CAJ | 학술논문

目的：提供一种琥珀酸美托洛尔缓释片的体外释放度测定方法。方法以pH6．8磷酸盐缓冲液为溶出介质，转速100 rpm，以高效液相色谱法测定含量，色谱柱为venusil MPC18（250 mm ×4．6 mm，5μm），流动相为pH 3．5的磷酸盐缓冲液－乙腈（75∶25），检测波长为274 nm，流速：1．0 mL· min－1。结果 A＝9．2322C＋7．3634（r＝0．9999），琥珀酸美托洛尔含量测定浓度在20～140 mg· L－1的范围内线性关系良好；自制制剂与进口制剂具有相似的体外释放特征。结论该法操作简便、准确、重现性好，适合琥珀酸美托洛尔缓释片的释放度测定。
목적：제공일충호박산미탁락이완석편적체외석방도측정방법。방법이pH6．8린산염완충액위용출개질，전속100 rpm，이고효액상색보법측정함량，색보주위venusil MPC18（250 mm ×4．6 mm，5μm），류동상위pH 3．5적린산염완충액－을정（75∶25），검측파장위274 nm，류속：1．0 mL· min－1。결과 A＝9．2322C＋7．3634（r＝0．9999），호박산미탁락이함량측정농도재20～140 mg· L－1적범위내선성관계량호；자제제제여진구제제구유상사적체외석방특정。결론해법조작간편、준학、중현성호，괄합호박산미탁락이완석편적석방도측정。
Objective To study the release rate of metoprolol succinate extended-release tablets in vitro.Methods In vitrorelease study was carried out using pH 6.8 phosphate buffer solution as release solution at 100 rpm.HPLC method was developed for quantita-tive determination.Column conditions:venusil MPC18 (4.6 mm ×250 mm,5 μm); mobile phase: pH 3.5 phosphate buffer solution-acetonitrile (75∶25 V/V);wavelength:274 nm;flow rate:1.0 mL· min-1 .Results Metoprolol succinate demonstrated a good lin-ear relationship within a range of 20~140 mg· L-1, A=9.232 2C +7.363 4(r=0.999 9).Homemade and imported drugs had similar in vitro release profiles.Conclusion The method is simple,accurate and suitable for release rate determination for metoprolol succinate extended-release tablets .