RP-HPLC法研究间尼索地平2种晶型在大鼠体内的组织分布特征  

Study on tissue distribution of m-nisoldipine polymorphs in rats by RP-HPLC

作　　者：王海荣[1] 王巧[1] 袁志芳[1] 张兰桐[1] 刘伟娜[1] 杜玉民[1] 李敏[1] 

机构地区：[1]河北医科大学药学院药物分析教研室,石家庄050017

出　　处：《药物分析杂志》2007年第3期319-324,共6页Chinese Journal of Pharmaceutical Analysis

基　　金：河北省科学技术厅重大攻关项目(课题编号06276407D)

摘　　要：目的:采用高效液相色谱法研究2种晶型间尼索地平在大鼠体内的组织分布特征。方法:生物样品在碱性条件下,加入内标尼莫地平,经乙酸乙酯提取后,进行 HPLC 测定。色谱柱为 Diamonsil^(TM)C_(18)柱(250 mm×4.6 mm,5μm);流动相为乙腈-水(62:38),流速1.0 mL·min^(-1);检测波长237 nm。结果:大鼠在口服 A 和 B 两种晶型间尼索地平(30 mg·kg^(-1))后,于10,30,150 min处死,两种晶型在30 min 时组织中浓度较高,150 min 时在除肺外的各脏器中浓度均呈下降趋势。组织匀浆中间尼索地平的线性关系、最低检测限、准确度和精密度均符合分析要求。结论:该法测定大鼠各组织中药物浓度准确、灵敏、可靠,为问尼索地平新药研究与开发提供实验依据。Objective ：To develop a sensitive and specific HPLC method for determination of the tissue distribution of m- nisoldipine polymorphs in rats. Methods：After adding nimodipine（ internal standard）and 0. 2 mL of 5 mol · L^- 1 NaOH solution to the tissue,the tissue samples were extracted with ethyl acetate and determined by HPLC. Analysis was performed on a C18 analytical column（250 mm ×4. 6 mm,5μm）. The mobile phase was acetonitrile -water（62： 38） ,at a flow rate of 1.0 mL min^-l and detected at 237 nm. Results：Rats were executed at 10,30,150 rain after an oral administration of A and B polymorphs. Tissue concentrations of A and B polymorphs at 30 min were higher than that at 150 min,except for that in lung. All the validation data, such as linearity, detection limit, accuracy and precision, were within the required limits. Conclusion ：The sensitivity allows the application of this method in determination of m - nisoldipine in rat tissue. It provides evidences for research and development of m - nisoldipine.

关 键 词：间尼索地平 多晶型 组织分布 反相高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]