CN1883620A

CN1883620A - Gel agent for treating superficial mycotic infection and method for preparing same

Info

Publication number: CN1883620A
Application number: CNA2006100834210A
Authority: CN
Inventors: 王丽娟
Original assignee: Individual
Current assignee: Individual
Priority date: 2006-05-31
Filing date: 2006-05-31
Publication date: 2006-12-27

Abstract

The invention discloses a gelling agent for treating fungus infection which is prepared from active constituents and right amount of gel base material, humectant, and preservative agent, the active constituents include mahonia stem, flavescent sophora root, Philippine violet herb, gallnut, pricklyash peel, the gel base material, humectant, preservative agent are preferably selected from carbomer, glycerin, and ethylparaben. The invention also discloses the process for preparing the medicament.

Description

A kind of gel for the treatment of mycotic infection of superficial part and preparation method thereof

Technical field

The present invention relates to a kind of gel for the treatment of mycotic infection of superficial part, the invention still further relates to the preparation method of this gel.

Background technology

Fungus does not almost exist nowhere at occurring in nature, and viability is extremely strong, and this bacterium does not contain chlorophyll, unglazed cooperation ability, only relies on parasiticly or saprophytic to survive.The environment that hobby is moist warm, the optimum growth temperature is 25-26 ℃, is all can grow under 3.0～10.0 conditions at pH value.Though vulnerable to high temperature (more than 45 ℃), temperature is having very strong adaptive faculty below 4 ℃.Ultraviolet, lonizing radiation etc. also there is suitable resistance.Based on above reason, the chance of human fungal infection also increases naturally thereupon.Mycotic infection of superficial part spreads all over regions of the world, also is common frdquently encountered disease in China.

Superficial mycosis has certain infectiousness, but both self infected, and also can infect other people.Cause of disease complexity easily repeatedly, belongs to one of difficult disease of department of dermatologry.

Common tinea has following several:

(1) tinea corporis

Remove beyond head, the palm sole of the foot, groin, pudendum and the first, the dermatosis that human body surface glabrous skin fungal infection is taken place is referred to as tinea corporis.

(2) tinea pedis

Tinea pedis is that pathomycete infects foot the most common caused superficial mycosis, and China is among the people to be referred to as " beriberi " or " dampness ".Tinea pedis occupies the majority with the young and the middle aged's morbidity.Child, gerontal patient are more rare, this may with these people's activities less, dry relevant between toe.Primary disease is sent out between toe well, especially third and fourth toe seam.This with above-mentioned position skin contact closely, moist, stuffiness, sweat evaporation is relatively poor relevant.

(3) tinea manuum

The tinea manuum is the superficial mycosis that betides facies palmaris, and is identical with motherland's medical science " fungal infection of hand and foot " performance.

The medicine that is used for the treatment of mycotic infection of superficial part at present has following a few class based on Western medicine:

1. antifungal antibiotic

Griseofulvin, amphotericin B, cannitracin, globoroseomycin, nystatin, hachimycin etc.; Plain B (echinocandinB) class of lipopeptid sour jujube coccus and derivant thereof; Nucleoside peptide class Buddhist nun Mycosporin Z (nikkomycin Z); Polyene antibiotics partricin (Partricin) and derivant thereof.

2 triazole antifungal agent things

Miconazole (miconazole) and clotrimazole (clotrimazole), econazole (econazole);

Triazole compounds: fluconazol, Yi Qukang.

3 propylamine antifungal agent

Naftifine (naftifine), terbinafine (terbinafine) and butenafine (butenafine).

4. thiocarbamic acid class

Holder tolnaftate (tolnaftate), tolciclate (tolciclate), liranaftate (1iranaftate).

5 thebaine classes

Amorolfine (amorolfine).

6 pyrrones antifungal agent

Ciclopirox olamine (ciclopirox olamine, ciclopiroxolamin, ciclopirox oxyethylamine).

Other: as flucytosine.

Though remarkable with the top drug effect, often simultaneously with serious toxic and side effects, patient's compliance is poor, and costs an arm and a leg, a part of medicine life-time service is easy to generate drug resistance, recurrence easily after the drug withdrawal.

Purple green pepper tinea tincture records in " national standard for traditional Chinese medicines compilation " department of dermatologry fascicle.Said preparation is made up of Caulis Mahoniae, Radix Sophorae Flavescentis, Herba Violae, Galla Chinensis, Pericarpium Zanthoxyli five kinds of Chinese medicine, Caulis Mahoniae heat clearing and damp drying, eliminating fire and detoxication in the side; Radix Sophorae Flavescentis clearing away heat and promoting diuresis, removing dampness and killing parasites; Herba Violae heat-clearing and toxic substances removing, removing heat from blood detumescence; Galla Chinensis astringe the lung pathogenic fire reducing, relieving diarrhea with astringents, arresting sweating; Pericarpium Zanthoxyli warming middle-JIAO to relieve pain, killing parasites for relieving itching.Above flavour of a drug are played heat clearing and damp drying altogether, the effect of killing parasites for relieving itching.It is the pure Chinese medicinal preparation of external curing tinea pedis, the tinea manuum and tinea corporis.This medicine is through clinical verification for many years, determined curative effect, no obvious toxic-side effects.But this medicine is a liquid preparation, runs off easily at agents area, and the local holdup time is short, influences the normal performance of curative effect of medication, and uses, preserves, transports also inconvenient.And we are developed as purple green pepper tinea gel dosage form with it, and purple green pepper tinea gel adopts hydrophilic gel substrate to make good looking appearance; Strong in the lesion tack, can overcome the deficiency of tincture in the volatile loss of agents area, prolong action time; Be easy to coating and use, good with the skin coupling, to mucocutaneous non-stimulated, no foreign body sensation; No greasy feeling, pollution clothes not, easy cleaning after the medication; Preparation technology is simple; Good stability; Carry, store, transportation etc. is more convenient.

Summary of the invention

One of purpose of the present invention provides a kind of gel for the treatment of mycotic infection of superficial part.

Another object of the present invention provides the preparation method of this gel.

Gel of the present invention is made up of active ingredient and suitable substrate, wetting agent, the antiseptic of making gel, and the raw material of wherein said active ingredient is made up of the component of following weight proportion: Caulis Mahoniae 20-100, Radix Sophorae Flavescentis 20-80, Herba Violae 20-80, Galla Chinensis 20-80, Pericarpium Zanthoxyli 10-60.

The suitable substrate of making gel of the present invention is selected from one or more in carbomer, chitosan, polyvinyl alcohol, guar gum, arabic gum, hydroxypropyl methylcellulose, the sodium carboxymethyl cellulose etc.;

Wetting agent of the present invention is selected from one or more in glycerol, Polyethylene Glycol, sorbitol, the glycerol etc.;

Antiseptic of the present invention is selected from one or more in ethyl hydroxybenzoate, benzoic acid, sorbitol, the Pyrusussuriensis potassium alcoholate etc.

Gel of the present invention, preferred weight proportion is: Caulis Mahoniae 50, Radix Sophorae Flavescentis 40, Herba Violae 40, Galla Chinensis 40, Pericarpium Zanthoxyli 30, carbomer 10-40, glycerol 10-40, ethyl hydroxybenzoate 1-4.

The preparation method of medicine of the present invention is: take by weighing Caulis Mahoniae, Radix Sophorae Flavescentis, Herba Violae, Galla Chinensis, Pericarpium Zanthoxyli five tastes medical material, be ground into coarse powder, according to the percolation under fluid extract and the extractum item (" an appendix I of Chinese pharmacopoeia version in 2005 O), add 50% alcohol dipping percolation after 24 hours; The collection liquid of filtering leaves standstill, and filters, and it is an amount of to get carbomer, adds medicinal liquid and stirs and make dissolving, adds glycerol, ethyl hydroxybenzoate, mends to full dose with 50% ethanol, stirs evenly, promptly.

The specific embodiment

Embodiment 1

Take by weighing Caulis Mahoniae 50g, Radix Sophorae Flavescentis 40g, Herba Violae 40g, Galla Chinensis 40g, Pericarpium Zanthoxyli 30g, be ground into coarse powder, the percolation under photograph fluid extract and the extractum item (" an appendix I of Chinese pharmacopoeia version in 2005 O), add 50% alcohol dipping after 24 hours, carry out percolation, collect percolate to 1000ml, leave standstill, filter, get carbomer 20g, add the medicinal liquid stirring and make dissolving, add glycerol 20g, ethyl hydroxybenzoate 2g, mend to full dose, stir evenly with 50% ethanol, make gel 1000g, promptly.

Clinical trial example 1

Be the definite safety of estimating clinical efficacy of the present invention and medicine, the present invention sums up mycotic infection of superficial part 55 examples altogether in practical clinical, be effective case and receive significant curative effect, do not find any toxic and side effects, now the clinical trial situation is summarized as follows.

Clinical data: all cases are the outpatient, totally 55 examples, tinea pedis 43 examples, wherein hands, tinea pedis amalgamator's 13 examples, tinea corporis 12 examples, male's case 34 people, women's case 21 people.The shortest person of the course of disease 3 days, elder 8 years, average 2 years.Before treatment, be diagnosed as superficial mycosis through clinical and fungus microscope examination, nearly 3 weeks not external or nearly January not oral any antifungal, antibacterium and corticosteroid formulations, and get rid of hormonal system illness such as diabetes etc. arranged.

Therapeutic Method: external, the medicine of getting embodiment of the invention preparation is an amount of, is applied to clean affected part, 2 times on the one.3 weeks of continuous use.Different during the treatment this is organized 55 examples and all is coated with 1 course of treatment with other antifungal, anti-inflammatory drug, and treatment finishes check fungus microscope examination, observe the curative effect.

Observational technique:

Observed for 3 weeks continuously, checked respectively and kept a record at the 1st, 14,21 day that goes to a doctor, or when having been cured, keep a record less than 21 days.Clinical symptoms comprises: erythema, pimple, vesicle, erosion, incrustation, desquamation, pruritus etc., according to the doing well,improving situation, binding to fungal is learned and is checked the judgement curative effect.

Curative effect judging standard:

Recovery from illness: skin lesion disappears fully, transference cure, and fungus is checked negative;

Produce effects: skin lesion disappears 〉=and 60%, symptom obviously alleviates, and the mild skin keratinization can be arranged, be chapped from the cold, negative fungal examination;

Effectively: the skin lesion 20-60% that disappears, subjective symptoms alleviates, the fungus microscope examination positive;

Invalid: the skin lesion less than 20% that disappears, symptom does not have improvement, the fungus microscope examination positive.

Clinical total effective rate comprises recovery from illness, produce effects, effective.The mycology effective percentage is that fungus microscope examination is turned out cloudy.

Therapeutic outcome:

Recovery from illness: 21 examples account for 38.2%;

Produce effects: 16 examples account for 29.1%;

Effectively: 13 examples account for 23.6%;

Invalid: 5 examples account for 9.1%.

Total effective rate is 90.9%, and all cases are not all found apparent side effect in therapeutic process.

Comprehensive above clinical experiment example, the medicine of the present invention's preparation is safe and effective aspect the treatment mycotic infection of superficial part.

Claims

1. gel for the treatment of mycotic infection of superficial part, it is characterized in that being made up of active ingredient and suitable substrate and the adjuvant of making gel, the weight proportion of each component is: Caulis Mahoniae 20-100, Radix Sophorae Flavescentis 20-80, Herba Violae 20-80, Galla Chinensis 20-80, Pericarpium Zanthoxyli 10-60, gel-type vehicle 10-40, wetting agent 10-40, antiseptic 1-4.

2. gel according to claim 1 is characterized in that the described suitable substrate of making gel is selected from one or more in carbomer, chitosan, polyvinyl alcohol, guar gum, arabic gum, hydroxypropyl methylcellulose, the sodium carboxymethyl cellulose etc.;

Described wetting agent is selected from one or more in glycerol, Polyethylene Glycol, sorbitol, the glycerol etc.;

Described antiseptic is selected from one or more in ethyl hydroxybenzoate, benzoic acid, sorbitol, the Pyrusussuriensis potassium alcoholate etc.

3. gel according to claim 1 is characterized in that the preferred weight proportioning of described active ingredient and gel-type vehicle, wetting agent, antiseptic is: Caulis Mahoniae 50, Radix Sophorae Flavescentis 40, Herba Violae 40, Galla Chinensis 40, Pericarpium Zanthoxyli 30, carbomer 10-40, glycerol 10-40, ethyl hydroxybenzoate 1-4.

4. the preparation method of gel according to claim 1 is characterized in that preparation process is as follows:

A) take by weighing Caulis Mahoniae, Radix Sophorae Flavescentis, Herba Violae, Galla Chinensis, Pericarpium Zanthoxyli five tastes medical material, be ground into coarse powder;

B) according to the percolation under fluid extract and the extractum item (" appendix IO of Chinese pharmacopoeia version in 2005), add 50% alcohol dipping and carry out percolation after 24 hours;

C) collect the liquid of filtering, leave standstill, filter;

D) it is an amount of to get carbomer, adds to stir in the medicinal liquid to make dissolving, adds glycerol, ethyl hydroxybenzoate again, mends to full dose with 50% ethanol, stirs evenly, promptly.