Medicine erdosteine composition granules for treating respiratory tract infection

A technology of erdosteine ​​and its composition, which is applied in the field of erdosteine ​​composition granules for the treatment of respiratory infections, can solve the problems of drug absorption speed or degree, poor water solubility of erdosteine, and effective bioavailability Low-level problems, to achieve the effect suitable for clinical application, good stability, high stability

Inactive Publication Date: 2015-10-21
QINGDAO LANSHENGYANG PHARMA & BIOTECH 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 granules for treating respiratory tract infection
  • Medicine erdosteine composition granules for treating respiratory tract infection
  • Medicine erdosteine composition granules for treating respiratory tract infection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Example 1: Preparation of Erdosteine ​​Crystals

[0026] Prepare a saturated acetone solution of erdosteine ​​crude product at 35°C, and then add a mixed solvent of isobutanol and petroleum ether whose volume is 5 times the volume of the saturated acetone solution, and the volume ratio of the isobutanol and petroleum ether is 3:1 After stirring evenly, stir while cooling down, the cooling rate is 10°C / hour, the stirring speed is 130 rpm, and at the same time, add ethanol whose volume is 4 times the volume of the mixed solvent of isobutanol and petroleum ether, and cool to -5°C Afterwards, the stirring was stopped, and the crystal was left to grow for 4 hours, filtered, and dried under reduced pressure to obtain the erdosteine ​​compound.

[0027] 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 performance liquid chromatography is 99.9%.

Embodiment 2

[0028] Example 2: The preparation of erdosteine ​​granules, the steps are as follows:

[0029] Prescription: in parts by weight as shown in Table 1

[0030] Table 1 Erdosteine ​​composition prescription

[0031]

[0032] Preparation:

[0033] 1) Processing of raw and auxiliary materials: use a vibrating sieve to sieve the raw materials to 80 meshes;

[0034] 2) Weighing: Weighing according to the process prescription;

[0035] 3) Mixing and granulation: Add the prescribed amount of erdosteine, calcium carbonate, sucrose, citric acid, and tartrazine into the wet mixing granulator, turn on the stirring motor for dry mixing for 10 minutes, add purified water, and wet mix and cut 200-220 seconds to make soft materials, choose 16-mesh stainless steel screen and install it in the spinning granulator to granulate;

[0036] 4) Drying and sieving: adjust the inlet air temperature of the fluidized dryer to 55-65°C, place the wet granules in the fluidized dryer for drying until ...

Embodiment 3

[0039] Example 3: The preparation of erdosteine ​​granules, the steps are as follows:

[0040] Prescription: in parts by weight as shown in Table 2

[0041] Table 2 Erdosteine ​​composition prescription

[0042]

[0043] Preparation:

[0044] 1) Processing of raw and auxiliary materials: use a vibrating sieve to sieve the raw materials to 80 meshes;

[0045] 2) Weighing: Weighing according to the process prescription;

[0046] 3) Mixing and granulation: Add the prescribed amount of erdosteine, calcium carbonate, sucrose, citric acid, and tartrazine into the wet mixing granulator, turn on the stirring motor for dry mixing for 10 minutes, add purified water, and wet mix and cut 200-220 seconds to make soft materials, choose 16-mesh stainless steel screen and install it in the spinning granulator to granulate;

[0047] 4) Drying and sieving: adjust the inlet air temperature of the fluidized dryer to 55-65°C, place the wet granules in the fluidized dryer for drying until ...

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Abstract

The invention discloses medicine erdosteine composition granules for treating respiratory tract infection and belongs to the technical field of medicine. The composition is prepared from erdosteine, calcium carbonate, cane sugar, citric acid, lemon yellow, purified water and magnesium stearate. The erdosteine is a new type crystal-form compound, the X-ray powder diffraction diagram obtained through measurement by the application of Cu-Ka rays is as shown in figure 1, and the erdosteine is different from the erdosteine reported in the prior art, tests find that the new type crystal-form erdosteine has good solubleness and high stability, the prepared granules are good in stability, and the medicine erdosteine composition granules for treating respiratory tract infection is 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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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/381A61P11/00C07D333/36
Inventor 刘学键
Owner QINGDAO LANSHENGYANG PHARMA & BIOTECH CO LTD
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