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A kind of ceftizoxime sodium liposome composition for injection and preparation method thereof

The technology of ceftizoxime sodium and liposome is applied in the field of ceftizoxime sodium liposome composition for injection and preparation thereof, and can solve the problems of high leakage rate and instability of ceftizoxime sodium liposome, etc. Achieving safe and effective clinical use, good stability and targeted effect

Active Publication Date: 2017-06-06
FUAN PHARM (GRP) CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] This ceftizoxime sodium liposome has higher encapsulation efficiency, can reach 92%, and average particle diameter is 94nm, but find that the leakage rate of this ceftizoxime sodium liposome is also high through the inventor's research, also unstable

Method used

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  • A kind of ceftizoxime sodium liposome composition for injection and preparation method thereof
  • A kind of ceftizoxime sodium liposome composition for injection and preparation method thereof
  • A kind of ceftizoxime sodium liposome composition for injection and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] prescription

[0028]

[0029]

[0030] Preparation Process:

[0031] 1) Dissolve soybean lecithin, egg yolk lecithin and cholesterol in 800ml of isopropanol, stir and mix evenly, heat up and evaporate to completely remove isopropanol, and obtain a phospholipid film;

[0032] 2) Add 1500ml of citrate buffer solution to the phospholipid film in step 1), if necessary, adjust the pH to 7.0 with sodium hydroxide solution and hydrochloric acid, stir to hydrate the phospholipid film, then high-speed homogeneous emulsification, microporous membrane filtration , to obtain the filtrate, add water for injection until the filtrate is 2000ml;

[0033] 3) Add ceftizoxime sodium, mannitol, and vitamin E to the filtrate of step 2), stir and emulsify homogeneously at high speed, filter, sterilize, freeze-dry and subpackage the filtrate, or fill the filtrate in vials and freeze-dry , obtain ceftizoxime sodium liposome lyophilized preparation finished product, ceftizoxime sodium ...

Embodiment 2

[0035] prescription

[0036]

[0037] Preparation Process:

[0038] 1) Dissolve soybean lecithin, egg yolk lecithin and cholesterol in 1800ml of chloroform: ethanol in a mixed solvent of 1:3, stir and mix evenly, heat up and evaporate to completely remove chloroform and ethanol to obtain a phospholipid film;

[0039] 2) Add 3000ml of citrate buffer solution to the phospholipid film in step 1), adjust pH to 7.0 with sodium hydroxide solution and hydrochloric acid if necessary, stir to hydrate the phospholipid film, then high-speed homogeneous emulsification, microporous membrane filtration,

[0040] Obtain filtrate, add water for injection until filtrate is 4000ml;

[0041] 3) Add ceftizoxime sodium, mannitol, and sodium sulfite to the filtrate of step 2), stir and emulsify at a high speed, filter, sterilize, freeze-dry and repack the filtrate, or fill the filtrate in vials and freeze-dry. Obtain the finished ceftizoxime sodium liposome freeze-dried preparation, ceftizoxim...

Embodiment 3

[0043] prescription

[0044]

[0045] Preparation Process:

[0046] 1) Dissolving soybean lecithin, egg yolk lecithin and cholesterol in 6000ml of absolute ethanol, stirring and mixing evenly, heating up and evaporating to completely remove ethanol to obtain a phospholipid film;

[0047]2) Add 1500ml of citrate buffer solution to the phospholipid membrane in step 1), if necessary, adjust the pH to 6.5 with sodium hydroxide solution and hydrochloric acid, stir to hydrate the phospholipid membrane, then high-speed homogeneous emulsification, microporous membrane filtration , to obtain the filtrate, add water for injection until the filtrate is 2000ml;

[0048] 3) Add ceftizoxime sodium, mannitol, and sodium sulfite to the filtrate of step 2), stir and emulsify at a high speed, filter, sterilize, freeze-dry and repack the filtrate, or fill the filtrate in vials and freeze-dry. Obtain the finished ceftizoxime sodium liposome freeze-dried preparation, ceftizoxime sodium 0.5g / b...

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Abstract

The invention discloses a ceftizoxime sodium liposome composition for injection and a preparation method thereof. The ceftizoxime sodium liposome composition comprises ceftizoxime sodium, phospholipid, cholesterol and citrate buffer solution, wherein the mass ratio of the phospholipid to cholesterol is (1.5-2):1. The ceftizoxime sodium liposome composition provided by the invention has the advantages of good stability, high encapsulation efficiency, low leakage rate, and is suitable for industrial production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a ceftizoxime sodium liposome composition for injection and a preparation method thereof. [0002] technical background [0003] Ceftizoxime sodium, chemical name: [6R-[6a,7b(Z)]]-7[[2,3-dihydro-2-imino-4-thiazolyl)(methoxyimino)acetyl ]amino]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid sodium salt, molecular formula C 13 H 12 N 5 NaO 5 S 2 , molecular weight 405.38. [0004] Ceftizoxime sodium is a third-generation cephalosporin with broad-spectrum antibacterial effect and is stable to broad-spectrum lactamase (including penicillinase and cephalosporinase) produced by various Gram-positive and Gram-negative bacteria. Enterobacteriaceae such as Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis have strong antibacterial effects, while Pseudomonas such as Pseudomonas aeruginosa and Acinetobacter are less sensitive to this prod...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/127A61K31/546A61P31/04
Inventor 蒋晨
Owner FUAN PHARM (GRP) CO LTD
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