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[Testing the sterility of injection preparations of penicillin series antibiotics]
Abstract:
The efficiency of 3 variants of the method for determination of microbial flora was compared on the injection preparation of potassium benzylpenicillin artificially infected with Staph. aureus 209P and the spores of Bac. subtilis ATCC 6633 in different doses and with different amounts of the preparation in the vials. The procedure of the preparation dissolution in the vial with the thioglycol medium containing penicillinase proved to be most effective. The microbe detection amounted to 100 per cent. The procedure was less labour- and time-consuming since addition of penicillinase to each vial with the thioglycol medium was excluded. The risk of the medium occasional infection with microbial flora during the assay was decreased.
Insights
This study compared microbial detection methods for potassium benzylpenicillin injections. Dissolving the preparation in thioglycol medium with penicillinase achieved 100% microbe detection efficiently and safely.
Area of Science:
- Microbiology
- Pharmaceutical Analysis
Background:
- Accurate microbial determination is crucial for injectable drug quality control.
- Potassium benzylpenicillin preparations require specific methods to overcome antibiotic interference.
Purpose of the Study:
- To compare the efficiency of three methods for determining microbial flora in potassium benzylpenicillin injections.
- To identify the most effective and practical method for microbial detection in this pharmaceutical preparation.
Main Methods:
- Artificial infection of potassium benzylpenicillin preparations with Staphylococcus aureus 209P and Bacillus subtilis ATCC 6633 spores.
- Comparison of three variants for sample dissolution and microbial flora determination.
- Utilizing thioglycol medium with and without penicillinase for microbe detection.
Main Results:
- The method involving dissolution in thioglycol medium containing penicillinase demonstrated the highest effectiveness.
- 100% microbe detection was achieved using the optimized method.
- This procedure was less labor-intensive and time-consuming, reducing the risk of contamination.
Conclusions:
- Dissolving potassium benzylpenicillin preparations in thioglycol medium with penicillinase is the most effective method for microbial flora determination.
- This optimized method enhances efficiency, reduces assay time, and minimizes contamination risks in pharmaceutical quality control.