Dexmedetomidine hydrochloride injection and preparation process thereof

2015 
The invention belongs to the technical field of drug preparation, and particularly relates to dexmedetomidine hydrochloride injection and a preparation process thereof. The dexmedetomidine hydrochloride injection comprises main materials and water for injection. The main materials comprise an active component and auxiliary materials. The auxiliary materials comprise an osmotic pressure modifier and a metal ion complexing agent. Dexmedetomidine hydrochloride serves as the active component. Sodium chloride serves as the osmotic pressure modifier. Compared with the prior art, the dexmedetomidine hydrochloride injection has the advantages that pH, content and related substance results of all embodiments are still qualified after the dexmedetomidine hydrochloride injection is subjected to high temperature, illumination and acceleration for 6 months and 24 months, and it is proved that the whole product is stable in quality. In addition, the dexmedetomidine hydrochloride injection is simple in preparation process, low in cost and beneficial to industrial production.
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