维生素B_(12)注射液抽验质量评价与分析  

Sample Quality Evaluation and Analysis of Vitamin B_(12) Injection

作　　者：伍小勇[1] 张晓丹[1] 金丽[1] 古卓良[1] 卜莹[1] 

机构地区：[1]南京军区联勤部药品仪器检验所,江苏南京210002

出　　处：《中国药物评价》2014年第6期330-332,共3页Chinese Journal of Drug Evaluation

摘　　要：目的:评价维生素B12注射液的质量情况。方法:按照国家评价性抽验计划总体要求,采用法定检验方法,结合探索性研究,对来自28个厂家的183批次样品进行检验,统计分析检验结果,并对其质量现状进行评价。结果:法定检验显示维生素B12注射液合格率100.0%;探索性研究显示部分产品有关物质含量偏高,并有一批次产品含量测定不合格;拟定了细菌内毒素限量;建立拉曼光谱定性分析模型,可对液体注射剂进行无损、快速鉴别。结论:按执行标准检验,合格率较好,但存在与规定有关物质检测及细菌内毒素限度等问题。建议改进现行质量标准,进一步加强对维生素B12注射液的监管。Objective： To evaluate the quality of vitamin B12 injection. Methods： According to the general requirements of national e- valuation programs, 183 batches of samples from 28 manufacturers were detected by using statutory test methods combined with the ex- ploratory research. The quality of injections was evaluated by analyzing statistical results. Results ：100% of vitamin B12 injection met the requirements of current specifications. Exploratory studies showed the content of some products related substances is high. And there was one substandard batches of content determination. Developed a bacterial endotoxin limit. A qualitative analysis model was established by Raman spectroscopy and liquid injections can be non-destructive, rapid identified by the model. Conclusion：The quality of vitamin B12 injection can meet the current specifications. There are still some problems in few enterprises, such as related substances is not specified and the test methods of bacterial endotoxin. It suggests improving current quality standard and further strengthening the supervision of vitamin B12 injection.

关 键 词：维生素B12注射液 评价性抽验 质量评价 

分 类 号：R927.2[医药卫生—药学]