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Citicoline sodium injection and preparation process thereof

A technology of 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 low stability of injections and easy deterioration during storage. and other problems, to achieve the effects of excellent stability, reducing storage deterioration and low impurity content

Pending Publication Date: 2022-03-25
ANHUI LIANYI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Chinese patent CN1395935 discloses a citicoline sodium injection and its preparation method. The injection is prepared by a one-step preparation method. The injection prepared under this process is not stable and contains more Impurities, prone to deterioration during storage

Method used

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  • Citicoline sodium injection and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] The present embodiment prepares 980,000 milliliters of citicoline sodium injection, and the specific implementation process is as follows:

[0024] Process S1, ingredients: check that the temperature of the negative pressure weighing room is 18-26°C, the humidity is 45%-65%, the relative pressure difference is ≥-5Pa, the negative pressure weighing hood is opened 20 minutes in advance for self-cleaning, and the medium-effect pressure difference is kept at 50-60Pa, high-efficiency differential pressure maintained at 100-200Pa, then weighed 122.5kg citicoline sodium (in line with QC-STP-160-01 standard), 8.33kg sodium chloride (in line with QC-STP-223-01 standard ) and 98g edetate disodium (conforming to the QC-STP-245-01 standard), measure 980L water for injection (conforming to the QC-STP-215-01 standard), and getting the above raw materials for subsequent use;

[0025] Process S2, concentrated and coarse filtration: check that all equipment containers, various pipes, fi...

Embodiment 2

[0030] The present embodiment prepares a batch of 980,000 milliliters of citicoline sodium injection, and the specific implementation process is as follows:

[0031] Process S1, ingredients: check that the temperature of the negative pressure weighing room is 18-26°C, the humidity is 45%-65%, the relative pressure difference is ≥-5Pa, the negative pressure weighing hood is opened 20 minutes in advance for self-cleaning, and the medium-effect pressure difference is kept at 50-60Pa, high-efficiency differential pressure maintained at 100-200Pa, then weighed 122.5kg citicoline sodium (in line with QC-STP-160-01 standard), 8.33kg sodium chloride (in line with QC-STP-223-01 standard ) and 98g edetate disodium (conforming to the QC-STP-245-01 standard), measure 980L water for injection (conforming to the QC-STP-215-01 standard), and getting the above raw materials for subsequent use;

[0032] Process S2, concentrated and coarse filtration: check that all equipment containers, variou...

Embodiment 3

[0037] This example repeats Example 2 to prepare a batch of 980,000 milliliters of citicoline sodium injection, and the specific formula and process control are exactly the same as those in Example 2.

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Abstract

The invention relates to a citicoline sodium injection and a preparation process thereof, and belongs to the technical field of injection preparation. The injection comprises the following raw materials: citicoline sodium, sodium chloride, edetate disodium and water for injection. The main working procedures are as follows: proportioning, concentrated preparation and rough filtration, diluted preparation and fine filtration, detection and post-treatment. According to the preparation method, liquid is prepared through a two-step method of concentrated preparation rough filtration and diluted preparation fine filtration, reasonable technological parameter setting is matched, the impurity content in the prepared injection is low, storage deterioration of the injection is relieved, and it is tested that the prepared injection shows excellent stability in a 4000 lx hard light acceleration simulation experiment at the temperature of 40 DEG C + / -2 DEG C, and the injection has the good application prospect. The preparation process provided by the invention is suitable for mass production of citicoline sodium injection, and is suitable for stable production of 980000 ml injection.

Description

technical field [0001] The invention belongs to the technical field of injection preparation, and in particular relates to a citicoline sodium injection and a preparation process thereof. Background technique [0002] Citicoline sodium, the chemical name is choline cytosine nucleoside diphosphate monosodium salt, citicoline sodium is a nucleoside derivative, it is an essential coenzyme in the synthesis of lecithin, it can reduce cerebrovascular resistance, increase Cerebral blood flow promotes the metabolism of brain substances, improves cerebral circulation, can enhance the function of the brain stem network structure related to consciousness, excites the pyramidal tract, promotes the recovery of damaged cells, and can also enhance the tension of cerebral blood vessels. Enhance cerebral blood flow, enhance the function of cell membrane, improve brain metabolism, clinically used to treat acute traumatic brain injury and disturbance of consciousness after brain surgery, usual...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/7068A61K47/18A61P25/00B01F33/82B01D36/00B01F101/22
CPCA61K9/08A61K9/0019A61K31/7068A61K47/183A61P25/00B01D36/00
Inventor 陈敬王振徐新云
Owner ANHUI LIANYI PHARMA
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