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A solid dispersion of ambroxol hydrochloride and composition thereof

A technology of ambroxol hydrochloride and solid dispersion, which is applied in directions such as pharmaceutical combinations, organic active ingredients, and non-active ingredients medical preparations, etc., can solve the problem of bad taste, left bitterness, numbness, and cannot completely cover ambroxol hydrochloride and other problems to achieve the effect of stable nature

Active Publication Date: 2006-11-22
CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD +1
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  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Ambroxol hydrochloride orally disintegrating tablets added with conventional flavoring agents and effervescent agents can disintegrate quickly, and can also temporarily cover the bitter taste and numbness of oral administration, but after complete disintegration, hydrochloric acid will still remain in the oral cavity The bitter taste and numbness of ambroxol mean that this conventional preparation method cannot completely cover the bad taste of ambroxol hydrochloride
[0008] CN1628647A applied for by Chengdu Biteer Pharmaceutical Co., Ltd. discloses a kind of ambroxol hydrochloride granule, and this invention covers the extremely strong bitter taste of medicine by adding flavoring agents (such as sucrose, stevioside, Firmenich) and essence , but the drug is slightly soluble in water, resulting in a small part of the drug dissolved in water still has a strong bitter taste and numbness

Method used

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  • A solid dispersion of ambroxol hydrochloride and composition thereof
  • A solid dispersion of ambroxol hydrochloride and composition thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Embodiment one, preparation ambroxol hydrochloride solid dispersion

[0039] After taking by weighing Eudragit L100-55 30g and adding in 95% ethanol for dissolving, Ambroxol Hydrochloride 30g is added in the above-mentioned solution for dissolving, and the evenly stirred liquid is spray-dried with a spray dryer (QP3 type, Beijing Research Institute of Chemical Industry, Ministry of Chemical Industry). The inlet temperature is controlled at 70-90° C., and the outlet temperature is controlled at 40-50° C. to obtain a powdery solid dispersion of ambroxol hydrochloride.

Embodiment 2

[0040] Embodiment two, preparation ambroxol hydrochloride solid dispersion

[0041] After taking by weighing Eudragit L100-55 60g and adding in 95% ethanol for dissolving, Ambroxol HCl 30g was added to dissolve in the above-mentioned solution, and the evenly stirred liquid was spray-dried with a spray dryer (QP3 type, Beijing Research Institute of Chemical Industry, Ministry of Chemical Industry). The inlet temperature is controlled at 70-90° C., and the outlet temperature is controlled at 40-50° C. to obtain a powdery solid dispersion of ambroxol hydrochloride.

Embodiment 3

[0042] Embodiment three, preparation ambroxol hydrochloride solid dispersion

[0043] Weigh Eudragit L100-55 90g, add 95% ethanol to dissolve, add Ambroxol Hydrochloride 30g to the above solution and dissolve, stir and mix the liquid with a spray dryer (QP3 type, Beijing Chemical Industry Research Institute, Ministry of Chemical Industry) to spray Drying, the inlet temperature is controlled at 70-90°C, and the outlet temperature is controlled at 40-50°C to obtain a powdery ambroxol hydrochloride solid dispersion.

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Abstract

The present invention relates to one kind of ambroxol hydrochloride dispersion and its preparation process and medicine composition. The ambroxol hydrochloride dispersion contains ambroxol hydrochloride and carrier material in the weight ratio of 1 to 0.3-10. The present invention aims at masking the bad smell of ambroxol hydrochloride.

Description

technical field [0001] The invention relates to a solid dispersion of ambroxol hydrochloride, a preparation method thereof, and a pharmaceutical composition containing the solid dispersion of ambroxol hydrochloride. Background technique [0002] Ambroxol Hydrochloride (Ambroxol Hydrochloride) chemical name: trans 4-[(2-amino-3,5 dibromo-phenyl)methyl]amino]cyclohexanol hydrochloride. The structural formula is as follows: [0003] [0004] Ambroxol hydrochloride is a new generation of respiratory mucus regulator, which can promote the production of pulmonary surfactant, regulate sputum secretion, improve airway clearance function, and help sputum discharge. It is suitable for acute and chronic respiratory diseases, such as acute and chronic bronchitis, bronchial asthma, bronchiectasis, tuberculosis, etc., which cause thick sputum and difficulty in coughing up sputum. [0005] Ambroxol hydrochloride is slightly soluble in water, and the taste of the...

Claims

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Application Information

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IPC IPC(8): A61K31/137A61K9/16A61K9/20A61K47/32A61K47/38A61P11/00
Inventor 陈素锐杨丽英梁敏白敏刘海丽
Owner CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD
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