A kind of dopexamine hydrochloride injection and preparation method thereof

Abstract

The invention discloses dopexamine hydrochloride injection. The dopexamine hydrochloride injection is composed of dopexamine hydrochloride, a complexing agent and a solvent. The formed injection has a specific pH value, and subpackaged into each ampoule bottle. A preparation method of the dopexamine hydrochloride injection comprises the following steps: in the water for injection with the 70% total volume, adding dopexamine hydrochloride and arginine with the prescription amount, stirring for dissolving, adding water for injection for making constant volume till reaching the total volume; adding with activated carbon with the volume accounting for 0.2% of the total volume, stirring for 15 min, and filtering by a filter membrane of 0.22 mu m; and taking 5mL of the obtained mixed liquid, canning into a 5mL ampoule bottle, charging nitrogen and carrying out heat sealing, and sterilizing at 121 DEG C for 15 min. According to the dopexamine hydrochloride injection and the preparation method thereof, the prescription is simple, the pH is 5-7, the injection is stable after compatibility of medicines, the content can not decline, the injection is particularly suitable for the clinic, wherein arginine is the human endogenous substance, the use amount of arginine is reasonable, and therefore, the safety is high. The use amount of the arginine is safe.

Description

technical field [0001] The invention belongs to the technical field of medicines, and relates to an injection used for treating exacerbation of chronic heart failure and perioperative heart failure, in particular to a dopexamine hydrochloride injection and a preparation method thereof. Background technique [0002] Dopexamine hydrochloride is a newly synthesized catecholamine drug. Its chemical structure is similar to that of dopamine, and it has a strong excitatory effect on β2 adrenergic receptors. The excitatory effect is weak; it can still inhibit the uptake of catecholamines by neurons. The positive frequency effect and positive inotropic effect of this product are through drug indirect stimulation of β1 adrenergic receptors, increasing the reflex activity of baroreceptors, inhibiting the reuptake of norepinephrine, and directly stimulating cardiac β2 adrenergic receptors And produced. This product can also increase the blood flow of kidney, cardiac muscle and skeleta...

AI Technical Summary

Problems solved by technology

However, the clinical usage of this product is to use after compatibility with 0.9% sodium chloride injection or 5% glucose injection. The Chinese Pharmacopoeia stipulates that the pH limits of 0.9% sodium chloride injection and 5% glucose injection are 4.5~7.0 respectively. and 3.5~6.5, after this product is compatible with it, the pH of the medicinal solution is likely to be higher than 5, so the content of the medicinal solution is unstable after compatibility, and it is difficult to guarantee the clinical efficacy and safety

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