Preparation method of oxiracetam oral membrane preparation

Abstract

The invention relates to a preparation method of an oxiracetam oral membrane preparation. The Oxiracetam oral dispersion membrane preparation is prepared from oxiracetam, a membrane forming material, a filling agent, a plasticizing agent, a flavoring agent and a saliva stimulating agent, wherein the membrane forming material comprises maltodextrin and at least the other macromolecular membrane forming material; the other macromolecular membrane forming material is selected from one or several of hydroxy propyl cellulose, branched starch, sodium alginate, Pulullan, povidone-vinyl acetate or sodium carboxymethylcellulose. The preparation method has the advantages that the technical problems of poor mechanic property, long disintegrating time, crispness, easiness in breaking and the like of the membrane preparation are solved, and the product quality is guaranteed; the preparation is simple, and is suitable for industrialized production.

Description

technical field [0001] The invention relates to oxiracetam, in particular to a method for preparing oxiracetam oral film. 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 oxiracetam with a certain ...

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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