复肝灵胶囊的制备及稳定性考察

目的：制备复肝灵胶囊，并对其稳定性进行考察。方法：用水煮法对丹参药材进行提取，经大孔树脂精制丹酚酸，用高效液相色谱法考察了丹参精制粉及其制剂中丹酚酸B的含量。结果：丹酚酸B在2．05—83．36ug·ml^-1的范围内线性关系良好（r=0．9999），回收率为101．09％，RSD为1．63％。复肝灵胶囊中丹酚酸B的含量为24．5％。结论：利用大孔树脂精制丹参水溶性成分，在有效地保留丹酚酸B等有效成分的同时，可有效减少丹参提取物中非酚酸类及杂质的含量，有利于提高制剂载药量，为丹参及其制剂的质量控制提供了分析方法。

Preparation and Stability Investigation of Fuganling Capsule

Objective： To prepare the Fuganling capsule and investigate its stability. Method： Salviae miltiorrhizae was extracted with the method of boifing water and the salvianolic acid B was purificated with macroporous resin. The content of salvianolic acid B in the purifier and preparation was determined by HPLC. Result： Good linearity of salvianolic acid B was obtained within the range of 2.05 -83.36ug·ml^-1（ r = 0.999 9）. The average recovery was 101.09%, and RSD was 1.63%. The content of salvianolic acid B in this preparation was 24.5%. Conclusion： Water-soluble components in salviae miltiorrhizae can be purified with macroporous resin column chromatogrcophy. The method is feasible and effective to increase the active components in water extracts and can be used for quality control of Salvia mihiorrhiza and its preparations.