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A kind of sodium valproate compound

A technology of sodium valproate and compounds, applied in the separation/purification of carboxylic acid compounds, active ingredients of anhydrides/acids/halides, organic chemistry, etc., can solve problems such as medical accidents, patient danger, and increased impurities

Active Publication Date: 2019-04-16
SICHUAN CREDIT PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This is because sodium valproate is very easy to absorb moisture during storage and transportation, resulting in the degradation of the main drug and the increase of impurities.
For injection products, the impurity content needs to be strictly controlled, otherwise it will not only affect the efficacy of the medicine, but also bring danger to the patient and cause medical accidents.

Method used

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  • A kind of sodium valproate compound
  • A kind of sodium valproate compound
  • A kind of sodium valproate compound

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Sodium valproate of the present invention is prepared according to the following steps:

[0041] A, pretreatment: get sodium valproate crude product 3kg, be dissolved in 15L water for injection, after fully dissolving, add the activated carbon of 0.1%g / mL, heat and stir, activated carbon is filtered and removed, obtain sodium valproate clarified aqueous solution, Then pass through a 0.22μm microporous membrane, and then pack in vials;

[0042] B. Pre-freezing: Put all the bottles in step (1) into a freeze dryer at -18°C, keep for 2 hours, continue to cool down to -45°C, and keep for 2 hours;

[0043] C. Freeze-drying: Continue vacuuming to 20Pa, then gradually increase the temperature of the plate to -30°C, and keep for 40 hours; then gradually increase the temperature of the plate to 0°C, and keep for 15 hours; then continue to increase the temperature of the plate to 15°C, keep for 5 hours;

[0044] D. Secondary drying: Continue vacuuming to 20Pa, then gradually inc...

Embodiment 2

[0046] Sodium valproate of the present invention is prepared according to the following steps:

[0047] A, pretreatment: get sodium valproate crude product 3kg, be dissolved in 17L water for injection, after treating fully dissolving, add the gac of 0.1%g / mL, heat and stir, gac is filtered and removed, get sodium valproate clarified aqueous solution, Then pass through a 0.22μm microporous membrane, and then pack in vials;

[0048] B. Pre-freezing: Put all the bottles in step (1) into a freeze dryer at -10°C, keep for 1 hour, continue to cool down to -40°C, and keep for 3 hours;

[0049] C. Freeze-drying: Continue vacuuming to 20Pa, then gradually increase the temperature of the plate layer to -10°C, and keep for 20 hours; then gradually increase the temperature of the plate layer to -5°C, and keep for 10 hours; then continue to increase the temperature of the plate layer to 10°C for 2 hours;

[0050] D. Secondary drying: Continue vacuuming to 20Pa, then gradually increase th...

Embodiment 3

[0052] Sodium valproate of the present invention is prepared according to the following steps:

[0053] A, pretreatment: get sodium valproate crude product 3kg, be dissolved in 20L water for injection, after fully dissolving, add the activated carbon of 0.1%g / mL, heat and stir, activated carbon is filtered and removed, obtain sodium valproate clarified aqueous solution, Then pass through a 0.22μm microporous membrane, and then pack in vials;

[0054] B. Pre-freezing: Put all the bottles in step (1) into a freeze dryer at -50°C and keep for 3 hours;

[0055] C. Freeze-drying: Continue to vacuumize to 20Pa, then gradually increase the temperature of the plate to -25°C for 30 hours; then gradually increase the temperature of the plate to -10°C and keep for 3 hours; then continue to increase the temperature of the plate to 5°C, keep for 6 hours;

[0056] D. Secondary drying: Continue vacuuming to 20Pa, then gradually increase the temperature of the plate layer to 35°C, and keep ...

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Abstract

The invention discloses a sodium valproate compound, which is characterized in that the compound exists in the form of crystal form IV, and also discloses a preparation method and application of the compound, as well as a pharmaceutical composition containing the compound. The crystal form of the sodium valproate of the present invention is characterized by good stability, low endotoxin, low hygroscopicity and moisture content, and improved water solubility and product appearance.

Description

technical field [0001] The invention provides a sodium valproate compound, specifically provides crystal form IV of the sodium valproate compound, and belongs to the field of medicine. Background technique [0002] Sodium valproate belongs to the sodium salt of saturated fatty acid, and its chemical name is 2-valproic acid sodium. It is a first-line broad-spectrum antiepileptic drug widely used clinically. Seizures, partial motor seizures, absence seizures and infantile spasms, etc., can also be used for the prevention and treatment of personality and behavioral disorders caused by epilepsy. In addition, it has been reported that the drug is also very effective in the treatment of diseases such as mania and depression. [0003] The mechanism of action of sodium valproate is related to the inhibition of voltage-sensitive sodium ion channels. It inhibits the metabolism of γ-aminobutyric acid, increases the accumulation of γ-aminobutyric acid in the brain, and achieves the ef...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07C53/128C07C51/42A61K31/19A61P25/08A61P25/18A61P25/24
Inventor 傅霖李文婕陈刚
Owner SICHUAN CREDIT PHARMA
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