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根据流体动力学平衡控释系统hydrodynamically balanced controlled drug delivery system,简称HBS~(TM))原理研制了复方潘生丁-HBS~(TM)系统。复方潘生丁-HBS~(TM)的体外溶出符合一级动力学过程,同位素γ-闪烁照相结果表明复方潘生丁-HBS~(TM)在胃内滞留时间(4～6 h)明显长于普通片(1～2 h)。采用荧光分光光度法测定了人单剂量口服复方潘生丁-HBS~(TM)及复方潘生丁市售普通胶囊(德国宝云家殷格翰大药厂)的潘生丁和水杨酸的血清浓度,并进行了药动学模型的拟合及药动学参数的估算,本品的体内外数据相关性显著(P<0.05)。
The compound dipyridamole-HBS TM system was developed according to the principle of hydrodynamically balanced controlled drug delivery system (HBS-TM). The in vitro dissolution of compound dipyridamole-HBS-TM was consistent with the first-order kinetics. The isotope gamma-scintigraphy showed that the compound dipyridamole-HBS TM had a significantly longer gastric residence time (4 ~ 6 h) ~ 2 h). The serum concentration of dipyridamole and salicylic acid in human single-dose oral dipyridamole-HBS ™ and compound dipyridamole common capsules (Germany Baoyin Ingelheim Pharmaceutical Factory) were determined by fluorescence spectrophotometry. The fitting of kinetic model and the estimation of pharmacokinetic parameters have significant correlation with in vitro and in vivo data (P <0.05).