布洛芬缓释胶囊的体内血药浓度及体外溶出度的相关性研究  

The correlation between plasma levels in vivo and dissolution in vitro of ibuprofen sustained-release capsule

作　　者：吴琳华[1] 付红焱[1] 刘红梅[1] 孙考祥[1] 田辉凯[1] 

机构地区：[1]哈尔滨医科大学附属第二医院临床药学药物研究所,黑龙江哈尔滨150086

出　　处：《中国药学杂志》2001年第6期397-399,共3页Chinese Pharmaceutical Journal

摘　　要：目的　测定布洛芬缓释胶囊中布洛芬的血药浓度 ,通过布洛芬缓释胶囊的体外溶出度实验 ,利用统计学方法研究其体内外参数的相关性、并提供质控方法。方法　采用高效液相色谱法测定血药浓度。溶出度采用中国药典 1995年版二部附录XC第一法测定 ,用美国HansonResearch生产的全自动溶出度测定仪操作。结果　布洛芬体外溶出度累积百分率与体内吸收百分率建立一元线性回归方程 :F=6 .2 2 0 5x +1.0 90 1(r=0 .975 5 ) ,线性范围 4.6～ 2 4.6 μg·mL-1。OBJECTIVE: To determine the plasma levels of ibuprofen after oral administration and to study the correlation between the absorption in vivo and the dissolution in vitro of ibuproten sustained-release capsule. METHODS: The plasma levels were determined by HPLC. The limearity was obtained over the range of 4.6-24.6 mg&middotmL-1. The dissolution was tested according to Vhinese Pharmacopoeia 1995 Appendices XC, using the first method. RESULTS: TSA linear regressive equation was established between the absorption percentage in vivo and the accumualte dissolution percentage in vitro of ibuprofen. F = 6. 2205x + 1. 0901 (r = 0.9755). CONCLUSION: There was a significant correlation between the dissolution in vitro and the absorption in vitro of ibuprofen sustained-release capsule.

关 键 词：布洛芬缓释胶囊 血药浓度 体外溶出度 

分 类 号：R971.1[医药卫生—药品] R969.1[医药卫生—药学]