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制备了丙戊酸钠缓释片（SRT），其释放曲线与国外缓释片（ Depakine Chrono.简称DC）基本一致。对SRT和普通片（CT）进行人体生物利用度比 较，10名健康男性志愿者随机交叉口服单剂量两种剂型后，利用HPLC测得血药浓度。SRT和C T的AUC分别为1143.6±139.6 μg·h/ml和1082.7±205.5 μg·h/ml，MRT分别为22.6 ±3.8 h和18.8±3.6 h，Cmax分别为47.7±7.5 μg/ml和67.0±8.6 μg/ml，T max分别为6.2±1.4 h和1.6±0.9 h。SRT的相对生物利用度为107.0%±10.7%。与CT相 比，SRT能明显推迟达峰时间并降低峰浓度（P<0.01），AUC无显著性差异（Ｐ>0.0 5）。10名受试者多剂量服用SRT和CT后，稳态时Cmin分别为91.8±14.7 μg/ml 和83.2±24.4 μg/ml，Cmax分别为134.4±23.2 μg/ml和134.4±38.3 μg/ml ，波动系数FI分别为0.374±0.092和0.483±0.162。
Sodium valproate sustained-release tablets (SRT) were prepared and their release curves were basically consistent with those of foreign sustained-release tablets (Depakine Chrono. DC for short). Compared to the bioavailability of SRT and conventional tablets (CT), 10 healthy male volunteers were randomized to receive single-dose and two-dose forms, and the plasma concentration was measured by HPLC. The AUC of SRT and CT were 1143.6 ± 139.6 μg · h / ml and 1082.7 ± 205.5 μg · h / ml respectively, MRT was 22.6 ± 3.8 h and 18.8 ± 3.6 h respectively, Cmax was 47.7 ± 7.5 μg / ml and 67.0 ± 8.6 μg / ml, T max were 6.2 ± 1.4 h and 1.6 ± 0.9 h, respectively. The relative bioavailability of SRT was 107.0% ± 10.7%. Compared with CT, SRT significantly delayed the peak time and decreased the peak concentration (P <0.01). There was no significant difference in AUC (P> 0.05). After 10 doses of SRT and CT, 10 subjects had Cmax of 91.8 ± 14.7 μg / ml and 83.2 ± 24.4 μg / ml at steady state, with Cmax of 134.4 ± 23.2 μg / ml and 134.4 ± 38.3 μg / ml respectively, Fluctuation coefficients FI were 0.374 ± 0.092 and 0.483 ± 0.162, respectively.