Objective:To establish a preparation method for dissolved matter test solution of polypropylene port for plastic infusion containers,and to provide a reference for a standard system for pharmaceutical packaging materials of this product.Methods:Determination for results of dissolved matter test solution by specific surface area method and mass method were compared and analyzed in pair.Results:There were differences in sample amount and con-tact area between the two methods,but the results of dissolved matter test solution were generally consistent.Paired sample Wilcoxon signed rank test and paired sample T-test were used in pH,readily oxidizable substances,and non-volatile substance which indicators are quantifiable.Results show that there were no significant differences between the test solution,with Cohen's d values of 0.153,0.218,and 0.296,respectively,which were small in magnitude.Conclusion:In the case of insignificant differences between the two sampling methods,for polypropyl-ene port for plastic infusion containers and other irregular products,it is recommended that the test solution is prepared by leaching by mass,that is,a leaching ratio of 0.2 g·mL-1 by mass or volume,with more reproducible results.This study provides a reference for the establishment of standard for polypropylene port for plastic infusion containers.
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