Preparation method of dexmedetomidine hydrochloride injection

Abstract

The invention discloses a preparation method of a dexmedetomidine hydrochloride injection. The preparation method comprises the following steps of: adding water for injection into a container, adding sodium chloride, stirring to completely dissolve sodium chloride, adding dexmedetomidine hydrochloride, and stirring and mixing; supplementing water for injection to a theoretical preparation amount, stirring, starting a circulating pipeline of a dispensing system, and circularly stirring and mixing; detecting the pH value and content of the liquid medicine; and after the detection is qualified, making bottles from polypropylene particles in a sterile environment by adopting blowing, filling and sealing integrated equipment, filling the liquid medicine and sealing. According to the preparation method disclosed by the invention, the bottles are made, filled and sealed in the sterile environment by adopting the polypropylene blowing, filling and sealing integrated equipment, the production link and the exposure time of the interior of the packaging material and the liquid medicine are reduced, and the quality controllability is excellent.

Description

technical field [0001] The invention relates to the technical field of pharmacy, in particular to a preparation method of dexmedetomidine hydrochloride injection. Background technique [0002] Dexmedetomidine hydrochloride injection, which is a relatively selective α-adrenergic receptor agonist, has a sedative effect. The main clinical indications are that it can be applied to surgical patients under general anesthesia, sedation during trachea, intubation and mechanical ventilation. [0003] It was launched in the United States in March 2000 under the product name Precedex, and in January 2004 in Japan under the product name Precedex. It was launched in the EU in 2011 under the product name Dexdor. Since Jiangsu Hengrui was first approved for listing in 2009, there have been many domestic The enterprise is approved for production. Most of the packaging forms adopted are glass ampoules, which are low in cost and suitable for mass production. However, the current production...

AI Technical Summary

Problems solved by technology

[0004] Therefore, the technical problem to be solved in the present invention is to overcome the defect of high compatibility risk between dexmedetomidine hydrochloride injection and packaging material in the prior art, thereby providing a preparation method of dexmedetomidine hydrochloride injection , through the use of polypropylene blow-fill-seal integrated machine equipment, to avoid changes in the pH value, effectively avoiding the generation of potential safety hazards

Images