浓缩丹参骨宝颗粒中水溶性有效成分质量控制研究.docVIP

浓缩丹参骨宝颗粒中水溶性有效成分质量控制研究 　　[摘要] 目的：建立丹参骨宝颗粒水溶性有效成分的质量控制方法。方法：采用薄层色谱法对丹参进行鉴别；采用高效液相色谱法测定主要成分丹参素和丹参酚酸B的含量，色谱柱为Hypersil ODS C18（4.6 mm×250 mm，5 μm），流动相为甲醇-水-冰醋酸（55∶45∶0.045，V/V），检测波长为281 nm，流速为1.0 ml/min，柱温为35℃。结果：薄层鉴别斑点清晰，重现性好。高效液相色谱法测定丹参素和丹参酚酸B在3.0～24.0 μg/ml和6.0～48.0 μg/ml线性关系良好（r=0.999 8和r=0.999 9），平均加样回收率分别为98.2％和99.5%。结论：本实验建立的分析方法灵敏可靠，可作为丹参骨宝颗粒中水溶性有效成分的质量控制。 　　[关键词] 丹参素；丹参酚酸B；质量控制 　　[中图分类号] R284.2 [文献标识码] A [文章编号] 1673-7210（2011）12（a）-067-03 　　 　　Quality control for hydrophilic active components in Danshen Gubao Granules 　　JIANG Guixiang1, LU Yingnian2, FAN Shijin2, ZHONG Liping2, CUI Liao2 　　1.Guangdong Shuanglin Biopharmacy Co. Ltd, the Engineering Center of Zhanjiang Biopharmacy, Guangdong Province, Zhanjang 524005, China; 2.Guangdong Medical College, Guangdong Key Lab for Research and Development of Natural Drugs, Guangdong Province, Zhanjang 524023, China 　　[Abstract] Objective: To establish a quality control method for hydrophilic active components in Danshen Gubao Granules. Methods: Salvia miltiorrhiza Bge. was identified by thin-layer chromatography, and the deteminations of Danshensu and Salvianic acid B were carried out by high performance liquid chromatography. Separations were performed on a Hypersil ODS C18 (4.6 mm×250 mm, 5 μm) column, the mobile phase was the mixed solvents of methnol-water-glacial acetic acid (55∶45∶0.045, V/V) which set at a flow rate of 1.0 ml/min, and the wave length for UV detection was 281 nm. The temperature was maintained at 35℃. Results: The TLC method was suitable for the identification of Salvia miltiorrhiza Bge.. The linearities for Danshensu and Salvianic acid B were obtained with in the range of 3.0-24.0 μg/ml and 6.0-48.0 μg/ml (r=0.999 8 and r=0.999 9), and the average recoveries were 98.2% and 99.5% respectively. Conclusion: This method is reliable and accurate that it can be used as a quality control method of hydrophilic active components in Danshen Gubao Granules. ???　[Key words] Danshensu; Salvianic ac