ABSTRACT
@#A sensitive and selective method for the determination of imidafenacin in human plasma using liquid chromatography combined with mass spectrometry was established, and was applied to the pharmacokinetic and bioequivalence studies of imidafenacin in healthy Chinese volunteers. After the liquid-liquid extraction pretreatment, samples were separated by UPLC on BEH C8(2. 1 mm×50 mm, 1. 7 μm)column with mobile phase 2 mmol/L ammonium acetate solution with 0. 2% acetic acid and acetonitrile using gradient elution. The mass instrument was operated in the positive ion mode, and the monitored transition was set at m/z 320. 2→238. 1 and m/z 330. 2→248. 2 for imidafenacin and IS(imidafenacin-d10), respectively. In the single-dose, double cycle, self-crossover clinical trial, 24 healthy Chinese volunteers received 0. 1 mg reference or test imidafenacin tablet orally under fasting condition. Drug concentration in plasma was determined by this method and the pharmacokinetic parameters were calculated by DAS 3. 2. 8 software. The linear range of the analysis method is 10. 0 pg/mL to 1 000 pg/mL. The extraction recoveries of the low medium and high concentration samples were 84. 0%, 88. 0% and 90. 0%, respectively. The matrix effects of low medium and high concentration samples were 105%, 100% and 101%, respectively. The pharmacokinetic parameters of imidafenacin for the reference and test tablets were as follows: cmax 524. 8 pg/mL vs 612. 6 pg/mL, tmax 1. 250 h vs 1. 063 h, AUC0-∞ 2 229 pg ·h/mL vs 2 466 pg ·h/mL. The reference and test tablets of imidafenacin were bioequivalent. This method proved to be rapid and accurate for the pharmacokinetic and bioequivalence studies of imidafenacin.
ABSTRACT
Objective To establish the differential templates of juvenile and children in Shandong with normal occlusion, according to the group of skeletal age. Methods 212 juvenile and children at the age of 8-16 years (107 males and 105 females) with normal occlusion in Shandong natives were took cephalomatric radiographs, and divided into different groups by cervical vertebrae skeletal age. Then these cephalomatric radiographs were scanned on the computer and 14 skeletal landmarks were vectorizated. An analytical method of Ricketts and McNamara with WinCept 7.0 was used to make statistics and variance analysis among gender and every group of cervical vertebrae skeletal age,and then established the templates. Results The juvenile and children in Shandong natives with normal occlusion had different templates. Conclusion By overlapping the same skeletal age of templates by SN plane, we can see that male face outline is greater than female and male mandibular plane angle is smaller than female. By overlapping the same gender of templates, there is a developmental trend of mandibular bone to be forward and downward, and to revolve anticlockwise with age.