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Sterility test method for antibiotic sustained-release pharmaceutical preparation

A slow-release drug, sterility inspection technology, applied in biochemical equipment and methods, microbial determination/inspection, etc. problems such as reports on the sterility inspection of drug-released pharmaceutical preparations, etc., to achieve the effect of reliable detection method and no effect on growth and survival

Active Publication Date: 2013-12-04
QILU PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This method is suitable for non-antibacterial test products, and the antibiotics in the antibiotic sustained-release pharmaceutical preparations have antibacterial activity, and the antibiotics do not have corresponding enzymes or milder conditions to degrade them, so direct inoculation cannot be used. Farai conducts a sterility test on the product
In summary, the above two inspection methods are not suitable for the sterility inspection of antibiotic sustained-release pharmaceutical preparations
Simultaneously also do not have the method report to the sterility inspection of antibiotic slow-release pharmaceutical preparation in the prior art

Method used

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  • Sterility test method for antibiotic sustained-release pharmaceutical preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Take 10 samples of azithromycin sustained-release eye drops (2.5ml / bottle), draw 1.25ml for each, a total of 12.5ml into a sterile Erlenmeyer flask, add 80ml of 5% sterile calcium chloride (0.036mol) solution, cover plug. After shaking, let it stand for precipitation, and tilt the Erlenmeyer flask to make the precipitation form a gel mass. Pour the mixed solution together with the precipitate into a sterile filter, wash the mixed cellulose filter membrane (pore size 0.45 μm) with 100ml / time×10 times of 0.1% sterile peptone aqueous solution, and wash another mixed cellulose filter membrane in the same way ( Pore ​​diameter 0.45μm). Put the filter membrane into 100ml of thioglycolate fluid medium and 100ml of modified Martin medium respectively, culture the thioglycolate fluid medium at 30-35°C, and cultivate the improved Martin medium at 23-28°C , cultivated for 14 days, and observed whether there was bacterial growth every day. Result: No apparent microbial growth. ...

Embodiment 2

[0043] Take 10 samples of azithromycin sustained-release eye drops (2.5ml / bottle) respectively, draw 1.25ml for each 12.5ml into a sterile conical flask, add 100ml of 5% sterile ferrous chloride (0.039mol) solution, cover plug. After shaking, let it stand for precipitation, and tilt the Erlenmeyer flask to make the precipitation form a gel mass. Pour the mixed solution together with the precipitate into a sterile filter, wash the mixed cellulose filter membrane (pore size 0.45 μm) with 100ml / time×10 times of 0.1% sterile peptone aqueous solution, and wash another mixed cellulose filter membrane in the same way ( Pore ​​diameter 0.45μm). Put the filter membrane into 100ml of thioglycolate fluid medium and 100ml of modified Martin medium respectively, culture the thioglycolate fluid medium at 30-35°C, and cultivate the improved Martin medium at 23-28°C , cultivated for 14 days, and observed whether there was bacterial growth every day. Result: No apparent microbial growth. T...

Embodiment 3

[0045] Take 10 samples of levofloxacin sustained-release eye drops (2.5ml / bottle) respectively, draw 1.25ml for each 12.5ml into a sterile Erlenmeyer flask, add 200ml of 10% sterile zinc sulfate (0.125mol) solution, cap the . After shaking, let it stand for precipitation, and tilt the Erlenmeyer flask to make the precipitation form a gel mass. Pour the mixed solution together with the precipitate into a sterile filter, wash the mixed cellulose filter membrane (pore size 0.45 μm) with 100ml / time×10 times of 0.1% sterile peptone aqueous solution, and wash another mixed cellulose filter membrane in the same way ( Pore ​​diameter 0.45μm). Put the filter membrane into 100ml of thioglycolate fluid medium and 100ml of modified Martin medium respectively, culture the thioglycolate fluid medium at 30-35°C, and cultivate the improved Martin medium at 23-28°C , cultivated for 14 days, and observed whether there was bacterial growth every day. Result: No apparent microbial growth. The...

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Abstract

The invention discloses a sterility test method for an antibiotic sustained-release pharmaceutical preparation, wherein a high-molecular polymer calcium polycarbophil is taken as a sustained-release matrix of the antibiotic sustained-release pharmaceutical preparation. The sterility test method comprises: employing a divalent cation metal salt as a precipitating agent to precipitate calcium polycarbophil in the antibiotic sustained-release pharmaceutical preparation, and further to have the antibiotic sustained-release pharmaceutical preparation filtered through a film, culturing the film, and determining whether the antibiotic sustained-release pharmaceutical preparation is sterile to realize sterility test. The sterility test method is applicable to sterility test on products which contain antibiotic and calcium polycarbophil as the sustained-release matrix, and cannot be filtered by employing the film.

Description

technical field [0001] The invention relates to a detection method for the sterility inspection of pharmaceutical preparations, in particular to a detection method for the sterility inspection of antibiotic sustained-release pharmaceutical preparations using high-molecular polymer polycarbophil as a sustained-release matrix, which belongs to the pharmaceutical quality inspection technology field. Background technique [0002] The sterility test method is a method used for the sterility of pharmaceuticals, medical devices, raw materials, excipients and other varieties required by the Pharmacopoeia. According to the 2010 edition of "Chinese Pharmacopoeia", there are membrane filtration method and direct inoculation method for the sterility test of the test product. Among them: (1) membrane filtration method: after taking a specified amount of the test product and filtering it through a membrane filter, take out the filter Membranes were incubated on medium for several days, a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12Q1/04
Inventor 王晶翼李红英姜小平
Owner QILU PHARMA CO LTD
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