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Medicinal erdosteine composition tablet for treating respiratory tract inflammation and preparation method of tablet

A technology of erdosteine ​​and composition, which is applied in the field of erdosteine ​​composition tablet for the treatment of respiratory inflammation, which 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 of high stability, good stability and high dissolution rate

Inactive Publication Date: 2015-11-18
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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  • Medicinal erdosteine composition tablet for treating respiratory tract inflammation and preparation method of tablet
  • Medicinal erdosteine composition tablet for treating respiratory tract inflammation and preparation method of tablet
  • Medicinal erdosteine composition tablet for treating respiratory tract inflammation and preparation method of tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

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

[0026] Get the erdosteine ​​raw material drug, add in the mixed solvent A of acetone, cyclohexane, N-methylacetamide whose volume is 8 times of the weight of erdosteine ​​at 30 ℃, acetone, cyclohexane, N-methyl Acetamide volume ratio is 3:2:2, obtains solution; Apply the constant magnetic field that magnetic field intensity is 1.5T then in the horizontal direction of the liquid surface of gained solution, and drop volume is in solution under the condition of this constant magnetic field. Mixed solvent B of methanol, isobutanol and water with 10 times the weight of erdosteine, the volume ratio of methanol, isobutanol and water is 2:3:4; hours, filtered, washed, and vacuum-dried to obtain the erdosteine ​​crystals.

[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 chroma...

Embodiment 2

[0028] Example 2: The preparation of erdosteine ​​sheet, step is as follows:

[0029] Prescription: in parts by weight

[0030]

[0031]

[0032] Preparation:

[0033] 1) Processing of raw and auxiliary materials: Pass erdosteine, sodium starch glycolate, lactose, and L-HPC21 through an 80-mesh sieve;

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

[0035] 3) Mixing and granulation: Add the prescribed amount of erdosteine, sodium starch glycolate, lactose, and L-HPC21 into the wet mixing granulator, turn on the stirring motor for dry mixing for 10 minutes, add 95% ethanol solution, wet Mix and cut 100-120 seconds to make soft materials, choose 16-mesh nylon mesh and install it in a swinging granulator to granulate;

[0036] 4) Drying: Adjust the inlet air temperature of the boiling dryer to 55-65°C, place the wet granules in the boiling dryer for drying until the moisture content is 1.5%-2.5%;

[0037] 5) Total blending: add the sized dry gra...

Embodiment 3

[0040] Example 3: The preparation of erdosteine ​​sheet, step is as follows:

[0041] Prescription: in parts by weight

[0042]

[0043] Preparation:

[0044] 1) Processing of raw and auxiliary materials: Pass erdosteine, sodium starch glycolate, lactose, and L-HPC21 through an 80-mesh sieve;

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

[0046]3) Mixing and granulation: Add the prescribed amount of erdosteine, sodium starch glycolate, lactose, and L-HPC21 into the wet mixing granulator, turn on the stirring motor for dry mixing for 10 minutes, add 95% ethanol solution, wet Mix and cut 100-120 seconds to make soft materials, choose 16-mesh nylon mesh and install it in a swinging granulator to granulate;

[0047] 4) Drying: Adjust the inlet air temperature of the boiling dryer to 55-65°C, place the wet granules in the boiling dryer for drying until the moisture content is 1.5%-2.5%;

[0048] 5) Total blending: add the sized dry granules, the pr...

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PUM

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Abstract

The invention relates to a medicinal erdosteine composition tablet for treating respiratory tract inflammation and a preparation method of the composition tablet, belonging to the technical field of medicine. The composition tablet is prepared from erdosteine, sodium carboxymethyl starch, lactose, L-HPC21, 95% of ethanol, magnesium stearate and peppermint essence. The erdosteine is a novel crystalline compound; as shown in X-ray powder diffraction pattern 1 obtained from Cu-K alpha-ray measurement, the erdosteine is different from that reported in the prior art; tests discover that the erdosteine novel crystalline compound is relatively good in dissolution and relatively high in stability; and the prepared tablet is high in dissolution degree, good in stability and quite suitable for clinical application.

Description

technical field [0001] The invention belongs to the technical field of medicines and relates to a tablet of 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 phar...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/381C07D333/36A61P11/00
Inventor 刘学键
Owner QINGDAO LANSHENGYANG PHARMA & BIOTECH CO LTD
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