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Meloxicam injection for treating rheumatoid arthritis and osteoarthritis and preparation method thereof

A technology for osteoarthritis and meloxicam, applied in anti-inflammatory agents, bone diseases, pharmaceutical formulations, etc., can solve the problems of slow absorption and low bioavailability, achieve fast absorption, good clinical application value, and ease Effects of pain symptoms

Inactive Publication Date: 2014-04-02
吉林修正药业新药开发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, there are many kinds of meloxicam preparations in the domestic field, the main dosage forms are tablets, capsules, and granules, but these solid preparations absorb slowly, have low bioavailability, and are easily affected by pH, enzymes, food, etc.

Method used

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  • Meloxicam injection for treating rheumatoid arthritis and osteoarthritis and preparation method thereof
  • Meloxicam injection for treating rheumatoid arthritis and osteoarthritis and preparation method thereof
  • Meloxicam injection for treating rheumatoid arthritis and osteoarthritis and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] (1) Weighing

[0023]

[0024] (2) Roughly wash, finely wash, and dry the selected ampoule after passing the inspection;

[0025] (3) Add 1000ml of water for injection into the batching tank, put the taken meglumine, polyethylene glycol-400, poloxamer, sodium chloride, glycine and sodium hydroxide into the batching tank, stir to dissolve , add meloxicam, heat up to about 80°C under stirring to dissolve, and control the pH value to 8.5-10.0 by adding or subtracting the amount of sodium hydroxide;

[0026] (4) Add 0.05g of activated carbon for needles, stir and absorb for 20-30 minutes, remove the carbon by coarse filtration, and add water for injection to 1500ml;

[0027] (5) Filter through a 0.45 μm microporous membrane until the solution is clear, potting 1,000 tubes, and then sterilize with 100°C circulating steam for 30 minutes.

Embodiment 2

[0029] (1) Weighing

[0030]

[0031]

[0032] (2) Roughly wash, finely wash, and dry the selected ampoule after passing the inspection;

[0033] (3) Add 1000ml of water for injection into the batching tank, put meglumine, polyethylene glycol-400, poloxamer, sodium chloride, glycine and sodium hydroxide into the batching tank, stir to dissolve, and then Add meloxicam, heat up to about 80°C under stirring to dissolve, and control the pH value to 8.5-10.0 by adding or subtracting the amount of sodium hydroxide;

[0034] (4) Add 0.05% (g / ml) activated carbon for needles, stir and adsorb for 20-30 minutes, filter to remove carbon, add water for injection to 1500ml;

[0035] (5) Filter through a 0.45 μm microporous membrane until the solution is clear, potting 1,000 tubes, and then sterilize with 100°C circulating steam for 30 minutes.

Embodiment 3

[0037] (1) Weighing:

[0038]

[0039] (2) Roughly wash, finely wash, and dry the selected ampoule after passing the inspection;

[0040] (3) Add 1000ml of water for injection into the batching tank, weigh the prescribed amount of meglumine, polyethylene glycol-400, poloxamer, sodium chloride, glycine and sodium hydroxide, put them into the batching tank, and stir Make it dissolve, add the prescribed amount of meloxicam, heat up to about 80°C under stirring to dissolve, and control the pH value from 8.5 to 10.0 by adding or subtracting the amount of sodium hydroxide;

[0041] (4) Add 0.05g of activated carbon for needles, stir and absorb for 20-30 minutes, remove the carbon by coarse filtration, and add water for injection to 1500ml;

[0042] (5) Filter through a 0.45 μm microporous membrane until the solution is clear, potting 1,000 tubes, and then sterilize with 100°C circulating steam for 30 minutes.

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Abstract

The invention provides a meloxicam injection for treating rheumatoid arthritis and osteoarthritis and a preparation method thereof. Every 1,500ml of injection comprises the following components in: 7.0-20g of meloxicam, 5-9.45g of meglumine, 20-150g of polyethylene glycol-400, 20-75g of poloxamer, 3-9g of glycine, 1.5-5.25g of sodium chloride and 0.225-2.25g of sodium hydroxide. The preparation method comprises the following steps: adding 1,000ml of injection water in a preparation tank, adding meloxicam, meglumine, polyethylene glycol-400, poloxamer, sodium chloride, glycine and sodium chloride; dissolving, and adding meloxicam; heating to 80 DEG C, and stirring for dissolving the meloxicam; adding 0.05g of needle activated carbon; stirring and adsorbing, and performing coarse filtration to remove charcoal; adding injection water to 1,500ml, and filtering with a 0.45mu m filter membrane until the mixture is clear; pouring into an ampoule, and sterilizing. The meloxicam injection has the active effects of quick absorption and high bioavailability, is not affected by pH, enzyme, foods and the like in the digestive tract, and has greatly increased curative effect.

Description

technical field [0001] The invention relates to an injection for treating human rheumatoid arthritis and osteoarthritis, belonging to the field of western medicine preparations Background technique [0002] Rheumatoid arthritis is a chronic systemic autoimmune autoimmune disease characterized by joint synovitis. Synovitis occurs repeatedly for a long time, which can lead to the destruction of cartilage and bone in the joints, joint dysfunction, and even disabled vasculitis. [0003] The prevalence rate of osteoarthritis in my country is 9.56%, of which 78.5% are over 60 years old. Joint pain and movement disorders plague the lives of many elderly people. The elderly have poor gastrointestinal tolerance, and most of them cannot tolerate the treatment of traditional NSAIDs. [0004] At present, the drugs for treating rheumatoid arthritis and osteoarthritis are generally divided into two categories: traditional Chinese medicine and western medicine, but most of them are solid...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/5415A61P29/00A61P19/02
Inventor 李君海高红梅白冰常红赵源慧
Owner 吉林修正药业新药开发有限公司
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