胞磷胆碱钠注射剂渗透压考察

Investigation of Osmotic Pressure of Citicoline Sodium Injection

目的:对不同企业的胞磷胆碱钠注射剂进行渗透压分析,为提高该品种的国家标准提供试验依据。方法:采用冰点降低法对国内45家生产企业的479批胞磷胆碱钠注射剂的渗透压值进行测定。结果:胞磷胆碱钠注射液渗透压值在359~692 m Osmol·kg^(-1)之间,注射用胞磷胆碱钠渗透压值在401~1 408 m Osmol·kg^(-1)之间,胞磷胆碱钠氯化钠注射液渗透压值在278~299 m Osmol·kg^(-1)之间。结论:国内不同厂家生产的胞磷胆碱钠注射液和注射用胞磷胆碱钠的渗透压值有较大差异,有必要在其质量标准中增设渗透压检查项,用以评价生产工艺的优劣。

Objective： To analyze the osmotic pressure of citicoline sodium injection from different manufacturers to provide experimental basis for improving the national standard of the product. Methods ： The cryoseopic method was used to detect the osmotic pressure of 479 batches of citicoline sodium injection from 45 pharmaceutical factories. Results： The osmotic pressure of citieoline sodium injection was within the range of 359-692 mOsmol·kg^-1 , that of eiticoline sodium for injection was within the range of 401-1408 mOsmol·kg^-1 , and that of citieoIine sodium chloride injection was within the range of 278-299 mOsmol·kg^-1. Conclusion： The osmotic pressure of eitieoline sodium injection and citicoline sodium for injection from different manufacturers is obviously different. It is necessary to detect osmotic pressure in the quality standard in order to evaluate the quality of preparation process.