- Preparation method of bromhexine hydrochloride impurity C
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The invention relates to the field of chemical pharmacy, in particular to a preparation method of bromhexine hydrochloride impurity C: N-methyl-N-cyclohexyl-2-aminobenzene methylamine. The method hasobvious advantages in the aspects of rapidness, high efficiency and economy. The prepared high-purity N-methyl-N-cyclohexyl-2-aminobenzene methylamine has important significance for the quality research of bromhexine hydrochloride. The preparation method comprises the following steps: (1) adding o-aminobenzyl alcohol into thionyl chloride in batches, reacting at room temperature, evaporating a solvent to dryness after the reaction is finished, adding a pulping solvent, pulping and filtering to obtain a compound 1; (2) adding the compound 1 into N-methylcyclohexylamine in batches, reacting at room temperature, after the reaction is finished, adding a solvent, refluxing, decolorizing with activated carbon, filtering, and evaporating filtrate to dryness to obtain an impurity C.
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Paragraph 0039-0040; 0044-0045; 0049-0050; 0054-0055
(2020/08/25)
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