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目的:建立高效液相色谱荧光法(HPLC-FLU)测定人血浆中唑吡坦的血药浓度并对其口服制剂人体生物等效性进行研究,为临床用药提供参考依据。方法:采用随机自身对照双周期交叉实验设计,18名健康受试者口服受试制剂和参比制剂10 mg,用HPLC-FLU法测定人血浆中的唑吡坦浓度,用非房室模型估算唑吡坦的药动学参数。结果:受试制剂和参比制剂的药动学参数如下:AUC_(0-τ)分别为(564.19±139.11)和(451.58±115.94)μg·h·L~(-1);AUC_(0-∞)分别为(588.49±139.40)和(474.56±119.43)μg·h·L~(-1);C_(max)分别为(155.48±39.43)和(125.11±33.33)μg·L~(-1);t_(max)分别为(0.75±0.27)和(1.14±0.31)h;t_(1/2)分别为(1.76±0.69)和(2.12±0.51)h。受试制剂的相对生物利用度为(126.0±12.0)%。结论:经统计学分析,两种国产唑吡坦片剂不具有生物等效性。
OBJECTIVE: To establish a HPLC-FLU method for the determination of zolpidem in human plasma and to study the bioequivalence of zolpidem in human plasma and to provide a reference for clinical use. METHODS: A randomized, double-crossover, randomized, controlled trial was designed. Eighteen healthy subjects received 10 mg of the test and reference preparations orally. The concentration of zolpidem in human plasma was determined by HPLC-FLU and was estimated using a non-compartmental model Zolpidem pharmacokinetic parameters. Results: The pharmacokinetic parameters of the test preparation and the reference preparation were as follows: AUC_ (0-τ) were (564.19 ± 139.11) and (451.58 ± 115.94) μg · h · L -1; ∞) were (588.49 ± 139.40) and (474.56 ± 119.43) μg · h · L -1, respectively; C max were (155.48 ± 39.43) and (125.11 ± 33.33) μg · L -1 ); t max were (0.75 ± 0.27) and (1.14 ± 0.31) h respectively; t 1/2 was 1.76 ± 0.69 and 2.12 ± 0.51 h respectively. The relative bioavailability of the test preparation was (126.0 ± 12.0)%. Conclusion: According to statistical analysis, the two domestic Zolpidem tablets are not bioequivalent.