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Mannitol sodium chloride injection and preparation method thereof

A technology for sodium chloride injection and injection, which is applied in the directions of alkaline/alkaline earth metal chloride active ingredients, blood diseases, pharmaceutical formulations, etc. Stable and reliable quality

Inactive Publication Date: 2012-07-04
蚌埠丰原涂山制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The object of the present invention is to provide a kind of glycerol fructose sodium chloride injection that solves the problem that 5-hydroxymethylfurfural exceeds the standard

Method used

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  • Mannitol sodium chloride injection and preparation method thereof
  • Mannitol sodium chloride injection and preparation method thereof
  • Mannitol sodium chloride injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Each 1000mL contains 100g of glycerin, 50g of fructose, 9g of sodium chloride, 0.1g of sodium metabisulfite, and the balance is water for injection.

[0021] The preparation method of above-mentioned glycerol fructose sodium chloride injection comprises the following steps:

[0022] (1) Take 400mL water for injection, put it into the container, add glycerin, sodium chloride and sodium metabisulfite 0.1g of the above ratio, stir to form solution A;

[0023] (2) Add the proportioned fructose in the above solution A, dissolve to form solution B, and adjust the pH value of the solution to 4.8;

[0024] (3) Add 0.3 g of activated carbon to the solution obtained in step (2) and leave it to stand after stirring, decarbonizing;

[0025] (4) Add water for injection to 1000mL;

[0026] (5) Fine filtration, filling and sterilization.

Embodiment 2

[0028] Each 1000mL contains 50g of glycerin, 100g of fructose, 9g of sodium chloride, 0.3g of sodium metabisulfite, and the balance is water for injection.

[0029] The preparation method of above-mentioned glycerol fructose sodium chloride injection comprises the following steps:

[0030] (1) Take 400mL of water for injection, put it into the container, add glycerin, sodium chloride and sodium metabisulfite 0.3g of the above ratio, and stir to form solution A;

[0031] (2) Add the fructose of the ratio in the above solution A and dissolve to form solution B, and adjust the pH value of the feed liquid to 5.0;

[0032] (3) Add 0.3 g of activated carbon to the solution B, stir and let it stand for decarbonization;

[0033] (4) Add water for injection to the full amount;

[0034] (5) Fine filtration, filling and sterilization.

Embodiment 3

[0036] Each 1000mL contains 50g of glycerin, 50g of fructose, 9g of sodium chloride, 0.5g of sodium metabisulfite, and the balance is water for injection.

[0037] The preparation method of above-mentioned glycerol fructose sodium chloride injection comprises the following steps:

[0038] (1) Take 400mL of water for injection, put it into the container, add glycerin, sodium chloride and sodium metabisulfite 0.5g of the above ratio, and stir to form solution A;

[0039] (2) Add the proportioned fructose in the above solution A and dissolve to form solution B, and adjust the pH of the feed liquid to 4.9;

[0040] (3) Add 0.3 g of activated carbon to the solution B, stir and let it stand for decarbonization;

[0041] (4) Add water for injection to the full amount;

[0042] (5) Fine filtration, filling and sterilization.

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Abstract

The invention discloses a mannitol sodium chloride injection and a preparation method thereof. The mannitol sodium chloride injection comprises the following components in percentage by weight: 5-10 percent of glycerol, 5-10 percent of fructose, 0.9 percent of sodium chloride and 0.01-0.05 percent of an antioxidant. The mannitol sodium chloride injection provided by the invention has high quality stability, the general problem of quick rising of 5-hydroxymethylfurfural existing in a mannitol sodium chloride injection product is solved, and safe clinical use is ensured effectively. Moreover, the preparation method provided by the invention is simple and convenient and is convenient for clinical use, and the product quality is stable and reliable.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a glycerol fructose sodium chloride injection and a preparation method thereof. Background technique [0002] Glycerin Fructose Sodium Chloride Injection is a high-osmotic dehydrating agent, through high-osmotic dehydration, it can reduce the water content of the brain and reduce intracranial pressure. For cerebrovascular disease, traumatic brain injury, brain tumor, intracranial inflammation and other causes of acute and chronic increased intracranial pressure, cerebral edema embolism. The effect of this product on reducing intracranial pressure is slow and lasts for a long time. This product enters the tissues of the whole body through the blood, and its distribution reaches equilibrium within about 2 to 3 hours. It enters the cerebrospinal fluid and brain tissue slowly, and clears it slowly. Most of this product is metabolized to CO 2 and water discharge. Becaus...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K33/14A61P7/10A61K31/047A61K31/7004
Inventor 李保琴
Owner 蚌埠丰原涂山制药有限公司
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