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目的:对?丙嗪颗粒剂,以?丙嗪片剂为参比制剂,进行药代动力学和相对生物利用度的研究。方法:采用双交叉试验设计,用高效液相色谱(HPLC-UV)法测定不同时相的血药浓度。结果:10名健康志愿者口服颗粒剂及参比制剂600mg后所得的药时曲线均符合一室开放模型。?丙嗪颗粒剂与片剂的主要药代动力学参数分别为:t1/2k(h):44.04±5.76和42.14±5.31;Cmax(mg·L-1):30.09±2.78和29.81±2.63;Tmax(h):2.80±1.03和3.00±1.05;MRT(h):67.07±7.83和70.51±6.59;AUC0-∝(mg·h·L-1):1884.78±203.78和1822.67±267.64;这些参数经交叉试验下的方差分析法证明差异无显著性(P>0.05)。?丙嗪颗粒剂对片剂的相对生物利用度(F%)为:104.64±8.44。结论:两种制剂的药代动力学参数lnAUC、lnCmax、lnMRT经交叉试验下的方差分析和双单侧检验法检验证明?丙嗪颗粒剂与片剂具有生物等效性。
OBJECTIVE: To study the pharmacokinetics and relative bioavailability of promethazine granules with the reference drug promethazine as reference preparation. Methods: The double-crossover design was used to determine the plasma concentration in different phases by HPLC-UV method. Results: Ten healthy volunteers oral granules and reference preparations after 600mg obtained drug curve are in line with a room open model. The main pharmacokinetic parameters of promethazine granules and tablets were: t1 / 2k (h): 44.04 ± 5.76 and 42.14 ± 5.31; Cmax (mg · L-1): 30.09 ± 2.78 and 29.81 ± 2.63; Tmax (h): 2.80 ± 1.03 and 3.00 ± 1.05; MRT (h): 67.07 ± 7.83 and 70.51 ± 6.59; AUC0-α (mg · h · L -1): 1884.78 ± 203.78 and 1822.67 ± 267.64; Analysis of variance under cross test showed no significant difference (P> 0.05). The relative bioavailability (F%) of promethazine granules to tablets was: 104.64 ± 8.44. CONCLUSIONS: The pharmacokinetic parameters lnAUC, lnCmax and lnMRT of the two preparations were tested by ANOVA and two-sided test to verify the bioequivalence between promethazine granules and tablets.