左舒必利滴剂人体生物等效性研究

Study on Human Body Bioequiavailability of Levosulpiride Drops

目的研究左舒必利滴剂的生物等效性。方法20名健康男性志愿者随机交叉单剂量口服受试制剂(左舒必利滴剂)或参比制剂(舒必利片剂)100 mg,采用反相高效液相色谱法测定血浆中药物浓度,并以3P97程序计算药动学参数和相对生物利用度。结果受试制剂和参比制剂的cmax分别为(392.98±158.62)和(415.02±137.80)μg.mL-1;tmax分别为(3.43±1.21)和(3.23±0.66)h;AUC0-36分别为(3602.99±761.15)和(3693.40±870.50)μg.L-1.h,AUC0-∞(3837.11±787.25)和(3958.60±881.07)μg.L-1.h,受试制剂的相对生物利用度为(98.7±12.0)%。结论受试制剂与参比制剂具有生物等效性。

OBJECTIVE To study the bioequiavailability of Levosulpiride drops. METHODS 20 healthy male volunteers were administered orally with single dose of levosulpiride drops or sulpiride tabs by randomized crossover way. The levosulpiride concentrations in blood were determined by RP-HPLC, and the pharmaeokinetics parameters and the relative bioavailability were calculated with 3p97 program. RESULTS The Cmax of the trial preparation and the reference preparation were （392.98 ± 158.62） μg·mL^-1 and （415.02 ± 137.80） μg·mL^-1 , respectively, the tmax were （3.43 ~ 1.21） h and （3.23 ±0.66） h respectively, the AUCo_36 were （3602.99 ± 761.15）μg·mL^-1·h and （3693.40±870.50）μg·mL^-1·h respectively, the AUC0-∞ were （3837.11 ±787.25） and （3958.60 ± 881.07 ）μg·L^-1 . h respectively, the relative bioavailability of trial preparation was （98.7 ± 12.0） %. CONCLUSION The results show that the trial preparation and the reference preparation were bioequivalent.