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Entecavir oral instant film agent and preparation method thereof

An oral instant film agent, entecavir technology, applied in the field of medicine, to achieve the effect of easy film release, stable chemical properties, and good toughness and strength

Active Publication Date: 2018-02-23
SUZHOU UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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.

Method used

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  • Entecavir oral instant film agent and preparation method thereof
  • Entecavir oral instant film agent and preparation method thereof
  • Entecavir oral instant film agent and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] A kind of entecavir oral cavity instant film of the present invention, its each component and its content are as follows:

[0043]

[0044] Wherein, polyvinyl alcohol accounts for 75% of graft copolymer gross weight in polyvinyl alcohol / polyethylene glycol graft copolymer, polyethylene glycol accounts for 25% of graft copolymer gross weight, polyvinyl alcohol / polyethylene glycol The molecular weight of the diol graft copolymer is 45000 Da.

[0045] The preparation method of the above-mentioned entecavir oral instant film is as follows:

[0046] Take the polyvinyl alcohol / polyethylene glycol graft copolymer of the above quality and add it into 10 mL of pure water under stirring, stir and dissolve to obtain a polymer gel. Then add entecavir, glycerin and sodium alginate therein, and stir evenly to obtain a drug-containing solution. The prepared drug-containing solution is left to stand or ultrasonically removed to remove air bubbles, and then evenly coated on a 2cm×1...

Embodiment 2

[0048] A kind of entecavir oral cavity instant film of the present invention, its each component and its content are as follows:

[0049]

[0050] Wherein, polyvinyl alcohol accounts for 75% of graft copolymer gross weight in polyvinyl alcohol / polyethylene glycol graft copolymer, polyethylene glycol accounts for 25% of graft copolymer gross weight, polyvinyl alcohol / polyethylene glycol The molecular weight of the diol graft copolymer is 45000 Da.

[0051] Entecavir oral cavity instant film was prepared with reference to the method of Example 1. The prepared film agent is transparent, moderate in film thickness, convenient for demoulding, and partially wrinkled.

Embodiment 3

[0053] A kind of entecavir oral cavity instant film of the present invention, its each component and its content are as follows:

[0054]

[0055] Wherein, polyvinyl alcohol accounts for 75% of graft copolymer gross weight in polyvinyl alcohol / polyethylene glycol graft copolymer, polyethylene glycol accounts for 25% of graft copolymer gross weight, polyvinyl alcohol / polyethylene glycol The molecular weight of the diol graft copolymer is 45000 Da.

[0056] Entecavir oral cavity instant film was prepared with reference to the method of Example 1. The prepared film agent is transparent, moderate in film thickness, convenient for demoulding, and partially wrinkled.

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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 ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K47/34A61K31/522A61P31/20
CPCA61K9/0056A61K9/7007A61K31/522A61K47/34
Inventor 曹青日魏腾
Owner SUZHOU UNIV
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