吲达帕胺缓释片的体内外相关性
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王知斌 ，唐景玲，杨亚军，李 洁，何仲贵
(沈阳药科大学 药学院，辽宁 沈阳 110016)
摘要：目的 研究吲达帕胺缓释片在体内外的相关性。方法 应用释放度测定法研究吲达帕胺缓释片的体外释药行为，用LC–MS法测定吲达帕安缓释片在人体内的血药浓度，按Wanger-Nelson公式计算药物吸收百分数，并与相应时间体外累积溶出度线性回归，进行体内外相关性考察。结果 吲达帕胺缓释片体内药动学特征符合单室一级吸收模型，血药浓度在24 h内表现平稳。以体内吸收百分率(Y)与体外释放百分率(X)建立线性回归方程：Y = 0.899 1X – 2.282，r= 0.994 5(P<0.01)。结论 吲达帕胺缓释片体外释放百分率和体内吸收百分率呈显著相关。
关键词：药剂学；吲达帕胺缓释片；体 外相关性；体内相关性；释放度；血药浓度
中图分类号：R94 文献标识码：A
In vitro and in vivo correlation of indapamide sustained-release tablets
WANG Zhi-bin，TANG Jing-ling，YANG Ya-jun，LI Jie，HE Zhong-gui
(School of Pharmcy, Shenyang Pharmaceutical University, Shenyang 110016, China)
Abstract：Objective To study the in vitro and in vivo correlation of indapamide sustained-release tablets. Methods The release tests in vitro were used to evaluate the behavior in vitro of the sustained-release tablets. LC-MS was applied for determining concentration of indapamide in human blood. The correlation was studied between the dissolution test in vitro and the absorption in vivo calculated by Wanger-Nelson method. Results Indapamide sustained-release tablets coincided with one-compartment model and provided a persistent blood drug level for at least 24 h. The linear regressive equation was established between the absorption rate in vivo and the accumulating release rate in vitro of indapamide. Conclusions There is a significant correlation between the absorption in vivo and the release in vitro of indapamide sustained- release tablets.
Key words：pharmaceutics; indapamide sustained-release tablets; in vitro correlation; in vivo correlation, release rate; whole blood concentration
王知斌 ，唐景玲，杨亚军，李 洁，何仲贵
(沈阳药科大学 药学院，辽宁 沈阳 110016)
摘要：目的 研究吲达帕胺缓释片在体内外的相关性。方法 应用释放度测定法研究吲达帕胺缓释片的体外释药行为，用LC–MS法测定吲达帕安缓释片在人体内的血药浓度，按Wanger-Nelson公式计算药物吸收百分数，并与相应时间体外累积溶出度线性回归，进行体内外相关性考察。结果 吲达帕胺缓释片体内药动学特征符合单室一级吸收模型，血药浓度在24 h内表现平稳。以体内吸收百分率(Y)与体外释放百分率(X)建立线性回归方程：Y = 0.899 1X – 2.282，r= 0.994 5(P<0.01)。结论 吲达帕胺缓释片体外释放百分率和体内吸收百分率呈显著相关。
关键词：药剂学；吲达帕胺缓释片；体 外相关性；体内相关性；释放度；血药浓度
中图分类号：R94 文献标识码：A
In vitro and in vivo correlation of indapamide sustained-release tablets
WANG Zhi-bin，TANG Jing-ling，YANG Ya-jun，LI Jie，HE Zhong-gui
(School of Pharmcy, Shenyang Pharmaceutical University, Shenyang 110016, China)
Abstract：Objective To study the in vitro and in vivo correlation of indapamide sustained-release tablets. Methods The release tests in vitro were used to evaluate the behavior in vitro of the sustained-release tablets. LC-MS was applied for determining concentration of indapamide in human blood. The correlation was studied between the dissolution test in vitro and the absorption in vivo calculated by Wanger-Nelson method. Results Indapamide sustained-release tablets coincided with one-compartment model and provided a persistent blood drug level for at least 24 h. The linear regressive equation was established between the absorption rate in vivo and the accumulating release rate in vitro of indapamide. Conclusions There is a significant correlation between the absorption in vivo and the release in vitro of indapamide sustained- release tablets.
Key words：pharmaceutics; indapamide sustained-release tablets; in vitro correlation; in vivo correlation, release rate; whole blood concentration
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