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目的 :对硫酸依替米星氯化钠注射液的有关物质进行更有效的控制。方法:新标准YBH01062014采用高效液相色谱-蒸发光散射检测法检测有关物质,原标准WS-807(x-593)-2002采用柱前衍生化HPLC-UV法检测有关物质,对比实验数据,分析哪种方法能更有效地控制其有关物质。结果:通过分析实验数据,新标准比原标准更能对硫酸依替米星氯化钠注射液的有关物质进行有效控制。结论 :新标准对硫酸依替米星氯化钠注射液的质控限度更加严格,能更好的控制药品质量,保证临床疗效。
Objective: To control more effectively the related substances of etimicin sodium chloride injection. Methods: The new standard YBH01062014 was detected by high performance liquid chromatography coupled with evaporative light scattering detection. The related substances were detected by the pre-column derivatization HPLC-UV method of WS-807 (x-593) -2002. Compared with the experimental data, Which method can control its related substances more effectively? Results: By analyzing the experimental data, the new standard is more effective than the original standard on the related substances of etimicin sodium chloride injection. Conclusion: The new standard on the quality of etimicin sodium chloride injection limits more stringent quality, better control of drug quality, to ensure clinical efficacy.