根黄分散片溶出度测定方法的研究  

Determination of the Dissolution of Genhuang Dispersible Tablets

作　　者：辛蕊华[1] 罗永江[1] 李维[2] 郑继方[1] 王贵波[1] 邓素平[1] 罗超应[1] 

机构地区：[1]中国农业科学院兰州畜牧与兽药研究所中国农科院新兽药工程重点实验室,甘肃兰州730050 [2]兰州市疾病预防控制中心,730030

出　　处：《时珍国医国药》2011年第6期1327-1328,共2页Lishizhen Medicine and Materia Medica Research

基　　金：国家"十一五"科技支撑计划项目资助(No.2008BADB4B03-1);中央级公益性科研院所基本科研业务费专项资金项目(No.BRF090404)

摘　　要：目的建立根黄分散片中黄芩苷溶出度的测定方法。方法依据《中国药典》2010版溶出度测定法第1法（篮法）,以蒸馏水为溶出介质,转速为100 r.min-1,于不同时间取样,采用RP-HPLC法在波长为280 nm处测定黄芩苷的含量,计算根黄分散片的累积释放度。结果该法加样回收率为97.27%,RSD为0.74%,在1.018-50.9μg.m l-1范围内浓度和峰面积呈良好的线性关系。使用该试验确定的方法,10 min时测定根黄分散片的累积溶出百分率达到标示量的99.10%。结论根黄分散片批内和批间黄芩苷的溶出累积释放百分率差异小,说明该方法简便易行、准确可靠且重现性好,可用于根黄分散片的质量控制。Objective To establish a method for the determination of baicalin dissolution in Genhuang dispersible tablets.Methods According to the Chinese Pharmacopoeia,water was used as the dissolution medium,with speed of 100r·min-1.The content of baicalin was determined at a wavelength of 280nm by RP-HPLC method,and the cumulative release of Genhuang dispersible tablet was calculated.Results The average recovery rate was 97.27% and the RSD was 0.74%.The calibration curve of baicalin was linear in the range of 1.018～50.9 μg·ml-1.With this method,the accumulation dissolution rate of the baicalin in Genhuang dispersible tablets reached 99.10% at 10 minute.Conclusion The difference in the cumulative release percentage of Genhuang dispersible tablets is not significant,so this method is simple,accurate,repeatable,which can be used for the quality control of Genhuang dispersible tablets.

关 键 词：根黄分散片 溶出度 

分 类 号：R284.2[医药卫生—中药学]