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目的评价健康人口服美洛昔康颗粒的生物等效性。方法 20名健康男性志愿者随机交叉单剂量口服美洛昔康颗粒或美洛昔康片15mg后,采用RP-HPLC紫外分析法检测血药浓度。结果美洛昔康颗粒及美洛昔康片的T_(max)分别为(3.3±1.6)和(4.7±1.1)h;C_(max)分别为(0.652±0.109)μg/h·mL和(0.532±0.106)μg/h·mL;T1/2分别为(26.56±11.29)h和(26.87±9.99)h;AUC_(0→96)分别为(20.083±6.182)μg/h·mL和(18.767±6.165)μg/h·mL;AUC_0→∞分别为(23.901±8.624)μg/h·mL和(22.452±7.548)μg/h·mL;美洛昔康颗粒的相对生物利用度F为(113.8±35.5)%。结论美洛昔康颗粒与美洛昔康片具有生物等效性。
Objective To evaluate the bioequivalence of oral meloxicam in healthy volunteers. Methods Twenty healthy male volunteers were randomized to receive a single oral dose of meloxicam granules or meloxicam tablets 15mg. The plasma concentration of the drug was measured by RP-HPLC. Results The T_ (max) of meloxicam granules and meloxicam tablets were (3.3 ± 1.6) and (4.7 ± 1.1) h, respectively; C max were 0.652 ± 0.109 μg / h · mL and (26.56 ± 11.29) h and (26.87 ± 9.99) h, respectively. The mean AUC values (0 → 96) were (20.083 ± 6.182) μg / h · mL and (18.767 ± 0.582 ± 0.106) μg / ± 6.165) μg / h · mL; AUC_0 → ∞ were (23.901 ± 8.624) μg / h · mL and (22.452 ± 7.548) μg / h · mL, respectively. The relative bioavailability of meloxicam particles F was (113.8 ± 35.5)%. Conclusion Meloxicam granules and meloxicam tablets have bioequivalence.