盐酸异丙肾上腺素及注射液的有关物质研究

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 on the related substances in isoprenaline hydrochloride and its injection. Methods: Related substances were determinated by HPLC method,and identificated by LC/MS method.The major impurity was been synthesized,chemical reactions,UV,IR and NMR proved its structure. Results: Sodium metabisulfite is added in injection as antioxidant,which can react with the active ingredient to form sulfonic acid derivatives.The sulfonic acid derivatives had been shown possess no activity and no toxicity by animal tests. Cconclusion: The method and limit to detective related substances is reasonable and reliable.

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