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Clarithromycin injection

A technology for clarithromycin and injections, applied in the field of clarithromycin injections, which can solve problems such as instability and failure to find prescriptions, and achieve the effects of good stability, strong solubility, and easy industrial production

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

[0004] There are also reports in the literature of reacting clarithromycin with acids (organic and inorganic acids) to make salts at home and abroad, but because no suitable formula has been found, it also shows instability

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] 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: clarithromycin hydrochloride injection

[0045] Add 75g (0.1mol) of clarithromycin, 25ml of 20% hydrochloric acid ethanol solution (containing about 0.1mol of hydrogen chloride) and 6000ml of ethyl acetate into a 10L reaction tank, stir at room temperature for 1 hour, after the raw materials are dissolved, no color transparent solution.

[0046] The solvent was recovered from the solution under reduced pressure, the residual solid was washed with absolute ethanol, and the ethanol was recovered under reduced pressure, dried, and pulverized to obtain 78.5 g of white solid powder, which was clarithromycin hydrochloride, and its solubility in water was about 20 mg / ml, at this concentration, the pH value of the solution is 5.86.

[0047] The above-mentioned solid powder i...

Embodiment 2

[0051] Add 75g (0.1mol) of clarithromycin, 15g of tartaric acid (0.1mol) dissolved in 300ml of ethanol and 6000ml of ethyl acetate into a 10L reaction tank, and stir at room temperature for 1.5 hours. After the raw materials are dissolved, they become colorless and transparent solution.

[0052]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 78.5 g of white solid powder, which was clarithromycin tartrate, and its solubility in water was about 40 mg / ml, at this concentration, the pH value of the solution is 5.46.

[0053] The above-mentioned solid powder is divided into antibiotic glass bottles under aseptic conditions according to a predetermined amount to obtain the sterile powder for clarithromycin tartrate injection of the present invention (specification is based on clarithromycin: 250 mg), and the chlorine Sodium chlo...

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Abstract

The present invention relates to one kind of Clarithromycin injection, and is especially one bacteria-free powder and solution of water soluble Clarithromycin salt for injection. The injection of the present invention has water soluble Clarithromycin salt, preferably hydrochloride and tartrate of Clarithromycin, as its active component. The present invention also provides the preparation processof bacteria-free powder and solution of water soluble Clarithromycin salt for injection.

Description

Technical field: [0001] The invention relates to a clarithromycin injection, in particular to a clarithromycin water-soluble salt injection sterile powder and solution type injection. The invention also provides a method for preparing the clarithromycin water-soluble salt injection sterile powder and injection solution. technical background: [0002] Clarithromycin (clari thromycin, also known as 6-O-methylerythromycin), is a new semi-synthetic macrolide antibiotics, which inhibits Antibacterial effect due to protein synthesis. In addition to having the microbiological activity of erythromycin and oral β-lactam drugs, clarithromycin has stronger antibacterial activity against Haemophilus influenzae and atypical pathogenic bacteria than the former two. In addition, in terms of structure, after the hydroxyl group at the 6-position of the fourteen-membered macrolide ring of the parent raw material erythromycin is replaced by a methoxy group, it shows stability to gastric acid...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K9/14A61K31/7048A61P31/04
Inventor 贝庆生
Owner GUANGZHOU PUIS PHARMA FACTORY
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