Preparation process of dexmedetomidine hydrochloride injection

Abstract

The invention relates to a preparation method of liquid medicine for injection, in particular to a preparation process of dexmedetomidine hydrochloride injection. The process comprises the following steps: A, soaking a neutral borosilicate ampoule in an inorganic acid solution, performing ultrasonic cleaning, performing blow-drying with compressed air, performing flushing, and performing sterilization and drying with a tunnel oven to obtain an acid-treated neutral borosilicate ampoule for later use; B, weighing dexmedetomidine hydrochloride and sodium chloride, adding water for injection for dissolving, and performing uniform stirring to obtain a dexmedetomidine hydrochloride injection crude product; and C, filtering the dexmedetomidine hydrochloride injection crude product, encapsulatingthe filtered crude product in the acid-treated neutral borosilicate ampoule, and carrying out high-pressure steam sterilization to obtain the finished product dexmedetomidine hydrochloride injection.The process is simple to operate and can effectively control the PH value, and the PH stability is high.

Description

technical field [0001] The invention relates to a preparation method of a medicinal liquid for injection, in particular to a preparation process of dexmedetomidine hydrochloride injection. Background technique [0002] Dexmedetomidine hydrochloride is the dextroisomer of the α2-adrenergic receptor agonist medetomidine. Compared with medetomidine, it has stronger selectivity to the central α2-adrenoceptor and has a half-life It is short and the dosage is very small. It is clinically suitable for sedation of intubated and ventilated patients during intensive care treatment. Selective effects on α2-adrenergic receptors can be seen when animals are slowly intravenously infused with 10-300 μg / kg dexmedetomidine, but at higher doses (1 mg / kg) slowly intravenously or rapidly intravenously administered It acts on both α1 and α2-receptors. [0003] The inventors believe that the dexmedetomidine hydrochloride compound contains hydrochloric acid groups, which will free acidic ions in...

AI Technical Summary

Problems solved by technology

[0003] The inventors believe that the dexmedetomidine hydrochloride compound contains hydrochloric acid groups, which will free acidic ions in the aqueous solution, and be directly filled in any existing commercially available ampoule that has not been generally treated, and have a slight interaction with the glass surface. However, no pH buffer reagent is added to the product, which will lead to changes in the pH value of the drug solution. After 12 months of long-term storage, the pH value will rise. The change in pH value and content will cause the quality and curative effect of the drug to be unstable, and even exceed the acceptable limit. become substandard drugs

This problem leads to short validity period of listed products

For the problems of this product, there are no effective solutions and literature reports so far. In order to stabilize the pH value of the injection, there are currently public technologies that use acetate, phosphate, citrate or glutamate as PH buffering agent, these PH buffering agents will affect the quality of the injection, and the dosage is difficult to control, and the validity period is also difficult to control

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