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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(GCMS)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 qualitatively study the dissolution of domestic infusion bag. Methods: The UV-Vis spectrum and GC-MS were used to analyze the spectral characteristics and ion fragmentation. The data were compared with the plastic infusion bottles manufactured by Guangdong Dako Pharmaceutical Co., Ltd. in parallel experiments. Results: A total of 30 samples of infusion solutions or experimental products packed in domestic infusion bags were tested for dissolution substances --- plasticizers and cetyl alcohol. The sample provided by Guangdong Dayu Pharmaceutical Co., Ltd. had no plasticizer dissolution . Conclusion: As soon as possible to develop domestic infusion bag quality standards and dissolution of the ingredients of the standard.