CAJ | 학술논문

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。
목적：평개유생소B12주사액적질량정황。방법：안조국가평개성추험계화총체요구，채용법정검험방법，결합탐색성연구，대래자28개엄가적183비차양품진행검험，통계분석검험결과，병대기질량현상진행평개。결과：법정검험현시유생소B12주사액합격솔100.0％；탐색성연구현시부분산품유관물질함량편고，병유일비차산품함량측정불합격；의정료세균내독소한량；건립랍만광보정성분석모형，가대액체주사제진행무손、쾌속감별。결론：안집행표준검험，합격솔교호，단존재여규정유관물질검측급세균내독소한도등문제。건의개진현행질량표준，진일보가강대유생소B12주사액적감관。
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 vi-tamin B12 injection.