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Preparation method of solution 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 pharmaceutical formulas, and can solve problems such as easy production of by-products, unsustainable 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] Salbutamol 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, and the product stability is not ideal.

Method used

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  • Preparation method of solution containing ambroxol hydrochloride and salbutamol sulfate
  • Preparation method of solution containing ambroxol hydrochloride and salbutamol sulfate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] prescription:

[0042] Salbutamol sulfate: 10g;

[0043] Ambroxol hydrochloride: 20g;

[0044] Poloxamer 188: 8g;

[0045] Meglumine: 8g;

[0046] Mannitol: 4g;

[0047] Propylene glycol: 15g;

[0048] Methylparaben: 1g;

[0049] Stevioside: 8g;

[0050] Purified water: add to 5L.

[0051] Its preparation method is:

[0052] 1) Take by weighing 80% of the prescribed amount of purified water, add the prescribed amount of ambroxol hydrochloride, stir to make it dissolve completely, continue to add the prescribed amount of salbutamol sulfate, poloxamer 188, meglumine, mannitol and propylene glycol, 50 Stir at ℃ for 20min until completely dissolved;

[0053] 2) Add purified water to the full amount, add methyl p-hydroxybenzoate and stevioside, stir to dissolve, filter through a 0.45 μm microporous membrane, fill, seal, pass the inspection, pack, and get ready.

Embodiment 2

[0055] prescription:

[0056] Salbutamol sulfate: 10g;

[0057] Ambroxol hydrochloride: 20g;

[0058] Poloxamer 188: 10g;

[0059] Meglumine: 8g;

[0060] Mannitol: 4g;

[0061] Propylene glycol: 15g;

[0062] Methylparaben: 0.5g;

[0063] Sorbitol: 8g;

[0064] Purified water: add to 5L.

[0065] Its preparation method is:

[0066] 1) Take by weighing 70% of the prescribed amount of purified water, add the prescribed amount of ambroxol hydrochloride, stir to make it dissolve completely, continue to add the prescribed amount of salbutamol sulfate, poloxamer 188, meglumine, mannitol and propylene glycol, 50 Stir at ℃ for 20min until completely dissolved;

[0067] 2) Add purified water to the full amount, add methyl p-hydroxybenzoate and sorbitol, stir to dissolve, filter with a 0.45 μm microporous membrane, fill, seal, pass the inspection, pack, and get ready.

Embodiment 3

[0069] prescription:

[0070] Salbutamol sulfate: 8g;

[0071] Ambroxol hydrochloride: 15g;

[0072] Poloxamer 188: 8g;

[0073] Meglumine: 6g;

[0074] Mannitol: 2g;

[0075] Propylene glycol: 10g;

[0076] Methylparaben: 0.5g;

[0077] Sucrose: 6g;

[0078] Purified water: add to 5L.

[0079] Its preparation method is:

[0080] 1) Take by weighing 60% of the prescribed amount of purified water, add the prescribed amount of ambroxol hydrochloride, stir to make it dissolve completely, continue to add the prescribed amount of salbutamol sulfate, poloxamer 188, meglumine, mannitol and propylene glycol, 55 Stir at ℃ for 25min until completely dissolved;

[0081] 2) Add purified water to the full amount, add methyl p-hydroxybenzoate and sucrose, stir to dissolve, filter with a 0.45 μm microporous membrane, fill, seal, pass the inspection, pack, and get ready.

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PUM

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Abstract

The invention relates to a solution containing ambroxol hydrochloride and salbutamol sulfate and belongs to the field of medicinal preparations. Poloxamer188, meglumine and mannitol are properly added into the solution so that the stability and bioavailability of ambroxol hydrochloride and salbutamol sulfate in the preparation can be remarkably improved, and the solution has 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 solution 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): A61K9/08A61K31/137A61K47/34A61K47/10A61K47/18A61P11/00A61P11/06
Inventor 王明刚任莉陈阳生
Owner CP PHARMA QINGDAO CO LTD
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