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Divalproex sodium sustained release tablets and preparation method thereof

A technology of sodium divalproex and sustained-release tablets, which can be applied in pharmaceutical formulations, medical preparations with inactive ingredients, anhydride/acid/halide active ingredients, etc., and can solve the volume of oral sustained-release preparations of sodium divalproex. It is difficult to swallow and other problems, and achieves the effect of reducing internal and external differences, the process is simple, and the process is easy to implement.

Active Publication Date: 2011-08-03
ZHONGSHUAI PHARMA SCI & TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Another object of the present invention is to solve the problem that divalproex sodium oral sustained-release preparations are too large and difficult to swallow

Method used

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  • Divalproex sodium sustained release tablets and preparation method thereof
  • Divalproex sodium sustained release tablets and preparation method thereof
  • Divalproex sodium sustained release tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0060] Prescription for 1000 divalproex sodium extended-release tablets

[0061]

[0062]

[0063] Preparation process and process (oscillating granulator granulation method):

[0064] Take the prescribed amount of medicine, microcrystalline cellulose, hydroxypropyl cellulose, carbomer, Starch, and calcium hydrogen phosphate, pass through an 80-mesh sieve, mix in a mixer for 1 hour, and set aside. Take an appropriate amount of 15% povidone solution, spray it into the standby powder and stir to make a soft material. Turn on the oscillating granulator, pass the soft material through a 24-mesh screen, extrude to form granules of suitable length, place in an oven to dry at 70 degrees Celsius for 60 minutes, check the uniformity and water content, and add the prescribed amount of stearin after passing the test Divalproex sodium and micropowder silica gel are mixed for 1 hour and then added to a tablet press for tableting to obtain divalproex sodium sustained-release tablets....

Embodiment 2

[0066] Prescription for 1000 divalproex sodium extended-release tablets

[0067]

[0068] Appropriate amount of 8% low-viscosity hydroxypropylmethylcellulose aqueous solution

[0069] Preparation process and process:

[0070] The medicine is pulverized with the prescribed amount of medicine, microcrystalline cellulose, hydroxypropyl cellulose, carbomer, Starch, and calcium hydrogen phosphate, and after passing through an 80-mesh sieve, mix it in a stirring mixer for 1 hour, and then mix the powder placed in a fluidized bed. Configure 8% low-viscosity hydroxypropyl methylcellulose aqueous solution, add the prescribed amount of micropowder silica gel and stir to make it into a suspension, and use a fluidized bed for granulation. The fluidized bed granulation process is: peristaltic pump infusion speed is 3ml / min, the pressure of the air compressor is 2Bar, and the air inlet temperature of the fluidized bed is 35°C; after a period of fluidization, take particles with a part...

Embodiment 3

[0072] Prescription for 1000 divalproex sodium extended-release tablets

[0073]

[0074] Preparation Process:

[0075] Preparation process of sustained-release tablet core:

[0076] The medicine is pulverized with the prescribed amount of medicine, microcrystalline cellulose, hydroxypropyl cellulose, lactose, carbomer, Starch, and calcium hydrogen phosphate, and mixed in a stirring mixer for 1 hour after passing through an 80-mesh sieve. Add the magnesium stearate and the talcum powder of recipe quantity, add in the tablet press machine after mixing 0.5 hour in the mixer and carry out direct tableting, both get slow-release tablet.

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Abstract

The invention belongs to the field of medicinal preparations, and particularly relates to divalproex sodium sustained release tablets and a preparation method thereof. The sustained release table comprises divalproex sodium, a retarding agent, a diluent, a disintegrant, a binder, a pH regulating agent, a lubricant, an antiadherent and the like.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a divalproex sodium sustained-release preparation and a preparation method thereof, and the invention also discloses relevant parameters of the preparation process. technical background [0002] Divalproex sodium is a central nervous system drug, also known as di-(2-propylvalerate) sodium hydrogen, which is an ionic compound formed by a molecule of valproic acid and a molecule of sodium valproate. It has the molecular formula: C 16 h 31 o 2 Na. The molecular weight is 310.41, and the structural formula is: [0003] [0004] Divalproex sodium is white fibrous crystal or powder, odorless, slightly astringent taste; slightly hygroscopic. This product is soluble in ethanol, slightly soluble in water, almost insoluble in ether. [0005] Divalproex sodium was originally an antiepileptic drug developed and marketed by Abbot Laboratories. It is a broad-spectrum antiepi...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K31/20A61K47/32A61K47/34A61K47/36A61K47/38A61K47/44A61P25/08
Inventor 孙卫东李学明
Owner ZHONGSHUAI PHARMA SCI & TECH CO LTD
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