摘要
目的:测定自制盐酸多西环素调释胶囊的体内血药浓度,通过盐酸多西环素调释胶囊的体外释放度实验,利用反卷积法研究其体内外参数的相关性。方法:按中国药典2005年版二部附录释放度测定第一法,以0.06mol.L-1盐酸溶液为释放介质,采用紫外分光光度法测定多西环素累积释放百分率。采用高效液相-紫外色谱法测定多西环素人体内血清药物浓度。结果:盐酸多西环素调释胶囊体内累积吸收百分率F与体外累积释放百分数X建立的一元线性回归方程为:F=1.314 7X-32.527,r=0.981 6。结论:盐酸多西环素调释胶囊体内外相关性显著,释放度测定方法可有效控制盐酸多西环素调释胶囊的内在质量和预测其生物利用度。
OBJECTIVE To determine the serum levels of doxycycline hyclate modified-release pellets after oral administra tion and to evaluate in vivo and in vitro correlation by deconvolution method. METHODS Using the 0. 06 mol L^-1 HCI as dissolution medium, to determine the accumulative release percentage in vitro by UV and the drug levels in serum by HPLC. RESULTS The linear regressive equation was established between the absorption percentage in vivo F and accumulate release percentage in vitro X of doxycycline hyclate modified-release pellets as F = 1. 3147X - 32. 527, r = 0. 9816. CONCLUSION The results suggest that there is a significant correlation between the absorption percentage in vivo and accumulate release percent age in vitro of doxycycline hyclate modified-release pellets.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2009年第8期630-634,共5页
Chinese Journal of Hospital Pharmacy
关键词
盐酸多西环素调释胶囊
释放度
血药浓度
体内外相关性
doxycycline hyclate modified-release pellets
accumulate release percentage
serum drug level
in vivo and in vitro correlation
