Levo oxiracetam oral cavity dispersing film preparation, and preparation method thereof

Abstract

The invention discloses a levo oxiracetam oral cavity dispersing film preparation. The levo oxiracetam oral cavity dispersing film preparation comprises 1 to 15 parts of levo oxiracetam, 85 to 95 parts of a film forming material, 5 to 10 parts of a plasticizer, and 2 to 5 parts of a saliva irritant. According to the preparation method, the above raw materials are subjected to full grinding and uniform mixing, and are delivered into a hot-melt lamination machine for extrusion so as to obtain a finished product. The appearance of the obtained levo oxiracetam oral cavity dispersing film preparation is complete, color is uniform, thickness is uniform, physical and chemical properties are stable, in oral cavity, the levo oxiracetam oral cavity dispersing film preparation can be dissolved with a small amount of saliva, taking of the levo oxiracetam oral cavity dispersing film preparation with water is not necessary, the levo oxiracetam oral cavity dispersing film preparation is convenient to eat, and the preparation method is simple, and is suitable for industrialized production.

Description

technical field [0001] The invention relates to oxiracetam, in particular to a levo-oxiracetam orodispersible film and a preparation method thereof. Background technique [0002] Oxiracetam (Oxiracetam) is a new generation of brain metabolism improving drugs, pyrrolidone (cyclic GABOB) derivatives, piracetam analogs, can promote the synthesis of phosphorylcholine and o-acethanolamine, promote brain metabolism, through the blood brain Barrier has a stimulating effect on specific central nervous pathways, improving intelligence and memory. It has a good curative effect on cerebrovascular disease, brain injury, brain tumor (postoperative), intracranial infection, dementia, and brain degenerative diseases. It is suitable for memory and intellectual impairment caused by mild to moderate vascular dementia, senile dementia and traumatic brain injury. Oxiracetam was synthesized for the first time in 1974 by the Italian Skeleton Bichem Company and launched in 1987. It has better co...

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.

[0005] 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

Although the orodispersible film has many advantages, the limitations of its film-forming materials and preparation technology lead to low drug loading, difficult control of disintegration time and tensile strength, and the need to mask taste in most cases, which restricts orodispersion Development and application of film agent

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