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Pharmaceutical composition of alanyl glutamine and compound amino acid

A technology of alanyl glutamine and compound amino acids, applied in the field of medicine, can solve the problems of unfavorable wide application of alanyl glutamine and amino acids, great difference in drug quality, influence on drug quality, etc., and achieves improvement of clinical application quality. and bioavailability, ease of procurement and dispensing, and improved safety

Inactive Publication Date: 2012-05-02
HAINAN LINGKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] At present, in China, the compatible application of alanyl glutamine for injection and compound amino acid injection is purchased by the drug unit from different manufacturers, and they are combined together during clinical application. In this way, the quality of the drug may vary due to different manufacturers. The difference is very large, and the compatibility application seriously affects the quality of the final drug, which further affects the treatment of patients
[0007] Patent document CN201223558Y discloses a double-chamber infusion bag containing amino acid injection and alanyl glutamine injection, but alanyl glutamine exists in the form of solution, which is unstable when left for a long time and will degrade
Zhou Xin and others pointed out that alanyl glutamine plus compound amino acid injection caused liver damage, which is not conducive to the wide application of alanyl glutamine and amino acid combination
[0008] In order to overcome the difficult technical problems existing in the combination of alanyl glutamine and compound amino acids in the prior art, the inventor proposes a new pharmaceutical composition of alanyl glutamine and compound amino acids and its application packaging

Method used

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  • Pharmaceutical composition of alanyl glutamine and compound amino acid

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Example 1 Preparation of Combination Packaged Drugs

[0035] Composition: 10g sterile freeze-dried powder of alanylglutamine for injection, 50ml water for injection and 250ml compound amino acid injection

[0036] making process:

[0037] 1. Preparation of Alanyl Glutamine for Injection

[0038] (1) Dissolve 1000g of alanylglutamine and 5000ml of water for injection in the batching room of the 10,000-class clean area to make a 20% solution, add 25g of medicinal charcoal, stir and adsorb for 20 minutes, decarburize by coarse filtration, and then Finely filter through a 0.22 μm microporous membrane, then pack in freeze-drying trays, the liquid surface thickness of the liquid medicine should not exceed 2 cm, and freeze-dry to obtain alanyl glutamine sterile freeze-dried powder.

[0039] (2) Class 100 clean area, under the condition of class 100, the relative humidity is controlled to be lower than 45%, and the automatic packaging machine is used for aseptic subpackaging...

Embodiment 2

[0048] Example 2 Preparation of Combination Packaged Drugs

[0049] Composition: 20g of alanylglutamine freeze-dried powder for injection, 100ml of water for injection and 500ml of compound amino acid injection

[0050] making process:

[0051] 1. Preparation of Alanyl Glutamine for Injection

[0052] (1) Dissolve 2000g of alanylglutamine and 10000ml of water for injection in the batching room of the 10,000-class clean area to make a 20% solution, add 50g of medicinal charcoal, stir and adsorb for 20 minutes, decarburize by coarse filtration, and then Finely filter through a 0.22 μm microporous membrane, then pack in freeze-drying trays, the liquid surface thickness of the liquid medicine should not exceed 2 cm, and freeze-dry to obtain alanyl glutamine sterile freeze-dried powder.

[0053] (2) Class 100 clean area, under the condition of Class 100, the relative humidity is controlled to be lower than 45%, and the automatic filling machine is used for aseptic subpackaging,...

experiment example 3

[0062] Experimental example 3 clinical trial

[0063] Investigation is carried out to the patient of the pharmaceutical composition of 20 routine admissions using alanyl glutamine and compound amino acid, one group is to use alanyl glutamine injection and compound amino acid injection (with the product of embodiment 1 of the present invention Commercially available products of equal concentration, produced by Shandong Lukang Chenxin Pharmaceutical Co., Ltd., batch number 20101101) 10 cases (referred to as combination 1), the other group is the use of alanyl glutamine sterile freeze-dried powder for injection and compound amino acids Injection (the product of Embodiment 1 of the present invention) 10 examples (combination 2 for short). The composition drugs used in the two groups are all of the same batch number, and the use time is 6 months after the production date. The course of treatment is 3 days, and the liver function of the two groups of patients is checked before an...

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Abstract

The invention relates to a pharmaceutical composition of alanyl glutamine aseptic frozen-dried powder for injection and compound amino acid injection, particularly a combined application package, comprising alanyl glutamine aseptic frozen-dried powder for injection, water for injection, and compound amino acid injection. When the pharmaceutical composition is used, the alanyl glutamine aseptic frozen-dried powder for injection is dissolved with water for injection, and then is mixed with compatible amino acid injection or transfusion containing amino acid, and intravenous infusion is used. The combined application package disclosed herein avoids the influence to quality caused by quality discrepancy of different factories when the combination is used, and greatly increases the safety of application of patients.

Description

technical field [0001] The invention relates to a pharmaceutical composition of alanyl glutamine and compound amino acid, in particular to a combined application package of alanyl glutamine sterile freeze-dried powder for injection and compound amino acid injection, belonging to the technical field of medicine . Background technique [0002] L-glutamine (L-Glutamine, Gln) is an essential amino acid in the body, and it is also the most abundant amino acid in the human body, and it plays an important role in the synthesis of proteins and nucleic acids. The content of Gln in plasma is as high as 0.8-0.9 mmol / L, accounting for about 20% of the total free amino acids. Gln is the energy source of metabolically active cells such as intestinal mucosal epithelial cells, renal tubular epithelial cells, and immunocompetent cells; it is considered to be the body's nitrogen source carrier, transporting nitrogen sources between tissues in the body, and playing an important role in removi...

Claims

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Application Information

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IPC IPC(8): A61K31/4172A61K31/198A61K9/19A61K9/08A61P3/02A61P17/02
Inventor 陶灵刚
Owner HAINAN LINGKANG PHARMA CO LTD
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