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Carbazochrome sodium sulfonate injection agent and preparation method thereof

A sodium carboxysulfonate injection and a technique for sodium carboxylate are applied in the field of medicine and can solve problems such as increased clinical adverse reactions, and achieve the effects of solving poor solubility and stability, good stability and few adverse reactions

Active Publication Date: 2021-10-08
KAMP PHARMA
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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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  • Carbazochrome sodium sulfonate injection agent and preparation method thereof
  • Carbazochrome sodium sulfonate injection agent and preparation method thereof
  • Carbazochrome sodium sulfonate injection agent and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Prescription: Sodium carbosulfonate 100g, glycine 8g, add water for injection to 20L.

[0024] Preparation Process:

[0025] 1) Dissolve the prescribed amount of glycine in 90% water for injection (25°C), adjust the pH to 5.5 with hydrochloric acid, and stir for 5 minutes;

[0026] 2) After the step 1) is mixed evenly, add the raw material of sodium carbosulfonate, and stir for 15 minutes.

[0027] 3) Add the remaining water for injection to make up the volume, then turn on the circulating filtration system to perform one-stage 0.45um and two-stage 0.22um filtration, and the material of the filter element is polyethersulfone.

[0028] 4) Potting.

[0029] 5) Use non-terminal sterilization method for sterilization and filtration.

Embodiment 2

[0031] Prescription: Sodium carbosulfonate 100g, glycine 12g, add water for injection to 20L.

[0032] Preparation Process:

[0033] 1) Dissolve the prescribed amount of glycine in 90% water for injection (40°C), adjust the pH to 6.5 with hydrochloric acid, and stir for 3 minutes;

[0034] 2) After the step 1) is mixed evenly, add the raw material of sodium carbosulfonate, and stir for 5 minutes.

[0035] 3) Add the remaining water for injection to make up the volume, then turn on the circulating filtration system to perform one-stage 0.45um and two-stage 0.22um filtration, and the material of the filter element is polyethersulfone.

[0036] 4) Potting.

[0037] 5) Use non-terminal sterilization method for sterilization and filtration.

Embodiment 3

[0039] Prescription: Sodium carbosulfonate 100g, glycine 5g, add water for injection to 20L.

[0040] Preparation Process:

[0041] 1) Dissolve the prescribed amount of glycine in 90% water for injection (30°C), adjust the pH to 6.0 with hydrochloric acid, and stir for 4 minutes;

[0042] 2) After the step 1) is mixed evenly, add the raw material of sodium carbosulfonate, and stir for 10 minutes.

[0043] 3) Add the remaining water for injection to make up the volume, then turn on the circulating filtration system to perform one-stage 0.45um and two-stage 0.22um filtration, and the material of the filter element is polyethersulfone.

[0044] 4) Potting.

[0045] 5) Use non-terminal sterilization method for sterilization and filtration.

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Abstract

The invention belongs to the technical field of medicine, and particularly relates to a carbazochrome sodium sulfonate injection agent and a preparation method thereof. The carbazochrome sodium sulfonate injection agent is composed of carbazochrome sodium sulfonate, glycine, hydrochloric acid and water, wherein the weight of the glycine accounts for 5%-15% of the weight of the carbazochrome sodium sulfonate, the pH value is 5-6.5, and the concentration of the carbazochrome sodium sulfonate is 5-10 g / L. The carbazochrome sodium sulfonate injection agent is good in stability, few in auxiliary materials, few in adverse reactions, capable of effectively solving the problems of poor solubility and stability of the carbazochrome sodium sulfonate injection agent, low in impurity content generated at high temperature, simple in process and benefit for large-scale production.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a sodium carbosulfate injection and a preparation method. 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. It plays a hemostatic effect 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, upper ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K47/18A61K47/04A61K31/404A61P7/04
CPCA61K9/08A61K9/0019A61K47/183A61K47/02A61K31/404A61P7/04
Inventor 曾灿丽刘选李昌亮贺莲张静杨世平刘娟
Owner KAMP PHARMA
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