论文部分内容阅读
目的验证国内标准测定依达拉奉注射液中依达拉奉含量与日本标准的一致性,确定国内标准的可行性。方法采用高效液相色谱法按照日本标准(内标法)和国内标准(外标法)分别测定含量。结果国内外两个标准测定同一厂家三批依达拉奉注射液中依达拉奉的平均含量分别为95.0%、(RSD为0.122%)和98.2%(RSD为0.305%)。结论国内外两个标准含量测定结果一致,差异无统计学意义。
Objective To verify the consistency of edaravone in edaravone injection with Japanese standards by domestic standards and determine the feasibility of domestic standards. Methods High performance liquid chromatography (HPLC) was used to determine the content according to Japanese standard (internal standard method) and domestic standard (external standard method). Results The average contents of edaravone in three batches of edaravone in the same factory were 95.0% (RSD 0.122%) and 98.2% (RSD 0.305%), respectively. Conclusion The results of the two standards at home and abroad are consistent, the difference was not statistically significant.