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Hydrobromic acid galanthamine controlled-release dry suspension and preparation method thereof

A technology of galantamine hydrobromide and dry suspension is applied in the directions of pharmaceutical formulations, medical preparations of inactive ingredients, and pharmaceutical combinations, which can solve the problems of poor medication compliance and short action time, and achieve the overcoming technology. difficult effect

Active Publication Date: 2015-02-11
CHANGSHAN BIOCHEM PHARM JIANGSU CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] At present, the galantamine hydrobromide listed at home and abroad is a non-sustained and controlled-release preparation, and the action time is short. It needs to be taken 4 to 6 times a day, which brings a lot of inconvenience to the patients. Because they are elderly, the drug compliance is poor.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] (1) Pulverize 1KG of galantamine hydrobromide and pass through 200 mesh.

[0024] (2) Prepare 1% hydroxypropyl methylcellulose as 500ml

[0025] (3) prepare 10% acrylic resin No. II 400ml

[0026] (4) Start the centrifugal granulation coating machine, turn on the blast, adjust the baffle, add 0.8kg of 200-mesh galantamine hydrobromide into the pot, open the spray gun, and spray hydroxypropyl methylcellulose for 10 minutes Finally, add the remaining galantamine hydrobromide powder while spraying until the particle size is 0.1mm to 0.3mm, stop spraying and adding powder, sieve the obtained particles, and dry at 50°C. Add the dried galantamine hydrobromide granules into the centrifugal granulation coating machine, turn on the spray gun, and spray the acrylic resin liquid until the acrylic resin No. II liquid is sprayed. The prepared granules were dried at 40° C. to obtain galantamine hydrobromide sustained-release granules A. Determination of galantamine hydrobromide co...

Embodiment 2

[0030] (1) Pulverize 1KG of galantamine hydrobromide and pass through a 120-mesh sieve.

[0031] (2) Weigh 600g of acrylic resin II

[0032] (3) Add (1) and (2) respectively to 50% acetone, stir fully, dissolve, and spray dry, control the inlet air temperature from 110°C to 130°C, and the outlet air temperature from 80°C to 90°C to produce hydrogen Galantamine Bromate A Granules. Determination of galantamine hydrobromide content.

[0033] (4) 2500g of gum arabic passed through 80 mesh sieve, 1500g of polyoxysorbate (Tween-60) passed through 80 mesh, 5000g of sodium phosphate passed through 80 mesh, 18000g of sucrose passed through 80 mesh, and a little essence were mixed. Produce B granules.

[0034] (5) According to each dose: A granule contains 20 mg of galantamine hydrobromide, B granule 1500 mg, mixed, sub-packaged to prepare galantamine hydrobromide slow-release dry mixture.

Embodiment 3

[0036] (1) Grind 1KG of galantamine hydrobromide, pass through 200 mesh, add 30 g of micronized talcum powder, and mix well.

[0037] (2) Prepare 0.5% hydroxypropyl methylcellulose as 700ml

[0038] (3) prepare 15% acrylic resin No. II 300ml

[0039] (4) Start the centrifugal granulation coating machine, turn on the blower, adjust the baffle, add 0.7kg of 200-mesh galantamine hydrobromide into the pot, open the spray gun, and spray hydroxypropyl methylcellulose for 8 minutes Finally, add the remaining galantamine hydrobromide powder while spraying until the particle size is 0.1mm to 0.3mm, stop spraying and adding powder, sieve the obtained particles, and dry at 50°C. Add the dried galantamine hydrobromide granules into the centrifugal granulation coating machine, turn on the spray gun, and spray the acrylic resin liquid until the acrylic resin liquid is sprayed. The prepared granules were dried at 40° C. to obtain A granules. Determination of galantamine hydrobromide conte...

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Abstract

The invention relates to a hydrobromic acid galanthamine controlled-release dry suspension and a preparation method thereof. The hydrobromic acid galanthamine controlled-release dry suspension comprises hydrobromic acid galanthamine controlled-release particles A and suspension auxiliary particles B, wherein the diameter of the hydrobromic acid galanthamine controlled-release particles A is 0.05mm-0.6mm, preferably 0.1-0.3mm, and the diameter of the suspension auxiliary particles B is 0.1-0.5mm. The hydrobromic acid galanthamine controlled-release dry suspension is taken once every day and has the grate positive significance in clinical treatment. The suspension auxiliary particles B are skillfully used, so that the technical difficulty of incapability of preparing the hydrobromic acid galanthamine controlled-release dry suspension in the prior art is overcome.

Description

technical field [0001] The invention relates to a galantamine hydrobromide medicine, in particular to a galanthamine hydrobromide slow-release dry suspension and a preparation method thereof. Background technique [0002] Galantamine hydrobromide (Galanthamine or Galantamine) is a phenanthridine alkaloid, which is extracted from the bulbs of daffodils. It is a second-generation reversible and competitive cholinesterase inhibitor. The base is weak, but it can selectively inhibit acetylcholinesterase, can strengthen the cholinergic nerve impulse in the central nervous system, can pass through the blood-brain barrier, and has a long-lasting effect and low toxicity. [0003] Alzheimer's disease - Alzheimer's disease (Alzheimer disease, AD) is a disease with a high incidence among the elderly, which is characterized by the gradual loss of cognitive functions (thinking, memory and reasoning), which seriously affects the daily life and work of patients, not only to patients It bri...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/00A61K31/55A61K47/32A61K47/36A61K47/38A61K47/44A61P25/28
Inventor 陶一飞
Owner CHANGSHAN BIOCHEM PHARM JIANGSU CO LTD