菲牛蛭提取物肠溶胶囊的质量研究

Quality Evaluation of Enteric Capsules of Poecilobdella manillensis Lesson Extract

测定了以羧甲淀粉钠为崩解剂的菲牛蛭提取物肠溶胶囊的体外释放。并考察了胶囊在含及不含胃蛋白酶的0．1mol／L盐酸中释放2h后内容物的残留生物活性。结果表明,肠溶胶囊可保护提取物的生物活性不受酸及胃蛋白酶的破坏。稳定性初步研究表明,制品在25℃、相对湿度60％条件贮存6个月,抗凝血酶、抗胰蛋白酶和抗糜蛋白酶活性基本不变,在pH 6．8磷酸盐缓冲液中46min累积释放率大于75％。

In vitro release of enteric capsules of Poecilobdella manillensis Lesson extract using sodium carboxymethyl starch as disintegrant was investigated. The remained biological activities of capsules dissolving in 0.1 mol/L HCI with or without pepsin for 2h were examined. The results showed that the enteric capsules could protect the extract from destroying by acid and pepsin. The results of preliminary stability test showed that the capsules stored at 25℃, 60%RH for 6 months had little change of biological activities including antithrombin activity, anti-trypsin activity and anti-alfapsin activity, and the accumulative release （%） in 45min in pH 6.8 phosphate buffer solution were still above 75 %.