Erdosteine composition for treating respiratory tract inflammation

A composition and respiratory technology, applied in the field of medicine, can solve problems such as poor water solubility of erdosteine, slow drug dissolution rate, and problems with drug absorption rate or degree, and achieve high stability, improved water solubility, and stable chemical properties Effect

Inactive Publication Date: 2015-09-02
苗怡文
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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 for treating respiratory tract inflammation
  • Erdosteine composition for treating respiratory tract inflammation
  • Erdosteine composition for treating respiratory tract inflammation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Example 1: Preparation of Erdosteine ​​Crystals

[0035] 1) Take the crude erdosteine ​​and add it to a methanol solution whose volume is 10-15 times the weight of erdosteine ​​at 15-25°C;

[0036] 2) After the crude erdosteine ​​is dissolved, add activated carbon for decolorization and filter;

[0037] 3) Add dropwise a mixed solvent of acetone and dichloromethane whose volume is 8-10 times the weight of erdosteine ​​to the filtrate obtained in step 2) under an ultrasonic field of 0.5-0.7KW, the volume ratio of acetone and dichloromethane is 3:2, until crystallization;

[0038] 4) Turn off the ultrasonic field, cool down to -5°C at a rate of 10-15°C / hour, let stand for 3-5 hours, filter, and dry under reduced pressure at 35-45°C for 3-5 hours to obtain the erdosteine crystals.

[0039] The X-ray powder diffraction pattern obtained by measuring the obtained erdosteine ​​crystal using Cu-Kα ray is as follows: figure 1 Shown, its purity as determined by high perform...

Embodiment 2

[0040] Example 2: The preparation of erdosteine ​​capsule, step is as follows:

[0041] Prescription such as table 1: by weight

[0042] Table 1 Prescription of Erdosteine ​​Capsules

[0043]

[0044] Preparation:

[0045] 1) Weigh the raw and auxiliary materials according to the prescription quantity;

[0046] 2) Prepare hypromellose solution: put purified water in a stainless steel bucket, add hypromellose and polysorbate 80, and wait for all to dissolve for later use;

[0047] 3) Mixing and granulation: add erdosteine, lactose, and microcrystalline cellulose into the wet mixing granulator, turn on the stirring motor for dry mixing for 10 minutes, add the prepared hypromellose solution, and wet mix 100-150 seconds to make soft materials, choose 14 mesh nylon mesh and install it in a swinging granulator to granulate;

[0048] 4) Drying: Set the inlet air temperature of the fluidized dryer to 60°C, dry until the water content is less than 3.0%, and select a 14-mesh n...

Embodiment 3

[0052] Example 3: The preparation of erdosteine ​​capsule, step is as follows:

[0053] Prescription such as table 2: by weight

[0054] Table 2 Prescription of Erdosteine ​​Capsules

[0055]

[0056] Preparation:

[0057] 1) Weigh the raw and auxiliary materials according to the prescription quantity;

[0058] 2) Prepare hypromellose solution: put purified water in a stainless steel bucket, add hypromellose and polysorbate 80, and wait for all to dissolve for later use;

[0059] 3) Mixing and granulation: add erdosteine, lactose, and microcrystalline cellulose into the wet mixing granulator, turn on the stirring motor for dry mixing for 10 minutes, add the prepared hypromellose solution, and wet mix 100-150 seconds to make soft materials, choose 14 mesh nylon mesh and install it in a swinging granulator to granulate;

[0060] 4) Drying: Set the inlet air temperature of the fluidized dryer to 60°C, dry until the water content is less than 3.0%, and select a 14-mesh ny...

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PUM

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Abstract

The invention discloses an erdosteine composition for treating respiratory tract inflammation, relating to the technical field of medicines. The erdosteine composition is prepared from erdosteine, lactose, microcrystalline cellulose, hydroxypropyl methylcellulose, polysorbate 80, purified water and silicon dioxide. The erdosteine is a novel crystal compound; an X-ray powder diffraction figure obtained by measurement by using Cu-Kalpha ray is shown in the figure 1; the erdosteine disclosed by the invention is different from erdosteine reported in the prior art; experiments show that the novel crystal compound has better solubleness and higher stability; and a prepared capsule is very applied to clinical application.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to an 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...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/381A61K9/48A61P11/10A61P29/00C07D333/36
Inventor 李波庄玉芝
Owner 苗怡文
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