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目的： 考察国产双氯酚酸钾胶囊剂的生物利用度。方法： １０ 名健康男性受试者交叉口服单剂量国产和进口双氯酚酸钾胶囊剂（ 片剂） ５０ ｍｇ ， 采用ＨＰＬＣ 法测定血浆中双氯酚酸钾浓度。结果： 国产及进口制剂的体内药代动力学主要参数分别为： Ｃｍａｘ 为２ ２０４－３ ±９１９－８ 和２ １０７－６ ±７３４－０ μｇ·Ｌ－ １ ； Ｔｐｅａｋ 为０－８ ±０－３ 和２－０ ±０－０ ｈ ； ＡＵＣ０ － ∞为３ １７３－６ ±８６８－５ 和３ １５４－８ ±８６６－０ μｇ·ｈ·Ｌ－ １ ； ｔ１／２ 为２－８ ±０－６ 和２－９ ±０－４ ｈ 。国产制剂的平均相对生物利用度为１００－９ ±７－１ ％ 。结果： 经统计学分析， 两种制剂间ＡＵＣ 无显著差异。
Objective: To investigate the bioavailability of domestic diclofenac potassium capsules. Methods: A total of 10 healthy male subjects were dosed with 50 mg domestic and imported diclofenac capsules (tablets) at the crossover point and the plasma concentrations of diclofenac potassium were determined by HPLC. Results: The main pharmacokinetic parameters of domestic and imported preparations were as follows: Cmax was 2 204-3 ± 919-8 and 2 107-6 ± 734-0 μg · L- 1; Tpeak was 0-8 ± 0- 3 and 2-0 ± 0-0 h; AUC0- ∞ of 3 173-6 ± 868-5 and 3 154-8 ± 866-0 μg · h · L-1; t1 / 2 of 2-8 ± 0- 6 and 2-9 ± 0-4 h. The average relative bioavailability of domestic preparations was 100-9 ± 7-1%. Results: The statistical analysis showed no significant difference in AUC between the two preparations.