以紫杉醇及紫杉醇注射液為例，根據(jù)《化學(xué)藥物雜質(zhì)研究的技術(shù)指導(dǎo)原則》，并參考《中國藥典》《美國藥典》《歐洲藥典》《英國藥典》，探討單一成分藥物有關(guān)物質(zhì)質(zhì)量控制研究要點：（1）不同來源（例如天然來源分離、半合成、發(fā)酵）單一成分藥物的有關(guān)物質(zhì)可能存在差異；（2）不同來源單一成分新藥原料藥與制劑的有關(guān)物質(zhì)控制側(cè)重點有所不同，新藥制劑的有關(guān)物質(zhì)側(cè)重于對降解產(chǎn)物制定限度；（3）4國藥典收錄的紫杉醇及其注射劑在有關(guān)物質(zhì)的控制上有所區(qū)別；（4）4國藥典或相關(guān)指導(dǎo)原則對有關(guān)物質(zhì)限度的要求基本一致；（5）通過中藥注冊分類途徑申報的，從天然來源分離得到的單一成分藥物及制劑需參照中國《化學(xué)藥物雜質(zhì)研究的技術(shù)指導(dǎo)原則》的相關(guān)要求進(jìn)行研究和控制。

In this paper, paclitaxel and Paclitaxel Injection as an example, according to the "Technical Guideline for the Study of Chemical Drug Impurities", and reference to the Chinese Pharmacopoeia, United States Pharmacopoeia, European Pharmacopoeia, British Pharmacopoeia, discuss the single component drug related substances quality control research points:(1) There may be differences in the relevant substances of single component drugs from different sources (such as natural sources, semi-synthetic, fermentation); (2) The control focus of related substances of new drug APIs from different sources with single components is different from that of new drug preparations. Related substances of new drug preparations focus on setting limits of degradation products; (3) There are differences in the control of related substances in paclitaxel and its injections recorded in the pharmacopoeia of four countries; (4) The pharmacopoeias of four countries or relevant guidelines have basically the same requirements for the limits of related substances; (5) Single component medicines and preparations isolated from natural sources that have been declared through the registration and classification of traditional Chinese medicine should be studied and controlled in accordance with the relevant requirements of "Technical Guideline for the Study of Chemical Drug Impurities".

R927.1

國家自然科學(xué)基金資助項目（81503347）