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Compound fenticonazole nitrate preparation and application thereof

A technology for fenticonazole nitrate and preparation, which is applied in the field of medicine, can solve the problems of inconvenient administration, slow onset of single fenticonazole nitrate, easy repetition and the like, and achieves good therapeutic effect, good sustained-release effect, good The effect of biocompatibility

Active Publication Date: 2015-05-20
仁和堂药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Its purpose is to solve diseases such as vaginitis, overcome the obvious shortcomings such as slow onset of action of single fenticonazole nitrate, easy and repeated drug withdrawal, and inconvenient administration, etc., to achieve the purpose of treating both symptoms and root causes

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] A compound fenticonazole nitrate preparation is characterized in that it is prepared from the following raw materials,

[0040]Fenticonazole nitrate 10g, active ingredients of traditional Chinese medicine 10g, poloxamer 407 30g, poloxamer 188 15g, carbomer 5g, propylene glycol 250g, glycerin 150g, sodium benzoate 5g, edetate disodium 0.3g , 475g of distilled water.

[0041] The active ingredients of the traditional Chinese medicine are prepared from the following raw materials in weight ratio:

[0042] 35 parts of Motherwort, 35 parts of Lemongrass, 30 parts of Dandelion, 30 parts of Plantago Seed, 25 parts of Cortex Phellodendri,

[0043] 25 parts of Caulis Spatholobus, 25 parts of Rhododendron, 22 parts of Eucommia, 20 parts of Panax notoginseng, 20 parts of Chuanxiong,

[0044] 15 parts of kudzu root, 15 parts of Puhuang, 10 parts of Angelica dahurica, 10 parts of astragalus, 10 parts of lily, 10 parts of Cyperus,

[0045] 10 parts of safflower, 5 parts of Liu Jin...

Embodiment 2

[0058] Toxicology research

[0059] 1 Acute toxicity test:

[0060] Divide 30 rabbits into 3 groups at random, 10 in each group, half male and half male, use 10% sodium sulfide to depilate the back of the rabbits, the depilatory area is about 150cm 2 . The making of damaged skin adopts sterilized iron file to scratch (taking blood as the degree), and after depilation, apply the preparation of the present invention 0.2, 0.5 and 0.7ml respectively in the depilation area and fix it with non-irritating adhesive tape, and each animal is divided into cages and raised From 1, 24, 48, 72 hours after 24 hours of administration to the seventh day, observe and record the changes of the animal's body weight, fur, luster, diet, eyes and mucous membranes, respiratory center, nervous system, limb activities and death every day After seven days, the rabbits were killed, and the changes in the heart, liver, spleen, lung, kidney and other organs were observed by dissection.

[0061] Results:...

Embodiment 3

[0076] 131 patients with vaginitis who chose to receive treatment voluntarily, inclusion criteria: aged over 18 years old, not menopausal; clinical diagnosis of vaginitis, non-pregnancy, no diabetes, tumors and other types of genital infection, no application within 1 month before seeing a doctor topical or systemic antifungal drugs. Randomly divided into two groups, the treatment group and the control group, including 66 cases in the treatment group and 65 cases in the control group. There was no significant difference in age and symptom composition between the two groups. Comparable (P>0.05).

[0077] treatment method

[0078] The basic treatment of each group was consistent, and the treatment group was given the compound fenticonazole preparation prepared in Example 1, which was applied once a day;

[0079] The control group was given suppositories prepared by CN103349755, administered vaginally, one tablet each time.

[0080] The above groups are forbidden to use drugs ...

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PUM

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Abstract

The invention relates to a compound fenticonazole nitrate preparation and an application thereof, belonging to a Chinese and Western compound preparation. The compound preparation is prepared from the following raw materials: 10g of fenticonazole nitrate, 10g of active ingredients of traditional Chinese medicines, 30g of poloxamer 407, 15g of poloxamer 188, 5g of carbomer, 250g of propylene glycol, 150g of glycerol, 5g of sodium benzoate, 0.3g of ethylene diamine tetraacetic acid and 475g of distilled water. The compound medicine disclosed by the invention can be used for treating both symptoms and root causes of vaginitis; and the compound medicine is non-toxic and harmless to human bodies, free from side effect, low in cost, simple and convenient in preparation and broad in application prospect.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a compound fenticonazole nitrate preparation and application thereof. Background technique [0002] Vaginitis is a common inflammatory disease in women with leucorrhea change, genital itching, genital burning pain, and dyspareunia as the main clinical manifestations. It may be accompanied by bladder irritation symptoms such as frequent urination, urgency, and painful urination. In severe cases, vaginal discharge may occur. A small amount of bleeding, the elderly may be accompanied by anemia, headache, dizziness, body weakness, insomnia and easy to wake up and other symptoms, it is a common gynecological disease that plagues women's health. Anatomically speaking, the female vulva is in a naturally closed state, and the front and rear walls of the vagina are also in a closed state at ordinary times. Indirect contact infection is a transmission route of fungal vaginit...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/8967A61K9/00A61P15/02A61P31/10A61K31/4174A61K35/24
Inventor 林凡友林凡儒王丽娟
Owner 仁和堂药业有限公司
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