摘要
目的 对2013年~2015年间不同批次的注射用盐酸表柔比星进行质量分析,评价国抽中注射用盐酸表柔比星的产品质量,并对现行检验标准的可行性进行评价。方法 按照现行的国家食品药品监督管理局标准YBH03762011和国家食品药品监督管理局标准YBH02502011对注射用盐酸表柔比星进行检测,并对药品的质量进行分析和统计。结果 根据目前实施的注射用盐酸表柔比星质量标准,对不同批次的药品进行分析,结果表明抽检10批次的注射用盐酸表柔比星均符合规定,且质量均一性良好。结论 注射用盐酸表柔比星是国家基本药物重点监测的对象,应该开展严格的质量评价研究以确保上市药品质量的安全性。
OBJECTIVE To analyze the quality of different batches of epirubicin hydrochloride injection from 2013 to 2015. According to the results ,the quality of the epirubicin hydrochloride injection and the feasibility of the current standards were evaluated. METHODS The epirubicin hydrochloride injections were inspected in accordance with the current quality control Standards, which were YBH03762011 and YBH02502011 approved by State Food and Drug Administration. RESULTS The results showed that 10 batches of epirubicin hydrochloride injection all conformed to the provisions. Their qualities were relatively uniform. CONCLUSION Epirubicin hydrochloride injection is the main monitoring drug of the national essential drugs. We should carry out strict quality evaluation to ensure its quality.
出处
《海峡药学》
2016年第8期86-89,共4页
Strait Pharmaceutical Journal
关键词
注射用盐酸表柔比星
质量分析
药品标准
Epirubicin Hydrochloride Injection
Quality analysis
Drug standards
