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Citicoline sodium glucose injection

A technology of glucose injection and citicoline sodium, applied in the field of citicoline sodium glucose injection, can solve the problems of poor thermal stability, high substance content, can not meet production and use, etc., achieve high stability, production The process is simple and the effect of reducing the production of related substances

Active Publication Date: 2014-09-10
HUIYINBI GRP JIANGXI EAST ASIA PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the sold Citicoline Sodium Glucose Injection has the problem of poor thermal stability during production and storage, and the content of related substances is relatively high, which cannot meet the needs of production and use.

Method used

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  • Citicoline sodium glucose injection
  • Citicoline sodium glucose injection
  • Citicoline sodium glucose injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Embodiment 1 Citicoline Sodium Glucose Injection

[0021]

[0022] Use 0.1N sodium hydroxide to adjust the pH value to 5.5-5.6, and add water for injection to 1000ml.

[0023] Preparation Process:

[0024] 1. Dissolving glucose in water, adding activated carbon for adsorption and filtering, diluting the filtrate with water to an isotonic concentration, thereby obtaining an isotonic aqueous solution of glucose; preferably, the water is water for injection;

[0025] 2. Add citicoline sodium, glycine and citric acid to the isotonic aqueous solution obtained in step 1, stir to dissolve, then add activated carbon to absorb and filter, and use 0.1N sodium hydroxide to adjust the pH value to 5.5- 5.6, Microporous membrane filtration.

Embodiment 2

[0027] Citicoline Sodium 3000mg

[0028] Glucose 40000mg

[0029] Citric acid 1300mg

[0030] Use 0.1N sodium hydroxide to adjust the pH value to 5.5-5.6, and add water for injection to 1000ml.

[0031] Preparation process: with embodiment 1.

Embodiment 3

[0033] Citicoline Sodium 3000mg

[0034] Glucose 40000mg

[0035] Glycine 1800mg

[0036] Use 0.1N sodium hydroxide to adjust the pH value to 5.5-5.6, and add water for injection to 1000ml.

[0037] Preparation process: with embodiment 1.

[0038] The indicators of the Citicoline Sodium Glucose Injection prepared in the above examples meet the relevant provisions of the 2010 edition of the Chinese Pharmacopoeia Part II.

[0039] Properties: Colorless clear liquid.

[0040] PH value: 5.5-5.6

[0041] Visible foreign matter: qualified

[0042] Sterility test: qualified

[0043] Insoluble particles: qualified

[0044] Content: Qualified

[0045] Related substances: individual impurities do not exceed 0.3%, and other impurities do not exceed 0.5%.

[0046] Stability test of citicoline sodium glucose injection:

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PUM

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Abstract

The invention relates to citicoline sodium glucose injection, belonging to the field of pharmaceutical preparations. The citicoline sodium glucose injection provided by the invention is composed of 3 g of citicoline sodium, 40 g of glucose, 1.8 g of glycine, and 1.3 g of citric acid; the pH value is adjusted to 5.5-5.6 by using sodium hydroxide; and water for injection is added till the citicoline sodium glucose injection is 1000 ml.

Description

technical field [0001] The invention relates to a citicoline sodium glucose injection, which belongs to the field of pharmaceutical preparations. Background technique [0002] The chemical name of citicoline sodium is the monosodium salt of choline cytosine nucleoside diphosphate, and its chemical structure is: [0003] [0004] The molecular formula is C14H25N4NaO11P2, and the molecular weight is 510.31. [0005] Citicoline sodium is a nucleoside derivative, which can enhance the activity of the brainstem ascending reticular structure activation system and pyramidal system, improve the level of consciousness and motor function; it can also reduce cerebral vascular resistance, increase cerebral blood flow, In particular, it increases the blood flow of the brain stem, thereby improving cerebral circulation, and has a certain effect on promoting the recovery and awakening of brain functions. It is mainly used for disturbance of consciousness after acute craniocerebral tra...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/7068A61K47/18A61K47/12A61P25/28A61P9/10A61P25/00
Inventor 王大冲翟绪武王建何榕王雪梅吴对荣
Owner HUIYINBI GRP JIANGXI EAST ASIA PHARMA CO LTD
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