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Voglibose film and preparation method thereof

A technology of voglibose and film preparations, which is applied in the direction of medical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc. It can solve problems such as embarrassment in taking medicine, affecting curative effect, and easy to forget. To achieve the effects of accelerated dissolution, high product added value, and fast onset of action

Active Publication Date: 2010-06-16
SHANGHAI MODERN PHARMA ENG INVESTIGATION CENT +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The in vitro dissolution rate of ordinary tablets is only about 83% in 30 minutes; the in vitro dissolution rate of dispersible tablets in 5 minutes is only about 40%, and it takes 15 minutes for complete dissolution, which affects the curative effect to varying degrees.
Moreover, voglibose is taken before meals, 3 times a day, which is extremely inconvenient for patients, especially on business trips and social occasions, where it is easy to forget or be ashamed to take the medicine

Method used

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  • Voglibose film and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0070] The prescription quantity is 5000 tablets (0.2mg specification) or 3333 tablets (0.3mg specification);

[0071] Voglibose 1g

[0072] Polyvinyl alcohol (PVA) 56g

[0073] Plasticizer Glycerin 10g

[0074] Titanium dioxide 2g

[0075] Aspartan 2g

[0076] Preparation:

[0077] Take voglibose and add 200ml of distilled water to dissolve, add glycerin and aspartame, stir to dissolve completely, then add titanium dioxide to make the dispersion uniform, then add PVA (molecular weight 130,000 Daltons), stir to form a solution, pass 80-mesh sieve to remove insoluble matter and vacuum defoaming. Then stretch the membrane solution on a stainless steel belt, dry at 80°C, emboss with an embossing roller, cut it into a certain size, peel it off from the stainless steel belt, and seal the package.

Embodiment 2

[0079] The prescription quantity is 7500 tablets (specification 0.2mg) or 5000 tablets (specification 0.3mg)

[0080] Voglibose 1.5g

[0081] Polymer film-forming material HPC 62.5g

[0082] Polymer film-forming material PEO 30g

[0083] Plasticizer PEG 400 3g

[0084] Acesulfame K 2g

[0085] Chlorophyll 1g

[0086] Dissolve the pigment chlorophyll in 10ml of ethanol, stir and mix with voglibose, HPC (molecular weight 80,000 Daltons), PEO (molecular weight 200,000 Daltons), PEG 400 and acesulfame potassium, heat to 100°C, melt , the embossing roller is extruded into a film and embossed, and cooled. After cutting into a certain size, it is sealed and packaged.

Embodiment 3

[0088] The prescription quantity is 50,000 tablets (0.3mg specification)

[0089] Voglibose 15g

[0090] Polymer film-forming material HPMC 50g

[0091] Plasticizer triacetin 18g

[0092] Plasticizer Tween-80 2g

[0093] Titanium dioxide 5g

[0094] Flavor xylitol 10g

[0095] Preparation:

[0096] Take voglibose and add 300ml of distilled water to dissolve, add glycerin, Tween-80 and xylitol, stir to dissolve, then add titanium dioxide to make the dispersion even, then add HPMC (molecular weight 20,000 Daltons), stir to form a solution, Pass through an 80-mesh sieve to remove insoluble matter, and place it overnight for vacuum degassing. Then spread the film solution on the plastic film, dry at 60°C, emboss with an embossing roller, cut into a certain size, peel off the plastic film, and seal the package.

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Abstract

The invention discloses a voglibose film and a preparation method thereof. The voglibose film comprises the following components by weight percent: 0.2-15% of voglibose, 40-99.8% of high molecular filming material, 0-20% of plasticizer, 0-5% of titanium pigment and 0-20% of flavouring agent, wherein the molecular weight of the high molecular filming material is 20000-300000. The invention is the voglibose film prepared by a solid dispersion technology, the medicine is highly dispersed in a carrier material and is encircled by the sufficient molecules of the carrier material, the high dispersivity of the medicine is ensured, the dissolving out of the medicine is quickened, the medicine enters the digestive tract along with saliva quickly, and the medicine effect is exerted.

Description

technical field [0001] The invention relates to a voglibose preparation. Background technique [0002] Diabetes is a condition in which blood sugar rises and there is sugar in the urine due to insufficient insulin in the body. Diabetes patients can be divided into insulin-dependent (type 1, namely IDDM) and non-insulin-dependent (type 2, namely NIDDM), and type 2 diabetes accounts for more than 80% of diabetic patients. At present, the treatment of type 1 diabetes is mainly insulin therapy; type 2 diabetes is treated with drugs, with the main goal of lowering blood sugar levels and alleviating symptoms. An important force emerging in the oral hypoglycemic drug market. [0003] Voglibose is an α-glucosidase inhibitor. Its mechanism of action is to competitively inhibit maltase, isomaltase, glycosidase, etc. on the intestinal mucosa to reduce the decomposition of disaccharides to monosaccharides. It leads to a reduction in the formation of D-glucose, thereby delaying the di...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K31/133A61K47/34A61K47/38A61K47/32A61K47/36A61P3/10A61K47/10
Inventor 陈芳侯惠民王健于垂亮夏怡然
Owner SHANGHAI MODERN PHARMA ENG INVESTIGATION CENT
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