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作 者:段明华[1] 韩冰[1] 李冰[2] 周长龙[3] 裴瑾[1]
机构地区:[1]吉林大学药学院,吉林长春130012 [2]空军航空大学飞行训练基地卫生科,吉林长春130012 [3]空军航空大学飞行训练基地一团,吉林长春130012
出 处:《中国医院药学杂志》2009年第21期1833-1836,共4页Chinese Journal of Hospital Pharmacy
摘 要:目的:制备重组人干扰素α2b直肠局部给药的栓剂,并考察其栓剂给药猕猴体内的生物利用度。方法:应用脂肪酸甘油酯Suppciore BM为基质,以Triton X-100为促吸收剂,制备重组人干扰素α2b栓。以栓剂在猕猴体内的吸收情况为指标,考察重组人干扰素α2b栓处方的使用剂量和有效性。结果:重组人干扰素α2b栓活性成分5倍于注射剂剂量,在猕猴体内吸收好,其AUC栓/AUC注为74%,故当重组人干扰素α2b栓的规格设定为临床注射剂给药剂量的5倍时,其在猕猴体内的吸收速度和程度与注射剂相当。结论:重组人干扰素α2b栓可增强患者的顺应性。OBJECTIVE To prepare the recombinant interferon a-2b suppository. The formulation is through rectal administration to produce systemic action. METHODS The suppository was studied by using suppciore BM as matrix and Triton X-100 as absorption enhancer. To study the dose and safety of the formulation by using the index of stability and pharmacokinet ics. RESULTS The dose of suppository is 5 times of injection,The suppository has good stability and bioequivalence compare to injection in monkey. The dose 5-fold of injection in specifications, the absorption degree and speed of suppository is similar to injection in vivo in monkeys. The dose 5-fold of injection in specifications, the absorption of suppository is similar to injection in vitro in monkeys. CONCLUSION The suppository can enhance the compliance of patients,has good actual applicability.
关 键 词:重组人干扰素α2b栓 猕猴体内吸收 药动学
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