摘要
目的:考察果糖二磷酸钠注射剂的质量现状及存在问题,对现行质量标准的科学性及检验方法进行研究,完善质量标准。方法:对15个企业共118批样品依据现行法定质量标准进行了检验,并开展了9项探索性研究检验,对该品种的质量及标准状况做出总体分析和评价。结果:按现行标准检验中,果糖二磷酸钠注射液共10批不合格,占注射液抽样总数的18.2%;注射用果糖二磷酸钠有1批不合格,占注射用粉针抽样总数的1.6%。探索性研究发现,果糖二磷酸钠注射剂对温度敏感;部分果糖二磷酸钠注射剂存在渗透压高(>1000 mOsm/kg)、铝含量较高和抗氧剂含量较高等质量安全风险。结论:注射用果糖二磷酸钠产品质量总体一般;果糖二磷酸钠注射液不合格率较高,整体质量较差。果糖二磷酸钠注射剂质量标准存在一定缺陷,有待进一步提高。
Objective:To investigate the quality status and existing problems of sodium fructose diphosphate injection,and study the scientificity and testing methods of the current quality standards and improve the quality standards.Methods:A total of 118 batches of samples from 15 enterprises were tested according to the current legal quality standards.9 exploratory research tests were carried out to make an overall analysis and evaluation of the quality and standard status of fructose sodium diphosphate injection.Results:According to the current standard inspection,a total of 10 batches of fructose sodium diphosphate injection were unqualified,accounting for 18.2%of the total injection samples;1 batch of fructose sodium diphosphate for injection was unqualified,accounting for 1.6%of the total samples of powder needles for injection.Exploratory studies have found that fructose sodium diphosphate injection is sensitive to temperature.Some fructose sodium diphosphate injections have quality and safety risks such as high osmotic pressure(>1000 mOsm/kg),high aluminum content and high antioxidant content.Conclusion:The product quality of fructose sodium diphosphate for injection is generally average;the unqualified rate of fructose sodium diphosphate injection is relatively high,and the overall quality is poor.There are certain defects in the quality standard of fructose sodium diphosphate injection,which needs to be further improved.
作者
刘冰滢
穆矛
邓锋
梁蔚阳
薛巧如
LIU Bingying;MU Mao;DENG Feng;LIANG Weiyang;XUE Qiaoru(Guangdong Institute for Drug Control,Guangzhou Guangdong 510663,China)
出处
《药品评价》
CAS
2022年第22期1366-1370,共5页
Drug Evaluation
基金
广东省医学科研基金(B2020198)。
关键词
果糖二磷酸钠注射剂
标准检验
探索性研究
质量评价
Fructose sodium diphosphate injection
Standard test
Exploratory study
Quality evaluation
