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Enteric medicinal composition for treating diabetes and preparation method thereof

A composition and anti-diabetic technology, which can be used in drug combinations, pharmaceutical formulas, sugar-coated pills, etc., can solve the problems of gastric irritation of the main drug, achieve uniform drug release, good quality controllability, and reduce individual differences

Active Publication Date: 2008-06-04
北京利龄恒泰药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The enteric-coated pharmaceutical composition of the present invention solves the problem of gastric irritation of the main drug and effectively reduces individual differences

Method used

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  • Enteric medicinal composition for treating diabetes and preparation method thereof
  • Enteric medicinal composition for treating diabetes and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Embodiment 1: the preparation of blank ball core

[0022] Get the microcrystalline cellulose 400g that crosses 80 mesh sieves, place in the centrifugal type one-step granulation coating pot, take 475ml water as binder, set the host speed to be 330r / min, the spray pump speed to be 25r / min, The injection pressure of the spray gun is 0.15MPa, the injection flow rate is 12L / min, and the centrifugal granulation is carried out. After the binder was added, the chassis continued to roll for 1 min to form microcrystalline cellulose core particles. Dry at 60°C for 2 hours.

[0023] Pass the dried microcrystalline cellulose core particles through a 26-mesh sieve, take the core particles under the sieve and pass through a 35-mesh sieve to obtain core particles with a particle size between 610 μm and 750 μm, weigh them, and calculate the average composition. The pellet rate was 61.8% (n=10).

Embodiment 2

[0024] Embodiment 2: ball core spraying medicine

[0025] Metformin Hydrochloride 250g

[0026] Hydroxypropyl Methyl Cellulose 20cps 10g

[0027] Talc powder 25g

[0028] water 800ml

[0029] Preparation process: Take 250g of metformin hydrochloride, 5g of hydroxypropyl methylcellulose, add 800ml of water, dissolve with slight heat under stirring, slowly add 25g of talcum powder before coating, and stir to form a suspension. Take 110 g of the blank pellet core prepared in Example 1 and place it in a fluidized bed one-step granulation coating pan. g / min. The above-mentioned medicinal solution is applied to the drug coating under the stirring state, and the drying is continued for 2 minutes after the coating is completed. Weighing, the calculated drug application rate is 94.5%, and the pellet adhesion degree is 3.4%.

[0030] Drug loading rate%=[(total weight of pellets-amount of blank pellet core-amount of binder) / dosage amount]×100%.

[0031] Degree of adhesion = (total...

Embodiment 3

[0032] Embodiment 3: ball core spraying medicine

[0033] Metformin Hydrochloride 250g

[0034] Hydroxypropyl Methyl Cellulose 6cps 10g

[0035] Talc powder 25g

[0036] water 800ml

[0037]Preparation process: Take 250g of metformin hydrochloride, 10g of hydroxypropyl methylcellulose, add 800ml of water, dissolve with slight heat under stirring, slowly add 25g of talcum powder before coating, and stir to form a suspension. Take 110g prepared in Example 1 and place it in a fluidized bed one-step granulation coating pot, set the air inlet temperature at 60°C, the air pressure at 0.35bar, the atomization pressure at 1.5bar, and the spray rate at 7.5g / min . The above-mentioned medicinal solution is applied to the drug coating under the stirring state, and the drying is continued for 2 minutes after the coating is completed. Weigh, and calculate drug application rate and degree of adhesion by the method in embodiment 2, the drug application rate is 97.6%, and the degree of ad...

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Abstract

The invention discloses a biguanide anti-diabetes medicine, in particular to a metformin hydrochloride enteric-coated medicine compound. The medicine compound is provided with a. a hollow pill core; b. a biguanide anti-diabetes medicine active component layer which is covered outside the hollow pill core; c. an enteric-coated layer which is covered outside the biguanide anti-diabetes medicine active component layer. The invention also discloses a method of preparing the medicine compound.

Description

technical field [0001] The invention relates to a pharmaceutical composition for treating diabetes and a preparation method thereof. In particular, it relates to a biguanide drug, especially an enteric-coated pharmaceutical composition of metformin hydrochloride and a preparation method thereof. Background technique [0002] Diabetes is a common endocrine disease. It is the third disease with the highest disability rate and fatality rate after cardiovascular disease and cancer. It has seriously endangered human health. Oral drugs for the treatment of type 2 diabetes are mainly divided into four categories, namely sulfonylureas, biguanides, α-glucosidase inhibitors and insulin sensitizers. The hypoglycemic effect of biguanide drugs is due to inhibiting the uptake of glucose by intestinal wall cells, promoting glycolysis and inhibiting hepatic gluconeogenesis, which will not cause hypoglycemia, and are widely used clinically. Such drugs include benzene Among phenformin, metf...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K9/28A61K31/155A61K47/30A61P3/10
Inventor 颜弘叶晓辉
Owner 北京利龄恒泰药业有限公司
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