HPLC法研究两种头孢拉定在韩国健康人体内的临床药动学及生物等效性

Hyunjin Kim, Shin-Hee Kim, Semi Kim, Jae-Sung Ahn, Ju‐Seop Kang
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引用次数: 1

摘要

本研究的目的是比较两种品牌头孢拉定500 mg胶囊在24名正常韩国志愿者体内的药代动力学和生物等效性。在给药后8小时的13个时间点采集血浆样本。采用高效液相色谱法测定了人血浆中头孢拉定的浓度。采用乙腈、甲醇、20 mM磷酸钾(15/5/80,v/v/v, pH 3.48)等容流动相分离分析柱cosmosil cholester (250 × 4.6 mM, 3 μm)。分析物用紫外(260 nm)检测。新的分析方法被描述为简单的样品制备,保留时间短(小于6分钟),使其适合用于临床试验。测定参比药和试验药血浆中AUC0-t (20.54 vs 18.42 μg·h/mL)、AUC0-infinity (21.22 vs 19.14 μg·h/mL)、Cmax (12.69 vs 12.81 μg/mL)、Tmax (1.22 vs 0.92 h)、半衰期(1.02 vs 1.13 h)、外推率(3.22% vs 3.75%)、Ke (0.73 vs 0.69 h - 1)等药代动力学参数。AUC0-t的药代动力学参数为87% ~ 95%,Cmax的药代动力学参数为91% ~ 115%,置信区间为90%。它们在KFDA指南的80% - 125%的生物等效性范围内得到满足。因此,我们的高效液相色谱法可以很好地应用于两种制剂在正常人体内的生物等效性和药代动力学研究。
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Clinical Pharmacokinetic and Bioequivalence Studies of Two Brands of Cephradine in Healthy Korean Using HPLC Method
The goal of our research was to compare the pharmacokinetics and evaluate the bioequivalence of two brands of cephradine 500 mg capsules in 24 normal Korean volunteers. The plasma samples were acquired at 13 time points for 8 h after administration. The concentrations of cephradine in human plasma were measured by a high-performance liquid chromatography (HPLC). Isocratic mobile phase which consisted of acetonitrile, methanol, and 20 mM potassium phosphate (15/5/80, v/v/v, pH 3.48) was used to separate the analytical column cosmosil cholester (250 × 4.6 mm, 3 μm). Analytes were detected in ultraviolet (260 nm). The novel analytical method was described as simple sample preparation, a short retention time (less than 6 min) and making it suitable for use in clinical trials. Pharmacokinetic parameters, such as AUC0-t (20.54 vs 18.42 μg·h/mL), AUC0-infinity (21.22 vs 19.14 μg·h/mL), Cmax (12.69 vs 12.81 μg/mL), Tmax (1.22 vs 0.92 h), half-life (1.02 vs 1.13 h), extrapolation (3.22% vs 3.75%), and Ke (0.73 vs 0.69 h–1) were determined for the reference and test drugs in plasma. Pharmacokinetic parameters with a 90% confidence interval were 87% - 95% for AUC0-t and 91% - 115% for Cmax. They were satisfied within the bioequivalence range 80% - 125% of the KFDA guidelines. Therefore, our HPLC method was well applied in a bioequivalence and pharmacokinetic study of two formulations in normal subjects.
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