| 流通池法测试雷帕霉素支架涂药工艺稳定性初探 |
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| 引用本文： | 章娜,冯晓明,黄绍杰,张志刚,杨腊虎. 流通池法测试雷帕霉素支架涂药工艺稳定性初探[J]. 药物分析杂志, 2012, 0(4): 575-577 |
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| 作者姓名： | 章娜 冯晓明 黄绍杰 张志刚 杨腊虎 |
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| 作者单位： | 中国食品药品检定研究院医疗器械检测中心;天津百畅医疗器械有限公司 |
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| 摘 要： | 目的:用美国药典流通池方法测试雷帕霉素药物洗脱冠脉支架体外释放度,作为企业出厂检验方法,以评价其工艺稳定性。方法:用美国药典释放度测定第4法规定的溶出装置联机紫外分光光度计。释放介质为2%十二烷基硫酸钠溶解在10%乙腈-PBS(pH=5.0)的缓冲液;检测波长为280 nm。结果:相同批号(n=6)和不同批号(n=3)的药物支架的雷帕霉素在24 h的释放曲线一致。结论:本法适合评价冠脉支架涂药的工艺稳定性,快速简便,符合美国药典流通池法的要求,检测结果较为满意。
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| 关 键 词： | 释放度 药物支架 雷帕霉素 流通池法 |
Primary discuss on flow-cell elution release test method at stability of rapamycin on drug-eluting stents |
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| ZHANG Na,FENG Xiao-ming,HUANG Shao-jie,ZHANG Zhi-gang,YANG La-hu. Primary discuss on flow-cell elution release test method at stability of rapamycin on drug-eluting stents[J]. Chinese Journal of Pharmaceutical Analysis, 2012, 0(4): 575-577 |
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| Authors: | ZHANG Na FENG Xiao-ming HUANG Shao-jie ZHANG Zhi-gang YANG La-hu |
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| Affiliation: | 1(1.National Institutes for Food and Drug Control,Beijng 100050 China; 2.Tianjin Bestchance Medical Device Co.,Ltd,Tianjin 300384,China) |
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| Abstract: | Objective:To establish a method for the analysis of release of rapamycin in drug eluting stents(DES) with flow-cell elution system.Method:Dissolution test method(modify USP 4) was adopted and used 50 mL the mixture of 2% SDS and 10% acetonitrile in PBS buffer(pH=5)as the release media.Keep the detective wavelength at 280 nm.Result:The release of rapamycin is identical to which between the same lots and different lots.Conclusion:The method is fast and convenient. |
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| Keywords: | release drug-eluting stents(DES) rapamycin flow-cell elution system |
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