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Method for preparing fructose diphosphate injection

A technology of sodium fructose diphosphate and injection, which is applied in the directions of medical preparations, pharmaceutical formulations, and drug delivery containing active ingredients, can solve the problems of product purity decline, acidity reduction, and osmotic pressure increase, and achieves good stability, Ease of clinical use and simple process

Active Publication Date: 2014-04-23
CISEN PHARMA
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  • 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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  • Method for preparing fructose diphosphate injection
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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 use; 2) Prepare a 0.05g / mL citric acid solution; 3) Measure 30L of cold water for injection, fill the water with nitrogen, and 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-ginsengdiol to prepare the medicinal solution; 4) Add 3kg of activated carbon to the medicinal solution, stir and absorb After 20 minutes, filter and decarbonize, add water for injection to 50L and adjust to the pH value adjusted in step 3) with citric acid solution at the same time; 5) take a sample and test, and then filter with a 0.22 micron microporous membrane after passing the test. Put it into a glass bottle sterilized by high-temperature drying, stoppering, sterilizing, capping, and packaging to obtain a finished product.

Embodiment 2

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

[0017] Preparation: 1) Cool the water for injection to below 40°C for use; 2) Prepare a 0.05g / mL citric acid solution; 3) Measure 30L of cold water for injection, fill the water with nitrogen, and weigh 10kg of sodium fructose diphosphate. Add stirring to dissolve, adjust the pH value to 3.5 with citric acid solution, add 0.2kg of 20(S)-3-methoxy-ginsengdiol to prepare the medicinal solution; 4) Add 4kg of activated carbon to the medicinal solution, stir and absorb After 30 minutes, filter and decarbonize, add water for injection to 100L and adjust to the pH value adjusted in step 3) with citric acid solution at the same time; 5) take a sample and test, and then filter with a 0.22 micron microporous filter membrane after passing the test. Put it into a glass bottle sterilized by high-temperature drying, stoppering, sterilizing, capping, and packaging 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 use; 2) Prepare a 0.05g / mL citric acid solution; 3) Measure 30L of cold water for injection, fill the water with nitrogen, and weigh 10kg of sodium fructose diphosphate. Add stirring to dissolve, adjust the pH value to 3.4 with citric acid solution, add 0.2kg of 20(S)-3-methoxy-ginsengdiol to prepare the medicinal solution; 4) Add 3kg of activated carbon to the medicinal solution, stir and absorb After 20 minutes, filter and decarbonize, add water for injection to 50L and adjust to the pH value adjusted in step 3) with citric acid solution at the same time; 5) take a sample and test, and then filter with a 0.22 micron microporous membrane after passing the test. Put it into a glass bottle sterilized by high-temperature drying, stoppering, sterilizing, capping, and packaging 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 medical preparation, and specifically relates to a preparation method of sodium fructose diphosphate injection. Background technique [0002] Fructose diphosphate (FDP) is an important intermediate metabolite in the body's glycolysis process. It exists in the human body and all other higher animal and plant cells. It has the activity of regulating several enzymes in sugar metabolism, restoring and improving cell metabolism. Level. Exogenous fructose diphosphate can act on the cell membrane. By activating the phosphofructokinase on the cell membrane, it increases the concentration of high-energy phosphate bonds and adenosine triphosphate in the cell, thereby promoting potassium ion influx, restoring the cell's resting state, and increasing red blood cell diphosphate The content of glyceric acid inhibits the release of oxygen free radicals and histamine. It is beneficial to cell energy metabolism and the utiliz...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/7024A61P9/10
Inventor 石井岗王静杜艺伟
Owner CISEN PHARMA
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