摘要
目的分析研究长春西汀注射液中的基因毒性杂质种类及来源,并采用高效液相色谱(HPLC)法测定其含量。方法采用HPLC法测定长春西汀注射液中所含有的基因毒性杂质的含量,并分析基因毒性杂质的来源及安全性。色谱柱:Waters XSELECT CSH C_(18)柱(4.6×250 mm,5μm);流动相:0.2 mol/L乙酸铵-乙腈;梯度洗脱;检测波长:280 nm;进样量:10μl;柱温:25℃;流速:1.0 ml/min。结果长春西汀注射液中含有基因毒性杂质苯甲醛和糠醛,不同厂家生产的长春西汀注射液中苯甲醛和糠醛的含量略有差异,苯甲醛含量在0.03%~0.07%之间,糠醛含量在0.006%~0.050%之间。结论长春西汀注射液中含有由辅料苯甲醇引入的基因毒性杂质苯甲醛,由辅料维生素C引入的基因毒性杂质糠醛。采用HPLC法可快速、准确的测定长春西汀注射液中两种基因毒性杂质的含量。
Objective To analysis the types,sources and assays of genotoxicimpurities in vinpocetine injection. Methods RP-HPLC was adopted to detect the genotoxic impurities in vinpocetine injection and analyze the source and variety of each genotoxic impurity.Column：Waters XSELECT CSH C18（4.6×250 mm,5 μm）;Mobile phase： acetonitrile and 0.2 mol/L annonium acetate solution;Gradient elution;Detector：spectrophotometer at 280 nm;Injection volume： 10 μl.Temperature： 25 ℃.Flow rate： 1.0 ml/min.Results There are two genotoxic impurities in vinpocetine injection（benzaldehyde and furfural）.The assays of benzaldehyde and furfural in different vinpocetine injections are diverse.The assays of benzaldehyde are between 0.03%-0.07%,the assays of furfural are between 0.006%-0.05 %. Conclusion There are twogenotoxic impurities in vinpocetine injection which come from the excipients（benzyl alcohol and vitamin C）.The RP-HPLC can be used to determine these genotoxic impurities quickly and exactly.
出处
《中国药物经济学》
2018年第2期42-44,57,共4页
China Journal of Pharmaceutical Economics
