The invention provides an
ambroxol hydrochloride injection and a preparation method thereof. The
ambroxol hydrochloride injection comprises 75 mg of
ambroxol hydrochloride, 16-30 mg of a pH buffer pair, 0.8-6.2 mg of a stabilizer and 80-84 mg of an
osmotic pressure regulator, and water for injection added to 10 ml, and the injection has a pH value of 4.8-5.2. The preparation method comprises the following steps: removing
residual oxygen from the water for injection by adopting a physical means such as simultaneously regulating and controlling
temperature and pressure intensity and introducing
nitrogen, taking 45-90% of water for injection, adding the pH buffer pair according to the formula amount, stirring for 10-30 minutes to completely dissolve, and controlling pH to be 4.8-5.2; adding
ambroxol hydrochloride according to the formula amount, and stirring for dissolving; adding the stabilizer, the
osmotic pressure regulator according to the formula amount and the residual water for injection, stirring for 10-40 min, filtering with a 0.22 mu m microporous filter membrane, filling, introducing
nitrogen for protection in the whole preparation and filling process, and sterilizing at 121 DEG C for 15 min to obtain the injection. The
ambroxol hydrochloride injection can effectively promote
elimination of
sputum of a patient, and is small in adverse reaction; meanwhile, has good storage stability, simple process and low cost.