Investigation on dissolved substances of polypropylene port for plastic infusion containers
10.19778/j.chp.2024.04.016
- VernacularTitle:塑料输液容器用聚丙烯接口溶出物供试液制备方法研究
- Author:
Fang LIN
1
;
Yanhui XU
;
Xiang LI
;
Jinfeng ZHENG
;
Xia ZHAO
Author Information
1. 福建省食品药品质量检验研究院,福州 350001
- Keywords:
polypropylene port;
dissolved matter test;
test liquid preparation;
plastic infusion containers;
pharma-ceutical packaging material standards
- From:
Drug Standards of China
2024;25(4):416-422
- CountryChina
- Language:Chinese
-
Abstract:
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.
