CN107638394B - Pharmaceutical composition of piperacillin sodium and sulbactam sodium compound - Google Patents

Pharmaceutical composition of piperacillin sodium and sulbactam sodium compound Download PDF

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CN107638394B
CN107638394B CN201710911608.3A CN201710911608A CN107638394B CN 107638394 B CN107638394 B CN 107638394B CN 201710911608 A CN201710911608 A CN 201710911608A CN 107638394 B CN107638394 B CN 107638394B
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sodium
piperacillin
sulbactam
sulbactam sodium
emulsion
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CN107638394A (en
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张健
刘洪艳
李励
蔡露露
潘慧琦
刘冬
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Shandong Erye Pharmaceutical Co.,Ltd.
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Suzhou Erye Pharmaceutical Co Ltd
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Abstract

The invention relates to a pharmaceutical composition of piperacillin sodium and sulbactam sodium compounds. The invention adopts creatinine and mannitol to form a stabilizer, polyvinylpyrrolidone as an emulsifier and trehalose as a freeze-drying supporting agent, thereby effectively improving the stability of piperacillin sodium and sulbactam sodium in the preparation and storage processes and ensuring the curative effect and safety of clinical use.

Description

Pharmaceutical composition of piperacillin sodium and sulbactam sodium compound
Technical Field
The invention relates to a pharmaceutical composition of piperacillin sodium and sulbactam sodium compounds.
Background
The piperacillin penicillin broad-spectrum antibiotic mainly has a bactericidal effect by interfering the synthesis of bacterial cell walls, is mainly used for infection caused by pseudomonas aeruginosa and various gram-negative bacilli, but is easily hydrolyzed by β -lactamase generated by bacteria to generate drug resistance.
Figure 227895DEST_PATH_IMAGE001
Piperacillin sodium
Sulbactam is an β -lactamase inhibitor, has far higher affinity to β -lactamase than other β -lactam antibiotics, has no or only weak antibacterial activity, but has irreversible inhibition effect on most important β -lactamase produced by β -lactam antibiotic resistant strains, can prevent the damage of drug-resistant bacteria on penicillin and cephalosporin antibiotics, has obvious synergistic effect with the penicillin and cephalosporin antibiotics, and can enhance the antibacterial activity and expand the antibacterial spectrum.
Figure 20840DEST_PATH_IMAGE002
Sulbactam sodium
The piperacillin sodium and sulbactam sodium compound preparation has large clinical dosage, definite curative effect and good market prospect, but has poor stability as most cephalosporin antibiotics, and cannot meet the quality requirement.
Disclosure of Invention
In order to solve the problem of poor stability of the existing piperacillin sodium and sulbactam sodium, the invention provides a stable piperacillin sodium and sulbactam sodium compound preparation and a preparation method thereof.
The invention provides a piperacillin sodium and sulbactam sodium composition which comprises the following components in parts by weight:
4 parts of piperacillin sodium;
1 part of sulbactam sodium;
2-3 parts of polyvinylpyrrolidone;
2-5 parts of creatinine;
1-5 parts of mannitol;
5-20 parts of trehalose.
The invention adopts creatinine and mannitol to form a stabilizer, polyvinylpyrrolidone as an emulsifier and trehalose as a freeze-drying supporting agent, effectively improves the stability of piperacillin sodium and sulbactam sodium in the preparation and storage processes, has quick dissolution of the preparation and ensures the curative effect and safety of clinical use.
The preparation method of the invention comprises the following steps:
under the protection of inert gas, polyvinylpyrrolidone, creatinine and mannitol are used as water solvents for injection, then piperacillin sodium and sulbactam sodium are added and mixed uniformly, and the mixture is heated in a water bath at 90 ℃ and stirred to be in a molten state;
shearing and stirring the liquid for 10min by using a tissue masher under the condition of keeping the temperature of the liquid at 70-90 ℃ at the rotating speed of 15000r/min to obtain a primary emulsion, and circularly emulsifying for 4 times by using a high-pressure homogenizer to obtain an emulsion;
and (3) adding trehalose into the emulsion, dissolving, filtering, packaging, and freeze-drying to obtain the piperacillin sodium and sulbactam sodium suspension powder injection.
Detailed Description
Example 1Preparation of piperacillin sodium and sulbactam sodium (4: 1) suspension powder injection
Prescription (100 bottles):
piperacillin sodium 50g
Sulbactam sodium 12.5g
Polyvinylpyrrolidone 25g
Creatinine 50g
Mannitol 25g
Trehalose 100g
Preparation method
Under the protection of inert gas, polyvinylpyrrolidone, creatinine and mannitol are dissolved in water for injection, then piperacillin sodium and sulbactam sodium are added, and the mixture is uniformly mixed and heated in a water bath at 90 ℃ and stirred to be in a molten state. Shearing and stirring the above liquid with a tissue masher at 70-90 deg.C for 10min at 15000r/min to obtain primary emulsion, and circularly emulsifying for 4 times with a high-pressure homogenizer to obtain emulsion. And adding trehalose into the emulsion, dissolving, filtering, packaging, and freeze-drying to obtain the piperacillin sodium and sulbactam sodium suspension powder injection.
ExamplesPreparation of 2 piperacillin sodium and sulbactam sodium (4: 1) suspension powder injection
Prescription (200 bottles):
piperacillin sodium 100g
Sulbactam sodium 25g
Polyvinylpyrrolidone 50g
Creatinine 100g
Mannitol 50g
Trehalose 200g
Preparation method
Under the protection of inert gas, polyvinylpyrrolidone, creatinine and mannitol are dissolved in water for injection, then piperacillin sodium and sulbactam sodium are added, and the mixture is uniformly mixed and heated in a water bath at 90 ℃ and stirred to be in a molten state. Shearing and stirring the above liquid with a tissue masher at 70-90 deg.C for 10min at 15000r/min to obtain primary emulsion, and circularly emulsifying for 4 times with a high-pressure homogenizer to obtain emulsion. And adding trehalose into the emulsion, dissolving, filtering, packaging, and freeze-drying to obtain the piperacillin sodium and sulbactam sodium suspension powder injection.
Example 3 Long term stability test
Batch number 1: 160515 batch size: 2000 bottles of specification: 0.75 g/bottle package: penicillin bottle
Examination conditions were as follows: 25 plus or minus 2 ℃/60 plus or minus 10% RH
Figure DEST_PATH_IMAGE003
Long-term stability tests show that the piperacillin sodium and sulbactam sodium composition has good stability in the preparation and storage processes, and ensures the curative effect and safety of clinical use.

Claims (1)

1. A piperacillin sodium and sulbactam sodium composition is characterized by comprising the following components:
Figure FDA0002237632180000011
the preparation method comprises the following steps: under the protection of inert gas, polyvinylpyrrolidone, creatinine and mannitol are dissolved in water for injection, then piperacillin sodium and sulbactam sodium are added, and the mixture is uniformly mixed and heated in a water bath at 90 ℃ and stirred to be in a molten state. Shearing and stirring the above liquid with a tissue masher at 70-90 deg.C for 10min at 15000r/min to obtain primary emulsion, and circularly emulsifying for 4 times with a high-pressure homogenizer to obtain emulsion. Adding trehalose into the emulsion, dissolving, filtering, packaging, and freeze drying.
CN201710911608.3A 2017-09-30 2017-09-30 Pharmaceutical composition of piperacillin sodium and sulbactam sodium compound Active CN107638394B (en)

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101269072A (en) * 2008-05-09 2008-09-24 郑飞雄 Pharmaceutical composition containing beta-lactamase restrainer and piperacillin sodium with steady content and preparation method thereof
CN101632670A (en) * 2009-08-26 2010-01-27 海南永田药物研究院有限公司 Suspension powder injection of piperacillin sodium and tazobactam sodium pharmaceutical composition and new application thereof
CN101632671A (en) * 2009-08-18 2010-01-27 海南永田药物研究院有限公司 Suspensoid powder injection of piperacillin sodium sulbactam sodium medicine composition and novel application thereof
CN105560243A (en) * 2016-01-10 2016-05-11 苏州二叶制药有限公司 Preparation method of piperacillin sodium and sulbactum sodium composition for injection

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101269072A (en) * 2008-05-09 2008-09-24 郑飞雄 Pharmaceutical composition containing beta-lactamase restrainer and piperacillin sodium with steady content and preparation method thereof
CN101632671A (en) * 2009-08-18 2010-01-27 海南永田药物研究院有限公司 Suspensoid powder injection of piperacillin sodium sulbactam sodium medicine composition and novel application thereof
CN101632670A (en) * 2009-08-26 2010-01-27 海南永田药物研究院有限公司 Suspension powder injection of piperacillin sodium and tazobactam sodium pharmaceutical composition and new application thereof
CN105560243A (en) * 2016-01-10 2016-05-11 苏州二叶制药有限公司 Preparation method of piperacillin sodium and sulbactum sodium composition for injection

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