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Medicine erdosteine composition tablet for treating airway inflammation

A technology for erdosteine ​​and a composition is applied in the field of drug erdosteine ​​composition tablets for treating respiratory tract inflammation, and can solve problems in drug absorption speed or degree, poor water solubility of erdosteine, and slow drug dissolution speed. and other problems, to achieve the effect of high stability, good stability and high dissolution

Inactive Publication Date: 2015-12-30
QINGDAO HUAZHICAO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Erdosteine ​​has poor water solubility and low effective bioavailability in the human body, and the absorption rate of the drug in the body is often determined by the speed of dissolution. The drug in the solid preparation must be disintegrated and dissolved before being absorbed. Then the process of turning into a solution, if the drug is not easily released from the formulation or the drug dissolves very slowly, there may be problems with the rate or extent of drug absorption in the formulation
[0006] Existing approaches to solve the poor water solubility of erdosteine ​​mainly include changing the dosage form, such as CN101606931B making it into dispersible tablets. Although the above preparations have improved the water solubility of the drug to a certain extent, there are also many defects.

Method used

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  • Medicine erdosteine composition tablet for treating airway inflammation
  • Medicine erdosteine composition tablet for treating airway inflammation
  • Medicine erdosteine composition tablet for treating airway inflammation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Example 1: Preparation of Erdosteine ​​Crystals

[0032] (1) Take erdosteine ​​raw material, add it into deionized water at 50°C, and the volume of deionized water is 5 times the mass of erdosteine;

[0033] (2) Stir until completely dissolved;

[0034] (3) Add activated carbon for decolorization and filter to obtain a clear solution;

[0035] (4) Move the clarified solution into a pressure vessel, add isopropanol dropwise at 5°C under the condition of controlling the pressure in the pressure vessel at 1.0Mpa and stirring, the stirring speed is controlled at 35rmp, and the volume of isopropanol is de 5 times the volume of ionized water;

[0036] (5) Release the pressure after the dropwise addition, cool the solution to -5°C at a rate of 10°C / min, let it stand for 2 hours, filter, wash, and dry under reduced pressure to obtain erdosteine ​​crystals.

[0037] The X-ray powder diffraction pattern obtained by measuring the obtained erdosteine ​​crystal using Cu-Kα ray ...

Embodiment 2

[0038] Example 2: Preparation of Erdosteine ​​Tablets

[0039] Prescription: 1.5 parts by weight of the erdosteine ​​crystal compound prepared in Example 1, 1.3 parts by weight of lactose, 0.45 parts by weight of crospovidone, 0.04 parts by weight of zinc oxide, 0.8 parts by weight of 95% ethanol , 0.07 parts by weight of polyethylene glycol 6000, 0.04 parts by weight of magnesium stearate.

[0040] Preparation:

[0041] (1) Processing of raw and auxiliary materials: sieve erdosteine, lactose, crospovidone and zinc oxide to 80 mesh;

[0042] (2) Weighing: Weighing according to the prescription;

[0043] (3) Adhesive preparation: dissolve the prescribed amount of polyethylene glycol 6000 in 95% ethanol and set aside;

[0044] (4) Granulation: add erdosteine, lactose, crospovidone, and zinc oxide into the wet mixing granulator, and dry mix for 10 minutes; add the prepared binder and wet mix and cut 2- 3min to make soft materials;

[0045] (5) Drying: Spread the wet granul...

Embodiment 3

[0049] Example 3: Preparation of Erdosteine ​​Tablets

[0050] Prescription: 1.5 parts by weight of the erdosteine ​​crystal compound prepared in Example 1, 1.4 parts by weight of lactose, 0.46 parts by weight of crospovidone, 0.05 parts by weight of zinc oxide, 1 part by weight of 95% ethanol , 0.08 parts by weight of polyethylene glycol 6000, 0.05 parts by weight of magnesium stearate.

[0051] Preparation:

[0052] (1) Processing of raw and auxiliary materials: sieve erdosteine, lactose, crospovidone and zinc oxide to 80 mesh;

[0053] (2) Weighing: Weighing according to the prescription;

[0054] (3) Adhesive preparation: dissolve the prescribed amount of polyethylene glycol 6000 in 95% ethanol and set aside;

[0055] (4) Granulation: add erdosteine, lactose, crospovidone, and zinc oxide into the wet mixing granulator, and dry mix for 10 minutes; add the prepared binder and wet mix and cut 2- 3min to make soft materials;

[0056] (5) Drying: Spread the wet granules ob...

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PUM

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Abstract

The invention discloses a medicine erdosteine composition tablet for treating airway inflammation, and belongs to the technical field of medicine. The composition is prepared from erdosteine, lactose, crospovidone, zinc oxide, 95% ethyl alcohol, polyethylene glycol 6000 and magnesium stearate. Erdosteine is a new crystal form compound, the X-ray powder diffraction pattern obtained by conducting measurement through Cu-K alpha rays is shown in the figure 1, erdosteine is different from erodstein reported in the prior art, tests show that the erdosteine new crystal form compound has high solubility and high stability, and the prepared table is high in dissolution rate and stability, and is quite suitable for clinical application.

Description

technical field [0001] The invention belongs to the technical field of medicines and relates to a tablet of erdosteine ​​composition for treating respiratory inflammation. 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, sodium thioethanesulfonate, and carbocysteine, all have varying degrees of mucus regulation, but they have some phar...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/381C07D333/36A61P11/00
Inventor 祝远彬
Owner QINGDAO HUAZHICAO PHARMA CO LTD
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