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Erdosteine pharmaceutical composition dry suspension for treating diseases of respiratory system

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

Inactive Publication Date: 2015-11-25
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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  • Erdosteine pharmaceutical composition dry suspension for treating diseases of respiratory system
  • Erdosteine pharmaceutical composition dry suspension for treating diseases of respiratory system
  • Erdosteine pharmaceutical composition dry suspension for treating diseases of respiratory system

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Example 1: Preparation of Erdosteine ​​Crystals

[0028] (1) Dissolve erdosteine ​​crystals in a mixed solvent of methanol and isopropyl ether, the required amount of solvent per gram of erdosteine ​​is 110ml, and the volume ratio of methanol to isopropyl ether is 5:3;

[0029] (2) After heating to 50°C to dissolve, add seed crystals after cooling to room temperature;

[0030] (3) Cool to below 0°C, stir and crystallize, the crystallization temperature is -20°C, filter, dry, collect crystals to obtain Erdosteine ​​crystals.

[0031] 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

[0032] Example 2: Preparation of Erdosteine ​​Dry Suspension

[0033] Prescription: in parts by weight, 15 parts of erdosteine ​​prepared in Example 1, 60 parts of sucrose, 19 parts of xylitol, 8 parts of disodium hydrogen phosphate, 4 parts of propylene glycol alginate, 0.5 part of sucralose, 9 parts of purified water.

[0034] Preparation:

[0035] 1) Processing of raw and auxiliary materials: use a pulverizer to pulverize erdosteine, sucrose, xylitol, disodium hydrogen phosphate, and propylene glycol alginate through an 80-mesh sieve;

[0036] 2) Weighing: Weighing according to the process prescription;

[0037] 3) Mixing granulation: Add the prescribed amount of erdosteine, sucrose, xylitol, disodium hydrogen phosphate, propylene glycol alginate, and sucralose into the wet mixing granulator, and turn on the stirring motor to dry mix for 10 Minutes, add the prescribed amount of purified water, wet mix and cut for 100-120 seconds to make soft materials, select 18-mesh s...

Embodiment 3

[0041] Example 3: Preparation of Erdosteine ​​Dry Suspension

[0042] Prescription: in parts by weight, 15 parts of erdosteine ​​prepared in Example 1, 61 parts of sucrose, 20 parts of xylitol, 8.5 parts of disodium hydrogen phosphate, 5 parts of propylene glycol alginate, 1 part of sucralose, 9.2 parts of purified water.

[0043] Preparation:

[0044] 1) Processing of raw and auxiliary materials: use a pulverizer to pulverize erdosteine, sucrose, xylitol, disodium hydrogen phosphate, and propylene glycol alginate through an 80-mesh sieve;

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

[0046] 3) Mixing granulation: Add the prescribed amount of erdosteine, sucrose, xylitol, disodium hydrogen phosphate, propylene glycol alginate, and sucralose into the wet mixing granulator, and turn on the stirring motor to dry mix for 10 Minutes, add the prescribed amount of purified water, wet mix and cut for 100-120 seconds to make soft materials, select 18 mesh...

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PUM

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Abstract

The invention relates to an erdosteine pharmaceutical composition dry suspension for treating diseases of respiratory system, and belongs to the technical field of medicine. The composition dry suspension is prepared from erdosteine, sucrose, xylitol, disodium hydrogen phosphate, propylene glycol alginate, sucralose and purified water. The erdosteine, different from that reported by the prior art, is a novel crystalline compound, and the X-ray powder diffraction pattern of the erdosteine measured by virtue of Cu-K alpha ray is as shown in Figure 1; tests discover that the erdosteine crystalline compound is relatively good in solubility and relatively high in stability; and the prepared dry suspension is good in stability, high in bioavailability, and the dry suspension is quite 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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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/381A61P11/00A61P11/12C07D333/36A61K47/36
Inventor 卢广民
Owner QINGDAO LANSHENGYANG PHARMA & BIOTECH CO LTD
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