Chemical Industry and Engineering Progress ›› 2022, Vol. 41 ›› Issue (S1): 461-468.DOI: 10.16085/j.issn.1000-6613.2022-1317

• Biochemical and pharmaceutical engineering • Previous Articles     Next Articles

Study of silica gel regeneration applied on cyclosporine A column chromatography

HUANG Ye1(), YAN Xing2, WU Qiaowei2, CHAI Xiaotao1, PAN Gongying2, ZHANG Jinfeng2, LI Xiangqian2()   

  1. 1.Joyang Laboratories, Yancheng 224300, Jiangsu, China
    2.School of Life Science and Food Engineering, Huaiyin Institute of Technology, Huai'an 223003, Jiangsu, China
  • Received:2022-07-13 Revised:2022-09-25 Online:2022-11-10 Published:2022-10-20
  • Contact: LI Xiangqian

环孢菌素A柱层析硅胶再生工艺

黄晔1(), 言行2, 吴巧薇2, 柴小涛1, 潘恭赢2, 张金峰2, 李相前2()   

  1. 1.江苏九阳生物制药有限公司,江苏 盐城 224300
    2.淮阴工学院生命科学与食品工程学院,江苏 淮安 223003
  • 通讯作者: 李相前
  • 作者简介:黄晔(1981—),男,高级工程师,研究方向制药工程。E-mail:13171811@qq.com

Abstract:

The industrial production of cyclosporine A involves fungal fermentation, extraction, concentration, crystallization, silica gel column chromatography, decolorization, secondary crystallization and other steps, among which silica gel column chromatography produces a large amount of waste silica gel, which is under great pressure of environmental protection treatment and high cost for enterprises. Based on this, the silica gel regeneration process of cyclosporine A column chromatography was studied in this paper, and the regeneration conditions were optimized by response surface methodology: four column volumes were backwashed with ethanol containing 0.26% polysorbitol, and 2.1 column volumes were forward washed with deionized water containing 0.15% hydrogen peroxide at a flow rate of 5mL/min. The recycled silica gel was pressed out with compressed air and dried until the moisture content was 6%. The yield of the regenerated silica gel can reach more than 75% when used according to the original process, and the yield of the third regenerated silica gel can still reach 75%. This study established a set of feasible cyclosporine purified silica gel regeneration process, which can effectively save factory production cost and reduce environmental pressure.

Key words: cyclosporine A, column chromatography, silica gel regeneration, purification

摘要:

环孢菌素A工业化生产涉及真菌发酵、萃取、浓缩、结晶、硅胶柱层析、脱色、二次结晶等步骤,目前硅胶柱层析步骤的硅胶只能一次使用,现实生产过程产生了大量的废硅胶,环保处理压力大、企业成本高。据此本文开展了环孢菌素A柱层析硅胶再生工艺研究,针对硅胶上吸附的杂质性质,研究了硅胶再生洗脱溶剂系统,通过响应面法优化再生条件,结果表明:选用含有0.26%聚山梨醇的乙醇反向冲洗4个柱体积,再使用双氧水浓度为0.15%的去离子水正向冲洗2.1个柱体积,冲洗流速为5mL/min;使用压缩空气将再生后的硅胶压出,烘干至水分含量为6%。按照本方法得到的再生硅胶按原工艺使用时,环孢菌素A回收率完全达标,并且可以三次重复使用达标。本研究建立了一套切实可行的环孢素纯化硅胶再生工艺,可有效节约工厂生产成本和减轻环境压力。

关键词: 环孢菌素A, 柱层析, 硅胶再生, 纯化

CLC Number: 

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