Oral solid preparation containing ambroxol hydrochloride and guaifenesin active components

Abstract

The present invention discloses an oral solid preparation containing ambroxal hydrochloride and guaifenesin active components. It is made up by using ambroxol hydrochloride and guaifenesin as active components and auxiliary material according to a certain ratio through a certain preparation process. Said oral solid preparation can be used for mainly curing the diseases of chronic bronchitis and periodic lower respiratory tract infection.

Description

technical field

[0001] The invention belongs to the field of pharmaceutical preparations, more specifically, an oral solid preparation containing active ingredients of ambroxol hydrochloride and guaiacol glyceryl ether Background technique

[0002] The chemical name of ambroxol hydrochloride is: trans 4-[(2-amino-3,5-dibromo-phenyl)methyl-amino]cyclohexanol hydrochloride. 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 transport. Compared with the first-generation and second-generation expectorant drugs, ambroxol h...

Examples

example 1

[0025] Example 1: (tablet) (quantity of 100 tablets)

[0026] Ambroxol Hydrochloride 3g

[0027] Guaifenesin 10g

[0028] Lactose 10g

[0029] Starch 2.0g

[0030] Polymicroketone 1.0g

[0031] Sodium carboxymethyl starch 1.0g

[0032] 8% starch slurry qs

[0033] Magnesium stearate qs

[0034] Talc powder qs

[0035] Pass the main drug and auxiliary materials through a 100-mesh sieve respectively, fully mix, then weigh the prescription amount of auxiliary materials and fully mix with the main drug. Then add 8% starch slurry to make soft material, granulate with 20 mesh sieve, dry at 55°C, and granulate with 18 mesh sieve. Finally, add the lubricant and mix evenly for tableting.

example 2

[0036] Example 2 (dispersible tablets) (100 tablets)

[0037] Ambroxol Hydrochloride 1.5g

[0038] Guaifenesin 10g

[0039] Lactose 10g

[0040] Microcrystalline Cellulose 3.0g

[0041] Carboxymethyl Starch Sodium Add 0.5g plus 1.0g

[0042] Aspartame 0.1g

[0043] Orange flavor 0.1g

[0044] 2% hypromellose qs

[0045] Silica qs

[0046] Pass the main drug and auxiliary materials through a 100-mesh sieve respectively, fully mix, then weigh the prescription amount of auxiliary materials and fully mix with the main drug. Then add binder to make soft material, granulate with 20-mesh sieve, dry at 55°C, and granulate with 18-mesh sieve. Add lubricant and remaining carboxymethyl starch sodium at last and mix and compress evenly.

example 3

[0047] Example 3: (orally disintegrating tablet) (quantity of 100 tablets)

[0048] Ambroxol Hydrochloride 1.5g

[0049] Guaifenesin 5.0g

[0050] Mannitol 10.0g

[0051] Microcrystalline Cellulose 2.0g

[0052] Croscarmellose Sodium, 1.0g

[0053] Magnesium stearate qs

[0054] Silica qs

[0055] Pass the main ingredient and auxiliary materials through a 100-mesh sieve, mix thoroughly, press the cake with a roller press, pass through a 18-mesh sieve with a granulator for granulation, and finally add a lubricant and mix evenly for tableting.

technical field

[0001] The invention belongs to the field of pharmaceutical preparations, more specifically, an oral solid preparation containing active ingredients of ambroxol hydrochloride and guaiacol glyceryl ether Background technique

[0002] The chemical name of ambroxol hydrochloride is: trans 4-[(2-amino-3,5-dibromo-phenyl)methyl-amino]cyclohexanol hydrochloride. 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 transport. Compared with the first-generation and second-generation expectorant drugs, ambroxol h...

Examples

example 1

[0025] Example 1: (tablet) (quantity of 100 tablets)

[0026] Ambroxol Hydrochloride 3g

[0027] Guaifenesin 10g

[0028] Lactose 10g

[0029] Starch 2.0g

[0030] Polymicroketone 1.0g

[0031] Sodium carboxymethyl starch 1.0g

[0032] 8% starch slurry qs

[0033] Magnesium stearate qs

[0034] Talc powder qs

[0035] Pass the main drug and auxiliary materials through a 100-mesh sieve respectively, fully mix, then weigh the prescription amount of auxiliary materials and fully mix with the main drug. Then add 8% starch slurry to make soft material, granulate with 20 mesh sieve, dry at 55°C, and granulate with 18 mesh sieve. Finally, add the lubricant and mix evenly for tableting.

example 2

[0036] Example 2 (dispersible tablets) (100 tablets)

[0037] Ambroxol Hydrochloride 1.5g

[0038] Guaifenesin 10g

[0039] Lactose 10g

[0040] Microcrystalline Cellulose 3.0g

[0041] Carboxymethyl Starch Sodium Add 0.5g plus 1.0g

[0042] Aspartame 0.1g

[0043] Orange flavor 0.1g

[0044] 2% hypromellose qs

[0045] Silica qs

[0046] Pass the main drug and auxiliary materials through a 100-mesh sieve respectively, fully mix, then weigh the prescription amount of auxiliary materials and fully mix with the main drug. Then add binder to make soft material, granulate with 20-mesh sieve, dry at 55°C, and granulate with 18-mesh sieve. Add lubricant and remaining carboxymethyl starch sodium at last and mix and compress evenly.

example 3

[0047] Example 3: (orally disintegrating tablet) (quantity of 100 tablets)

[0048] Ambroxol Hydrochloride 1.5g

[0049] Guaifenesin 5.0g

[0050] Mannitol 10.0g

[0051] Microcrystalline Cellulose 2.0g

[0052] Croscarmellose Sodium, 1.0g

[0053] Magnesium stearate qs

[0054] Silica qs

[0055] Pass the main ingredient and auxiliary materials through a 100-mesh sieve, mix thoroughly, press the cake with a roller press, pass through a 18-mesh sieve with a granulator for granulation, and finally add a lubricant and mix evenly for tableting.

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