复方丹参缓释片总丹酚酸体外释放度的研究  

Determination of in vitro dissolution of total salvianolic acid of Compound Danshen sustained-release Tablets

作　　者：李苑新[1] 袁旭江[1] 霍务贞[1] 姜红宇[1] 朱盛山[1] 

机构地区：[1]广东药学院中药开发研究所,广东广州510240

出　　处：《中成药》2006年第5期636-638,共3页Chinese Traditional Patent Medicine

基　　金：国家自然基金课题(编号:30472198);国家中医药管理局课题(编号:04-05ZP50);广东省自然基金课题(编号:04105450)

摘　　要：目的：建立复方丹参缓释片总丹酚酸释放度的紫外测定方法，评价其释药行为。方法：用紫外分光光度法和释放度试验，以丹酚酸B为对照品，测定复方丹参缓释片中总丹酚酸在不同释放时间的累积释放度。结果：丹酚酸B对照品在286nm有最大吸收，在4．9～98μg／mL范围内与吸收度呈良好的线性关系（A=0．0207C-0．0321，r=0．9998），总丹酚酸体外释药行为符合Higuchi方程：Mt／M∞=0．3408t^1/2-0．117，r=0．9966。结论：本法简便、快速，可用于控制复方丹参缓释片的质量。AIM： To establish a UV method of determing the dissolution of total salvianolic acid of Compound Danshen sustained-release Tablets, and to evaluate its release behavior. METHODS： With the salvianolic acid B as standard, ultraviolet spectrophotometry and the release test were applied to determine the dissolution of total salvianolic acid of Compound Danshen sustained-release Tablets in distinct dissolution. RESULTS： Salvianolic acid B had the maximum absorption peak at 286 nm, and a good linearity within the range of d. 9 - 98 μg/mL（ A = 0.0207C -0. 0321 ,r =0. 9998）, and total salvianolic acid had a good dissolution fit with Higuchi Square Mt/M∞=0. 3408t^1/2 -0. 117 ,r =0. 9966. CONCLUSION： The UV method is simple, quick, and can be used for quality control of the preparation.

关 键 词：复方丹参缓释片 总丹酚酸 释放度 紫外分光光度法 

分 类 号：R927.11[医药卫生—药学]