| abstract |
The application relates to the technical field of medicine, in particular to a urapidil hydrochloride injection and a preparation method thereof. The preparation method provided by the present application includes the following steps: weighing water for injection, cooling to below 30°C, vacuuming and filling with nitrogen, adding urapidil hydrochloride, cosolvent and buffer to the water for injection, stirring until completely dissolved, to obtain the first Mixing the solution, during the stirring and dissolving process, ensure that the temperature of the first mixed solution is lower than 30 ° C; add water for injection below 30 ° C to the first mixed solution, and stir until the mixture is uniform to obtain a second mixed solution, and the stirring process In the process, ensure that the temperature of the second mixed solution is lower than 30 °C; filter the second mixed solution through a filter element to obtain a filtrate; fill the filtrate with nitrogen, potting, and then sterilize, cool, lamp inspection, and leak detection to obtain uranium hydrochloride Dil injection. |