摘要
目的评价国内不同企业生产的注射用单磷酸阿糖腺苷的质量现状及存在问题,完善质量标准。方法对15个企业共162批样品依据现行法定质量标准进行了检验,并对样品的有关物质、原料、细菌内毒素、含量、渗透压、金属离子、辅料等进行了探索性研究。结果按照法定检验,总合格率为100%;根据探索性研究结果,修订质量标准,按拟定标准检验,有32批不合格,占抽样总数的20%,不合格项目为有关物质。探索性研究发现,注射用单磷酸阿糖腺苷的杂质主要由原料引入,原料析晶次数越多,杂质越少。结论纳入本品整体质量水平较好。目前国内注射用单磷酸阿糖腺苷的质量标准存在缺陷,需进一步修订完善。
OBJECTIVE To evaluate the suitability of statutory standards and the quality status of vidarabine monophosphate for injection of different domestic manufactures and improve the quality standards.METHODS A total of 162 batches of samples from 15 enterprises were tested according to the statutory standards.Exploratory research tests were carried out including related substances,raw materials,bacterial endotoxin,content,osmotic pressure,heavy metal,supplementary materials,etc.RESULTS The qualified rate was 100% by the statutory testing methods.The quality standard was revised according to the result of exploratory research.The samples were tested according to the revised standard,32 batches were unqualified,accounting for 20% of the total samples,the main nonconforming item was related substances.Exploratory studies had found that impurities had a great relationship with raw materials.The more crystallization times of raw materials,the less impurities.CONCLUSION The overall quality of vidarabine monophosphate for injection is good.The current quality standards of vidarabine monophosphate for injection have defects and should be further revised and improved.
作者
吴娜
杨承勇
薛巧如
陈华
WU Na;YANG Chengyong;XUE Qiaoru;CHEN Hua(Guangdong Institution for Drug Control,Guangzhou,Guangdong 510663,China)
出处
《今日药学》
CAS
2023年第9期681-685,共5页
Pharmacy Today
基金
广东省医学科学技术研究基金(B2021404)
广东省药品监督管理局2022年科技创新项目(2022TDB02)。
关键词
注射用单磷酸阿糖腺苷
有关物质
探索性研究
质量分析
vidarabine monophosphate for injection
related substances
exploratory study
quality analysis
