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Stable fructose composition preparation and preparation method thereof

A technology of composition and fructose, which is applied in the direction of drug combination, medical preparations of non-active ingredients, non-active ingredients of polymer compounds, etc., can solve the problems of large pH value changes, failure to meet quality requirements, poor stability, etc., to achieve The preparation method is simple, the drug availability is improved, and the safe dosage is large

Inactive Publication Date: 2014-09-03
海南紫竹星药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] In order to overcome the deficiencies of the prior art and solve the problems of the poor stability of fructose injections prepared by the prior art, the increase of related substances after long-term storage, the great change of pH value, and the inability to meet the quality requirements within the validity period, the present invention provides a stable fructose injection The composition preparation and its preparation method solve the above problems, provide more reliable technical support for the use of fructose for injection, improve the safety of clinical medication of fructose injection, and prolong the storage time of injection, which is conducive to industrialized mass production

Method used

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  • Stable fructose composition preparation and preparation method thereof
  • Stable fructose composition preparation and preparation method thereof
  • Stable fructose composition preparation and preparation method thereof

Examples

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Effect test

Embodiment 1

[0044]

[0045] Preparation Process:

[0046] Add sterile β-fructose to the reaction kettle at room temperature and suspend it in water for injection; add sterile glycerin to adjust the pH value and dissolve it completely to obtain an aqueous solution of fructose / glycerin; After adding, adjust the pH value to 6.0 to dissolve all β-fructose; add hydroxypropyl-β-cyclodextrin (HP-β-CD) to the reaction kettle, stir and clathrate for 1.0 hour; add water for injection to dilute to the required quality concentration, then filtered through a 0.45 μm microporous membrane, and finally filtered through a 0.22 μm microporous membrane, subpackaged, and freeze-dried to obtain the fructose freeze-dried powder for injection.

Embodiment 2

[0048]

[0049] Preparation Process:

[0050] Add sterile β-fructose to the reaction kettle at room temperature and suspend it in water for injection; add sterile glycerin to adjust the pH value and dissolve it completely to obtain an aqueous solution of fructose / glycerin; After adding, adjust the pH value to 6.5 to completely dissolve the sterile β-fructose; add hydroxypropyl-β-cyclodextrin (HP-β-CD) to the reaction kettle, stir and clathrate for 1.5 hours; add water for injection to dilute to the The mass concentration is required, then filtered through a 0.45 μm microporous membrane, and finally filtered through a 0.22 μm microporous membrane, and then packaged to obtain fructose injection.

Embodiment 3

[0052]

[0053] Preparation Process:

[0054] Add sterile β-fructose to the reaction kettle at room temperature and suspend it in water for injection; add sterile glycerin to adjust the pH value and dissolve it completely to obtain an aqueous solution of fructose / glycerin; After adding, adjust the pH value to 7.0 to completely dissolve the sterile β-fructose; add hydroxypropyl-β-cyclodextrin (HP-β-CD) to the reaction kettle, stir and clathrate for 2.0 hours; add water for injection to dilute to the The mass concentration is required, then filtered through a 0.45 μm microporous membrane, and finally filtered through a 0.22 μm microporous membrane, subpackaged, and freeze-dried to obtain the fructose freeze-dried powder for injection.

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Abstract

The invention relates to belongs to the field of medicament synthesis and preparation thereof, and relates to the stable fructose composition preparation and preparation method thereof. Aseptic beta-fructose is suspended in water, and aseptic fructose is added for adjusting pH for dissolving the aseptic beta-fructose totally, and the aqueous solution of fructose / glycerin is obtained, and hydroxypropyl-beta-cyclodextrin (HP-beta-CD) is added into the aqueous solution for clathration, and after package and freeze drying, the fructose powder injection for injection is obtained. The preparation method provided by the invention is simple, and the fructose glycerin compound is clathrated by hydroxypropyl-beta-cyclodextrin, thereby the water-solubility and stability of fructose medicament are increased, and the biological availability of the medicament is improved; the preparation technology is simple and is suitable for industrial production.

Description

technical field [0001] The invention relates to an energy and body fluid supplement medicine and a preparation method thereof, in particular to a stable fructose composition and a preparation method thereof, and belongs to the field of pharmaceutical preparations. Background technique [0002] Fructose, chemical name: D-(-)-fructopyranose, molecular formula: C 6 h 12 o 6 , molecular weight: 180.16. It is an intermediate product in the process of glucose metabolism clinically. Exogenous fructose diphosphate can act on the cell membrane to increase the concentration of high-energy phosphate bonds and adenosine triphosphate in the cell by activating phosphofructokinase on the cell membrane, thereby promoting potassium Ion influx restores the resting state of cells, increases the content of diphosphoglycerate in red blood cells, inhibits the release of oxygen free radicals and histamine, and is beneficial to shock, ischemia, hypoxia, tissue damage, extracorporeal circulation,...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K9/08A61K31/7004A61K47/40A61K47/10A61P7/08
Inventor 张宏民
Owner 海南紫竹星药业股份有限公司
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