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

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Example Embodiment

[0049] Example 1: Preparation of divalproex sodium sustained-release tablets

[0050] Table 1 Formula of divalproex sodium sustained-release tablets (200 tablets)

[0051] Ingredients

[0052] Preparation method: firstly weigh the stearic acid and heat it to melt, add the prescription amount of sodium divalproate, stir evenly, add and granulate with microcrystalline cellulose, cool to room temperature, pass through a 30-mesh sieve, add lubricant magnesium stearate And silicon dioxide, ready to be obtained by pressing.

Example Embodiment

[0053] Example 2: Preparation of divalproex sodium sustained-release tablets

[0054] Table 2 Formula of divalproex sodium sustained-release tablets (200 tablets)

[0055] Ingredients

[0056] 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 sodium divalproex, mix well, add microcrystalline cellulose, stir and cool to room temperature, pass 30 mesh Sieve, add lubricant magnesium stearate and silicon dioxide, and press to get it.

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

Example Embodiment

[0058] Example 3: Preparation of divalproex sodium sustained-release tablets

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

[0060] Ingredients

[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 sodium divalproate, microcrystalline cellulose and lactose mixture, stir evenly and cool to room temperature, over 30 Mesh sieve, add lubricant magnesium stearate and silicon dioxide, and press the tablet to obtain it.

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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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