CN105030737A - Compound bifonazole film coating agent and preparation method thereof - Google Patents
Compound bifonazole film coating agent and preparation method thereof Download PDFInfo
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- CN105030737A CN105030737A CN201510606194.4A CN201510606194A CN105030737A CN 105030737 A CN105030737 A CN 105030737A CN 201510606194 A CN201510606194 A CN 201510606194A CN 105030737 A CN105030737 A CN 105030737A
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- bifonazole
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- resorcinol
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Abstract
The invention discloses a compound bifonazole film coating agent and a preparation method thereof. The compound bifonazole film coating agent obtained through preparation can dissolve cuticula layers according to the broad spectrum antifungal effect of bifonazole and by being matched with 6% of resorcinol, and the effect of eliminating fungi and bacteria, preventing corrosion and relieving itching are achieved, the film coating agent and the resorcinol are reasonable in compatibility, the pharmacological action is enhanced, the obtained film agent is used for treating tinea of feet and hands, and a good curative effect is achieved. As a cutin dissolving agent, resorcinol can improve the seepage force of the bifonazole into the dermis and raising the transdermal absorption rate of medicine, the pharmacological effect can be brought into full play, the treatment course is shortened, and the cure rate is raised; polyvinyl alcohol is adopted as a film coating material, when the film is formed after coating, the medicine contained in the film can be distributed evenly and released slowly, the medicine can act for a long time, the curative effect is remarkable, the coating expansion performance is good, the agent is non-irritating, the agent can be applied externally for 3-5 minutes, then the film can be formed after the agent gets dried, the medicine film is easy to clean, and the protective effect on a wound surface is achieved.
Description
Technical field
The present invention relates to liniment preparation field, specifically refer to a kind of Bifonazole Compound liniment and preparation method thereof.
Background technology
Tinea manus and pedis is department of dermatologry common frdquently encountered disease, and traditional treatment medicine mostly is single preparations of ephedrine, and compound preparation commonly uses glucocorticoid and antifungal drug compatibility, and because hormonal medicaments treatment fungal infection has untoward reaction, Clinical practice has limitation.In recent years, the domestic clinical combination rifampicin capsules used, by bifonazole and 5% salicylic acid, 5% benzoic acid compatibility, curative effect certainly.Salicylic acid, benzoic acid are similar drug, and compatibility working concentration is added, comparatively large to Skin and mucosa irritation, easily cause local excitation symptom and contact dermatitis.
Summary of the invention
The object of the present invention is to provide a kind of for fast treating tinea manus and pedis, alleviate patient's slight illness, Bifonazole Compound liniment that untoward reaction is few.
Another object of the present invention is to the preparation method that a kind of Bifonazole Compound liniment for fast treating tinea manus and pedis is provided.
The present invention is achieved through the following technical solutions: a kind of Bifonazole Compound liniment, represents with weight, and by bifonazole 4 ~ 22g, resorcinol 37 ~ 73g, polyvinyl alcohol 24 ~ 59g, glycerol 83 ~ 125g, purified water 200 ~ 600g, ethanol 500 ~ 900g form.
In order to better real the present invention, further, represent with weight, described bifonazole is 12g, and resorcinol is 65g, polyvinyl alcohol 50g, glycerol 100g, purified water 400g, ethanol 500g.
A preparation method for Bifonazole Compound liniment, comprises the following steps:
(1) add 400g purified water and 100g glycerol at 50g polyvinyl alcohol, make it fully swelling, stand-by;
(2) get bifonazole 12g to dissolve in 100g alcoholic solution, stir, stand-by;
(3) get resorcinol 65g to dissolve in 250g alcoholic solution, stir, stand-by;
(4) three kinds of solution mixing step (1), (2), (3) obtained, and add alcoholic solution to 1000ml, stir.
In order to realize method of the present invention better, further, whipping process is completed by magnetic stirring apparatus.
In order to realize method of the present invention better, further, the whipping process of described step (3) is completed by magnetic stirring apparatus.
In order to realize method of the present invention better, further, the mixer of three kinds of solution in described step (4) uses high range beaker to complete.
The present invention compared with prior art, has the following advantages and beneficial effect:
(1) the present invention can dissolve horny layer according to the broad-spectrum antifungal effect of bifonazole and 6% resorcinol, and tool antifungal, antibacterial and anticorrosion, itching-relieving action, both reasonable compatibilities, pharmacological action strengthens, make liniment treatment tinea manus and pedis, there is good curative effect;
(2) the present invention selects resorcinol as keratin-lytic agent, can improve bifonazole to the penetration of corium and the percutaneous absorption rate accelerating medicine, can give full play to drug effect, Shorten the Treatment Process, improve cure rate;
(3) the MIC scope of the Bifonazole Compound liniment in the present invention to 35 of clinical separation routine common causative fungus antibacterial experiment in vitro is 1.6 ~ 13.1gL
-1, the MIC of 1% bifonazole gel is 3.3 ~ 24.5mgL
-1, result is consistent with clinical observation on the therapeutic effect;
(4) the present invention adopts polyvinyl alcohol as class coating material, and after coating film forming, contained drug can distribute and slow releasing equably, makes drug effect lasting and evident in efficacy;
(5) stretchability of the present invention is good, nonirritant, outer painting 3 ~ 5min and drying and forming-film, medicine film easy cleaning, to wound surface and tool protective effect.
Detailed description of the invention
Below in conjunction with embodiment, the present invention is described in further detail, but embodiments of the present invention are not limited thereto, without departing from the idea case in the present invention described above, according to ordinary skill knowledge and customary means, make various replacement and change, all should comprise within the scope of the invention.
Embodiment:
The Bifonazole Compound liniment of the present embodiment, represents with weight, and described bifonazole is 12g, and resorcinol is 65g, polyvinyl alcohol 50g, glycerol 100g, purified water 400g, ethanol 500g.
Concrete preparation method, comprises the following steps:
(1) add 400g purified water and 100g glycerol at 50g polyvinyl alcohol, make it fully swelling, stand-by;
(2) get bifonazole 12g to dissolve in 100g alcoholic solution, stir, stand-by;
(3) get resorcinol 65g to dissolve in 250g alcoholic solution, stir, stand-by;
(4) three kinds of solution mixing step (1), (2), (3) obtained, and add alcoholic solution to 1000ml, stir.
Wherein, the whipping process of described step (2) is completed by magnetic stirring apparatus; The whipping process of described step (3) is completed by magnetic stirring apparatus; The mixer of three kinds of solution in described step (4) uses high range beaker to complete.
One, obtained Bifonazole Compound liniment irritation test
Selective body quality is about the healthy rabbits 3 of 2 ~ 3kg, and a mao 3cm is shaved in every rabbit veutro portion
2, by this product even spread, bid, the dermoreaction respectively after observed and recorded 24h, 48h, 72h, is showed no rubescent, dermexanthesis or phenomenon of blistering.
Two, clinical efficacy
200 routine tinea manus and pedis patients, are divided into seminar 100 example by patient by medical order, matched group 100 example.Seminar, man 57 example, female 43 example; 18 ~ 66 years old age; The course of disease 10 days ~ 8 years; In tinea pedis case, vesicle 20 example, interphalangeal erosion type 19 example, squama keratinization type 50 example; Vesicle 4 example in the tinea manuum, interphalangeal erosion type 2 example, squama keratinization type 5 example.In matched group, man 55 example, female 45 example; 17 ~ 68 years old age; The course of disease 9 days ~ 10 years; In tinea pedis case, vesicle 21 example, interphalangeal erosion type 18 example, squama keratinization type 48 example; Vesicle 4 example in the tinea manuum, interphalangeal erosion type 3 example, squama keratinization type 6 example.Inclusion criteria: clinical symptoms and the sign with cutaneous fungal infection, fungus microscope examination and/or the cultivation positive, clarify a diagnosis as tinea manus and pedis patient; Exclusion standard: (1) local is associated with severe bacterial infections or merges eczema, contact dermatitis etc.; (2) the serious heart, liver, kidney diaseases person is had; (3) prolonged application glucocorticoid person; In (4) 2 months, system uses antifungal drug, local topical antifungal drug person in first quarter moon; (5) Pregnant and lactant women.To the local bacterial mixed infection that treatments period occurs, adopt 1: 5000 potassium permanganate solution soak, and take the circumstances into consideration to use anti-bacterial drug, do not affect continual cure.2 groups of no significant differences (P>0.05) in sex, age, the course of disease, the state of an illness etc.
Use Bifonazole Compound liniment; Matched group uses 1% bifonazole gel, and 2 groups of equal medicines for external application are in affected part, and qd, 4 weeks was 1 course for the treatment of, and after drug withdrawal, follow up a case by regular visits to 2 weeks, judges curative effect, observe untoward reaction simultaneously at the end of the course for the treatment of.
Efficacy assessment standard is fully recovered: for erythra disappears completely, and gargalesthesia disappears, fungus microscope examination and cultivation feminine gender.Effective: be deflorescence more than 60%, gargalesthesia obviously alleviates, fungus microscope examination and cultivation feminine gender.Take a turn for the better: be deflorescence 20% ~ 60%, gargalesthesia weakens, fungus microscope examination and the cultivation positive.Invalid: for deflorescence is less than 20%, pain of itching is the same or increase the weight of, fungus microscope examination and the cultivation positive.Recovery from illness+effective calculating effective percentage, 2 groups of comparitive study χ
2inspection.
After one course for the treatment of, 2 groups of comparitive study, in table 1.
2 groups respectively have 3 examples (3%) medication, 1 week interior local skin to occur minimal irritation symptom; When there is 1 example (1%) in seminar, matched group has 4 examples (4%) to treat, skin lesion ulceration place's medication concurrent bacterial infects, and contact dermatitis appears in local.
Although illustrate and describe embodiments of the invention, those having ordinary skill in the art will appreciate that: do not departing under principle of the present invention and aim and can carry out multiple change, amendment, replacement and modification to these embodiments, scope of the present invention is by claim and equivalents thereof.
Claims (6)
1. a Bifonazole Compound liniment, is characterized in that: represent with weight, and by bifonazole 4 ~ 22g, resorcinol 37 ~ 73g, polyvinyl alcohol 24 ~ 59g, glycerol 83 ~ 125g, purified water 200 ~ 600g, ethanol 500 ~ 900g form.
2. a kind of Bifonazole Compound liniment according to claim 1, is characterized in that: represent with weight, and described bifonazole is 12g, and resorcinol is 65g, polyvinyl alcohol 50g, glycerol 100g, purified water 400g, ethanol 500g.
3. the preparation method of a kind of Bifonazole Compound liniment according to claim 1 and 2, is characterized in that: comprise the following steps:
(1) add 400g purified water and 100g glycerol at 50g polyvinyl alcohol, make it fully swelling, stand-by;
(2) get bifonazole 12g to dissolve in 100g alcoholic solution, stir, stand-by;
(3) get resorcinol 65g to dissolve in 250g alcoholic solution, stir, stand-by;
(4) three kinds of solution mixing step (1), (2), (3) obtained, and add alcoholic solution to 1000ml, stir.
4. the preparation method of a kind of Bifonazole Compound liniment according to claim 3, is characterized in that: the whipping process of described step (2) is completed by magnetic stirring apparatus.
5. the preparation method of a kind of Bifonazole Compound liniment according to claim 3, is characterized in that: the whipping process of described step (3) is completed by magnetic stirring apparatus.
6. the preparation method of a kind of Bifonazole Compound liniment according to claim 3, is characterized in that: the mixer of three kinds of solution in described step (4) uses high range beaker to complete.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510606194.4A CN105030737A (en) | 2015-09-22 | 2015-09-22 | Compound bifonazole film coating agent and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201510606194.4A CN105030737A (en) | 2015-09-22 | 2015-09-22 | Compound bifonazole film coating agent and preparation method thereof |
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| CN105030737A true CN105030737A (en) | 2015-11-11 |
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| CN201510606194.4A Pending CN105030737A (en) | 2015-09-22 | 2015-09-22 | Compound bifonazole film coating agent and preparation method thereof |
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Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2005004989A2 (en) * | 2003-07-01 | 2005-01-20 | Todd Maibach | Film comprising therapeutic agents |
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- 2015-09-22 CN CN201510606194.4A patent/CN105030737A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2005004989A2 (en) * | 2003-07-01 | 2005-01-20 | Todd Maibach | Film comprising therapeutic agents |
Non-Patent Citations (1)
| Title |
|---|
| 李淼等: "复方联苯苄唑涂膜剂的制备及临床应用", 《中国医院药学杂志》 * |
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Application publication date: 20151111 |