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Diacetyl amide acetate ethylenediamide freeze dried powder injection, large volume injection and their preparing method

A technology of ethylenediamine diacetaminoacetate and freeze-dried powder injection is applied in the field of hemostatic drugs, which can solve the problems of being susceptible to pollution, unstable performance, inconvenient operation, transportation and storage, etc. Cost and effect of preventing pollution

Inactive Publication Date: 2003-09-03
于航
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, this kind of agent is greatly affected by light, heat, oxygen and water, its performance is unstable, it is easily polluted, and it is not easy to operate, transport and store

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] (1) Freeze-dried powder injection prescription:

[0016] Ethylenediamine diacetamidoacetic acid 200g

[0017] Mannitol 100g

[0018] Sodium hydroxide (0.1mol / l) 3g

[0019] Add water for injection to 3000ml

[0020] Made 1000 pieces

[0021] (2) Preparation process: Take the prescription amount of ethylenediamine diacetamidoacetic acid and freeze-dried support agent, add water for injection and stir to dissolve, adjust the pH to 6 with a pH regulator, add 0.1% active carbon for needles in the solution, stir at room temperature for 15 minutes, filter and replenish Add water for injection to 3000ml, pass through a 0.2um microfiltration membrane, measure the content, and fill it into 7ml vials, each 3ml. Put the filled sample into a freeze dryer, first lower the temperature to -45°C, keep it warm for 2 hours, vacuumize after heating, and raise the temperature at about 2°C / hour, when the temperature reaches -5°C, press 5°C / hour Heat up to 25°C within 1 hour, keep warm ...

Embodiment 2

[0023] (1) Freeze-dried powder injection prescription:

[0024] Ethylenediamine diacetamidoacetic acid 200g

[0025] Dextrose 100g

[0026] Sodium carbonate (0.1mol / l) 5g

[0027] Add water for injection to 3000ml

[0028] Made 1000 pieces

[0029] (2) preparation process: with embodiment 1

Embodiment 3

[0031] (1) Freeze-dried powder injection prescription:

[0032] Ethylenediamine Diacetinate 400g

[0033] Hydrolyzed Gelatin 150g

[0034] Sodium hydroxide (0.1mol / l) 3g

[0035] Add water for injection to 3000ml

[0036] Prepare 1000 sticks

[0037] (2) preparation process: with embodiment 1

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PUM

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Abstract

A freeze dried powdered injection and high-dosage injection of diacetylamino ethyldiamine acetate, used as anastaltic, and their preparing process are disclosed. Said freeze dried powdered injection contains diacetylamino ethyldiamine acetate, supporting agent for freeze drying, and pH regulator. Said high-dosage injection contains diacetylamino ethyldiamine acetate, osmotic pressure regulator, and pH regulator. Its advantages are high stability, no pollution, and high staltic effect.

Description

Technical field: [0001] The invention belongs to hemostatic drugs, in particular to a freeze-dried powder injection of ethylenediamine diacetylaminoacetate, a large-capacity injection and their prescription and preparation method. Background technique: [0002] Ethylenediamine diacetylaminoacetate is a new generation of hemostatic drug, which can stop bleeding through the following mechanisms: (1) inhibit plasminogen activator, so that plasminogen cannot be activated into plasmin, thereby inhibiting the dissolution of fibrin and producing Hemostatic effect. (2) Promote the release of active substances from platelets, enhance the aggregation and adhesion of platelets, shorten the coagulation time, and produce hemostatic effect. (3) Enhance capillary resistance, reduce capillary permeability, thereby reducing bleeding. At present, this kind of agent is greatly affected by light, heat, oxygen and water, has unstable performance, is easily polluted, and is inconvenient to oper...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/221A61P7/04
Inventor 于航
Owner 于航
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