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Divalproex sodium sustained-release agent composition and preparation method thereof

A technology of sodium divalproex and composition, which is applied in the directions of drug combination, anhydride/acid/halide active ingredient, pharmaceutical formulation, etc., can solve the problems of easy caking, difficult continuous production, easy sticking and flushing, etc. Long-lasting effect, reduced tablet size, and ease of administration

Inactive Publication Date: 2016-04-06
JS INNOPHARM (SHANGHAI) LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, divalproex sodium is easy to aggregate, and it is easy to agglomerate during long-term storage. At the same time, the melting point of divalproex sodium is 90-100 ° C, and it is easy to stick and punch during the tableting process, making continuous production difficult.

Method used

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  • Divalproex sodium sustained-release agent composition and preparation method thereof

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Experimental program
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Effect test

Embodiment 1

[0049] Embodiment 1: Preparation of divalproex sodium sustained-release tablet

[0050] Table 1 divalproex sodium sustained-release tablet (200 tablets) formula

[0051] Element

[0052] Preparation method: first weigh stearic acid, heat and melt, add divalproex sodium in the prescribed amount, stir evenly, add microcrystalline cellulose to granulate, cool to room temperature, pass through a 30-mesh sieve, and add lubricant magnesium stearate And silicon dioxide, tablet that is.

Embodiment 2

[0053] Embodiment 2: Preparation of divalproex sodium sustained-release tablet

[0054] Table 2 divalproex sodium sustained-release tablet (200 tablets) formula

[0055] Element

Dosage (200 tablets)

divalproex sodium

100.0g

hydrogenated castor oil

25.0g

microcrystalline cellulose

20.0g

Magnesium stearate

2.0g

silica

1.5g

[0056] Preparation method: first weigh 25.0g of hydrogenated castor oil, heat to 85°C, and continue to stir to melt, add the prescribed amount of divalproex sodium, mix well, add microcrystalline cellulose, stir and cool to room temperature, pass through 30 mesh Sieve, add lubricant magnesium stearate and silicon dioxide, and compress into tablets.

[0057] Under the conditions of USPII, 100rpm and 37°C, the drug release profile in the 0.1Mol / L hydrochloric acid of the sustained-release tablet can be found in figure 1 .

Embodiment 3

[0058] Embodiment 3: the preparation of divalproex sodium sustained-release tablet

[0059] Table 3 divalproex sodium sustained-release tablets (200 tablets) formula

[0060] Element

[0061] Preparation method: first weigh 25.0g of hydrogenated castor oil, heat to 85°C, and continue to stir to melt, add the prescription amount of divalproex sodium, a mixture of microcrystalline cellulose and lactose, stir evenly and cool to room temperature, pass 30 Mesh sieve, add lubricant magnesium stearate and silicon dioxide, and press into tablets to obtain.

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Abstract

The invention provides a divalproex sodium sustained-release agent composition. The composition comprises divalproex sodium accounting for 60 to 80% of the total weight of the composition, a sustained-release material accounting for 10 to 39% of the total weight of the composition and a lubricating agent accounting for 1 to 10% of the total weight of the composition, wherein the sustained-release material is one selected from the group consisting of stearic acid, hydrogenated castor oil, glyceryl behenate, palm wax and mixtures of the above-mentioned substances, and the lubricating agent is one selected from the group consisting of magnesium stearate, silica, talcum powder and mixtures of the above-mentioned substances. The invention also provides a preparation method for the divalproex sodium sustained-release agent composition. The composition is simple in formula, needs no accessory materials like a binder and a disintegrating agent essential in conventional preparation production and provides a sustained-release preparation with stable curative effect, long-lasting action and convenience in administration for clinical practice. Compared with the prior art, the invention has the following advantages: the preparation method for a divalproex sodium sustained-release tablet is simple and effective and can be easily scaled-up.

Description

technical field [0001] The invention relates to a divalproex sodium slow-release agent composition and a preparation method thereof. Divalproex sodium is dispersed in the matrix sustained-release material to improve drug release behavior and provide a better preparation for clinical use. Background technique [0002] Epilepsy is a chronic disease with recurrent seizures, protracted course, and sudden brain dysfunction. It is characterized by sudden abnormal high-frequency discharge of brain neurons and spreading to the surroundings. Epilepsy is one of the oldest human diseases. Depending on the location of the neurons, the clinical manifestations are also different. The types of seizures are divided into partial seizures, generalized seizures, and generalized tonic-clonic seizures. [0003] Divalproex sodium is a drug listed after sodium valproate and valproic acid for the treatment of epilepsy, migraine and mania. The three are hydrolyzed in the body to produce valproate ...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K31/20A61K47/44A61K47/14A61P25/08A61P25/06A61P25/18
Inventor 张劲涛张军波
Owner JS INNOPHARM (SHANGHAI) LTD
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