红花黄色素缓释骨架片质量控制方法的研究

Studies on Quality Control for Safflower Yellow Sustained-release Matrix Tablets

目的:建立红花黄色素缓释骨架片的质量控制方法。方法:采用紫外-可见分光光度法和高效液相色谱法分别测定红花黄色素(SY)和羟基红花黄色素A(HSYA)的含量。结果:分光光度法测定SY样品含量的回归方程:A=13.326C+0.0008,在0.01598～0.04795mg·mL-1线性关系良好(r=0.9999),平均加样回收率为99.6%;高效液相色谱法测定HSYA样品含量的回归方程:A=3.16×106W-2.42×104,在0.06689～0.7358μg线性关系良好(r=0.9999),平均加样回收率为96.3%。结论:本实验方法简便,准确,重复性好,可作为红花黄色素缓释骨架片的质量控制方法。

Objective： To establish methods to control the quality of Safflower Yellow Sustained-release Ma- trix Tablets. Methods： The content of tatol Safflower yellow （SY） was determined by UV method, and the content of Hydroxysafflower Yellow A （HSYA） was determined by HPLC method. Results： The regression equation to determine the content of SY was A = 13. 326C ＋ 0. 000 8 and the linear correlation was observed in the rang 0. 015 98 - 0. 047 95 mg.mL^-1 （ r = 0. 999 9 ） , the mean recovery rate was 99.59%. Meanwhile, the regression equation to determine the content of HSYA was A = 3. 16 × 10^6 W - 2. 42 × 10^4 and the linear correlation was observed in the rang 0. 066 89 -0. 735 8μg （r =0. 999 9） , the mean recovery rate was 96.3%. Conclusion： The methods are simple, accurate and reproducible to control the quality of Safflower Yellow Sustained-release Matrix Tablets.