Sustained-release oral ulcer film having biological adhesion and preparation method of sustained-release oral ulcer film

A bioadhesion and oral ulcer technology, applied in the field of medicine, can solve the problems of affecting the action time of the film, short residence time, drug loss, etc., and achieve the effect of inhibiting the growth of wound bacteria, reducing the shaping process, and preventing wound infection

Active Publication Date: 2017-12-01
HARBIN QIANBAINA BIOPHARM
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For oral ulcers, the clinical treatment is mainly symptomatic with topical medications. Clinical medications include powders, ointments, films and injections, etc., but most of them directly affect the curative effect due to the short action time in the mouth.
Such as powders such as traditional Chinese medicine Bingboran Powder, which must be applied to the affected area during use, and the medicine will be quickly lost with saliva; ointment is difficult to apply to the affected area; although the commonly used film agent can be attached to the ulcer surface, it is very easy to fall off Dissolves and disappears within a few minutes, drug penetration is not enough
[0004] For the currently commonly used oral ulcer treatment film, the main problem is: due to the special physiological environment of the oral cavity, most of the film has low adhesion and short residence time in the oral cavity, and it is difficult to adapt to the characteristics of the oral cavity to achieve continuous treatment at the ulcer site. effective effect
In order to enhance the adhesion performance and action time of the film in the oral cavity, and make it suitable for the physiological structure and environment of the oral cavity, many films are prepared as thin and flexible films, but this will affect the action time of the film So that the lesion site can not achieve effective effect
Although the film with sufficient action time increases the thickness of the film and prolongs the action time, it has the disadvantages of poor conformability in the oral cavity, strong foreign body sensation, and easy to fall off.

Method used

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  • Sustained-release oral ulcer film having biological adhesion and preparation method of sustained-release oral ulcer film
  • Sustained-release oral ulcer film having biological adhesion and preparation method of sustained-release oral ulcer film
  • Sustained-release oral ulcer film having biological adhesion and preparation method of sustained-release oral ulcer film

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preparation example Construction

[0041] A preparation method of a bioadhesive slow-release oral ulcer film, the specific preparation steps are as follows:

[0042] 1) Take 580ml of solvent for each 100g film, when the formula contains polylactic acid, polylactic acid-glycolic acid copolymer, and ethyl cellulose, use 45% ethanol to dissolve, and use purified water to dissolve other ingredients. When the formula contains chitosan, add 10ml of glacial acetic acid, add bioadhesive materials, slow-release film-forming materials and stir until completely dissolved;

[0043] 2) Add drug, plasticizer and support agent to the mixed solution in step 1) and stir to obtain mixed solution A;

[0044] 3) 20ml of 75% ethanol was used to dissolve the antibacterial agent and flavoring agent of every 100g film to obtain mixed solution B;

[0045] 4) Mix the mixed solution A with the mixed solution B, and stir evenly to obtain a spare liquid;

[0046]5) The film-forming process of quantitative titration by electron row gun, s...

Embodiment 1

[0050] Prescription: calculated per 100g film

[0051]

[0052]

[0053] Process: Take 580ml of purified water, add 10mL of glacial acetic acid, add chitosan, glucosamine, hydroxypropyl methylcellulose, polyvinyl alcohol and stir until completely dissolved; add carbomer, acetic acid to the above solution in turn Amethasone, vitamin B6, Chinese medicine extract, propylene glycol, glycerol and talcum powder are stirred evenly to obtain mixed solution A; bacteriostatic agent and corrective agent of prescription amount are dissolved with 20ml 75% ethanol, and mixed solution B is obtained; Mixed solution A Mix with the mixed solution B and stir evenly to obtain a spare liquid; the film forming process adopts the method of quantitative titration with an electronic gun, drop into a cylindrical aluminum foil blister at a constant temperature of 30-70°C and dry for 15-90 minutes to form a preliminary film; the initial film is formed Then put it into a constant temperature (20-50°...

Embodiment 2

[0055] Prescription: calculated per 100g film

[0056]

[0057]

[0058] Process: Take 580ml of purified water, add 10mL of glacial acetic acid, add chitosan, methyl cellulose and hydroxypropyl cellulose in turn and stir until completely dissolved; add vitamin B2, vitamin B6, vitamin C, lidocaine to the above solution in turn Caine, gentamicin, titanium dioxide powder and glycerin are stirred evenly to obtain mixed solution A; bacteriostatic agent and flavoring agent of formula quantity are dissolved with 20ml 75% ethanol, and mixed solution B is obtained; Mixed solution A and mixed solution B Mix and stir evenly to obtain a spare liquid; the film-forming process adopts the method of quantitative titration with an electronic gun, drop into a cylindrical aluminum foil blister at a constant temperature of 30-70°C and dry for 15-90 minutes to form a preliminary film; after the initial film is formed, put The constant temperature (20-50°C) and constant humidity (10%-70%) sys...

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Abstract

The invention relates to a sustained-release oral ulcer film having biological adhesion and a preparation method of the sustained-release oral ulcer film. According to the formula, the sustained-release oral ulcer film having the biological adhesion consists of the following components in percentage by weight: 5-50% of a bio-adhesion material, 5-80% of a sustained-release film forming material, 0.5-10% of a medicine, 1-50% of a supporting agent, 1-20% of a plasticizer, 0.1-0.5% of a bacteriostatic agent and 0.5-1% of a flavoring agent. The film provided by the invention, which is prepared in a specific production mode, is good in stability, and excellent biological adhesion and sustained-release performance of the film can be kept for a long time; a soluble sustained-release gel can be gradually formed as the film is adhered to an ulcer surface and absorbs water, so that contact of the ulcer surface with external side is prevented; the oral ulcer film provided by the invention has the characteristics of diminishing inflammation, alleviating pain, achieving an antibacterial effect and being free from toxins, irritation, mutagenic action and the like; and the oral ulcer film can promote growth of blood vessel endothelium and proliferation of fibroblasts and keratinocytes, and subsequently, the oral ulcer film can promote regeneration, repair of healing of the ulcer surface.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a bioadhesive slow-release oral ulcer film and a preparation method thereof. Background technique [0002] Recurrent oral ulcer, also known as recurrent aphthous ulcer, is a disease with the highest incidence rate in oral mucosal diseases. For recurrent oral ulcers, local administration is mainly used in clinical practice. The common dosage forms include powder, injection, ointment and film. [0003] In daily life, oral ulcers caused by bites, burns, abrasions, scratches, etc. are more common. Once oral ulcers are formed, it not only affects the normal life and diet of patients, but sometimes even causes systemic diseases. For oral ulcers, clinical symptomatic treatment is mainly based on topical medications. Clinical medications include powders, ointments, films, injections and other dosage forms, but most of them directly affect the curative effect due to the sh...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K47/36A61K47/32A61K47/26A61K47/38A61K47/10A61K47/14A61K47/12A61K47/22A61K47/44A61K47/42A61K47/34A61K36/8984A61K31/7036A61K31/79A61P1/02A61P31/04A61P31/02A61P29/00A61K31/573A61K31/4415A61K31/525A61K31/167A61K31/375
CPCA61K9/0002A61K9/006A61K9/7007A61K31/167A61K31/375A61K31/4415A61K31/525A61K31/573A61K31/7036A61K31/79A61K36/195A61K36/232A61K36/284A61K36/288A61K36/315A61K36/484A61K36/704A61K36/804A61K36/855A61K36/8968A61K36/8969A61K36/8984A61K47/10A61K47/12A61K47/14A61K47/22A61K47/26A61K47/32A61K47/34A61K47/36A61K47/38A61K47/42A61K47/44A61K2300/00
Inventor 高纳新
Owner HARBIN QIANBAINA BIOPHARM
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