressed into tablet; Carry out the disodium clomedate tablet tabletting with silicified microcrystalline cellulose as excipient, when the tabletting speed reaches 50000 tablets / hour, although the tablet is still Maintain good strength, but the brittleness reaches 2.5%, and the brittleness is still high

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] A kind of anhydrous disodium clometris phosphate medicine tablet, adopts the raw material of following percentage by weight:

[0049] Anhydrous disodium chloromethanediphosphate 800g;

[0050] fructo-oligosaccharide 91g;

[0051] Starch octenyl succinate 3g;

[0052] Silica 3g;

[0053] Kaolin 3g;

[0054] water 100g;

[0055] Dry and pulverize fructooligosaccharides, octenyl starch succinate, silicon dioxide and kaolin together and pass through a 1mm sieve, then add anhydrous disodium chloroformate and water and mix evenly, use 9× in a tableting device 20mm punching machine, made into anhydrous clomedipate disodium pharmaceutical tablets with an average weight of 1180mg (±2%).

Embodiment 2

[0057] A kind of anhydrous disodium clometris phosphate medicine tablet, adopts the raw material of following percentage by weight:

[0058] Anhydrous disodium chloromethanediphosphate 800g;

[0059] fructo-oligosaccharide 94g;

[0060] Starch octenyl succinate 2g;

[0061] Silica 2g;

[0062] Kaolin 2g;

[0063] water 100g;

[0064] Dry and pulverize fructooligosaccharides, octenyl starch succinate, silicon dioxide and kaolin together and pass through a 1mm sieve, then add anhydrous disodium chloroformate and water and mix evenly, use 9× in a tableting device 20mm punching machine, made into anhydrous clomedipate disodium pharmaceutical tablets with an average weight of 1180mg (±2%).

[0065] Prepare the anhydrous chlormedipate disodium pharmaceutical tablet (tablet A) of embodiment 1 and the anhydrous chlormedipate disodium pharmaceutical tablet (tablet B) of embodiment 2 under different tabletting speeds, and investigate Its crushing strength and fragility, the specif...

Embodiment 3

[0071] A kind of anhydrous disodium clometris phosphate medicine tablet, adopts the raw material of following percentage by weight:

[0072] Anhydrous disodium chloromethanediphosphate 800g;

[0073] fructo-oligosaccharide 88g;

[0074] Starch octenyl succinate 4g;

[0075] Silica 4g;

[0076] Kaolin 4g;

[0077] water 100g;

[0078] Dry and pulverize fructooligosaccharides, octenyl starch succinate, silicon dioxide and kaolin together and pass through a 1mm sieve, then add anhydrous disodium chloroformate and water and mix evenly, use 9× in a tableting device 20mm punching machine, made into anhydrous clomedipate disodium pharmaceutical tablets with an average weight of 1180mg (±2%).

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PUM

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Abstract

The invention discloses a fructo-oligosaccharide tablet excipient which includes, by weight, 88% to 96% of fructo-oligosaccharide, 1% to 5% of an octenyl succinic anhydride modified starch, 1% to 5% of silicon dioxide and 1% to 5% of kaolin. The fructo-oligosaccharide tablet excipient is good in liquidity, molding, and demoulding, and can be used for preparing medicine tablets with medicine and water through direct compression. The invention further discloses a medicine tablet which includes, by weight, 75% to 85% of an active pharmaceutical ingredient, 5% to 15% of the fructo-oligosaccharidetablet excipient and 5% to 15% of water. The fructo-oligosaccharide tablet excipient and the active pharmaceutical ingredient have no incompatibility and reaction, have good dissolubility and liquidity, and are suitable for direct compression of various medicines. The invention further discloses a preparation method of the medicine tablet. The preparation method is simple, and easy to implement, operate and control.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a directly compressible and easy-flowing fructo-oligosaccharide tablet excipient prepared by using fructo-oligosaccharide tablet excipient, a drug tablet and a drug tablet prepared by using the fructo-oligosaccharide tablet excipient The preparation method of the agent. Background technique [0002] Tablet accounts for more than one-third of all pharmaceutical dosage forms and is a very important pharmaceutical dosage form. Excipients play a vital role in drug stability and absorption efficiency, and are the core of drug tablet making. Appropriate tablet excipients are required to be safe, non-toxic, have no side effects, have no incompatibility or reaction with the main drug, and have good fluidity, so that the main drug can be dispersed evenly and have a large adsorption force to the main drug. It is suitable for direct tablet compression. The prepared tablet has the advantages of hig...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/36A61K47/26A61K47/02A61K9/20
Inventor 阮晖李青青吴慧斌刘松柏陈放诸文颖
Owner 安吉东来药用辅料有限责任公司
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