右旋糖酐铁分散片的人体生物等效性研究

目的研究右旋糖酐铁分散片的人体药代动力学和生物等效性。方法健康志愿者20名,随机双交叉单剂量口服右旋糖酐铁分散片和右旋糖酐铁片,剂量分别为100 mg,剂间间隔2周。于服药后36 h内多点抽取静脉血;用原子吸收分光光度法测定血浆中铁浓度。用3p97药代动力学程序计算相对生物利用度和评价生物等效性。结果单剂量口服试验制剂和参比制剂后血浆中铁Cmax分别为(1.609±0.256)mg/L和(1.576±0.196)mg/L;Tmax分别为(3.800±0.616)h和(4.200±0.523)h;AUC(0-36)分别为(16.056±4.874)(mg.h)/L和(15.518±4.162)(mg.h)/L;AUC(0-inf)分别为(17.235±5.061)(mg.h)/L和(16.522±4.246)(mg.h)/L;试验制剂与参比制剂人体相对生物利用度为(104.1±19.8)%。结论试验制剂与参比制剂具有生物学等效性。

Bioequivalence study on ferrous dextranum dispersible tablets in human body

Objective It is to study the pharmacokinetics and bioequivalence of ferrous dextranum dispersible tablets in human body.Methods Ferrous dextranum dispersible tablets and ferrous dextranum tablets whose dosage were both 100 mg were given to 20 healthy volunteers in a random crossover study interval two weeks. Venous blood was multipoint taken suction in 36 hours after treatment.The concentration of ferrous in plasma was determined with atomic absorption spectrometry.The bioavailability and bioequivalence were calculated and evaluated with 3p97 pharmacokinetics program.Results After single dose test preparation and control preparation taken orally,the pharmacokinetics parameters for ferrous were as follows: C_(max) were(1.609±0.256) mg/L and(1.576±0.196) mg/L,T_(max) were(3.800±0.616) h and(4.200±0.523) h,AUC_((0-36)) were(16.056±4.874)(mg·h)/L and(15.518±4.162)(mg·h)/L,AUC_((0-inf)) were(17.235±5.061)(mg·h)/L and(16.522±4.246)(mg·h)/L.The relative bioavailability of test preparation and control preparation in human body was(104.1±19.8)%.Conclusion The test preparation and control preparation have bioequivalence.