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 chromatographymass 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.
Key words
diterpene ginkgolides meglumine injection /
infusion set for single use /
compatibility
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