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A glycerin and fructose injection and preparation method thereof

A quality control method and technology of glycerin, which can be used in pharmaceutical formulations, medical preparations containing active ingredients, drug delivery, etc., and can solve problems such as backward production technology, unreasonable formulations, and poor stability

Inactive Publication Date: 2006-11-22
曾列丹
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The existing glycerin fructose injection has unreasonable formula, backward production technology and poor stability. Based on the existing technology, we have screened the prescription process of glycerin fructose injection, obtained a new formula, improved technology, the stability is greatly improved

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0071] 1. Prescription research (1000 bottles)

[0072] Glycerin 25kg

[0073] Fructose 12.5kg

[0074] Sodium chloride 2.25kg

[0075] Appropriate amount of water for injection

[0076] Full volume 250L

[0077] 2. Preparation process (1000 bottles)

[0078] a. Take 50L of water for injection, add the prescribed amount of glycerin, fructose and sodium chloride, stir to dissolve;

[0079] b. Then add 0.1% (w / v, 50g) activated carbon for injection by volume, stir well, and heat to about 70°C, stir for 30 minutes, decarbonize by coarse filtration while hot; let cool to room temperature;

[0080] c. Add water for injection to nearly full amount, measure the pH value and content of the solution, and control the pH value between 4.0 and 5.0;

[0081] d. Repeatedly filter with a 0.22 μm microporous membrane until the solution is clear;

[0082] e. The filtrate is filled in 250ml colorless and transparent infusio...

Embodiment 2

[0087] 1. Prescription research (500 bottles)

[0088] Glycerin 25kg

[0089] Fructose 12.5kg

[0090] Sodium chloride 2.25kg

[0091] Appropriate amount of water for injection

[0092] Full volume 250L

[0093] 2. Preparation process (500 bottles)

[0094] a. Take 50L of water for injection, add the prescribed amount of glycerin, fructose and sodium chloride, stir to dissolve;

[0095] b. Then add 0.1% (w / v, 50g) activated carbon for injection by volume, stir well, and heat to about 70°C, stir for 30 minutes, decarbonize by coarse filtration while hot; let cool to room temperature;

[0096] c. Add water for injection to nearly full amount, measure the pH value and content of the solution, and control the pH value between 4.0 and 5.0;

[0097] d. Repeatedly filter with a 0.22 μm microporous membrane until the solution is clear;

[0098] e. The filtrate is filled in 250ml colorless and transparent infusion ...

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PUM

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Abstract

The present invention relates to one kind of glycerine-fructose injection and its preparation process. The injection in 250 liters consists of glycerine fructose in 25 kg, fructose in 12.5 kg, sodium chloride in 2.25 kg and water for injection for the rest, and may be compounded into 1000 bottles of transfused solution of 250 ml each or 500 bottles of transfused solution of 500 ml each. The present invention also provides the preparation process of the injection.

Description

Technical field: [0001] The invention relates to a pharmaceutical preparation, in particular to a compound drug injection containing glycerin and fructose as main active ingredients. Background technique: [0002] High intracranial pressure is the most common disease in neurosurgery. Mannitol has been used in clinical treatment for a long time, and the effect is good, but it has many side effects such as rebound phenomenon, electrolyte disorder, and renal function damage. Since 1961, Virno in the United States used glycerol Antihypertensive, because of its hemolytic side effects, it has not been widely promoted. Since the 1980s, the research on the compatibility of glycerol has achieved great success. Adding fructose to glycerol can reduce its hemolytic side effects. Therefore, it is widely used in clinical practice. [0003] Glycerin fructose injection is a hypertonic injection made of glycerin fructose. Through the pharmacological effect of hypertonic dehydration, it is ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/7004A61K9/08A61K31/047A61P43/00
Inventor 曾列丹
Owner 曾列丹
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