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目的 :评价国产丙戊酸钠无糖口服液和进口丙戊酸钠糖浆两种制剂的生物等效性。方法 :2 0例健康男性志愿者双周期随机交叉口服单剂量 10 0 0mg(2 5mL)国产丙戊酸钠无糖口服液和进口丙戊酸钠糖浆两种制剂 ,分别于服药前及服药后 0 .33,0 .6 7,1,1.5 ,2 ,4 ,8,12 ,2 4 ,36 ,4 8及 72h采集血样。用高效液相 荧光色谱法测定血清中丙戊酸钠的浓度 ,并对试验数据进行处理。结果 :单次口服国产及进口丙戊酸钠制剂的Cmax分别为 (112 .6 5±16 .91)和 (110 .2 2± 15 .2 0 ) μg·mL- 1 ;Tmax分别为 (0 .86± 0 .38)和 (1.0 9± 0 .4 8)h ;AUC0～ 72h 分别为 (1980 .2 4±2 75 .82 )和 (195 0 .11± 30 5 .6 0 ) μg·h·mL- 1 ;AUC0～∞ 分别为 (2 0 88.19± 313.2 5 )和 (2 0 75 .30± 36 7.5 8) μg·h·mL- 1 ;单次口服国产丙戊酸钠无糖口服液的相对生物利用度F0～ 72h 为 (10 2 .96± 15 .37) % ,F0～∞ 为 (10 2 .2 5±15 .6 1) %。结论 :单次口服国产丙戊酸钠无糖口服液和进口丙戊酸钠糖浆具有生物等效性。
OBJECTIVE: To evaluate the bioequivalence of domestic sodium valproate and oral sodium valproate syrup. Methods: Twenty healthy male volunteers were randomized to receive a single dose of 100 mg (25 mL) of domestic sodium valproate oral solution and two sodium valproate syrup formulations at two-cycle randomized crossover intervals before and after taking the drug Blood samples were taken at 0, 33, 0, 6, 7, 1, 1.5, 2, 4, 8, 12, 24, 36, 48 and 72h. The concentration of sodium valproate in serum was determined by high performance liquid chromatography and the experimental data were processed. Results: The Cmax of domestic and imported sodium valproate were (112.56 ± 16.91) and (110.22 ± 15.2) μg · mL-1, respectively; the Tmax was (0 .86 ± 0.38) and (1.09 ± 0.48) h, respectively. AUC0 ~ 72h were (1980.24 ± 2 75.82) and (195.011 ± 305.56) μg · h · mL-1; AUC0 ~ ∞ were (2 0 88.19 ± 313.2 5) and (2 0 75 .30 ± 36 7.5 8) μg · h · mL-1, respectively; The relative bioavailability of liquid was (10 2 .96 ± 15. 37)% for F0 ~ 72h and (102.5 ± 15 .61)% for F0 ~ ∞. Conclusion: The single oral oral sodium valproate oral solution and imported sodium valproate syrup are bioequivalent.