CN1284332A - Onychomycosis cream and its production process - Google Patents
Onychomycosis cream and its production process Download PDFInfo
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- CN1284332A CN1284332A CN 99111408 CN99111408A CN1284332A CN 1284332 A CN1284332 A CN 1284332A CN 99111408 CN99111408 CN 99111408 CN 99111408 A CN99111408 A CN 99111408A CN 1284332 A CN1284332 A CN 1284332A
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- onychomycosis
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- tinea
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Abstract
The present invention relates to azole organic compound containing medicine cream for treating onychomycosis and its preparation. Onychomycosis cream contains Ketoconazole, Terbinafine, hexadecyl alcohol, white vaseline, dodecyl sodium sulfate, glycerol, azatroketone laurate, napagin A and water, and is prepared through mixing while heating and stirring. It has high treating effect on onychomycosis of fingernail and toenail and obvious treating effect on tinea manuum, tinea pedis, tinea corporis, tinea cruris and tinea versicolor, and has, unlike oral medicine, no toxic side effect.
Description
The present invention relates to the compositions and the method for making thereof of the treatment tinea unguium of azole organic compound.
In a single day fungus invades the deck and gets tinea unguium, sick first thickening, muddiness is taupe, the visible flour shape of first end desquamation, often separate with nail matrix on the deck, not only hinders attractive in appearance, and the trickle dexterous action of influence finger, cut finger (toe) as not noting sterilization, can the oneself infect mutually, tinea unguium is not treated majority and be cannot be cured all one's life.Any treatment tinea unguium medicine is to be killed or suppresses breeding and the hypertrophy of fungus in first, or adopts the method for pulling out the disease first, to reach the purpose of healing.
With the more obstinate refractory of tinea unguium (being commonly called as tinea unguium), be easy to recurrence again in the tinea.Although produce many antifungal drugs at present both at home and abroad, for example treatment such as itraconazole, terbinafine tinea unguium has certain curative effect, all is oral medication, and the course of treatment is long, and certain side effect is arranged, and costs an arm and a leg, and is difficult for being accepted by general patient.
In the 5th the Asia department of dermatologry conference that 1998 hold in Beijing, Novartis has been reported the comparison to continuous therapy of terbinafine and itraconazole flooding treatment toenail tinea that participate in 36 medical centers of six countries (English, moral, meaning, Finland, Iceland, Holland), the patient of 496 examples is divided into four groups of oral medications that carry out system, and followed up a case by regular visits to for 72 weeks, as a result the fungus cure rate the former be 40%, the latter is 25%; Fully cure rate is respectively 65% and 26%, and conclusion is: " treat tinea unguium, the continuous therapy curative effect of terbinafine obviously is better than the itraconazole flooding, P＜0.0001, no significant difference between two groups of untoward reaction.”
It is less that domestic scholars is reported routine number to the curative effect of above-mentioned two medicines treatment toe (finger) tinea, and observing time is still short, does not still have final conclusion.
In addition, every routine patient's medicine valency is quite expensive in the 496 cases grouping of the sharp pharmacy experimental observation of Novartis and the medication as can be seen from Table 1, as 84 of terbinafine 12 all medications, is roughly equal to about 2000 yuan of RMB; 3 months courses of treatment of itraconazole, need more than 1000 yuan of RMB approximately.
The course of treatment and the expense of table 1 treatment 1 routine toenail tinea
| Grouping and medicine for treatment | Every routine medicine valency (RMB: unit) |
| T 12Terbinafine 250mg/ days * 12 all T 16Terbinafine 250mg/ days * 16 all T 3Itraconazole 400mg/ days * 7,3 weeks were 1 course of treatment at interval, 3 totally months T 4Itraconazole 400mg/ days * 7,3 weeks were 1 course of treatment at interval, 4 totally months | Totally 84 tablets of medicines, be roughly equal to 2000 totally 112 tablets of medicines, be roughly equal to 3000 totally 84 tablets of medicines, be roughly equal to 1000 totally 112 tablets of medicines, be roughly equal to 1500 |
Annotate: T
12Expression l2 week, T
16Expression l6 week, I
3Represent 3 months, I
4Represent 4 months.
Purpose of the present invention just is to develop a kind of external curing tinea unguium disease, low price, and a kind of cream that therapeutic effect is good is avoided the toxic and side effects of oral medicine, is easy to be accepted by the patient.
Another object of the present invention is exactly the compound method that works out the sick cream of external curing tinea unguium.
In order to seek the treatment tinea unguium of local topical medicine, passed through research repeatedly and clinical observation for many years, invented effective local application of the present invention cream, the most effective antibacterial or germ killing drugs have mainly been adopted in the prescription, the excipient that utilization has transdermal effect passes through skin with antibacterials, penetrate into nail root portion, Deck Drain, suppress the propagation of fungus and kill the interior fungus of first, make it growth and passing along with the deck, germ-carrying sick deck is constantly wiped out, and finally grows aseptic and glossiness new first and refers to (toe) first.
A kind of onychomycosis cream compositions of the present invention, contain ketoconazole 20～80 weight portions, terbinafine HCl [Tefbinafine, (E)-and N (6.6-dimethyl-second-heptene-4 one alkynes)-N-methyl isophthalic acid-naphthalene methylamine hydrochloric salt] 10～40 weight portions, hexadecanol 190～760 weight portions, white vaseline 250～1000 weight portions, sodium lauryl sulphate 6～24 weight portions, glycerol 100～400 weight portions, Laurel nitrogen _ ketone 30～120 weight portions, Ethyl Hydroxybenzoate 1～4 weight portion, 400～1600 milliliters of formed cream of distilled water.
Two kinds of antifungal drugs in this compositions, have been selected for use, mainly be to consider from the mechanism of action of this medicine and the effectiveness of treatment tinea unguium, terbinafine HCl has the effect of the Squalene of inhibition Cycloxygenase, play antibacterial and germ-resistant dual function, ketoconazole has the cytochrome P 450 enzymes of inhibition system, stronger bacteriostasis is arranged, and deep mycosis is also had better therapeutic effect.The antifungal drug of above-mentioned different mechanism of action is imported Intradermal infiltration nail root, deck simultaneously, play strong antibacterial and bactericidal action, become comparatively ideal tinea unguium local topical medicine.
The compound method of a kind of onychomycosis cream compositions of the present invention, by prescription ketoconazole 20～80 weight portions, terbinafine HCl [Terbinafine, (E)-and N (6.6-dimethyl-second-heptene-4-alkynes)-N-methyl isophthalic acid-naphthalene methylamine hydrochloric salt] 10～40 weight portions, hexadecanol 190～750 weight portions, white vaseline 250～1000 weight portions, sodium lauryl sulphate 6～24 weight portions, glycerol 100～400 weight portions, Laurel nitrogen _ ketone 30～120 weight portions, Ethyl Hydroxybenzoate 1～4 weight portion, 400～1600 milliliters of batchings of distilled water; By preparing burden hexadecanol, white vaseline, glycerol, Laurel nitrogen _ ketone, Ethyl Hydroxybenzoate and distilled water in container, under agitating heating, form emulsion, under agitation add sodium lauryl sulphate, ketoconazole and terbinafine HCl to the cream that forms the emulsifiable paste shape with fixed attention.
Mixing speed when stirring does not have any influence to the quality of product, only stirs; Said weight portion can be gram, jin, kilogram, ton.The temperature of heating with 60-75 ℃ for well.Ketoconazole that is added or hydrochloric acid spy are good than naphthols with the 100-200 order that sieves, and their granularity is thin more good more.
The usage of onychomycosis cream compositions of the present invention is: treatment tinea unguium, earlier with brothers' greasy dirt washes clean, dry, with thumb or forefinger onychomycosis cream ointment of the present invention is applied to disease nail root portion and perionychium skin place, rubbed gently 3-5 minute, make medicine infiltrate skin, be coated with stranding every night once, simultaneously sick first wiped out or scraped off, recover normal fully until the deck, be coated with this medicine outside general and both seen from the nail root place have normal deck to grow after one week, coating is coated with stranding once, about about three months after January next day of changing into continuously, can make fingernail deck (toenail medication 5-6 month), grow normal new first.Look into fungus before, during and after the treatment, treat continuous 3 funguses in back and check feminine gender, be judged to healing.
Onychomycosis cream compositions of the present invention is outstanding especially to tinea manus and pedis, tinea corporis and cruris, tinea versicolor curative effect, can directly be applied to the skin lesion place, and every day 2 times, 1～2 all skin lesion can disappear.Generally have no adverse reaction.
Contraindication is to onychomycosis cream allergy sufferers of the present invention, anemia of pregnant woman and the careful usefulness of women breast-feeding their children.
The storage practice of medicine of the present invention is, and is airtight, is stored in shady and cool place.
The advantage of onychomycosis cream compositions of the present invention and compound method thereof just is:
1. example surplus onychomycosis cream compositions local topical of the present invention treatment tinea unguium patient 200, its cure rate is more than 60%, and total effective rate has no side effect more than 90%.
The main cause of treatment failure is that the patient fails to adhere to accomplishing continuous and regular medication.Because the nail growth cycle is very fast, coming off from nail root length to the first end approximately needs about 3 months, and toenail then needs 6 months, if therapy discontinued, residual fungus can breed again and stretches to nail root portion in the deck, causes the deck that pathological changes takes place once more.
2. onychomycosis cream compositions of the present invention is the local topical medicine, has avoided the toxicity of oral medicine, and low price is easy to be accepted by the patient.More remarkable to tinea manus and pedis, tinea corporis and cruris, tinea versicolor curative effect.
3. the compound method of onychomycosis cream compositions of the present invention, process equipment is simple, is easy to grasp promote.
Below the present invention is further illustrated with embodiment, will help the present invention and advantage thereof are done further to understand, and protection scope of the present invention is not subjected to the restriction of these embodiment, and protection scope of the present invention is decided by claim.
Embodiment 1
The onychomycosis cream compositions of present embodiment contains ketoconazole 50 gram, terbinafine HCl 25 grams, hexadecanol 480 grams, white vaseline 630 grams, sodium lauryl sulphate 15 grams, glycerol 250 grams, laurocapram 75 grams, Ethyl Hydroxybenzoate 2.5 grams, distilled water and forms cream for 1000 milliliters.
Its compound method is, by above-mentioned prescription batching, earlier with hexadecanol, white vaseline, glycerol, Laurel nitrogen _ ketone, Ethyl Hydroxybenzoate and distilled water are heated with stirring in container under 70 ℃ the temperature and form emulsion, under agitation add sodium lauryl sulphate, cross 100 mesh sieve ketoconazoles and extremely form the cream shape with fixed attention than naphthols with the hydrochloric acid spy who crosses 100 mesh sieves.
Embodiment 2
The onychomycosis cream compositions of present embodiment contains 20 kilograms of ketoconazoles, 25 kilograms of terbinafine HCls, 190 kilograms of hexadecanol, 250 kilograms of white vaselines, 6 kilograms of sodium lauryl sulphates, 100 kilograms of glycerol, 30 kilograms of Laurel nitrogen _ ketone, 1 kilogram of Ethyl Hydroxybenzoate, 400 liters of formation of distilled water cream.
Its compound method is substantially with embodiment 1, and only different is that formation emulsion is stirred in heating under 60 ℃ temperature, and ketoconazole is crossed 150 mesh sieves, and the hydrochloric acid spy also crosses 150 mesh sieves than naphthols.
Embodiment 3
The onychomycosis cream compositions of present embodiment contains 80 kilograms of ketoconazoles, 40 kilograms of terbinafine HCls, 760 kilograms of hexadecanol, 1000 kilograms of white vaseline, 24 kilograms of sodium lauryl sulphates, 400 kilograms of glycerol, Laurel nitrogen _ ketone 120 kg, 4 kilograms of Ethyl Hydroxybenzoates, 1600 liters of distilled water, the cream of formation.
Its compound method is substantially with embodiment 1, and only different is is heated to stir under 75 ℃ the temperature and forms emulsion, and ketoconazole was 200 mesh sieves, and the hydrochloric acid spy also was 200 mesh sieves than naphthols.
Embodiment 4
The onychomycosis cream compositions of present embodiment contains the cream of ketoconazole 40 grams, terbinafine HCl 20 grams, hexadecanol 380 grams, white vaseline 500 grams, sodium lauryl sulphate 12 grams, glycerol 200 grams, Laurel nitrogen _ ketone 60 grams, Ethyl Hydroxybenzoate 2 grams, 800 milliliters of formation of distilled water.
The method of its preparation is fully with embodiment 1.
Embodiment 5
The onychomycosis cream compositions of present embodiment contains the cream of ketoconazole 60 grams, terbinafine HCl 35 grams, hexadecanol 600 grams, white vaseline 800 grams, sodium lauryl sulphate 20 grams, glycerol 350 grams, Laurel nitrogen _ ketone 85 grams, Ethyl Hydroxybenzoate 3 grams, 1400 milliliters of formation of distilled water.
The method of its preparation is fully with embodiment 1.
Claims (4)
1.-plant the onychomycosis cream compositions, it is characterized in that, contain ketoconazole 20～80 weight portions, terbinafine HCl 10～40 weight portions, hexadecanol 190～760 weight portions, white vaseline 250～1000 weight portions, sodium lauryl sulphate 6～24 weight portions, glycerol 100～400 weight portions, Laurel nitrogen _ ketone 30～120 weight portions, Ethyl Hydroxybenzoate 1～4 weight portion, 400～1600 milliliters of formed cream of distilled water.
2. the compound method of an onychomycosis cream compositions is characterized in that, may further comprise the steps:
(1) by prescription ketoconazole 20～80 weight portion, terbinafine HCl 10～40 weight portions, hexadecanol 190～760 weight portions, white vaseline 250～1000 weight portions, sodium lauryl sulphate 6～24 weight portions, glycerol 100～400 weight portions, Laurel nitrogen _ ketone 30～120 weight portions, Ethyl Hydroxybenzoate 1～4 weight portion, 400～1600 milliliters of batchings of distilled water
(2) by preparing burden hexadecanol, white vaseline, glycerol, Laurel nitrogen _ ketone, Ethyl Hydroxybenzoate and distilled water in container, under agitating heating, form emulsion, under agitation add sodium lauryl sulphate, ketoconazole and terbinafine HCl to forming emulsifiable paste shape cream with fixed attention.
3. according to the compound method of a kind of onychomycosis cream compositions of claim 2, it is characterized in that the temperature of heating is 60-75 ℃.
4. according to the compound method of a kind of onychomycosis cream compositions of claim 2, it is characterized in that ketoconazole that is added or terbinafine HCl are the 100-200 order that sieves.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 99111408 CN1284332A (en) | 1999-08-13 | 1999-08-13 | Onychomycosis cream and its production process |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 99111408 CN1284332A (en) | 1999-08-13 | 1999-08-13 | Onychomycosis cream and its production process |
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| Publication Number | Publication Date |
|---|---|
| CN1284332A true CN1284332A (en) | 2001-02-21 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 99111408 Pending CN1284332A (en) | 1999-08-13 | 1999-08-13 | Onychomycosis cream and its production process |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101502580B (en) * | 2009-03-20 | 2011-02-02 | 汪世龙 | External-use medicament for treating tinea manus and pedis |
-
1999
- 1999-08-13 CN CN 99111408 patent/CN1284332A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101502580B (en) * | 2009-03-20 | 2011-02-02 | 汪世龙 | External-use medicament for treating tinea manus and pedis |
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