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Terbinafine hydrochloride tablets and preparation method thereof

A technology for terbinafine hydrochloride and naphthene tablets, which is applied in pharmaceutical formulations, medical preparations with non-active ingredients, and medical preparations containing active ingredients, etc. complex issues

Inactive Publication Date: 2020-02-25
NANJING CHENGONG PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] At present, the production process of this variety is relatively complicated, the quality is not easy to control, the raw material drug has high static electricity, and it accounts for a relatively high proportion in the prescription, and it is easy to appear sticking phenomenon during tablet compression
In addition, terbinafine hydrochloride is a pH-dependent drug, which has a large amount of dissolution in acidic media and almost no dissolution in pH 6.8 media. Improper formulation composition and process development will lead to low dissolution in media in the acid-base range
The quality of the generic Terbinafine Hydrochloride Tablets sold in the market is somewhat different from that of the original drug, and cannot be used more effectively for the treatment of diseases

Method used

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  • Terbinafine hydrochloride tablets and preparation method thereof
  • Terbinafine hydrochloride tablets and preparation method thereof
  • Terbinafine hydrochloride tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Prepare Terbinafine Hydrochloride Tablets according to the following method: the Terbinafine Hydrochloride Tablets are made up of the following raw materials in parts by weight:

[0035] 250 parts of terbinafine hydrochloride, 67.5 parts of microcrystalline cellulose, 20 parts of sodium starch glycolate, 7 parts of hydroxypropyl methylcellulose, 4 parts of magnesium stearate, and 2 parts of silicon dioxide.

[0036] (1) micronizing the terbinafine hydrochloride for subsequent use;

[0037] (2) Adhesive preparation: weigh hydroxypropyl methylcellulose, add purified water under continuous stirring, stir evenly, and set aside;

[0038] (3) Granulation: the terbinafine hydrochloride, microcrystalline cellulose and half of the amount of sodium carboxymethyl starch were placed in a wet granulator and mixed for 10 to 20 minutes. Add the binder within seconds and continue granulation for a total of 2 to 4 minutes before discharging; tighten the screen, slowly add the soft mate...

Embodiment 2

[0044] Prepare Terbinafine Hydrochloride Tablets according to the following method: the Terbinafine Hydrochloride Tablets are made up of the following raw materials in parts by weight:

[0045] Terbinafine hydrochloride 300 parts, lactose 78 parts, croscarmellose sodium 40 parts, starch slurry 4 parts, talcum powder 4 parts.

[0046] (1) micronizing the terbinafine hydrochloride for subsequent use;

[0047] (2) Adhesive preparation: take starch slurry, add purified water under continuous stirring, stir evenly, and set aside;

[0048] (3) Granulation: place the croscarmellose sodium of described terbinafine hydrochloride, lactose and 2 / 3 amount in wet granulator and mix for 10~20 minutes, add binding agent, in 30 Finish adding the binder within ~60 seconds, continue to granulate for a total of 2 ~ 4 minutes, and discharge; tighten the screen, slowly add the soft material to the oscillating granulator, and pass through a 16-mesh to 24-mesh stainless steel sieve to granulate;

...

Embodiment 3

[0054] Prepare Terbinafine Hydrochloride Tablets according to the following method: the Terbinafine Hydrochloride Tablets are made up of the following raw materials in parts by weight:

[0055] 250 parts of terbinafine hydrochloride, 58 parts of mannitol and corn starch, 36 parts of crospovidone, 9 parts of ethyl cellulose and hydroxypropyl methyl cellulose, 16 parts of magnesium stearate.

[0056] (1) micronizing the terbinafine hydrochloride for subsequent use;

[0057] (2) Adhesive preparation: weigh ethyl cellulose and hydroxypropyl methyl cellulose, add purified water under constant stirring, stir evenly, and set aside;

[0058] (3) Granulation: the crospovidone of described terbinafine hydrochloride, mannitol and cornstarch and 20 parts of amounts is placed in wet granulator and mixes for 10~20 minutes, adds binding agent, in 30~60 Add the binder within seconds and continue granulation for a total of 2 to 4 minutes before discharging; tighten the screen, slowly add the ...

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Abstract

The invention discloses terbinafine hydrochloride tablets and a preparation method thereof. The terbinafine hydrochloride tablets consist of terbinafine hydrochloride and pharmaceutic adjuvants, wherein the pharmaceutic adjuvants comprise a filling agent, a disintegrating agent, an adhesive and a lubricating agent. By adopting a wet granulation process, the terbinafine hydrochloride tablet is simple in preparation process, easy to operate, controllable in quality, good in reproducibility and suitable for industrial large-scale production, and the obtained terbinafine hydrochloride tablet is smooth in surface, high in dissolution rate, small in dissolution difference among batches, high in in in-vivo bioavailability, bioequivalent to a reference preparation in human body, and consistent with the reference preparation in quality.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a terbinafine hydrochloride tablet and a preparation method thereof. Background technique [0002] Terbinafine hydrochloride, chemical name: (E)-N-(6,6-dimethyl-2-hepten-4-ynyl)-N-methyl-1-naphthylmethylamine hydrochloride, molecular formula for C 21 h 25 N·HCl, molecular weight 232, chemical structure formula: [0003] Terbinafine hydrochloride is a broad-spectrum antifungal drug, which is currently widely used in the treatment of superficial mycosis, with good efficacy, high safety and low recurrence rate. [0004] According to social epidemiological investigations and studies, fungal infection is a disease with a high incidence rate, and has the characteristics of high reinfection rate. At present, the incidence rate of fungal infection has reached 78%, which has promoted the rapid growth of the antifungal drug market. The data shows that from 2006 t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/137A61K47/38A61K47/36A61K47/04A61P31/10
CPCA61K9/2009A61K9/2054A61K9/2059A61K31/137A61P31/10
Inventor 史志迅
Owner NANJING CHENGONG PHARM CO LTD
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