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Injection carbazochrome sodium sulfonate suspension and preparation method thereof

A technology of sodium carbosulfonate and suspension, which is applied in the field of medicine, can solve the problems of increasing clinical adverse reactions, achieve the effects of improving bioavailability, improving stability and solubility, and improving therapeutic index

Active Publication Date: 2014-07-30
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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Abstract

The invention relates to the technical field of medicine, and discloses a suspensoid of sodium carbosulfonate for injection and a preparation method thereof. Composition, the parts by weight of each component are: 1 part of sodium carbosulfonate; 1.5-8.5 parts of a pharmaceutically acceptable biological carrier; 0.1-1.8 parts of a stabilizer; and 2-5 parts of a freeze-drying protective agent. The present invention improves the stability and solubility of the sodium carbosulfonate, and there is no obvious change in various indicators detected after long-term storage, ensuring that the product quality is qualified within the validity period; it can be administered slowly for a long time, and the bioavailability is greatly improved. The pharmaceutically acceptable biological carrier, that is, the protein, is degraded in the body, has no toxicity and no immunogenicity, and can effectively improve the therapeutic index of the drug, reduce the toxicity of the drug and reduce the side effects of the drug.

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