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Preparation method of dropping pills containing ambroxol hydrochloride and salbutamol sulfate

A technology of ambroxosalbutamol and salbutamol sulfate, which is applied to medical preparations with non-active ingredients, medical preparations containing active ingredients, and pill delivery, and can solve problems such as easy production of by-products, short-lasting effects, and reduced effects , to achieve the effect of treating acute and chronic bronchitis, increasing the content of active ingredients and improving stability

Active Publication Date: 2016-02-17
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 dropping pills
[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 dropping pills containing ambroxol hydrochloride and salbutamol sulfate
  • Preparation method of dropping pills containing ambroxol hydrochloride and salbutamol sulfate
  • Preparation method of dropping pills containing ambroxol hydrochloride and salbutamol sulfate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Prescription: (1000 pills)

[0043] Salbutamol sulfate: 10g;

[0044] Ambroxol hydrochloride: 20g;

[0045] Poloxamer 188: 8g;

[0046] Meglumine: 8g;

[0047] Mannitol: 4g;

[0048] PEG400: 40g;

[0049] PEG6000: 1500g.

[0050] Preparation:

[0051] 1) Fully mix PEG400 and PEG6000 to form a matrix mixture, place the matrix mixture in a heating container and heat to melt while stirring;

[0052]2) Take salbutamol sulfate, ambroxol hydrochloride, poloxamer 188, meglumine, and mannitol, mix them uniformly, add them to the matrix mixture, and continue heating until a molten liquid is obtained;

[0053] 3) Adjust the temperature control system of the dripping pill machine so that the dripper temperature of the dripping machine is heated and kept at 80°C, the temperature of the simethicone oil is cooled, and the upper temperature of the simethicone oil is kept at 10°C, and the bottom temperature is -5 ℃ state;

[0054] 4) Pour the molten liquid into the material fu...

Embodiment 2

[0056] Prescription: (1000 pills)

[0057] Salbutamol sulfate: 10g;

[0058] Ambroxol hydrochloride: 30g;

[0059] Poloxamer 188: 8g;

[0060] Meglumine: 6g;

[0061] Mannitol: 2g;

[0062] PEG400: 30g;

[0063] PEG6000: 1000g.

[0064] The preparation method is:

[0065] 1) Fully mix PEG400 and PEG6000 to form a matrix mixture, place the matrix mixture in a heating container and heat to melt while stirring;

[0066] 2) Take salbutamol sulfate, ambroxol hydrochloride, poloxamer 188, meglumine, and mannitol, mix them uniformly, add them to the matrix mixture, and continue heating until a molten liquid is obtained;

[0067] 3) Adjust the temperature control system of the dripping pill machine so that the dripper temperature of the dripping machine is heated and kept at 90°C, the temperature of the liquid paraffin is cooled, and the upper temperature of the liquid paraffin is kept at 10°C, and the bottom temperature is -5°C;

[0068] 4) Pour the molten liquid into the mat...

Embodiment 3

[0075] Prescription: (1000 pills)

[0076] Salbutamol sulfate: 8g;

[0077] Ambroxol hydrochloride: 30g;

[0078] Poloxamer 188: 8g;

[0079] Meglumine: 6g;

[0080] Mannitol: 4g;

[0081] PEG400: 30g;

[0082] PEG6000: 1200g.

[0083] Preparation:

[0084] 1) Fully mix PEG400 and PEG6000 to form a matrix mixture, place the matrix mixture in a heating container and heat to melt while stirring;

[0085] 2) Take salbutamol sulfate, ambroxol hydrochloride, poloxamer 188, meglumine, and mannitol, mix them uniformly, add them to the matrix mixture, and continue heating until a molten liquid is obtained;

[0086] 3) Adjust the temperature control system of the dripping pill machine so that the dripper temperature of the dripping machine is heated and kept at 90°C, the temperature of the liquid paraffin is cooled, and the upper temperature of the liquid paraffin is kept at 10°C, and the bottom temperature is -5°C;

[0087] 4) Pour the molten liquid into the material funnel of...

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PUM

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Abstract

The invention relates to dropping pills containing ambroxol hydrochloride and salbutamol sulfate and belongs to the field of medicinal preparations. Poloxamer188, meglumine and mannitol are properly added into the dropping pills so that the stability and bioavailability of ambroxol hydrochloride and salbutamol sulfate in the preparation can be remarkably improved, and the dropping pills have stable quality and a remarkable effect and can effectively treat acute or 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 dropping pill 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): A61K9/20A61K31/137A61K47/34A61K47/10A61K47/18A61P11/00A61P11/06
Inventor 王明刚任莉陈阳生
Owner CP PHARMA QINGDAO CO LTD
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