摘要
目的通过对2013年全国范围内抽取的羚羊感冒片进行标准检验及探索性研究,对该品种的质量及标准状况作出总体分析与评价。方法针对法定标准检验项目不完善的问题,采用高效液相色谱-蒸发光散射检测法(HPLC-ELSD)进行山银花的筛查;采用高效液相色谱法进行金银花、甘草、连翘、牛蒡子等药味中多指标性成分的含量同时测定;采用近红外光谱扫描法建立近红外光谱库,为快速检验提供依据。结果法定标准检验与探索性研究结果之间存在显著差异。结论探索性研究结果表明法定标准存在较多缺陷,应进一步完善现行质量标准,全面控制产品的质量。
Objective To evaluate the quality situation and problems of Lingyang Ganmao Tablets by testing and ana- lyzing samples collected from drug manufacture and market all over China in 2013. Methods To combine the legal test with exploratory research. To inspect Lonicera confusa DC. by HPLC - ELSD ; To determine contents of honeysuckle, liquo- rice, torsythia, burdock by HPLC ; To establish NIR spectrum database as the foundation for instant test ; To comply statistical analysis for the results of legal test and exploratory research. Results There were obvious differences between the results of legal test and exploratory research. Conclusion The results of exploratory research demonstrated that many defects existed in the legal drug specifications, and a series of exclusive, accurate, and sensitive methods should be established to fully con- trol the quality of sodium aescinate for injection.
出处
《药学研究》
CAS
2014年第9期514-515,518,共3页
Journal of Pharmaceutical Research
基金
山东省自然科学基金2013(No.R2013HM074)
作者简介
林林，女，主管药师，研究方向：药品检验，E—mail：linlinsfda@163．com
