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Preparation method of stable alanyl-glutamine preparation for injection

A technology for alanyl glutamine and injections, which is applied in the field of preparation of alanyl glutamine preparations for injections, can solve problems such as consumption of too much drying medium, unsatisfactory effects, and errors in product accuracy, and achieve Good stability and curative effect, fast sample dissolution and fast drying effect

Inactive Publication Date: 2017-08-18
SHANGHAI PHARMA DONGYING JIANGSU PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Regarding the preparation of alanyl glutamine freeze-dried powder, due to the limitation of the process method, different preparation methods usually have different applicable production scales, so if the adjustment of the production scale often requires certain adjustments to the process, at the same time , because in the traditional preparation method, the grasp of some details is not in place, resulting in errors in the accuracy of the product, and the effect is not very ideal
Regarding spray drying, it is better for treating solid powder with low water content. If the water content in the raw material is high, too much drying medium will be consumed, which will result in large heat consumption, high energy consumption, and high production cost. In addition, the method is complicated to operate. , there are certain problems in the large-scale production of the process
[0006] In order to overcome the insoluble technical problem that alanyl glutamine for injection exists in the prior art, the inventor proposes a new method for preparing stable alanyl glutamine injection sterile powder

Method used

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  • Preparation method of stable alanyl-glutamine preparation for injection
  • Preparation method of stable alanyl-glutamine preparation for injection
  • Preparation method of stable alanyl-glutamine preparation for injection

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Embodiment 1

[0016] Preparation of Alanyl Glutamine Sterile Powder for Injection

[0017] Prescription: Alanyl Glutamine Sterile Powder for Injection 10g, Water for Injection 50ml

[0018] making process:

[0019] In the batching room of the 10,000-class clean area, dissolve 500g of alanylglutamine and 2500ml of water for injection to make a solution of about 20%, add 30g of medicinal activated carbon, stir and absorb for 40 minutes, coarsely filter, decarbonize, and then Finely filter with a 0.22 μm microporous membrane, and microwave-dry the filtrate to obtain alanyl glutamine sterile powder.

[0020] Class 100 clean area, under the condition of class 100, the relative humidity is controlled below 45%. Automatic dispensing machine is used for aseptic dispensing, 10g / bottle, stoppering, capping, light inspection, labeling, and packaging.

Embodiment 2

[0021] The preparation of embodiment 2 injection alanylglutamine

[0022] Prescription: Alanyl glutamine powder for injection 20g, water for injection 100ml

[0023] making process:

[0024] In the batching room of the 10,000-class clean area, dissolve 1000g of alanylglutamine and 5000ml of water for injection to make a solution of about 20%, add 50g of medicinal activated carbon, stir and absorb for 60 minutes, coarsely filter, decarbonize, and then Finely filter with a 0.22 μm microporous membrane, and microwave-dry the filtrate to obtain alanyl glutamine sterile powder.

[0025] Class 100 clean area, under the condition of class 100, the relative humidity is controlled below 45%. Automatic dispensing machine is used for aseptic dispensing, 20g / bottle, stoppering, capping, light inspection, labeling, and packaging.

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Abstract

The invention relates to a preparation of stable alanyl-glutamine preparation for injection. The alanyl-glutamine injection is sterile powder; the sterile alanyl-glutamine powder for injection is prepared by a microwave drying method. The preparation method has the advantages of solving the problem of poor preparation stability of the existed alanyl-glutamine injection, facilitating the clinical drug use and drug configuration, saving cost, and further guaranteeing the quality and treatment effect of the clinical drug.

Description

technical field [0001] The invention relates to the preparation of alanyl glutamine preparation for injection, in particular to a sterile powder of alanyl glutamine for injection prepared by a microwave drying method, which belongs to the technical field of medicine. Background technique [0002] L-Glutamine (Gln) is an essential amino acid in the body and plays an important role in protein and nucleic acid synthesis. The content of Gln in plasma is as high as 0.8-0.9 mmol / L, accounting for about 20% of the total free amino acids. Gln is the energy source of metabolically active cells such as intestinal mucosal epithelial cells, renal tubular epithelial cells, and immunocompetent cells; it is considered to be the body's nitrogen source carrier, transporting nitrogen sources between tissues in the body, and playing an important role in removing ammonia and other toxic substances. Features. Alanyl glutamine is rapidly decomposed by dipeptidase in the body to release L-glutam...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/05A61K9/14A61P3/02
CPCA61K9/0019A61K9/14A61K38/05
Inventor 刘冬燕姜丽华王坚朱贇黄升
Owner SHANGHAI PHARMA DONGYING JIANGSU PHARMA CO LTD