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Ambroxol salbutamol solution

A technology of ambroxol salbutamol and salbutamol sulfate, which is applied in the field of pharmaceutical preparations, can solve problems such as easy production of by-products, non-durable effect, and reduced effect, and achieve the goal of treating acute and chronic bronchitis, increasing the content of active ingredients, and improving stability Effect

Active Publication Date: 2018-06-05
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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  • Ambroxol salbutamol solution
  • Ambroxol salbutamol solution

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 the purified water of recipe quantity 80%, add the ambroxol hydrochloride of recipe quantity, stir and make it dissolve completely, continue to add the salbutamol sulfate, poloxamer 188, meglumine, mannitol and propylene glycol of recipe quantity, 50 Stir at ℃ for 20min until all dissolved;

[0053] 2) Add purified water to the full amount, add methylparaben and stevioside, stir to dissolve, filter with a 0.45 μm microporous membrane, fill, seal, pass the inspection, and package.

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 the purified water of recipe quantity 70%, add the ambroxol hydrochloride of recipe quantity, stir and make it dissolve completely, continue to add the salbutamol sulfate, poloxamer 188, meglumine, mannitol and propylene glycol of recipe quantity, 50 Stir at ℃ for 20min until all dissolved;

[0067] 2) Add purified water to the full amount, add methylparaben and sorbitol, stir to dissolve, filter with a 0.45 μm microporous membrane, fill, seal, pass the inspection, and package.

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 the purified water of recipe quantity 60%, add the ambroxol hydrochloride of recipe quantity, stir and make it dissolve completely, continue to add the salbutamol sulfate, poloxamer 188, meglumine, mannitol and propylene glycol of recipe quantity, 55 Stir at ℃ for 25min until all dissolved;

[0081] 2) Add purified water to the full amount, add methylparaben and sucrose, stir to dissolve, filter with a 0.45 μm microporous membrane, fill, seal, pass the inspection, and package.

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PUM

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Abstract

The invention relates to ambroxoxalbutamol solution, which belongs to the field of pharmaceutical preparations. The solution of the present invention adds poloxamer 188, meglumine and mannitol in an appropriate amount, which can significantly improve the stability and bioavailability of ambroxol hydrochloride and salbutamol sulfate in the preparation, with stable quality and remarkable effect. Treatment of respiratory diseases such as acute and chronic bronchitis and asthma.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an ambroxol salbutamol 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 thoracic cavity. In mild cases, cough, chest pain, and breathing are affected. In severe cases, breathing difficulties, hypoxia, and even respiratory failure lead to death. The city has the third highest mortality rate and the first in the countryside. What should be paid more attention is that due to air pollution, smoking, aging population and other factors, chronic obstructive pulmonary disease (referred to as chronic obstructive pulmonary disease, including chronic bronchitis, emphysema, and pulmonary heart disease), bronchial asthma, lung cancer, etc. The morbidity and mortality of diseases such as diffuse interstitial fibrosis of the lungs, a...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/137A61K47/10A61K47/18A61P11/00A61P11/06
Inventor 王明刚任莉陈阳生
Owner CP PHARMA QINGDAO CO LTD
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