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Tebinaifen hydrochloride suppository and its preparation method

A suppository, hydrochloric acid technology, applied in the directions of suppository delivery, antifungal agent, pharmaceutical formulation, etc., can solve the problems of poor patient tolerance, toxic and side effects, inconvenient use, etc., to avoid mucosal irritation, lasting therapeutic effect, and slow treatment. effect of action

Active Publication Date: 2006-09-13
魏锐 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Although terbinafine hydrochloride has already been used to treat fungal infections of the female reproductive tract, due to oral preparations such as terbinafine hydrochloride tablets, it is difficult for the drug to accumulate in large quantities in the genital tract mucosa, and it must be used in large doses to produce curative effect. Produce larger toxic and side effects; and dosage forms such as suppressant, cream, gel are inconvenient to use, and it is not easy to achieve better results
Although there are vaginal effervescent tablets on the market at present, it is also difficult to achieve the desired effect because of the strong irritation of vaginal effervescent tablets and the poor tolerance of patients.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Party:

[0025] Terbinafine Hydrochloride 50g

[0026] Tween-80 18g

[0027] Menthol 9g

[0028] Semi-synthetic fatty acid glyceride type 36 1655g

[0029] 1000 capsules

[0030] making process:

[0031] 1. Take semi-synthetic fatty acid glyceride type 36, heat and melt, and the temperature drops to 40-50°C;

[0032] 2. Drug treatment: terbinafine hydrochloride 100-mesh fine powder plus Tween-80, menthol and grind evenly;

[0033] 3. Mixing: Quickly add semi-synthetic fatty acid glycerides into the medicine powder and stir quickly, stirring evenly;

[0034] 4. Molding: inject the drug into the plug mold, measure the filling amount, and cool down;

[0035] 5. Packaging: packaging, inspection, and finished product.

Embodiment 2

[0037] Party:

[0038] Terbinafine Hydrochloride 50g

[0039] Span-60 10g

[0040] Menthol 2.5g

[0041] Semi-synthetic coconut oil 1000g

[0042] 1000 capsules

[0043] Preparation method is the same as embodiment 1

Embodiment 3

[0045] Party:

[0046] Terbinafine Hydrochloride 50g

[0047] Tween-60 10g

[0048] Menthol 15g

[0049] Semi-synthetic coconut oil 2500g

[0050] 1000 capsules

[0051] Preparation method is the same as embodiment 1

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PUM

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Abstract

A suppository of terbinafine hydrochloride for treating the fungus infection of woman's reproduction tract is prepared from terbinafine hydrochloride, matrix and dissolving promoter. Its preparing process is also disclosed.

Description

Technical field: [0001] The invention relates to a suppository and a preparation method thereof, more precisely, the present invention relates to a terbinafine hydrochloride suppository for treating fungal infections of the reproductive tract of women and a preparation method thereof. Background technique: [0002] Fungal infection of the female genital tract is a common mucosal infection, mostly in pregnant women and diabetic patients. In recent years, the disease has gradually increased. At present, there are two main methods of drug administration for the treatment of this disease: topical administration and oral administration. [0003] Terbinafine hydrochloride, whose chemical name is (E)-N-(6.6-dimethyl-2-heptene-4-yne)-N-methyl-1-naphthylmethylamine hydrochloride, is a Allylamine antifungal drugs, its mechanism of action is to specifically interfere with the early biosynthesis of fungal sterols, selectively inhibit the activity of fungal squalene cyclooxygenase, and...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/137A61K9/02A61P31/10A61P15/02
Inventor 魏锐程琪
Owner 魏锐
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