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Glutamine dipeptide and compound amino acid medicinal composition prepared with solvent crystallization method

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 differences in the quality of medicines, affecting the quality of medicines, etc., so as to improve the quality of clinical application. and bioavailability, ease of procurement and dispensing, and efficacy in reducing liver damage

Active Publication Date: 2012-10-03
灵康药业集团股份有限公司
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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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  • Glutamine dipeptide and compound amino acid medicinal composition prepared with solvent crystallization method
  • Glutamine dipeptide and compound amino acid medicinal composition prepared with solvent crystallization method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Example 1 Preparation of Combination Packaged Drugs

[0042] Composition: Alanyl glutamine sterile powder for injection 10g, water for injection 50ml and compound amino acid injection 250ml

[0043] making process:

[0044] 1. Preparation of Alanyl Glutamine for Injection

[0045] (1) In the batching room of the 10,000-class clean area, heat and dissolve 1000g of alanylglutamine and 8000ml of 50% ethanol solution to make a solution of about 12.5%, add 16g of medicinal activated carbon, stir and absorb for 30 minutes, and filter Decarburization, and fine filtration through a 0.22μm microporous membrane, the filtrate was placed at a low temperature of 0-4°C for 20 hours, a large number of crystals were precipitated, filtered, and dried, and then the filter cake was dried under reduced pressure at 50°C for 4 hours , to obtain alanyl glutamine sterile powder.

[0046] (2) Class 100 clean area, under the condition of class 100, the relative humidity is controlled to be l...

Embodiment 2

[0055] Example 2 Preparation of Combination Packaged Drugs

[0056] Combination: 20g of alanyl glutamine powder for injection, 100ml of water for injection and 500ml of compound amino acid injection

[0057] making process:

[0058] 1. Preparation of Alanyl Glutamine for Injection

[0059] (1) In the batching room of the 10,000-class clean area, heat and dissolve 2000g of alanylglutamine and 16000ml of 50% ethanol solution to form a solution of about 12.5%, add 32g of medicinal activated carbon, stir and absorb for 30 minutes, and filter Decarburization, and fine filtration through a 0.22μm microporous membrane, the filtrate was placed at a low temperature of 0-4°C for 20 hours, a large number of crystals were precipitated, filtered, and dried, and then the filter cake was dried under reduced pressure at 50°C for 4 hours , to obtain alanyl glutamine sterile powder.

[0060] (2) Class 100 clean area, under the condition of class 100, the relative humidity is controlled to ...

experiment example 3

[0069] Experimental example 3 Stability test

[0070] A batch of samples were prepared according to Example 1 of 201110267409.6, and compared with the samples prepared in Example 1 of the present invention, an accelerated test was carried out at a high temperature of 40°C and a relative humidity of 75%±5% for 6 months. The results are shown in Table 1.

[0071] Table 1 Stability and dissolution rate determination results

[0072]

[0073] As can be seen from Table 1, the dissolution rate of the sample prepared in Example 1 of 201110267409.6 is significantly slow, and the relevant substances increase during the acceleration of 6 months; while the dissolution rate of the sample prepared in Example 1 of the present invention is very fast, and the relevant substances change after 6 months of acceleration smaller. It fully demonstrates the superiority of the present invention in improving stability and dissolution rate.

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Abstract

The invention relates to a medicinal composition of glutamine dipeptide sterile powder for injection and a compound amino acid injection, prepared with a solvent crystallization method, in particular to a combined application package. The medicinal composition comprises glutamine dipeptide sterile powder for injection, water for injection and a compound amino acid injection. Due to the adoption of the combined application package disclosed by the invention, great convenience is brought to the requirement of clinical administration; great convenience is brought to purchase and dispensation of an administration unit, and cost is saved; the combined application package is made for emergent use, and plays a great role in ensuring the stability of every single medicament, and the clinical application quality and bioavailability of a medicament can be enhanced; and the composition disclosed by the invention has the effect of remarkably reducing liver damage.

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 powder for injection and compound amino acid injection prepared by a solvent crystallization method. field of medical technology. Background technique [0002] L-Glutamine (Gln) is an essential amino acid in the body and the most abundant amino acid in the human body. 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 removing ammonia and ...

Claims

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Application Information

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IPC IPC(8): A61K38/05A61K9/14A61P3/02A61K31/198A61K31/401A61K31/405A61K31/4172
Inventor 陶灵刚
Owner 灵康药业集团股份有限公司
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