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N(2)-L-alanyl-L-glutamine preparation for injection and preparation method thereof

A technology of glutamine and alanyl, which is applied in the field of N-L-alanyl-L-glutamine preparation for injection and its preparation, can solve the problems of poor stability and rehydration, auxiliary materials affecting product content, and product freezing type. Not good and other problems, to achieve high stability, avoid moisture absorption and slow oxidation, good water solubility

Active Publication Date: 2011-11-02
GUIZHOU YIBAI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The object of the present invention is to provide a kind of N (2)-L-alanyl-L-glutamine for injection and preparation method thereof, to solve the problem of excessive moisture in existing products, poor product frozen type, stability and Problems such as poor rehydration and excipients affecting product content

Method used

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  • N(2)-L-alanyl-L-glutamine preparation for injection and preparation method thereof
  • N(2)-L-alanyl-L-glutamine preparation for injection and preparation method thereof
  • N(2)-L-alanyl-L-glutamine preparation for injection and preparation method thereof

Examples

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Effect test

Embodiment 1

[0083] (1) Get 1000g of N(2)-L-alanyl-L-glutamine raw material, add the water for injection of the total amount of the prepared drug solution, the total amount of the prepared drug solution is 5000ml, fully stir to make it completely dissolve to a concentration of 20% solution;

[0084] (2) Add activated carbon for needles with a total amount of 0.3% of the dosing solution, stir and dissolve for 10 minutes, filter and decarbonize, and then perform sterilizing filtration through a 0.2 μm filter;

[0085] (3) Take the filtrate and put it in a sterilized freeze-drying tray, each tray has a thickness of 12 mm, put it into the freezer of a freeze dryer, and pre-freeze it. The pre-freezing temperature is -40 ° C, and keep it for 3.5 hours after reaching the temperature. , vacuuming, the vacuum degree is: 10-25Pa, heating, the temperature rises to -20°C, maintains for 1 hour, rises to -10°C, maintains for 4 hours, heats up to -5°C, maintains for 1 hour, rises to 0°C, and waits Keep ...

Embodiment 2

[0088](1) Get 1250g of N(2)-L-alanyl-L-glutamine raw material, add the water for injection of the total amount of the prepared drug solution, the total amount of the prepared drug solution is 5000ml, fully stir to make it completely dissolve to a concentration of 25% solution;

[0089] (2) Add activated carbon for needles with a total amount of 0.1% of the solution, stir and dissolve for 20 minutes, filter for decarbonization, and then perform sterilizing filtration through a 0.2 μm filter;

[0090] (3) Take the filtrate and place it in a sterilized freeze-drying tray. The thickness of each tray is 10 mm. Put it into the freezer of the freeze dryer for pre-freezing. The pre-freezing temperature is -50 ° C, and keep it for 5 hours after reaching the temperature. , vacuuming, the vacuum degree is: 10-25Pa, heating, the temperature rises to -20°C, keeps for 2 hours, rises to -10°C, keeps for 3 hours, heats up to -5°C, keeps for 2 hours, rises to 0°C, and waits Keep warm for 1 ho...

Embodiment 3

[0093] (1) Get 1100g of N(2)-L-alanyl-L-glutamine raw material, add the water for injection of the total amount of the prepared medicinal liquid, the total amount of the prepared medicinal liquid is 5000ml, fully stir to make it completely dissolve to a concentration of 22% solution;

[0094] (2) Add activated carbon for needles with a total amount of 0.4% of the dosing solution, stir and dissolve for 5 minutes, filter and decarbonize, and then perform sterilizing filtration through a 0.2 μm filter;

[0095] (3) Take the filtrate and place it in sterilized freeze-drying trays. The thickness of each tray is 15 mm. Put it into the freezer of the freeze dryer for pre-freezing. The pre-freezing temperature is -45 ° C and keep for 2 hours after reaching the temperature. , vacuuming, the vacuum degree is: 10-25Pa, heating, the temperature rises to -20°C, maintains for 0.5 hours, rises to -10°C and maintains for 6 hours, heats up to -5°C, maintains for 0.5 hours, rises to 0°C, and wa...

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Abstract

The invention discloses an N(2)-L-alanyl-L-glutamine preparation for injection and a preparation method thereof. The preparation is prepared through directly preparing a liquid with a raw material N(2)-L-alanyl-L-glutamine, freeze-drying, and carrying out separate packing. The method comprises the following steps: (1) taking the raw material N(2)-L-alanyl-L-glutamine, adding water for injection, and fully stirring to completely dissolve N(2)-L-alanyl-L-glutamine; (2) adding needle active carbon to a solution obtained in step (1), fully stirring, filtering to decarburize, and carrying out germ filtering through passing through a filter with a diameter of 0.2 [mu]m; (3) putting a filtrate obtained in step 2 into a sterilized freeze-dried disc, loading the disc into a cooling chamber of a freeze dryer, and carrying out pre-freezing, vacuumizing, heating, sublimation drying, desorption drying, and vacuum break to end freeze-drying; and (4) accessing high purity nitrogen for drying and degerming, taking out of the chamber, carrying out asepsis packing, tamponading, and capping. So N(2)-L-alanyl-L-glutamine for injection is obtained.

Description

technical field [0001] The invention belongs to the technical field of chemical pharmacy, and in particular relates to an N(2)-L-alanyl-L-glutamine preparation for injection and a preparation method thereof. Background technique [0002] N(2)-L-alanyl-L-glutamine is a dipeptide substance obtained by the condensation reaction of alanine and glutamine. After entering the body, N(2)-L-alanyl-L- Glutamine is rapidly hydrolyzed into alanine and glutamine, providing glutamine for patients receiving parenteral nutrition. [0003] Glutamine plays an important role in the human body. Some important cell functions, such as protein synthesis, phagocytosis of cells, proliferation of lymphocytes, and energy supply of intestinal mucosal cells, must rely on sufficient glutamine. It is very beneficial to supplement exogenous glutamine clinically. Under various stress conditions such as trauma and infection, the requirement of glutamine increases greatly. At this time, supplementing approp...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K38/05A61P3/02
Inventor 窦啟玲宋婧瑜隋东虎冯志刚周黎亚
Owner GUIZHOU YIBAI PHARMA CO LTD
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