Preparation method of glutamine dipeptide for injection

A technology of alanyl glutamine and glutamine, which is applied in the field of preparation of alanyl glutamine for injection, can solve the problems of dry agglomeration, poor stability and resolubility, and low purity, and achieve impurity control Good effect, low content of related substances, uniform temperature transfer effect

Active Publication Date: 2017-10-24
HAINAN JINXING PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The dosage forms of similar domestic products are mainly injections and powder injections, but injections have the disadvantages of high impurity content, low purity, and inconvenient transportation and storage.
[0004] At present, there are mainly the following problems in the actual production of alanyl

Method used

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  • Preparation method of glutamine dipeptide for injection
  • Preparation method of glutamine dipeptide for injection
  • Preparation method of glutamine dipeptide for injection

Examples

Experimental program
Comparison scheme
Effect test

Example Embodiment

[0024] Example 1:

[0025] The prescription of alanyl glutamine for injection of the present invention: every 40.0 kg of alanyl glutamine for injection contains 10.0 kg of N(2)-L-alanyl-L-glutamine raw material, 0.4 kg of activated carbon for injection and water for injection 29.6kg.

[0026] (1) put into the water for injection of recipe quantity in the dosing tank, control the water for injection temperature to be 30 ℃, in the dosing tank, add the N(2)-L-alanyl-L-glutamine raw material of recipe quantity , stir to dissolve completely;

[0027] (2) Weigh the activated carbon of the recipe quantity, add a small amount of water for injection, make the activated carbon slowly absorb water to form carbon slurry, add the carbon slurry to the medicinal liquid, stir and adsorb for 10 minutes;

[0028] (3) The medicinal liquid is filtered through titanium rod decarbonization, coarse filtration with 0.45um polyethersulfone filter element, redundant filtration with 0.22um polyethersu...

Example Embodiment

[0031] Example 2:

[0032] The prescription of alanylglutamine for injection of the present invention: identical with embodiment 1.

[0033] (1) put into the water for injection of recipe quantity in the dosing tank, control the water for injection temperature to be 20 ℃, in the dosing tank, add the N(2)-L-alanyl-L-glutamine raw material of recipe quantity , stir to dissolve completely;

[0034] (2) take by weighing the activated carbon of the recipe quantity, add a small amount of water for injection, make the activated carbon slowly absorb water to form carbon slurry, add the carbon slurry to the medicinal liquid, stir and adsorb for 8 minutes;

[0035] (3) The medicinal liquid is filtered through titanium rod decarbonization, coarse filtration with 0.45um polyethersulfone filter element, redundant filtration with 0.22um polyethersulfone filter element, and sterile filtration with 0.22um polyethersulfone filter element;

[0036] (4) After the lyophilizer partition is coole...

Example Embodiment

[0038] Example 3:

[0039] The prescription of alanylglutamine for injection of the present invention: identical with embodiment 1.

[0040] (1) put into the water for injection of recipe quantity in the dosing tank, control the water for injection temperature to be 40 ℃, in the dosing tank, add the N(2)-L-alanyl-L-glutamine raw material of recipe quantity , stir to dissolve completely;

[0041] (2) take by weighing the activated carbon of the recipe quantity, add a small amount of water for injection, make the activated carbon slowly absorb water to form carbon slurry, add the carbon slurry to the medicinal liquid, stir and adsorb for 12 minutes;

[0042] (3) The medicinal liquid is filtered through titanium rod decarbonization, coarse filtration with 0.45um polyethersulfone filter element, redundant filtration with 0.22um polyethersulfone filter element, and sterile filtration with 0.22um polyethersulfone filter element;

[0043](4) After the lyophilizer partition is coole...

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Abstract

The invention discloses a preparation method of glutamine dipeptide for injection. The glutamine dipeptide is prepared through liquid preparation, degerming, freeze-drying and split charging of an N(2)-L-alanyl-L-glutamine material. Through optimization of preparation parameters of a product, the problems that the product is poor in stability, poor in frozen form, non-ideal in impurity control and relatively high in moisture content in the prior art are solved.

Description

technical field [0001] The invention belongs to the technical field of chemical pharmacy, and in particular relates to a preparation method of alanyl glutamine for injection. Background technique [0002] Glutamine is a conditionally essential amino acid, which can be converted from glucose in the body. It is the most abundant free amino acid in the human body and an important nitrogen carrier and donor. The main energy source of metaplastic cells helps to maintain the shape of the intestinal tract and the function of the immune system. It is an important precursor 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 ammonia during heat sterilization, so it cannot be directly used as a drug. effect. [0003] The common name of alanyl glutamine is N(2)-L-alanyl-L-glutamine, which has high sol...

Claims

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Application Information

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IPC IPC(8): A61K38/05A61K9/14A61P3/02
CPCA61K9/0019A61K9/14A61K38/05
Inventor 张丽杰刘全胜
Owner HAINAN JINXING PHARMA
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