固体复合酶和混悬液酶测定果糖二磷酸钠含量的2种方法比较

 目的 比较固体复合酶试剂及混悬液酶试剂的果糖二磷酸钠（sodium fructose diphosphate，FDP）含量测定方法。方法 在固体复合酶试剂或混悬液酶试剂的作用下，通过测量还原型辅酶Ⅰ（β-nicotinamide adenine dinucleotide reduced form，NADH）在340 nm处吸光度的变化来测定FDP的含量。结果 采用固体复合酶试剂测定, FDP在0.1~0.6 mg·mL^-1内线性关系良好（r=0.999 7），平均回收率为99.3%，RSD为0.80%（n=9）；采用混悬液酶试剂测定，FDP在0.05~0.4 mg·mL^-1内线性关系良好（r=0.999 0），平均回收率为99.8%， RSD为1.38%（n=9）。结论 固体复合酶试剂测定FDP含量的方法简便、准确，专属性、实用性强，可代替混悬液酶试剂用于FDP的含量测定。

Comparison of Determination of Sodium Fructose Diphosphate by Solid Compound Enzyme and Suspension Enzyme

OBJECTIVE To evaluate the bioavailability and bioequivalence of oseltamivir capsule in Chinese health male volunteers. METHODS A randomized， two period， two treatment， two sequence crossover bioequivalence trial was designed， 24 Chinese health volunteers were randomly divided into two groups， each group was orally given single dose oseltamivir phosphate (tamifla) or test capsule. The active metabolite oseltamivir carboxylate of oseltamivir in the plasma were determined by liquid chromatographic-tandem mass spectrometric (HPLC-MS/MS) method. The pharmacokinetics parameters and relative bioavailability were calculated to evaluate the bioequivalence of test capsule and tamifla. RESULTS ρ_max of the active metabolite were （625.17±147.76） and （633.57±115.28）μg·L^-1 for test capsule and tamifla respectively, t_max were （4.5±1.0） and （4.5±1.2）h, t_1/2β were （8.13±1.13） and （7.79±0.89）h, MRT were （12.09±1.38） and （11.95±1.03）h, AUC_0-24 were （7 247.02±1 720.33） and （7 506.16±1 454.36） μg·h·L^-1. Compared with the reference of tamifla capsule， the bioavailability F_0-24 of the test capsule was （105.8±17.7）%.The main pharmacokinetics parameters of AUC_0-24， ρ_max and t_max showed no statistically significant difference between the two capsules. CONCLUSION The test capsule and tamifla capsule are bioequivalent.