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Nú¿2ú®-L-alanyl-L-glutamine injection and its preparation method

A technology of glutamine and alanyl, which is applied in the field of N-L-alanyl-L-glutamine for injection and preparation thereof, can solve problems such as inconvenience in transportation and storage, and achieve the effects of being convenient for transportation and improving stability

Inactive Publication Date: 2005-04-06
灵康药业集团股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The domestically marketed N(2)-L-alanyl-L-glutamine preparation is an injection, which is not convenient for transportation and storage

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0012] Weigh 50g of N(2)-L-alanyl-L-glutamine, add water for injection to dissolve, and prepare a 20% solution, add 0.1% (w / v) medicinal charcoal, absorb for 20 minutes, and filter Decarbonization; fine filtration with a φ0.22μm microporous membrane, and spray drying to obtain a sterile powder.

[0013] Weigh 50g of mannitol and dissolve it in water for injection to make a 10% solution, add 0.1% (w / v) medicinal charcoal, absorb for 20 minutes, and decarbonize by coarse filtration; , spray-dried to obtain sterile powder.

[0014] Take 10 g of the above-mentioned N(2)-L-alanyl-L-glutamine sterile powder and 10 g of mannitol sterile powder, mix them evenly, and separate them in a class 100 clean area that meets the requirements of GMP under a relative humidity of 55%. Assemble, ready to use, 10g / piece.

Embodiment 2

[0016] Weigh 80g of N(2)-L-alanyl-L-glutamine, add water for injection to dissolve, and prepare a 20% solution, add 0.1% (w / v) medicinal charcoal, absorb for 20 minutes, and filter Decarbonization; fine filtration with a φ0.22μm microporous membrane, freeze-dried to obtain a sterile powder.

[0017] Weigh 80g of mannitol and dissolve it with water for injection to make a 10% solution, add 0.1% (w / v) medicinal charcoal, absorb for 20 minutes, and decarbonize by coarse filtration; , and freeze-dried to obtain sterile powder.

[0018] Take 20 g of the above-mentioned N(2)-L-alanyl-L-glutamine sterile powder and 20 g of mannitol sterile powder, mix them evenly, and separate them in a 100-class clean area that meets the requirements of GMP under a relative humidity of 55%. Assemble, ready to use, 20g / piece.

Embodiment 3

[0020] Weigh 50g of N(2)-L-alanyl-L-glutamine, add water for injection to dissolve, and prepare a 20% solution, add 0.1% (w / v) medicinal charcoal, absorb for 20 minutes, and filter Decarbonization; fine filtration with a φ0.22μm microporous membrane, and spray drying to obtain a sterile powder.

[0021] Weigh 50g of mannitol and dissolve it in water for injection to make a 10% solution, add 0.1% (w / v) medicinal charcoal, absorb for 20 minutes, and decarbonize by coarse filtration; , spray-dried to obtain sterile powder.

[0022] Take 10 g of the above-mentioned N(2)-L-alanyl-L-glutamine sterile powder and 5 g of mannitol sterile powder, mix them evenly, and separate them in a 100-class clean area that meets the requirements of GMP under a relative humidity of 55%. Assemble, ready to use, 10g / piece.

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PUM

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Abstract

The invention provides a N(2)-L-alanyl-glutamine for injection and its preparing method, it has mixed N(2)-L-alanyl-glutamine and mannite to make N(2)-L-alanyl-glutamine whose mess percentage density is 50-100%. The invention has increased the stability of medicine greatly, convenient for transportation and storage, suitable for sicker in catabolism and hypermetabolism condition who needs glutamine.

Description

technical field [0001] The invention relates to N(2)-L-alanyl-L-glutamine for injection and a preparation method thereof. Background technique [0002] N(2)-L-alanyl-L-glutamine is a component of parenteral nutrition for patients requiring glutamine supplementation, including those in catabolic and hypermetabolic conditions. [0003] The domestically marketed N(2)-L-alanyl-L-glutamine preparation is an injection, which is inconvenient for transportation and storage. Contents of the invention [0004] The invention provides N(2)-L-alanyl-L-glutamine for injection which is convenient for transportation and storage and a preparation method thereof. [0005] N(2)-L-alanyl-L-glutamine for injection of the present invention consists of N(2)-L-alanyl-L-glutamine and mannitol, and contains N(2)- The weight percent concentration of L-alanyl-L-glutamine is 50-100%. [0006] A preparation method of N(2)-L-alanyl-L-glutamine for injection...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K31/198A61K47/10A61P3/02
Inventor 陶灵刚陈胜龙
Owner 灵康药业集团股份有限公司
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