目的:对盐酸异丙肾上腺素及注射液中所含的有关物质进行了研究。方法:采用液相色谱法对原料和注射液中的有关物质进行了测定;液质联用法鉴定主要杂质的结构;合成出其中最大的杂质;四谱解析确证其结构;进行了初步的药理、毒理研究。结果:该杂质即主成分与抗氧剂焦亚硫酸钠反应生成的磺酸化物,对麻醉猫的血压无影响,大剂量给药情况下不引起小鼠明显毒性反应。结论:有关物质研究结果为方法的建立和限度的确定提供了依据。 OBJECTIVE: To study the related substances contained in isoproterenol hydrochloride and injection. Methods: The related substances in raw materials and injection were determined by liquid chromatography. The structures of major impurities were identified by liquid chromatography-mass spectrometry (LC-MS / MS). The largest impurity was synthesized and the structure was confirmed by four spectrum analysis. The preliminary pharmacology, Toxicological research. Results: The impurity was sulfonated by the reaction between the main component and antioxidant sodium metabisulfite, which had no effect on the blood pressure of anesthetized cats and did not cause obvious toxic reaction in mice under the condition of high dose. Conclusion: The results of the related substances provide the basis for the establishment of the method and the determination of the limit.