高速逆流色谱纯化他克莫司工艺放大研究  

Purification and scale-up of tacrolimus using high speed countercurrent chromatography

作　　者：温耀明[1] 肖丽华[1] 庄鸿[1] 乐占线[1] 陈秀明[1] 郑卫[1] 

机构地区：[1]福建省微生物研究所,福州350007

出　　处：《中国抗生素杂志》2014年第4期267-271,共5页Chinese Journal of Antibiotics

摘　　要：目的探讨由小型放大到中型高速逆流色谱纯化他克莫司的方法。方法在小型高速逆流色谱上成功分离纯化他克莫司基础上,研究放大到中型高速逆流色谱上相关参数,包括流动相的选择、流速、进样量和连续进样时间、次数等。结果成功地在中型高速逆流色谱上纯化了3批次共18克他克莫司粗品,得到纯度99.2%的9克样品,每批次进样量放大18倍情况下的纯化效果与小型高速逆流色谱上相似。结论本研究为放大到大型高速逆流色谱上和进行连续工业化生产提供了参考。Objective Purification and scale-up of tacrolimus using high-speed countercurrent chromatography. Methods On the basis of successful separation and purification of tacrolimus using small high-speed countercurrent chromatography, the parameters of medium-sized high-speed countercurrent chromatography are studied, including the choice of mobile phase, flow rate, injection volume and continuous injection time. Results Three batches of 18 grams of crude tacrolimus are purified using medium-sized high-speed countercurrent chromatography and obtain 9g samples of purity 99.2%. In the case of each batch injection volume of 18 times magnification, purification effect is similar to the small high-speed countercurrent chromatography. Conclusion This study provides a reference for scale-up to large high-speed countercurrent chromatography and continuous industrial production.

关 键 词：高速逆流色谱 他克莫司 放大 纯化 

分 类 号：R979.5[医药卫生—药品]