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Fudosteine oral solid composition

A tablet, stable technology, applied in the direction of drug combination, medical preparations of non-active ingredients, respiratory diseases, etc., can solve the problem of content reduction

Active Publication Date: 2010-05-12
AVENTIS PHARMA HAINAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, it is mentioned in the patent that when fudosteine ​​is used together with additives commonly used in solid preparations, such as various sugars, sugar alcohols, cellulose, etc., discoloration occurs, and sometimes the content is reduced

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] Preparation Process

[0018] Pulverize fudosteine ​​and pass through a 100-mesh sieve, mannitol and sucrose respectively pass through a 80-mesh sieve, and mix in a fast stirring granulator according to the prescription amount. Take the prescription amount of tartrazine 60 and add it to 1000g of water to dissolve it, and add it to the mixture to make a soft material. Pass through a 14-mesh sieve, dry in an oven at 55°C, pass through a 12-mesh sieve for granulation, add the prescribed amount of essence to obtain uniform and full-colored granules, and fill them into aluminum-plastic composite film bags.

Embodiment 2

[0021] Preparation Process

[0022] Fudosteine ​​was pulverized through a 100-mesh sieve, and sorbitol, sucrose, and maltodextrin were respectively passed through a 80-mesh sieve. After the prescription amount of fudosteine ​​was mixed with the auxiliary materials in equal amounts, they were mixed in a rapid stirring granulator to prepare For soft materials, pass through a 14-mesh sieve, dry in an oven at 55°C, pass through a 12-mesh sieve for granulation, and obtain uniform and full granules. Fill in capsule shell.

Embodiment 3

[0025] Preparation Process

[0026] Fudosteine ​​is pulverized through a 100-mesh sieve, mannitol and dextrin are respectively passed through a 80-mesh sieve, and the prescription amount of fudosteine ​​is mixed with the excipients in equal amounts, and mixed in a rapid stirring granulator to make a soft material. Pass through a 18-mesh sieve, dry in an oven at 55°C, pass through an 18-mesh sieve for granulation, add the prescribed amount of magnesium stearate and talcum powder, mix well, and compress into tablets.

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PUM

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Abstract

The invention discloses a stable fudosteine drug combination, containing carbohydrate and / or sugar alcohol selected from lactose and is used as the filler. The combination has good stability and is used to expel phlegm to stop cough.

Description

technical field [0001] The present invention relates to a stable oral solid composition, especially a pharmaceutical composition containing fudosteine, which can be stored for a long time without discoloration. Background technique [0002] Chemicals with an expectorant effect that are widely used in clinical practice, such as bromhexine, acetylcysteine, and carboxymethylcysteine, all have varying degrees of phlegm-regulating effects. Fudosteine ​​is a new type of expectorant that belongs to cysteine ​​derivatives. It was first listed in Japan on December 17, 2001. Its basic pharmacological effects are the inhibition of goblet cell proliferation, the breaking of the disulfide bond of mucin in bronchial secretions, and the regulation of the normal state of mucus and mucosa in the respiratory tract. It is an expectorant with high efficiency and low toxicity, and it is expected to become the replacement product of similar drugs such as acetylcysteine ​​and carboxymethylcystein...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/198A61K47/26A61K47/36A61P11/10A61P11/14
Inventor 田瑞琴
Owner AVENTIS PHARMA HAINAN
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