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Aceglutamide composition freeze-dried powder injection for injection

A technology of acetylglutamine and freeze-dried powder injection, which is applied in the direction of freeze-dried delivery, drug combination, powder delivery, etc., to improve the ability of the central nervous system, good resolubility, and enhance the effect of repair

Inactive Publication Date: 2014-02-05
HAINAN WEI KANG PHARMA QIANSHAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] As a new type of drug carrier, chitosan nanoparticles are non-toxic, good biocompatibility and biodegradability, which can improve the stability of drugs, change the route of administration, increase the absorption of drugs, and improve the biological properties of drugs. Utilization and other characteristics enable the drug to achieve controlled release and targeted therapy in the body. At present, there is no pharmaceutical dosage form containing chitosan nanoparticles in clinical practice.

Method used

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  • Aceglutamide composition freeze-dried powder injection for injection
  • Aceglutamide composition freeze-dried powder injection for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Preparation of acetylglutamine composition freeze-dried powder for injection (specification: 100 mg, calculated as acetylglutamine), in 1000 vials.

[0035] 1. Prescription:

[0036] Acetyl Glutamine 100g

[0037] Chitosan Nanoparticles 200g

[0038] Water for injection 2000ml

[0039] 2. Preparation process:

[0040] 1) Weigh 200g of chitosan nanoparticles and slowly add to 2000ml of water for injection (while adding, stir until dissolved.

[0041] 2) Continue to add 100g of acetylglutamine and stir to dissolve until clear.

[0042] 3) Use sodium hydroxide to adjust the pH to 5.5-6.0, add activated carbon with 0.1% volume of water for injection and stir for 30 minutes; then decarburize and circulate and filter through titanium rods for 30 minutes; then sterilize through 0.45 μm and 0.22 μm Circulate filtration for 30 minutes; detect the content of intermediates, and calculate the filling amount of 100 mg per bottle based on acetylglutamine.

[0043] 4) Fill accor...

Embodiment 2

[0045] Preparation of acetylglutamine composition freeze-dried powder for injection (specification: 100 mg, calculated as acetylglutamine), in 1000 vials.

[0046] 1. Prescription:

[0047] Acetyl Glutamine 100g

[0048] Chitosan Nanoparticles 160g

[0049] Water for injection 2000ml

[0050] 2. Preparation process:

[0051] 1) Weigh 160g of chitosan nanoparticles and slowly add to 2000ml of water for injection, stir until dissolved while adding.

[0052] 2) Continue to add 100g of acetylglutamine and stir to dissolve until clear.

[0053]3) Adjust the pH to 5.5-6.0 with sodium hydroxide, add activated carbon with 0.1% volume of water for injection and stir for 30 minutes; then decarburize and circulate and filter through titanium rods for 30 minutes; then sterilize by 0.45 μm and 0.22 μm Circulate filtration for 30 minutes; detect the content of intermediates, and calculate the filling amount of 100 mg per bottle based on acetylglutamine.

[0054] 4) Fill according to t...

Embodiment 3

[0056] Preparation of acetylglutamine composition freeze-dried powder for injection (specification: 100 mg, calculated as acetylglutamine), in 1000 vials.

[0057] 1. Prescription:

[0058] Acetyl Glutamine 100g

[0059] Chitosan Nanoparticles 250g

[0060] Water for injection 2000ml

[0061] 2. Preparation process:

[0062] 1) Weigh 250g of chitosan nanoparticles and slowly add to 2000ml of water for injection, stir until dissolved while adding.

[0063] 2) Continue to add 100g of acetylglutamine and stir to dissolve until clear.

[0064] 3) Adjust the pH to 5.5-6.0 with sodium hydroxide, add activated carbon with 0.1% volume of water for injection and stir for 30 minutes; then decarburize and circulate and filter through titanium rods for 30 minutes; then sterilize by 0.45 μm and 0.22 μm Circulate filtration for 30 minutes; detect the content of intermediates, and calculate the filling amount of 100 mg per bottle based on acetylglutamine.

[0065] 4) Fill according to ...

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Abstract

The invention provides an aceglutamide composition freeze-dried powder injection for injection, and relates to the technical field of medicines and medicine preparation. The aceglutamide composition freeze-dried powder injection for injection comprises the following raw material components in parts by weight: 2.35-6.35 parts of aceglutamide, 6.70-10.70 parts of chitosan nanoparticles and 84.96-88.96 parts of water for injection. The aceglutamide composition freeze-dried powder injection for injection has the advantages that 1) the composition can remarkably enhance the repairing effect of aceglutamide, the use level of aceglutamide can be clinically reduced, and the adverse reaction of aceglutamide can be alleviated; 2) the chitosan nanoparticles have the effect of targeted therapy and are taken as a medicine carrier to improve the bioavailability of aceglutamide, thereby facilitating clinical application; 3) the chitosan nanoparticles can replace mannitol as a freeze-dried skeleton agent of the freeze-dried powder injection, so that the activity of mannitol on human body is eliminated.

Description

Technical field: [0001] The invention relates to the technical field of medicine and medicine manufacture, in particular to a freeze-dried powder injection of an acetylglutamine composition for injection. Background technique: [0002] Acetylglutamine is the acetylated compound of glutamine, which is decomposed into glutamic acid and gamma-aminobutyric acid (GABA) after passing through the blood-cerebrospinal fluid barrier. Glutamate is involved in the transmission of information in the central nervous system. γ-aminobutyric acid can antagonize the excitability of glutamate, improve nerve cell metabolism, maintain nerve stress ability and reduce blood ammonia, and improve brain function. Its chemical structure is as follows: [0003] [0004] Patients with acute severe craniocerebral injury often have significant neurological pathological symptoms and a series of pathophysiological changes. Especially for elderly patients, the symptoms are more serious, and many critica...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/198A61K47/36A61K31/722A61P25/28A61P25/00
Inventor 汪六一汪金灿黄吉林
Owner HAINAN WEI KANG PHARMA QIANSHAN
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