盐酸丙酰左卡尼汀有关物质的合成研究

目的 为了更好的控制盐酸丙酰左卡尼汀产品的质量,建立健全盐酸丙酰左卡尼汀原料药的质量标准。方法 根据盐酸丙酰左卡尼汀的合成路线及工艺条件,分析并合成了原料药中可能存在的4种有关物质并经¹H-NMR、MS等进行了结构确证。结果 合成了盐酸丙酰左卡尼汀中存在的4种有关物质,为以后合成建立药物质量标准所需对照品提供了参考。结论各个有关物质的合成方法所用起始原料经济、简单易得,收率较高,所得产品纯度较高,合成工艺简便、条件温和、易于操作,合成路线可行。

Preparation of the related substances ofpropionyl levocarnitine hydrochloride

Objective To establish and improve the quality standards for propionyl levocanrnitine hydrochloride API and to control the quality of the drug. Methods Four related substances that might exist in the API were synthesized according to the technologic route and conditions of the synthesis, and the structures were confirmed by ¹H-NMR and MS.Results These substances provided reference for the synthesis of reference substances needed for the quality standards of the drug. Conclusions The raw materials for the synthesis were available with high coefficient of recovery. The product had high purity. The processing was simple, operative and feasible.