The invention discloses
ambroxol hydrochloride syrup and a preparation process thereof, and belongs to the technical field of pharmaceutical preparations. The
ambroxol hydrochloride syrup comprises
ambroxol hydrochloride, a stabilizing cosolvent, a
sweetening agent, a
preservative, a pH
regulator, essence and a
solvent. Wherein the stable cosolvent is a composition of
propylene glycol,
meglumine and
propylene carbonate, and the
sweetening agent is a composition of
cane sugar and a functional
sweetening agent. The preparation process comprises the steps of low-temperature pretreatment of the main
drug and the stable cosolvent,
dissolution and mixing of the auxiliary materials, pH adjustment and essence addition, constant-volume
filtration, encapsulation and the like. Through the synergistic effect of a composite stable cosolvent
system and a specific preparation process, the storage stability of
ambroxol hydrochloride is remarkably improved, meanwhile, the taste of the preparation is optimized, the preparation is wide in applicable crowd, the preparation process is simple and controllable, and good clinical application value and industrialization prospects are achieved.