CAJ | 학술논문

目的：建立柳氮磺吡啶肠溶片耐酸力和溶出度检测方法。方法溶出度试验采用篮法,依次以0.1 mol/L HCl和pH 7.5磷酸盐缓冲液作为溶出介质,转速100 r/min。高效液相色谱法对耐酸力和溶出度进行检测,采用Intersil ODS-3 C18(250 mm×4.6 mm,5μm)色谱柱,以水-异丙醇-乙腈-冰醋酸(22：11：7：0.4)为流动相,柱温40℃,流速为1.0 ml/min,检测波长为254 nm。结果柳氮磺吡啶浓度在25~300μg/ml范围内线性良好(r=0.9999)；平均回收率(n=9)为100.1%,RSD为0.4%,溶液在24 h内稳定,滤膜对主药没有吸附。结论该耐酸力和溶出度检测方法准确、重现性好、操作简单,能够有效控制产品的内在质量。
목적：건립류담광필정장용편내산력화용출도검측방법。방법용출도시험채용람법,의차이0.1 mol/L HCl화pH 7.5린산염완충액작위용출개질,전속100 r/min。고효액상색보법대내산력화용출도진행검측,채용Intersil ODS-3 C18(250 mm×4.6 mm,5μm)색보주,이수-이병순-을정-빙작산(22：11：7：0.4)위류동상,주온40℃,류속위1.0 ml/min,검측파장위254 nm。결과류담광필정농도재25~300μg/ml범위내선성량호(r=0.9999)；평균회수솔(n=9)위100.1%,RSD위0.4%,용액재24 h내은정,려막대주약몰유흡부。결론해내산력화용출도검측방법준학、중현성호、조작간단,능구유효공제산품적내재질량。
Objective To establish detection methods for acid tolerance and dissolution rate in sulfasalazine enteric-coated tablet.Methods Basket method was applied in detection of dissolution rate, with 0.1 mol/L HCl and pH 7.5 phosphate buffer solution as dissolution media, and revolving speed by 100 r/min. High performance liquid chromatography was used in detection of acid tolerance and dissolution rate. Intersil ODS-3 C18 (250 mm×4.6 mm, 5μm) was chromatographic column, and water-isopropanol-acetonitrile-glacial acetic acid (22∶11∶7∶0.4) was mobile phase, with column temperature as 40℃, flow velocity as 1.0 ml/ min, and detection wave length as 254 nm.Results Sulfasalazine had good linear in 25~300μg/ml (r=0.9999), with the average recovery rate (n=9) as 100.1% andRSD was 0.4%. The solution was stable within 24 h, and basic remedy was not absorbed by filter membrane.Conclusion This is an accurate detection method for acid tolerance and dissolution rate, with good reproducibility and simple operation. It can effectively control inherent quality of product.