Entecavir oral instant film agent and preparation method thereof

Abstract

The invention relates to an entecavir oral instant film agent and a preparation method thereof. By referring to the total weight, the entecavir oral instant film agent is prepared from, by mass, 0.05-15% of entecavir, 55-90% of polyving akohol / polyethylene glycol grafted copolymer, 5-15% of glycerin plasticizer, 0.5-15% of sodium alginate disintegrating agent. The invention provides a preparationmethod of the entecavir oral instant film agent, which includes steps of (1), mixing polyving akohol / polyethylene glycol grafted copolymer with water evenly to obtain polymer gel; (2), adding entecavir in the polymer gel; after mixing evenly, adding plasticizer and sodium alginate disintegrating agent, so as to obtain drug-containing solution; (3), degassing the drug-containing solution and thencoating on a substrate; drying at 40-60 DEG C and then cutting, so as to obtain the entecavir oral instant film agent. The entecavir oral instant film agent can significantly accelerate the disintegrating time limit of the film agent and solve the shortcoming that the most oral solid preparation is applied along with water at present; the film agent cannot delay the drug applying time in the absence of water resource and improves the drug compliance of a patient.

Description

technical field [0001] The invention relates to the field of medicine, in particular to an entecavir oral instant film and a preparation method thereof. Background technique [0002] Entecavir is a cyclopentylguanine nucleoside analog, which is an oral nucleoside drug for selective anti-hepatitis B virus (HBV), and its structural formula is as follows: [0003] [0004] Because oral preparations have a long dissolution time and low dissolution rate, it is difficult for patients who need to take effect in a short period of time (1 hour or half an hour). In addition, traditional tablets also have problems such as oral administration with water and low compliance. Therefore, it is necessary to study a dosage form that is convenient for oral administration and rapid release. [0005] Oral solid immediate-release preparations include orally disintegrating tablets, sublingual tablets, dispersible tablets and orally dissolving film (RDF). Among them, RDF is a preparation made ...

AI Technical Summary

Problems solved by technology

[0007] So far, there is no report on making Entecavir into oral instant film preparation at home and abroad, so the research on making Entecavir into oral instant film preparation is very important and has far-reaching significance.

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