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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 formulations, medical preparations with no active ingredients, medical preparations containing active ingredients, etc., which can solve the problem of increasing dosage, unstable products, and increasing production costs and other issues to achieve the effect of improving the pass rate of light inspection

Active Publication Date: 2012-05-23
NORTH CHINA PHARMA COMPANY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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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 and preparation method thereof

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Effect test

Embodiment 1

[0020] a, take by weighing citicoline sodium 2.5Kg, EDTA-2Na5g, water for injection 20000ml;

[0021] b. To be prepared in a 10,000-level environment, firstly heat the water for injection to 30°C, add 0.05% activated carbon for injection, filter after 20 minutes of adsorption, then add citicoline sodium, stir and dissolve, and use a mass-volume ratio concentration of 10 % sodium bisulfite solution to adjust the pH value to 6.5;

[0022] c. Heat the feed liquid prepared in step b to 65°C, keep it warm for 10 minutes, then add 0.05% activated carbon for injection (according to the mass ratio of feed liquid volume to activated carbon) and EDTA-2Na, stir, dissolve, and decarburize, Use a 0.2um two-stage filter to filter, and after the temperature of the feed liquid drops below 40°C, it is subpackaged into 2ml / bottle in a 100-level environment, filled and sealed (nitrogen protection), leak detection, light inspection, and packaging, and the specifications are obtained. 2ml: 0.25g ...

Embodiment 2

[0024] a, take by weighing citicoline sodium 5Kg, EDTA-2Na5g, water for injection 20000ml;

[0025] b. To be prepared in a 10,000-level environment, firstly heat the water for injection to 28°C, add 0.02% activated carbon for injection, filter after 30 minutes of adsorption, then add citicoline sodium, stir and dissolve, and use a mass-volume ratio concentration of 5 % sodium bisulfite solution to adjust the pH value to 7.0;

[0026] c. Heat the feed liquid prepared in step b to 60°C, keep it warm for 8 minutes, then add 0.02% activated carbon for injection (according to the mass ratio of feed liquid volume to activated carbon) and EDTA-2Na, stir, dissolve, and decarburize, Use a 0.2um two-stage filter to filter, and after the temperature of the feed liquid drops below 40°C, it is subpackaged into 2ml / bottle in a 100-level environment, filled and sealed (nitrogen protection), leak detection, light inspection, and packaging, and the specifications are obtained. 2ml: 0.5g of ci...

Embodiment 3

[0028] a, weigh citicoline sodium 0.1Kg, EDTA-2Na 5g, water for injection 20000ml;

[0029] b. To be prepared in a 10,000-grade environment, firstly heat the water for injection to 30°C, add 0.04% activated carbon for injection, filter after 25 minutes of adsorption, then add citicoline sodium, stir and dissolve, and use a mass-volume ratio concentration of 8 % sodium bisulfite solution to adjust the pH value to 7.5;

[0030] c. Heat the feed liquid prepared in step b to 60°C, keep it warm for 10 minutes, then add 0.05% activated carbon for injection (according to the mass ratio of feed liquid volume to activated carbon) and EDTA-2Na, stir, dissolve, and decarburize, Use a 0.2um two-stage filter to filter, and after the temperature of the feed liquid drops below 40°C, it is subpackaged into 2ml / bottle in a 100-level environment, filled and sealed (nitrogen protection), leak detection, light inspection, and packaging, and the specifications are obtained. 2ml: 100mg of citicoli...

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Abstract

The invention discloses a citieoline sodium injection with good quality and low cost, and provides a method for preparing the injection simultaneously. The citieoline sodium injection provided by the invention is prepared from 1,000-5,000g of citieoline sodium, 5g of versene disodium and 20,000ml of water for injection, and is 2-5ml per tube. The preparation method comprises the following steps of: weighing each component; heating the water for injection to 28-30 DEG C, adding 0.02-0.05 percent of injection active carbon, adsorbing for 20-30 minutes, and filtering; and heating a feed liquid to 60-65 DEG C, preserving heat for 8-10 minutes, adding 0.02 percent of injection active carbon, stirring, dissolving, decarburizing, filtering, lowering temperature of the feed liquid to be below 40 DEG C, and performing split charging. Due to the adoption of the method, the pollution levels and endotoxin levels of relevant substances of a product and microorganisms are effectively controlled, and the stability and light inspection yield of the product are increased.

Description

technical field [0001] The invention relates to a pharmaceutical preparation and a preparation method thereof, in particular to a citicoline sodium injection and a preparation process thereof. Background technique [0002] The main component of Citicoline Sodium Injection is Citicoline Sodium, whose chemical name is the monosodium salt of choline cytosine nucleoside diphosphate. Citicoline sodium is a nucleoside derivative. Because it can reduce cerebrovascular resistance, increase cerebral blood flow, promote brain substance metabolism, and improve cerebral circulation, it is clinically used to treat acute traumatic brain injury and disturbance of consciousness after brain surgery. . Citicoline sodium is a derivative of cytosine nucleotides, and it is an essential coenzyme in the synthesis of lecithin. It has the function of enhancing the brain stem network structure related to consciousness, and has an excitatory effect on the pyramidal tract, so that damaged cells can be...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/7068A61K47/16A61P25/00A61P25/16A61P25/28A61P27/06
Inventor 梁凤林张辛庭赵辉赵霞段瑞婷
Owner NORTH CHINA PHARMA COMPANY
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