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pH-时滞型苦参结肠靶向微丸包衣工艺研究及体外评价 被引量:14

Coating technique of pH-time lag colon-specific matrine delivery mini-pill
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摘要 目的:对苦参微丸包控释衣、肠溶衣,制备得pH-时滞型结肠靶向微丸,并对其释放性能进行评价。方法:以苦参碱、氧化苦参碱体外释放度及微丸的外观为指标,对包衣辅料用量、包衣增重等进行筛选。结果:控释层包衣液由2%乙基纤维素、0.4%邻苯二甲酸二乙酯、2%滑石粉的乙醇溶液组成,包衣增重15%。肠溶层包衣液由5%Eudragit S100、3%滑石粉和0.5%柠檬酸三乙酯的乙醇溶液组成,包衣增重35%。该制剂在人工胃液2h后中未见苦参碱、氧化苦参碱的释放,在人工小肠液4h后两指标累积释放百分率均<15%,在人工结肠液2h后分别释放80.7%、83.5%。结论:该微丸能在结肠定位释药。 AIM:To study the coating technique of pH-time lap colon-specific matrine delivery mini-pill consisted of the time lag release coating (inner layer) and enteric coating (out layer). METHODS:To filter the coating composition based on the index of dissolution of matrine and oxymatrine in vitro and the appearance rating of miui-pill. RESULTS:4 The coating composition of inner layer was the alcoholic solution,consisted of 2% EC,0.4% DEP and 2% talc powder. Then the coating composition of out layer was the alcoholic solution consisted of 5% Eudragit S100, 3% talc powder and 0.5% TEC. The dissolution tests in vitro indicated that matrine and oxymatrine were not dissolved in the simulated gastric juice in 2 h. The accumulative amount of matrine and oxymatrine were less than 15% in the simulated intestinal fluid in 4 h. The amount of matrine and oxymatrine were 80.7% and 83.5% in the simulated colon juice in 2 h. CONCLUSION: The mini-pill could achieve the goal of delivering in the specific colon.
出处 《中成药》 CAS CSCD 北大核心 2009年第12期1841-1844,共4页 Chinese Traditional Patent Medicine
基金 国家"十一五"科技支撑计划(2006BAI09B08-14) 四川省科技支撑项目(2008SZ0044) 成都市科技计划(07GGYB520SF-010)
关键词 pH-时滞型结肠靶向微丸 包衣工艺 体外评价 pH time lag colon-specific matrine delivery mini-pill coating technique evaluation in vivo
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