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目的:考察生产制备过程中各种因素对盐酸洛美沙星注射液有关物质的影响,从而找到确实可靠的工艺控制方法。方法:采用不同的工艺条件制备盐酸洛美沙星注射液,并用高效液相色谱仪进行产品有关物质的检测与分析。结果:配制温度与配制时间对盐酸洛美沙星注射液有关物质影响较明显,灭菌温度对其影响较不明显;配制中金属离子对产品有关物质影响较大,但加入少量EDTA络合剂后可降低。结论:采用加入少量EDTA络合剂,且低温与短时间配制,盐酸洛美沙星注射液有关物质可降低。
OBJECTIVE: To investigate the influence of various factors on the related substances of Lomefloxacin Hydrochloride Injection in the process of production and preparation, so as to find a reliable and reliable method of process control. Methods: The Lomefloxacin Hydrochloride Injection was prepared under different technological conditions, and the related substances were detected and analyzed by high performance liquid chromatography. Results: The effects of preparation temperature and preparation time on the related substances of lomefloxacin hydrochloride injection were obvious, and the sterilization temperature had little effect on the related substances. The metal ions in the preparation had a significant impact on the related substances, but after adding a small amount of EDTA complexing agent Can be reduced. Conclusion: The addition of a small amount of EDTA complexing agent, and low temperature and short time preparation, lomefloxacin hydrochloride injection related substances can be reduced.