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Citicoline sodium glucose injecta and preparation process thereof

A technology of glucose injection and citicoline sodium is applied in the directions of medical preparations with non-active ingredients, medical preparations containing active ingredients, drug delivery, etc. The effect of quality stability, promotion of awakening, and good application prospects

Active Publication Date: 2013-04-10
HUNAN KELUN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the existing citicoline sodium glucose injection has the problems of poor thermal stability and excessive related substances.

Method used

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  • Citicoline sodium glucose injecta and preparation process thereof
  • Citicoline sodium glucose injecta and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Preparation prescription:

[0030] Main ingredient: Citicoline Sodium 2.5g

[0031] Isotonic agent: glucose 50g

[0032] Stabilizer: malic acid 0.5g

[0033] Sodium sulfite 0.5g

[0034] pH regulator 10% sodium hydroxide appropriate amount

[0035] Add water for injection to 1000ml

[0036] Preparation Process:

[0037] (1) Add an appropriate amount of water for injection into the concentrated preparation tank, heat, put in the prescribed amount of glucose, malic acid, and sodium sulfite, stir to dissolve, add the prescribed amount of activated carbon for injection, boil for 15 minutes, and decarbonize the solution through a titanium rod filter , the filtrate is pumped into the dilute distribution tank.

[0038] (2) Put the prescribed amount of citicoline sodium and an appropriate amount of 10% sodium hydroxide solution into the dilute preparation tank, add water for injection to the full amount, and stir evenly.

[0039] (3) After testing the liquid content and ...

Embodiment 2

[0042] Preparation prescription:

[0043] Main ingredient: Citicoline Sodium 2.5g

[0044] Isotonic agent: glucose 50g

[0045] Stabilizer: sodium malate 0.5g

[0046] Sodium bisulfite 0.5g

[0047] pH regulator 10% sodium hydroxide appropriate amount

[0048] Add water for injection to 1000ml

[0049] Prepared by the technique of Example 1.

Embodiment 3

[0051] Preparation prescription:

[0052] Main ingredient: Citicoline Sodium 2.5g

[0053] Isotonic agent: glucose 50g

[0054] Stabilizer: malic acid 0.5g

[0055] Sodium metabisulfite 0.5g

[0056] pH regulator 10% sodium hydroxide appropriate amount

[0057] Add water for injection to 1000ml

[0058] Prepared by the technique of Example 1.

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PUM

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Abstract

The invention discloses a citicoline sodium glucose injecta and a preparation process thereof. The citicoline sodium glucose injecta mainly contains the active ingredients: citicoline sodium, isotonic agent glucose, a stabilizer, a pH regulator and water for injection, wherein the stabilizer is selected from one or two of malic acid, sale compounds thereof and sulfite compounds; the pH regulator is one or more of sodium hydroxide, hydrochloric acid, malic acid and apple sodium; the weight ratio of the active ingredients of the Citicoline sodium to the isotonic agent glucose is 1:(20-100), theweight ratio of the active ingredients of the citicoline sodium to the stabilizer is 1:(0.02-2), and the stabilizer is added to solve the problem of unstable heating and excessive related substances of the injecta in the production and storage process and improve the quality stability and the safe validation of medicaments.

Description

technical field [0001] The invention relates to western medicine and its preparation process, in particular to citicoline sodium glucose injection and its preparation process. Background technique [0002] The chemical name of the main drug of citicoline sodium glucose injection is: monosodium salt of choline cytosine nucleoside diphosphate. [0003] This product is a nucleoside derivative. Citicoline can enhance the function of the brainstem reticular structure, especially the activation system of the ascending reticular structure closely related to consciousness; increase the function of the pyramidal system, improve motor paralysis; improve brain circulation. , by reducing the resistance of cerebral blood flow, increasing cerebral blood flow and promoting brain substance metabolism, it has a certain effect on promoting the recovery of brain function and waking up. [0004] During the production and storage process of this product, the relevant substances in the quality i...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/7068A61K47/26A61P9/10A61P25/00
Inventor 朱朝清任查梁隆程志鹏
Owner HUNAN KELUN PHARMA
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