质量提取法测试直立式聚丙烯输液袋包装的葡萄糖注射液密封完整性

Mass extraction method for the closure integrity testing of upright polypropylene infusion bag

目的建立质量提取法对直立式聚丙烯输液袋包装的葡萄糖注射液(规格:250 mL:12.5 g)的密封完整性进行测试。方法进行方法参数设定及系统适用性、检出限与检测范围、耐用性、精密度等方法学验证,以及对直立式聚丙烯输液袋包装的葡萄糖注射液(规格:250 mL:12.5 g)加速0、3、6个月样品的密封完整性进行测定。结果质量提取法方法检出限为3μm;精密度(RSD)为2.07%~5.60%。结论本次研究采用的质量提取法可以用于直立式聚丙烯输液袋的密封完整性测试,该方法灵敏度较高,操作简单,结果真实可靠。

Objective To test the sealing integrity of upright polypropylene infusion bag(250 mL)by mass extraction method.Methods The parameters of the method was set,and the system sensitivity,detection limit and detection range,durability,and precision of the method was verified.The sealing integrity of glucose injection(250 mL:2.25 g)packaged in upright polypropylene infusion bag was determined after 0,3 and 6 months acceleration.Results The detection limit of the mass extraction method was 3μm;RSD of repeatability was 2.07%~5.60%.Conclusion The mass extraction method used in this study can be used to test the sealing integrity of upright polypropylene infusion bag.This method has high sensitivity,simple operation and reliable results.