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Aztreonam/arginine medicinal composition lipid microsphere injection

A technology of arginine and aztreonam, which is applied in the field of medicine, can solve the problems of complex preparation process, loss of organic solvent, poor stability, etc., and achieve the effects of simple preparation process, improved stability, and improved encapsulation efficiency

Inactive Publication Date: 2010-12-15
HAINAN LINGKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, the vibration during storage, transportation, and subpackaging can easily lead to the separation of the two components, uneven mixing, and aztreonam and L-arginine cannot be fully contacted and protected, resulting in the solubility of aztreonam between each bottle , dissolution rate, stability, etc.
[0010] The 3rd, adopt the method of recrystallization after aztreonam and arginine are salified, and its advantage is that can guarantee two kinds of components packing dosage, ratio, stability, shortcoming is to use and loss poisonous organic solvent, not only to Potentially harmful effects on the body and not friendly to the environment
[0011] Chinese patent CN101579336A discloses aztreonam and its production method. It is composed of aztreonam and L-arginine, which is prepared by aseptic subpackaging. The raw and auxiliary materials are directly mixed, sieved, and subpackaged, but the stability is poor. Decomposed by light and heat, the aqueous solution is quickly hydrolyzed and oxidized, and it is easy to deteriorate, which affects the efficacy and quality of the medicine
The preparation process of the above-mentioned patents is relatively complicated, and the yield of liposomes is low, and the clinical effect is not obvious

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] Example 1 Preparation of Aztreonam / Arginine Injection

[0053] Prescription: (100 bottles)

[0054] Aztreonam 50g

[0055] Arginine 39g

[0056] Polymeric anhydride 100g

[0057] Propylene glycol 25g

[0058] Fatty Acid Sorbitan 80 25g

[0059] Sodium chloride 90g

[0060] Preparation Process:

[0061] (1) 50g of aztreonam, 25g of propylene glycol and 90g of sodium chloride are dissolved in 1000ml of water for injection to obtain an aqueous phase;

[0062] (2) 100g polymeric anhydride and 25g fatty acid sorbitan 80 are dissolved in 600ml of dichloromethane and ethyl acetate mixed solvent with a volume ratio of 5:1 to obtain an oil phase;

[0063] (3) Slowly drop the water phase obtained above into the oil phase under stirring conditions, control the dropping speed to 5ml / min, stir for 10min after dropping, then transfer to a high-speed homogenizer and stir at a high speed for 3 times at a speed of 15000r / min, each 10min, to obtain a uniform white emulsion;

[...

Embodiment 2

[0066] Example 2 Preparation of Aztreonam / Arginine Injection

[0067] Prescription: (100 bottles)

[0068] Aztreonam 100g

[0069] Arginine 78g

[0070] Polymeric anhydride 500g

[0071] Propylene glycol 80g

[0072] Fatty Acid Sorbitan 80 200g

[0073] Sodium chloride 300g

[0074] Preparation Process:

[0075] (1) 100g of aztreonam, 80g of propylene glycol and 300g of sodium chloride are dissolved in 2000ml of water for injection to obtain an aqueous phase;

[0076] (2) 500g polymeric anhydride and 200g fatty acid sorbitan 80 are dissolved in 2000ml of dichloromethane and ethyl acetate mixed solvent with a volume ratio of 5:1 to obtain an oil phase;

[0077] (3) Slowly drop the water phase obtained above into the oil phase under stirring conditions, control the dropping speed to be 10ml / min, stir for 30min after dropping, then transfer to a high-speed homogenizer for high-speed stirring for 5 times at a speed of 15000r / min, each 5min, to obtain a uniform white emuls...

Embodiment 3

[0080] Example 3 Preparation of Aztreonam / Arginine Injection

[0081] Prescription: (100 bottles)

[0082] Aztreonam 200g

[0083] Arginine 156g

[0084] Polymeric anhydride 700g

[0085] Propylene glycol 130g

[0086] Fatty Acid Sorbitan 80 240g

[0087] Sodium chloride 480g

[0088] Preparation Process:

[0089] (1) 200g aztreonam, 130g propylene glycol and 480g sodium chloride are dissolved in 4000ml water for injection to obtain the aqueous phase;

[0090] (2) 700g polymeric anhydride and 240g fatty acid sorbitan 80 are dissolved in 3000ml of dichloromethane and ethyl acetate mixed solvent with a volume ratio of 5:1 to obtain an oil phase;

[0091] (3) Slowly drop the water phase obtained above into the oil phase under stirring conditions, control the dropping speed to 8ml / min, stir for 20min after dropping, then transfer to a high-speed homogenizer for high-speed stirring 4 times at a speed of 15000r / min, 7min each time, to obtain a uniform white emulsion;

[00...

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Abstract

The invention provides an aztreonam / arginine medicinal composition lipid microsphere injection. The aztreonam / arginine medicinal composition lipid microsphere injection is mainly prepared from the following components in part by weight: 1 part of aztreonam, 0.7 to 8 parts of arginine, 1 to 8 parts of poly-anhydride, 0.1 to 2 parts of propylene glycol, 0.2 to 5 parts of fatty acid sorbitan 80 and 0.9 to 6 parts of sodium chloride.

Description

technical field [0001] The invention relates to a lipid microsphere injection of aztreonam / arginine pharmaceutical composition, belonging to the technical field of medicine. Background technique [0002] Aztreonam is a synthetic monocyclic β-lactam antibiotic, which was first developed by Bristol-Myers Squibb Company in the United States and first launched in Italy in 1984. It is the first monocyclic β-lactam antibiotic for clinical use. Aztreonam is a bacterial bactericide with high antibacterial activity against most aerobic Gram-negative bacteria, including Escherichia coli, Klebsiella pneumoniae and Oxitobacter, aerogenes, cloacae, Proteus, Serratia, Citrobacter, Shigella and other Enterobacteriaceae bacteria, as well as influenza bacilli, Neisseria gonorrhoeae, Neisseria meningitidis, etc., which also have good antibacterial effect on Pseudomonas aeruginosa effect. Clinically, it is mainly used to treat various infections caused by sensitive aerobic gram-negative bact...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K9/16A61K31/427A61K47/30A61P31/04
Inventor 王明
Owner HAINAN LINGKANG PHARMA CO LTD
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