黄杨宁片溶出度测定方法研究及溶出行为评价  

A research of dissolution method of Huangyangning tablets and evaluation of dissolution behavior

作　　者：吴嫣艳 郭青 周佳益 WU Yan-yan;GUO Qing;ZHOU Jia-yi(Jiangsu Institute for Food and Drug Control,Nanjing 210000,China;China Pharmaceutical University,Nanjing 210009,China)

机构地区：[1]江苏省食品药品监督检验研究院,南京210000 [2]中国药科大学,南京210009

出　　处：《药物分析杂志》2019年第12期2273-2278,共6页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立黄杨宁片的溶出度方法,并对不同厂家样品进行溶出曲线评价。方法:采用反相HPLC法,使用Agela Durashell RP C18色谱柱(4.6 mm×250 mm,5μm)分离,以0.01 mol·L^-1庚烷磺酸钠与0.01mol·L^-1磷酸二氢钾等量混合水溶液(含0.2%三乙胺,用磷酸调节pH至3.5)-乙腈(77∶23)为流动相,流速1.0 mL·min^-1,检测波长206 nm;溶出度试验采用小杯法,以150 mL的0.1 mol·L^-1盐酸溶液为溶出介质,转速75 r·min^-1。结果:环维黄杨星D进样量在0.025 5~4.084 8μg范围内线性关系良好(r=1.000);平均回收率为97.6%(n=6);不同厂家黄杨宁片的溶出行为有较大差异。结论:建立的HPLC溶出度测定方法简单灵敏可靠,能较好地体现不同厂家样品间的溶出差异。Objective:To establish a method to determine the dissolution of Huangyangning tablets and evaluate the dissolution behavior of samples from different manufacturers. Methods:The RP-HPLC was used,and the separation was performed on a Agela Durashell RP C18(4.6 mm×250 mm,5 μm)column,the mixed solution(finally containing 0.2% triethylamine and adjusted pH to 3.5 with phosphoric acid)in an equal quantity of 0.01 mol·L^-1 sodiumheptanesulfonate solution and 0.01 mol·L^-1 potassium dihydrogen phosphate solution-acetonitrile(77:23)as a mobile phase,the flow rate was 1.0 mL·min^-1,the detection wavelength was at 206 nm;The cup method was used for the dissolution test with 150 mL of 0.1 mol·L^-1 hydrochloric acid solution as the dissolution medium and the rotation rate was set at 75 r·min^-1. Results:Cyclovirobuxine D revealed a good linearity within the range of 0.025 5-4.084 8 μg(r=1.000). The average recoveries were 97.6%(n=6).The dissolution behavior showed a significant difference among products from different manufacturers. Conclusion:The established dissolution method is simple,sensitive and credible which can reflect differences on dissolution among products from different manufacturers.

关 键 词：黄杨宁片 环维黄杨星(cyclovirobuxine D) 高效液相色谱法 溶出度 溶出行为评价 

分 类 号：R917[医药卫生—药物分析学]