Pharmaceutical composition for stabilizing ambroxol hydrochloride granula
A technology of ambroxol hydrochloride and its composition, which is applied in the field of pharmaceutical preparations, can solve the problems affecting the quality of medicines and the inconvenience of industrial production, and achieve the effects of being suitable for large-scale industrial production, improving appearance and storage time, and saving costs
Active Publication Date: 2008-10-01
TIANJIN INSTITUTE OF PHARMA RESEARCH
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Problems solved by technology
Therefore, if monosaccharides and disaccharides, especially lactose, are not used in the prescription of pharmaceutical compositions, it will bring a lot of inconvenience to large-scale industrial production and affect the quality of medicines.
Method used
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example 1
[0025] Ambroxol Hydrochloride 0.3g
[0026] Glucose 3.5g
[0027] Mannitol 5.5g
[0028] Aspartame 0.2g
[0029] Sodium metabisulfite 0.005g
[0030] Flavor 0.05g
example 2
[0032] Ambroxol Hydrochloride 0.3g
[0033] Lactose 4.5g
[0034] Sucrose 5.0g
[0035] Aspartame 0.1g
[0036] Thiourea 0.01g
[0037] Flavor 0.1g
example 3
[0039] Ambroxol Hydrochloride 0.3g
[0040] Glucose 1.7g
[0041] Mannitol 4.6g
[0042] Aspartame 0.1g
[0043] Sodium bisulfite (potassium) 0.03g
[0044] Flavor 0.05g
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The stabilized medicine composition of ambroxol hydrochloride granule consists of ambroxol hydrochloride as effective component, stabilizer and pharmaceutically acceptable soluble supplementary material in proportion of 1 to 0.01-1 to 15-50, preferably 1 to 0.05-0.2 to 15-30. The medicine composition of the present invention has no chemical pick-up forming unstable brown agglomeration during the combination of ambroxol hydrochloride with monosaccharide or polysaccharide, especially lactose, has simple operation and low cost, and is suitable for industrial production.
Description
technical field [0001] The invention belongs to the field of pharmaceutical preparations, and more specifically relates to a granule of ambroxol hydrochloride, a medicine for reducing mucus and expectorant. Background technique [0002] The chemical name of ambroxol hydrochloride is: trans 4-[(2-amino-3,5-dibromo-phenyl)methyl-amino]cyclohexanol hydrochloride. For its preparation method, refer to GB1991, 2239242. has the following structure: [0003] [0004] Ambroxol hydrochloride is a new generation of airway mucus regulator, which has excellent expectorant effect and can significantly promote the synthesis and secretion of alveolar surfactant. Ambroxol hydrochloride can stimulate bronchial mucus glands to secrete more flowable mucus, dilute sputum, reduce viscosity, and increase the production and secretion of pulmonary surfactant, thereby reducing airway resistance, reducing mucus adhesion, and activating Mucociliary blanket functions to facilitate mucociliary tran...
Claims
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IPC IPC(8): A61K31/137A61K47/20A61K47/02A61K9/16A61P11/10
Inventor 任晓文马晋李洪起连潇嫣徐为人
Owner TIANJIN INSTITUTE OF PHARMA RESEARCH
