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Levodopa preparation and preparation method and application thereof

A technology for levodopa preparations, which is applied in the field of medicine, can solve the problems of inability to prepare high-concentration solution preparations, poor solubility and stability of levodopa, and uneven preparations of levodopa, so as to improve drug compliance and solubility , the effect of volume reduction

Active Publication Date: 2020-09-25
SHANGHAI JINGXIN BIOLOGICAL MEDICAL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0022] Aiming at the problems of unevenness, non-portability, and poor compliance of levodopa preparations in the prior art, and because of the poor solubility and stability of levodopa, it is impossible to prepare high-concentration solution-type preparations and cannot be used in combination with patch-type infusion pumps One of the objectives of the present invention is to provide a levodopa preparation with ultra-high concentration and stable quality. compliance

Method used

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  • Levodopa preparation and preparation method and application thereof
  • Levodopa preparation and preparation method and application thereof
  • Levodopa preparation and preparation method and application thereof

Examples

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Effect test

Embodiment 1～12 and comparative example 1～6

[0093] Embodiment 1~12 is the levodopa preparation of preferred formula of the present invention;

Embodiment 5

[0138] The levodopa of embodiment 5 (double antioxidant), embodiment 41 (double antioxidant), embodiment 21 (single reduction antioxidant sodium metabisulfite), embodiment 40 (single reduction antioxidant sodium sulfite) After the preparation sample was stored for 3 months (3M), samples were taken to detect the content and related substances. The test results are shown in Table 10.

[0139] Table 10 embodiment 5, embodiment 21 and embodiment 41 long-term stability test result

[0140]

[0141] Investigation result shows, the monoantioxidant sample stability that contains sodium pyrosulfite is better, and the single antioxidant sample LD impurity that contains sodium sulfite has obvious growth; Contrast double antioxidant sample and the double antioxidant sample phase of embodiment 5 Higher impurity than CD, so samples containing sodium metabisulfite monoantioxidant and samples containing sodium metabisulfite and free radical scavenging dual antioxidant are preferred.

[01...

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Abstract

The present invention discloses a levodopa preparation. The levodopa preparation comprises the following components, 13-36 wt% of levodopa, dopa decarboxylase inhibitor in weight ratio of 1: (4-10) tolevodopa, arginine in ratio of (0.3-1.0) to total moles of levodopa and dopa decarboxylase inhibitor, meglumine in ratio of (0.05-0.8): 1 to total moles of levodopa and dopa decarboxylase inhibitor,pH regulator used for adjusting pH of solution to 9.6-10, 0.01-1 wt% of antioxidant, 0.01-0.5 wt% of EDTA and balance of water. The levodopa preparation is a high-concentration solution preparation, and the unit volume of the preparation can be reduced to 3 mL. The levodopa preparation can be used in combination with the second generation of patch pump to improve the use convenience and medicationcompliance in patient treatment. The invention also discloses a preparation method and an application of the 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 levodopa preparation, a preparation method thereof and an application thereof. Background technique [0002] 1. Parkinson's incidence and medication needs [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...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K45/06A61K31/12A61K31/165A61K31/198A61K31/277A61K47/18A61P25/16
CPCA61K45/06A61K31/198A61K31/165A61K31/12A61K31/277A61K47/183A61K47/18A61P25/16A61K2300/00
Inventor 陈琰刘烁华鹿月侯建
Owner SHANGHAI JINGXIN BIOLOGICAL MEDICAL
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