Ceftizoxime sodium-containing pharmaceutical composition

A technology of ceftizoxime sodium and composition, which is applied in the field of new pharmaceutical preparation compositions, can solve the problems of only 12 months of validity, unsatisfactory dissolution speed, easy fluctuation of pH value, etc., and achieves rapid dissolution and good tolerance. , good stability

Active Publication Date: 2012-10-10
哈药集团股份有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Ceftizoxime Sodium Injection, which is already on the market, is a powder injection, but it still needs to be stored at low temperature to avoid discoloration of the drug during use
In addition, during the production process, activated carbon is added for decolorization and then filtered, which may easily lead to insufficient content. The pH value of the product is prone to fluctuations during storage, which is unstable. At the same time, the dissolution rate is not ideal, and the validity period is only 12 months.

Method used

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  • Ceftizoxime sodium-containing pharmaceutical composition
  • Ceftizoxime sodium-containing pharmaceutical composition
  • Ceftizoxime sodium-containing pharmaceutical composition

Examples

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Effect test

Embodiment 1

[0051] Ceftizoxime sodium 500g;

[0052] Mannitol 150g;

[0053] Calcium EDTA 2g;

[0054] Vitamin C 1.5g,

[0055] 2000ml of disodium hydrogen citrate and trisodium citrate buffer solution with a molar ratio of 1:4,

[0056] Add water for injection to 4000ml

[0057]

[0058] 1000 bottles

[0059] Preparation: First mix 2000ml of disodium hydrogen citrate and trisodium citrate buffer solution, then take the above-mentioned amount of ceftizoxime sodium, mannitol, calcium EDTA, vitamin C and citric acid buffer solution, and then dilute to 4000ml, filtered through a filter membrane with a pore size of 0.22um, sterile spray-dried, and then packaged.

[0060] Wherein, the preparation method of disodium hydrogen citrate and trisodium citrate buffer solution is as follows: weigh disodium hydrogen citrate 13g, trisodium citrate 60g and dissolve in 2000ml water for injection to obtain a buffer solution with...

Embodiment 2

[0062] Ceftizoxime sodium 1000g;

[0063] Mannitol 200g;

[0064] Calcium EDTA 3g;

[0065] Vitamin C 2g,

[0066] 2000ml of disodium hydrogen citrate and trisodium citrate buffer solution with a molar ratio of 1:4,

[0067] Add water for injection to 4000ml

[0068]

[0069] 1000 bottles

[0070] Preparation: First mix 2000ml of disodium hydrogen citrate and trisodium citrate buffer solution, then take the above-mentioned amount of ceftizoxime sodium, mannitol, calcium EDTA, vitamin C and citric acid buffer solution, and then dilute to 4000ml, filtered through a filter membrane with a pore size of 0.22um, sterile spray-dried, and then packaged.

Embodiment 3

[0072] Ceftizoxime sodium 500g;

[0073]Mannitol 100g;

[0074] Calcium EDTA 1g;

[0075] Vitamin C1g,

[0076] 2000ml of disodium hydrogen citrate and trisodium citrate buffer solution with a molar ratio of 1:4,

[0077] Add water for injection to 4000ml

[0078]

[0079] 1000 bottles

[0080] Preparation: First mix 2000ml of disodium hydrogen citrate and trisodium citrate buffer solution, then take the above-mentioned amount of ceftizoxime sodium, mannitol, calcium EDTA, vitamin C and citric acid buffer solution, and then dilute to 4000ml, filtered through a filter membrane with a pore size of 0.22um, sterile spray-dried, and then packaged.

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PUM

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Abstract

The invention relates to a novel pharmaceutical preparation composition, in particular to a ceftizoxime sodium-containing preparation for injection and a preparation method for the ceftizoxime sodium-containing preparation. The ceftizoxime sodium-containing preparation for injection comprises the following components: ceftizoxime sodium, mannitol, EDTA (Ethylene Diamine Tetraacetic Acid) calcium,vitamin C, sodium hydrogen citrate, 2000ml of trisodium citrate buffer solution and water for injection.

Description

Technical field: [0001] The invention relates to a new pharmaceutical preparation composition, in particular to an injection preparation of ceftizoxime sodium, its prescription, application and preparation method. Background technique: [0002] Ceftizoxime sodium, a semi-synthetic third-generation cephalosporin, has a broad antibacterial spectrum. Similar to cefotaxime, it has a moderate antibacterial effect on Gram-positive bacteria and a strong effect on Gram-negative bacteria. Including: Staphylococcus aureus, Streptococcus, Pneumococcus, Haemophilus influenzae, Streptococcus pneumoniae, Enterobacter, Klebsiella, Proteus and Enterobacteriaceae. Some Gram-negative bacteria resistant to first-generation cephalosporins and gentamicin may be sensitive to this product. But Streptococcus faecalis and methicillin-resistant Staphylococcus are not sensitive to this product. Mainly used for sepsis caused by sensitive bacteria, respiratory system infection, urinary and reproductiv...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/546A61K47/22A61K47/12A61P31/04
Inventor 孙志嘉杨新春王喜军陈桂芹孙秀敏
Owner 哈药集团股份有限公司
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