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A kind of bromhexine hydrochloride orally dissolving film and preparation method thereof

A technology of bromhexine hydrochloride and mouth-dissolving film, applied in the field of bromhexine hydrochloride mouth-dissolving film and preparation thereof, can solve problems such as unfinished growth and development, and achieve the advantages of high added value of products, simple production process and reduced production cost. Effect

Active Publication Date: 2020-08-28
BEIJING UNION UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Children's physiology is special. Although their organs correspond to those of adults, their growth and development have not yet been completed.

Method used

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  • A kind of bromhexine hydrochloride orally dissolving film and preparation method thereof
  • A kind of bromhexine hydrochloride orally dissolving film and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Bromhexine hydrochloride, hydroxypropyl methylcellulose are pulverized to 80 orders, accurately weigh 2.5g bromhexine hydrochloride and 3.0g hydroxypropyl methylcellulose and 0.7g glycerol (plasticizer and defoaming agent) agent), bromhexine hydrochloride was dissolved in a beaker containing 25g of water, fully stirred to dissolve, added glycerol, stirred evenly to dissolve, slowly added hydroxypropyl methylcellulose and 0.03g orange essence, mixed Heat the solution to 38°C and keep it warm, fully stir at a speed of 60rpm to dissolve and form a glue, let it stand for defoaming, then scrape it out with a tongue depressor and apply it evenly on the glass plate, the direction is always the same, and use a tongue depressor Gently press the film until a uniform 1.5mm thick film appears on the glass plate, let it stand overnight to dry, and gently tear off the film from the glass plate after the film is completely dry to obtain bromine hydrochloride Hexa new oral dissolving f...

Embodiment 2

[0045] Grind bromhexine hydrochloride and hydroxypropyl methylcellulose to 80 meshes, accurately weigh 2.5g of bromhexine hydrochloride, dissolve bromhexine hydrochloride in a beaker filled with 25g of water, fully stir to dissolve, and let it stand for 5 minutes After about 10 minutes, after the bubbles are completely eliminated, add plasticizer 0.7g glycerol, stir evenly to dissolve it, place it in a water bath at 35°C to heat and keep it warm, and slowly add 4.0g hydroxypropyl methylcellulose and 1.0g defoaming agent Tween 20, and 0.03g of orange flavor, fully stirred at a speed of 60rpm to form a glue solution, sealed the bottle mouth with plastic wrap and left to stand overnight, scraped out the obtained glue solution with a tongue depressor and spread it evenly on a glass plate , the direction is always consistent, and gently press the film with a tongue depressor until a uniform 1.5mm thick film appears on the glass plate, let it stand overnight to dry, and gently remove...

Embodiment 3

[0053] Grind bromhexine hydrochloride and hydroxypropyl methylcellulose to 80 meshes, accurately weigh 2.5g of bromhexine hydrochloride, dissolve bromhexine hydrochloride in a beaker filled with 25g of water, fully stir to dissolve, and let it stand for 5 minutes After about 10 minutes, after the bubbles are completely eliminated, add plasticizer 0.7g PEG1000, stir evenly to dissolve, place in a water bath at 35°C to heat and keep warm, slowly add 3.0g hydroxypropyl methylcellulose, 0.7g GPE20, 0.03g banana Essence, fully stirred and dissolved at a speed of 70rpm to form a glue, seal the bottle with plastic wrap and let it stand overnight, scrape the obtained glue with a tongue depressor and apply it evenly on the glass plate, the direction is always the same, and use a tongue depressor Gently press the film until a uniform 1.5mm thick film appears on the glass plate, let it stand overnight to dry, and gently tear off the film from the glass plate after the film is completely d...

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Abstract

The invention discloses a bromhexine hydrochloride mouth-dissolving film and a preparation method thereof. The bromhexine hydrochloride mouth-dissolving film is prepared from, by weight, 5-10 parts of bromhexine hydrochloride, 5-20 parts of film-forming agents, 1-5 parts of plasticizers, 1-2 parts of defoaming agents, 0.5-1 part of flavoring agents and 40-70 parts of water. The preparation method includes the steps: (1) dissolving the bromhexine hydrochloride in the water and sufficiently stirring and dissolving the bromhexine hydrochloride; (2) sequentially adding the plasticizers and the flavoring agents into the water, uniformly stirring the plasticizers and the flavoring agents and completely dissolving the plasticizers and the flavoring agents; (3) slowly adding the film-forming agents and the defoaming agents into solution obtained in the step (2), slowly stirring the solution, uniformly mixing the agents and the solution, heating the obtained solution to reach the temperature of 35-38 DEG C, and standing until complete defoaming to obtain glue solution; (4) preparing the film by a tape casting method, slightly tearing off the film after complete drying, and clipping and packaging the film as per specifications. The bromhexine hydrochloride mouth-dissolving film is rapid in medicine release, pleasant in taste, convenient to carry, applicable to child and elderly patients and low in cost, and can be taken without water.

Description

technical field [0001] The invention relates to a bromhexine hydrochloride orally soluble film and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. Background technique [0002] Bromhexine hydrochloride is mainly used for patients with chronic bronchitis and asthma who have sticky sputum that is difficult to cough up. It can directly act on bronchial glands, promote the release of lysosomes in mucus-secreting cells, and differentiate and crack the sticky sugar fibers in sputum; it can also inhibit the synthesis of acid glycoproteins in mucous glands and goblet cells, causing them to secrete Small molecule glycoproteins with low viscosity, so that the viscosity of sputum is reduced and it is easy to cough up. In addition, bromhexine hydrochloride can also stimulate the gastric mucosa to reflexively increase the secretion of the respiratory glands and dilute the sputum. Bronchitis, asthma, emphysema and other sticky phlegm are no...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/70A61K47/10A61K47/26A61K31/136A61P11/00A61P11/06A61P11/10
CPCA61K9/006A61K9/7007A61K31/136A61K47/10A61K47/26
Inventor 霍清陶凤云杨晓方程红霞
Owner BEIJING UNION UNIVERSITY