胞磷胆碱钠注射剂对小鼠异常毒性的影响

Effect of Citicoline sodium injection on abnormal toxicity in mice

目的研究胞磷胆碱钠注射液对小鼠异常毒性的影响。方法参照《中国药典》2010版,附录XI C异常毒性检查法,按照尾静脉注射给药法试验,考察原料来源、灭菌工艺、杂质及渗透压对小鼠异常毒性的影响。结果不同企业的原料生产的胞磷胆碱钠注射剂均未使小鼠出现毒性反应症状及死亡;长时间的高温灭菌,高含量的杂质和高渗透压均可是小鼠出现毒性反应症状及死亡。结论胞磷胆碱钠注射液的异常毒性受到多种因素的影响,加强对生产工艺的控制非常必要。

【Objective】To study the effects of Citicoline sodium injection on abnormal toxicity in mice.【Methods】According to the Chinese Pharmacopoeia 2010 edition, Appendix XI C test for abnormal toxicity, in accordance with tail intravenous injection test, sources of materials, sterilization process, impurities and osmotic pressure were investigated to the influence on abnormal toxicity.【Results】Different enterprises of raw material to produce Citicoline sodium injection led to toxicity symptoms and death in mice, while long time high temperature sterilization, high content of impurity and high osmotic pressure generated the opposite results. 【Conclusions】Many factors have influence on abnormal toxicity of Citicolinesodium injection. It is necessary to strengthen the control of production process.