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Erdosteine composition dry suspension for treating respiratory system disease

A technology for respiratory diseases and dry suspensions, applied in the field of medicine, can solve the problems of drug absorption speed or degree, poor water solubility of erdosteine, slow drug dissolution speed, etc., and achieve high stability and good stability , good solubility effect

Inactive Publication Date: 2016-01-13
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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  • Erdosteine composition dry suspension for treating respiratory system disease
  • Erdosteine composition dry suspension for treating respiratory system disease
  • Erdosteine composition dry suspension for treating respiratory system disease

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Example 1: Preparation of Erdosteine ​​Crystals

[0024] Dissolve erdosteine ​​in a mixed solvent of methanol and dimethyl sulfoxide whose volume is 6 times the weight of erdosteine ​​at 40°C. The volume ratio of methanol to dimethyl sulfoxide is 5:3.5; Add a mixed solvent of ethanol and ether whose volume is 10 times the weight of erdosteine ​​at a speed of 2:1, stir while adding, control the temperature at 40°C, and grow the crystal for 3 hours; then Add ethanol and dichloromethane whose total volume is 8 times the weight of erdosteine ​​at a speed of 20ml / min. After growing the crystal for 1 hour, cool down to -5°C at a speed of 10°C / hour, and then keep stirring at 110 rpm Stirring per minute for crystallization and crystal growth for 4 hours; filtering, washing, and drying under reduced pressure to obtain erdosteine ​​crystal compound.

[0025] The X-ray powder diffraction pattern obtained by measuring the obtained erdosteine ​​crystal using Cu-Kα ray is as follo...

Embodiment 2

[0026] Example 2: Preparation of Erdosteine ​​Dry Suspension

[0027] Prescription: 1.5 parts by weight of the erdosteine ​​crystal compound prepared in Example 1, 2.3 parts by weight of sorbitol, 0.08 parts by weight of potassium metaphosphate, 0.15 parts by weight of gum arabic, 0.015 parts by weight of glycyrrhizin .

[0028] Preparation:

[0029] (1) Processing of raw and auxiliary materials: sieve erdosteine ​​and potassium metaphosphate to 80 mesh;

[0030] (2) Weighing: Weighing according to the prescription;

[0031] (3) Mixing: Put erdosteine, potassium metaphosphate, sorbitol, gum arabic, and glycyrrhizin into the three-dimensional motion mixer, set the pre-mixing speed to 15 rpm, and the mixing time to 30 minutes;

[0032] (4) Packaging: Calculate the theoretical loading range according to the content of the materials obtained from the total blending, and then carry out sub-packaging.

Embodiment 3

[0033] Example 3: Preparation of Erdosteine ​​Dry Suspension

[0034] Prescription: 1.5 parts by weight of the erdosteine ​​crystal compound prepared in Example 1, 2.4 parts by weight of sorbitol, 0.1 parts by weight of potassium metaphosphate, 0.2 parts by weight of gum arabic, 0.02 parts by weight of glycyrrhizin .

[0035] Preparation:

[0036] (1) Processing of raw and auxiliary materials: sieve erdosteine ​​and potassium metaphosphate to 80 mesh;

[0037] (2) Weighing: Weighing according to the prescription;

[0038] (3) Mixing: Put erdosteine, potassium metaphosphate, sorbitol, gum arabic, and glycyrrhizin into the three-dimensional motion mixer, set the pre-mixing speed to 15 rpm, and the mixing time to 30 minutes;

[0039] (4) Packaging: Calculate the theoretical loading range according to the content of the materials obtained from the total blending, and then carry out sub-packaging.

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Abstract

The invention discloses an erdosteine composition dry suspension for treating a respiratory system disease and belongs to the technical field of medicine. A composition is prepared from erdosteine, sorbitol, potassium metaphosphate, acacia gum and glycyrrhizin. The erdosteine is a novel crystalline compound and is different from erdosteine in the prior art, and an X-ray powder diffraction pattern shown as figure 1 is obtained by means of measurement with Cu-Kalpha rays. Through experiments, the novel erdosteine crystalline compound has good solubility and high stability, and the prepared dry suspension is high in stability and bioavailability and extremely suitable for clinical application.

Description

technical field [0001] The invention belongs to the technical field of medicine and relates to a dry suspension of Erdosteine ​​composition for treating respiratory diseases. 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 p...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K31/381C07D333/36A61P11/00
Inventor 刘学键
Owner QINGDAO HUAZHICAO PHARMA CO LTD
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