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Ambroxol hydrochloride oral fast-dissolving film and preparation method thereof

A technology of ambroxol hydrochloride and oral instant film, which is applied in the direction of medical formula, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve the problems of inconvenient carrying and inability to take medicine in time, and achieve the goal of carrying Convenience, rapid onset, and compliance-enhancing effects

Inactive Publication Date: 2013-01-02
天津市聚星康华医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Another object of the present invention is to provide a kind of ambroxol hydrochloride oral fast-dissolving film that is easy to carry and take conveniently, which solves the common dosage forms of ambroxol hydrochloride such as oral liquid and syrup, which are inconvenient to carry, and in the absence of water. The problem of not taking medicine on time

Method used

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  • Ambroxol hydrochloride oral fast-dissolving film and preparation method thereof
  • Ambroxol hydrochloride oral fast-dissolving film and preparation method thereof
  • Ambroxol hydrochloride oral fast-dissolving film and preparation method thereof

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Effect test

Embodiment 1

[0030] Each tablet contains ambroxol hydrochloride 15mg, and the composition of every 1000 tablets of ambroxol hydrochloride oral instant film is:

[0031]

[0032] The preparation process is as follows:

[0033] Solution A: Prepare 30% glycerin aqueous solution, 0.3% xanthan gum aqueous solution, 0.5% sodium alginate aqueous solution, and 0.3% carmine aqueous solution respectively, and set aside;

[0034] B Mixing and film coating: Weigh ambroxol hydrochloride, sucralose and microcrystalline cellulose, disperse with glycerin aqueous solution, add xanthan gum aqueous solution and sodium alginate aqueous solution under stirring, continue stirring for 15 minutes, then add pigment aqueous solution Mix with fruity liquid essence, stir to make it evenly mixed, let stand at 502 for 10 minutes, then apply evenly on the plate, and dry at 50°C;

[0035] C stripping, cutting, packaging.

[0036]Evaluation: The appearance of the film is pink, relatively flexible, the dissolution and...

Embodiment 2

[0038] Each ambroxol hydrochloride oral instant film contains 15 mg of ambroxol hydrochloride, and the prescription for every 1000 film formulations is:

[0039]

[0040] The preparation process is as follows:

[0041] Solution A: Prepare 30% glycerin aqueous solution, 0.3% xanthan gum aqueous solution, 0.5% sodium alginate aqueous solution, and 0.3% carmine aqueous solution respectively, and set aside;

[0042] B Mixing and film coating: Weigh ambroxol hydrochloride, sucralose and microcrystalline cellulose, mix them, disperse them with glycerin solution, add xanthan gum aqueous solution and sodium alginate aqueous solution under stirring, continue stirring for 15 minutes, then add Pigment aqueous solution and fruity liquid essence, stir to mix evenly, stand at 60°C for 10 minutes, apply evenly on the plate, and dry at 60°C;

[0043] C stripping, cutting, packaging.

[0044] Evaluation: The film is pink in appearance and generally flexible. It dissolves and disperses slo...

Embodiment 3

[0046] Each ambroxol hydrochloride oral instant film contains 15 mg of ambroxol hydrochloride, and the prescription for every 1000 film formulations is:

[0047]

[0048]

[0049] The preparation process is as follows:

[0050] Solution A: prepare 30% glycerin aqueous solution, 5% polyvinyl alcohol-polyethylene glycol copolymer aqueous solution, 0.3% xanthan gum aqueous solution, 0.5% sodium alginate aqueous solution, 1% citric acid aqueous solution, and 0.3% carmine Pigment aqueous solution, spare;

[0051] B prepares ambroxol hydrochloride drug resin: take ambroxol hydrochloride, dissolve with 1200ml of 0.5% aqueous citric acid solution, add polacrilin potassium resin after stirring and dissolving at room temperature, and continue stirring for 1 hour for ion exchange to obtain ambroxol hydrochloride The drug resin suspension was left to stand for 10 minutes, then suction filtered, washed with water, dried at 50°C, and crushed through a 200-mesh sieve to obtain the amb...

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Abstract

The invention belongs to the technical field of medicines and relates to an ambroxol hydrochloride oral fast-dissolving film and a preparation method thereof. The ambroxol hydrochloride oral fast-dissolving film is used for dissolving sticky secretion in the respiratory tract, promoting sputum excretion and improving the respiratory condition, and is good in taste, fast in drug release and effect working and favorable for improving drug compliance of patients, especially child patients and senile patients. In addition, the ambroxol hydrochloride oral fast-dissolving film is convenient to carry and take and solves the problem that the existing common drug forms of ambroxol hydrochloride, such as oral liquid and syrup, are inconvenient to carry and can not be taken timely without water.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an oral instant film containing ambroxol hydrochloride and a preparation method thereof. It can quickly dissolve or disintegrate in the oral cavity, release the drug, and take effect quickly in the gastrointestinal tract after swallowing. It has the effect of dissolving viscous secretions inside the respiratory tract, promoting mucus elimination, and reducing mucus retention, thereby promoting expectoration and improving respiratory conditions. Background technique [0002] In recent years, due to the continuous development of the economy, the population is gradually increasing, the number of cars has increased greatly, and the problem of air pollution has become increasingly prominent. In addition, due to the influence of various factors such as dry air, sandstorms, and indoor decoration pollution, respiratory diseases are gradually increasing, and they have become th...

Claims

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Application Information

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IPC IPC(8): A61K9/70A61K31/137A61K47/38A61P11/00A61P11/10
Inventor 赵伟刘婷婷卢欣李化淋
Owner 天津市聚星康华医药科技有限公司
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