High-concentration levodopa preparation and preparation method and application thereof

Abstract

The invention discloses a high-concentration levodopa preparation. The high-concentration levodopa preparation comprises the following components: 13-36% of levodopa by weight, a dopa decarboxylase inhibitor with a weight ratio of 1:(4-10) to levodopa, arginine with a molar ratio of (0.4-1):1 to the sum of the mole number of levodopa and dopa decarboxylase inhibitor, meglumine with a weight ratioof (0.5-0.65):1 to arginine, a pH regulator for adjusting the pH value of a solution to 10.1-10.9, 0.01-1% of an antioxidant by weight, 0.01-0.5% of EDTA and the balance water. The high-concentrationlevodopa preparation is a high-concentration solution preparation, the volume of the preparation per unit can be reduced to 2 mL, the preparation can be combined with an infusion pump of the smallestvolume, and the preparation can be carried and used for 24 hours conveniently and continuously by patients, so that use convenience and medication compliance of patient treatment are improved greatly.The invention also discloses a preparation method and application of the high-concentration levodopa preparation.

Description

technical field [0001] The invention belongs to the technical field of medicine and relates to a compound composition, in particular to a high-concentration levodopa preparation and its preparation method and application. Background technique [0002] 1. Parkinson's incidence and drug demand [0003] Parkinson's is a degenerative disease of the nervous system, and the incidence rate is higher in the elderly over 65 years old. It is estimated that the current number of Parkinson's patients in my country is nearly 3 million, accounting for 50% of the global number of patients with the disease. With the serious aging of my country and the prolongation of life expectancy, it is predicted that there will be 5 million Parkinson's patients by 2030. [0004] Levodopa has always been considered a milestone drug for the treatment of Parkinson's disease. As an intermediate metabolic precursor of dopamine, it can penetrate the blood-brain barrier and restore the concentration of dopami...

AI Technical Summary

Problems solved by technology

[0021] Therefore, there are problems such as inhomogeneity, non-portability, and poor compliance for levodopa preparations in the prior art, and because levodopa solubility and stability are poor Due to the technical problem that high-concentration solution-type preparations cannot be prepared and cannot be combined with patch-type infusion pumps, one of the purposes of the present invention is to provide a high-concentration levodopa preparation with ultra-high concentration and stable quality, which can be used with small Volume patch infusion pump is used in combination, which is convenient for patients to carry and use, and can effectively improve medication compliance

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