Preparation method of diphenhydramine hydrochloride oral instant film agent

A technology of diphenhydramine hydrochloride and oral instant film, which is applied in the direction of medical preparations with non-active ingredients, medical preparations containing active ingredients, and pharmaceutical formulas, and can solve the difficulty of diphenhydramine hydrochloride in taste-masking, process Complicated and uncontrollable conditions

Active Publication Date: 2015-12-30
HEFEI HUAFANG PHARMA SCI & TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, those skilled in the art know that when using cyclodextrin inclusion complexation and solid dispersion technology to cover the taste, the conditions are not easy to control
And the final product must be verified by special means, such as X-diffraction, differential thermal analysis (DSC), etc., the process is complicated
[0007] Diphenhydramine hydrochloride tastes bitter, followed by a sense of numbness. Since the orally disintegrating tablet disintegrates in the oral cavity faste

Method used

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  • Preparation method of diphenhydramine hydrochloride oral instant film agent
  • Preparation method of diphenhydramine hydrochloride oral instant film agent
  • Preparation method of diphenhydramine hydrochloride oral instant film agent

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017]

[0018] Weigh the prescription amount of Eudragit E100 into 100ml water, adjust the pH 4-5 with 1% hydrochloric acid solution, add diphenhydramine hydrochloride and polyoxyethylene N10 and stir evenly, adjust the pH 6-7 with 5% sodium bicarbonate solution, To obtain a polymer gel, add the prescribed amount of triethyl citrate, citric acid, and menthol, shear at high speed (10000rpm) for 3 minutes, repeat 3 times, and let stand for 8h under vacuum to remove air bubbles. You have to scrape the gel. Scrape the glue on a stainless steel plate with a film coater, and dry it at a temperature between 50°C and 60°C. Then the film agent obtained by knife coating is peeled from the plastic film, and the film agent can be obtained by cutting and packing.

Embodiment 2

[0020]

[0021] Weigh the prescribed amount of Eudragit E100 into 100ml of water, adjust pH 4-5 with 1% hydrochloric acid solution, add diphenhydramine hydrochloride and sodium alginate and stir evenly, adjust pH 6-7 with 5% sodium bicarbonate solution to get Polymer gel, add prescription amount of triethyl citrate, sodium citrate, menthol, shear at high speed (10000rpm) for 3 minutes, repeat 3 times, let stand for 8h under vacuum condition to remove air bubbles, namely You have to scrape the gel. Scrape the glue on a stainless steel plate with a film coater, and dry it at a temperature between 50°C and 60°C. Then the film agent obtained by knife coating is peeled from the plastic film, and the film agent can be obtained by cutting and packing.

Embodiment 3

[0023]

[0024]

[0025] Weigh the prescription amount of Eudragit EPO into 100ml of water, adjust the pH 4-5 with 1% hydrochloric acid solution, add diphenhydramine hydrochloride and hypromellose and stir well, adjust the pH 6 with 5% sodium bicarbonate solution 7. Obtain polymer gel, add prescription amount of glycerin, sodium citrate, menthamide, shear at high speed (10000rpm) for 3 minutes, repeat 3 times, and let stand for 8h under vacuum condition to remove air bubbles. Gel for scraping. Scrape the glue on a stainless steel plate with a film coater, and dry it at a temperature between 50°C and 60°C. Then the film agent obtained by knife coating is peeled from the plastic film, and the film agent can be obtained by cutting and packing.

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PUM

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Abstract

The invention belongs to the field of pharmaceutic preparations, and particularly relates to a diphenhydramine hydrochloride oral instant film agent and a preparation method thereof. The film agent comprises the following components in percent by weight: 1 to 10% of diphenhydramine hydrochloride, 10 to 80% of taste-masking agent, 10 to 50% of film-forming materials, 1 to 10% of plasticizer, 1 to 6% of saliva stimulants and 1 to 3% of other auxiliary materials. The diphenhydramine hydrochloride oral instant film agent can be taken without water and can be quickly dissolved in oral cavities, so that the phenomenon that patients with alzheimer's diseases hide and spit medicine in the oral cavities can be avoided, and the medication compliance of the patients is facilitated. The main medicine prepared by using the preparation method is uniformly dispersed in the film-forming materials, the appearance of a finished product is good, the main medicine is quickly dissolved, the stability is good, the product dose is accurate, almost no dust is emitted in the process of production, and the problems of labor protection and environmental pollution can be solved.

Description

technical field [0001] The invention belongs to the field of chemical pharmacy, and in particular relates to a diphenhydramine hydrochloride oral instant film and a preparation method thereof. Background technique [0002] Allergic skin diseases are skin diseases caused by allergens. Specific allergens can be divided into four categories: contact allergens, inhalation allergens, ingestion allergens, and injection allergens. Each type of allergen can cause corresponding allergic skin diseases, the main manifestations of which are various dermatitis, eczema, and measles. Each type of allergen can cause corresponding allergic skin diseases, the main manifestations are various dermatitis, eczema, measles, drug eruption, contact dermatitis and so on. [0003] Currently, the most widely used treatment for allergic skin diseases is the use of antihistamines. Antihistamine drugs have a history of clinical application for many years. Its main mechanism of action is to block the H1 ...

Claims

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Application Information

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IPC IPC(8): A61K9/70A61K31/135A61K47/48A61K47/32A61K47/34A61P37/08A61P17/00
Inventor 何勇高永好吴宗好
Owner HEFEI HUAFANG PHARMA SCI & TECH
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