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.