更昔洛韦氯化钠注射液与聚丙烯输液瓶的相容性评价

Compatibility Evaluation of the Ganciclovir and Sodium Chloride Injection and Polypropylene Infusion Bottle

关键词:  聚丙烯输液瓶  更昔洛韦氯化钠注射液  提取试验  迁移试验  吸附试验  每日允许最大暴露量(PDE)  分析评价阈值(AET)

Key words:  polypropylene infusion bottle  Ganciclovir and Sodium Chloride injection  extraction study  migration study  adsorption study  permitted daily exposure(PDE)  analytical evaluation threshold(AET)

摘要:

目的 探讨聚丙烯输液瓶的安全性及其与更昔洛韦氯化钠注射液的相容性。方法 建立抗氧剂、抗酸剂的检测方法，通过提取试验、迁移试验和吸附试验研究注射液与包装材料的相互作用，根据添加剂的毒理学研究资料评价其相容性。结果 抗氧剂及其氧化物和降解物采用HPLC测定，报告限为0.098~0.98 μg·mL^-1；抗酸剂中的镁、铝元素采用AAS测定，报告限为0.025~0.1 μg·mL^-1。各添加剂的分析评价阈值为0.83~117 μg·mL^-1，均高于各自报告限。提取和迁移试验中注射液中未检出添加剂成分，也未见API被明显吸附。结论 聚丙烯输液瓶浸出物含量低于每日允许最大暴露量，对更昔洛韦氯化钠注射液没有吸附作用，相容性好。

Abstract:

OBJECTIVE To investigate the safety of polypropylene infusion bottle and it's compatibility with the Ganciclovir and Sodium Chloride injection. METHODS The determination methods of antioxidants and antacids were established; the interaction on injection and packing materials were measured through extraction, migration and adsorption test; and the compatibility was evaluated by the reported toxicology research data of additives. RESULTS The antioxidants and their oxides and/or degradation products were determined by HPLC, and their reporting thresholds were 0.098-0.98 μg·mL^-1. The contents of Mg and Al in the antacids were determined by AAS, and their reporting thresholds were 0.025-0.1 μg·mL^-1. While the analytical evaluation thresholds of each additives were 0.83-117 μg·mL^-1, it was higher than their respective reporting threshold. In the extraction and migration experiments, no additive and obvious adsorption of API were found in the injection. CONCLUSION The extracts of polypropylene infusion bottles are lower than their permitted daily exposure. The packing material does not adsorb Ganciclovir and Sodium Chloride injection and has good compatibility.