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N(2)-L-alanyl-L-glutamine liposome injection and preparation method thereof

A technology of glutamine fat and glutamine, which is applied in the field of medicine, can solve the problems of high preparation cost and high requirements for powder injections, achieve stable product quality, reduce drug side effects, and improve the effect of drug therapeutic index

Active Publication Date: 2010-01-27
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

[0007] Aiming at the problems that the current N(2)-L-alanyl-L-glutamine solution is easy to decompose after long-term storage, the powder injection has high requirements and high preparation cost, the purpose of the present invention is to provide a kind of N(2)-L-glutamine -Alanyl-L-glutamine liposome injection, encapsulated with liposomes by reverse-phase evaporation method, which solves the above-mentioned problems

Method used

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  • N(2)-L-alanyl-L-glutamine liposome injection and preparation method thereof
  • N(2)-L-alanyl-L-glutamine liposome injection and preparation method thereof
  • N(2)-L-alanyl-L-glutamine liposome injection and preparation method thereof

Examples

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Effect test

Embodiment 1

[0028] Example 1 Preparation of N(2)-L-alanyl-L-glutamine liposome injection

[0029] Prescription (100 bottles): N(2)-L-alanyl-L-glutamine 10g

[0030] Soy Lecithin 120g

[0031] Cholesterol 20g

[0032] Poloxamer 188 300g

[0033] Sodium deoxycholate 15g

[0034] Sodium chloride 45g

[0035] Preparation Process

[0036] (1) 120g soybean lecithin, 20g cholesterol, 15g sodium deoxycholate and 300g poloxamer 188 are dissolved in 800ml of ethanol;

[0037] (2) 10 g of N(2)-L-alanyl-L-glutamine and 45 g of sodium chloride were dissolved in 2000 ml of phosphoric acid-disodium hydrogen phosphate buffer solution with a pH value of 5.0;

[0038] (3) Mix the two and stir to form a W / O emulsion, heat and stir to evaporate, when the mixture reaches a viscous state, add 3000ml of phosphoric acid-disodium hydrogen phosphate buffer solution with a pH value of 5.0, continue to heat and stir to evaporate to remove the re...

Embodiment 2

[0052] Example 2 Preparation of N(2)-L-alanyl-L-glutamine liposome injection

[0053] Prescription (100 bottles): N(2)-L-alanyl-L-glutamine 20g

[0054] Egg Yolk Lecithin 450g

[0055] Cholesterol 30g

[0056] Poloxamer 188 600g

[0057] Sodium deoxycholate 20g

[0058] Glucose 500g

[0059] Preparation Process

[0060] (1) 450g egg yolk lecithin, 30g cholesterol, 20g sodium deoxycholate and 600g poloxamer 188 were dissolved in 2000ml of isopropanol;

[0061] (2) 20 g of N(2)-L-alanyl-L-glutamine and 500 g of glucose were dissolved in 5000 ml of citric acid-sodium citrate buffer solution with a pH value of 7.0;

[0062] (3) Mix the two and stir to form a W / O emulsion, heat and stir to evaporate, and when the mixture reaches a viscous state, add 5000ml of citric acid-sodium citrate buffer solution with a pH value of 7.0, continue to heat and stir to evaporate Remove residual isopropanol, sonicate for 30...

Embodiment 3

[0064] Example 3 Preparation of N(2)-L-alanyl-L-glutamine liposome lyophilizate

[0065] Prescription (100 bottles): N(2)-L-alanyl-L-glutamine 10g

[0066] Soy Lecithin 80g

[0067] Cholesterol 12g

[0068] Poloxamer 188 60g

[0069] Sodium deoxycholate 8g

[0070] Mannitol 200g

[0071] Preparation Process

[0072] (1) 10g soybean lecithin, 12g cholesterol, 8g sodium deoxycholate and 60g poloxamer 188 are dissolved in 500ml of acetone;

[0073] (2) Dissolve 10 g of N(2)-L-alanyl-L-glutamine in 200 ml of phosphoric acid-dipotassium hydrogen phosphate buffer solution with a pH value of 6.0;

[0074] (3) Mix the two and stir to form a W / O emulsion, heat and stir to evaporate, when the mixture reaches a viscous state, add 200ml of phosphoric acid-dipotassium hydrogen phosphate buffer solution with a pH value of 6.0, continue to heat and stir to evaporate to remove the residual Acetone, sonicated for 30 mi...

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Abstract

The invention provides an N(2)-L-alanyl-L-glutamine liposome injection and a preparation method thereof. The N(2)-L-alanyl-L-glutamine liposome injection is made of N(2)-L-alanyl-L-glutamine liposome and random existent auxiliary materials. The N(2)-L-alanyl-L-glutamine liposome is prepared form the following components by weight: 1 part of N(2)-L-alanyl-L-glutamine, 5-25 parts of phospholipid, 1-3 parts of cholesterol, 5-35 parts of poloxamer 188 and 0.5-2 parts of sodium deoxycholate. The invention overcomes the defect of the poor stability of the N(2)-L-alanyl-L-glutamine liposome injection in the prior art and reduces the cost of the preparation.

Description

technical field [0001] The invention relates to a liposome preparation, in particular to an N(2)-L-alanyl-L-glutamine liposome injection and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] N(2)-L-alanyl-L-glutamine is a component of parenteral nutrition, which can promote positive nitrogen balance, regulate muscle protein synthesis, and prevent intestinal mucosal passage caused by long-term parenteral nutrition. Increased permeability and atrophy, and can enhance immune function and prevent the occurrence of bacteremia. N(2)-L-alanyl-L-glutamine can be decomposed into -glutamine and alanine in the body, and its properties can supplement -glutamine through parenteral nutrition infusion. The amino acids released by the decomposition of the dipeptide are stored in the corresponding parts of the body as nutrients and metabolized according to the needs of the body. For diseases that may cause the depletion of glutamine i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/10A61K9/127A61K9/19A61K47/34A61K38/05A61P3/02A61K47/10A61K47/28
Inventor 陶灵刚
Owner 灵康药业集团股份有限公司