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目的:建立对氯苯氧乙酸血药浓度的HPLC测定法,用于人体生物等效性研究。方法:采用随机双交叉实验设计,20名男性健康受试者分别单次口服受试制剂和参比制剂200 mg,用HPLC法测定对氯苯氧乙酸的血药浓度。结果:受试制剂和参比制剂的AUC0-τ分别为(33.28±8.16)和(33.08±7.87)μg·h·ml-1;AUC0-∞分别为(34.92±7.80)和(34.08±7.85)μg·h·ml-1;Cmax分别为(12.62±2.79)和(12.55±2.83)μg·ml-1;tmax分别为(2.11±0.37)和(2.07±0.32)h;t1/2分别为(6.01±2.86)和(6.12±2.74)h。受试制剂的相对生物利用度为(101.2±12.7)%。经统计学检验,两制剂的AUC0～∞、Cmax、tmax、t1/2差异无统计学意义(P>0.05)。结论:受试制剂和参比制剂具有生物等效性。
OBJECTIVE: To establish an HPLC method for the determination of p-chlorphenoxyacetic acid in human plasma for its bioequivalence study. Methods: A randomized double-crossover design was used. Twenty healthy male subjects received a single oral dose of 200 mg of the test and reference preparations, respectively. The plasma concentrations of p-chlorphenoxyacetic acid were determined by HPLC. Results: The AUC0-τ of test preparation and reference preparation were (33.28 ± 8.16) and (33.08 ± 7.87) μg · h · ml-1, respectively. The AUC0-∞ were 34.92 ± 7.80 and 34.08 ± 7.85, (12.62 ± 2.79) and (12.55 ± 2.83) μg · ml-1, respectively; tmax was (2.11 ± 0.37) and (2.07 ± 0.32) h respectively; t1 / 2 was 6.01 ± 2.86) and (6.12 ± 2.74) h. The relative bioavailability of the test preparation was (101.2 ± 12.7)%. Statistically, there was no significant difference in AUC0 ~ ∞, Cmax, tmax and t1 / 2 between the two preparations (P> 0.05). Conclusion: The test and reference preparations are bioequivalent.