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目的:探讨氧氟沙星葡萄糖注射液中有关物质的成分、来源和对其进行有效控制的方法。方法:对0.2％氧氟沙星空白液和5％葡萄糖空白液及氧氟沙星葡萄糖注射液经不同处理后进行高效液相测定。结果:在同一出峰时间(约4.5min),0.2％氧氟沙星空白液灭菌前后无明显吸收峰,5％葡萄糖空白液和氧氟沙星葡萄糖注射液在热的条件下有一个明显的吸收峰。结论:氧氟沙星葡萄糖注射液中的有关物质主要为5-羟甲基糠醛,是葡萄糖的分解产物,可通过控制pH值及灭菌温度有效控制本品质量。
Objective: To explore the composition, origin and effective control of the related substances in ofloxacin and glucose injection. Methods: 0.2% of ofloxacin blank solution and 5% dextrose solution and ofloxacin glucose injection after different treatments for high performance liquid phase determination. Results: At the same peak time (about 4.5 min), 0.2% of ofloxacin blank solution had no significant absorption peak before and after sterilization, 5% glucose blank solution and ofloxacin glucose injection had a significant Absorption peak. Conclusion: The related substances in ofloxacin and glucose injection are mainly 5-hydroxymethylfurfural, which is the decomposition product of glucose. The quality of this product can be effectively controlled by controlling the pH and sterilization temperature.