制備型高效液相色譜法是一種使用高壓、大流量液體輸送系統(tǒng)在高分辨率、大內(nèi)徑、高載量分離柱上進(jìn)行樣品高純度分離的液相色譜制備方法。應(yīng)用該方法分離的產(chǎn)品在純度、回收率、分離效率等方面遠(yuǎn)遠(yuǎn)優(yōu)于傳統(tǒng)的制備方法，因此在藥物研究、生產(chǎn)領(lǐng)域得到廣泛應(yīng)用。介紹制備型高效液相色譜法的研究概況，特點(diǎn)，影響制備型高效液相色譜分離純化的因素，以及在藥物雜質(zhì)研究中的實(shí)際應(yīng)用，并對(duì)制備型高效液相色譜技術(shù)存在的問題與發(fā)展方向進(jìn)行總結(jié)。

Preparative high performance liquid chromatography (HPLC) is a way to use high-pressure, large flow of liquid delivery system for high-purity separation of the sample on high-resolution, large internal diameter, high capacity separation column. Application of the method for the separation of products in terms of purity, recovery, separation efficiency is far superior to the traditional method of preparation, and it is widely used in drug research and production fields. The efficient preparative HPLC steps, the preparative HPLC research and development direction, and the research on drug impurities in practical applications have been summarized. This article describes the research profile, characteristics of preparative HPLC, and factors that influence the process of separation and purification, steps to develop and establish the method, as well as the application of preparative HPLC in the study on impurities of drugs. Finally, the existing problems of the present preparative HPLC and the developing trend have also been discussed.