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Ceftizoxime sodium liposome composition for injection and preparation method thereof

A 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. To achieve the effect of safe and effective clinical use, good stability and good reconstitution

Active Publication Date: 2015-04-08
FUAN PHARM (GRP) CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] 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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  • Ceftizoxime sodium liposome composition for injection and preparation method thereof
  • Ceftizoxime sodium liposome composition for injection and preparation method thereof
  • Ceftizoxime sodium liposome composition for injection and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0026] prescription

[0027]

[0028]

[0029] Preparation Process:

[0030] 1) Dissolve soybean lecithin, egg yolk lecithin and cholesterol in 800ml of isopropanol, stir and mix uniformly, heat up and evaporate to completely remove isopropanol, and obtain a phospholipid membrane;

[0031] 2) Add 1500ml of citrate buffer to the phospholipid membrane of step 1), if necessary, adjust the pH to 7.0 with sodium hydroxide solution and hydrochloric acid, stir to hydrate the phospholipid membrane, and then homogenize and emulsify at high speed, and filter with a microporous membrane. , To obtain the filtrate, add water for injection to the filtrate to 2000ml;

[0032] 3) Add ceftizoxime sodium, mannitol, and vitamin E to the filtrate of step 2), homogenize and emulsify at high speed, filter, sterilize, freeze-dry the filtrate, or fill the filtrate in a vial for freeze-drying , Obtain the finished product of ceftizoxime sodium liposome lyophilized preparation, ceftizoxime sodium 0.5g / bottle....

Embodiment 2

[0034] prescription

[0035]

[0036] Preparation Process:

[0037] 1) Dissolve soybean lecithin, egg yolk lecithin and cholesterol in 1800ml chloroform:ethanol 1:3 mixed solvent, stir and mix uniformly, heat up and evaporate to completely remove chloroform and ethanol to obtain a phospholipid membrane;

[0038] 2) Add 3000ml of citrate buffer solution to the phospholipid membrane of step 1), adjust the pH to 7.0 with sodium hydroxide solution and hydrochloric acid if necessary, stir to hydrate the phospholipid membrane, then homogenize at high speed, and filter with microporous membrane.

[0039] Obtain the filtrate, add water for injection to the filtrate to 4000ml;

[0040] 3) Add ceftizoxime sodium, mannitol, and sodium sulfite to the filtrate of step 2), homogenize and emulsify at high speed, filter, sterilize, freeze-dry the filtrate, or fill the filtrate in a vial for freeze-drying, The finished product of ceftizoxime sodium liposome lyophilized preparation was obtained, ceftizo...

Embodiment 3

[0042] prescription

[0043]

[0044] Preparation Process:

[0045] 1) Dissolve soybean lecithin, egg yolk lecithin and cholesterol in 6000ml of absolute ethanol, stir and mix uniformly, heat up and evaporate to completely remove the ethanol to obtain a phospholipid membrane;

[0046] 2) Add 1500ml of citrate buffer to the phospholipid membrane of step 1), if necessary, adjust the pH to 6.5 with sodium hydroxide solution and hydrochloric acid, stir to hydrate the phospholipid membrane, and then homogenize and emulsify at high speed, and filter with a microporous membrane. , To obtain the filtrate, add water for injection to the filtrate to 2000ml;

[0047] 3) Add ceftizoxime sodium, mannitol, and sodium sulfite to the filtrate of step 2), homogenize and emulsify at high speed, filter, sterilize, freeze-dry the filtrate, or fill the filtrate in a vial for freeze-drying, The finished product of ceftizoxime sodium liposome freeze-dried preparation was obtained, 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 specifically relates to a ceftizoxime sodium liposome composition for injection and a preparation method thereof. technical background [0002] 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 , The molecular weight is 405.38. [0003] Ceftizoxime sodium is a third-generation cephalosporin, with a broad-spectrum antibacterial effect, stable to broad-spectrum lactamase (including penicillinase and cephalosporinase) produced by a variety of gram-positive and gram-negative bacteria. Enterobacteriaceae such as Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis have strong antibacterial effects. Pseudomonas and Acinetobacter such as Pseudomonas aeruginosa have poor sensitivity to this product. The effec...

Claims

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Application Information

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IPC IPC(8): A61K9/127A61K31/546A61P31/04
Inventor 蒋晨
Owner FUAN PHARM (GRP) CO LTD
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