目的 鑒定消旋山莨菪堿未知雜質(zhì)。方法 采用多種色譜、光譜方法聯(lián)合對(duì)消旋山莨菪堿中的未知雜質(zhì)進(jìn)行分析，確定未知雜質(zhì)結(jié)構(gòu)。結(jié)果 消旋山莨菪堿在存儲(chǔ)過程中因水解而產(chǎn)生雜質(zhì)，經(jīng)過高效液相色譜法、液相色譜-質(zhì)譜聯(lián)用技術(shù)、薄層色譜法和核磁共振技術(shù)鑒定，雜質(zhì)為6β-羥基托品和托品酸。結(jié)論 消旋山莨菪堿中的雜質(zhì)為水解產(chǎn)物6β-羥基托品和托品酸，應(yīng)對(duì)這兩種雜質(zhì)進(jìn)行質(zhì)量控制。

Objective To identify the impurity of racanisodamine.Methods Several chromatographic and spectroscopic methods were used to analyze and identify the unknown impurities in racanisodamine.Results During storage, the impurities were produced by hydrolysis of racanisodamine. The impurities were 6β-hydroxy tropine and tropine acid after identifying by HPLC, LC-MS, TLC and NMR.Conclusion 6β-hydroxy tropine and tropine acid were hydrolysis products of racanisodamine, which were the impurities. The quality control of the two impurities should be carried out.

國家自然科學(xué)基金項(xiàng)目（81403071）；北京市自然科學(xué)基金項(xiàng)目（7172130）；北京中醫(yī)藥大學(xué)自主課題項(xiàng)目（2017-JYB-XS-075）