银杏二萜内酯葡胺注射液与一次性输液器的相容性考察

Compatibility between Diterpene Ginkgolides Meglumine Injection and Infusion Sets for Single Use

通过提取、迁移及吸附试验,全面考察银杏二萜内酯葡胺注射液与常用的4种材质[聚氯乙烯(PVC)、烯烃类热塑性弹性体(TPE)、聚氨酯类弹性体(TPU)、超低密度聚乙烯(ULDPE)]输液器的相容性。采用电感耦合等离子体质谱(ICP-MS)、气相色谱-质谱(GC-MS)、高效液相色谱(HPLC)等方法测定样品中的可提取物和迁移物。以银杏二萜内酯葡胺注射液说明书为依据,模拟临床实际输液状况以考察输液器中相关成分的提取和迁移情况,同时参照银杏二萜内酯葡胺注射液药品质量标准考察4种材质输液器对药品的吸附情况。提取试验中,TPU输液器可提取出金属元素和抗氧剂1010,抗氧剂1010检出量超出分析评价阈(AET)值;PVC输液器可提取出部分金属元素和邻苯二甲酸酯类;TPE输液器可提取出金属离子、苯乙烯、抗氧剂1010;ULDPE输液器可提取出金属离子,其他均未检出。迁移试验中,PVC中的邻苯二甲酸酯类成分有迁移,但低于安全值,其他材质中的各成分均未见明显迁移。吸附试验中,注射液流经4种材质输液器后pH值、紫外吸光度、含量测定等指标均无明显变化。结果表明,银杏二萜内酯葡胺注射液与TPU、PVC、TPE、ULDPE输液器相容性良好。本试验为临床正确选择输液器、保证用药安全提供参考依据。

Through extraction,migration and adsorption tests,the compatibilities between diterpene ginkgolides meglumine injection and four commonly used materials[polyvinyl chloride(PVC),polylefin thermoplastic elastomer(TPE),thermoplastic polyurethane(TPU)and ultra low density polyehtylene(ULDPE)]infusion sets for single use were fully investigated.Using inductively coupled plasma mass spectrometry(ICP-MS),gas chromatography-mass spectrometry(GC-MS)and high performance liquid chromatography(HPLC)to determine the extractables and leachables from the infusion sets.According to the instruction of diterpene ginkgolides meglumin injection,the relevant components extracted and migrated from the infusion sets were investigated by simulating actual clinical situation.At the same time,the quality of diterpene ginkgolides meglumine injection after infusing through infusion sets with different materials was tested according to its quality standards.In the extraction test,the the metal elements and antioxidant 1010 could be extracted from TPU infusion sets,and the antioxidant 1010 exceeded the analytical evaluation threshold(AET)value;some metal elements and phthalates could be extracted from PVC infusion sets;some metal elements,styrene,antioxidant 1010 could be extracted from TPE infusion sets;some metal elements could be extracted from ULDPE infusion sets,but none of the others were detected.Although the phthalate components migrated out of the PVC materid,they were all below the safe values,and none of the components in other materials had undergone significant migration.In the adsorption test,the pH values,UV absorption values and contents of the injection flowing through the four materials of the infusion sets were not significantly changed.These results showed that the diterpene ginkgolides meglumine injection had good compatibility with infusion sets of TPU,TPE,PVC and ULDPE,which provided a reference for the correct choice of infusion in clinical practice and to guarantee the safety of medication.