中国药房2012，Vol.23Issue(1)：29-31,3.DOI:10.6039/j.issn.1001-0408.2012.01.10
HPLC法测定盐酸米诺环素缓释片在犬体内的血浆浓度及其药动学研究
Determination of the Concentration of Minocycline Hydrochloride Sustained-release Tablet in Dog Plasma by HPLC and Its Pharmacokinetic Study
刘统斌 1邬向东 2杨东菁 3王雪芹4
作者信息
- 1. 上海现代哈森(商丘)药业有限公司,河南商丘476000
- 2. 河南中帅医药科技发展有限公司,郑州450003
- 3. 河南大学医学院,河南开封475001
- 4. 河南省食品药品检验所,郑州450003
- 折叠
摘要
Abstract
OBJECTIVE: To establish a method for the determination of the concentration of Minocycline hydrochloride sustained-release tablets (MHST) (using HPMC as matrix) in dog plasma and to study the pharmacokinetics of domestic and imported preparations. METHODS: HPLC method was adopted. The determination was performed on Scienhome C18 column with mobile phase consisted of acetonitrile-tetrahydrofuran-water (contain 1.5% triethylamine, 2% sodium heptanesulfonate, pH adjusted to 3.0 using phosphoric acid) (150:30:850) at flow rate of 1.0 mL·min-1. The injection volume was 50 μL, and detection wavelength was set at 280 nm. Beagle dogs were randomized into test preparation (domestic) group and reference preparation (imported) group with 5 dogs in each group. They were given MHST 18mg·kg-1 intragastrically. Plasma concentrations of 2 groups were investigated before administration and 60 h after administration. Pharmacokinetic parameters were calculated. RESULTS: The linear range of MH was 0.125~10 mg·L-1 (r=0.999). The average extraction recovery was 70.3%. The average method recovery was 89.3%. The RSDs of inter-day and intra-day were no more than 6.4%. Pharmacokinetic parameters of test preparation and reference preparation were as follows: tmax: (4.42 ± 1.24) h and (4.33 ± 1.07) h; Cmax: (4.29 ± 1.13) mg·L-1 and (4.33 ± 0.83) mg·L-1; AUG0~60h: (48.19 ± 16.64) mg·h·L-1 and (48.31 ± 15.00) mg·h·L-1, respectively. CONCLUSION: The method is specific, sensitive and effective for the determination of the concentration of MH in dog plasma. There is no significant difference in pharmacokinetic parameters between domestic and imported preparations.关键词
盐酸米诺环素缓释片/高效液相色谱法/犬/国产制剂/进口制剂/药动学Key words
Minocycline hydrochloride sustained-release tablet/ HPLC/ Dogs/ Domestic preparation/ Imported preparation/ Pharmacokinetics分类
医药卫生引用本文复制引用
刘统斌,邬向东,杨东菁,王雪芹..HPLC法测定盐酸米诺环素缓释片在犬体内的血浆浓度及其药动学研究[J].中国药房,2012,23(1):29-31,3.
