降压片质量标准提高研究

Enhancement of Quality Standard for Jiangya Tablets

目的:建立降压片的质量控制方法。方法:采用薄层色谱法对降压片中决明子、山楂进行定性鉴别;HPLC法测定黄芩中黄芩苷、汉黄芩苷、黄芩素、汉黄芩素含量,色谱柱为Agilent ZORBAX SB-C18(250 mm×4.6 mm,5μm);柱温为30℃;流动相为甲醇(A)-0.2%磷酸溶液(B),梯度洗脱;流速为1.0 m L·min-1;检测波长为278 nm。结果:TLC斑点清晰、分离度好,阴性无干扰;黄芩苷、汉黄芩苷、黄芩素、汉黄芩素分别在0.118 0~2.360 0μg(r=0.999 9)、0.046 6~0.932 0μg(r=0.999 8)、0.048 7~0.974 0μg(r=0.999 9)、0.039 7~0.794 0μg(r=0.999 9)与峰面积呈良好的线性关系;平均回收率分别为98.58%(RSD为1.14%,n=6)、98.48%(RSD为0.83%,n=6)、98.99%(RSD为0.77%,n=6)、99.28%(RSD为0.78%,n=6)。结论:本方法简便、准确,能有效控制降压片的质量。

Objective： To establish a quality control method for Jiangya tablets. Methods： TLC was used to deter- mine Cassiae Semen, Crataegi Fructus, and the content of baicalin, wogonoside, baicalein, wogonin was determined by HPLC. The Agilent ZORBAX SB-C18（250 mm ×4. 6 mm, 5 μm）column was used for the separation and, the temperature of column was 30 ℃ with methanol（ solvent A） -0. 2% phosphoric acid （ solvent B） as mobile phase consisted. The flow rate was 1.0 mL · min - i, and the detection wavelength was 278 nm. Results： The spots of TLC were fairly clear with a good separation and without interference of the negative samples. Baicalin, wogonoside, baicalein and wogonin all showed good linearity at 0.1180-2.3600 μg, r=0.9999, 0.0466-0.9320 μg, r=0.9998, 0.0487-0.9740 μg, r=0.9999, 0.0397-0.7940 μg, r= 0. 999 9, respectively. The average recoveries were 98.58% （ RSD = 1.14% , n = 6） ; 98.48% （ RSD = 0. 83% , n = 6） ; 98. 99% （ RSD = 0. 77%, n = 6） ; 99.28% （ RSD = 0. 78%, n = 6）, respectively. Conclusion： The method is simple, ac- curate and can effectively control the quality of Jiangya tablets.