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Terbinafine hydrochloride granules and use method thereof

A technology of terbinafine hydrochloride and granules, which is applied in the field of medicine, can solve the problems of not being able to use drugs to the severity of the lesion, long treatment time, and great physical damage, and achieve the effects of increasing drug efficacy, short treatment time, and high safety

Pending Publication Date: 2021-01-08
上海桓华制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] But when it is used in practice, at present, the treatment of tinea pedis and onychomycosis with terbinafine hydrochloride all adopts the oral mode, and oral terbinafine hydrochloride may have adverse reactions, which is harmful to the body. , it cannot be used, and it is not targeted, the onset is slow, the efficacy of the drug reaches the lesion, the treatment time is long, the drug cannot be used according to the severity of the lesion, and the safety is not high

Method used

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  • Terbinafine hydrochloride granules and use method thereof
  • Terbinafine hydrochloride granules and use method thereof

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Effect test

Embodiment 1

[0025] The invention provides a kind of terbinafine hydrochloride granule, wherein the main material used comprises by weight: 75 parts of terbinafine hydrochloride, 35 parts of crospovidone, 65 parts of low-substituted hydroxypropyl cellulose and nitrogen 5 parts of ketones, the auxiliary materials include by weight: 5 parts of povidone K30, 9 parts of silicon dioxide, 4 parts of magnesium stearate and 100 parts of starch;

[0026] It also includes the preparation method of terbinafine hydrochloride granules, and the specific operation steps are:

[0027] Step 1: raw material pretreatment, drying terbinafine hydrochloride, crospovidone, low-substituted hydroxypropyl cellulose and starch respectively, then passing through 80-mesh sieves respectively, weighing according to the prescription amount for use;

[0028] Step 2: prepare a mixed slurry, prepare a mixed slurry with 9 parts of starch and povidone K30, then add azone into the mixed slurry, stir evenly, place and cool to b...

Embodiment 2

[0038] The invention provides a kind of terbinafine hydrochloride granules, wherein the main materials used include by weight: 85 parts of terbinafine hydrochloride, 40.5 parts of crospovidone, 77.5 parts of low-substituted hydroxypropyl cellulose and nitrogen 8.5 parts of ketones, the auxiliary materials include by weight: 7.5 parts of povidone K30, 12 parts of silicon dioxide, 6 parts of magnesium stearate and 113.5 parts of starch;

[0039] It also includes the preparation method of terbinafine hydrochloride granules, and the specific operation steps are:

[0040] Step 1: raw material pretreatment, drying terbinafine hydrochloride, crospovidone, low-substituted hydroxypropyl cellulose and starch respectively, then passing through 80-mesh sieves respectively, weighing according to the prescription amount for use;

[0041]Step 2: prepare a mixed slurry, prepare 7 parts of starch and povidone K30 to make a mixed slurry, then add azone into the mixed slurry, stir evenly, place ...

Embodiment 3

[0051] The invention provides a kind of terbinafine hydrochloride granule, wherein the main material used comprises by weight: 95 parts of terbinafine hydrochloride, 45 parts of crospovidone, 85 parts of low-substituted hydroxypropyl cellulose and nitrogen 11 parts of ketones, the auxiliary materials include by weight: 11 parts of povidone K30, 15 parts of silicon dioxide, 8 parts of magnesium stearate and 130 parts of starch;

[0052] It also includes the preparation method of terbinafine hydrochloride granules, and the specific operation steps are:

[0053] Step 1: raw material pretreatment, drying terbinafine hydrochloride, crospovidone, low-substituted hydroxypropyl cellulose and starch respectively, then passing through 80-mesh sieves respectively, weighing according to the prescription amount for use;

[0054] Step 2: prepare a mixed slurry, prepare a mixed slurry by mixing 6 parts of starch and povidone K30, then add azone into the mixed slurry, stir evenly, place and c...

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Abstract

The invention discloses terbinafine hydrochloride granules. The terbinafine hydrochloride granules comprise 75-95 parts by weight of terbinafine hydrochloride, 35-45 parts by weight of polyvinylpolypyrrolidone, 65-85 parts by weight of low-substituted hydroxypropyl cellulose and 5-11 parts by weight of azone, and auxiliary materials comprise 5-11 parts by weight of polyvidone K30, 9-15 parts by weight of silicon dioxide, 4-8 parts by weight of magnesium stearate and 100-130 parts by weight of starch. Low-substituted hydroxypropyl cellulose is added as a disintegrating agent, and polyvinylpolypyrrolidone is added as an efficient disintegrating agent, so that rapid disintegration of the medicine and acceleration of dissolution of the medicine during use are facilitated; and the product preparation is granules, rapid dissolution of the product in water is facilitated, terbinafine hydrochloride granules are different from traditional oral administration modes during use; and an external application mode is adopted, and then feet or hands containing lesions are soaked in the liquid medicine, so that the application method has pertinence, medicine loss is prevented, the dosage can be adjusted according to the severity degree of the lesions, the effect taking speed is high, the safety is high, the side effect is small, the curative effect is remarkable, the treatment time is short, and the applicable object range is wide.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a terbinafine hydrochloride granule and a using method thereof. Background technique [0002] Tinea pedis (commonly known as athlete's foot) is caused by fungal infection. The skin damage often occurs on one side (that is, one foot) first, and then infects the opposite side after several weeks or months. The blisters mainly appear on the abdomen and side of the toe, and finally It is common between the third and fourth toes, and can also appear on the sole of the foot. It is a deep vesicle that can gradually merge into a bullae. The skin lesions of tinea pedis have a characteristic, that is, the boundary is clear and can gradually expand outward. Onychomycosis, commonly known as "onychomycosis", refers to the disease caused by dermatophytes invading the nail plate or under the nail. Onychomycosis is caused by dermatophytes. Nail infection caused by fungi such as , yeast and non...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/137A61K47/38A61K47/36A61K47/32A61K47/22A61K47/04A61P17/00A61P31/10
CPCA61K9/1652A61K9/1635A61K9/1617A61K9/1611A61K9/1694A61K9/0014A61K31/137A61P17/00A61P31/10
Inventor 张文生韩峰肖娟
Owner 上海桓华制药有限公司