A bioadhesive slow-release oral ulcer film and its preparation method

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 medicine, and specifically relates to a slow-release oral ulcer film with biological adhesion and a preparation method thereof. Background technique [0002] Recurrent oral ulcers, also known as recurrent aphthous ulcers, are the most common oral mucosal diseases. For recurrent oral ulcers, the main clinical application is local administration to the affected area. Common dosage forms include powder, injection, ointment and film. [0003] In daily life, oral ulcers caused by bites, burns, abrasions, and scratches are more common. Once oral ulcers form, not only affect the patient's normal life and diet, but sometimes even cause systemic diseases. For oral ulcers, the clinical focus is on symptomatic treatment of topical medications. The clinical medications include powders, ointments, membranes and injections, but most of them have a short intraoral action time, which directly affects the efficacy. For exampl...

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.

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