The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to an
ambroxol hydrochloride oral solution and a preparation process thereof, and the preparation process comprises the following steps: heating
purified water to 60-80 DEG C, adding
sorbitol and L-
cysteine into the
purified water, stirring and dissolving for 10-30 minutes, adding
hydroxyethyl cellulose, uniformly dispersing, and cooling to 48-52 DEG C to obtain a first
mixed solution; adding
ambroxol hydrochloride,
benzoic acid and
glycerol into the first
mixed solution, stirring until the
ambroxol hydrochloride,
benzoic acid and
glycerol are completely dissolved, finally adding essence, and uniformly mixing; and finally, fixing the volume to a set volume by adopting
purified water. According to the preparation method disclosed by the invention, through collaborative optimization of dual effects of L-
cysteine and a specific feeding sequence, even if the content of
sorbitol reducing sugar is greater than 0.3%, the content of an
impurity B can still be controlled to be less than or equal to 0.3%, the content of an
impurity F can still be controlled to be less than or equal to 0.2%, the deviation between the content of related substances and a
reference preparation is less than or equal to + / -0.3%, and the stability is excellent.