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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2.05～83.36μg·ml~(-1)的范围内线性关系良好(r=0.999 9),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。
Objective: To prepare Fuganling capsule and investigate its stability. Methods: Salvia miltiorrhiza was extracted by water boiling method. Salvianolic acid was purified by macroporous resin. The contents of salvianolic acid B in refined Salvia miltiorrhiza powder and its preparation were investigated by HPLC. RESULTS: The linearity of salvianolic acid B was in the range of 2.05-83.36 μg·ml -1 (r=0.999 9). The recovery was 101.09% and the RSD was 1.63%. The content of salvianolic acid B in Fuganling capsule was 24.5%. Conclusion: The use of macroporous resin to refine the water-soluble components of Salvia miltiorrhiza can effectively reduce the content of non-phenolic acids and impurities in Salvia miltiorrhiza extract while effectively retaining salvianolic acid B and other active ingredients, and is beneficial to increase the drug loading of the formulation. Provides analytical methods for quality control of Salvia miltiorrhiza and its preparations.