国产输液袋溶出物定性实验研究

Studies on dissoluble substances of domestic infusion bags

目的：定性研究国产输液袋溶出物质。方法：紫外光谱扫描、气相色谱质谱（ＧＣＭＳ）测定，分析光谱特征、离子碎片，并与广东大制药有限公司塑料输液瓶做平行实验比较。结果：采用国产输液袋包装的输液剂或实验试制品共３０个样品，均检查出溶出性物质———增塑剂、鲸腊醇，广东大制药有限公司提供的样品无增塑剂溶出。结论：尽快制订国产输液袋的质量标准及溶出性成分的限量标准。

OBJECTIVE: To analyse the chemical constituents of the dissoluble substances from domestic plastic infusion bags. METHODS: The dissoluble compounds were elucidated on basis of ultraviole tspectra and GC/MS,respectively. RESULTS: Diethylphthalate and 1hexadecaty nol were found to be the dissoluble substances of domestic plastic infusion bags. CONCLUSION: The results showed the necessity to establish the physical,chemical,toxicological and biological limits for domestic plastic infusion bags,particularly the ultraviolet absorbence Value limits at 200400nm wavelength.