摘要：目的研究中国健康受试者空腹、餐后单次口服依托考昔片的药动学及安全性。方法将68例健康受试者随机分为空腹组和餐后组,采用双周期交叉试验设计进行给药,LC-MS/MS测定人血浆中依托考昔浓度,用WinNonLin软件计算药动学参数,比较国产依托考昔片和原研参比制剂药动学差异以及不同性别和进食对托考昔片药动学的影响。以受试者生命体征及体格检查、实验室检查值以及心电图变化为指标进行依托考昔片安全性评价。结果空腹组受试制剂和参比制剂的药动学参数Tmax为1.25,1.25 h,Cmax为(2767.50±421.89),(2707.81±674.90)ng·mL^(−1),AUC0-∞为(52967.87±13843.25),(53479.56±16066.32)h·ng·mL^(−1);餐后组受试制剂和参比制剂的药动学参数Tmax为2.50,1.75 h,Cmax为(2000.61±314.89),(2209.06±429.05)ng·mL^(−1),AUC0-∞为(51450.80±17241.02),(49287.23±16192.87)h·ng·mL^(−1);餐后组受试制剂和参比制剂Tmax差异具有统计学意义(P<0.05),但不具有临床意义。受试者空腹、餐后口服依托考昔片后,Tmax、Cmax差异具有统计学意义(P<0.01),但AUC0-∞差异无统计学意义;不同性别受试者空腹口服依托考昔片后,主要药动学参数Tmax、Cmax、AUC_(0-∞)均无统计学意义,但女性受试者餐后口服依托考昔片后t_(1/2)、AUC_(0-∞)较男性受试者高(P<0.05)。空腹和餐后给药后不良事件涉及多系统,均为轻度,无严重不良反应。结论国产依托考昔片和原研参比制剂具有生物等效性;进食影响依托考昔片的吸收速度,但不影响其吸收程度;空腹给药后依托考昔片的药动学参数无性别差异,但餐后给药后t_(1/2)、AUC_(0-∞)存在性别差异。依托考昔片在中国健康受试者中具有良好的安全性和耐受性。

摘要：基于扩张状态观测器的自抗扰控制器具有不依赖于被控对象的具体数学模型,并对内外扰动有较强的抗干扰能力的特点,通过非线性配置构成的非线性状态误差反馈控制律。本文将自抗扰控制方法引入双馈风力发电功率控制系统中有功与无功的解耦控制,并对自抗扰控制器进行了详细设计及参数整定,使控制系统具有良好的适应性和鲁棒性,且具有无超调、无静差的控制效果。仿真结果展现了基于自抗扰控制的双馈风力发电系统功率控制的优良特性,验证了该控制策略的有效性。

摘要：Aim To develop a sensitive and accurate HPLC method for the determination of fleroxacin in human plasma, and study its pharmacokinetics in healthy subjects. Methods The analytes were isolated fi＇om plasma by simple protein precipitation with methanol, separated on a Diamonsil C18 column by isocratic elution with the mobile phase consisted of 1% triethylamine at pH 4.8 （adjusted with phosphoric acid） and acetonitrile （80/20, V/V） at a flow rate of 1.0 ***^-1 and analyzed by fluorescence detector with an excitation at 290 nm and emission 458 nm. The pharmacokinetic study of fleroxacin was performed according to a double period crossover design. Results The weighted （1/x） calibration curve was linear over the plasma concentration range of 0.025 - 8.00 μ***^-1 The inter- and intra-day precisions （RSD/%） were no more than 5.16%, and the method accuracies and extraction recoveries at three concentrations ranged firom 99.1% to 100.9%, and 86.7% to 92.0%, respectively. Following oral administration at a dose of 400 mg fleroxacin, the main pharmacokinetic parameters for test and reference capsules were Cmax5.08 ± 0.78 and 5.38 ± 1.40 μ***^-1, tmax 1.72 ±0.79 and 1.82 ± 0.78 h, t1/2 11.68 ± 1.27 and 11.38 ± 1.51 h^-1, AUC0-∞ 78.44 ± 11.44 and 76.53 ± 13.24 μ***^-1.h, respectively. Conclusion The method is sensitive and accurate, and suitable for human pharmacokinetic study of fleroxacin.