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Oral solid preparation containing ambroxol hydrochloride and salbutamol active components

A technology of ambroxol hydrochloride and solid preparations, applied in the field of pharmaceutical preparations, can solve the problems of high production cost, easy precipitation, easy mold and deterioration, etc., and achieve the effects of low production cost, simple process and convenient portability

Inactive Publication Date: 2008-01-09
GUANGZHOU LIXIN PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The solution has the advantage of being easy to absorb, but there are also many disadvantages in storage, especially the climate difference between the north and the south of my country. The solution is easy to precipitate and precipitate in the winter in the north, and it is easy to mold and deteriorate in the south and decompose when exposed to light.
Solution also has disadvantages such as inconvenient to carry, higher production cost, etc.

Method used

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  • Oral solid preparation containing ambroxol hydrochloride and salbutamol active components

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0023] Example 1: (tablet) (quantity of 100 tablets)

[0024] Ambroxol Hydrochloride 1.5g

[0025] Salbutamol Sulfate 0.2g

[0026] Lactose 8.0g

[0027] Starch 2.0g

[0028] Polymicroketone 1.0g

[0029] Sodium carboxymethyl starch 1.0g

[0030] 8% starch slurry qs

[0031] Magnesium stearate qs

[0032] Talc powder qs

[0033] 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 starch slurry to make soft material, granulate with a 20-mesh sieve, dry at 55°C, and granulate with a 18-mesh sieve. Finally, add the lubricant and mix evenly for tableting.

example 2

[0034] Example 2 (dispersible tablets) (100 tablets)

[0035] Ambroxol Hydrochloride 0.75g

[0036] Salbutamol Sulfate 0.2g

[0037] Lactose 10.0g

[0038] Microcrystalline Cellulose 1.0g

[0039] Carboxymethyl Starch Sodium Add 1.0g plus 0.5g

[0040] Aspartame 0.1g

[0041] Orange flavor 0.1g

[0042] 2% hypromellose qs

[0043] Silica qs

[0044] 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

[0045] Example 3: (orally disintegrating tablet) (quantity of 100 tablets)

[0046] Ambroxol Hydrochloride 3.0g

[0047] Salbutamol Sulfate 0.4g

[0048] Mannitol 18.0g

[0049] Microcrystalline Cellulose 2.0g

[0050]Croscarmellose Sodium, 1.0g

[0051] Magnesium stearate qs

[0052] Silica qs

[0053] Pass the main ingredient and auxiliary materials through a 100-mesh sieve, mix thoroughly, press the cake with a roller press, and then use a sizing agent to pass through a 18-mesh sieve for granulation, and finally add a lubricant and mix evenly for tableting.

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PUM

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Abstract

The present invention discloses an oral solid preparation containing ambroxol hydrochloride and salbutamol active components. It is formed from ambroxol hydrochloride, salbutamol and auxiliary material according to a certain mixing ratio. Said oral solid preparation has the obvious synergistic action for remitting the symptoms of dyspnea, etc. due to respiratory tract obstruction diseases of bronchial asthma, chronic bronchitis and pulmonary emphysema, etc.

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 albuterol 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 hydrochloride h...

Claims

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Application Information

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IPC IPC(8): A61K31/137A61K9/20A61K9/48A61K9/14A61K47/38A61P11/06
Inventor 郭嘉林邹美香任晓文孙歆慧张彩霞
Owner GUANGZHOU LIXIN PHARM CO LTD
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