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A kind of citicoline sodium injection and preparation method thereof

A technology for citicoline sodium and injection, which is applied in pharmaceutical formulations, medical preparations with inactive ingredients, and medical preparations containing active ingredients, etc., can solve the problem of reducing the safety and reliability of citicoline sodium injection. It has the advantages of good market application prospect, simple preparation method and improved stability.

Active Publication Date: 2022-07-15
江西润泽药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the existing citicoline sodium injection is unstable in the process of production and storage, and it is easy to deteriorate, resulting in increased impurity content, which reduces the safety and reliability of citicoline sodium injection

Method used

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  • A kind of citicoline sodium injection and preparation method thereof
  • A kind of citicoline sodium injection and preparation method thereof
  • A kind of citicoline sodium injection and preparation method thereof

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preparation example Construction

[0029] The present invention also provides a kind of preparation method of described Citicoline Sodium Injection, comprising the following steps:

[0030] (1) Dissolve citicoline sodium, disodium cytidine triphosphate and ginsenoside Rg1 in 50-60 vol% water for injection, then adjust the pH to 5.7-6.3 with a pH regulator, and then cool down to 3-5 ℃, and pass CO 2 20~60min, obtain medicinal liquid A;

[0031] (2) adding medicinal charcoal to the medicinal solution A, stirring and adsorbing for 15-45 min, decarbonizing and filtering, then adding glutathione, a stabilizer, an isotonicity agent and the remaining 40-50 vol% water for injection to obtain liquid B;

[0032] (3) filtering medicinal liquid B with a microporous membrane of 0.2~0.5 μm, then feeding nitrogen to nitrogen saturation, then filling and sealing in nitrogen flow to obtain semi-finished product of Citicoline Sodium Injection;

[0033] (4) The semi-finished product of Citicoline Sodium Injection is sterilize...

Embodiment 1

[0041] A kind of Citicoline Sodium Injection, its raw material composition is as shown in Table 1, and concrete preparation method is as follows:

[0042] (1) 60g citicoline sodium was mixed in 200mL ethanol to obtain a suspension, the suspension was filtered to obtain a filtrate and a filter cake, then the filter cake was dissolved in 300mL water to obtain a mixed solution, then the mixed solution was Pre-freeze at -32°C and 2Pa for 1.5h, then heat up to 35°C and keep for 1h to obtain the refined product of citicoline sodium;

[0043] Dissolve 50g of citicoline sodium refined product, 7.5g of cytidine triphosphate disodium, 0.25g of ginsenoside Rg1 in 462.38mL of water for injection, and then use a pH adjuster (consisting of 0.1mol / L citric acid and 0.1mol / L sodium citrate according to the volume ratio of 1:2.64) to adjust the pH value to 5.7-6.3, then cool down to 3-5 °C, and pass CO 2 30min, obtain medicinal liquid A;

[0044] (2) Add 1 g of medicinal charcoal to the me...

Embodiment 2

[0048] A kind of Citicoline Sodium Injection, its raw material composition is as shown in Table 1, and concrete preparation method is as follows:

[0049] (1) 60g citicoline sodium was mixed in 200mL ethanol to obtain a suspension, the suspension was filtered to obtain a filtrate and a filter cake, then the filter cake was dissolved in 300mL water to obtain a mixed solution, then the mixed solution was Pre-freeze at -32°C and 2Pa for 1.5h, then heat up to 35°C and keep for 1h to obtain the refined product of citicoline sodium;

[0050] Dissolve 50g of citicoline sodium refined product, 5g of cytidine triphosphate disodium, 0.4g of ginsenoside Rg1 in 463.13mL of water for injection, and then use a pH adjuster (consisting of 0.1mol / L citric acid and 0.1mol / L). L sodium citrate is composed according to the volume ratio of 1:2.64) to adjust the pH value to 5.7 to 6.3, then cool down to 3 to 5 ° C, and pass CO 2 45min, obtain medicinal liquid A;

[0051] (2) Add 1 g of medicinal...

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Abstract

The invention relates to the technical field of drug preparation, in particular to a citicoline sodium injection and a preparation method thereof. The citicoline sodium injection includes active ingredients, auxiliary materials and water for injection, and the active ingredients include citicoline Choline sodium, disodium cytidine triphosphate, ginsenoside Rg1 and glutathione, and the auxiliary materials include stabilizer, isotonicity agent and pH adjuster. The present invention can improve the stability of the citicoline sodium injection and prolong the storage time by adding active ingredients disodium cytidine triphosphate, ginsenoside Rg1 and glutathione into the citicoline sodium injection.

Description

technical field [0001] The invention relates to the technical field of drug preparation, in particular to a citicoline sodium injection and a preparation method thereof. Background technique [0002] Citicoline sodium, the chemical name is the monosodium salt of choline cytosine nucleoside diphosphate, Citicoline sodium is a nucleoside derivative and is an essential coenzyme in the synthesis of lecithin, which can reduce cerebral vascular resistance, Increase cerebral blood flow to promote cerebral material metabolism, improve cerebral circulation, can enhance the function of the brainstem reticular structure related to consciousness, stimulate the pyramidal tract, promote the recovery of damaged cells, and enhance the tension of cerebral blood vessels , and enhance cerebral blood flow, enhance the function of cell membranes, improve brain metabolism, and clinically used for the treatment of acute traumatic brain injury and disturbance of consciousness after brain surgery. ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K38/06A61K9/08A61P25/00A61K31/704A61K31/7068
CPCA61K38/06A61K47/183A61P25/00A61K9/0019A61K9/08A61K31/704A61K31/7068A61K2300/00
Inventor 廖年生邹明明胡贤德眭荣春
Owner 江西润泽药业有限公司
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