HPLC法测定复方苦木消炎片中穿心莲内酯溶出度

Dissolution Determination of Andrographolide in Compound Kumu Xiaoyan Tablets by HPLC

目的:建立复方苦木消炎片中穿心莲内酯溶出度的测定方法,并对市售产品进行溶出度的测定。方法:采用高效液相色谱法测定穿心莲内酯的溶出度。用500ml 0.2%十二烷基硫酸钠为溶出介质,使用转篮法在100r·min^(-1)的转速下进行溶出度的试验,于45min取样测定。结果:穿心莲内酯的浓度在0.37-3.70μg·ml^(-1)范围内呈良好的线性关系(r=0.999 8),回收率为99.4%,RSD为0.22%(n=6)。在45min取样测定,复方苦木消炎片中穿心莲内酯的溶出度不低于标示量的80%。结论:本方法简便,结果准确可靠,可用于复方苦木消炎片中穿心莲内酯的溶出度的测定。

Objective:To establish a method for the dissolution determination of andrographolide in compound Kumu Xiaoyan tablets and determine the dissolution of a marketed product.Method:Andrographolide was detected by an HPLC method.0.2%Sodium lauryl sulfate(500ml) was used as the dissolution medium.A suspended basket method with a stirring rate of 100 r ? min^(-1) was used,and the sampling time was 45 min.Result:The dissolution of andrographolide showed good linearity within the range of 0.37~3.70μg ? ml^(-1)(r=0.999 8).The recovery was 99.4%(RSD=0.22%,n=6).In the sampling time,the dissolution of andrographolide was not below 80%of the labeled content.Conclusion:The method is simple with great stability and accuracy,which can be used in the dissolution determination of andrographolide in compound Kumu Xiaoyan tablets.