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Preparation method of glycerin and fructose injection

A technology for injection and fructose, applied in the field of medical injection, can solve the problems of yellowing of solution color, accelerated fructose degradation, damage, etc., and achieve the effect of shortening heating time and reducing degradation

Inactive Publication Date: 2010-02-10
BENGBU BBCA MEDICINE SCI DEV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] In glycerol-fructose injection, fructose is unstable and easy to degrade to produce 5-HMF, which leads to a drop in pH value and a yellowish color of the solution, among which 5-HMF can damage human striated muscles and internal organs, thus causing infusion reactions
The reason for this problem is that the original glycerol-fructose injection process uses hydrochloric acid to adjust the pH value. Fructose is unstable in aqueous solution or during high-temperature sterilization, and is easily degraded to form 5-HMF, which produces [H+], resulting in a drop in pH value. The drop in pH in turn accelerates the degradation of fructose to produce 5-HMF

Method used

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  • Preparation method of glycerin and fructose injection

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Effect test

Embodiment 1

[0025] a) Dissolve 100g of glycerin, 50g of fructose and 9g of sodium chloride in about 170ml of water for injection and fully dissolve.

[0026] b) add activated carbon (weight ratio) accounting for about 2 / 10,000 of the total production amount, boil and stir for 15 minutes, and filter to remove carbon.

[0027] c) Add water for injection to the full amount (1000ml), then add activated carbon accounting for 1 / 10,000 of the total amount produced, stir, and adjust the pH value to 5.2 with acetic acid and sodium acetate (1:1) buffer solution. The full production volume mentioned here refers to the total production volume of a batch.

[0028] d) Intermediate inspection (content: 0.873% to 0.927% of sodium chloride, pH value: 4.7 to 5.2). e) Filtration to remove carbon, fine filtration with a 0.45μm filter, check for foreign matter, and fill after passing the test.

[0029] f) Sterilize with moist heat at 121°C for 10 minutes, and cool quickly.

[0030] Among them, the intermed...

Embodiment 2

[0032] a) Dissolve 100g of glycerin, 50g of fructose and 9g of sodium chloride in about 165ml of water for injection and fully dissolve.

[0033] b) Add activated carbon accounting for about 2 / 10,000 of the total production amount, boil and stir for 15 minutes, and filter to remove carbon.

[0034] c) Add water for injection to the full amount (1000ml), then add activated carbon accounting for about 1 / 10,000 of the total amount produced, stir, and adjust the pH value between 5.2 with lactic acid and sodium lactate (1:1) buffer.

[0035] d) Intermediate inspection (content: 0.873% to 0.927% of sodium chloride, pH value: 4.7 to 5.2).

[0036] e) Filtration to remove carbon, fine filtration with a 0.45μm filter, check for foreign matter, and fill after passing the test.

[0037] f) Sterilize with moist heat at 121°C for 10 minutes, and cool quickly.

[0038] Wherein the intermediate inspection method is with embodiment 1.

Embodiment 3

[0040] a) Dissolve 100g of glycerin, 50g of fructose and 9g of sodium chloride in about 170ml of water for injection and fully dissolve.

[0041] b) Add about 2 / 10,000 activated carbon, boil and stir for 15 minutes, filter to remove charcoal.

[0042] c) Add water for injection to the full amount (1000ml), then add about 1 / 10,000th of the total amount of production of activated carbon, stir, and adjust the pH value between 5.2 with acetic acid and sodium acetate (1:1) buffer solution.

[0043] d) Intermediate inspection (content: 0.873% to 0.927% of sodium chloride, pH value: 4.7 to 5.2).

[0044] e) Filtration to remove carbon, fine filtration with a 0.45μm filter, check for foreign matter, and fill after passing the test.

[0045] f) Sterilize with moist heat at 115°C for 30 minutes, and cool quickly.

[0046] Wherein the intermediate inspection method is with embodiment 1.

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Abstract

The invention relates to a preparation method of glycerin and fructose injection, comprising the following steps: adopting a buffer solution to regulate the pH value of glycerol and fructose aqueous solution to be 4.0 to 5.5, carrying out moist heat sterilization at the temperature of 115 DEG C for 30 minutes or at the temperature of 121 DEG C for 10 minutes after filling, and then cooling. The pHvalue of the glycerin and fructose injection prepared by the preparation method is stable, and the content of 5-HMF is low. The invention adopts the sterilization process of a quick cooling sterilizer, thereby shortening the heating time during the sterilization process and reducing the degradation of fructose.

Description

technical field [0001] The present invention relates to medical injection, in particular, the present invention relates to a kind of preparation method of glycerol-fructose injection. Background technique [0002] Glycerin Fructose Injection is a colorless clear liquid; the taste is slightly sweet and slightly salty. Glycerin fructose injection enters the whole body tissues through the blood, and reaches equilibrium within about 2 to 3 hours after distribution. It enters the cerebrospinal fluid and brain tissue slowly, and the clearance is also slow. Most of it is metabolized into CO 2 and water discharge. Glycerin Fructose Injection is a hyperosmotic preparation. Through hyperosmotic dehydration, it can reduce the water content of the brain and reduce intracranial pressure. The effect of reducing intracranial pressure is slow and lasts for a long time. [0003] In glycerol-fructose injection, fructose is unstable and easy to degrade to produce 5-HMF, which leads to a drop...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/7004A61K47/12A61K47/02A61P7/10A61P25/00A61K31/047
Inventor 陈文婕李晓云赵辉魏珺璇王军吕芳杨廷戴荣欢
Owner BENGBU BBCA MEDICINE SCI DEV
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