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Pharmaceutical erdosteine composite granules for treating respiratory tract infection

A technology of erdosteine ​​and composition, which is applied in the field of erdosteine ​​composition granules for the treatment of respiratory tract infection, and can solve the problems of drug absorption speed or degree, poor water solubility of erdosteine, and slow drug dissolution rate and other issues, to achieve the effect suitable for clinical application, good stability and high stability

Inactive Publication Date: 2016-01-13
杨献美
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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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  • Pharmaceutical erdosteine composite granules for treating respiratory tract infection
  • Pharmaceutical erdosteine composite granules for treating respiratory tract infection
  • Pharmaceutical erdosteine composite granules for treating respiratory tract infection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Example 1: Preparation of Erdosteine ​​Crystals

[0025] Prepare a saturated methanol solution of erdosteine ​​crude product at 30°C, then add a mixed solvent of ethanol and ether whose volume is 8 times the volume of the saturated methanol solution, the volume ratio of ethanol and ether is 3:1, and stir evenly, Stir while cooling down, the cooling rate is 15°C / hour, the stirring speed is 95 rpm, and at the same time, add propanol with a volume 4 times the volume of the mixed solvent of ethanol and ether, stop stirring after cooling to -5°C, and let it stand for cultivation. crystallized for 3 hours, filtered, and dried under reduced pressure to obtain erdosteine ​​crystal compound.

[0026] The X-ray powder diffraction pattern that the prepared erdosteine ​​crystal uses Cu-Kα ray measurement to obtain is as follows figure 1 shown.

Embodiment 2

[0027] Example 2: Preparation of Erdosteine ​​Granules

[0028] Prescription: 1.5 parts by weight of the erdosteine ​​crystal compound prepared in Example 1, 1.2 parts by weight of sucrose, 0.3 parts by weight of lactitol, 0.02 parts by weight of vanillin, and 0.5 parts by weight of purified water.

[0029] Preparation:

[0030] (1) Processing of raw and auxiliary materials: sieve erdosteine, lactitol, and vanillin to 80 meshes;

[0031] (2) Weighing: Weighing according to the prescription;

[0032] (3) Granulation: add erdosteine, sucrose, lactitol, and vanillin to the wet mixing granulator, and dry mix for 10 minutes; add wetting agent, purified water, wet mix and cut for 1-1.5min, 16 Granulated soft materials;

[0033] (4) Drying and sieving: distribute the wet granules obtained from granulation evenly on the baking tray of the oven, set the temperature at 55-65°C, and the total drying time is 2.5-3.0 hours, and sieve the dried material to 40 meshes for granulation;

...

Embodiment 3

[0036] Example 3: Preparation of Erdosteine ​​Granules

[0037] Prescription: 1.5 parts by weight of the erdosteine ​​crystal compound prepared in Example 1, 1.3 parts by weight of sucrose, 0.4 parts by weight of lactitol, 0.03 parts by weight of vanillin, and 0.6 parts by weight of purified water.

[0038] Preparation:

[0039] (1) Processing of raw and auxiliary materials: sieve erdosteine, lactitol, and vanillin to 80 meshes;

[0040] (2) Weighing: Weighing according to the prescription;

[0041] (3) Granulation: add erdosteine, sucrose, lactitol, and vanillin to the wet mixing granulator, and dry mix for 10 minutes; add wetting agent, purified water, wet mix and cut for 1-1.5min, 16 Granulated soft materials;

[0042] (4) Drying and sieving: distribute the wet granules obtained from granulation evenly on the baking tray of the oven, set the temperature at 55-65°C, and the total drying time is 2.5-3.0 hours, and sieve the dried material to 40 meshes for granulation;

...

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Abstract

The invention discloses pharmaceutical erdosteine composite granules for treating respiratory tract infection and belongs to the technical field of medicine. A composite is made from erdosteine, cane sugar, lactitol, vanillin and purified water. The erdosteine is a novel-crystal form compound, an X-ray powder diffraction pattern is obtained by measurement using Cu-KAlpha ray is shown in 1, and this erdosteine is different from that reported in the prior art, and testing shows that the erdosteine novel-crystal form compound has better solubility and higher stability, and the prepared granules are good in stability and very suitable for clinical application.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a erdosteine ​​composition granule for treating respiratory infection. 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 pharmacol...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/381C07D333/36A61P11/00A61P11/10
Inventor 杨献美
Owner 杨献美
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