双黄连分散片溶出度测定  

Determination of the Dissolution Rate of Shuanghuanglian Dispersible Tablets

作　　者：王玉鹏[1] 赵丽华[1] 

机构地区：[1]武警安徽省总队医院药剂科,合肥市230041

出　　处：《中国药房》2010年第47期4473-4475,共3页China Pharmacy

摘　　要：目的:建立双黄连分散片中黄芩苷的溶出度测定方法。方法:以pH4.5的乙酸铵冰醋酸溶液900mL作为溶出介质,采用桨法,转速为50r·min-1,以高效液相色谱法测定累积溶出百分率,绘制累积溶出曲线,并进行样品的溶出度测定。结果:黄芩苷进样量在20.96～188.64μg范围内与峰面积积分值呈良好的线性关系(r=0.9998);平均回收率为97.97%,RSD=1.13%(n=6)。对3批双黄连分散片进行溶出度测定,其中黄芩苷在20min的溶出率均达90%以上。结论:本方法灵敏、准确、快速,适用于双黄连分散片的质量控制。OBJECTIVE： To establish the determination method for the dissolution rate of baicalin in Shuanghuanglian dispersible tablets. METHODS： 900 mL glacial acetic acid solution of ammonium acetate （pH=4.5） was adopted as dissolution medium with paddle method at rotation rate of 50 r·min-1. The cumulative dissolution percentage was determined by HPLC. And the cumulative dissolution curve and the dissolution rate of Shuanghuanglian dispersible tablets were determined. RESULTS： The linear range of baicalin was 20.96～188.64 μg （r=0.999 8） with an average recovery of 97.97% （RSD=1.13%,n=6）. The dissolution rate of 3 batches of Shuanghuanglian dispersible tablets was determined, reaching above 90% in the duration of 20 minute tests. CONCLUTION： The method is sensitive, accurate and rapid for the quality control of Shuanghuanglian dispersible tablets.

关 键 词：双黄连分散片 黄芩苷 溶出度 高效液相色谱法 

分 类 号：R283.64[医药卫生—中药学] R927[医药卫生—中医学]