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Preparation method of ambroxol salbutamol powder

A technology of ambroxol salbutamol powder and salbutamol sulfate, which is applied in the field of pharmaceutical preparations, can solve problems such as easy production of by-products, unsustainable effect, and reduced effect, and achieve the treatment of acute and chronic bronchitis, increase the content of active ingredients, and improve stability Effect

Active Publication Date: 2016-02-24
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] In the prior art, there are dosage forms such as solutions and granules containing ambroxol hydrochloride and salbutamol sulfate, but there are no reports of powders
[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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  • Preparation method of ambroxol salbutamol powder
  • Preparation method of ambroxol salbutamol powder
  • Preparation method of ambroxol salbutamol powder

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] prescription:

[0040] Salbutamol sulfate: 10g;

[0041] Ambroxol hydrochloride: 20g;

[0042] Poloxamer 188: 8g;

[0043] Meglumine: 8g;

[0044] Mannitol: 4g;

[0045] Lactose: 600g;

[0046] Magnesium Stearate: Appropriate amount.

[0047] Its preparation method is:

[0048] 1) Weigh the raw and auxiliary materials of the prescription amount, pass through a 100-mesh sieve for subsequent use;

[0049] 2) Stir and mix the sieved albuterol sulfate, ambroxol hydrochloride, poloxamer 188, meglumine, mannitol and lactose in equal increments, add magnesium stearate and mix evenly, and then pack it.

Embodiment 2

[0051] prescription:

[0052] Salbutamol sulfate: 8g;

[0053] Ambroxol hydrochloride: 15g;

[0054] Poloxamer 188: 8g;

[0055] Meglumine: 8g;

[0056] Mannitol: 4g;

[0057] Starch: 500g;

[0058] Magnesium Stearate: Appropriate amount.

[0059] Its preparation method is:

[0060] 1) Weigh the raw and auxiliary materials of the prescription amount, and pass through 80 mesh sieves respectively for subsequent use;

[0061] 2) Stir and mix the sieved albuterol sulfate, ambroxol hydrochloride, poloxamer 188, meglumine, mannitol and starch according to the method of increasing in equal amounts, add magnesium stearate and mix evenly, and then pack it.

Embodiment 3

[0063] Salbutamol sulfate: 8g;

[0064] Ambroxol hydrochloride: 16g;

[0065] Poloxamer 188: 8g;

[0066] Meglumine: 8g;

[0067] Mannitol: 2g;

[0068] Dextrin: 500g;

[0069] Micronized silica gel: appropriate amount.

[0070] Its preparation method is:

[0071] 1) Weigh the raw and auxiliary materials of the prescription amount, pass through a 100-mesh sieve for subsequent use;

[0072] 2) Stir and mix the sieved albuterol sulfate, ambroxol hydrochloride, poloxamer 188, meglumine, mannitol and dextrin according to the method of equal increments, add micropowder silica gel and mix evenly, and then pack it.

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Abstract

The invention relates to a preparation method of ambroxol salbutamol powder and belongs to the field of medicinal preparations. An appropriate amount of poloxamer 188, meglumine and mannitol are added into the powder, the stability and bioavailability of ambroxol hydrochloride and salbutamol sulfate in the preparation can be significantly improved, and the ambroxol salbutamol powder is stable in quality, significant in effect and capable of effectively treating acute and chronic bronchitis, asthma and other respiratory diseases.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an ambroxoxalbutamol powder 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. [0...

Claims

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Application Information

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IPC IPC(8): A61K31/137A61K9/14A61P11/06A61P11/00
CPCA61K9/145A61K9/146A61K31/137A61K2300/00
Inventor 王明刚任莉陈阳生
Owner CP PHARMA QINGDAO CO LTD