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Ilepcimide oral instant film agent and preparation method thereof

A technology of oral instant film and solubilizer, which is applied in the direction of pharmaceutical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., which can solve the problems of inability to cover taste, poor compliance of children, and failure to achieve the taste and other problems, to achieve the effect of good taste, good compliance and fast onset of action

Active Publication Date: 2020-02-28
北京斯利安药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] (2) Ileximide is derived from pepper, which has a strong spicy taste of pepper, and patients, especially children, have poor compliance
But described product does not reach the effects such as rapid onset, no need to drink water, good mouthfeel, etc., and the taking of dry suspension and capsule still needs to drink water, and the addition of flavoring agent or flavoring agent also can only adjust taste, can't achieve It has the function of masking the taste, and its dissolution rate is only 70-85%.

Method used

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

Examples

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preparation example Construction

[0042] The present invention also provides a method for preparing the above-mentioned ileexamine oral instant film, which comprises the following steps:

[0043] A) Mix the ilesiamine and the solubilizer, and then extrude and granulate to obtain a solid dispersion of ilesiamine;

[0044] Mixing the film-forming agent with warm water at 50-70°C to obtain a polymer gel, and mixing the polymer gel, plasticizer, disintegrant and flavoring agent to obtain a glue liquid;

[0045] B) Mixing the ilexamide solid dispersion and the glue solution to obtain a drug-containing solution;

[0046] C) Carrying out vacuum degassing treatment on the drug-containing solution, forming a film, and drying to obtain an oral quick-dissolving film of ilexamide.

[0047] In the preparation method of the instant oral film of ilexamine provided by the present invention, the components and proportions of the raw materials used are the same as the above, and will not be repeated here.

[0048] In the present invention...

Embodiment 1

[0075] Table 1 Example 1 Ingredients and contents of each raw material

[0076]

[0077]

[0078] Preparation:

[0079] 1) Ileexamine raw material and the solubilizer copovidone S-630 are mixed uniformly in a mixer, and the hot-melt extruding machine pellets are added, the temperature is controlled at 110°C, the screw speed is controlled at 55rpm, and the Ilexiamine solid dispersion is prepared. ,spare.

[0080] 2) Under stirring, the film-forming agent copovidone S-630 is placed in warm water at 60° C. to obtain a polymer gel; the dosage ratio of the film-forming agent to the warm water is 1 g: 10 mL.

[0081] 3) Under stirring, add plasticizer propylene glycol, disintegrant croscarmellose sodium (CCNa), and flavoring agent strawberry flavor to the copovidone S-630 polymer gel, and stir well.

[0082] 4) Under the stirring state, add the solid dispersion of ilexamine and stir evenly to obtain a drug-containing solution.

[0083] 5) Vacuum degassing the chemical solution to form a film ...

Embodiment 2

[0087] Table 2 Example 2 Each raw material component and content

[0088]

[0089]

[0090] Preparation:

[0091] 1) Ilexiamine raw material and the solubilizer copovidone S-630 are mixed uniformly in a mixer, and the hot-melt extruder granules are added, the temperature is controlled at 103℃, the screw speed is controlled at 40rpm, and the Ilexiamine solid dispersion is prepared. ,spare.

[0092] 2) Under stirring, the film-forming agent copovidone S-630 is placed in warm water at 70° C. to obtain a polymer gel; the dosage ratio of the film-forming agent to the warm water is 1 g: 15 mL.

[0093] 3) Under stirring, add plasticizer propylene glycol, disintegrant croscarmellose sodium (CCNa), and flavoring agent sweet orange flavor to the copovidone S-630 polymer gel, and stir evenly.

[0094] 4) Under the stirring state, add the solid dispersion of ilexamine and stir evenly to obtain a drug-containing solution.

[0095] 5) Vacuum degassing the chemical solution to form a film (the film t...

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Abstract

The invention relates to the technical field of pharmaceutical preparations, in particular to an ilepcimide oral instant film agent and a preparation method thereof. The ilepcimide oral instant film agent is prepared from, by weight, 10-50 parts of ilepcimide, 15-60 parts of a solubilizer, 20-40 parts of a film forming agent, 5-20 parts of a disintegrating agent and 10-40 parts of a plasticizer, wherein the solubilizer comprises copovidone. By selection of appropriate auxiliary materials and scientific consumption ratios, the obtained ilepcimide oral instant film agent has advantages of quickness in dissolution, fast action, convenience in taking without water drinking, great taste and high compliance of child patients.

Description

Technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to an oral quick-dissolving film of ilexamine and a preparation method thereof. Background technique [0002] Epilepsy is a chronic disease of the central nervous system and requires long-term medication. At present, the effective rate of anti-epileptic drugs used clinically is only 70% to 80%. Anti-epileptic drugs cannot prevent the formation of epileptic foci and the progression of the disease, but can only relieve symptoms. In addition, there are many adverse reactions of antiepileptic drugs, involving multiple systems of the human body. Common adverse reactions include skin rash, dizziness, nausea, anorexia, abnormal mental behavior, abnormal liver and kidney function, endocrine system dysfunction, and lymphadenopathy. Moreover, patients with epilepsy often need to take long-term medication or take several anti-epileptic drugs at the same time, which can aggravat...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K31/4525A61K47/32A61P25/08
CPCA61K31/4525A61K9/006A61K47/32A61P25/08A61K9/7007
Inventor 蔡正军张正全马克阳苏颖罗丽莲肖艳皎韩雅慧易斌张晓丽钟敏
Owner 北京斯利安药业有限公司
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