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Doxofylline sustained-release pellets and preparation method thereof

A technology of doxofylline and sustained-release pellets is applied in the directions of pharmaceutical formulations, medical preparations with non-active ingredients, and drug combinations, which can solve problems such as inability to completely and effectively treat diseases, and achieve improved bioavailability and preparation. The method is simple and easy to implement, and the effect of drug stability is good.

Inactive Publication Date: 2016-06-08
HARBIN SHENGJI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] At present, there are many drugs on the market for the treatment of dyspnea caused by bronchial asthma, wheezing chronic bronchitis and other bronchospasm, but most of the drugs can only be used in the onset of symptoms. Relieve symptoms, but cannot completely and effectively treat such diseases

Method used

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  • Doxofylline sustained-release pellets and preparation method thereof

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Comparison scheme
Effect test

Embodiment 1

[0033] A doxofylline sustained-release pellet, comprising a drug-containing pellet and a coating layer, the coating layer wraps the drug-containing pellet, and the drug-containing pellet includes: 200mg doxofylline, 70mg blank pill Core, 110-160mg filler, 18-68mg lubricant, 2-10mg binder, the coating layer includes: 45-225mg Eudragit NE30D, 7-68mg talcum powder.

[0034] The optimal mass ratio of raw materials in the drug-containing pellets is: 200mg doxofylline, 70mg blank pellet core, 150mg filler, 20mg lubricant and 10mg binder.

[0035] The optimal mass ratio of raw materials in the coating layer is: 95mg Eudragit NE30D, 21mg talcum powder.

[0036] The filler is microcrystalline cellulose.

[0037] Described lubricant is talcum powder.

[0038] The binder is hypromellose.

[0039] The coating layer also includes traces of sodium lauryl sulfate or polyethylene glycol.

Embodiment 2

[0041] A preparation method of doxofylline sustained-release pellets, comprising the following steps:

[0042] Step 1: Prepare materials: according to the above mass ratio, use a pulverizer to pulverize doxofylline, and pass through a 100-mesh sieve;

[0043] Step 2: Mixing: Weigh doxofylline and microcrystalline cellulose according to the above mass ratio, put them into a three-dimensional mixer and mix for 30 minutes to make drug fine powder, take them out for later use;

[0044] Step 3: Preparation of adhesive: Weigh an appropriate amount of hypromellose according to the above mass ratio, add an appropriate amount of hot water to prepare an adhesive with a concentration of 2%, and set aside;

[0045] Step 4: Pill making: put the mixed drug fine powder into the feeding tank of the centrifugal pellet machine, put the adhesive into the liquid supply tank, put the blank pellet core into the pot, turn on the machine, adjust the parameters, and start spraying When the ...

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Abstract

The invention provides doxofylline sustained-release pellets. The doxofylline sustained-release pellets comprise medicine-containing pellets and coating layers, wherein the medicine-containing pellets are coated by the coating layers; the medicine-containing pellets comprise 200 mg of doxofylline, 70 mg of hollow pellet cores, 110-160 mg of a filling agent, 18-68 mg of a lubricating agent and 2-10 mg of an adhesive; the coating layers comprise 45-225 mg of Eudragit NE30D and 7-68 mg of talcum powder. A preparation method of the doxofylline sustained-release pellets comprises the following processes: 1, material preparation; 2, mixing; 3, preparation of the adhesive; 4, preparation of the pellets; 5, preparation of a coating agent; 6, coating; 7, filling; and 8, aluminum-plastic packaging and preparation of finished products. The doxofylline sustained-release pellets which can effectively treat bronchial asthma, asthmatic chronic bronchitis and dyspnea and other symptoms caused by bronchospasm is provided; as two kinds of advanced technologies, namely novel sustained-release preparations and pellet preparations, are adopted, the doxofylline sustained-release pellets have stable treatment effects and higher bioavailability and have the advantages of good medicine stability, convenience in packaging, transportation and storage and the like; the preparation method is simple and practicable and is suitable for industrial production.

Description

technical field [0001] The invention belongs to the field of chemical medicine sustained-release preparations, in particular to a doxofylline sustained-release pellet and a preparation method thereof. Background technique [0002] Dyspnea is an important symptom of respiratory insufficiency, which is the patient's subjective feeling of insufficient air or breathing effort; objectively, it is manifested as changes in respiratory frequency, depth, and rhythm. Dyspnea caused by bronchial asthma, wheezing chronic bronchitis and other bronchospasm is even more unpredictable. [0003] Bronchial asthma (bronchialasthma) is a chronic airway inflammation involving a variety of cells, especially mast cells, eosinophils, and T lymphocytes. In susceptible individuals, this inflammation can cause recurrent wheezing, shortness of breath, chest tightness, and (or) Cough and other symptoms mostly occur at night and (or) in the early morning, and the airway is more responsive to various sti...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/52A61K31/522A61K47/32A61P11/00
Inventor 马玉国
Owner HARBIN SHENGJI PHARMA
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