丹参抗肝硬化水溶性成分纯化工艺的研究

Study on purification technology of anti-hepatic cirrhosis water-soluble components from radix salvia

目的:优选丹参抗肝硬化水溶性成分的分离纯化工艺。方法:采用大孔树脂吸附法纯化丹参抗肝硬化水溶性成分,以丹酚酸B含量为考核指标,通过大孔树脂的筛选、泄露曲线、上样浓度、上样速度、吸附时间、洗脱剂浓度、洗脱剂用量和洗脱速率等因素的考察,确定其最佳纯化工艺。结果:最佳纯化工艺为选择AB 8型大孔树脂,上样液浓度0.4 g生药·mL-1,上样速度2 mL·min-1,上样体积3 BV,吸附时间3 h,洗脱流速3 mL·min-1,水洗脱体积3 BV,洗脱剂40%乙醇,洗脱剂用量10 BV,得到丹参总酚酸的纯度为76.23%,符合申报新药中要求有效成分质量分数达到50%以上。结论:该工艺具有操作简单、节省溶剂等优点,具有较好的推广应用前景。

Objective：To optimize the purification process of anti-hepatic cirrhosis water-soluble compo- nents from radix salvia. Methods：The anti-hepatic cirrhosis water-soluble components in radix salvia were purified with macroporous resin,taking the content of salvianolic acid B as an index. The best purification process was es- tablished by screening the maeroporous resin and investigating the leak curve,concentration of sample, flow rate of sample loading, adsorption time, concentration of eluent, content of eluent, elution rate, and other factors. Results： The best purification process of salvianolic acid B involved AB-8 macroporous resin, 0.4 g.mL-1 crude drug solution at a loading rate of 2 mL＂ rain-1 with a volume of 3 BV, adsorption time of 3 h,water washing at a rate of 2 mL＂ rain- with a volume of 3 BV, and 40% ethanol washing with a volume of 10 BV. The purity of salvianolie acid B was 76.23% ,consistent with the requirement for new drug application that the mass fraction of active ingredients should be more than 50%. Conclusion：The process is simple and solvent-saving,and has a good application prospect.