长春胺胃滞留缓释片的辅料相容性研究  

Drug-excipient Compatibility Study on Vincamine Gastro-retentive Extended-release Tablets

作　　者：张梁[1] 蒋海松[2] 周建平[1] 

机构地区：[1]中国药科大学药剂学教研室,南京210009 [2]北京科信必成医药科技发展有限公司哈尔滨分公司,哈尔滨150008

出　　处：《药学与临床研究》2013年第2期109-113,共5页Pharmaceutical and Clinical Research

基　　金：国家"十二五"重大新药创制计划(No.2011ZX09401-018)

摘　　要：目的:考察长春胺胃滞留缓释片处方中药物与辅料之间的相容性。方法:应用差示扫描量热技术(DSC)对药物与辅料混合样品进行筛选检测,使用高效液相色谱法(HPLC)对影响因素条件(强光4500 Lx±500 Lx、高温60℃、高湿90%±5%RH)与稳定性加速实验条件(40℃、75%RH)下放置的样品进行检测,对DSC筛选结果进行验证与补充。结果和结论:在考察的3种助流剂、润滑剂中硬脂酸镁最优,2种稀释剂中优化微晶纤维素较优,2种粘合剂均应尽量避免使用,2种产气剂中碳酸钙较优,2种缓释材料中羟丙甲纤维素较优。Objective： To assess the compatibility of vincamine with some currently employed pharmaceutical excipients in gastroretentive extended-release formulations. Methods： Differential scanning calorimetry （DSC） was used as a screening technique for the selection of excipients. As the conclusions based on DSC results alone can be often misleading and inconclusive, the results obtained with DSC was verified with high performance liquid chromatography stearate was found to be a better lubricant, Prosolv 90 a （HPLC）. Results and Conclusion： Magnesium forming agent and HPMC K100M a better release-retarding recommendable. better diluent, calcium carbonate a better gasgel-forming polymer while no binder was found

关 键 词：长春胺 辅料 相容性 差示扫描量热 

分 类 号：R943[医药卫生—药剂学] TQ460.6[医药卫生—药学]