Zhang Min, Ignatova Svetlana, Liang Qionglin, Wu Jun Frank, Sutherland Ian, Wang Yiming, Luo Guoan
Modern Engineering Center for Traditional Chinese Medicine, School of Pharmacy, East China University of Science and Technology, Shanghai 200237, China.
J Chromatogr A. 2009 May 1;1216(18):3869-73. doi: 10.1016/j.chroma.2009.02.067. Epub 2009 Mar 3.
A large-scale purification of salvianolic acid B from Salvia miltiorrhiza Bunge is presented. The method development began with selection of the solvent system, then optimization of the operating parameters and ended up with linear scale-up from an analytical to a preparative instrument. Three factors were used for method optimization and scale-up estimation: purity, process throughput and process efficiency. Preparation was achieved using a two-phase solvent system comprising hexane-ethyl acetate-methanol-acetic acid-water (1:5:1.5:0.00596:5, v/v). This preparation yielded 475 mg of salvianolic acid B with a purity of 96.1% from 1.5 g of crude extract. The process throughput of crude was 2.23 g/h while process efficiency per gram of target compound was 0.769 g/h. Two factors-process environmental risk factor and process evaluation factor were used for evaluation of the separation process.
本文介绍了从丹参中大规模纯化丹酚酸B的方法。方法开发始于溶剂系统的选择，然后是操作参数的优化，最终从分析仪器线性放大至制备仪器。使用三个因素进行方法优化和放大估计：纯度、工艺通量和工艺效率。采用由己烷-乙酸乙酯-甲醇-乙酸-水（1:5:1.5:0.00596:5，v/v）组成的两相溶剂系统进行制备。该制备方法从1.5 g粗提取物中得到了475 mg纯度为96.1%的丹酚酸B。粗品的工艺通量为2.23 g/h，而每克目标化合物的工艺效率为0.769 g/h。使用两个因素——过程环境风险因素和过程评估因素对分离过程进行评估。
