Azlocillin sodium medicinal composition for injection and preparation method for azlocillin sodium medicinal composition for injection

An azlocillin and composition technology, which is applied in the field of azlocillin sodium nanoparticle injection for injection and its preparation, can solve the problems of poor drug redissolving and stability, affecting the safety and effectiveness of drug trial, and the like. Wide range of drug storage conditions, excellent stability, and the effect of avoiding degradation

Inactive Publication Date: 2012-12-05
海南美好西林生物制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

The above patents are for the prescription and production process of azlocillin sodium for injection in the conventional field, and the resolubility and stability of the prepared drug are poor, which greatly affects the safety and effectiveness of the drug trial

Method used

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  • Azlocillin sodium medicinal composition for injection and preparation method for azlocillin sodium medicinal composition for injection
  • Azlocillin sodium medicinal composition for injection and preparation method for azlocillin sodium medicinal composition for injection

Examples

Experimental program
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Effect test

Embodiment 1

[0057] The preparation of embodiment 1 azlocillin sodium nanoparticle injection

[0058] Prescription 100 bottles

[0059] Azlocillin Sodium 600g

[0060] n-Butyl cyanoacrylate 700g

[0061] Polyethylene glycol 7g

[0062] Glycine 700g

[0063] Preparation Process:

[0064] (1) Add 200g of azlocillin sodium and 7g of polyethylene glycol into 2.4L of water for injection, stir to dissolve, and adjust the pH to 2.0-3.0 with sulfuric acid.

[0065] (2) Add 700g of n-butyl cyanoacrylate to the above solution under stirring, stir at room temperature for 6 hours, add 700g of glycine, continue stirring until completely dissolved, and adjust the pH to 6.0-8.0 with sodium hydroxide.

[0066] (3) Filter the above solution with a 0.22 μm microporous membrane to obtain azlocillin sodium nanoparticle solution.

[0067] (4) Dispense the above solution into sterilized vials, pre-freeze at -40°C to -50°C for 3 hours, freeze-dry with a freeze dryer, seal with a sterile rubber stopper, and...

Embodiment 2

[0068] The preparation of embodiment 2 azlocillin sodium nanoparticle injection

[0069] Prescription 100 bottles

[0070] Azlocillin Sodium 200g

[0071] Propyl cyanoacrylate 600g

[0072] Polyethylene glycol 6g

[0073] Hydrolyzed Gelatin 600g

[0074] Preparation Process:

[0075] (1) Add 200g of azlocillin sodium and 6g of polyethylene glycol into 2L of water for injection, stir to dissolve, and adjust the pH to 2.0-3.0 with formic acid.

[0076] (2) Add 600g of propyl cyanoacrylate to the above solution under stirring, stir at room temperature for 5 hours, add 600g of hydrolyzed gelatin, continue stirring until completely dissolved, and adjust the pH to 6.0-8.0 with sodium bicarbonate.

[0077] (3) Filter the above solution with a 0.22 μm microporous membrane to obtain azlocillin sodium nanoparticle solution.

[0078] (4) Dispense the above solution into sterilized vials, pre-freeze at -40°C to -50°C for 3 hours, freeze-dry with a freeze dryer, seal with a sterile r...

Embodiment 3

[0079] The preparation of embodiment 3 azlocillin sodium nanoparticle injection

[0080] Prescription 100 bottles

[0081] Azlocillin Sodium 200g

[0082] n-Butyl cyanoacrylate 600g

[0083] Poloxamer 6g

[0084] Mannitol 600g

[0085] Preparation Process:

[0086] (1) Add 100g of azlocillin sodium and 5g of poloxamer into 2L of water for injection, stir to dissolve, and adjust the pH to 1.0-2.0 with hydrochloric acid.

[0087] (2) Add 600g of n-butyl cyanoacrylate to the above solution under stirring, stir at room temperature for 5 hours, add 600g of mannitol, continue stirring until completely dissolved, and adjust the pH to 6.0-8.0 with sodium bicarbonate.

[0088] (3) Filter the above solution with a 0.22 μm microporous membrane to obtain azlocillin sodium nanoparticle solution.

[0089] (4) Dispense the above solution into sterilized vials, pre-freeze at -40°C to -50°C for 3 hours, freeze-dry with a freeze dryer, seal with a sterile rubber stopper, and then seal wit...

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Abstract

The invention discloses an azlocillin sodium medicinal composition, namely azlocillin sodium nanoparticle injection. The azlocillin sodium nanoparticle injection consists of azlocillin sodium, a carrier material, stabilizer and excipient, and the effective average particle size of nanoparticles is 10 to 200nm. The invention discloses a preparation method for the injection; and the method comprises the following steps of: mixing the azlocillin sodium and the stabilizer in water for injection, adjusting pH value, and adding the carrier material and the excipient to obtain the azlocillin sodium nanoparticle injection. The injection has the advantages of high redissolution performance, excellent stability, high medicine loading capacity and the like, and the process is suitable for industrial large-scale production.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a pharmaceutical composition of azlocillin sodium for injection and a preparation method thereof, and to an azlocillin sodium nanoparticle injection for injection and a preparation method thereof. Background technique [0002] Azlocillin is one of the broad-spectrum penicillins, which has strong antibacterial activity against most Gram-positive cocci and negative bacilli, especially against Pseudomonas aeruginosa, including drug-resistant Pseudomonas aeruginosa. . Clinically, it is mainly used for various infections caused by sensitive Gram-positive bacteria and negative bacteria and Pseudomonas aeruginosa infection, including sepsis, meningitis, endocarditis, suppurative pleurisy, peritonitis and lower respiratory tract, gastrointestinal tract Tract, biliary tract, urinary tract, bone and soft tissue and reproductive organs infection, gynecological and obstetrical infection, mal...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/10A61K31/431A61K47/16A61K47/18A61K47/26A61K47/28A61K47/42A61K47/34A61P31/04
Inventor 魏雪纹李强
Owner 海南美好西林生物制药有限公司
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