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Citicoline sodium injection and preparation method thereof

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

Active Publication Date: 2019-03-29
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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  • Citicoline sodium injection and preparation method thereof
  • Citicoline sodium injection and preparation method thereof
  • 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, cytidine triphosphate disodium, and ginsenoside Rg1 in 50-60 vol% water for injection, then adjust the pH value to 5.7-6.3 with a pH regulator, and then cool down to 3-5 ℃, and through CO 2 20-60 minutes to get liquid A;

[0031] (2) Add medicinal charcoal to medicinal liquid A, stir and adsorb for 15-45min, then carry out decarbonization and filtration, then add glutathione, stabilizer, isotonic agent and remaining 40-50vol% water for injection to obtain Liquid B;

[0032] (3) Filter the medicinal solution B with a microporous membrane of 0.2-0.5 μm, then pass nitrogen gas until the nitrogen gas is saturated, and then fill and seal in the nitrogen flow to obtain the semi-finished product of citicoline sodium injection;

[0033] (4) Sterilize the semi-finished product of citicoline sodium ...

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 is mixed uniformly in 200mL ethanol to obtain a suspension, the suspension is filtered to obtain a filtrate and a filter cake, then the filter cake is dissolved in 300mL water to obtain a mixed solution, and then the mixed solution Pre-freeze at -32°C and 2Pa for 1.5h, then raise the temperature to 35°C and keep it warm for 1h to obtain the refined product of citicoline sodium;

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

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

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 is mixed uniformly in 200mL ethanol to obtain a suspension, the suspension is filtered to obtain a filtrate and a filter cake, then the filter cake is dissolved in 300mL water to obtain a mixed solution, and then the mixed solution Pre-freeze at -32°C and 2Pa for 1.5h, then raise the temperature to 35°C and keep it warm for 1h to obtain the refined product of citicoline sodium;

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

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

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Abstract

The present invention relates to the technical field of pharmaceutical preparation and particularly relates to a citicoline sodium injection and a preparation method thereof. The citicoline sodium injection comprises active ingredients, auxiliary materials and water for injection, the active ingredients comprise citicoline sodium, cytidine disdoium triphosphate, ginsenoside Rg1 and glutathione, and the auxiliary materials comprise a stabilizer, an isotonic agent and a pH adjusting agent. By adding the active ingredients of the cytidine disdoium triphosphate, ginsenoside Rg1 and glutathione tothe citicoline sodium injection, stability of the citicoline sodium injection can be improved and storage time is prolonged.

Description

technical field [0001] The invention relates to the technical field of medicine 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, and citicoline sodium is a nucleoside derivative, which is an essential coenzyme in the synthesis of lecithin, which can reduce cerebrovascular resistance, Increase cerebral blood flow to promote brain substance metabolism, improve cerebral circulation, enhance the function of brainstem reticular structure related to consciousness, excite pyramidal bundles, 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, clinically used to treat acute traumatic brain injury and disturbance of consciousness caused by brain surgery. [0003] Injection...

Claims

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Application Information

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Patent Type & Authority Applications(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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