摘要
目的建立测定阿莫西林和盐酸氨溴索血药浓度及药物代谢动力学（简称为药代动力学）的研究方法。方法采用高效液相色谱（HPLC）法,色谱柱为Inertsil ODS-2柱（150 mm×4.6 mm,5μm）,流动相为甲醇-p H=4的0.01 mol/L醋酸铵溶液（8∶92,V/V）检测波长为244 nm,温度为25℃,流速为1.0 m L/min,进样体积为20μL。结果阿莫西林质量浓度在12.3～200μg/m L、盐酸氨溴索质量浓度在0.72～11μg/m L范围内与峰面积线性关系良好;低、中、高3个质量浓度的日内精密度RSD分别为0.65%,5.81%,3.08%,日间RSD分别为1.10%,9.28%,3.01%;低、中、高3个质量浓度阿莫西林的平均回收率分别为（99.97±0.47）%,（99.56±2.05）%和（100.17±1.53）%,盐酸氨溴索平均回收率分别为（88.06±1.06）%,（91.22±2.10）%和（95.10±1.88）%;血药浓度峰浓度为（109.33±19.82）μg/m L,达峰时间为（3.01±0.76）h,血浆半衰期为（8.12±2.40）h。结论 HPLC法检测简便、准确,可为阿莫西林盐酸氨溴索人体内药代动力学研究提供基础。
Objective To establish a determination method for blood drug concentration and pharmacokinetics of amoxicillin and ambroxol hydrochloride. Methods HPLC method was used, the column chromatography： Inertsil ODS-2 column（50 mm × 4. 6 mm, 5μm）; mobile phase： methanol -0. 01 mol/L ammonium acetate solution （pH = 4） （8： 92, V/V）, wavelength was 244 nm; the temperature was 25℃; the flow rate was 1.0 mL/min, the injection volume was 20 μL. Results The mass concentration of amoxicillin in the range of 12. 3- 200 μg/mL, ambroxol hydrochloride in the range of 0.72- 11 μg/mL showed a good linear relationship with peak area; the rel- ative standard deviations（RSD） were 0. 65%, 5.81% and 3.08% for the low, medium and high quality concentrations, the RSDs of day to day precision was 1.10%, 9.28%, 3.01%;the average recovery rates of amoxicillin for the low, medium and quality concentration were （99.97±0.47） %, （99.56±2.05）% and （100.17±1.53） % respectively, and the average recovery rates of ambroxol hy- drochloride for the low, medium and quality concentration were （88.06±1.06）%, （91.22±2. 10）% and （95.10±1.88）% respectively; the plasma concentration was （109.33 ±19.82） μg/mL, the peak time was （3.01±0.76） h, and the plasma half-life was （8. 12 ±2.40）h. Conclusion The HPLC method is simple, accurate, which can provide a reference for human pharmacokinetics study of amoxi- cillin and ambroxol hydrochloride .
出处
《中国药业》
CAS
2016年第3期40-42,共3页
China Pharmaceuticals
