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

A technology of glutamine and alanyl, applied in the field of N-L-alanyl-L-glutamine for injection and its preparation, can solve the problems of inconvenient transportation and storage, and achieve the effect of convenient transportation and improved stability

Inactive Publication Date: 2008-10-29
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 of the present invention comprises the foll...

Claims

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Application Information

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