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Terbinafine hydrochloride capsule

A technology of terbinafine hydrochloride and terbinafine, which is applied in the direction of antifungal agents, can solve the problems of affecting the stability and curative effect of preparations, high degree of unsaturation, high electron cloud density, etc., and achieves convenient clinical application and fast absorption , easily disintegrating effect

Inactive Publication Date: 2003-09-10
成都锦绣生物医药科技有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, only tablets, powders and other dosage forms are currently available
The main ingredient terbinafine hydrochloride not only has a special odor, but also has a high degree of unsaturation in the structure, a high electron cloud density on the naphthalene ring, and is a salt of organic macromolecules, so it is easy to be exposed to light, heat and humidity. Affected, easy to decompose, destroy its molecular structure, mainly generate various impurities such as double bond cis structure, polymer, nitrogen oxide and naphthoquinone, thus affecting the stability and curative effect of its preparation to a large extent

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0006] Embodiment 1: get 50g of terbinafine hydrochloride, 80g of starch, and 15g of microcrystalline cellulose, dry the starch first, pass through a 120 mesh sieve, mix evenly with terbinafine and microcrystalline fiber, and pass through 120 mesh twice Sieve, fill in the hard capsule, make 1000 capsules of the present invention. Each capsule contains 50mg of Terbinafine.

Embodiment 2

[0007] Embodiment 2: Take 250g of terbinafine hydrochloride, measure 200g of polyethylene glycol 4000, first mix terbinafine with 1 / 5 amount of polyethylene glycol 4000, pulverize with a colloid mill, and then add the remaining amount of polyethylene glycol Alcohol is mixed to obtain medicinal liquid, and gelatin solution (gelatin: glycerin: water=10: 5.5: 12) is prepared in addition for subsequent use, and medicinal liquid and gelatin solution are obtained 1000 soft capsules of the present invention by an automatic rotary capsule rolling machine. Each capsule contains 250mg of Terbinafine.

Embodiment 3

[0008] Embodiment 3: Get terbinafine hydrochloride 600g, lactose 50g, polyvinylpyrrolidone 15g, hydroxypropyl methylcellulose 80g, talcum powder 50g. Mix hydroxypropyl methylcellulose and terbinafine evenly, add lactose, make pellets with polyvinylpyrrolidone liquid, fill capsules, and obtain 1000 long-acting sustained-release capsules of the present invention. Each capsule contains Terbinafine 600mg.

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PUM

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Abstract

The Terbinafine hydrochloride capsule preparation contains Terbinafine hydrochloride as main medicine component and auxiliary components. Terbinafine hydrochloride has the chemical name of (E)-N-(6,6-dimethyl-2-heptene-4-yne)-N-methyl-1-menaphthyl amine hydrochloride, and the chemical general expression of C21H25N.HCl. The auxiliary components include common additive for preparing capsule. The Terbinafine hydrochloride capsule preparation is superior to Terbinafine hydrochloride tablet, powder and other preparation forms, is lightproof and moistureproof, and can mask the bad taste of medicine component, delay medicine decomposition and promote the absorption of medicine component.

Description

technical field [0001] The invention relates to a medicine for treating sensitive fungal infection, in particular to a capsule preparation of terbinafine hydrochloride Background technique [0002] Terbinafine hydrochloride is a new generation of allylamine antifungal drugs. Its molecular structure has a specific group with a branched acetylene side chain, which can significantly selectively inhibit a single fungal enzyme squalene epoxidase (Squalene epoxidase). It is the key enzyme that catalyzes squalene to synthesize ergosterol, the main component of fungal cell wall. Because the enzyme is inhibited, the oxidation of squalene to ergosterol is blocked, resulting in the accumulation of squalene in the cells and the lack of ergosterol, thereby affecting the function of the fungal cell wall and exerting a killing effect on various sensitive fungi. Side effects are mild. However, there are only dosage forms such as tablets and powders at present. The main ingredient terbina...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/137A61P31/10
Inventor 邓聪肖华冀广沁徐琨谭薇周旋
Owner 成都锦绣生物医药科技有限责任公司
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