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Prulifloxacin nano spheres and preparation method thereof

A technology of prulifloxacin and nanospheres, which is applied in the field of preparation of prulifloxacin nanospheres, can solve the problems of prulifloxacin being insoluble in water and poor bioavailability, and overcome chemical and physiological instability Enhanced stability, improved stability, and increased in vitro stability

Active Publication Date: 2013-04-17
NANJING ZENKOM PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0018] The purpose of the present invention is to provide a prulifloxacin nanosphere with a small particle size and a preparation method thereof, which solves the problems of prulifloxacin insoluble in water and poor bioavailability

Method used

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  • Prulifloxacin nano spheres and preparation method thereof
  • Prulifloxacin nano spheres and preparation method thereof
  • Prulifloxacin nano spheres and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0026] prescription:

[0027]

[0028] According to the above weight ratio, take prulifloxacin, medium chain oil, lecithin and polyethylene glycol lauryl hydroxystearate and put them into a high-speed homogenizer at about 60°C for mixing; then add Glycerin water, keep warm at about 65°C, stir at a high speed to form colostrum, put it into a high-temperature homogenizer, and circulate it 4-10 times under a pressure of 20-100MPa to form a uniform emulsion, adjust the pH to neutral, It is prepared into an emulsion, cooled to room temperature, and filtered through a filter membrane, firstly through a 0.45um filter membrane, and then through a 0.2um filter membrane to achieve the effect of sterilization, and then degassed, discharged, and packaged to obtain the product.

Embodiment 2

[0030] prescription:

[0031]

[0032] According to the above weight ratio, take prulifloxacin, soybean oil, egg yolk lecithin and polyethylene glycol lauryl hydroxystearate and put them into a high-speed homogenizer at about 60°C for mixing; then add Glycerin water, keep warm at about 65°C, stir at a high speed to form colostrum, put it into a high-temperature homogenizer, and circulate it 4-10 times under a pressure of 20-100MPa to form a uniform emulsion, adjust the pH to neutral, It is prepared into an emulsion, cooled to room temperature, and filtered through a filter membrane, firstly through a 0.45um filter membrane, and then through a 0.2um filter membrane to achieve the effect of sterilization, and then degassed, discharged, and packaged to obtain the product.

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PUM

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Abstract

The invention discloses prulifloxacin nano spheres and a preparation method thereof. The nano spheres solve the problems that prulifloxacin is not dissolved in water and has poor bioavailability and the like. The diameter of the nano spheres is below 100 nanometers, the sterile purpose can be fulfilled by filtering and removing bacteria, the stability is increased, the in vivo circular degradation speed is delayed, the stress effect is reduced, and the medicinal effect is improved. The prulifloxacin nano spheres consist of the following components by weight: 0.2 to 1.5 grams of prulifloxacin,15 to 45 grams of oil for injection, 10 to 25 grams of emulsifier, 10 to 25 grams of co-emulsifier, 8 to 13 grams of glycerol and 450 to 500 grams of water for injection.

Description

technical field [0001] The invention belongs to the field of pharmaceutical manufacturing and relates to a new dosage form of prulifloxacin, in particular to a preparation method and application of prulifloxacin nanospheres. Background technique [0002] Prulifloxacin is a third-generation fluoroquinolone spectrum antibacterial drug jointly developed by Japan Shinyaku Corporation and Meiji Seika Corporation. It was registered in Japan on October 8, 2002, and went on the market on December 6 of the same year. [0003] 1. Pharmacology and Toxicology [0004] Prulifloxacin is a lipophilic prodrug of the thiabutidine quinoline carboxylic acid derivative NM394 (AF3013). After oral administration, NM441 is easily absorbed from the intestinal tract, and is hydrolyzed into the active form NM394 in vivo to exert a broad-spectrum antibacterial effect. Belonging to quinolone antibiotics, it inhibits bacterial DNA synthesis by inhibiting the activity of bacterial DNA topoisomerase II ...

Claims

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Application Information

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IPC IPC(8): A61K9/107A61K31/496A61P31/04
Inventor 徐卓业汪磊文意芬
Owner NANJING ZENKOM PHARMA
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