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Dispersible tablet for treating respiratory diseases and preparation method thereof

A respiratory disease and dispersion technology, applied in respiratory diseases, dispersion liquid delivery, organic chemical methods, etc., can solve the problems of poor solubility of erdosteine, poor compressibility, easy sticking and flushing, etc. Dissolution, improve solubility, and prevent sticking

Active Publication Date: 2019-08-13
SHANDONG LUOXIN PHARMA GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0021] The object of the present invention is to provide a new pharmaceutical composition preparation (especially dispersible tablet) for the treatment of respiratory diseases and its preparation method, and provide the crystal form and preparation process of erdosteine ​​hydrate, thereby solving the problem of erdosteine ​​hydrate. Problems such as poor solubility of stein, poor compressibility, and easy sticking during production

Method used

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  • Dispersible tablet for treating respiratory diseases and preparation method thereof
  • Dispersible tablet for treating respiratory diseases and preparation method thereof
  • Dispersible tablet for treating respiratory diseases and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0060] Embodiment 1: the preparation of erdosteine ​​hydrate

[0061] (1) Get erdosteine ​​crude product 100g, be dissolved in the temperature that 500ml acetone and 200ml ethanol form after grinding and sieving is in the mixed solution of 30 ℃, obtains erdosteine ​​solution;

[0062] (2) add 0.05g of activated carbon for decolorization for 25 minutes, and filter;

[0063] (3) Under the condition of a stirring rate of 23rmp, add 3 times the volume of the erdosteine ​​solution with normal saline at a temperature of -10°C dropwise at a constant speed, and the dropwise addition is completed within 1 hour;

[0064] (4) After the dropwise addition was completed, the temperature was lowered to -10°C and the stirring was continued for 1 h at a stirring rate of 12 rpm, and white crystals were precipitated after standing for 4 h, and filtered;

[0065] (5) Washing successively with distilled water and ethyl acetate, followed by vacuum drying to obtain 98.75 g of erdosteine ​​hydrate c...

Embodiment 2

[0073] Embodiment 2: the preparation of erdosteine ​​hydrate

[0074] (1) Get erdosteine ​​crude product 100g, be dissolved in the temperature that 500ml acetone and 100ml ethanol form after grinding and sieving is in the mixed solution of 25 ℃, obtains erdosteine ​​solution;

[0075] (2) Add 0.1 g of activated carbon for decolorization for 20 minutes, and filter;

[0076] (3) Under the condition of a stirring rate of 20rmp, add 4 times the volume of erdosteine ​​solution with physiological saline at a temperature of 5°C dropwise at a constant speed, and the dropwise addition is completed within 1.5 hours;

[0077] (4) After the dropwise addition was completed, the temperature was lowered to 5° C. and the stirring was continued for 2 h at a stirring rate of 10 rpm, and white crystals were precipitated after standing for 5 h, and filtered;

[0078] (5) Washing with distilled water and ethyl acetate successively, followed by vacuum drying to obtain 98.52 g of erdosteine ​​hydra...

Embodiment 3

[0084] Embodiment 3: the preparation of erdosteine ​​hydrate

[0085] (1) Get erdosteine ​​crude product 100g, be dissolved in the temperature that 500ml acetone and 300ml ethanol form after grinding and sieving is in the mixed solution of 35 ℃, obtains erdosteine ​​solution;

[0086] (2) add 0.02g of activated carbon for decolorization for 30 minutes, and filter;

[0087] (3) Under the condition of a stirring rate of 25rmp, add 2 times the volume of erdosteine ​​solution with normal saline at a temperature of -15°C dropwise at a constant speed, and the dropwise addition is completed within 0.5h;

[0088] (4) After the dropwise addition, cool down to -15°C and continue to stir for 0.5h at a stirring rate of 15rmp, let stand for 3h to precipitate white crystals, and filter;

[0089] (5) Washing successively with distilled water and ethyl acetate, followed by vacuum drying to obtain 98.67 g of erdosteine ​​hydrate crystals.

[0090]Measured by powder X-ray diffraction method, ...

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Abstract

The invention relates to an erdosteine dispersing tablet for treating diseases of respiratory systems and a method for preparing the dispersing tablets. The erdosteine dispersing tablet comprises erdosteine, hydroxy propyl celluloses, sodium carboxymethyl starch, polyethylene glycol 4000-6000, microcrystalline celluloses 102, crospovidone, magnesium stearate and povidone K30. The erdosteine is erdosteine monohydrate, a molecular formula of the erdosteine is C8H11NO4S2.H2O, and characteristic diffraction peaks are displayed at 3.323, 8.484, 12.661, 21.823, 30.645, 31.161, 33.209, 36.161 and 38.935 positions of X-ray powder diffraction spectra expressed at diffraction angles of 2 theta+ / -0.2 degrees. As discovered in tests, the erdosteine dispersing tablet and the method have the advantages that the erdosteine dispersing tablet is good in stability and high in bioavailability, and problems of poor solubility and compressibility, sticking easiness in production procedures and the like of erdosteine dispersing tablets in the prior art can be solved.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a dispersible tablet for treating respiratory diseases and a preparation method thereof, more specifically, to an erdosteine ​​dispersible tablet and a preparation method thereof. Background technique [0002] Phlegm is the product of respiratory inflammation, which can irritate the respiratory mucosa, cause cough and asthma, and aggravate infection. When patients with acute and chronic bronchitis or chronic lung disease have respiratory failure, if the patient's sputum is too viscous or forms sputum plugs, it can block the airway and cause suffocation. Therefore, it is of great significance to use mucus sputum regulators to dissolve mucus sputum, make it thinner, lower its viscosity, accelerate the movement of mucous membranes and cilia in the respiratory tract, and improve the transport function. [0003] The currently marketed mucus regulators, such as bromhexine, sod...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/381A61K47/38C07D333/36A61P11/00A61P11/10
CPCA61K9/0095A61K9/2059A61K31/381C07B2200/13C07D333/36
Inventor 于德峰刘庆利孟凡磊
Owner SHANDONG LUOXIN PHARMA GRP CO LTD
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