最新製備型HPLC技術在樣品純化上的應用

The New Technologies of Preparative HPLC on the Applications of Sample Purification

周泳杉(Yun-Shan Chou)

《科儀新知》 144期 (2005/02) Pp. 72-87

https://doi.org/10.29662/IT.200502.0008

摘要

本文介紹三類製備型層析系統，分別用在新藥開發和製造領域中純化生物性分子和藥物有效成分。「分析放大系統」主要用於獲取實驗性樣品，以提供實驗室研發以及新藥開發之用；另外，該系統亦可獲取足夠的組成，供給結構分析、藥品測試以及臨床試驗使用。「高產率放大系統」可以藉由非線性超載，將製備能力放到最大；它是一桌上型高壓製備層析設備，主要協助實驗室純化臨床試驗或是生產所需的成分。「生產放大系統」則是用以作為生物性分子或是藥物有效成分的大量生產製造。這三類系統可以協助研究人員更了解人類蛋白質、藥物在分子結構、動力學以及功能上的特性，以提供在研究階段關鍵性的分析，並且可提供藥品有效成分或生物性藥品的量產。

並列摘要

This article introduces three kinds of preparative chromatography used in purifying bio molecules and active ingredient pharmaceutical compounds for drug discovery and manufacture. ”Analytical Scale-up System” is used in the fields of purified of experimental compounds during laboratory research, drug discovery, or compounds in sufficient quantities for structure analysis, drug testing and clinical trials. The ”High Throughput Scale-up System” can be scale-up in the nonlinear overload condition for maximizing capability. It is a bench-top preparative HPLC solution on helping laboratories purifies compounds for clinical trials prior to full-scale production. The ”Process Scale-up System” is a complete preparative chromatography solution for purifying production volumes of bio molecules and active ingredient drug compounds used at pharmaceutical manufacturing. All these kinds of preparative HPLC design help scientists understand the structure, dynamics, and function of human proteins and prospective pharmaceutical compounds; perform critical analyses throughout the development process; and purify production quantities of active drug ingredients and bio-pharmaceuticals.