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A pharmaceutical composition for preventing or treating inflammatory diseases

A technology of medicine and pharmacy, applied in the field of medicine, can solve the problems of many adverse reactions and limited widespread use, and achieve the effects of low retinal cytotoxicity and significant anti-inflammatory effect

Active Publication Date: 2021-09-24
HAINAN SIMCERE PHARMA CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there are many adverse reactions in its clinical application, which limits its further widespread use.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Embodiment 1: the effect of hydroxychloroquine sulfate and leflunomide combination treatment mouse arthritis

[0027] Dosage group design: normal control group, model control group (normal saline), hydroxychloroquine sulfate (15mg / kg) group, leflunomide (0.25mg / kg) group, leflunomide (0.5mg / kg) group, Hydroxychloroquine sulfate / leflunomide combined administration 8:1 group A (5mg / kg hydroxychloroquine sulfate+0.5mg / kg leflunomide), hydroxychloroquine sulfate / leflunomide combined administration 24:1 group ( 15mg / kg hydroxychloroquine sulfate+0.5mg / kg leflunomide), hydroxychloroquine sulfate / leflunomide combined administration 48:1 group (15mg / kg hydroxychloroquine sulfate+0.25mg / kg leflunomide), The ratio is calculated on a molar basis.

[0028]Construction of collagen mouse arthritis animal model: mice were used as test animals, 80 SPF grade DBA / 1 mice, male, 7-8 weeks old, weighing 18-22g, were randomly divided into 8 groups. Except for the normal group, the mouse CI...

Embodiment 2

[0041] Example 2: The composition of hydroxychloroquine sulfate and leflunomide has lower cytotoxicity to retinal cells

[0042] The main serious risk of long-term administration of hydroxychloroquine is retinal accumulation and subsequent ocular toxicity (Terahi et al., 2008. Semin Opthal. (3): 201-208. PMID). ARPE-19 is a human retinal pigment epithelial cell line with differentiated properties (Dunn et al., Exp Eye Res. 1996 62(2):155-69).

[0043] The present invention quantifies the cytotoxicity by measuring the composition of hydroxychloroquine sulfate and leflunomide based on lactate dehydrogenase (LDH) release. ARPE-19 cells were grown to 90% confluency, and subsequently exposed to 10 μg / ml of hydroxychloroquine sulfate and a combination of hydroxychloroquine sulfate and leflunomide (containing 10 μg / ml of hydroxychloroquine sulfate and 2 μg / ml of leflunomide, equivalent Cell death was quantified subsequently by lactate dehydrogenase (LDH) release assay (Abeam) at a w...

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PUM

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Abstract

The invention discloses a pharmaceutical composition, including hydroxychloroquine and leflunomide, and relates to the use of leflunomide in the preparation of drugs for alleviating the side effects of hydroxychloroquine and its salts, such as retinal cytotoxicity. The compound composition has the remarkable effect of synergist and reducing toxic and side effects.

Description

technical field [0001] The invention belongs to the field of medicines, in particular to a pharmaceutical composition, in particular to a compound pharmaceutical composition of hydroxychloroquine and leflunomide. Background technique [0002] Inflammation contributes to the pathogenesis of inflammatory diseases or diseases associated with inflammation such as: (1) autoimmune diseases including rheumatoid arthritis (RA), systemic lupus erythematosus (SLE); (2) degenerative diseases such as osteoarthritis (OA); etc. Some inflammatory diseases can be treated with anti-inflammatory agents including hydroxychloroquine or leflunomide. [0003] Hydroxychloroquine, whose chemical name is 2-[[4-[(7-chloro-4-quinolyl)amino]pentyl]ethylamino]-ethanol, belongs to antimalarial drugs like chloroquine, because it has the ability to inhibit antigen presentation, Inhibit synovial hyperplasia and other effects, has been used in the treatment of rheumatic diseases such as systemic lupus eryt...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/4706A61K31/42A61P29/00A61P37/02A61P3/00A61P27/02
CPCA61K31/42A61K31/4706A61K2300/00
Inventor 冯洪刚许向阳刘彩连
Owner HAINAN SIMCERE PHARMA CO LTD
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