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Orally disintegrating tablet of ambroxol hydrochloride and preparation method thereof

A technology of ambroxol hydrochloride and orally disintegrating tablet is applied in the field of ambroxol hydrochloride orally disintegrating tablet and preparation thereof, and can solve the problems of poor compliance, long disintegration time, inconvenient taking and the like

Inactive Publication Date: 2010-12-08
YICHANG HEC CHANGJIANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The ordinary tablets of ambroxol hydrochloride take a long time to disintegrate, children, elderly patients with dysphagia are inconvenient to take, poor compliance, etc., which affect the therapeutic effect of ambroxol hydrochloride

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment l

[0032] Ambroxol hydrochloride 0.17 g

[0033] Mannitol 122.00g

[0034] Microcrystalline Cellulose 13.00g

[0035] Low-substituted hydroxypropyl cellulose 12.00g

[0036] Aspartame 2.50g

[0037] 95% ethanol solution appropriate amount

[0038] Orange flavor 1.67g

[0039] Talc powder 1.50g

[0040] Micronized silica gel 1.50 g

[0041] Crospovidone 12.00 g

[0042] Magnesium stearate 3.00 g

[0043] A total of 1000 pieces were made

[0044] Preparation method: The raw material of ambroxol hydrochloride is passed through a 100-mesh sieve. Mix the raw materials with microcrystalline cellulose, mannitol (passed through a 150-mesh sieve), L-HPC and aspartame according to the prescription ratio, prepare a soft material with 90% ethanol solution, granulate with a 20-mesh sieve, and dry at 60°C , 18-mesh sieve, plus excipients PVPP and magnesium stearate according to the prescription ratio, fully mixed, and then compressed into tablets.

Embodiment 2

[0046]Ambroxol Hydrochloride 8.39g

[0047] Microcrystalline Cellulose 14.00g

[0048] Mannitol 113.61g

[0049] Glycyrrhizin 1.67 g

[0050] Peach Flavor 1.67g

[0051] Low-substituted hydroxypropyl cellulose 12.00 g

[0052] Aspartame 2.50 g

[0053] 3% PVPk30 50% ethanol solution appropriate amount

[0054] Crospovidone 12.00g

[0055] Magnesium Stearate 3.00g

[0056] A total of 1000 pieces were made

[0057] Preparation method: The raw material of ambroxol hydrochloride is passed through a 100-mesh sieve. Mix the raw materials with microcrystalline cellulose, mannitol, L-HPC, and aspartame according to the prescription ratio, grind for 30 minutes, pass through a 100-mesh sieve, prepare a soft material with 3% PVPk3050% ethanol solution, and granulate with a 20-mesh sieve. Dry at 60°C, sieve with 18 meshes, add excipients PVPP and magnesium stearate according to the prescription ratio, mix well, and press into tablets.

Embodiment 3

[0059] Ambroxol Hydrochloride 13.4g

[0060] Lactose 8.00g

[0061] Mannitol 121.00g

[0062] Croscarmellose Sodium 12.00 g

[0063] Disodium Glycyrrhizinate 2.69 g

[0064] 90% ethanol solution appropriate amount

[0065] PEG-6000 (polyethylene glycol) 1 g

[0066] Crospovidone 12 g

[0067] Magnesium Stearate 1.5g

[0068] A total of 1000 pieces were made

[0069] Preparation method: The raw material of ambroxol hydrochloride is passed through a 100-mesh sieve. Mix the raw materials with lactose, mannitol, CCNA, and aspartame according to the prescription ratio, grind for 30 minutes, pass through a 100-mesh sieve, prepare a soft material with 90% ethanol solution, granulate with a 20-mesh sieve, dry at 60°C, and 18 mesh Sieve the granules, add PVPP, PEG-6000 (passed through a 100-mesh sieve) and magnesium stearate in the prescribed ratio, mix thoroughly, and press into tablets.

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PUM

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Abstract

The invention discloses an orally disintegrating tablet of ambroxol hydrochloride and a preparation method thereof, which can effectively treat acute and chronic respiratory diseases (such as thick sputum and expectoration difficulty due to acute and chronic bronchitis, bronchial asthma, bronchiectasis, tuberculosis and the like.) The invention aims to provide an orally disintegrating tablet of ambroxol hydrochloride for wide patients and medical staff, i.e. a new preparation of a clinical medicine, which has rapid absorption, high bioavailability, no water for taking, little side effect and more convenience and is prepared by using ambroxol hydrochloride as a raw material, adding some special kinds of accessories in a certain proportion according to a technical measure disclosed in the invention. The product of the invention has sweet and fragrant taste, rapid effect and high bioavailability and is particularly easy to improve the drug compliance of patients.

Description

technical field [0001] The present invention relates to a medicine for treating acute and chronic respiratory diseases: such as acute and chronic bronchitis, bronchial asthma, bronchiectasis, pulmonary tuberculosis, etc. Ambroxol hydrochloride oral tablet and preparation method thereof. Background technique [0002] Ambroxol hydrochloride is the active metabolite of ambroxol as bromhexine. It is a new mucolytic drug, which has the functions of dissolving and secreting mucus and promoting the elimination of mucus. At the same time, it can promote the secretion of pulmonary surfactant and can promote The bronchial cilia emptying movement is conducive to the discharge of airway secretions, achieving significant expectoration and improving respiratory conditions. It has low toxicity, strong expectorant and lung function improvement effects, and is one of the most commonly used expectorant drugs. It is mainly used clinically for reducing phlegm and anti-inflammation. This produ...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/137A61K47/38A61P11/10
Inventor 周捍东李勇
Owner YICHANG HEC CHANGJIANG PHARMA CO LTD
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