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Meloxicam compound and tablets thereof

A meloxicam compound technology, applied in the field of meloxicam compounds and its tablets, can solve the problems of poor tablet stability and influence on drug efficacy, and achieve shortened disintegration time limit, excellent bioavailability, good stability effect

Active Publication Date: 2014-05-07
ANHUI YOUCARE KAIYUE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in long-term application, it is found that the tablet with meloxicam as the main active ingredient has poor stability, which affects the efficacy of the drug.

Method used

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  • Meloxicam compound and tablets thereof
  • Meloxicam compound and tablets thereof
  • Meloxicam compound and tablets thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0063] Embodiment 1, the preparation of meloxicam compound

[0064] (1) Take 50g of meloxicam raw material, add an appropriate amount of NaOH solution with a mass percentage concentration of 10% at 0°C, stir to dissolve meloxicam, and then add 250ml of a mixed solvent of dimethylformamide and methanol (The volume ratio of dimethylformamide and methanol in the mixed solvent is 1:0.2), stir to obtain a clear solution;

[0065] (2) Add 0.01% (g / ml) activated carbon to the clear solution obtained in step (1) for decolorization, stir for 0.5 hours, filter to obtain the filtrate;

[0066] (3) Heat the filtrate obtained in step (2) to 20°C, add hydrochloric acid to adjust the pH value to 6 while stirring, and the stirring speed is 90r / min;

[0067] (4) After the addition, continue to add dropwise acetone at 20°C under the condition of a stirring speed of 20r / min. The volume ratio of acetone to the mixed solvent of dimethylformamide and methanol is 3:1; Stand at 0°C for 3 hours, fil...

Embodiment 2

[0069] Embodiment 2, the preparation of meloxicam compound

[0070] (1) Take 50g of meloxicam raw material, add an appropriate amount of NaOH solution with a mass percentage concentration of 15% at 5°C, stir to dissolve meloxicam, and then add 500ml of a mixed solvent of dimethylformamide and methanol (The volume ratio of dimethylformamide and methanol in the mixed solvent is 1:0.5), stir to obtain a clear solution;

[0071] (2) Add 0.02% (g / ml) activated carbon to the clear solution obtained in step (1) for decolorization, stir for 0.5 to 1.5 hours, and filter to obtain the filtrate;

[0072] (3) Heat the filtrate obtained in step (2) to 30°C, add hydrochloric acid to adjust the pH value to 5 while stirring, and the stirring speed is 120r / min;

[0073] (4) After the addition, continue to drop acetone at 30°C under the condition of a stirring speed of 30r / min. The volume ratio of acetone to the mixed solvent of dimethylformamide and methanol is 5:1; after the dropwise additio...

Embodiment 3

[0075] Embodiment 3, the preparation of meloxicam compound

[0076] (1) Take 50g of meloxicam raw material, add an appropriate amount of NaOH solution with a mass percentage concentration of 12% at 3°C, stir to dissolve meloxicam, and then add 350ml of a mixed solvent of dimethylformamide and methanol (The volume ratio of dimethylformamide and methanol in the mixed solvent is 1:0.3), stir to obtain a clear solution;

[0077] (2) Add 0.015% (g / ml) activated carbon to the clear solution obtained in step (1) for decolorization, stir for 1 hour, filter to obtain the filtrate;

[0078] (3) Heat the filtrate obtained in step (2) to 25°C, add hydrochloric acid to adjust the pH value to 6 while stirring, and the stirring speed is 110r / min;

[0079] (4) After the addition, continue to drop acetone at 25°C under the condition of a stirring speed of 25r / min. The volume ratio of acetone to the mixed solvent of dimethylformamide and methanol is 4:1; after the dropwise addition, cool down ...

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Abstract

The invention relates to a meloxicam compound and tablets thereof. The meloxicam compound has the chemical structural formula shown as a formula (I) described in the specification. The meloxicam compound is a crystalline compound. An X-ray powder diffraction diagram obtained by measuring Cu-KAlpha rays is shown as the figure 1 described in the specification. Every 100 tablets are prepared from the meloxicam taken as an active ingredient and various auxiliary materials in parts by weight: 5 to 10 parts of meloxicam, 50 to 70 parts of microcrystalline cellulose, 20 to 40 parts of pregelatinized starch, 10 to 30 parts of low-substituted hydroxypropyl cellulose, 3 to 5 parts of poloxamer, 10 to 20 parts of carboxymethyl starch sodium and a proper amount of aqueous solution of 3% PVP (Polyvinyl Pyrrolidone) K30 and 0.5 to 1 part of magnesium stearate. The meloxicam compound has the good solubility. The tablets prepared from the meloxicam compound are excellent in dissolution and good in stability, and have the good bioavailability.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a meloxicam compound and a tablet thereof. Background technique [0002] Meloxicam (MLX) is a new type of non-steroidal anti-inflammatory drug (NSAIDs), which was first launched in South Africa in 1996 by Boehringer Ingelheim of Germany. Studies have reported that MLX is a preferential and selective inhibitor of cyclooxygenase-2 (COX-2) at low doses (less than 15 mg per day). Compared with traditional NSAIDs such as naproxen, ibuprofen, and piroxicam, MLX has similar anti-inflammatory and analgesic effects, while the gastrointestinal tolerance is significantly improved. During the medication period, patients have almost no gastrointestinal perforation, bleeding, and ulcers , less nausea and vomiting. [0003] CN103054872A discloses a meloxicam pharmaceutical composition and a preparation method thereof. The meloxicam pharmaceutical composition comprises the follo...

Claims

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Application Information

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IPC IPC(8): C07D417/12A61K31/5415A61K9/20A61K9/28A61K47/36
CPCC07D417/12
Inventor 李琦杨磊
Owner ANHUI YOUCARE KAIYUE PHARMA
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