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Sodium triphosphate transfusion and its prepn. technique

A technology of disodium cytidine triphosphate and disodium cytidine phosphate, which is applied in the field of disodium cytidine triphosphate injection, can solve the problem of thermal instability, loss of content, and difficulty in maintaining stability of an aqueous solution of disodium cytidine triphosphate. problems, to achieve broad application prospects, reduce the chance of pollution, and facilitate long-term storage.

Inactive Publication Date: 2006-09-20
GUANGDONG JIANXIN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, literature reports and test results show that the aqueous solution of cytidine triphosphate disodium triphosphate is unstable when heated, and is easily hydrolyzed to generate CDP and CMP. Content loss, and difficult to maintain stability during long-term storage

Method used

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  • Sodium triphosphate transfusion and its prepn. technique
  • Sodium triphosphate transfusion and its prepn. technique

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Preparation prescription:

[0032] Main drug: cytidine triphosphate disodium 0.020kg (calculated as cytidine triphosphate disodium)

[0033] Stabilizer: Guanidine Carbonate 2.500kg

[0034] PH value regulator: glycine 0.938kg

[0035] Isotonic regulator: sodium chloride 2.250kg

[0036] Water for injection up to 250L

[0037] Makes 1000 bottles

[0038] Preparation Process:

[0039] a. Take guanidine carbonate 2.5kg, be dissolved in the water for injection of 70L, stir and dissolve;

[0040] b. Add glycine, stir to make it dissolve, adjust the pH value of the solution to 8.0~8.5, and the amount of glycine added is 0.938kg;

[0041] c. Add 0.02kg cytidine triphosphate disodium and 2.25kg sodium chloride, stir evenly;

[0042] d. Add 0.1% (w / v) activated carbon for needles, stir for 20 minutes, decarbonize by coarse filtration, add nearly full amount of water for injection;

[0043] e. Determination of intermediates, f...

Embodiment 2

[0046] Preparation prescription:

[0047] Cytidine triphosphate disodium 0.005kg

[0048] Arginine 0.625kg

[0049] Sodium bicarbonate 0.500kg

[0050] Anhydrous sodium carbonate 0.250kg

[0051] Sodium chloride 2.250kg

[0052] Water for injection up to 250L

[0053] Makes 1000 bottles

[0054] Prepared by the technique of Example 1.

Embodiment 3

[0056] Preparation prescription:

[0057] Cytidine triphosphate disodium 0.010kg

[0058] Tween-80 1.250kg

[0059] Disodium hydrogen phosphate 0.325kg

[0060] Sodium dihydrogen phosphate 0.00625kg

[0061] Sodium chloride 2.250kg

[0062] Water for injection up to 250L

[0063] Makes 1000 bottles

[0064] Prepared by the technique of Example 1.

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Abstract

A cytidine disodium triphosphate perfusion is prepared from cytidine disodium triphosphate, stabilizer chosen from guanidine carbonate, arginine and tween-80, pH regulator, isotonic regulator and the water for injection through dissolving, filtering, pouring in bottles and sterilizing.

Description

technical field [0001] The invention relates to a cytidine triphosphate disodium injection, in particular to a cytidine triphosphate disodium infusion for direct intravenous injection, and also relates to a preparation process of the infusion. Background technique: [0002] Cytidine Disodium Triphosphate (Cytidine Disodium Triphosphate, Cytidine-5′-triphosphate disodium salt) has the molecular formula C 9 h 14 N 3 Na 2 o 14 P 3 , molecular weight 527.14. [0003] 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-...

Claims

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Application Information

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IPC IPC(8): A61K31/7068A61K9/08
Inventor 黄邦信
Owner GUANGDONG JIANXIN PHARMA
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