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Sodium valproate injection, preparation method and applications thereof

A technology of sodium valproate and injection, which is applied in the fields of pharmaceutical formula, active ingredients of anhydride/acid/halide, drug delivery, etc., and can solve the problems that the safety and stability of valproic acid injection prescriptions have no reference significance, etc. Achieve excellent safety, low manufacturing cost, and simple configuration

Inactive Publication Date: 2016-06-08
SICHUAN CREDIT PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Among them, the first document discloses oral liquid, and it only examines the content changes of sodium valproate, which has no reference significance for the safety and stability of valproic acid injection prescriptions; the second document mentions The Sodium Valproate Injection is only limited to the pharmacological research of animals, and has not been used in humans, let alone the stability and safety issues when used in humans.

Method used

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  • Sodium valproate injection, preparation method and applications thereof
  • Sodium valproate injection, preparation method and applications thereof
  • Sodium valproate injection, preparation method and applications thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0050] prescription:

[0051]

[0052] Adjust the pH to 7.9;

[0053] Preparation method: dissolve the pH adjuster with water for injection, add sodium valproate, dissolve and stir evenly, supplement the pH adjuster / water for injection, adjust the pH value and the amount of water for injection, add 0.1% activated carbon for injection, and refill the filtrate Filter with a 0.22 μm filter membrane, divide the obtained medicinal solution into separate packages, and sterilize it by autoclaving.

Embodiment 2

[0055] prescription:

[0056]

[0057] Adjust the pH to 8.0;

[0058] Preparation method: with embodiment 1.

Embodiment 3

[0060] prescription:

[0061]

[0062] Adjust the pH to 8.1;

[0063] Preparation method: with embodiment 1.

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PUM

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Abstract

The invention provides a sodium valproate injection, which is prepared from sodium valproate (active component), a pH adjuster, and injection water, wherein the pH of the injection is 7.9 to 8.1. The invention also provides a preparation method of the injection. The provided sodium valproate injection does not contain any stabilizer or antiseptic, so the defect that in the prior art, the safety of auxiliary materials is uncontrollable in clinic is overcome, and thus the safety of injection is guaranteed. Moreover, the injection is nonirritant and is insoluble in blood, the clinical safety can be ensured, the manufacturing cost of the sodium valproate injection is low, and the safety is excellent. Compared with sodium valproate injections, which contains or does not contain a stabilizing agent and is in other pH range, the experiment data of six month accelerated stability and twelve month long term stability of prepared sodium valproate injection is better.

Description

technical field [0001] The invention relates to a sodium valproate injection. 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 solid powder with strong hygroscopicity. This product is white crystalline powder or granules, slightly smelly of valproic acid, hygroscopic, easily soluble in water, easily soluble in ethanol, almost insoluble in acetone. This product is highly hygroscopic and will increase in weight after absorbing moisture. In order to improve its hygroscopicity, a small amount of organic acid is usually added to sodium valproate to form a complex between the two. The pKa is 4.6, and the pH value of 5% aqueous solution is 7.5-9.0. [0003] Clinically, sodium valproate is an antiepileptic drug with a broad antiepileptic spectrum and can be used to treat petit mal seizures, myoclonic seizures, generalized seizures,...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/19A61P25/08
Inventor 何勤陈刚李晓莉李文婕
Owner SICHUAN CREDIT PHARMA