保泰松糖衣片溶出度测定方法改进研究  

Improvement research of a determination method for dissolution of phenylbutazone tablets

作　　者：王柳 孙婷 王琛 赵春杰[1] 姜建国 乔晓宁 蒋凝 WANG Liu;SUN Ting;WANG Chen;ZHAO Chunjie;JIANG Jianguo;QIAO Xiaoning;JIANG Ning(School of Pharmacy,Shenyang Pharmaceutical University,Shenyang 110016,China;Heibei Institute for Drug and Medical Device Control,Shijiazhuang 050011,China)

机构地区：[1]沈阳药科大学药学院,辽宁沈阳110016 [2]河北省药品医疗器械检验研究院,河北石家庄050011

出　　处：《沈阳药科大学学报》2022年第2期156-163,共8页Journal of Shenyang Pharmaceutical University

摘　　要：目的改进保泰松糖衣片的溶出度测定方法。方法采用七种溶出介质和三个不同转速对保泰松溶出方法进行考察,对比不同厂家样品的溶出行为。应用高效液相色谱法测定保泰松溶出量,色谱柱为Agilent Eclipse XDB-C_(18)(250 mm×4.6 mm,5μm),柱温30℃,以0.02 mol·L^(-1)醋酸钠缓冲液-乙腈(体积比30∶70,V/V)为流动相,检测波长为240 nm,流速1.0 mL·min^(-1),进样量20μL。结果确立以磷酸盐缓冲液(pH6.8)900 mL为溶出介质,转速为100 r·min^(-1)的溶出条件,不同厂家保泰松片的溶出曲线存在明显差异。保泰松在0.01~0.40 g·L^(-1)质量浓度内线性关系良好(r=0.9999),室温放置8 h稳定。结论该溶出方法区分力效果好,可行性强,测定方法较原紫外分光光度法灵敏度更高、准确度更好,可为提高保泰松片的质量标准,建立合理的溶出度测定方法提供技术支持。Objective To improve the method of dissolution determination of phenylbutazone tablets.Methods The dissolution of Phenylbutazone was investigated by using seven kinds of dissolution media and three different rotational speeds to compare the dissolution behavior of samples from different factories.HPLC was used for detection.An Agilent Eclipse XDB-C_(18)column(250 mm×4.6 mm,5μm)was used and the volumn temperature was 30℃.Mobile phase consisted of a mixture of 0.02 mol·L^(-1)sodium acetate buffer-acetonitrile(30∶70,V/V)at the flow rate of 1.0 mL·min^(-1),the detection wavelength was 240 nm,and injection volumn was 20μL.Results The method of dissolution was established.900 mL pH 6.8 phosphate buffer was used as the dissolution medium,and the rotation speed was 100 r·min^(-1).Obvious difference of dissolution curves between different companies was observed.Phenylbutazone has a good linear relationship in the range of 0.01~0.40 g·L^(-1)(r=0.9999),the sample solution was stable within 8 hours.Conclusion The dissolution method has good discrimination effect and strong feasibility.The determination method is more sensitive and reproducible than UV,which can provide technical support for improving the quality standard of phenylbutazone tablets and establishing a reasonable method for determination of dissolution.

关 键 词：高效液相色谱法 保泰松 溶出度 溶出曲线 紫外-分光光度法 方法改进 

分 类 号：R917[医药卫生—药物分析学]