摘要
目的通过对15个生产企业的226批国家评价性抽验品种胞磷胆碱钠注射液的有关物质检测结果进行统计,分析不同原料来源与灭菌工艺对胞磷胆碱钠注射液的有关物质的影响。方法按《中国药典》2010年版对样品有关物质进行检验,采用方差分析评价不同原料来源与灭菌工艺对有关物质的影响。所有数据处理使用SPSS13.0完成。结果选用日本产的原料生产的样品,其5′-胞苷酸明显高于苏州产的原料生产的样品,其他单个杂质和其他杂质总和明显低于苏州产的原料生产的样品。采用F0>8的灭菌工艺生产的样品,其有关物质明显高于F0=8的样品。结论应提高我国原料质量标准中其他单个杂质和其他杂质总量的限度,提高我国原料质量;在选择灭菌工艺时,应同时兼顾灭菌效力和药物的稳定性。
Objective To analyze the influences of different sources of raw materials and sterilization processes on related substances in Citicoline Sodium Injection through testing related substances in 226 batches of Citicoline Sodium Injection from 15 manufacturers which were the varieties for national assessment.Methods The related substances in the samples were tested according to the requirements of Chp 2010.Analysis of variance was adopted to evaluate the influences of different sources of raw materials and sterilization processes on related substance.Results 5＇-cytidine monophosphates in samples made of raw materials from Japan were significantly higher than those in samples made of raw materials from Suzhou China,and the total content of other single impurities and other impurities were obviously lower than those made of materials from Suzhou.Related substances in samples produced by F0〉8 sterilization process were evidently higher than those by F0=8 sterilization process.Conclusion The quality of Chinese raw materials should be improved through increasing the limits of the total content of other single impurities and other impurities in the quality standard of citicoline sodium.Manufacturers need to select suitable sterilization process while taking into account the sterilization effectiveness and stability of the drug.
出处
《中国药事》
CAS
2014年第1期48-52,共5页
Chinese Pharmaceutical Affairs
基金
国家药品计划抽验项目(编号化2012054079033)
关键词
胞磷胆碱钠注射液
有关物质
国家评价性抽验
原料来源
灭菌工艺
Citicoline Sodium Injection
related substance
national assessment program
source of raw materials
sterilization process
