胞磷胆碱钠氯化钠注射液及其注射液细菌内毒素检查法的研究

Study on bacterial endotoxin test for citicoline and sodium chloride injection

目的:胞磷胆碱钠氯化钠注射液是一种新型制剂,我们对其进行了细菌内毒素检查方法的研究,同时对原剂型胞磷胆碱钠注射液也进行了该方法研究。方法:对五个厂家的10批样品,采用不同生产厂家和规格的TAL,进行了干扰试验和细菌内毒素检查。结果:本品高浓度时对TAL与细菌内毒素的凝集反应有干扰作用,经稀释后可排除。结论:本品的不干扰浓度,以胞磷胆碱钠计为0.25mg·ml^(-1),可采用细菌内毒素检查法进行质量控制。

Citicoline and sodium chloride injection is a sort of new preparations. To control it by bacterial endotoxin test was carried through to improve the quality standard and insure the security in clinic. The research for citicoline injection was went on synchronously. Methods :Different products of tachypleus amebocyte lysate (TAD were used for the investigation of disturb and bacterial endotoxin test for 10 groups of sample which were produced by five factories. Results:The most concentration of citicoline and sodium chloride injection had disturbed the reaction. The interference was eliminated after dilution. Conclusion: The noninterference concentration of citicoline is 0. 25mg·ml-1. Bacterial endotoxin test could be used to control the quality.