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目的:制备丹皮酚-β-环糊精包合物(Pae-β-CYD)的结肠定位释药片剂。方法:以Pae-β-CYD,果胶,乙酸钙作为片芯,Eudragit S100乙醇溶液包衣,考察包衣增重、增塑剂用量、熟化时间与温度等因素对包衣片体外释药的影响。结果:包衣增重为12%,增塑剂用量为20%时,熟化温度为45℃,熟化时间为12 h,Pae-β-CYD片剂在果胶酶或大鼠结肠内容物中的释药时滞为5～6 h。结论:Pae-β-CYD结肠定位释药片剂显示pH环境和酶降解依赖释药特征。
OBJECTIVE: To prepare colon-specific release tablets of paeonol-β-cyclodextrin inclusion complex (Pae-β-CYD). METHODS: Pae-β-CYD, pectin and calcium acetate were used as cores to coat Eudragit S100 ethanol solution. The effects of coating weight gain, plasticizer dosage, aging time and temperature on the release of the coated tablets in vitro influences. Results: When the coating weight was 12% and the amount of plasticizer was 20%, the aging temperature was 45 ℃ and the aging time was 12 h. The Pae-β-CYD tablets in pectinase or rat colon contents Drug release lag is 5 ~ 6 h. CONCLUSIONS: Pae-β-CYD colon-specific release tablets show pH-dependent and enzyme-dependent degradation-release characteristics.