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Cytidine disodium triphosphate suspension powder injection and preparation method thereof

A technology of cytidine triphosphate disodium and powder injection, which is applied in the fields of pharmaceutical formulation, powder delivery, and medical preparations containing active ingredients, and can solve the problems of affecting the efficacy and safety of drugs, loss of activity, and easy breakage, etc., to achieve Improve bioavailability, improve therapeutic index, improve the effect of stability

Active Publication Date: 2013-08-14
SHANGHAI JINCHENG PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The phosphate bond of disodium cytidine triphosphate is easy to break when heated, and rapidly degrades into sodium cytidine monophosphate and disodium cytidine diphosphate and loses its activity, which easily affects the efficacy and safety of the drug
[0004] Aiming at the characteristics of thermal instability of cytidine triphosphate disodium injection, Chinese published patent number: CN 101658498 B (name: cytidine triphosphate disodium and refined Amino acid freeze-dried product and preparation method thereof), the product of this invention, the stability needs to be further improved

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Example 1 Cytidine triphosphate disodium suspension powder injection, calculated according to the prescription 20mg (1000 bottles):

[0032] Prescription: Cytidine Triphosphate Disodium 20g

[0033] Human Serum Albumin 60g

[0034] Mannitol 50g

[0035] Preparation Process:

[0036] (1) Dissolve 20 g of disodium cytidine triphosphate in ethyl formate to form solution A;

[0037] (2) Dissolve 60g of human serum albumin in 5% glucose aqueous solution to form solution B;

[0038] (3) Disperse solution B in solution A and shear at high speed for 2 minutes to form colostrum C;

[0039] (4) Forming a stable emulsion of colostrum C under high pressure and high shear force or cavitation;

[0040] (5) The emulsion is evaporated under reduced pressure to produce a colloidal system composed of protein-coated pharmacologically active substances, which is sterilized by filtration;

[0041] (6) Add 50 g of mannitol, freeze-dry to remove water, and prepare cyt...

Embodiment 2

[0047] Example 2 Cytidine triphosphate disodium suspension powder injection, calculated according to the prescription 40mg (1000 bottles):

[0048] Prescription: Cytidine Triphosphate Disodium 40g

[0049] Human Serum Albumin 200g

[0050] Sorbitol 100g

[0051] Preparation Process:

[0052] (1) Dissolve 40 g of disodium cytidine triphosphate in ethyl formate to form solution A;

[0053] (2) Dissolve 200g of human serum albumin in 0.9% sodium chloride aqueous solution to form solution B;

[0054] (3) Disperse solution B in solution A and shear at high speed for 3 minutes to form colostrum C;

[0055] (4) Forming a stable emulsion of colostrum C under high pressure and high shear force or cavitation;

[0056] (5) The emulsion is evaporated under reduced pressure to produce a colloidal system composed of protein-coated pharmacologically active substances, which is sterilized by filtration;

[0057] (6) Add 100 g of sorbitol, freeze-dry to remove water, ...

Embodiment 3

[0063] Example 3Cytidine triphosphate disodium suspension powder injection, calculated according to the prescription 10mg (1000 bottles):

[0064] Prescription: Cytidine Triphosphate Disodium 10g

[0065] Human Serum Albumin 45g

[0066] Lactose 35g

[0067] Preparation Process:

[0068] (1) Dissolve 10 g of disodium cytidine triphosphate in ethyl formate to form solution A;

[0069] (2) Dissolve 45g of human serum albumin in 5% glucose aqueous solution to form solution B;

[0070] (3) Disperse solution B in solution A and shear at high speed for 4 minutes to form colostrum C;

[0071] (4) Forming a stable emulsion of colostrum C under high pressure and high shear force or cavitation;

[0072] (5) The emulsion is evaporated under reduced pressure to produce a colloidal system composed of protein-coated pharmacologically active substances, which is sterilized by filtration;

[0073] (6) Add 35 g of lactose, freeze-dry to remove water, and prepare cytid...

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PUM

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Abstract

The invention relates to novel preparation formulation of cytidine disodium triphosphate, in particular to cytidine disodium triphosphate suspension powder injection and a preparation method thereof. The powder-injection comprises the following components as per parts by weight: 1 part of cytidine disodium triphosphate, 0.1 to 10 parts of surface active agent and 2 to 15 parts of cryoprotectant. The powder injection improves the stability of cytidine disodium triphosphate, can be slowly administrated in body for a long time, and greatly improves the bioavailability. Protein of the surface active agent (stabilizing agent) is degraded in body, has no toxicity and immunogenicity, can effectively increase the pharmacological treatment index, and reduces the drug toxicity and the drug side-effect.

Description

technical field [0001] The invention relates to a new dosage form of disodium cytidine triphosphate, in particular to a suspension powder injection of disodium cytidine triphosphate and a preparation method thereof. Background technique [0002] Cytidine triphosphate disodium is a nucleotide derivative and a coenzyme drug that participates in the synthesis and metabolism of phospholipids in the body. It can pass through the blood-cerebrospinal fluid barrier. It is the intermediate product and energy source of cephalin synthesis and nucleic acid metabolism. It can also improve the stability and reconstruction ability of the membrane structure of nerve cells, support the survival of nerve cells, delay cell aging and death, and improve the quality of nerve cells. Anti-injury ability, promote neurite outgrowth. It can effectively prevent nerve cell injury or secondary death after ischemia, stabilize the liver cell membrane, promote the repair of liver cells after injury, nouris...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/7068A61K47/42A61P25/00A61P9/00A61P3/02
Inventor 傅苗青傅永宝傅贤龙
Owner SHANGHAI JINCHENG PHARMACEUTICAL CO LTD
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