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A kind of preparation method of sodium fructose diphosphate injection

A technology of sodium fructose diphosphate and injection, which is applied in the directions of medical preparations containing active ingredients, pharmaceutical formulations, drug delivery, etc., can solve the problems of reducing acidity, decreasing product purity, increasing osmotic pressure, etc., and achieving a simple and convenient process. Clinical use, good stability

Active Publication Date: 2015-11-11
CISEN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Chinese patent (CN200710032254.1) discloses a preparation method of sodium fructose diphosphate injection. In this method, the liquid is treated with cation exchange resin to reduce acidity, remove metal cations, absorb colored impurities and pyrogens, increase The effect of the clarity of the medicinal solution avoids the disadvantages of reduced product purity, increased osmotic pressure, and impact on drug safety caused by acid radical ions introduced by adjusting the acidity with acid, and provides a high-purity and stable sodium fructose diphosphate injection
However, this method still only removes the impact of impurities on the stability of sodium fructose diphosphate, and the problem of its own stability has not been resolved.

Method used

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  • A kind of preparation method of sodium fructose diphosphate injection
  • A kind of preparation method of sodium fructose diphosphate injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] Example 1: sodium fructose diphosphate injection (10g:50ml).

[0015] Preparation: 1) Cool the water for injection to below 40°C for later use; 2) Prepare 0.05g / mL citric acid solution; 3) Measure 30L of cooled water for injection, fill the water with nitrogen, weigh 10kg of sodium fructose diphosphate, Add and stir to dissolve, adjust the pH value to 3.3 with citric acid solution, add 0.2kg of 20(S)-3-methoxy-panaxadiol to prepare the medicinal solution; 4) add 3kg of activated carbon to the medicinal solution, stir and absorb For 20 minutes, filter and decarbonize, add water for injection to 50L and at the same time adjust to the pH value adjusted in step 3) with citric acid solution; Put it into a glass bottle that has been dried and sterilized at high temperature, stopper it, sterilize it, crimp the cap, and pack it to obtain a finished product.

Embodiment 2

[0016] Example 2: sodium fructose diphosphate injection (10 g: 100 ml).

[0017] Preparation: 1) Cool the water for injection to below 40°C for later use; 2) Prepare 0.05g / mL citric acid solution; 3) Measure 30L of cooled water for injection, fill the water with nitrogen, weigh 10kg of sodium fructose diphosphate, Add and stir to dissolve, adjust the pH value to 3.5 with citric acid solution, add 0.2kg of 20(S)-3-methoxy-panaxadiol to prepare the medicinal solution; 4) add 4kg of activated carbon to the medicinal solution, stir and absorb For 30 minutes, filter and decarbonize, add water for injection to 100L and at the same time adjust to the pH value adjusted in step 3) with citric acid solution; Put it into a glass bottle that has been dried and sterilized at high temperature, stopper it, sterilize it, crimp the cap, and pack it to obtain a finished product.

Embodiment 3

[0018] Example 3: sodium fructose diphosphate injection (10g:50ml).

[0019] Preparation: 1) Cool the water for injection to below 40°C for later use; 2) Prepare 0.05g / mL citric acid solution; 3) Measure 30L of cooled water for injection, fill the water with nitrogen, weigh 10kg of sodium fructose diphosphate, Add and stir to dissolve, adjust the pH value to 3.4 with citric acid solution, add 0.2kg of 20(S)-3-methoxy-panaxadiol to prepare the medicinal solution; 4) add 3kg of activated carbon to the medicinal solution, stir and absorb For 20 minutes, filter and decarbonize, add water for injection to 50L and at the same time adjust to the pH value adjusted in step 3) with citric acid solution; Put it into a glass bottle that has been dried and sterilized at high temperature, stopper it, sterilize it, crimp the cap, and pack it to obtain a finished product.

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Abstract

The invention discloses a method for preparing a fructose diphosphate injection. The method comprises the following steps: (1) cooling injection water to below 40 DEG C for later use; (2) weighing a pH regulating agent, and stirring with injection water to dissolve; (3) weighing 20-80 percent by weight of injection water, introducing nitrogen into water, weighing the prescribed fructose diphosphate, adding, stirring and dissolving the fructose diphosphate, regulating the pH value to be 3-4 by using the pH regulating agent solution, and adding an auxiliary material to prepare q liquid medicine; (4) adding activated carbon into the liquid medicine, stirring and adsorbing for 10-40 minutes, filtering and decarburizing, adding the injection water to a prescribed amount, and simultaneously regulating the pH value the same as that in the step (3) by using the pH regulating agent solution; (5) sampling to inspect, filtering with a microfiltration membrane of 0.22 micron after the sample is qualified, filling into a glass bottle which is baked and sterilized at high temperature, plugging, sterilizing, capping and packaging to obtain a finished product. Compared with the prior art, the fructose diphosphate injection prepared by the method is simple in process, safe and reliable, good in stability and convenient in clinical application.

Description

technical field [0001] The invention belongs to the technical field of medicine preparation, 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 has the ability to regulate the activity of several enzymes in sugar metabolism, restore and improve cell metabolism. Level. 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 an...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/7024A61P9/10
Inventor 石井岗王静杜艺伟
Owner CISEN PHARMA
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