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Preparation method of fructose sodium diphosphate powder injection

A technology of sodium fructose diphosphate and powder injection, which is applied in the preparation of sugar derivatives, chemical instruments and methods, sugar derivatives, etc. It can solve the problems of high equipment requirements, poor absorbability, poor stability, etc., and achieve improved yield and quality Stability, economical production process, and the effect of reducing allergenicity

Inactive Publication Date: 2020-12-22
HAINAN HUALON PHARM
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Oral preparations of sodium fructose diphosphate are poorly absorbed by the gastrointestinal tract, which affects drug efficacy. Although injections are more convenient to administer than powder injections, because sodium fructose diphosphate itself has the characteristics of carbohydrates, the stability of liquid Poor and not conducive to storage and transportation, so the use of powder injections is on the rise in recent years
[0004] Freeze-dried sodium fructose diphosphate has strong hygroscopicity in the air, is easy to stick on the surface, and has poor stability. However, most of the existing aseptic packaging preparations have low yield, high impurity content, and unstable product quality. question
Invention patent 201210288458.2 provides an improved production method of sodium fructose diphosphate aseptic powder, which can efficiently prepare aseptic quality products, but requires the use of hollow fiber membrane ultrafiltration modules and integrated vacuum rotary drying equipment. more demanding
Invention application 201010614727.0 discloses a process for producing sodium fructose diphosphate aseptic powder under high temperature and high concentration conditions, but research shows that sodium fructose diphosphate produced under this condition will produce more impurities and the product purity is low

Method used

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  • Preparation method of fructose sodium diphosphate powder injection
  • Preparation method of fructose sodium diphosphate powder injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030]1) Put 5kg of crude fructose diphosphate and 25L of water for injection in a clean container for stirring and dissolving, and then add 100g of activated carbon to the container for decolorization and stirring. The stirring time is 25 minutes;

[0031]2) Decarburize and filter the solution to obtain a filtrate, and rinse the filtered activated carbon with 5L of water for injection, combine the rinsed solution with the filtrate, and perform sterile filtration to obtain a crude solution of sterile sodium fructose diphosphate;

[0032]3) Control the temperature of the crystallization tank to 25°C, add 18L of sterilized 95% ethanol to it, and then mix the crude sodium fructose diphosphate solution obtained in step 2) with 24L of sterilized Water ethanol is added to the above 95% ethanol, the stirring speed is 90r / min, the dripping time of the absolute ethanol is 2h, after the addition, it is allowed to stand for 1 hour for crystal growth;

[0033]4) Add 60L of absolute ethanol to the crysta...

Embodiment 2

[0036]1) Put 100kg of crude fructose diphosphate sodium and 250L of water for injection in a clean container for stirring and dissolving, and then add 2kg of activated carbon to the container for decolorization and stirring. The stirring time is 30 minutes;

[0037]2) Decarburize and filter the solution to obtain a filtrate, and rinse the filtered activated carbon with 50L of water for injection, combine the rinsed solution with the filtrate, and perform sterile filtration to obtain a crude solution of sterile sodium fructose diphosphate;

[0038]3) Control the temperature of the crystallization tank to 20°C, add 60L of sterilized 95% ethanol to it, and then mix the crude sodium fructose diphosphate solution obtained in step 2) with 420L of sterilized Water ethanol is added to the above 95% ethanol, the stirring speed is 65r / min, the dripping time of absolute ethanol is 2.5h, and after the addition, it is allowed to stand for 2 hours for crystal growth;

[0039]4) Add 600L of absolute ethano...

Embodiment 3

[0042]1) Put 30kg of crude fructose diphosphate and 50L of water for injection in a clean container for stirring and dissolving, and then add 600g of activated carbon to the container for decolorization and stirring. The stirring time is 35 minutes;

[0043]2) Decarburize and filter the solution to obtain a filtrate, and rinse the filtered activated carbon with 10L of water for injection, combine the rinsed solution with the filtrate, and perform sterile filtration to obtain a crude solution of sterile sodium fructose diphosphate;

[0044]3) Control the temperature of the crystallization tank to 16°C, add 24L of sterilized 95% ethanol to it, and then mix the crude sodium fructose diphosphate solution obtained in step 2) with 144L of sterilized Water and ethanol were simultaneously added to the above 95% ethanol, the stirring speed was 50r / min, and the dripping time of the absolute ethanol was 1.5h, after the addition, it was allowed to stand for 1.5 hours for crystal growth;

[0045]4) Add 1...

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PUM

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Abstract

The invention discloses a preparation method of a fructose sodium diphosphate powder injection. According to the method, the yield and quality stability of fructose sodium diphosphate are effectivelyimproved by adopting the modes such as accurately proportioning a ratio of a solute and a solvent, adjusting an addition amount of ethanol, and controlling crystallization temperature and stirring speed in the preparation process. According to the preparation method, seed crystals do not need to be added in the recrystallization process, and the preparation method has the advantages of simple andconvenient operations and simplified production steps. The purity of fructose sodium diphosphate produced by the preparation method is also improved, and the sensitization of fructose sodium diphosphate is reduced.

Description

Technical field[0001]The present invention belongs to the field of pharmacy. More specifically, the present invention relates to a method for refining crude sodium fructose diphosphate, which can be used to prepare sodium fructose diphosphate powder injection.Background technique[0002]Fructose 1,6-diphosphate (FDP) is a cellular metabolite that exists in the human body and can regulate the activity of various enzymes in glucose metabolism. Exogenous fructose diphosphate can increase the concentration of adenosine triphosphate and creatine phosphate in cells, promote potassium influx, increase the content of diphosphoglycerate in red blood cells, inhibit oxygen free radicals and histamine release and other pharmacological effects, and can reduce The damage of the body caused by ischemia and hypoxia, especially for ischemic heart disease, shows a good protective effect. Both fructose diphosphate and glucose have the effect of directly supplying heat energy, replenishing body fluids an...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07H11/04C07H1/06
CPCC07H1/06C07H11/04
Inventor 陈益智陈雪君
Owner HAINAN HUALON PHARM
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