摘要
目的:测定自制丙戊酸钠缓释片的体内血药浓度,通过丙戊酸钠缓释片的体外释放度实验,利用统计学方法研究其体内外参数的相关性。方法:按中国药典2000年版二部附录XD释放度测定第一法,以磷酸盐缓冲液为释放介质,采用HPLC- 紫外色谱法测定丙戊酸钠累积溶出百分率。采用HPLC-荧光色谱法测定人体内血清药物浓度。结果:丙戊酸钠缓释片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=1.369X-5.457,r=0.9842,p<0.01。结论:丙戊酸钠缓释片体内外相关性显著,释放度测定方法可有效控制丙戊酸钠缓释片的内在质量和预测其生物利用度。
Objective:To determine the serum levels of sodium valproate delayed - release tablets after oral administration and to evaluate in vivo and in vitro correlation by Wanger - Nelson method. Methods:Using the phosphate buffer as dissolution medium,to determine the accumulative release percentage in vitro and the drug levels in serum by HPLC. Result:The linear regressive equation was established between the absorption percentage in vivo F and accumulate release percentage in vitro X of sodium valproate delayed - release tablets as F=1.369X-5.457 ,r= 0.9842,p<0.01. Conclusion:The results suggest that there is a significant correlation between the absorption percentage in vivo and accumulate release percentage in vitro of sodium valproate delayed - release tablets.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2005年第7期803-806,共4页
Chinese Journal of Pharmaceutical Analysis
