脂必泰胶囊溶出度测定的方法研究
投稿时间:2018-06-02  修订日期:2018-11-12  点此下载全文
引用本文:施磊,叶隽,宋磊.脂必泰胶囊溶出度测定的方法研究[J].药学实践杂志,2019,37(2):170~172,187
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作者单位E-mail
施磊 上海市静安区食品药品检验所, 上海 200435  
叶隽 上海市静安区食品药品检验所, 上海 200435  
宋磊 上海市交通大学医学院附属同仁医院, 上海 200050 13661829392@qq.com 
中文摘要:目的 建立脂必泰胶囊溶出度的测定方法。方法 采用ZABAX-C18色谱柱(250 mm×4.6 mm,5 μm),甲醇-0.05%磷酸(80:20)为流动相;流速1.0 ml/min;检测波长238 nm。按《中华人民共和国药典》2015年版四部溶出度测定第三法(小杯法),采用SOTAX AT7智能药物溶出仪,通过对溶出介质、转速和取样时间的优化选择,确定脂必泰胶囊中红曲的有效成分洛伐他汀溶出度测定方法。结果 本研究建立的色谱条件,专属性良好。洛伐他汀的线性范围1.63~122.2 μg/ml (r=1.000 0)。样品的溶出度均一性良好,以含1.0%十二烷基硫酸钠的磷酸盐溶液(pH 7.0)为溶出介质,取样时间为45 min,转速为100 r/min。溶出度均不低于80%。结论 本研究建立的方法可用于脂必泰胶囊溶出度的测定,能有效控制药品的质量,为提高脂必泰胶囊质量标准提供依据。
中文关键词:脂必泰胶囊  洛伐他汀  溶出度  色谱法  高效液相
 
Study on the dissolution determination of Zhibitai capsules
Abstract:Objective To develop a method for the determination of the dissolution of Zhibitai capsules.Methods The chromatographic analysis was carried out on a ZABAX-C18column(250 mm×4.6 mm,5 μm)with methanol-0.05% phosphate solution(60∶40) as mobile phase.The flow rate was 1.0 ml/min and the detection wavelength was 238 nm.According to the third dissolution method (small glass-method) described in the Pharmacopoeia of the People's Republic of China (2015Edition,Volume 4),the dissolution determination conditions were established using SOTAX AT7 intelligent drug dissolution instrument,and dissolution medium,rotational speed and sampling time were selected.Results The method showed perfect specificity under the established chromatographic conditions.The linear ranges of lovastatin was 1.63-122.2 μg/ml(r=1.000 0).The dissolution rates of the samples were consistent.The 1.0% sodium dodecyl sulfate in phosphate solution (pH 7.0) was selected as release media,rotational speed was 100 r/min,the sampling time point was 45 min.The dissolution limit was not less than 80% of the labeled amount.Conclusion The established method could be used for the dissolution determination and the quality control,and provide reference for the improvement of quality standards of Zhibitai capsules.
keywords:Zhibitai capsules  lovastatin  dissolution  chromatography  high performance liquid
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