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Preparation method of organ preservation solution

A technology for organ preservation solution and preparation process, which is applied in the field of organ preservation solution preparation, and achieves the effects of solving oxidative decomposition, stabilizing the properties of raw materials, and reducing preparation time.

Active Publication Date: 2012-07-04
HUAREN PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Aiming at the problems existing in the prior art, the present invention provides a method for preparing an organ preservation solution, which solves the problem of oxidative decomposition of acetylcysteine ​​in the process of preparation and storage. The preparation method is simple and has good stability.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] The preparation method of the organ preservation solution described in this embodiment:

[0034] (1) Weigh each component in liquid A according to the prescription amount per 2000ml of organ preservation liquid:

[0035] Dextran 40 36g

[0036] Acetylcysteine ​​1.6g

[0037] Sodium hydroxide 0.40g

[0038] First add the prescribed amount of dextran 40 to 60% of the prepared water for injection at 70°C, stir until dissolved, then add an appropriate amount of activated carbon, stir and absorb for 15 minutes, filter and remove carbon for 20 minutes; In the final preparation tank;

[0039] Dissolve the prescribed amount of acetylcysteine ​​and its equimolar sodium hydroxide with an appropriate amount of water for injection to form sodium acetylcysteine ​​and put it into the above-mentioned dextran 40 solution, and dilute to 1000ml with water for injection at 40°C;

[0040] Use hydrochloric acid to adjust the pH value of the liquid to 4.5-5.0, first evacuate to -0.1MPa, ...

Embodiment 2

[0053] (1) Weigh each component in liquid A according to the prescription amount per 2000ml of organ preservation liquid:

[0054] Dextran 40 44g

[0055] Acetylcysteine ​​2.0g

[0056] Sodium hydroxide 0.48g

[0057] First add the prescribed amount of dextran 40 to 60% of the prepared water for injection at 80°C, stir until dissolved, then add an appropriate amount of activated carbon, stir and absorb for 20 minutes, filter and remove carbon for 30 minutes; transfer to the oxygen removal treatment In the final preparation tank;

[0058] Dissolve the prescribed amount of acetylcysteine ​​and its equimolar sodium hydroxide with an appropriate amount of water for injection to form sodium acetylcysteine ​​and put it into the above-mentioned dextran 40 solution, and dilute to 1000ml with water for injection at 30°C;

[0059] Use hydrochloric acid to adjust the pH value of the liquid to 4.5-5.0, first evacuate to -0.1MPa, then fill in nitrogen with a purity ≥ 99.9% to 0.1MPa, an...

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Abstract

The invention provides a preparation method of organ preservation solution, which is characterized by comprising carrying out combination preparation to dextran 40, acetylcysteine and sodium hydroxide, filling, sterilizing, and obtaining product solution A; performing combination preparation to potassium citrate, mannitol, potassium chloride, sodium hydrogen phosphate, sodium dihydrogen phosphate, adenosine and magnesium sulfate, filling, sterilizing, and obtaining product solution B, evenly mixing the solution A and the solution B which are of the same volume, and obtaining the organ preservation solution. First acetylcysteine and sodium hydroxide which are equimolar are dissolved with each other to form sodium acetylcysteine, raw materials are dissolved easily, preparation time is reduced, and the raw materials existing in the form of sodium acetylcysteine are stable in nature. The preparation method solves the problem of oxygenolysis of acetylcysteine in the organ preservation solution in the preparation and storage process, is simple and good in stability.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a method for preparing an organ preservation solution. Background technique [0002] Any clinical organ transplantation first requires high-quality donors, which is the prerequisite and fundamental guarantee for the success of organ transplantation. Although hypothermia and cold ischemia can delay cell death, this process causes organ damage at the beginning, resulting in a series of tissue morphology, physiological and ultrastructural changes, including cell edema, intercellular edema, intracellular Acidification, reperfusion injury, calcium overload, vascular endothelial injury and energy deficiency, etc. After the organ is isolated, the cessation of oxygen supply can trigger the degradation of cells and tissues mediated by superoxide ions, free radicals and nitric oxide molecules, as well as a series of pro-apoptotic events, resulting in cell edema, tissue energy deficiency,...

Claims

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Application Information

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IPC IPC(8): A01N1/02
Inventor 叶芳孙怡王振恒
Owner HUAREN PHARMACEUTICAL CO LTD
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