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N(2)-L-alanyl-L-glutamine aseptic powdery preparation and process for prepairing same

A technology of glutamine and sterile powder, applied in the direction of powder transportation, etc., can solve the problems of unqualified bacterial inspection, increase of preparation cost, increase of adverse reactions, etc., and achieve the effect of increasing safety

Inactive Publication Date: 2005-10-12
哈尔滨智诚医药科技研究院
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] Because N(2)-L-alanyl-L-glutamine injection is unstable to light and heat, after high-temperature steam sterilization, related substances increase, resulting in an increase in adverse reactions, which has brought great harm to the safety of medication for patients. It is a big hidden danger, and because N(2)-L-alanyl-L-glutamine injection is unstable to light and heat, it brings great inconvenience to the transportation and storage of the product, and virtually increases the cost of the preparation. cost
We know that general N(2)-L-alanyl-L-glutamine raw materials cannot be directly used as injection powder due to unqualified bacterial inspection
[0015] In order to overcome the increase of related substances after N(2)-L-alanyl-L-glutamine injection is sterilized by high temperature steam, the inconvenience of transportation and storage and the general N(2)-L-alanyl-L- Due to the shortcomings of glutamine raw materials such as unqualified bacterial inspection, the present invention provides N(2)-L-alanyl-L-glutamine solvent crystalline sterile powder preparation and its preparation method

Method used

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  • N(2)-L-alanyl-L-glutamine aseptic powdery preparation and process for prepairing same
  • N(2)-L-alanyl-L-glutamine aseptic powdery preparation and process for prepairing same
  • N(2)-L-alanyl-L-glutamine aseptic powdery preparation and process for prepairing same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Under sterile conditions (the instruments and equipment used in the following operations have been aseptically treated), add 10kg of N(2)-L-alanyl-L-glutamine raw materials to 20kg of distilled water, stir and heat at 30-50°C, Dissolve, add 0.3kg of medical activated carbon, stir at this temperature for 20 minutes, filter out the activated carbon, filter the filtrate through a 0.22μm microporous membrane, sterilize the filtrate, stir at 30-50°C and add sterile ethanol dropwise to the filtrate until crystals are precipitated (Consumption of ethanol 20L), stirring slowly for 1.5 hours, slowly adding 17.14L of sterile ethanol dropwise within 1.5 hours at room temperature, stirring slowly for 2 hours after dropping, filtering the precipitated crystals, washing with an appropriate amount of cold ethanol, and drying under reduced pressure at 80°C to prepare Constant weight, 8.53 kg of white crystalline powder obtained.

Embodiment 2

[0038] Under sterile conditions (the instruments and equipment used in the following operations have been aseptically treated), add 10kg of N(2)-L-alanyl-L-glutamine raw materials to 20kg of distilled water, stir and heat at 30-50°C, Dissolve, add 0.3kg of medical activated carbon, stir at this temperature for 20 minutes, filter out the activated carbon, filter the filtrate through a 0.22μm microporous membrane, sterilize the filtrate, stir at 30-50°C and add sterile ethanol dropwise to the filtrate until crystals are precipitated (Consumption of ethanol 20L), slowly stirred for 1.5 hours, slowly added 60L of sterile ethanol dropwise within 1.5 hours at room temperature, slowly stirred for 2 hours after dropping, filtered the precipitated crystals, washed with an appropriate amount of cold ethanol, and dried under reduced pressure at 80°C to obtain a constant Weight, the obtained white crystalline powder 9.26 kg.

Embodiment 3

[0040] Under sterile conditions (the instruments and equipment used in the following operations have been aseptically treated), add 10kg of N(2)-L-alanyl-L-glutamine raw materials to 20kg of distilled water, stir and heat at 30-50°C, Dissolve, add 0.3kg of medical activated carbon, stir at this temperature for 20 minutes, filter out the activated carbon, filter the filtrate through a 0.22μm microporous membrane, sterilize the filtrate, stir at 30-50°C and add sterile ethanol dropwise to the filtrate until crystals are precipitated (Consumption of ethanol 20L), stir slowly for 1.5 hours, slowly add 160L of sterile ethanol dropwise within 1.5 hours at room temperature, slowly stir for 2 hours after dropping, filter the precipitated crystals, wash with an appropriate amount of cold ethanol, and dry under reduced pressure at 80°C to obtain a constant Weight, the obtained white crystalline powder 9.28 kg.

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Abstract

An aseptic powder of N(2)-L-alanyl-L-glutamine is prepared through adding N(2)-L-alanyl-L-glutamine to distilled water in aseptic condition, stirring, heating for dissolving, adding medical activated carbon, stirring, filtering for removing activated carbon, millipore filtering for removing bacteria, adding aseptic alcohol to educe out crystals, filtering, washing with cold alcohol, and vacuum drying. It has high optical and thermal stability.

Description

[0001] (1) Fields [0002] The present invention relates to a pharmaceutical product, specifically a medical product characterized by a special physical form. (two), background technology [0003] At present, N(2)-L-alanyl-L-glutamine preparations are injections, which must be sterilized by high-temperature steam during production, because N(2)-L-alanyl-L-glutamine Amide injection is unstable to light and heat. We have verified this through experiments. The test process is as follows: [0004] 1. Heat factor destruction test of N(2)-L-alanyl-L-glutamine injection: [0005] (1) Test method: Take N(2)-L-alanyl-L-glutamine injection, imitate commercially available packaging, place it at a high temperature of 80°C, and take samples at 10 days, 20 days, and 30 days respectively Detect all related substances. [0006] (2), test results: [0007] [0008] (3) Results: After N(2)-L-alanyl-L-glutamine injection was placed at 80°C for 30 days, all indicators increased to varying ...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K31/198
Inventor 马玉国
Owner 哈尔滨智诚医药科技研究院
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