Medicaments solution

Abstract

The invention discloses a pharmaceutical solution which takes levosimendan or medicine salt thereof as an active ingredient, takes absolute ethyl alcohol as a solvent, and also comprises maleic acid and solubilizer polyvidone. The pH valve of the pharmaceutical solution ranges from 3 to 4; wherein, the weight-to-volume ratio of the levosimendan or the medicine salt thereof is 0.2 to 0.3 percent, and 0.25 percent is optimized; the weight-to-volume ratio of the maleic acid is 0.001 to 0.01 percent, and the range from 0.005 to 0.009 percent is optimized; the weight-to-volume ratio of the polyvidone is 0.5 to 2 percent, and 1 percent is optimized. A stability experiment shows that pharmaceutical solution has better stability.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a medicine solution with levosimendan or a medicine salt thereof as an active ingredient. Background technique [0002] Levosimendan (Levosimendan) is a new type of drug for the treatment of heart failure - cardiomyopathy inotropic drugs, also known as calcium sensitizers. Researched and developed by Orion Corporation of Finland, it was first launched in Switzerland in October 2000. It is suitable for short-term intravenous injection treatment after hospitalization for acute decompensated severe chronic heart failure. When conventional drugs alone are not effective enough, it is used as an additional drug. sex therapy. The marketed dosage form is injection, the trade name is Simdax, and the specifications are 5ml: 12.5mg and 10ml: 25mg. The drug has a unique dual mode of action, which can increase cardiac output and dilate blood vessels. It does not increase the heart rate whi...

AI Technical Summary

Problems solved by technology

[0003] Chinese patent CN0081245.3 discloses the technology of the drug solution of levosimendan. This patent discloses the use of ethanol as a solvent, adding an organic acid with a pKa of 2-4 and a solubilizer. This patent is aimed at the levosimendan to a certain extent. The physical and chemical properties of the preparation have been studied, but the weight-to-volume ratio of its organic acid is 0.03%-0.6%, and the dosage is relatively large. It is well known that when more organic acids are added to the intravenous infusion drug preparation, it will cause blood vessels in patients to The human body needs to metabolize these organic acids. Although these organic acids are harmless to the human body, they are not beneficial. The more ineffective ingredients are added, the greater the burden on patients; the patent The solubilizer was not selected for the chemical properties of levosimendan, but it was just determined for granted, and no in-depth research was carried out for the molecular properties of levosimendan. These defects led to the phenomenon of levosimendan or its medicinal salt Unstable substances, because of the preparation, causing a large number of adverse reactions, especially those caused by the degradation products of levosimendan or its medicinal salts

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