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目的:对异氟烷质量进行系统研究。方法:采用GC法考察其含量及杂质,并用理化法进行纯度检查。结果:GCF10 法测定含量精确、省时、t 检验、F检验表明与美国药典23 版法无明显差异( P>0-05);GCECD 法分析包含在主峰尾部的杂质,适于控制异氟烷质量。结论:所拟质量控制项目优于美国药典23 版法。
Objective: To systematically study the quality of isoflurane. Methods: GC method was used to investigate its content and impurities, and physical and chemical methods were used for purity check. Results: The GC-F10 method was accurate, time-saving, t-test and F-test showed no significant difference with the United States Pharmacopoeia (P> 0-05); GC -ECD analysis of impurities contained in the tail of the main peak, Control isoflurane quality. Conclusion: The proposed quality control program is superior to the United States Pharmacopoeia 23 edition.