Method for preparing alanyl-glutamine injection

A technology of alanyl glutamine and injection, which is applied in the fields of pharmaceutical formulation, drug delivery, metabolic diseases, etc., can solve the problems of poor stability and achieve good stability

Active Publication Date: 2014-04-16
CISEN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Chinese patent (CN200410070336) reported a kind of N(2)-L-alanyl-L-glutami...

Method used

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  • Method for preparing alanyl-glutamine injection
  • Method for preparing alanyl-glutamine injection
  • Method for preparing alanyl-glutamine injection

Examples

Experimental program
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Effect test

Embodiment 1

[0016] Example 1: Alanyl glutamine injection (10g:50ml).

[0017] Preparation: 1) Boil the water for injection, add 15L of water for injection into the concentrated preparation tank, cool down to 45°C, add 10kg of alanyl glutamine, stir for 30 minutes, after the raw materials are completely dissolved, add 0.05kg of moistened Wet the needles with activated carbon, stirred and adsorbed for 20 minutes, and poured into the diluted tank. Rinse the concentrated preparation tank 4 times with water for injection cooled below 45°C, and pull all the flushing water into the thin preparation tank; l Sodium hydroxide solution to adjust the ph value to 5.7, add 0.05kg of wetted activated carbon for needles, add water for injection to the full amount, and cycle for 40 minutes; 3) Sampling to detect endotoxin, content, and ph value; 4) Semi-finished product inspection Filling after passing the test, 50ml / bottle, the filling temperature is controlled at 50°C; 5) Sterilize at 115°C for 30 minu...

Embodiment 2

[0018] Example 2: Alanyl glutamine injection (20g:100ml).

[0019] Preparation: 1) Boil water for injection, add 30L of water for injection into the concentrated preparation tank, cool down to 45°C, add 20kg of alanylglutamine, stir for 30 minutes, after the raw materials are completely dissolved, add 0.15kg of moistened Wet the needles with activated carbon, stirred and adsorbed for 20 minutes, and poured into the diluted tank. Rinse the concentrated preparation tank 4 times with the water for injection cooled below 45°C, and pull all the flushing water into the thin preparation tank; 2) After the liquid medicine in the concentrated preparation tank is finished, add water for injection to 90L, and use 0.1mol / l Sodium hydroxide solution to adjust the pH value to 5.8, add 0.15 kg of wetted activated carbon for needles that absorbs 5% of its mass trans-lycopene, add water for injection to the full amount, and cycle for 40 minutes; 3) Sampling to detect endotoxin, content, and ...

Embodiment 3

[0020] Example 3: Alanyl glutamine injection (20g:100ml).

[0021] Preparation: 1) Boil water for injection, add 30L of water for injection into the concentrated preparation tank, cool down to 45°C, add 20kg of alanylglutamine, stir for 30 minutes, after the raw materials are completely dissolved, add 0.15kg of moistened Wet the needles with activated carbon, stirred and adsorbed for 20 minutes, and poured into the diluted tank. Rinse the concentrated preparation tank 4 times with the water for injection cooled below 45°C, and pull all the flushing water into the thin preparation tank; 2) After the liquid medicine in the concentrated preparation tank is finished, add water for injection to 90L, and use 0.1mol / l Sodium hydroxide solution to adjust the ph value to 5.8, add 0.15 kg of wetted activated carbon for needles that absorbs cis-lycopene accounting for 5% of its mass, add water for injection to the full amount, and pull the cycle for 40 minutes; 3) Sampling to detect en...

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Abstract

The invention belongs to the technical field of medicine preparation, and in particular relates to a method for preparing an alanyl-glutamine injection. The method comprises the following steps: (1) adding 30 percent by prescription of injection water and alanyl-glutamine by prescription into a concentrated preparation tank, stirring until the raw materials are completely dissolved, adding wet injection activated carbon, stirring and adsorbing, pumping into a diluted preparation tank, washing the concentrated preparation tank in a fractional manner with 10-60 percent by prescription of injection water, and drawing all the washing water into the diluted preparation tank; (2) filling injection water to 90 percent of the prescription amount after the liquid medicine in the concentrated preparation tank is drawn, regulating the pH value to 5.5-6.3 with a pH value regulating agent, adding the wet injection activated carbon, filling the injection water to full dose, circulating the drawing action for 30-40 minutes; (3) filling, sterilizing and sub-packaging. Compared with the prior art, the alanyl-glutamine injection prepared by the method is safe, reliable and good in stability.

Description

technical field [0001] The invention belongs to the technical field of medicine preparation, and in particular relates to a preparation method of alanyl glutamine injection. Background technique [0002] Glutamine is a conditionally essential amino acid. It is the most abundant free amino acid in the human body and an important nitrogen carrier and donor. It is also the main energy source for rapid metaplastic cells such as intestinal epithelial cells and lymphocytes in the body. It helps to maintain the shape of the intestinal tract and the function of the immune system. It is an important precursor substance for the synthesis of nucleic acids, proteins, purines, pyrimidines, etc., and is also a regulator of protein synthesis and decomposition. However, due to glutamine's low water solubility and instability in solution, it can generate toxic glutamic acid and ammonia during heat sterilization, so it cannot be directly used as a drug. Only by converting it into stable deriv...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K38/05A61P3/00
Inventor 王静孔健李瑞明孙文敬卢秀莲杜振新
Owner CISEN PHARMA
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