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A kind of preparation method of cytidine triphosphate disodium freeze-dried powder injection

A technology of disodium cytidine triphosphate and freeze-dried powder injection, which can be used in freeze-dried delivery, medical preparations containing active ingredients, powder delivery, etc. Uniformity, small loss of active ingredients, etc., to achieve the effect of reducing reconstitution time

Active Publication Date: 2018-01-16
HUNAN KELUN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

During the freeze-drying process, the water directly sublimes without going through the liquid state, so that the physical and chemical properties and shape of the dried material are basically unchanged, the loss of active ingredients is small, and the sealed storage period is long
[0004] However, the existing preparation method cannot control the uniformity of disodium cytidine triphosphate in the product, causing the product to agglomerate or not completely dissolved during use, so that the obtained product has the problem of long reconstitution time, which is not conducive to the product clinical application

Method used

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Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0028] The invention provides a preparation method of cytidine triphosphate disodium freeze-dried powder injection, comprising the following steps:

[0029] a) mixing cytidine disodium triphosphate, excipients and the first water for injection, and adjusting the pH value to obtain a mixed solution A;

[0030] b) mixing the mixed solution A with the second water for injection, followed by filtering, freezing and drying to obtain cytidine triphosphate disodium freeze-dried powder injection;

[0031] The mass ratio of the first water for injection to the second water for injection is 8:(1-3).

[0032] In the present invention, mixed solution A is obtained by mixing cytidine disodium triphosphate, excipients and first water for injection, and adjusting the pH value. In the present invention, cytidine triphosphate disodium, excipients and first water for injection are firstly mixed. In the present invention, the disodium cytidine triphosphate is the main drug, and the source of t...

Embodiment 1

[0050] Prepare 1000 sticks of cytidine triphosphate disodium freeze-dried powder injection with a specification of 20 mg / bottle:

[0051] (1) First, 20g cytidine triphosphate disodium and 40g mannitol are added to 1200g water for injection, stirred at 40°C to obtain a mixed solution of cytidine triphosphate disodium and mannitol; then use a mass concentration of 10% The arginine solution was adjusted to pH 6; then 0.75 g of activated carbon was added and stirred for 15 min, and then the titanium rod was decarbonized to obtain a mixed solution A.

[0052] (2) Mix the above-mentioned mixed solution A with 300 g of water for injection, and then go through the fine filtration of 0.45 μm microporous filter element and the fine filtration of 0.22 μm microporous filter element, then fill and half-tamp; then place the product in a lyophilizer, and Freeze at -40°C for 2 hours, then control the heating rate at 7°C / h to 35°C, and then dry for 3.5 hours to obtain cytidine triphosphate lyo...

Embodiment 2

[0055] Prepare 500 sticks of cytidine triphosphate disodium freeze-dried powder injection with a specification of 40 mg / bottle:

[0056] (1) First, 20g cytidine triphosphate disodium and 20g mannitol are added to 1200g water for injection, stirred at 40°C to obtain a mixed solution of cytidine triphosphate disodium and mannitol; then use a mass concentration of 10% The arginine solution was adjusted to pH 6.5; then 0.75 g of activated carbon was added and stirred for 15 min, and then the titanium rod was decarbonized to obtain a mixed solution A.

[0057] (2) Mix the above-mentioned mixed solution A with 150 g of water for injection, fine filter through a 0.45 μm microporous filter element and a 0.22 μm microporous filter element in turn, fill and half-tamp; then place the product in a lyophilizer, Freeze at -45°C for 2 hours, then control the heating rate at 8°C / h to 40°C, and then dry for 5 hours to obtain cytidine triphosphate disodium freeze-dried powder injection. The obs...

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Abstract

The invention provides a preparation method of a cytidine disdoium triphosphate freeze-dried powder injection. The preparation method comprises the following steps of: (a) mixing cytidine disdoium triphosphate, an excipient with first water for injection, and adjusting the pH value to obtain mixed solution A; and (b) mixing the mixed solution A with second water for injection, and filtering, freezing and drying in sequence so as to obtain the cytidine disdoium triphosphate freeze-dried powder injection, wherein the mass ratio of the first water for injection to the second water for injection is 6:(3-5). Compared with the prior art, the preparation method provided by the invention can be used for effectively controlling the content of impurities in the cytidine disdoium triphosphate freeze-dried powder injection and increasing the mass stability and the yield of products; and experimental results show that the impurity content of the cytidine disdoium triphosphate freeze-dried powder injection prepared through the preparation method provided by the invention is below 0.41%.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a preparation method of cytidine triphosphate disodium freeze-dried powder injection. Background technique [0002] Cytidine triphosphate disodium is a nucleotide derivative that participates in the synthesis and metabolism of phospholipids in the body. It can pass through the blood-cerebrospinal fluid barrier. It is an intermediate product and energy source for brain phospholipid synthesis and nucleic acid metabolism, and can also improve the membrane properties of nerve cells. Structural stability and reconstruction ability, support nerve cell survival, delay cell aging and death, improve nerve cell resistance to damage, and promote neurite growth. At present, the clinical cytidine triphosphate disodium can effectively prevent the secondary death of nerve cell injury or ischemia, and can also stabilize the liver cell membrane, promote the repair of liver cel...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/7068A61P25/00A61P1/16A61P9/10A61P9/00
Inventor 李全学廖孝曙逯佩荣余泽勇刘志军荣超刘思川程志鹏万阳浴葛均友
Owner HUNAN KELUN PHARMA
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