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vigabatrin solid preparation and preparation method thereof

A technology of vigabatrin and solid preparations, applied in pill delivery, pharmaceutical formulations, medical preparations of non-active ingredients, etc.

Active Publication Date: 2022-07-08
WUHAN WUYAO SCI & TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Considering the important therapeutic effect of vigabatrin, the quality control of vigabatrin is very important, but in the prior art, there are few studies on impurity control of vigabatrin preparations

Method used

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  • vigabatrin solid preparation and preparation method thereof
  • vigabatrin solid preparation and preparation method thereof

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preparation example Construction

[0047] The present invention also provides a method for preparing vigabatrin tablets, the preparation method comprising: dissolving a binder in a first anhydrous alcohol solvent to obtain a binding solution; Filling agents, disintegrating agents, etc. (also including alginic acid) are mixed with the binding solution, granulated, and dried to obtain dried granules; the dried granules and lubricant are mixed and compressed to obtain the described vigabatrin tablets.

[0048] In still other embodiments of the present invention, the present invention provides a preparation method of vigabatrin-coated tablets, the preparation method comprising: dissolving a binder in a first anhydrous alcohol solvent, so as to obtain binding solution; mix vigabatrin, filler, disintegrant, etc. (also including alginic acid) with the binding solution, granulate, and dry to obtain dry granules; after the dry granules and Lubricants are mixed and compressed to obtain vigabatrin tablets; the vigabatrin...

Embodiment 1

[0054] Embodiment 1 provides a kind of vigabatrin film-coated tablet and preparation method thereof, wherein each component of this vigabatrin film-coated tablet is as shown in Table 1 below:

[0055] Table 1 Ingredient of vigabatrin film-coated tablet

[0056]

[0057]

[0058] The preparation method of this vigabatrin film-coated tablet is as follows:

[0059] (1) According to Table 1, ethyl cellulose and povidone K30 were weighed and dissolved in the wetting agent dehydrated alcohol to prepare a binding solution with a mass percentage of 10%.

[0060] (2) according to table 1, take raw material vigabatrin, microcrystalline cellulose, sodium carboxymethyl starch, alginic acid and place in wet mixing granulator, mix for several minutes to uniform, then add above-mentioned ethyl fiber containing The adhesive solution of vegan and povidone K30 is added, and the soft material is made by cutting and stirring.

[0061] (3) Passing the prepared soft material through a 24-me...

Embodiment 2

[0066] Embodiment 2 provides a kind of vigabatrin film-coated tablet and preparation method thereof, wherein each component of this vigabatrin film-coated tablet is as shown in Table 2 below:

[0067] Table 2 Composition of vigabatrin film-coated tablets

[0068]

[0069]

[0070] Preparation:

[0071] (1) According to Table 2, take by weighing ethyl cellulose and povidone K30 and dissolve them in wetting agent anhydrous isopropanol, and prepare a binding solution with a mass percentage of 12%.

[0072] (2) according to table 2, take by weighing raw material vigabatrin, mannitol, sodium carboxymethyl starch, alginic acid and place in wet mixing granulator, mix for several minutes to uniform, then add above-mentioned containing ethyl cellulose and The adhesive solution of povidone K30 is added while cutting and stirring to make soft material.

[0073](3) Passing the prepared soft material through a 24-mesh sieve, granulating, and drying in an oven at 45°C.

[0074] (4)...

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Abstract

The invention relates to the field of pharmaceutical preparations, in particular to a vigabatrin solid preparation and a preparation method thereof. The provided preparation method of the vigabatrin solid preparation comprises: dissolving a binder in a first anhydrous alcohol solvent to obtain a binding solution; dissolving the vigabatrin acid, pharmaceutically acceptable auxiliary materials and the binding The solution is mixed, granulated, and dried to prepare and obtain the vigabatrin solid preparation. Also provided is a vigabatrin solid preparation obtained according to the above preparation method. The provided vigabatrin solid preparation or the vigabatrin solid preparation prepared according to the provided preparation method has good stability and low impurity A and total impurity content.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a vigabatrin solid preparation and a preparation method thereof. Background technique [0002] Epilepsy is a disease characterized by the dysfunction of the central nervous system caused by the abnormal discharge of neurons in repeated attacks. While traditional antiepileptic drugs can control most epilepsy, 20-30% still cannot be effectively controlled. [0003] Aminohexenoic acid, the chemical name is 4-amino-5-hexenoic acid, selectively inhibits γ-aminobutyric acid (GABA) transaminase, thereby increasing the concentration of GABA in the brain and producing anti-epileptic effects. In 2009, vigabatrin was designated by the FDA as an adjunctive therapy for the treatment of infantile spasms and local complex seizures in adults with refractory epilepsy, which is a rare disease drug. [0004] However, in the field of rare disease prevention and relief, my country's progr...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/197A61K9/36A61K47/38A61K47/36A61P25/08A61P21/02
CPCA61K31/197A61K9/2866A61K9/2059A61P25/08A61P21/02
Inventor 张美娜王亚军冯小路郭婷婷殷晶莉杨波
Owner WUHAN WUYAO SCI & TECH