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Sodium valproate pharmaceutical composition

A technology of sodium valproate and its composition, which is applied in the field of medicine, can solve the problems of slow dissolution, injection pain, poor drug redissolution, etc., and achieve good stability

Active Publication Date: 2016-03-09
长春海悦药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Sodium valproate for injection sold on the market is a freeze-dried product, which has the following defects and deficiencies: ①The medicine is not freeze-dried well, and its appearance is loose and uneven; Slow and incomplete dissolution; such shortcomings will bring the following hazards to clinical medication: undissolved particles embolize blood vessels; undissolved particles stimulate blood vessels and cause phlebitis; injection pain, etc.

Method used

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  • Sodium valproate pharmaceutical composition
  • Sodium valproate pharmaceutical composition
  • Sodium valproate pharmaceutical composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0072] Dissolve 115g of sodium valproate, 0.1g of disodium edetate, and 5g of sodium sulfite in 161g of dimethylacetamide, add 52g of propylene glycol, adjust the pH to 8.3 with trishydroxyaminomethane, and treat with 0.05% activated carbon. Filter, add water for injection to 1000ml, pot, and sterilize at 100°C for 30 minutes.

Embodiment 2

[0074] Dissolve 115g of sodium valproate and 5g of sodium sulfite in 167g of dimethylacetamide, add 62g of propylene glycol, adjust the pH value to 8.4 with trishydroxyaminomethane, treat with 0.05% activated carbon, filter, add water for injection to 1000ml, and potting , 100 ℃ flow-through sterilization for 30 minutes.

Embodiment 3

[0076] Dissolve 115g of sodium valproate, 0.25g of disodium edetate, and 5g of sodium sulfite in 173g of dimethylacetamide, add 70g of propylene glycol, adjust the pH to 8.5 with trishydroxyaminomethane, and treat with 0.05% activated carbon. Filter, add water for injection to 1000ml, pot, and sterilize at 100°C for 30 minutes.

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Abstract

The present invention belongs to the technical field of medicine, and provides a pharmaceutical composition containing sodium valproate, wherein the pharmaceutical composition comprises sodium valproate, dimethyl acetamide, propylene glycol, trishydroxy aminomethane and an antioxidant. The present invention provides the new pharmaceutical composition containing the sodium valproate injection, and a preparation method of a preparation of the pharmaceutical composition containing the sodium valproate injection. According to the present invention, the wherein the pharmaceutical composition is suitable for mass production, and has good stability.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a pharmaceutical composition containing sodium valproate and a preparation thereof. Background technique [0002] Sodium valproate is a first-line broad-spectrum antiepileptic drug. The chemical structural formula is as follows: [0003] [0004] The chemical name of sodium valproate is 2-sodium valproate, molecular formula: C 8 h 15 NaO 2 , with a molecular weight of 166.2, is a white, odorless, crystalline water-soluble powder. It is a better antiepileptic drug and is suitable for various epilepsy (petit mal seizures, focal epilepsy, psychomotor seizures and mixed seizures) and The prevention and treatment of personality and behavior disorder caused by epilepsy can be prepared into oral preparations and injection preparations. At present, the specifications of oral preparations include tablet: 100mg, 200mg, syrup: 5ml: 200mg, 500mg. Sodium valproate can be...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/19A61K47/18A61K9/08
Inventor 韩翠娟郝昕程琳琳
Owner 长春海悦药业股份有限公司