Special omeprazole solvent for injection as well as preparation method thereof

A technology for omeprazole and injection, applied in the field of special solvent for omeprazole for injection and its preparation field, can solve the problems of poor water solubility, discoloration, affecting the clinical application of the product, etc., to solve the problem of poor stability and realize large-scale The effect of industrial production

Inactive Publication Date: 2018-11-20
REYOUNG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0003] Omeprazole has poor water solubility, with a solubility of about 0.5 mg / mL. When dissolved in conventional solvents, problems such as precipitation and discoloration occur in a short period of time, which affects the clinical application of the product

Method used

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  • Special omeprazole solvent for injection as well as preparation method thereof
  • Special omeprazole solvent for injection as well as preparation method thereof

Examples

Experimental program
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Embodiment 1

[0033] The special solvent for omeprazole for injection described in present embodiment 1, raw material composition is as follows:

[0034]

[0035] Add water for injection of 2 / 5 of the total volume of the prepared liquid into the preparation tank; when the water temperature drops below 30°C, first add citric acid into the preparation tank and stir to dissolve, then add polyethylene glycol 400, and stir well; Use 1mol / L sodium hydroxide solution to adjust the pH at 4.65; then weigh 0.1% activated carbon in the total volume of the medicinal solution, prepare it into a carbon slurry and add it to the preparation tank, add water for injection to the total volume, circulate and stir for 5 minutes; Activated carbon is filtered out by a 2μm titanium alloy filter; the medicinal liquid is filtered into a closed fine filter tank through a sterilizing filter; Finished product of omeprazole special solvent for injection.

[0036] Through the long-term investigation of the stability ...

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Abstract

The invention belongs to the technical field of medicine and particularly relates to a special omeprazole solvent for injection as well as a preparation method thereof. The special omeprazole solventfor injection comprises the following raw materials: polyethylene glycol 400, citric acid, sodium hydroxide and water for injection. The special omeprazole solvent for injection solves the problem that the omeprazole solution prepared by the conventional method is low in stability, is liable to change color and is liable to degrade. By the preparation method, the industrialized production requirement is met, and large-scale industrialized production can be realized.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a special solvent for omeprazole for injection and a preparation method thereof. Background technique [0002] Omeprazole is a benzimidazole derivative, insoluble in water and easily soluble in alkali; its chemical structure contains a sulfinyl group and is unstable in aqueous solution. The stability of its aqueous solution is easily affected by many factors such as pH value, light, heavy metal ions, oxidants, etc. It is relatively stable under alkaline conditions and easy to decompose under acidic conditions. The decomposition products are sulfone compounds and thioether compounds, which appear discoloration and turbidity , and even precipitation. [0003] Omeprazole has poor water solubility, with a solubility of about 0.5 mg / mL. When dissolved in conventional solvents, problems such as precipitation and discoloration occur in a short period of time, which affects...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/4439A61K47/10A61K47/12A61K47/02A61P1/04
CPCA61K31/4439A61K9/0019A61K9/08A61K47/02A61K47/10A61K47/12A61P1/04
Inventor 苗得足黄京山孙兆宾徐凯
Owner REYOUNG PHARMA
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