Citicoline Sodium injection pharmaceutical composition and preparation method thereof

A technology of citicoline sodium and injection, which is applied in the field of citicoline sodium injection pharmaceutical composition and preparation method, and can solve problems such as product instability, increased dosage, and increased related substances

Inactive Publication Date: 2015-04-08
CHENGDU TIANTAISHAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But in fact, the boiling water ingredients cause the instability of the product and increase the related substances; the secondary adsorption process is theoretically established, but it is not advisable in actual production, because there is no auxiliary material in the prescription, and the secondary adsorption of 0.1% activated carbon will make the liquid medicine The content is reduced by 6-10%. If the content reaches the standard, the dosage must be increased, thus increasing the production cost

Method used

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  • Citicoline Sodium injection pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0085] Embodiment 1: Preparation of Citicoline Sodium Injection

[0086] formula:

[0087] Citicoline Sodium

0.25g，

Water for Injection

Appropriate amount, add to 2mL.

[0088] Preparation method:

[0089] (1) Take an appropriate amount of water for injection (70% of the formula amount) to dissolve citicoline sodium;

[0090] (2) Use 0.1mol / L hydrochloric acid solution or 0.1mol / L sodium hydroxide solution to adjust the pH value of the solution to between 6.5 and 7.0;

[0091] (3) Heat the solution to 60°C to 70°C, add 1‰ of the current solution volume of activated carbon for needles to the solution, absorb for 20 to 30 minutes, decarbonize, circulate and filter, and add water for injection to the full amount of the formula;

[0092] (4) Sterilize and filter the prepared medicinal solution through a 0.22 μm microporous membrane, dispense into ampoules, fill with nitrogen gas, melt seal the ampoules, and sterilize with circulating steam at 100...

Embodiment 2

[0093] Embodiment 2: Preparation of Citicoline Sodium Injection

[0094] formula:

[0095] Citicoline Sodium

0.1g，

Water for Injection

Appropriate amount, add to 2mL.

[0096] Preparation method:

[0097] (1) Take an appropriate amount of water for injection (60% of the formula amount) to dissolve citicoline sodium;

[0098] (2) Use 0.1mol / L hydrochloric acid solution or 0.1mol / L sodium hydroxide solution to adjust the pH value of the solution to between 6.5 and 7.0;

[0099] (3) Heat the solution to 60°C to 70°C, add 1‰ of the current solution volume of activated carbon for needles to the solution, absorb for 20 to 30 minutes, decarbonize, circulate and filter, and add water for injection to the full amount of the formula;

[0100] (4) Sterilize and filter the prepared medicinal solution through a 0.22 μm microporous membrane, dispense into ampoules, fill with nitrogen gas, melt seal the ampoules, and sterilize with circulating steam at 100°...

Embodiment 3

[0101] Embodiment 3: Preparation of Citicoline Sodium Injection

[0102] formula:

[0103] Citicoline Sodium

0.5g，

Water for Injection

Appropriate amount, add to 2mL.

[0104] Preparation method:

[0105] (1) Take an appropriate amount of water for injection (80% of the formula amount) to dissolve citicoline sodium;

[0106] (2) Use 0.1mol / L hydrochloric acid solution or 0.1mol / L sodium hydroxide solution to adjust the pH value of the solution to between 6.5 and 7.0;

[0107] (3) Heat the solution to 60°C to 70°C, add 1‰ of the current solution volume of activated carbon for needles to the solution, absorb for 20 to 30 minutes, decarbonize, circulate and filter, and add water for injection to the full amount of the formula;

[0108] (4) Sterilize and filter the prepared medicinal solution through a 0.22 μm microporous membrane, dispense into ampoules, fill with nitrogen gas, melt seal the ampoules, and sterilize with circulating steam at 100°...

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Abstract

The invention relates to a citicoline sodium injection pharmaceutical composition and a preparation method thereof. Particularly, the invention belongs to the technical field of medicines, relates to a pharmaceutical composition for treating consciousness disturbance caused by acute craniocerebral trauma and brain surgery and particularly relates to an injection pharmaceutical composition for treating consciousness disturbance caused by acute craniocerebral trauma and brain surgery. More particularly, the invention relates to the citicoline sodium injection pharmaceutical composition and a preparation method of citicoline sodium injection. The citicoline sodium injection comprises citicoline sodium and injection water, wherein the injection water serves as a solvent, and the concentration of citicoline sodium is 0.01g / ml-1g / ml. The citicoline sodium injection has excellent pharmaceutical properties explained in the specification.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a pharmaceutical composition for treating disturbance of consciousness caused by acute craniocerebral trauma and brain surgery, in particular to a pharmaceutical composition for treating disturbance of consciousness caused by acute craniocerebral trauma and brain surgery The injection pharmaceutical composition, more particularly relates to a kind of citicoline sodium injection pharmaceutical composition, the present invention also relates to the preparation method of this injection. Background technique [0002] Citicoline Sodium (Citicoline Sodium) is the monosodium salt of choline cytosine nucleoside diphosphate, its molecular formula is C14H25N4NaO11P2, its molecular weight is 510.31, and its chemical structure is as follows: [0003] [0004] Citicoline sodium is white crystal or crystalline powder; odorless. Citicoline Sodium is easily soluble in water, but insoluble in ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/7068A61P25/00A61P25/28
Inventor 方专王敬江威左伟姚波龙成全赵东明
Owner CHENGDU TIANTAISHAN PHARMA
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