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Cefodizime sodium composition and preparation method thereof

A technology of cefodizime sodium and its composition, which is applied in the field of stable cefodizime sodium composition and its preparation, can solve the problems of insufficient antibacterial spectrum of cefodizime sodium, failure to meet quality requirements, increase of related substances, etc., and achieve prescription The process is simplified, the efficacy of the drug is not changed, and the safe dose is large.

Inactive Publication Date: 2011-11-30
AMICOGEN CHINA BIOPHARM CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] In order to overcome the deficiencies in the existing cefodizime sodium, to solve the existing technology preparation of cefodizime sodium for injection antimicrobial spectrum is not enough, and the stability of the current cefodizime sodium for injection preparations is relatively poor, long-term placement of related substances increases, resulting in Can not meet the problems such as the quality requirement in the period of validity, the present invention provides a kind of stable cefodizime sodium and clavulanate potassium mixed composition preparation and preparation method thereof, expanded the antibacterial spectrum of cefodizime sodium, improved The stability of cefodizime sodium provides more reliable technical support for the use of cefodizime sodium for injection

Method used

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  • Cefodizime sodium composition and preparation method thereof
  • Cefodizime sodium composition and preparation method thereof
  • Cefodizime sodium composition and preparation method thereof

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Experimental program
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Embodiment 1

[0039] The proportioning of composition is:

[0040]

[0041] Preparation Process:

[0042]Add sterile cefodizime sodium to the reaction kettle at room temperature and dissolve it in water for injection; add sterile potassium clavulanate, stir to make it completely dissolve, and obtain the aqueous solution of the mixture of cefodizime sodium and clavulanate potassium; Add hydroxypropyl-β-cyclodextrin (HP-β-CD) to the mixture, stir and clathrate for 1.0 hour; add water for injection to dilute to the required content of cefodizime sodium preparation for injection, and then use a 0.45 μm microporous filter Membrane filtration, and finally filtration through a 0.22 μm microporous membrane, subpackaging, and freeze-drying to obtain cefodizime sodium / clavulanate potassium freeze-dried powder for injection.

Embodiment 2

[0044]

[0045] Preparation Process:

[0046] Add sterile cefodizime sodium to the reaction kettle at room temperature and dissolve in water for injection; add sterile L-clavulanate potassium, stir to make it all dissolve, and obtain the aqueous solution of cefodizime sodium and clavulanate potassium mixture; Add hydroxypropyl-β-cyclodextrin (HP-β-CD) into the reaction kettle, stir and clathrate for 1.5 hours; then filter through a 0.45 μm microporous membrane, and finally filter through a 0.22 μm microporous membrane, and separate Pack, obtain cefodizime sodium injection.

Embodiment 3

[0048]

[0049] Preparation Process:

[0050] Add sterile cefodizime sodium to the reaction kettle at room temperature and dissolve it in water for injection; add sterile potassium clavulanate, stir to make it completely dissolve, and obtain the aqueous solution of the mixture of cefodizime sodium and clavulanate potassium; Add hydroxypropyl-β-cyclodextrin (HP-β-CD) to the mixture, stir and clathrate for 0.5 hour; add water for injection to dilute to the required content of cefodizime sodium preparation for injection, and then use a 0.45 μm microporous filter Membrane filtration, and finally filtration through a 0.22 μm microporous membrane, subpackaging, and freeze-drying to obtain cefodizime sodium / clavulanate potassium freeze-dried powder for injection.

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Abstract

The invention relates to the field of drug synthesis and preparation thereof, relates to a preparation method of an antibacterial drug, in particular to a stable cefodizime sodium composition preparation and a preparation method thereof. The present invention directly dissolves sterile cefodizime sodium in water, adds sterile potassium clavulanate to dissolve it completely, and obtains an aqueous solution of cefodizime sodium / clavulanate potassium, and adds hydroxypropyl-β to the aqueous solution. -Cyclodextrin (HP-β-CD) inclusion, sub-package, and freeze-drying to obtain Cefodizime Sodium / Clavulanate Potassium for Injection. The preparation method provided by the invention is simple, and the cefodizime sodium / clavulanic acid potassium salt is clathrated with hydroxypropyl-β-cyclodextrin, which increases the stability of the sterile cefodizime sodium drug and reduces its toxic and side effects , improve drug availability, and the preparation process is simple, suitable for industrial production.

Description

technical field [0001] The invention relates to an antibacterial drug and a preparation method thereof, in particular to a stable cefodizime sodium composition and a preparation method thereof. Background technique [0002] Cefodizime sodium belongs to the third generation of cephalosporin antibiotics for injection. It was developed by Hearst Company of Germany and Dapeng Company of Japan. It was listed in Japan under the trade name "Neucef" in May 1990. In 1994, Cefodizime Sodium for Injection (Modi) was registered in my country by Hoechst-Russell Company in Germany. [0003] Cefodizime is the world's first third-generation cephalosporin with immune-enhancing function. It has a broad antibacterial spectrum and is mainly used clinically for pneumonia, bronchitis, and pharyngitis caused by sensitive bacteria such as Streptococcus and pneumococcus. , tonsillitis, pyelonephritis, urinary tract infection, gonococcal urethritis, cholecystitis, cholangitis, gynecological infectio...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/546A61K31/424A61P31/04
Inventor 赵新祥郭冬梅王玲陈建明陈晶
Owner AMICOGEN CHINA BIOPHARM CO LTD
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