Preparation method of diphenhydramine hydrochloride oral instant film agent

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 ...

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 faster, any bad smell of the drug must be covered up, but for diphenhydramine hydrochloride orally disintegrating tablets, Taste masking is more difficult, the bitter taste is obvious, and it is easily soluble in water, so the bitter taste and numbness of diphenhydramine hydrochloride will be released quickly during the course of taking, so the taste masking of diphenhydramine hydrochloride is to some extent It is more difficult and is the core problem to be solved in the preparation process

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