Heat-resistant Properties in Autoclaving of New Polycarbonate Bottles Containing a Disinfectant of Chlorhexidine Digluconate Solution

概要

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Heat-resistant polycarbonate bottle were newly devised for autoclave sterilization of chlorhexide digluconate solution,a disinfectant. To assess the usefulness in the clinical application, the shape transformation of the bottles and the chemical stability of their content of 0.05% chlorhexidine digluconate solution were examined after autoclaving in comparison with those of glass bottles and of their contents. The autoclaving experiment was performed at 115℃ for 30 minutes. After autoclaving, the polycarbonate bottles increased slightly of less than 1.62% in outer diameter, whereas the change with glass bottles was unmeasurable. Levels of chlorhexidine digluconate and p-chloroaniline, its decomposition product, were determined in both types of bottles by high-performance liquid chromatography at 1 day and 1, 3, and 6 months after autoclaving. Levels of chlorhexidine digluconate remaining until 6 months after autoclaving were more than 98% and 97% in the polycarbonate and glass bottles, respectively. p-Chloroaniline was generated after autoclaving in levels of 0.02-0.90 μg/ml in the polycarbonate bottles and of 0.06-0.90 μg/ml in the glass bottles throughout the study. These results suggest that the newly devised polycarbonate bottles are resistant to heat and mechanical shocks, and that they are as useful as the presently used glass bottles for sterilizing and storing the chlorhexidine digluconate solution.
日本医療薬学会の論文
1994-10-20