PDF(Pubmed)
Abstract：
UNASSIGNED: In order to measure the plasma levels of Losartan and Bosentan, a sensitive Reverse Phase-High Performance Liquid Chromatography (RP-HPLC) technique was developed.
UNASSIGNED: To compare bioavailability, the Area Under the Curve (AUC), peak plasma concentration (Cmax), and time to Cmax (Tmax) were employed. The standard curve (150-2400 ng/ml) was linear (R2=0.999), relative errors were between 2.4 to 10.05% and the coefficient of variation (CV%) ranged from 1.52 to 10.88. A single dosage (test and reference) was used for the in vivo investigation, which involved 16 healthy individuals.
UNASSIGNED: The AUC0-48, AUC0-, Cmax, and Tmax of the test and reference had no statistically significant differences. The Cmax and 95% confidence intervals of the ratio of Cmax of the two formulations were 0.93-0.96 and 97.6-135%, respectively.
UNASSIGNED: Therefore, it was established that generic Bosentan was equivalent to Bosentan from Actelion and that both medications could be regarded as equally effective in clinical settings. The blood level of Bosentan could be measured using this straightforward procedure in all hospital laboratories.
UNASSIGNED: To compare bioavailability, the Area Under the Curve (AUC), peak plasma concentration (Cmax), and time to Cmax (Tmax) were employed. The standard curve (150-2400 ng/ml) was linear (R2=0.999), relative errors were between 2.4 to 10.05% and the coefficient of variation (CV%) ranged from 1.52 to 10.88. A single dosage (test and reference) was used for the in vivo investigation, which involved 16 healthy individuals.
UNASSIGNED: The AUC0-48, AUC0-, Cmax, and Tmax of the test and reference had no statistically significant differences. The Cmax and 95% confidence intervals of the ratio of Cmax of the two formulations were 0.93-0.96 and 97.6-135%, respectively.
UNASSIGNED: Therefore, it was established that generic Bosentan was equivalent to Bosentan from Actelion and that both medications could be regarded as equally effective in clinical settings. The blood level of Bosentan could be measured using this straightforward procedure in all hospital laboratories.
摘要：
■为了测量氯沙坦和波生坦的血浆水平，开发了一种灵敏的反相高效液相色谱（RP-HPLC）技术。
■为了比较生物利用度，曲线下面积(AUC),血浆峰值浓度(Cmax),使用时间至Cmax(Tmax)。标准曲线（150-2400ng/ml）呈线性关系（R2=0.999），相对误差为2.4~10.05%,变异系数(CV%)为1.52~10.88.单一剂量（测试和参考）用于体内研究，其中涉及16名健康个体。
■AUC0-48，AUC0-，Cmax,测试和参考的Tmax差异无统计学意义。两种制剂的Cmax和Cmax比值的95%置信区间分别为0.93-0.96和97.6-135%,分别。
■因此，已确定仿制药Bosentan与Actelion的Bosentan等效,并且两种药物在临床环境中可被视为同等有效.波生坦的血液水平可以在所有医院实验室使用这个简单的程序进行测量。
■为了比较生物利用度，曲线下面积(AUC),血浆峰值浓度(Cmax),使用时间至Cmax(Tmax)。标准曲线（150-2400ng/ml）呈线性关系（R2=0.999），相对误差为2.4~10.05%,变异系数(CV%)为1.52~10.88.单一剂量（测试和参考）用于体内研究，其中涉及16名健康个体。
■AUC0-48，AUC0-，Cmax,测试和参考的Tmax差异无统计学意义。两种制剂的Cmax和Cmax比值的95%置信区间分别为0.93-0.96和97.6-135%,分别。
■因此，已确定仿制药Bosentan与Actelion的Bosentan等效,并且两种药物在临床环境中可被视为同等有效.波生坦的血液水平可以在所有医院实验室使用这个简单的程序进行测量。
