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Preparation method and clinical application of acetylcysteine powdered injection and acetylcysteine infusion

A technology for acetylcysteine ​​and prescriptions, which can be used in powder delivery, medical preparations containing active ingredients, freeze-dried delivery, etc., and can solve the problem of no powder injection

Inactive Publication Date: 2006-07-12
姜建国 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] Acetylcysteine ​​has been widely used clinically as an expectorant in China for many years. The clinical dosage forms are spray (powder mist), effervescent tablets, etc. At present, there is no powder injection (including freeze-dried injection, solvent crystal powder) , non-solvent crystalline powder, etc.) and large infusions are on the market,

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0073] Preparation method of acetylcysteine ​​(freeze-dried powder injection) for injection

[0074] ① Prescription

[0075]Acetylcysteine ​​2000g

[0076] Appropriate amount of sodium hydroxide

[0077] Add water for injection to 5000ml

[0078] A total of 1000 bottles were made

[0079] ② Preparation

[0080] Take the prescribed amount of acetylcysteine, add water 4000ml, add sodium hydroxide to adjust the pH value to 2.5-6.5 to dissolve, decolorize with activated carbon, remove pyrogens, set the volume to 5000ml, filter through a microporous membrane, fill in 5ml / bottle, Freeze-dried and packaged to obtain (freeze-dried needles).

example 2

[0082] Preparation method of acetylcysteine ​​(non-solvent crystalline powder) for injection

[0083] ① Prescription

[0084] Acetylcysteine ​​4000g

[0085] Appropriate amount of sodium hydroxide

[0086] Add water for injection to 5000ml

[0087] A total of 1000 bottles were made

[0088] ② Preparation

[0089] Take the prescribed amount of acetylcysteine ​​and add 5000ml of water for injection to dissolve, add sodium hydroxide to adjust the pH value to 2.5-6.5, decolorize and depyrogenate with activated carbon, filter through a 0.22μm microporous membrane, and spray dry aseptically to prepare Sterile powder, mixed evenly, 4.0g / bottle, aseptically dispensed into glass bottles, covered with butyl rubber stoppers, rolled aluminum caps, and packaged to obtain (non-solvent crystalline powder).

example 3

[0091] Preparation method of acetylcysteine ​​(vehicle crystalline powder) for injection

[0092] ① Prescription

[0093] Acetylcysteine ​​2000g

[0094] Arginine 1000g

[0095] Crystallization solvent Appropriate amount

[0096] A total of 1000 bottles were made

[0097] ② Preparation

[0098] Take the prescribed amount of acetylcysteine, add 3000 g of water at 80°C to dissolve, decolorize with activated carbon, remove pyrogens, filter through a microporous membrane, cool down to 2°C, crystallize, separate solid and liquid, and reduce solids at 80°C Press and dry to make aseptic powder, add 1000g of aseptic arginine, mix well, and inject (vehicle crystalline powder) through aseptic subpackaging and packaging.

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PUM

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Abstract

The acetylcysteine has always been widely used as expectorant in clinic in domestic, with the using form being spray (powder spray) and effervescence tablet, the invention relates to a method for preparing the powder injection of acetylcysteine (comprising freeze-drying injection, dissolvent crystalline powder, un-dissolvent crystalline powder, etc) and large fluid infusion and its clinical application, the powder injection of acetylcysteine can not only be used in form of injection and spray for removing the phlegm, but most importantly it can be used in form of injection for treating various hepatitis, especially the light or heavy chromic, acute hepatitis B, and etc.

Description

1. Technical field [0001] The invention belongs to the preparation method and clinical application of novel pharmaceutical preparation acetylcysteine ​​powder injection (including freeze-dried injection, solvent crystallization powder, non-solvent crystallization powder, etc.) and infusion. 2. Background technology [0002] Acetylcysteine ​​has been widely used clinically as an expectorant in China for many years. The clinical dosage forms are spray (powder mist), effervescent tablets, etc. At present, there is no powder injection (including freeze-dried injection, solvent crystal powder) , non-solvent crystalline powder, etc.) and large infusions are on the market, [0003] The present invention relates to the preparation method and clinical application of acetylcysteine ​​powder injection (including lyophilized injection, solvent crystallization powder, non-solvent crystallization powder, etc.) Injection administration route and spray administration route (powder mist) ar...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/198A61K9/19A61P11/10A61P1/16A61P31/12
Inventor 姜建国肖文辉
Owner 姜建国
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