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目的对气相色谱法(GC)测定人血浆中卵磷脂络合碘药物浓度及生物等效性进行研究。方法 6例健康受试者作为研究对象,随机分别服用受试制剂和参比制剂。结果使用曲线下面积(AUCO-t)进行计算,卵磷脂络合碘胶囊的相对生物利用率93.4%~120.0%;使用AUCO-∞进行计算,卵磷脂络合碘胶囊的相对生物利用率59.9%~134.7%。结论 GC法测定人血浆中卵磷脂络合碘药物浓度可行性强,适合于临床推广应用;两种制剂体内生物总用等效,临床应给予高度重视。
Objective To determine the concentration and bioequivalence of lecithin-complexed iodine in human plasma by gas chromatography (GC). Methods Six healthy subjects were randomly divided into test and reference preparations. The results were calculated using the area under the curve (AUCO-t) and the relative bioavailability of lecithin-iodine capsules was 93.4% -120.0%. Using AUCO-∞, the relative bioavailability of lecithin-iodine capsules was 59.9% ~ 134.7%. Conclusion GC method for determination of human plasma leukotriene complex iodine drug concentration is feasible and suitable for clinical application; two kinds of preparations in vivo bio-equivalent, clinical should be given high priority.