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Diabetin for injection and its preparation process

A fructose technology for injection, which is applied in the field of fructose for injection and its preparation, can solve the problems of inconvenient transportation and storage, and achieve the effect of convenient transportation and improved stability

Inactive Publication Date: 2005-04-06
灵康药业集团股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This kind of fructose injection is not convenient for transportation and storage

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Put fructose (50g) and absolute ethanol into the reaction bottle at a weight ratio of 1:8 in the batching room of the 10,000-class clean area, slowly heat up to 70°C, stir until the solid dissolves, add 0.25g of medicinal charcoal, and stir for 30 minutes. Filtrate while it is hot, and place the filtrate in a class 100 purification zone for 60 hours to crystallize. Filter the medicinal solution and rinse with 1 times the amount of absolute ethanol. Vacuum drying at 50-55°C for 12 hours to obtain sterile fructose powder;

[0020] Take 12.5g of the above-mentioned sterile fructose powder, sub-pack it in a 100-grade clean area that meets the requirements of GMP at a relative humidity below 45%, and obtain 12.5g / support.

Embodiment 2

[0022] Put fructose (50g) and absolute ethanol into the reaction bottle at a weight ratio of 1:5 in the batching room of the 10,000-class clean area, slowly heat up to 70°C, stir until the solid dissolves, add 0.25g of medicinal charcoal, and stir for 30 minutes. Filtrate while it is hot, and place the filtrate in a class 100 purification zone for 70 hours to crystallize. Filter the medicinal solution and rinse with 1 times the amount of absolute ethanol. Vacuum drying at 50-55°C for 8 hours to obtain sterile fructose powder;

[0023] Get 25g of the above-mentioned sterile fructose powder, sub-pack it in a 100-grade clean area that meets the requirements of GMP at a relative humidity below 45%, and obtain 25g / support.

Embodiment 3

[0025] Put fructose (50g) and absolute ethanol into the reaction bottle at a weight ratio of 1:10 in the batching room of the 10,000-class clean area, slowly heat up to 70°C, stir until the solid dissolves, add 0.25g of medicinal charcoal, and stir for 30 minutes. Filtrate while it is hot, and place the filtrate in a Class 100 purification zone for 80 hours to crystallize. Filter the medicinal solution and rinse with 1 times the amount of absolute ethanol. Vacuum drying at 50-55°C for 9 hours to obtain sterile fructose powder;

[0026] Take 12.5g of the above-mentioned sterile fructose powder, sub-pack it in a 100-grade clean area that meets the requirements of GMP at a relative humidity below 45%, and obtain 12.5g / support.

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PUM

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Abstract

The invention discloses an injection fructose and its preparing method, making fructose and minstra into an injection fructose containing the fructose in weight percent of 50-100%. It is applied to making fluid infusion on the patients in need of supplementing water and energy sources in the condition of insulin resisting or being unsuitable to use glucose because of burns and wounds, operation, infection, etc. It enriches the forms of the fructose, extremely strengthening the drug stability and simultaneously more convenient to transport and store.

Description

technical field [0001] The invention relates to a fructose for injection and a preparation method thereof. Background technique [0002] Fructose is a left-handed six-carbon sugar, which is called fructose because it is widely found in various fruits. After entering the human body, fructose can combine with intestinal mucosal epithelial cell carrier protein and absorb into the body, and then interact with specific fructokinase in the liver, kidney, and small intestine to participate in in vivo metabolism. Fructose is mainly catalyzed by fructokinase in the liver, kidney and small intestine to generate 1-phosphate fructose; in the body, fructose can be converted into glucose or synthetic glycogen, but glucose or synthetic glycogen cannot be reversely converted into fructose; because fructose can bypass glycolysis The rate-limiting enzyme (phosphofructokinase) in the solution, then in the liver, the decomposition rate of fructose is faster than that of g...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K31/70A61K47/10A61P5/50
Inventor 陶灵刚陈胜龙
Owner 灵康药业集团股份有限公司
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