血脂灵胶囊质量标准研究

Quality Standard for Xuezhiling Capsules

目的建立血脂灵胶囊的质量标准。方法采用薄层色谱（TLC）对制何首乌、山楂、决明子进行定性鉴别，用高效液相色谱（HPLC）测定制何首乌中2,3，5，4’-四羟基二苯乙烯-2-O-β-D-葡萄糖苷的含量。结果薄层色谱中，供试品溶液色谱在与对照药材或对照品色谱相应位置上出现相同颜色的斑点，阴性无干扰；HPLC中，2，3，5，4’-四羟基二苯乙烯-2-O-β-D-葡萄糖苷在0—0．82μg范围内线性关系良好（r=0．9999），平均回收率为97．4％。结论薄层色谱法呈现斑点清晰、特异性强，可用于血脂灵胶囊的鉴别；高效液相色谱法简便快速、精密度高、准确度好，可用于该药的质量控制。

Objective To establish the quality standard for Xuezhiling Capsules. Methods Radix polygoni, Multiflori preparata, Fructus crataegi,Semen cassiae were identified by TLC. The contents of 2,3,5,4：Tetrahydroxystilbene-2-O-β-D-glucoside in Radix polygoni Multiflori preparata was determined by HPLC. Results Spots obtained from the test solutions had the same color in reference solution and medical material in the same location, and the blank solution had no interference. The linear range of albi- florin was from 0 to 0.82μg（ r = 0. 9999）, the averge recovery was 97.4%. Conclusion In TLC, the spots are very clear and specific to identify the herbal medicine in Xuezhiling Capsules. It is simple , quick, highly precise and accurate for HPLC to control the quality of Xuezhiling Capsules.