Ceftezole sodium liposome lyophilized preparation and preparation method thereof

A technology of ceftezole sodium fat and ceftezole sodium, which is applied in the field of ceftezole sodium liposome freeze-dried preparation and preparation, can solve the problem of temperature, light, humidity instability, easy precipitation, and increase the safety of clinical medication Sex and other issues, to achieve good stability and improved security

Inactive Publication Date: 2012-07-04
双鹤药业(海南)有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Because this product is unstable to temperature, light, and humidity, it is prone to precipitation during use, and it is easy to cause quality changes during production, transportation, and use, which increases the safety of clinical medication.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Ceftezole sodium 1.0 weight unit

[0020] Egg yolk lecithin 1.8 weight units

[0021] Cholesterol 0.5 weight unit

[0022] Mannitol 1.0 weight unit

[0023] Sodium bicarbonate 3.0 weight units

[0024] Take by weighing recipe quantity ceftezole sodium, mannitol, mix and dissolve in water, stir evenly, stand-by; Cholesterol is dispersed and dissolved in water, dried under reduced pressure to form a membrane material, added to the above-mentioned aqueous solution, and ultrasonically treated to the required particle size and uniformity to obtain ceftezole sodium liposome suspension; constant volume, sterilization, Sub-package and carry out vacuum freeze-drying to obtain the ceftezole sodium liposome freeze-dried preparation.

Embodiment 2

[0026] Ceftezole sodium 1.0 weight unit

[0027] Egg yolk lecithin, soybean lecithin 1.5 weight units

[0028] Cholesterol 4.5 weight units

[0029] Mannitol 1.5 weight units

[0030] Sodium hydrogen phosphate 2.0 weight units

[0031] Take by weighing recipe quantity ceftezole sodium, mannitol, mix and dissolve in water, stir evenly, stand-by; , soybean lecithin, and cholesterol are dispersed and dissolved in water, dried under reduced pressure to form a film material, added to the above aqueous solution, and ultrasonically treated to the required particle size and uniformity to obtain ceftezole sodium liposome suspension; constant volume , sterilized, subpackaged, and vacuum freeze-dried to obtain the ceftezole sodium liposome freeze-dried preparation.

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PUM

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Abstract

The present invention provides a ceftezole sodium liposome lyophilized preparation and a preparation method thereof. According to the preparation method, ceftezole sodium, an excipient and a blank film material of a neutral lecithin and cholesterol are mixed, an ultrasonic treatment is performed, and treatments of volume metering, sterilization, subpackaging and freeze drying are performed to obtain the ceftezole sodium liposome lyophilized preparation. With the ceftezole sodium liposome lyophilized preparation prepared by the method of the present invention, disadvantages of the existing formations are overcome, the quality is stable, and the safety of the drug application in clinic is enhanced.

Description

Technical field: [0001] The invention relates to a cephalosporin drug for treating respiratory system infection, urinary system infection, sepsis and peritonitis, in particular to a ceftezole sodium liposome freeze-dried preparation and a preparation method. Background technique: [0002] Ceftezole sodium, its chemical name is: (6R,7R)-3-[(1,3,4-thiadiazol-2-yl)thiomethyl]-8-oxo-7-[2- Sodium (1H-tetrazol-1-yl)acetamido]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate. This product is a semi-synthetic cephalosporin derivative. Its mechanism of action is to exert an antibacterial effect by inhibiting the synthesis of bacterial cell walls. Cocci and aerobic Gram-negative bacteria have antibacterial effect. It is clinically used to treat respiratory system infection, urinary system infection, sepsis, peritonitis, etc. [0003] This product is white to light yellow crystalline powder, odorless and hygroscopic. Most of the dosage forms currently on the market are aseptically...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/127A61K31/546A61P11/00A61P13/00A61P31/04
Inventor 魏雪纹李强
Owner 双鹤药业(海南)有限责任公司
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