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Ambroxol and salbutamol capsule

A technology of ambroxol salbutamol and salbutamol sulfate is applied in the directions of capsule delivery, medical preparations of non-active ingredients, organic active ingredients, etc., and can solve the problems of unsustainable effect, increase side effects, reduce effects and the like, and achieve an increase in the content of active ingredients , the treatment of respiratory diseases, the effect of improving stability

Inactive Publication Date: 2016-03-23
CP PHARMA QINGDAO CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It is suitable for the prevention and treatment of bronchospasm in patients with bronchial asthma, asthmatic bronchitis and emphysema, and relieves symptoms such as dyspnea caused by airway obstructive diseases such as bronchial asthma, chronic bronchitis and emphysema. Its advantage is that it works quickly , can quickly improve the patient's symptoms, relieve spasm, relieve asthma, and eliminate phlegm. Beta-agonist desensitization and even resistance to asthma therapy
[0006] Dosage forms such as solutions and granules containing ambroxol hydrochloride and salbutamol sulfate already exist in the prior art, but there is no report of capsules
[0007] In addition, albuterol sulfate and ambroxol hydrochloride are the active ingredients in the same minimum preparation unit. During long-term storage, due to possible chemical compatibility changes between the ingredients, by-products are likely to be produced, which will reduce the effect or increase side effects. Product stability not ideal

Method used

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  • Ambroxol and salbutamol capsule
  • Ambroxol and salbutamol capsule

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] prescription:

[0047] Salbutamol sulfate: 6g;

[0048] Ambroxol hydrochloride: 16g;

[0049] Poloxamer 188: 8g;

[0050] Meglumine: 4g;

[0051] Mannitol: 6g;

[0052] Lactose: 40g;

[0053] Sodium carboxymethyl starch: 6g;

[0054] Hypromellose: Appropriate amount.

[0055] Preparation:

[0056] 1) Weigh the raw and auxiliary materials of the prescription amount, pass through a 100-mesh sieve for later use;

[0057] 2) Take the sieved hypromellose and add distilled water to make a binder solution;

[0058] 3) Mix the sieved salbutamol sulfate, ambroxol hydrochloride, meglumine, poloxamer 188, mannitol, lactose and hypromellose in equal increments, and add the above binder solution to prepare into soft material;

[0059] 4) After granulating with a 40-mesh sieve, dry at 60°C for 45 minutes, pass through a 20-mesh sieve for granulation, and put it into an empty capsule.

Embodiment 2

[0061] prescription:

[0062] Salbutamol sulfate: 8g;

[0063] Ambroxol hydrochloride: 18g;

[0064] Poloxamer 188: 8g;

[0065] Meglumine: 3g;

[0066] Mannitol: 7g;

[0067] Starch: 40g;

[0068] Sodium carboxymethyl starch: 7g;

[0069] Precrossed starch: appropriate amount.

[0070] Preparation:

[0071] 1) Weigh the raw and auxiliary materials of the prescription amount, pass through 80-mesh sieve respectively;

[0072] 2) Take the sieved precrossed starch and add distilled water to make a binder solution;

[0073] 3) Mix the sieved salbutamol sulfate, ambroxol hydrochloride, meglumine, poloxamer 188, mannitol, starch and sodium carboxymethyl starch in equal increments, and add the above adhesive solution to prepare into soft material;

[0074] 4) After granulating with a 40-mesh sieve, dry at 60°C for 45 minutes, pass through a 20-mesh sieve for granulation, and put it into an empty capsule.

Embodiment 3

[0076] prescription:

[0077] Salbutamol sulfate: 8g;

[0078] Ambroxol hydrochloride: 18g;

[0079] Poloxamer 188: 8g;

[0080] Meglumine: 4g;

[0081] Mannitol: 6g;

[0082] Starch: 50g;

[0083] Microcrystalline cellulose: 8g;

[0084] Povidone: Appropriate amount.

[0085] Preparation:

[0086] 1) Weigh the raw and auxiliary materials of the prescription amount, pass through 80-mesh sieve respectively;

[0087] 2) Take the sieved povidone and add distilled water to make a binder solution;

[0088] 3) Mix the sieved salbutamol sulfate, ambroxol hydrochloride, meglumine, poloxamer 188, mannitol, starch and microcrystalline cellulose evenly in equal increments, and add the above binder solution to prepare soft material;

[0089] 4) After granulating with a 40-mesh sieve, dry at 60°C for 45 minutes, pass through a 20-mesh sieve for granulation, and put it into an empty capsule.

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Abstract

The invention relates to an ambroxol and salbutamol capsule, and belongs to the field of a pharmaceutical preparation. The capsule, which is added with proper amounts of poloxamer 188, meglumine and mannitol, can significantly improve the stability and the bioavailability of ambroxol hydrochloride and salbutamol sulfate in a preparation; and the capsule is stable in quality and significant in effect, and the capsule is capable of effectively treating such diseases of respiratory system as acute and chronic bronchitis, asthma and the like.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an ambroxoxalbutamol capsule and a preparation method thereof. Background technique [0002] Respiratory system disease is a common and frequently-occurring disease. The main lesions are in the trachea, bronchi, lungs, and chest cavity. Mild cases often cause coughing, chest pain, and respiratory problems. Severe cases have dyspnea, hypoxia, and even death due to respiratory failure. The death rate in the city is the third, while in the countryside it is the first. What should be paid more attention to is that due to air pollution, smoking, population aging and other factors, chronic obstructive pulmonary disease (referred to as COPD, including chronic bronchitis, emphysema, pulmonary heart disease), bronchial asthma, lung cancer, etc. , Pulmonary diffuse interstitial fibrosis, and the morbidity and mortality of diseases such as pulmonary infection are increasing. [...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/137A61K9/48A61K47/34A61K47/26A61P11/00A61P11/06
CPCA61K31/137A61K9/1623A61K9/1641A61K2300/00
Inventor 王明刚陈阳生任莉刘晓霞孙桂玉臧云龙
Owner CP PHARMA QINGDAO CO LTD
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