胞磷胆碱钠注射剂三种剂型有关物质比较

Comparison of Related Substances in Three Dosage Forms of Citicoline Sodium Injection

目的:测定胞磷胆碱钠注射剂三种剂型的有关物质,对有关物质结果进行统计分析,比较剂型优劣。方法:采用现行法定标准测定24家企业400批胞磷胆碱钠注射液、8家企业49批注射用胞磷胆碱钠及7家企业30批胞磷胆碱钠氯化钠注射液的有关物质,并对胞磷胆碱钠注射液、注射用胞磷胆碱钠和胞磷胆碱钠氯化钠注射液的5'-胞苷酸和其他杂质总量(各杂质总量)进行对比分析。结果:三种剂型之间的有关物质测定结果有显著性差异,注射用胞磷胆碱钠优于胞磷胆碱钠注射液,胞磷胆碱钠注射液优于胞磷胆碱钠氯化钠注射液。结论:建议相关生产企业根据剂型特点,提高工艺水平,降低有关物质含量,以提高产品质量。本研究为医疗机构临床用药提供参考。

Objective:to determine the related substances in three dosage forms of citicoline sodium injection,to analyze the results of related substances,and to compare the advantages and disadvantages of dosage forms.Methods:the related substances of 400 batches of citicoline sodium injection in 24 enterprises,49 batches of citicoline sodium for injection in 8 enterprises and 30 batches of citicoline sodium and sodium chloride injection in 7 enterprises were determined by current legal standards.The total amount of 5'-cytidine acid and other impurities(total amount of each impurity)in citicoline sodium injection,citicoline sodium for injection and citicoline sodium chloride injection were compared and analyzed.Results:There were significant differences in the determination results of related substances among the three dosage forms.Citicoline sodium for injection was superior to citicoline sodium injection,and citicoline sodium injection was superior to citicoline sodium chloride injection.Conclusion:according to the characteristics of dosage forms,it is suggested to improve the technology level and reduce the content of related substances.Improve product quality.This study provides a reference for clinical medication in medical institutions.