Bromhexine hydrochloride freeze-dried injection and preparation method thereof

Abstract

The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to a stable bromhexine hydrochloride lyophilized powder injection which is characterized in that the lyophilized powder injection is prepared from the following components: 4g of bromhexine hydrochloride, 110g of mannitol and 2g to 8g of meglumine, wherein, the pH value of citric acid is adjusted to 2.0 to 4.0 and water for injection is added up to 2,000ml. The lyophilized powder injection prepared by the invention has higher stability.

Description

technical field [0001] The invention belongs to the technical field of medicines, in particular to a stable bromhexine hydrochloride freeze-dried powder injection. Background technique [0002] Bromhexine Hydrochloride, also known as hexyl ammonium bromide, benzylcyclohexyl bromide, bisupin, bisputum, bissupin, benzylcyclohexyl bromide, is an expectorant, which is a semi-synthetic derivative of duckbilline The hydrochloride salt of the substance was the earliest effective ingredient in the Indian folk expectorant and cough medicine Duckbill flower. It was first synthesized by Keck in 1963 and listed in 1965. my country began to produce it in 1973. Britain, France, Germany, the Netherlands, Switzerland, Italian, Portuguese, and Chinese Pharmacopoeias have all been recorded. Bromhexine hydrochloride is white or off-white crystalline powder; odorless, tasteless, slightly soluble in water. [0003] Bromhexine hydrochloride can directly act on bronchial glands, promote the releas...

AI Technical Summary

Problems solved by technology

Tablets are easy to cause adverse reactions such as nausea and stomach discomfort after patients use them, and because bromhexine hydrochloride is insoluble in water, the dissolution rate of ordinary tablets is slow and the dissolution rate is low, and the stability of injections is poor. At present, in order to overcome the above-mentioned The defect has already been prepared into freeze-dried powder injection, but because bromhexine hydrochloride itself is not stable, although the freeze-dried preparation has a certain improvement on the stability of the preparation due to its dosage form characteristics, various factors such as light and temperature will affect the stability of the preparation. The stability of the preparation is still greatly affected, so the freeze-dried preparation still needs to be stored away from light, and after a long period of storage, the content of bromhexine hydrochloride freeze-dried powder injection drops significantly, and the impurity content increases significantly