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Freeze-dried injection containing carbazochrome sodium sulfonate and method of preparing the same

A technology of freeze-dried powder injection and sodium carbosulfonate, which is applied in the field of pharmaceutical preparations, can solve problems such as redissolution, and achieve the effects of rapid dissolution, stable product quality, and good solution clarity

Inactive Publication Date: 2008-09-03
SUZHOU SIXTH PHARMA PLANT OF JIANGSU WUZHONG PHARMA GROUP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The invention discloses a freeze-dried powder injection of sodium carbosulfonate. The preparation of sodium carbosulfonate into the freeze-dried powder injection effectively overcomes the problems of degradation and drug precipitation during storage of sodium carbosulfonate injection. On the other hand, The present invention solves the problem of redissolving freeze-dried preparations in use by adding co-solvent

Method used

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  • Freeze-dried injection containing carbazochrome sodium sulfonate and method of preparing the same
  • Freeze-dried injection containing carbazochrome sodium sulfonate and method of preparing the same
  • Freeze-dried injection containing carbazochrome sodium sulfonate and method of preparing the same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Component Weight (according to 1000 count)

[0033] Sodium carbosulfonate 20g

[0034] Mannitol 6g

[0035] Thiourea 0.1g

[0036] Preparation process: Mix the above three components, add 500ml of water for injection to dissolve, and dilute the water for injection to 1000ml so that the concentration of the sodium carbosulfonate solution is 2%. Sterilize and filter with a 0.22 μm microporous membrane, fill in a container with a filling volume of 1 ml / bottle, freeze-dry, press stopper, crimp the cap, and pack.

Embodiment 2

[0038] Component Weight (according to 1000 count)

[0039] Sodium carbosulfonate 20g

[0040] Mannitol 14g

[0041] Dextran 4g

[0042] Sodium formaldehyde sulfoxylate 0.2g

[0043] The preparation method is the same as in Example 1.

Embodiment 3

[0045] Component Weight (according to 1000 count)

[0046] Sodium carbosulfate 40g

[0047] Mannitol 28g

[0048] Xylose 8g

[0049] Sodium formaldehyde sulfoxylate 0.4g

[0050] Thiourea 0.2g

[0051] The preparation method is the same as in Example 1.

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Abstract

The invention relates to the pharmaceutical preparation field, particularly to carbazochrome sodium sulfonate lyophilized powder for injection, which is characterized in that the stability of carbazochrome sodium sulfonate is improved by adding thiourea and / or sodium formaldehyde sulfoxylate, the solubility of the lyophilized powder for injection is improved by adding mannitol, and the obtained carbazochrome sodium sulfonate lyophilized powder for injection has stable quality.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a freeze-dried powder injection of sodium carbosulfonate and a preparation method thereof. Background technique [0002] Carbazochrome Sodium Sulfonate is a chemical derivative of Adrenochrome. Its chemical name is 1-methyl-6-oxo-2,3,5,6-tetrahydroindole-5-semicarbazone-2-sodium sulfonate, CAS: 51460-26-5. Its structure was first reported in Japan in the 1970s. The main reason for its appearance is to improve the adverse reactions caused by the poor water solubility of Anluoxue and the need to add a large amount of salicylic acid to aid dissolution. These chemical substances can reduce the permeability of capillaries and enhance the retraction of broken ends of capillaries, and are often used for various bleedings caused by increased capillary permeability. At present, domestic medicine is clinically used for bleeding of urinary system, upper gastrointestinal tract, ...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/404A61K47/10A61K47/20
Inventor 刘凤珍李全林钟慎政夏建平沈建伟汪志超
Owner SUZHOU SIXTH PHARMA PLANT OF JIANGSU WUZHONG PHARMA GROUP
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