诺氟沙星胶囊的质量分析与研究

Quality analysis and research of norfloxacin capsules

目的考察国内生产的诺氟沙星胶囊的质量现状及存在的问题。方法按照2017年度浙江省药品质量风险考核计划的要求,采用中国药典2015年版方法结合探索性研究对57批抽验样品进行检验,统计分析检验结果,并开展了溶出度、水分、有关物质等探索性研究。结果法定检验结果显示57批样品合格率为91.2%。探索性研究结果显示:(1)现行溶出度方法溶出介质的配制方法、pH值的波动、离子强度的变化、pH计的性能以及不同溶出度仪均会影响溶出度的结果;受试样品的溶出曲线均与诺氟沙星原研片不相似;(2)水分会影响样品的溶出度,铝塑包装外增加防潮袋会减少水分对溶出度的影响;(3)有关物质方法研究发现57批样品中5批样品检出已知杂质E超标,而按照法定标准无法检测出杂质E,法定标准无法控制药品的质量,需修订提高。结论目前诺氟沙星胶囊的产品质量基本符合现行标准的要求,但现行法定标准存在缺陷,需改进和提高。

Objective To inspect and assess the quality conditions of norfloxacin capsules and the existed problems.Methods According to the requirements of drug quality risk assessment programs of Zhejiang province in 2017,the ChP 2015 methods combined with the exploratory research were used to test 57 samples and the results were were analyzed statistically.The exploratory research on dissolution,moisture and related substances was carried out.Results Statutory test showed that the pass rate of the 57 batches of samples was 91.2%.The exploratory research results showed that:(1)The preparation methods for dissolution media,fluctuations in pH,changes in ionic strength,pH meter performance,and different dissolution meters of the statutory dissolution method all affected dissolution results.(2)Moisture affected the dissolution rate of the sample.Increasing the moisture-proof film reduced the effect of moisture on dissolution.(3)The study on the determination of related substances found that 5 out of 57 batches of samples detected that impurity E exceeded the standard,and impurity E could not be detected according to statutory standards.The statutory standards could not control the quality of norfloxacin capsules and needed to be improved.Conclusion At present,the product quality of norfloxacin capsules basically meets the requirements of current statutory standards,but the statutory standards are flawed and need to be improved.