Terbinaphthol hydrochloride gel and preparation method thereof

A technology for terbinafine hydrochloride and gel, which is applied to pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc., can solve the problems of reduced gel adhesion, error-prone mixing sequence, Complex preparation process and other problems, to achieve the effect of increasing concentration gradient, promoting transdermal absorption, and simple preparation process

Pending Publication Date: 2021-12-14
浙江得恩德制药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the preparation process is complex and the mixing sequence is prone to errors
Carbomer gel is sensitive to acidic substances, benzoic acid in the components may lead to reduced gel adhesion
[0009] The existing gel preparation technologies disclosed above are all traditional terbi hydrochloride gel formulations and preparation methods. Although certain beneficial effects have been achieved, there are still some deficiencies: the proportion of ethanol in the preparation is too high, all above 20%. , will inevitably bring some stimulation to the lesion
Most of the additives used in the prescription come from petroleum refining products. On the one hand, it will inevitably cause some irritation to the skin, and on the other hand, it will also cause certain damage to the environment.

Method used

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  • Terbinaphthol hydrochloride gel and preparation method thereof
  • Terbinaphthol hydrochloride gel and preparation method thereof
  • Terbinaphthol hydrochloride gel and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] 1) Prescription

[0045]

[0046] 2) Preparation of

[0047] (A) the prescribed amount of hydrochloric acid than naphthol Laid uniformly dispersed in 20, a mixture of sunflower oil and Tween 1.2 propylene glycol;

[0048] (B) the mixture in (a) was added with stirring in purified water containing a disodium hydrogen phosphate, mixed, allowed to stand for 1h to achieve phase equilibrium, resulting microemulsion drug;

[0049] (C) the amount of gellan gum formulation is uniformly dispersed in hot water (purified water, b) 80 ℃ and stirred to dissolve, cooled down to below 50 ℃;

[0050] And (d) all of the drug was transferred to a microemulsion gellan gum aqueous solution, stir, cooled to room temperature to obtain terbinafine hydrochloride phenol gel.

Embodiment 2

[0052] 1) Prescription

[0053]

[0054] 2) Preparation of

[0055] (A) the prescribed amount of hydrochloric acid than naphthol Laid uniformly dispersed in 20, a mixture of sunflower oil and Tween 1.2 propylene glycol;

[0056] (B) the mixture in (a) was added with stirring in purified water containing a disodium hydrogen phosphate, mixed, allowed to stand for 1h to achieve phase equilibrium, resulting microemulsion drug;

[0057] (C) the amount of gellan gum formulation is uniformly dispersed in hot water (purified water, b) 80 ℃ and stirred to dissolve, cooled down to below 50 ℃;

[0058] And (d) all of the drug was transferred to a microemulsion gellan gum aqueous solution, stir, cooled to room temperature to obtain terbinafine hydrochloride phenol gel.

Embodiment 3

[0060] 1) Prescription

[0061]

[0062]

[0063] 2) Preparation of

[0064] (A) the prescribed amount of hydrochloric acid than naphthol Laid uniformly dispersed in 20, a mixture of sunflower oil and Tween 1.2 propylene glycol;

[0065] (B) the mixture in (a) was added with stirring in purified water containing a disodium hydrogen phosphate, mixed, allowed to stand for 1h to achieve phase equilibrium, resulting microemulsion drug;

[0066] (C) the amount of gellan gum formulation is uniformly dispersed in hot water (purified water, b) 80 ℃ and stirred to dissolve, cooled down to below 50 ℃;

[0067] And (d) all of the drug was transferred to a microemulsion gellan gum aqueous solution, stir, cooled to room temperature to obtain terbinafine hydrochloride phenol gel.

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PUM

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Abstract

The invention belongs to the field of pharmaceutical preparations, and particularly relates to a terbinaphthol hydrochloride gel with biocompatibility, no toxicity and no irritation and a preparation method thereof. The preparation method comprises the following steps: mixing a terbinaphthol hydrochloride-entrapped microemulsion with a gellan gum aqueous solution, uniformly stirring, and cooling to room temperature, wherein the microemulsion is prepared from Tween 20, sunflower seed oil, 1, 2-propylene glycol, disodium hydrogen phosphate and water, and the preparation process is simple. The gel shows a fluid gel characteristic, such as a shear thinning non-Newtonian fluid characteristic, further has better stability and coating property, and is suitable for large-scale production.

Description

technical field [0001] The invention relates to a new preparation of an external medicine and a preparation method thereof, specifically a terbinafine hydrochloride gel with a biocompatible, non-toxic and non-irritating matrix and a preparation method thereof. Background technique [0002] Terbinafine hydrochloride, its chemical name is (E)-N-(6,6-dimethyl-2-hepten-4-ynyl)-N-methyl-1-carboxamide naphthalene hydrochloric acid. It is an allylamine drug with broad-spectrum antifungal activity synthesized by Novartis. It can specifically interfere with the early biosynthesis of fungal sterols, highly selectively inhibit fungal squalene epoxidase, and hinder the epoxidation reaction of squalene in the process of fungal cell membrane formation, thereby achieving the effect of killing or inhibiting fungi . It is highly hydrophobic and therefore tends to accumulate in hair, skin, nails and fatty tissue and is used to treat dermatophyte infections and other fungal skin infections. ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/06A61K31/137A61K47/02A61K47/10A61K47/36A61K47/44A61P17/00A61P31/10A61K9/107A61K47/26
CPCA61K31/137A61K9/06A61K9/0014A61K47/02A61K47/10A61K47/44A61K47/36A61P31/10A61P17/00A61K9/1075A61K47/26
Inventor 金春晖金鹿鸣张慧云王学英
Owner 浙江得恩德制药股份有限公司
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