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Cytidine disodium triphosphate freeze-dried powder-injection for injection

A technology of cytidine triphosphate disodium and freeze-dried powder injection, which is applied in the field of prescription of cytidine triphosphate disodium freeze-dried powder injection, which can solve the problems of content reduction and unstable content of cytidine triphosphate disodium , to achieve the effects of easy operation, broad application prospects and simple preparation process

Inactive Publication Date: 2009-09-02
SICHUAN KELUN PHARMA RES INST CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, the content of commercially available cytidine triphosphate disodium for injection is unstable during storage, and the stability of samples obtained by different prescriptions and preparation processes of manufacturers is still quite different, and it should be placed for 18 months (validity period) After the content is reduced between 35% and 85%

Method used

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  • Cytidine disodium triphosphate freeze-dried powder-injection for injection
  • Cytidine disodium triphosphate freeze-dried powder-injection for injection
  • Cytidine disodium triphosphate freeze-dried powder-injection for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Preparation prescription:

[0022]

[0023] Preparation Process:

[0024] (1) Weigh the prescribed amount of dextran 40, put it in a liquid tank, add water for injection to make a 10% solution, heat to boil, stir to dissolve. Add water for injection to 80% of the total volume and cool the solution to below 40°C for use.

[0025] (2) Pour the accurately weighed cytidine disodium triphosphate, guanidine carbonate and arginine into the above solution, stir to dissolve them, and then adjust the pH value with dilute hydrochloric acid to control the pH value between 6.0 and 6.5 . After the pH value is adjusted to the control range, add the weighed activated carbon (0.25%, g / L) into the liquid medicine, stir well, and let it stand for 15 minutes. Filter and decarbonize the liquid medicine and press it into the dilute tank, and add injection Water to the full amount, take samples for intermediate inspection, after the pH value of the liquid medicine is checked and passed,...

Embodiment 2

[0031] Preparation prescription:

[0032]

[0033] Prepared by the technique of Example 1.

Embodiment 3

[0035] Preparation prescription:

[0036]

[0037] Prepared by the technique of Example 1.

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Abstract

The invention discloses a prescription of a cytidine disodium triphosphate freeze-dried powder-injection for injection and a process for preparing the same. The powder-injection consists of an active component of cytidine disodium triphosphate, a stabilizer of guanidine carbonate and / or arginine, an excipient of mannitol or dextran 40, as well as a pH regulator, wherein the weight ratio of the active component to the stabilizer to the excipient is 1:0.5-5:0.5-5, and the weight ratio of the guanidine carbonate to the arginine in the stabilizer is 2-4:1; and the addition of the pH regulator is standardized to control the pH value of the powder-injection between 6.0 and 6.5. The process for preparing the cytidine disodium triphosphate freeze-dried powder-injection comprises the steps of dissolving the prescription quantity of each component into certain amount of injection water, and then performing filtration, filling, pre-freezing, and freeze drying. The cytidine disodium triphosphate freeze-dried powder-injection and the method improve the stability of the active component, and solve the problems that the cytidine disodium triphosphate in the prior freeze-dried powder-injection is decomposed to a large extent in the process of preservation and the effectiveness of the medicament is reduced. Besides, the cytidine disodium triphosphate freeze-dried powder-injection and the method improve the using safety of the medicament and are advantageous for the long-time storage of medicaments.

Description

technical field [0001] The invention relates to the prescription field of cytidine triphosphate disodium lyophilized powder injection for injection, and also relates to a preparation process of the cytidine triphosphate disodium lyophilized powder injection. Background technique [0002] The chemical name of disodium cytidine triphosphate is: disodium cytidine-5-triphosphate. Cytidine triphosphate disodium is a nucleotide drug, and its main medicinal component, cytidine triphosphate, participates in the synthesis and metabolism of nucleic acid and phospholipids in the body, and promotes the synthesis of proteins. It can regulate and promote the synthesis and construction of nerve cells, glial cells and blood vessel wall cell membrane structures, and can resist nerve cell damage caused by excitatory amino acids and free radicals. Therefore, it can support the survival of the above-mentioned cells, enhance their activity, delay their death, improve their anti-injury, regenera...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/7068A61K47/18A61K47/36A61P25/00A61P9/10
Inventor 朱朝清任查雷芳刘萍梁隆程志鹏
Owner SICHUAN KELUN PHARMA RES INST CO LTD
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