浓缩丹参骨宝颗粒中水溶性有效成分的质量控制研究

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HypersilODSC18（4．6mm×250mm，5μm），流动相为甲醇-水-冰醋酸（55：45：0．045，V/V），检测波长为281nm，流速为1．0ml／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—24．0μg/ml和6．0-48．0μg/ml线性关系良好（1=0．9998和r=0．9999），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。

Quality control for hydrophilic active components in Danshen Gubao Granules

Objective： To establish a quality control method for hydrophilic active components in Danshen Gubao Gran- ules. 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 Hy- persil ODS Cls （4.6 mm×250mm,5μm） 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.