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A kind of ilexamide oral quick-dissolving film and preparation method thereof

An oral instant film agent and film-forming agent technology, which is applied in the direction of medical formula, medical preparations with no active ingredients, medical preparations containing active ingredients, etc., can solve the problems of inability to cover taste, poor compliance of children, and dissolution rate Only to achieve and other problems, to achieve the effect of good taste, good compliance, fast dissolution

Active Publication Date: 2022-05-17
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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  • A kind of ilexamide oral quick-dissolving film and preparation method thereof
  • A kind of ilexamide oral quick-dissolving film and preparation method thereof
  • A kind of ilexamide oral quick-dissolving film and preparation method thereof

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preparation example Construction

[0042] The present invention also provides a preparation method of the above-mentioned ileximide oral fast-dissolving film, comprising the following steps:

[0043] A) mixing the ileximide and the solubilizer, extruding and granulating to obtain the ileximide solid dispersion;

[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 solution;

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

[0046] C) performing vacuum degassing treatment on the drug-containing solution, forming a film, and obtaining the eleximide oral instant film after drying.

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

[0048] In the invention, the ilex...

Embodiment 1

[0075] Each raw material component and content of table 1 embodiment 1

[0076]

[0077]

[0078] Preparation:

[0079] 1) The raw material drug of ilesiamine and copovidone S-630, a solubilizer, were uniformly mixed in a mixer, then added to a hot-melt extruder to granulate, the temperature was controlled at 110°C, and the screw speed was controlled at 55 rpm to prepare a solid dispersion of ilesiamine ,spare.

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

[0081] 3) Add plasticizer propylene glycol, disintegrant croscarmellose sodium (CCNa) and flavoring agent strawberry essence to copovidone S-630 polymer gel under stirring state, and stir evenly.

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

[0083] 5) Carry out vacuum degassing treatm...

Embodiment 2

[0087] Each raw material component and content of table 2 embodiment 2

[0088]

[0089]

[0090] Preparation:

[0091] 1) The raw material drug of ilesiamine and copovidone S-630, a solubilizer, were uniformly mixed in a mixer, then added to a hot-melt extruder to granulate, the temperature was controlled at 103°C, and the screw speed was controlled at 40rpm to prepare a solid dispersion of ilesiamine ,spare.

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

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

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

[0095] 5) Carry out vacuum degassing treatment...

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Abstract

The invention relates to the technical field of pharmaceutical preparations, in particular to an oral instant film of eleximide and a preparation method thereof. The oral instant film of ileximide comprises, in parts by weight: 10-50 parts of ilesiamine; 15-60 parts of solubilizer; 20-40 parts of film-forming agent; 5-20 parts of disintegrating agent; 10-40 parts of plasticizer; the solubilizer includes copovidone. The ileximide oral instant film of the present invention is through the selection of appropriate auxiliary materials, combined with scientific dosage ratios, so that the obtained ileximide oral instant film can be quickly dissolved in the oral cavity, has a quick effect, and does not need drinking water. It is convenient to take, has a good taste, and has good compliance with children.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to an oral instant film of eleximide and a preparation method thereof. Background technique [0002] Epilepsy is a chronic disorder of the central nervous system that requires long-term drug treatment. Currently, the effective rate of antiepileptic drugs used clinically is only 70% to 80%. Antiepileptic 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 rash, dizziness, nausea, anorexia, abnormal mental behavior, abnormal liver and kidney function, endocrine system dysfunction, and enlarged lymph nodes. Moreover, patients with epilepsy often need to take drugs for a long time or take several antiepileptic drugs at the same time, which will aggravat...

Claims

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Application Information

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Patent Type & Authority Patents(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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