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目的:探讨制备中药提取物时间依赖型结肠定位释药包衣片药物释放的影响因素和体外延时的时间。方法:以苦参总碱为模型药物,以EudragitN E 30 D为包衣材料制备包衣片,用释放度测定法考察影响药物释放的因素。结果:膨胀剂种类、包衣增重和包衣液中致孔剂浓度是影响药物释放的关键因素。制备的苦参总碱包衣片体外延时时间均可达到3～4h。结论:本实验为以时间为开关的中药提取物结肠定位释药系统的进一步研究奠定了基础。
OBJECTIVE: To investigate the factors influencing the drug release of time-dependent colon-specific drug delivery tablets and the time-delay in vitro. Methods: Taking matrine alkaloids as model drug, the coated tablets were prepared by using Eudragit N E 30 D as coating material, and the factors influencing drug release were investigated by the method of release assay. Results: The types of expansive agents, the weight gain of coating and the concentration of porogen in the coating solution were the key factors affecting drug release. Preparation of Sophora total alkaloid coated tablets in vitro delay time can reach 3 ~ 4h. Conclusion: This experiment lays the foundation for the further study on the colon-specific drug delivery system of traditional Chinese medicine extracted with time.