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Fructose diphosphate sodium sterile powder injection and preparation method thereof

A technology of sodium fructose diphosphate and sterile powder injection, which is applied in the field of medicine and can solve the problems of easy bonding of hygroscopic surfaces, unfavorable storage and transportation, and poor stability, so as to save resources, improve drug stability, and reduce hygroscopicity. Effect

Active Publication Date: 2015-07-08
HAINAN GENERAL & KANGLI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, there are 4 dosage forms of sodium fructose diphosphate in clinical use, which are solution, powder injection, capsule and tablet. Tablets and capsules of sodium fructose diphosphate are poorly absorbed and their efficacy is affected. And the solution of sodium fructose diphosphate, although administration is more convenient than powder injection, because sodium fructose diphosphate itself has the characteristic of carbohydrate substance, the stability of liquid state is relatively poor, also is unfavorable for storage and transportation, so in recent years powder The use of injections is on the rise year by year, which lays the foundation for the production of powder injections
However, freeze-dried sodium fructose diphosphate has strong hygroscopicity in the air, easy bonding on the surface, and poor stability.
Although CN101953793A solves this problem, it needs to quote the organic solvent acetone for crystallization, washing, etc., which is not environmentally friendly and has high cost

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] A kind of sodium fructose diphosphate sterile powder injection, the formula is as follows:

[0029] Sodium fructose diphosphate 750g,

[0030] Polyethylene glycol 15-hydroxystearate 80g,

[0031] Vitamin C 40g.

[0032] Dissolve sodium fructose diphosphate and vitamin C with 1000 mL of water for injection; then add polyethylene glycol 15-hydroxystearate and stir to dissolve evenly; continue stirring, add 1 g of activated carbon for needles at the same time, stir for 30 minutes, and filter to remove carbon; use 0.22 Sterilize and filter with μm microporous membrane, dehydrate and dry. The obtained aseptic sodium fructose diphosphate powder can be divided into 2.5 grams, 5 grams, 7.5 grams or 10 grams of infusion bottles of different specifications.

Embodiment 2

[0034] The difference between this embodiment and embodiment 1 is that the formula is different:

[0035] Sodium fructose diphosphate 700g,

[0036] Polyethylene glycol 15-hydroxystearate 90g,

[0037] Vitamin C 20g.

Embodiment 3

[0039] The difference between this embodiment and embodiment 1 is that the formula is different:

[0040] Sodium fructose diphosphate 800g,

[0041] Polyethylene glycol 15-hydroxystearate 70g,

[0042] Vitamin C 30g.

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PUM

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Abstract

The invention provides fructose diphosphate sterile sodium powder injection comprising fructose 60-100 parts of diphosphate sterile sodium, 5-10 parts of 15-hydroxystearic acid macrogol ester and 1-5 parts of vitamin C. The invention further provides a preparation method of the fructose diphosphate sterile sodium powder injection. The preparation method comprises: dissolving diphosphate sterile sodium, 15-hydroxystearic acid macrogol ester and glucose in injection water by stirring, decoloring, filtering, sterilizing and drying to obtain the fructose diphosphate sterile sodium powder injection. The fructose diphosphate sterile sodium powder injection provided by the invention is unlikely adhered on the surface, and is good in liquidity and small in hygroscopicity in the air, thereby improving the medicine stability and facilitating the preparation production; no organic solvent is used, thereby saving resources, lowering the cost and reducing the environmental pollution; the fructose diphosphate sterile sodium powder injection is simple to prepare and is suitable for industrial production.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a sterile powder injection of sodium fructose diphosphate and a preparation method thereof. Background technique [0002] Fructose diphosphate (fructose-1,6-diphosphate, FDP) is a cell metabolite present in the human body, which can regulate the activity of various enzyme systems in glucose metabolism, improve the state of cell hypoxia and ischemia, and is beneficial to damage Recovery of liver cells. When the phosphate concentration in the circulating blood is lower than the normal concentration, it will cause phosphorus metabolism disorder, usually showing symptoms such as hemolysis, fatigue, weakness and convulsions, which is called hypophosphatemia (hypophosphatemia, also known as hypophosphatemia) ). There are many reasons for hypophosphatemia. Long-term infusion (glucose) can increase the uptake of phosphate by cells, which can lead to hypophosphatemia; long-term use of ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/7024A61P3/12A61P9/10
Inventor 王志涛王海树曹俊林小雪
Owner HAINAN GENERAL & KANGLI PHARMA
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