A film that dissolves rapidly in the oral cavity and its preparation method

A rapid, film-based technology, applied in the field of medicine, can solve the problems of preparation prescriptions that have not been reported in the literature, tablet packaging, inconvenient transportation for patients to take medicine, and high fragility, so as to shorten the pain time, reduce the decomposition of the gastrointestinal tract, The effect of simple preparation process

Active Publication Date: 2016-02-03
SUZHOU RENBEN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Dosage forms used for emergency medicine, such as orally disintegrating tablets, sublingual tablets, and dispersible tablets, have some shortcomings. For example, special freeze-drying equipment is required for production by freeze-drying methods, and most orally disintegrating tablets are highly brittle. Disadvantages, which bring inconvenience to the packaging, transportation and patient administration of tablets
Compared with the above-mentioned dosage forms, the oral instant film preparation process is simple, non-brittle, easy to carry and the formulation prescription proposed by the present invention has not been reported in the literature yet.

Method used

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  • A film that dissolves rapidly in the oral cavity and its preparation method
  • A film that dissolves rapidly in the oral cavity and its preparation method
  • A film that dissolves rapidly in the oral cavity and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Oral fast-dissolving film disintegration time determination method:

[0033] Put 100mL of distilled water into a 100mL beaker and place it on an electromagnetic stirrer, in a constant temperature water bath at 37°C, with a stirring speed of 50r / min, take 10 sheets of medicine film (1cm×1cm) at will, one piece at a time, and clamp the test film in the clip Place in the water bath to start timing. Record the time when the film breaks, that is, the disintegration time limit of the film.

Embodiment 2

[0035] Determination of mechanical properties of oral instant film:

[0036] Using a universal material tester (Instron3365), the film was cut to a size of about 2cm×0.5cm (balanced at 43%RH for a week), and the tensile speed was 5mm min -1 , each film is stretched longitudinally until the film breaks. Calculation of mechanical properties such as elastic modulus (EM) and elongation percentage (E%) of oral instant film is as follows. The elastic modulus refers to the ratio of the applied stress to the strain force during the elastic deformation stage, which can be calculated using the following formula:

[0037] Modulus of elasticity = Applied stress / Strain force / Cross-sectional area

[0038] The percentage extension is calculated by the following formula:

[0039] Elongation percentage = length at break - original length / original length x 100

Embodiment 3

[0041] components content Hydroxypropyl Methyl Cellulose (5 centipoise) 3g glycerin 0.3 mL active ingredient Appropriate amount purified water 15mL

[0042] Specific operation process: disperse hydroxypropyl methylcellulose (5 centipoise) in purified water under stirring, fully disperse and dissolve to obtain a gel, add the prescribed amount of glycerin, add active ingredients while stirring, fully disperse, and degas , the above-mentioned gel is uniformly coated on a flat plate by an automatic coating machine, blasted, heated and dried at a heating temperature of 60° C., and cut to obtain an oral instant film. The film is transparent and light yellow in color, with good release performance and general flexibility. The disintegration time limit is 92s.

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Abstract

The invention discloses a film agent quickly dissolved in the oral cavity and a preparation method thereof. The film agent consists of the following components in percentage by weight: 0.1 to 70 percent of medicinal active ingredients, 30 to 90 percent of water-soluble film forming material, 2 to 20 percent of plasticizer, 0 to 5 percent of disintegrating agent, and 1 to 20 percent of water, wherein the medicinal active ingredients are selected from modified or non-modified cobra venom, sumatriptan succinate, ergotamine dihydrogen tartrate and lomerizine hydrochloride or flunarizine hydrochloride. The film agent is quick in response, and avoids decomposition in gastrointestinal tracts due to oral administration to reduce the treatment effect. The preparation method is simple, economic and practical, and facilitates industrialized batch production.

Description

technical field [0001] The invention relates to the technical field of medicines, in particular to a thin film preparation for treating joint autoimmune diseases and migraine medicine that dissolves rapidly in the oral cavity and a preparation method thereof. Background technique [0002] Autoimmune disease is a kind of common disease with complex etiology, recurrent attacks, and great harm. Because most of the etiology is unknown, it is difficult to treat. Among them, rheumatic (rheumatoid) arthritis has a high incidence rate, and repeated attacks can cause joint deformities, affect function, and lose labor force. Simple physical treatment of Chinese cobra venom can achieve the purpose of reducing toxicity and increasing efficiency. The modified cobra venom has a good effect of inhibiting inflammation, pain and immune response and treating Freund's adjuvant arthritis, which can be used to treat Rheumatoid arthritis, systemic lupus erythematosus and other diseases, and oral...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/70A61K35/583A61K31/4045A61K31/48A61K31/495A61P37/02A61P29/00A61P25/06
Inventor 秦正红崔京浩司奇丁晓兰
Owner SUZHOU RENBEN PHARMA
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