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目的 :单剂量口服舒林酸胶囊 (试验品 )对普通片 (对照品 )的相对生物利用度研究。方法 :按双周期交叉试验 ,8位健康男性受试者服药后 ,采用快速、准确的HPLC法测定其血药浓度。以 3p97药动学程序计算。结果 :宁波制药厂生产的舒林酸胶囊对普通片的相对生物利用度为 97.6% ;方差分析与双单侧检验示明 ,两制剂AUC间无显著性差异 (P >0 .0 5) ,试验品生物利用度参数AUC平均值的 90 %可信限 ( 89.7%～ 1 0 4 .8% )落在对照品 (片剂 )的 80 %～ 1 2 5%置信区间内。结论 :试验品与对照品具有生物等效性。
OBJECTIVE: To study the relative bioavailability of single-dose oral sulindac capsules (test product) to common tablets (control). Methods: According to a two-cycle crossover test, 8 healthy male subjects took their blood samples and determined their plasma concentration by rapid and accurate HPLC method. Calculated with 3p97 pharmacokinetics program. Results: The relative bioavailability of sulindac capsules produced by Ningbo Pharmaceutical Factory to ordinary tablets was 97.6%. Analysis of variance and double unilateral test showed that there was no significant difference (P> 0.05) The 90% confidence limits (89.7% -140.8%) of the test article bioavailability parameters AUC fall within the 80% to 125% confidence intervals of the reference substance (tablet). Conclusion: The test substance and the reference substance are bioequivalent.