Proposed phase 2/ step 2 in-vitro test on basis of EN 14561 for standardised testing of the wound antiseptics PVP-iodine, chlorhexidine digluconate, polihexanide and octenidine dihydrochloride

根据 EN 14561 建议进行第 2 阶段/第 2 步体外试验,用于对伤口消毒剂 PVP-碘、葡萄糖酸氯己定、聚己内酰胺和盐酸奥替尼啶进行标准化测试

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作者:Kathrin Schedler, Ojan Assadian, Uta Brautferger, Gerald Müller, Torsten Koburger, Simon Classen, Axel Kramer

Background

Currently, there is no agreed standard for exploring the antimicrobial activity of wound antiseptics in a phase 2/ step 2 test protocol. In the present study, a standardised in-vitro test is proposed, which allows to test potential antiseptics in a more realistically simulation of conditions found in wounds as in a suspension test. Furthermore, factors potentially influencing test

Conclusion

Overall, this method allowed testing and comparing differ liquid and gel based antimicrobial compounds in a standardised setting.

Methods

This proposed phase 2/ step 2 test method was modified on basis of the EN 14561 by drying the microbial test suspension on a metal carrier for 1 h, overlaying the test wound antiseptic, washing-off, neutralization, and dispersion at serial dilutions at the end of the required exposure time yielded reproducible, consistent test

Results

The difference between the rapid onset of the antiseptic effect of PVP-I and the delayed onset especially of polihexanide was apparent. Among surface-active antimicrobial compounds, octenidine was more effective than chlorhexidine digluconate and polihexanide, with some differences depending on the test organisms. However, octenidine and PVP-I were approximately equivalent in efficiency and microbial spectrum, while polihexanide required longer exposure times or higher concentrations for a comparable antimicrobial efficacy.

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