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Preparation method of fructose diphosphate sodium injection

A technology of sodium fructose diphosphate and injection, which is applied in the field of medicine, can solve problems such as product purity reduction, free phosphate content exceeding the standard, and osmotic pressure increase, so as to solve the problem of excessive free phosphate, improve safety and purity, and improve Effects on Quality and Safety

Active Publication Date: 2018-01-19
广东宏远集团药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

And if the pH of the sodium fructose diphosphate solution is regulated by adding an acid regulator, it is necessary to solve the problems such as reduced product purity and an increase in osmotic pressure brought by the acid regulator added
[0004] In addition, high-temperature sterilization is still used in the production process of sodium fructose diphosphate injection. Under high temperature conditions, sodium fructose diphosphate is prone to produce free phosphate, resulting in excessive free phosphate content in the injection after sterilization. Affect the quality of the injection
However, if sterilization is carried out at a lower temperature, the effectiveness of sterilization cannot be guaranteed.

Method used

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

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Embodiment 1

[0020] Embodiment 1, sodium fructose diphosphate injection prescription of the present invention (in 1000 bottles)

[0021] Prescription 1: Sodium fructose diphosphate 5kg, sodium bisulfite 1 / 10000 (w / v), 50% NaOH solution and water for injection 50000ml.

[0022] Prescription 2: sodium fructose diphosphate 10kg, sodium bisulfite 1 / 10000 (w / v), 50% NaOH solution and water for injection 100000ml.

Embodiment 2

[0023] Embodiment 2, preparation technology of sodium fructose diphosphate injection of the present invention

[0024] A) Weigh fructose diphosphate sodium according to prescription 1, add water for injection to dissolve, the liquid passes through 732 type cation exchange resin, replace until the pH of the liquid drops to 2.5, add sodium bisulfite, stir and mix well, then add activated carbon Adsorption, decarbonization;

[0025] B) Heat the above-mentioned decarbonized medicinal solution at 80°C for 0.5h; then heat at 55°C for 0.5h; finally heat at 40°C for 0.5h, add sterile sodium hydroxide solution after sterilization Adjust the pH to 3.9-4.2, and after passing the inspection, pack it separately to get the product.

Embodiment 3

[0026] Embodiment 3, preparation technology of sodium fructose diphosphate injection of the present invention

[0027] The difference between Example 3 and Example 2 is that step A) is replaced until the pH of the medicinal solution drops to 2.2, and the remaining parameters and operations are as in Example 2.

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Abstract

The invention belongs to the field of medicine, and more specifically relates to a preparation method of a fructose diphosphate sodium injection. The method mainly comprises the following steps: liquid medicine passes through 732 type cation exchange resin, after the pH value of the liquid medicine is reduced to 2.0-3.0, gradient cooling and disinfection are carried out. One key point of the technology is utilization of cation exchange resin for reducing acidity of the liquid medicine, and the problems of reduction of injection purity due to introduction of acidity conditioning agents, increasing of osmotic pressure, and the like are avoided, at the same time, impurities in the liquid medicine are removed, and quality and safety of the medicine are substantially improved. The other key point is that utilization of cation exchange resin reduces pH value of the liquid medicine to the largest extent, and at the same time, gradient cooling and disinfection are combined in order to solve the problem that the content of injection free phosphate exceeds the standard due to high temperature disinfection, further safety and purity of the medicine are improved.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a preparation method of sodium fructose diphosphate injection. Background technique [0002] Fructose diphosphate (FDP) is an important intermediate metabolite in the process of glucose glycolysis in the body. It exists in the cells of the human body and all other higher animals and plants. It can regulate the activity of several enzymes in sugar metabolism and restore and improve the molecular level of cell metabolism. . Exogenous fructose diphosphate can act on the cell membrane, by activating phosphofructokinase on the cell membrane, increasing the concentration of high-energy phosphate bonds and adenosine triphosphate in the cell, thereby promoting the influx of potassium ions, restoring the resting state of cells, and increasing the concentration of diphosphate in red blood cells The content of glyceric acid inhibits the release of oxygen free radicals and histamine, whi...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/7024A61K47/02A61K47/32A61P3/12A61L2/04
Inventor 黄金维罗四通邓小兰罗广生蒋琼毛锐强
Owner 广东宏远集团药业有限公司
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