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Cytidine disodium triphosphate and arginine composition and preparation method thereof

A technology of disodium cytidine triphosphate and arginine, which is applied in the field of the composition of disodium cytidine triphosphate and arginine and its preparation, can solve the problems of poor stability, short storage time and the like, and achieves good stability, The effect of long storage time without local irritation and pain

Active Publication Date: 2009-08-19
山东北大高科华泰制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The currently marketed cytidine triphosphate disodium product has poor stability and short storage time, so developing a cytidine triphosphate freeze-dried powder injection with good stability and long storage time has far-reaching clinical significance

Method used

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  • Cytidine disodium triphosphate and arginine composition and preparation method thereof
  • Cytidine disodium triphosphate and arginine composition and preparation method thereof
  • Cytidine disodium triphosphate and arginine composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0008] Embodiment 1: Preparation of freeze-dried powder injection

[0009] Cytidine Triphosphate Disodium 40g

[0010] Mannitol 60g

[0011] Appropriate amount of arginine to adjust the pH value to 6.0

[0012] Add water for injection to 1500ml

[0013]

[0014] Make 1000 pieces

[0015] Preparation Process:

[0016] (1) Dissolving: take the mannitol of the prescribed amount by weighing into a sterile container, add 80% of the prescribed amount of water for injection at normal temperature, and stir to dissolve;

[0017] (2) Depyrogenation: Weigh 0.1% activated carbon and stir continuously in the same direction for about 15 minutes, then filter to remove carbon;

[0018] (3) Add main ingredient: take the disodium cytidine triphosphate of prescription quantity and add in the above-mentioned filtrate, stir to dissolve;

[0019] (4) Adjust the pH value: use 0.5mol / L arginine solution to adjust the pH value to 6.0, and replenish...

Embodiment 2

[0025] Embodiment 2: Preparation of freeze-dried powder injection

[0026] Cytidine Triphosphate Disodium 80g

[0027] Mannitol 120g

[0028] Appropriate amount of arginine to adjust the pH value to 6.0

[0029] Add water for injection to 3000ml

[0030]

[0031] Make 1000 pieces

[0032] The preparation process is the same as that of Preparation Example 1.

Embodiment 3

[0033] Embodiment 3: the selection of excipient

[0034] In order to make the appearance of freeze-dried products more beautiful, suitable excipients should be selected as scaffolds. Commonly used excipients include glucose, lactose, mannitol, sucrose, etc. The results of selected excipients are shown in the table below.

[0035] Table 1: Excipient Selection Results of Cytidine Triphosphate Disodium for Injection 40mg

[0036]

[0037] Table 2: Excipient Selection Results of Cytidine Triphosphate Disodium for Injection 80mg

[0038]

[0039] From the screening results of the above tests, it can be seen that no matter it is 40mg or 80mg, when mannitol is used as an excipient, its appearance is the best. Therefore, mannitol was initially selected as the excipient, and its dosage needs to be investigated by single factor. The results are shown in Table 3.

[0040] Table 3: Single factor inspection results

[0041]

[0042] From the results of single factor investigat...

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PUM

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Abstract

The invention relates to a combination of cytidine disodium triphosphate and arginine, and the preparation method thereof; the freeze-dried powder adopts arginine as the pH regulator, has good stability, long storage time, and no local irritation and pain.

Description

technical field [0001] The invention relates to a composition of disodium cytidine triphosphate and arginine and a preparation method thereof. Background technique [0002] Cytidine triphosphate disodium is a nucleotide drug, and its main medicinal ingredient: cytidine triphosphate participates in the synthesis and metabolism of nucleic acid and phospholipids in the body, and promotes protein synthesis. 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 amino acids and free radicals, thereby supporting the survival, enhancing activity, and delaying death of the above-mentioned cells. Improve the ability of cells to resist damage, regeneration and repair, and promote the effect of neurite re-growth. At the same time, it can improve the nerve function of innervating blood vessels and play a role in anti-arteriosclerosis. Clinically, it is mainly use...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/7068A61K31/198A61K47/16A61K9/19A61P25/00A61P9/14
Inventor 宁辉曲海军荆凡波
Owner 山东北大高科华泰制药有限公司
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