Oxiracetam oral quick-dissolving membrane preparation and preparation method thereof

Abstract

An oxiracetam oral film prepared by oxiracetam, a film-forming material, a filler, a plasticizer, a saliva stimulating agent and a flavoring agent, the prepared oxiracetam oral instant film, which is in It can be dissolved in a small amount of saliva in the mouth, and can be used without water, which is convenient for medication; and it is not easy to spit out after sticking to the tongue, which is suitable for patients with dysphagia, and it is absorbed through the mucosa, avoiding the first-pass elimination effect and improving The bioavailability is improved, the medicinal dosage is reduced, thereby reducing the side effects of the drug. The preparation method of the invention is simple to operate, does not need large-scale industrial equipment, and is suitable for industrial production.

Description

technical field [0001] The invention relates to oxiracetam, in particular to an oxiracetam oral instant film and a preparation method thereof. Background technique [0002] Oxiracetam, chemically named 4-hydroxy-2-oxo-1-pyrrolidineacetamide, is a nootropic drug synthesized for the first time in 1974 by the Italian Shi Kebichem company. Aminobutyric acid (GABOB) derivatives are central nervous system drugs that can promote learning, enhance memory, and protect damaged nerve cells. Its structure is as follows: [0003] [0004] Since it was put on the market, due to its good effect, high safety, wide range of indications, few drug interactions and low toxicity, it has been the leading product in the treatment of dementia drugs, with injections, capsules, tablets and other dosage forms successively Development and listing. [0005] CN104069074A discloses a freeze-dried preparation of oxiracetam for injection, which is obtained by first forming an aqueous solution of oxira...

AI Technical Summary

Problems solved by technology

This type of preparation is directly injected into tissues or blood vessels, and there is no absorption process or the absorption process is very short, so the blood concentration can quickly reach the peak to play a role; Most require higher equipment conditions, and the drugs in the injection are generally dispersed in water as micron-sized solid particles in the molecular state, with a large degree of dispersion, and high-temperature sterilization often results in drug hydrolysis, oxidation, and solid particle coalescence Stability issues such as large size

At the same time, because the injection directly and quickly enters the human body without the protection of the normal physiological barrier of the human body, if the dosage is improper or the injection is too fast, or there is a problem with the quality of the drug, it may bring harm to the patient, or even cause irreparable consequences.

In addition, injection pain, inability to administer drugs by the patient, local induration of injection, and vascular inflammation caused by intravenous injection are all problems in clinical application.

[0006] CN101732251A discloses a liposome of oxiracetam, which is prepared from oxiracetam, phospholipids, cholesterol, Tween 80 and an appropriate amount of osmotic pressure regulator and buffer solution; the liposome has good stability and encapsulation efficiency High, low toxicity and side effects; but the liposome preparation process is complicated, not suitable for large-scale production; more importantly, the curative effect of liposomes in the human body remains to be further studied, and there are few liposome preparations for clinical use in China at present

Oral dispersible tablets also have the problem of choking, but sucking dispersible tablets has a very slow onset of action, and there is a gritty and bitter taste, which is not conducive to taking

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