Method for preparing levorotatory oxiracetam oral dispersible film preparation

Abstract

The invention discloses a method for preparing a levorotatory oxiracetam oral dispersible film preparation. The levorotatory oxiracetam oral dispersible film preparation is made by using a film forming material, a plasticizer, a filling agent, a saliva irritant, correctant and levorotatory oxiracetam as raw materials and through coating, drying and stripping by using a film coating and drying machine for a medicinal film. According to the method, the levorotatory oxiracetam oral dispersible film preparation is prepared by using a film coating machine for the medicinal film; the thickness, the coating speed and the drying temperature of the oral dispersible film preparation are strictly controlled; thus, the process is stabilized; the quality of a product is guaranteed; aspects of the brittlement, the disintegration time limit, the dissolution time and the like of the levorotatory oxiracetam oral dispersible film are enabled to be more beneficial to clinical application.

Description

technical field [0001] The invention relates to levo-oxiracetam, in particular to a method for preparing levo-oxiracetam orodispersible film. 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 concentra...

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 oral film has many advantages, the limitations of its film-forming materials and preparation technology lead to low drug loading, the disintegration time and tensile strength are not easy to control, and most of the time it needs to mask the taste, which restricts the oral film. development and application of

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