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Preparation and Uses of Citicoline sodium injection

Oct 21，2024

What is Citicoline sodium injection?

Citicoline sodium injection is an injectable pharmaceutical composition for the treatment of acute craniocerebral trauma and brain surgery-induced disorders of consciousness. The main component of the injection is C14H25N4NaO11P2, chemically known as cytidine diphosphate choline ester monosodium salt. C14H25N4NaO11P2 has the appearance of a white crystalline or crystalline powder, odourless, easily soluble in water, insoluble in ethanol, acetone, chloroform.

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C14H25N4NaO11P2 is a nucleoside derivative, a necessary coenzyme in the process of lecithin synthesis, with the enhancement of the brainstem reticular formation and consciousness-related functions, so that the pyramidal fasciculus excitation rises, prompting the restoration of damaged cells, the enhancement of cerebral vascular tone, the increase in cerebral blood flow, the enhancement of the cell membrane function, and the improvement of cerebral metabolism. Clinically, it is mainly used for consciousness disorder caused by acute injury of central nervous system. Acute stroke caused by neurological injury, surgical site infection, impaired consciousness, Parkinson's disease, dementia, glaucoma, etc. have significant efficacy.

Preparation

Preparation of Citicoline sodium injection.

Molecular Formula: c14H25N4NaO11P2 0.4g, appropriate amount of water for injection, add 2ml.

Production method:

(1) Take appropriate amount of water for injection (70% of the proportion of the formula) to dissolve C14H25N4NaO11P2;

(2) Adjust the pH of the solution to between 6.5 and 7.0 with 0.1mol/L hydrochloric acid solution or 0.1mol/L sodium hydroxide solution;

(3) Heat the solution to 60 DEG C ~ 70 DEG C, add 1 ‰ of the existing volume of the solution of ordinary needle activated carbon, adsorption for 20 ~ 30min, decarburisation, circular filtration, rehydration and injection of the formula of the full dose;

(4) will be prepared by 0.22 μm microporous filter membrane aseptic filtration of the drug solution, divided into ampoules, filled with nitrogen, ampoules sealed, 100 degrees Celsius flow steam sterilisation for 30 minutes, to get the finished product.

Uses

Citicoline sodium injection is a drug to improve cell metabolism, clinically it is mainly used for acute brain injury and postoperative cerebral consciousness disorders, limb function can be gradually restored to the hemiparesis caused by stroke, but also can be used for other function and consciousness disorders caused by acute injury of the central nervous system, and also used for ischemic cerebrovascular and vascular dementia.

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