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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 glutamine powder injection: first, the moisture in the finished product is not easy to control, and excessive moisture will affect the stability of the product; , shrinkage, dry caking, looseness and discoloration
The third is poor stability and resolubility; the fourth is unsatisfactory impurity control

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

Embodiment 1

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

[0026] (1) Put the prescribed amount of water for injection into the liquid preparation tank, control the temperature of the water for injection to 30°C, and add the prescribed amount of N(2)-L-alanyl-L-glutamine raw material into the liquid preparation tank , stir to dissolve completely;

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

[0028] (3) The liquid medicine is filtered through titanium rod for carbon removal, coarse filtration with 0.45um polyethersulfone filter element, redundant filtration with ...

Embodiment 2

[0032] The prescription of alanyl glutamine for injection of the present invention: same as embodiment 1.

[0033] (1) Put the prescribed amount of water for injection into the liquid preparation tank, control the temperature of the water for injection to 20°C, and add the prescribed amount of N(2)-L-alanyl-L-glutamine raw material into the liquid preparation tank , stir to dissolve completely;

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

[0035] (3) The liquid medicine is filtered through titanium rod for carbon removal, 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 partition of the lyophi...

Embodiment 3

[0039] The prescription of alanyl glutamine for injection of the present invention: same as embodiment 1.

[0040] (1) Put the prescribed amount of water for injection into the liquid preparation tank, control the temperature of the water for injection to 40°C, and add the prescribed amount of N(2)-L-alanyl-L-glutamine raw material into the liquid preparation tank , stir to dissolve completely;

[0041] (2) Take the activated carbon of the prescribed amount, add a small amount of water for injection, make the activated carbon slowly absorb water to form a carbon slurry, add the carbon slurry to the medicinal solution and stir and adsorb for 12 minutes;

[0042] (3) The liquid medicine is filtered through titanium rod for carbon removal, 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 partition of the lyophil...

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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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