金芍胶囊的质量标准  

Study on Quality Standard for Jinshao Capsules

作　　者：蒋东旭[1,2] 王德杭[1,2] 黄有带 景运条 梁颖敏[1,2] 赖小平[1,2] 

机构地区：[1]广州中医药大学,广州510006 [2]广州中医药大学中医药数理工程研究院 [3]广东德鑫制药有限公司

出　　处：《中国药师》2010年第9期1251-1254,共4页China Pharmacist

摘　　要：目的:建立金芍胶囊的质量标准。方法:采用TLC法鉴别方中赤芍、延胡索、黄柏、莪术、苍术、当归、香附;采用HPLC法测定盐酸小檗碱、芍药苷的含量。结果:在TLC色谱中可检出赤芍、延胡索、黄柏、莪术、苍术、当归、香附的特征斑点,清晰,易于观察;盐酸小檗碱在0.084～2.122μg范围内线性关系良好(r=0.999 9),平均回收率为99.06%,RSD=1.33%(n=6);芍药苷在0.079～1.983μg范围内线性关系良好(r=0.999 8),平均回收率为98.94%,RSD=1.88%(n=6)。结论:方法简便、准确、稳定且无干扰,可作为该制剂的质量控制方法。Objective： To establish a quality standard for the jinshao granules. Method： Radix Paeoniae Rubra,Rhizoma Corydalis, Cortex Phellodendri, Rhizoma Curcumae, Rhizoma Atractylodis, Radix Angelicae Sinansis ,Rhizoma Cyperi were identified by TLC. The content of Berberine Hydroehloride and Paeoniflorin were determined by HPLC. Result： Radix Paeoniae Rubra, Rhizoma Corydalis, Cortex Phellodeadri, Rhizoma Curcumae, Rhizoma Atractylodis, Radix Angelicae Sinensis, Rhizoma Cyperi could be detected by TLC, and easily to observe;The Berberine Hydrochloride had a good linearity in the range of 0. 084-2. 122 μg （r = 0. 999 9 ）. The average recovery was 99.06% with RSD = 1.33% （n = 6 ） ;The Paeoniflorin had a good linearity in the range of 0. 079-1. 983 μg（ r = 0. 999 9 ）. The average recovery was 98. 94% with RSD = 1.88% （n = 6 ）. Conclusion： The method is simple, accurate, reliable, reproducible and with strong specificity, which can be used as quality control standard of jinshao granules.

关 键 词：金芍胶囊 质量标准 薄层色谱法 高效液相色谱法 

分 类 号：TQ460.72[医药卫生—药物分析学]