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Roxithromycin injection

A technology for roxithromycin and injection, applied in the field of roxithromycin injection, can solve problems such as poor water solubility of roxithromycin, and achieve the effects of less adverse reactions, simple preparation process and low cost

Inactive Publication Date: 2003-11-05
GUANGZHOU PUIS PHARMA FACTORY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Our research found that the reaction of hydrochloric acid, tartaric acid and lactobionic acid with roxithromycin to form corresponding salts can significantly improve the disadvantage of poor water solubility of roxithromycin, which is suitable for making injections

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0053] The object of the present invention is achieved through the following examples and experimental examples, and the experimental examples do not imply any limitation to the present invention. Embodiment 1: Roxithromycin Hydrochloride Injection

[0054] Add 84g (0.1mol) roxithromycin, 25ml20% hydrochloric acid ethanol solution (containing about 0.1mol hydrogen chloride) and 4000ml acetone into a 10L reaction tank, stir at room temperature for 0.5 hour, the raw material is dissolved and becomes a yellow transparent solution .

[0055] The solvent was recovered from the solution under reduced pressure, the residual solid was washed with absolute ethanol, the ethanol was recovered under reduced pressure, dried, and pulverized to obtain 82.6 g of white solid powder, the water solubility was about 25 mg / ml, and the pH value of the solution at this concentration was 6.25.

[0056] Above-mentioned solid powder is packed in antibiotic glass bottle by predetermined amount under a...

Embodiment 2

[0058] The above-mentioned injection is divided into antibiotic glass bottles according to the predetermined dose, and then freeze-dried to obtain roxithromycin hydrochloride freeze-dried powder, which is dissolved and diluted with sodium chloride injection or glucose injection before use. For intravenous infusion. Embodiment 2: Roxithromycin tartrate injection

[0059] Add 84g (0.1mol) of roxithromycin, 15g of tartaric acid (0.1mol) in 300ml of ethanol and 4000ml of absolute ethanol into a 10L reaction tank, stir at room temperature for .5 hours, and the dissolved raw materials will be a solution Colorless and transparent solution.

[0060] The solvent was recovered from the solution under reduced pressure, the residual solid was washed with absolute ethanol, the ethanol was recovered under reduced pressure, dried, and pulverized to obtain 92.5 g of white solid powder, the solubility in water was about 42 mg / ml, and the pH of the solution at this concentration was The value i...

Embodiment 3

[0063] The above-mentioned injections are divided into predetermined doses into antibiotic glass bottles, and then freeze-dried to obtain roxithromycin tartrate freeze-dried powder. Before use, dissolve and dilute with sodium chloride injection or glucose injection. For intravenous infusion. Embodiment 3: Roxithromycin lactobionate injection

[0064] 84g (0.1mol) roxithromycin, 22g lactobionic acid (0.1mol) are dissolved in the solution that 300ml hot water forms and 5000ml ethanol joins in a 10L reaction tank, stirs 2.5 hours at room temperature, after raw material dissolving is Pale yellow transparent solution.

[0065] The solvent was recovered from the solution under reduced pressure, the residual solid was washed with absolute ethanol, the ethanol was recovered under reduced pressure, dried, and pulverized to obtain 98 g of white solid powder, the solubility in water was about 18 mg / ml, and the pH value of the solution at this concentration was 6.52.

[0066] The above...

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Abstract

The present invention relates to Roxithromycin injection and is especially bacteria-free powder and solution of water soluble Roxithromycin salt, such as Roxithromycin hydrochloride, Roxithromycin tartrate and Roxithromycin lactobionate, for injection. The present invention also provides the preparation process of bacteria-free powder and solution of water soluble Roxithromycin salt for injection.

Description

Technical field: [0001] The invention discloses a roxithromycin injection, especially sterile powder for injection of roxithromycin water-soluble salt and solution type injection. Bacteria powder and solution type injection method. technical background: [0002] Roxithromycin (9-[0-[(2-methoxyethoxy)-methyl]oxime] erythromycin) is a semi-synthetic 14-membered ring macrolide antibiotic. The mechanism is the same as that of erythromycin. The antibacterial spectrum and antibacterial effect are basically similar to erythromycin, the effect on Gram-positive bacteria is slightly worse than that of erythromycin, and the effect on Legionella pneumophila is stronger than that of erythromycin. The antimicrobial effect on Chlamydia pneumoniae, Mycoplasma pneumoniae, and Ureaplasma urealyticum is similar to or slightly stronger than that of erythromycin. [0003] About 2 hours after a single oral dose of roxithromycin 150mg, the peak plasma concentration is 6.6-7.9mg / L, and eating ca...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/7048A61P31/04
Inventor 贝庆生
Owner GUANGZHOU PUIS PHARMA FACTORY
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