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Terbinafine hydrochloride vaginal effervescent tablet and preparation method thereof

A technology of terbinafine hydrochloride and effervescent tablets, which is applied in the field of medicine, can solve the problems of complex production process and high cost of excipients, and achieve the effects of simple preparation process, easy operation and improved stability

Inactive Publication Date: 2009-09-30
杜波 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Qilu Pharmaceutical Factory has already sold it, but because the mannitol used in its prescription has medicinal effects, the cost of excipients is high, and the production process is relatively complicated

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] Embodiment 1: Terbinafine hydrochloride vaginal effervescent tablet, the prescription component is:

[0015] Terbinafine Hydrochloride 150g

[0016] Lactose 70g

[0017] Citric acid 100g

[0018] Sodium bicarbonate 100g

[0019] Low-substituted hydroxypropyl cellulose 30g

[0020] Sodium Lauryl Sulfate 10g

[0021] Magnesium Stearate 2g

[0022] Anhydrous ethanol amount

[0023] Makes 1000 pieces

[0024] Preparation process: a) Treatment of raw and auxiliary materials: drying and dehydrating the required raw and auxiliary materials respectively, passing through 100 sieves, and weighing according to the prescription amount for later use. b) Preparation of soft materials: Take terbinafine hydrochloride, lactose, citric acid, sodium bicarbonate, low-substituted hydroxypropyl cellulose and sodium lauryl sulfate, mix them uniformly by equal addition method, and use an appropriate amount of anhydrous Ethanol for soft materials. c) Granulation: the prepared soft mate...

Embodiment 2

[0026] Embodiment 2: Terbinafine hydrochloride vaginal effervescent tablet, the prescription component is:

[0027] Terbinafine Hydrochloride 150g

[0028] Microcrystalline Cellulose 100g

[0029] Tartaric acid 140g

[0030] Sodium carbonate 130g

[0031] Sodium carboxymethyl starch 15g

[0032] Sodium Lauryl Sulfate 15g

[0033] Magnesium Stearate 10g

[0034] 5% polyvinylpyrrolidone ethanol solution appropriate amount

[0035] Makes 1000 pieces

[0036] Preparation process: a) Treatment of raw and auxiliary materials: drying and dehydrating the required raw and auxiliary materials respectively, passing through 100 sieves, and weighing according to the prescription amount for later use. b) Preparation of soft materials: take terbinafine hydrochloride, microcrystalline cellulose, tartaric acid, sodium carbonate, sodium carboxymethyl starch and sodium lauryl sulfate, mix them uniformly with equal addition method, and use an appropriate amount of 5% polystyrene Vinylpyrr...

Embodiment 3

[0038] Embodiment 3: Terbinafine hydrochloride vaginal effervescent tablet, the prescription component is:

[0039] Terbinafine Hydrochloride 150g

[0040] Starch 100g

[0041] Citric acid 90g

[0042] Sodium bicarbonate 90g

[0043] Cross-linked polyvinylpyrrolidone 10g

[0044] Sodium Lauryl Sulfate 10g

[0045] Talc powder 5g

[0046] Anhydrous ethanol amount

[0047] Makes 1000 pieces

[0048] Preparation process: a) Treatment of raw and auxiliary materials: drying and dehydrating the required raw and auxiliary materials respectively, passing through 100 sieves, and weighing according to the prescription amount for later use. b) Preparation of soft material: take terbinafine hydrochloride, starch, citric acid, sodium bicarbonate, cross-linked polyvinylpyrrolidone and sodium lauryl sulfate, mix them uniformly by equal addition method, and use appropriate amount of absolute ethanol Solution to prepare soft materials. c) Granulation: the prepared soft material is gra...

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Abstract

The invention discloses a terbinafine hydrochloride vaginal effervescent tablet and a preparation method thereof. The terbinafine hydrochloride vaginal effervescent tablet mainly comprises a basic remedy of terbinafine hydrochloride, an effervescent auxiliary material and other auxiliary materials, wherein the effervescent auxiliary material consists of organic acid and carbonate; and other auxiliary materials consist of one or more of a disintegrant, a binding agent, a diluting agent and a lubricating agent and a surfactant. The invention is suitable for women to administrate in vagina; and the medicament can be disintegrated in a shortest time, generates fine and even foam and is favorable for fully absorbing pharmacodynamical ingredients, so patients are easy to accept the medicament, and the medicament is suitable to be clinically popularized and applied. The invention also discloses the preparation method which ensures that the quality of products is stable, the preparation process is simple, the quality is controllable and the cost is lower, so the preparation method is suitable for industrial large-scale production. The terbinafine hydrochloride vaginal effervescent tablet prepared by the invention is mainly applied to monilial vaginitis and has unique effect.

Description

field of invention [0001] The invention relates to a terbinafine hydrochloride tablet and a preparation method thereof, belonging to the technical field of medicines. technical background [0002] Terbinafine hydrochloride is a new generation of allylamine antifungal drugs developed on the basis of naftifine. Terbinafine has broad antibacterial spectrum, low inhibitory concentration, and remarkable clinical effect. Terbinafine hydrochloride has dual effects of antibacterial and bactericidal. Its mechanism of action is highly selective inhibition of fungal squalene epoxidase, which hinders the formation of fungal cell membranes, thereby playing an antibacterial role; at the same time, after this product inhibits squalene epoxidase, the precursor squalene It still accumulates in a large amount in fungal cells, leading to the death of fungal cell poisoning, thus playing a bactericidal effect. Clinical trials have shown that the cure rate of terbinafine in treating psoriasis ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/135A61P15/02
Inventor 杜波邵长凯
Owner 杜波
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