复方单硝酸异山梨酯缓释片人体血药浓度测定的方法学研究

Study on Determinations of Compound Isosorbide Mononitrate Sustained Release Tablet in Human Plasma

摘要: 目的建立复方单硝酸异山梨酯缓释片的人体血药浓度测定方法。方法应用GC和HPLC分别测定血浆中5-单硝酸异山梨酯和水杨酸的浓度。结果本实验建立的血药浓度测定方法，血浆中内源性物质不干扰测定，线性范围5-单硝酸异山梨酯为2.72～696.50 ng·mL-1，水杨酸为0.2～20 mg·mL-1，日内和日间精密度均小于15%。结论建立的测定方法适用于复方单硝酸异山梨酯缓释片在人体的血药浓度测定及药代动力学研究。

Abstract: OBJECTIVE To establish the determination methods of compound isosorbide mononitrate sustained release tablet in human plasma. METHODS The plasma concentration of 5-isosorbide mononitrate and salicylic acid were determined by GC and HPLC method respectively. RESULTS The linear range of 5-isosorbide mononitrate and salicylic acid were (2.72-696.50) ng·mL-1 and (0.2-20) μg·mL-1, within- and between-series RSD were both<15%. CONCLUSION The established methods can be used for determination and pharmacokinetic studies of compound isosorbide mononitrate sustained release tablet in humans.