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Medicinal composition of sulbenicillin sodium for injection and preparation method thereof

A technology of sulfobenicillin sodium and a composition, which is applied in the field of sulfobenicillin sodium nanoparticle injection and its preparation, can solve problems such as complex preparation process, achieve the effects of good resolubility, less allergic reaction and improved drug stability

Active Publication Date: 2012-06-27
FUAN PHARM (GRP) CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, its preparation process is too complicated, and a large amount of toxic, flammable and explosive organic solvents are used, which poses a great safety hazard

Method used

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  • Medicinal composition of sulbenicillin sodium for injection and preparation method thereof
  • Medicinal composition of sulbenicillin sodium for injection and preparation method thereof
  • Medicinal composition of sulbenicillin sodium for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0064] The preparation of embodiment 1 sulbenicillin sodium nanoparticle injection

[0065] Prescription 100 bottles

[0066] Sulbenicillin Sodium 100g

[0067] Methyl cyanoacrylate 500g

[0068] Dextran 5g

[0069] Mannitol 500g

[0070] Preparation Process:

[0071] (1) Add 100 g of sulfbenicillin sodium and 5 g of dextran into 2 L of water for injection, stir to dissolve, and adjust the pH value to 1.0 to 2.0 with hydrochloric acid.

[0072] (2) Add 500 g of methyl cyanoacrylate to the above solution under stirring, stir at room temperature for 4 hours, add 500 g of mannitol, continue stirring until completely dissolved, and adjust the pH value to 5.0-7.0 with sodium hydroxide.

[0073] (3) The above solution is filtered with a 0.22um microporous membrane to obtain a solution of sulbenicillin sodium nanoparticles.

[0074] (4) Divide the above solution into sterilized vials, pre-freeze at -45°C to -55°C for 3 hours, freeze-dry with a freeze dryer, seal with a sterile ...

Embodiment 2

[0075] The preparation of embodiment 2 sulbenicillin sodium nanoparticle injection

[0076] Prescription 100 bottles

[0077] Sulbenicillin Sodium 100g

[0078] Propyl cyanoacrylate 500g

[0079] Dextran 5g

[0080] Glucose 500g

[0081] Preparation Process:

[0082] (1) Add 100 g of sulfbenicillin sodium and 5 g of dextran into 2 L of water for injection, stir to dissolve, and adjust the pH value to 2.0 to 3.0 with formic acid.

[0083] (2) Add 500 g of propyl cyanoacrylate to the above solution under stirring, and then stir at room temperature for 5 hours, then add 500 g of glucose, continue stirring until completely dissolved, and adjust the pH value to 5.0-7.0 with sodium bicarbonate.

[0084] (3) The above solution is filtered with a 0.22um microporous membrane to obtain a solution of sulbenicillin sodium nanoparticles.

[0085] (4) Divide the above solution into sterilized vials, pre-freeze at -45°C to -55°C for 3 hours, freeze-dry with a freeze dryer, seal with a ...

Embodiment 3

[0086] The preparation of embodiment 3 sulbenicillin sodium nanoparticle injection

[0087] Prescription 100 bottles

[0088] Sulbenicillin Sodium 100g

[0089] n-Butyl cyanoacrylate 500g

[0090] Poloxamer 5g

[0091] Mannitol 500g

[0092] Preparation Process:

[0093] (1) Add 100 g of sulfbenicillin sodium and 5 g of dextran into 2 L of water for injection, stir to dissolve, and adjust the pH value to 1.0 to 2.0 with hydrochloric acid.

[0094] (2) Add 500 g of n-butyl cyanoacrylate to the above solution under stirring, and then stir at room temperature for 5 hours, then add 500 g of mannitol, continue stirring until completely dissolved, and adjust the pH value to 5.0-7.0 with sodium hydroxide .

[0095] (3) The above solution is filtered with a 0.22um microporous membrane to obtain a solution of sulbenicillin sodium nanoparticles.

[0096] (4) Divide the above solution into sterilized vials, pre-freeze at -45°C to -55°C for 3 hours, freeze-dry with a freeze dryer, ...

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Abstract

The invention discloses a medicinal composition of sulbenicillin sodium, in particular sulbenicillin sodium nano particle injection. The sulbenicillin sodium nano particle injection consists of sulbenicillin sodium, a carrier material, a stabilizer and an excipient, wherein the effective mean particle size of nano particles is 10 to 200nm. The invention also discloses the preparation method of the injection. The preparation method comprises the following steps of: mixing the sulbenicillin sodium and the stabilizer in water for injection, regulating a pH value, adding the carrier material and the excipient to obtain solution of sulbenicillin sodium nano particles, and freeze-drying to obtain the nano particle injection. The sulbenicillin sodium nano particle injection has the advantages ofhigh resolubility, high stability, high loading rate, high clinical experiment safety and the like, and the process is suitable for industrialized mass production.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a pharmaceutical composition of sulbenicillin sodium for injection and a preparation method thereof, more specifically, to a sulbenicillin sodium nanoparticle injection and a preparation method thereof. Background technique [0002] Sulbenicillin Sodium, its chemical name is (2S,5R,6R)-3,3-Dimethyl-6-(2-phenyl-2-sulfoacetamido)-7-oxo-4-sulfur Hetero-1-azabicyclo【3.2.0】heptane-2-carboxylic acid disodium salt, molecular formula C 16 h 16 N 2 Na 2 o 7 S 2 , molecular weight 458.42, structural formula: [0003] [0004] Sulbenicillin is a broad-spectrum semi-synthetic penicillin antibiotic that exerts its bactericidal effect by inhibiting the synthesis of bacterial cell walls. This product also has antibacterial activity against hemolytic streptococcus, Streptococcus pneumoniae, and staphylococcus that does not produce penicillinase, and has certain effects on anaerobic bact...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/43A61P31/04
Inventor 黄涛夏荣华陈小勇李述平张稳稳
Owner FUAN PHARM (GRP) CO LTD
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