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Process for the manufacture of particles containing antibotics and their application

A technology of antibiotics and granules, which is applied in the field of preparation of antibiotic granules and its application, and can solve the problems that gentamicin sulfate is not economical, etc.

Active Publication Date: 2007-07-04
HERAEUS MEDICAL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This method of preparing gentamicin sulfate is not economical

Method used

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  • Process for the manufacture of particles containing antibotics and their application

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] 10.1 g of gentamicin sulfate (AK648, Fujiang / Fukang) was dissolved in 10.0 g of pyrogen-free distilled water. This solution was added dropwise to a mixture of 50 ml of isopropanol and 50 ml of methanol with stirring. Within seconds, initial pellets are formed. Stirring was stopped after half an hour. After 4 hours the precipitated primary pellets decompose. The resulting pellet was aspirated, followed by stirring in methanol at room temperature for half an hour to obtain a precipitate, which was then dehydrated in vacuo until constant weight. The total yield is 9.8 g. After sieving, 7.3 g of particles having a sieving fraction of 63 to 250 µm was obtained. Figure 1 is an image of these particles revealed by light-optical microscopy.

Embodiment 2

[0022] 10.1 g of gentamicin sulfate (AK648, Fujiang / Fukang) was dissolved in 10.0 g of pyrogen-free distilled water. This solution was added dropwise to a boiling mixture of 50 ml of isopropanol and 50 ml of methanol with stirring at reflux. Within seconds, initial pellets are formed. Stirring was stopped after half an hour and the solvent mixture was allowed to stand at reflux. After 5 hours the resulting pellet was cooled to room temperature, suctioned, followed by stirring in methanol at room temperature for half an hour to give a precipitate, which was then dehydrated in vacuo until constant weight. The total yield is 9.6 g. After sieving, 6.6 g of particles having a sieving fraction of 63 to 250 µm was obtained.

Embodiment 3

[0024] 7.7 g of gentamicin sulfate (AK648, Fujiang / Fukang) and 5.8 g of clindamycin hydrochloride (AK 862) were dissolved in 10.0 g of pyrogen-free distilled water. This solution was added dropwise to a mixture of 50 ml of isopropanol and 50 ml of methanol. Within seconds, initial pellets are formed. Stirring was stopped after half an hour. After 5 hours the precipitated primary pellets decompose. The resulting pellet was aspirated, followed by stirring in methanol at room temperature for half an hour to obtain a precipitate, which was then dehydrated in vacuo until constant weight. The total yield was 11.2 g. After sieving, 6.4 g of particles having a sieve fraction of 63 to 250 µm were obtained.

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Abstract

A method for producing antibiotic / antibiotics-particles characterized in that an aqueous solution of an amino glycoside-antibiotic or an aqueous solution comprising two or more amino glycoside-antibiotics is mixed under agitation with a solvent mixture comprising isopropanol and at least one additional alcohol, with the volume ratio of the solvent mixture to the aqueous solution being at least 3 to 1 and with the suspension developed being agitated until the primarily yielded coarse antibiotic / antibiotics aggregates disintegrate into particles, which have a grain size smaller than 400 mum.

Description

technical field [0001] The object of the present invention is to provide a method for preparing antibiotic granules and its use. Here, antibiotic particles mean particles having a particle size up to about 400 μm, especially in the range of 63-400 μm. technical background [0002] Aminoglycoside antibiotics are typical bactericidal spectrum antibiotics with obvious post-antibacterial effects. Aminoglycoside antibiotics, especially gentamicin in the form of gentamicin sulfate, are used in polymethylmethacrylate bone cements (K.-D. Kuehn: bone cements, Springer Verlag, 2000). Polymethyl methacrylate bone cement is used in surgery and orthopedics to fix brackets. Here, after hardening of the bone cement, there is a risk of bacterial infection at the interface between the bone tissue and the polymethylmethacrylate bone cement. Effective protection against bacterial infection can be obtained by inserting bactericidal antibiotics into the bone paste, which are dissolved from th...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K31/7036A61K31/702A61K31/7048A61P31/04A61L27/54
CPCA61K9/1688A61K31/70A61P31/00A61P31/04
Inventor K·D·屈恩S·福格特
Owner HERAEUS MEDICAL
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