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Injection carbazochrome sodium sulfonate suspension and preparation method thereof

A technology for sodium carboxysulfonate and injection, which is applied in the field of medicine, can solve problems such as increasing clinical adverse reactions, and achieve the effects of improving bioavailability, reducing side effects of drugs, and improving therapeutic index.

Active Publication Date: 2012-07-25
SHANGHAI JINCHENG PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

These adverse factors have had a major impact on the clinical application of carbosulfonate sodium products, and clinical adverse reactions have increased significantly

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Carbosulfonate sodium suspension for injection, calculated according to prescription 40mg (1000 bottles):

[0032] Prescription: Sodium carbosulfonate 40g

[0033] Human Serum Albumin 100g

[0034] Sodium chloride 20g

[0035] Fructose 100g

[0036] Preparation Process:

[0037] (1) Dissolve 40 g of sodium carbosulfonate in an organic solvent until it is completely dissolved, and keep it sealed to form an organic phase;

[0038] (2) Disperse 100g of human serum albumin and 20g of sodium chloride in water for injection, set to dissolve, and stir to dissolve into the water phase;

[0039] (3) Under cooling conditions, transfer the aqueous phase and the organic phase to a microfluidizer, and homogenize under the condition of 5000~30000Psi to obtain a suspension containing sodium carbosulfate;

[0040] (4) Sterilizing and filtering the prepared sodium carbene sulfonate suspension through a 0.22 μm filter membrane to obtain a sterile sodium carbene ...

Embodiment 2

[0043] Carbosulfonate sodium suspension for injection, calculated according to prescription 20mg (1000 bottles):

[0044] Prescription: Sodium carbosulfonate 20g

[0045] Human Serum Albumin 80g

[0046] Citric acid 8g

[0047] Mannitol 60g

[0048] Preparation Process:

[0049] (1) Dissolve 20 g of sodium carbosulfonate in an organic solvent until it is completely dissolved, and keep it sealed to form an organic phase;

[0050] (2) Disperse 80g of human serum albumin and 8g of citric acid in water for injection, set to dissolve, stir to dissolve into water phase;

[0051] (3) Under cooling conditions, transfer the aqueous phase and the organic phase to a microfluidizer, and homogenize under the condition of 5000~30000Psi to obtain a suspension containing sodium carbosulfate;

[0052] (4) Sterilizing and filtering the prepared sodium carbene sulfonate suspension through a 0.22 μm filter membrane to obtain a sterile sodium carbene sulfonate suspension; ...

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PUM

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Abstract

The invention discloses an injection carbazochrome sodium sulfonate suspension and a preparation method thereof, relating to the technical field of medicines. The injection carbazochrome sodium sulfonate suspension is a powder injection and comprises the following components in parts by weight: 1 part of carbazochrome sodium sulfonate, 1.5-8.5 parts of pharmaceutically acceptable biological carrier, 0.1-1.8 parts of stabilizing agent and 2-5 parts of freezing protective agent. According to the invention, the stability and the dissolvability of the carbazochrome sodium sulfonate are improved, the injection carbazochrome sodium sulfonate suspension has no remarkable change of various indexes through detection after being placed for a long time, the quality of the injection carbazochrome sodium sulfonate suspension within a valid period is ensured to be qualified; and the injection carbazochrome sodium sulfonate suspension can be slowly administrated for a long time, thus bioavailability is greatly improved. The pharmaceutically acceptable biological carrier, i.e. protein, is degraded in vivo without toxicity and immunogenicity; and meanwhile, medicine therapeutic indexes can be effectively increased, and medicine toxicity is lowered and medicine side effects are reduced.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a suspension of sodium carbosulfonate for injection and a preparation method thereof. Background technique [0002] Carbazochrome sodium (Carbazochrome sodium) is a sulfonic acid derivative that was modified and modified by Japan Tanabe Pharmaceutical Co., Ltd. in 1992 to modify and modify the chemical structure of epinephrine, and found in the study of structure-activity relationship that the water solubility was increased by about 50 times. Its chemical name is It is 1-methyl-6-oxo-2,3,5,6-tetrahydroindole-5-semicarbazone-2-sodium sulfonate, that is, sodium carbosulfonate, which is a new generation of adrenaline derivatives for hemostasis drug. He stops bleeding by enhancing the elasticity of capillaries, reducing the permeability of capillaries, promoting the activity of thrombin and the dissolution of fibrinogen. Clinically, it can be used for diseases of urinary system, u...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/10A61K31/404A61K47/42A61P7/04
Inventor 傅苗青
Owner SHANGHAI JINCHENG PHARMACEUTICAL CO LTD
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