论文部分内容阅读
目的探析阿立哌唑口腔崩解片在健康人体的生物利用度;方法筛选20名健康男性,并且随机分为两组,按照服用规定以及注意事项,分别服用口腔崩解片和普通片剂,采取血样,通过高效液相色谱-紫外检测方法,内标为海柯皂苷元,对阿立哌唑在血浆中的浓度进行测定;结果对服用阿立哌唑和参比制剂20mg后0～216h的主要药代动力学参数进行测定和分析,分析结果显示两组间差异无统计学意义,两者的药代动力学曲线变化情况基本一致。2种制剂生物通过t检验和方差分析证明等效;结论口腔崩解片采用口服适用于老人、儿童和吞咽困难者,对于提高服药依从性十分有利。
Objective To investigate the bioavailability of aripiprazole orally disintegrating tablets in healthy volunteers. Methods 20 healthy men were screened and randomly divided into two groups. Orally disintegrating tablets and common tablets were taken according to the prescription and precautions, respectively. Blood samples were taken and the concentration of aripiprazole in plasma was determined by HPLC-UV method with the internal standard of Hecogenin. Results After taking 20 mg of aripiprazole and reference formulation, The main pharmacokinetic parameters were measured and analyzed. The results showed that there was no significant difference between the two groups, and the changes of the two pharmacokinetic curves were basically the same. The bioactivity of the two preparations proved to be equivalent by t-test and variance analysis. Conclusion Orally disintegrating tablets are suitable for elderly, children and those with difficulty swallowing, which is very beneficial for improving medication adherence.