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Sodium valproate injection

A technology of sodium valproate and injection, applied in the direction of anhydride/acid/halide active ingredients, drug delivery, medical preparations of non-active ingredients, etc., can solve medical accidents, affect drug efficacy, and have no valproic acid Sodium injection and other issues

Active Publication Date: 2016-02-17
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.
[0007] At present, there is no sodium valproate injection in the domestic market, and there is no literature report on sodium valproate injection

Method used

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  • Sodium valproate injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] prescription:

[0047]

[0048] Adjust the pH to 4.8;

[0049] Preparation:

[0050] Add the prescribed amount of EDTA-2NaCa and sodium valproate into the water for injection, stir to dissolve completely, adjust the pH value of the solution to 7.6, then dilute the volume with water for injection to the required concentration; then add activated carbon for injection Stir for 30 minutes, filter with a 0.22 μm filter membrane, divide the obtained medicinal solution into separate packages, and sterilize by autoclaving to obtain the product.

Embodiment 2

[0052] prescription:

[0053]

[0054] Adjust the pH to 8.2;

[0055] Preparation method: with embodiment 1.

Embodiment 3

[0057] prescription:

[0058]

[0059]

[0060] Adjust the pH to 7.6;

[0061] Preparation method: with embodiment 1.

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Abstract

The invention provides a sodium valproate injection. The sodium valproate injection is composed of sodium valproate, a stabilizing agent, a pH regulating agent and water for injection, wherein EDTA (ethylene diamine tetraacetic acid)-2NaCa serves as the stabilizing agent. By adoption of the EDTA-2NaCa serving as the stabilizing agent, stability of the sodium valproate injection in preparation and storage is evidently superior to that of sodium valproate injections adopting other stabilizing agents, to be more specific, the sodium valproate injection in preparation and storage is small in pH value variation range, related substances are less increased, and active ingredients are less reduced. Therefore, safety of the sodium valproate injection can be further improved by adoption of the EDTA-2NaCa serving as the stabilizing agent.

Description

technical field [0001] The invention relates to a sodium valproate injection and a preparation method thereof. Background technique [0002] 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, water-soluble crystalline powder with strong hygroscopicity and is suitable for various types of seizures, such as petit mal seizures, focal seizures, psychomotor seizures, mixed seizures Prevention and treatment of seizures, status epilepticus, and personality and behavioral disorders caused by epilepsy. [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 effect of inhibiting the excessive discharge of focal neurons and the spread of abnormal discharge. [0004] At present, sodium...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/19A61K47/18
Inventor 何勤陈健涛林科名李文婕陈刚
Owner SICHUAN CREDIT PHARMA
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