藤茶素分散片的制备与含量测定  

Preparation and content determination of Tengchasu dispersible tablets

作　　者：陈卫卫[1] 覃洁萍[1] 许晨霞[1] 

机构地区：[1]广西中医学院,南宁530001

出　　处：《中国新药杂志》2008年第20期1776-1779,共4页Chinese Journal of New Drugs

基　　金：广西科技厅资助项目(桂科能05112001-3A2)

摘　　要：目的：研制藤茶素分散片，并建立其含量测定方法。方法：采用正交试验法优选藤茶素分散片的处方，利用RP—HPLC测定该片中双氢杨梅树皮素的含量。结果：该片的优化处方为：藤茶素、交联聚维酮（内加：外加=3：2）、徽品纤维素（内加：外加=2：3）和预胶化淀粉（内加：外加=3：2）分别是处方量的48％，10％，15％和20％，片重为0．25g。该片中双氢杨梅树皮素在0．400～2．00μg范围线性良好（r=0．9999），平均回收率为97．2％，RSD为0．85％。结论：该片溶出度高、分散均匀性好，制备工艺简便。RP—HPLC测定含量简便可靠，可作为藤茶素分散片的质量控制方法。Objective：To prepare Tengchasu dispersible tablets and determine its eontent by HPLC assay. Methods：The formulation of Tengchasu dispersible tablets was optimized by orthogonal test. The content of dihydromyricetin was determined by RP-HPLC. Results：The optimal formulation was as follows： the contents of Guangxi total flavone, crospovidonethe, microerystalline cellulose and pregelatinized starch of the prescription were 48%, 10% , 15% and 20%, respectively. The ratios of before granulation to after pre-compress were 3： 2,2： 3,3： 2, respectively. The tablet weight was 0.25 g. The good linearity was obtained in the range of 0. 400 - 2.00 μg（r = 0. 999 9） for dihydromyricetin in Tengchasu dispersible tablets. The average recovery rate was 97.2% with RSD 0. 85%. Conclusion：The tablets can be prepared easily. It showed good distribution homogeneity and high dissolution rate. RP-HPLC is simple and reliable. It can be applied to the quality control of Tengchasu dispersable tablets.

关 键 词：藤茶素分散片 制备工艺 正交试验 双氢杨梅树皮素 反相高效液相色谱法 

分 类 号：R927.2[医药卫生—药学] R977.15