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目的:评价痰咳净滴丸与痰咳净散在健康人体内的生物等效性。方法:20名健康男性志愿者双周期随机交叉单剂量口服痰咳净滴丸(受试制剂)和痰咳净散(参比制剂),各折合咖啡因40mg。用毛细管高效液相色谱法测定血浆中咖啡因的血药浓度,对主要药动学参数进行统计分析,对二者进行生物等效性评价。结果:受试制剂与参比制剂的药动学参数分别为:Cmax(0.89±0.16)、(0.93±0.16)μg.mL-1,tmax(0.6±0.3)、(0.5±0.2)h,t1/2(6.54±1.27)、(6.48±0.98)h,MRT(8.62±1.32)、(8.58±1.18)h,CL(6.88±1.65)、(6.76±1.40)L.h-1,AUC0~29(5.73±1.36)、(5.80±1.17)μg.h.mL-1,AUC0~∞(6.14±1.37)、(6.15±1.16)μg.h.mL-1。用面积法估算的受试制剂相对于参比制剂的人体生物利用度为(98.77±12.65)%,且两制剂的参数Cmax、AUC0~29、AUC0~∞和tmax经统计学检验均无显著性差异(P>0.05)。结论:受试制剂与参比制剂具有生物等效性。
OBJECTIVE: To evaluate the bioequivalence of Tankejing droppipe and Tankejiejing in healthy volunteers. Methods: Twenty healthy male volunteers were randomly divided into two groups. Randomized crossover single oral dose of TanKeKe pills (test preparation) and TanKeNan Powder (reference preparation) were taken, each equivalent caffeine 40mg. The plasma concentration of caffeine in plasma was determined by capillary high performance liquid chromatography. The main pharmacokinetic parameters were statistically analyzed and the bioequivalence was evaluated. Results: The pharmacokinetic parameters of test preparation and reference preparation were Cmax (0.89 ± 0.16), (0.93 ± 0.16) μg.mL-1, tmax (0.6 ± 0.3), (0.5 ± 0.2) h, t1 /2(6.54 ± 1.27), (6.48 ± 0.98) h, MRT (8.62 ± 1.32), (8.58 ± 1.18) h, CL (6.88 ± 1.65), (6.76 ± 1.40) Lh-1, AUC0~29 ± 1.36), (5.80 ± 1.17) μg.h.mL-1, AUC0 ~ ∞ (6.14 ± 1.37), (6.15 ± 1.16) μg.h.mL-1. The bioavailability of the test formulation relative to the reference formulation estimated by the area method was (98.77 ± 12.65)%, and the parameters Cmax, AUC0 ~ 29, AUC0 ~ ∞ and tmax of the two formulations were not statistically significant Difference (P> 0.05). Conclusion: The test preparation and the reference preparation are bioequivalent.