A kind of levodopa preparation and preparation method and application thereof

A technology for levodopa preparations, which is applied in the field of medicine, can solve problems such as the inability to prepare high-concentration solution-type preparations, poor solubility and stability of levodopa, and uneven preparations of levodopa, so as to improve drug compliance and avoid drug Effects of precipitation, avoidance of irritation and toxicity

Active Publication Date: 2022-05-24
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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  • A kind of levodopa preparation and preparation method and application thereof
  • A kind of levodopa preparation and preparation method and application thereof
  • A kind of levodopa preparation and preparation method and application thereof

Examples

Experimental program
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Effect test

Embodiment 1～12 and comparative example 1～6

[0093] Embodiments 1-12 are the levodopa preparations of the preferred formulations of the present invention;

Embodiment 5

[0138] Levodopa of Example 5 (Dual Antioxidant), Example 41 (Double Antioxidant), Example 21 (Single Reduction Antioxidant Sodium Metabisulfite), Example 40 (Single Reduction Antioxidant Sodium Sulfite) After the preparation samples were 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 Example 5, Example 21 and Example 41 long-term stability test results

[0140]

[0141] The investigation results show that the single antioxidant sample containing sodium metabisulfite has better stability, while the single antioxidant sample containing sodium sulfite has a significant increase in LD impurities; The impurity is higher than CD, so the single antioxidant sample containing sodium metabisulfite and the sample containing sodium metabisulfite and free radical scavenging double antioxidant are preferred.

[0142] Use the levodopa preparation sample solutions of Example 5 (double ant...

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Abstract

The invention discloses a levodopa preparation, which comprises the following components: 13-36wt% levodopa, a dopa decarboxylase inhibitor with a weight ratio of 1:4-10 to levodopa, and levodopa and The molar sum ratio of dopa decarboxylase inhibitor is the arginine of 0.3~1.0:1, and the ratio of the molar sum of levodopa and dopa decarboxylase inhibitor is the meglumine of 0.05~0.8:1, uses The pH adjusting agent used to adjust the pH of the solution to 9.6-10, the antioxidant of 0.01-1 wt%, the EDTA of 0.01-0.5 wt%, and the balance of water. The levodopa preparation is a high-concentration solution preparation, the volume of the unit preparation can be reduced to 3mL, and it can be used in combination with the second-generation patch pump to improve the convenience of use and medication compliance of patients. The invention also discloses the preparation method and 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 and a preparation method and application thereof. Background technique [0002] The incidence of Parkinson's disease and the need for medication [0003] Parkinson's is a neurodegenerative disease with a high incidence in people over the age of 65. It is estimated that there are nearly 3 million Parkinson's patients in my country, accounting for 50% of the world's patients with the disease. [0004] Levodopa has always been regarded as a landmark drug in 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 dopamine in the brain. However, we know that the conversion of levodopa to dopamine is catalyzed by aromatic L-amino acid decarboxylase, which is ubiquitous in the intestinal mucosa, liver, brain and brai...

Claims

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Application Information

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Patent Type & Authority Patents(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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