CN101422448A - Miconazole nitrate film and preparation method and pharmacy use thereof - Google Patents
Miconazole nitrate film and preparation method and pharmacy use thereof Download PDFInfo
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- CN101422448A CN101422448A CNA2008102431976A CN200810243197A CN101422448A CN 101422448 A CN101422448 A CN 101422448A CN A2008102431976 A CNA2008102431976 A CN A2008102431976A CN 200810243197 A CN200810243197 A CN 200810243197A CN 101422448 A CN101422448 A CN 101422448A
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Abstract
The invention discloses a new preparation formulation-a film agent of miconazole nitrate, which is made by miconazole nitrate, film-forming material, a plasticizer, a film material lytic agent and an antiseptic according to certain weight ratio; a preparation method thereof comprises the following four steps: step I. proper amount of the film material lytic agent is added into the film-forming material, fully mixed and then rested for being fully expanded; step II. the film material lytic agent is added into the miconazole nitrate to lead the miconazole nitrate to be dissolved, then the plasticizer is added to lead the miconazole nitrate to be clarified; step III. the film-forming material in step I is arranged in water bath and heated; proper amount of plasticizer is added and evenly mixed with the antiseptic; the main medicament dissolved in step II is added and arranged on the water bath, heated and evenly stirred; and step IV. the medicine slurry is evenly paved on a glass board by a board scraping method, blown and dried for 5 to 10min, thus instantly forming the film. The film agent of miconazole nitrate prepared by the invention is characterized by small size, light weight, convenient use, high safety and good stability, as well as long residual action and quick effect; moreover, the preparation technique is simple and the maneuverability is high.
Description
Technical field
The invention belongs to the chemicals field, be specifically related to a kind of membrane and preparation method thereof, more properly, the present invention relates to miconazole nitrate film that is used for the treatment of the female genital fungal infection and preparation method thereof.
Background technology
The female genital fungal infection is a kind of common mucosal infections, is commonly encountered diseases in the gynaecopathia and frequently-occurring disease, relates to female patient, especially trimester of pregnancy and the diabetics of each ages.This sick medicine of treatment mainly contains local application and oral administration dual mode at present.
Miconazole nitrate, its chemical name are 1-[2-(2, the 4-Dichlorobenzene base)-2-[(2, the 4-Dichlorobenzene base) methoxyl group] ethyl]-nitrate of 1h-imidazoles.Miconazole is artificial synthetic 1-phenethyl imdazole derivatives, be the broad-spectrum antifungal medicine, dermatophytosis, candidiasis, yeast and other algae, ascomycetes, cryptococcus etc. are had inhibition and killing action, gram-positive cocci and bacillus are also had antibacterial action.Miconazole is by the activity of interference cell pigment P-450, thus the biosynthesis of the main steroid-ergosterol of inhibition fungal cell membrane, and the damage fungal cell membrane also changes its permeability, so that important intracellular matter leaks outside; This product also can suppress the triacylglycerol of fungus and the biosynthesis of phospholipid, and the activity of inhibited oxidation enzyme and peroxidase causes that the cell hydrogen peroxide is gathered and causes degeneration of cell submicroscopic structure and necrocytosis.Then can suppress it changes the aggressive mycelia into from spore process to Candida albicans.Miconazole nitrate is white crystals or crystalline powder, and is tasteless, water insoluble, and ether is dissolved in chloroform, ethanol slightly.Miconazole nitrate is the medicine that comes out the seventies in 20th century, and after being succeeded in developing by Schering Plough, miconazole nitrate was got permission listing as the broad-spectrum antifungal medicine in 1984, and commodity are called " Lotrimin ".1989, these product were introduced Chinese market by Xi'an Yang Sen company, and commodity are called " daktarin ".At present, under " the power handful " of science popularization, products propaganda, become widely known brand.1993, miconazole was got permission listing in China, now has been one of important kind of gynecological's classes of anti-infective medicine.To the end of the year 2005, SFDA has issued 7 miconazole nitrate suppositorys and has produced official written reply.Except that suppository, the preparation on the market also has tablet, soft capsule, ointment, powder, solution, gel, vagina effervescence etc.
Though miconazole nitrate is used for the treatment of the female genital fungal infection already, owing to take oral formulations such as miconazole nitrate, medicine is difficult to come together in a large number the reproductive tract mucosa, must heavy dose ofly use and could produce curative effect, thus the bigger toxic and side effects of generation.And dosage forms such as liniment, cream, gel are used inconvenience, nor reach effect preferably easily.Though suppository is arranged in the market, the drug loading of suppository is big, repeatedly uses outbreak and the lighter patient of symptom easily produce some untoward reaction repeatedly.
Summary of the invention
The present inventor is in order to solve the shortcoming of the above-mentioned preparation of miconazole nitrate, and the experiment through a large amount of has prepared a kind of miconazole nitrate film that is used for the treatment of the female genital tract fungal infection.Miconazole nitrate film of the present invention contains miconazole nitrate, filmogen, plasticizer, film material lytic agent and antiseptic, and another object of the present invention is the preparation method of this membrane.
A kind of miconazole nitrate film that is used for the treatment of the female genital fungal infection is characterized in that it is made by following materials of weight proportions:
Miconazole nitrate, filmogen, plasticizer, film material lytic agent and antiseptic are 1 by weight :～9:.5～4:24～43:0.0002～0.02.
Above-mentioned filmogen is a kind of in polyvinyl alcohol, chitosan hydrochlorate, alginic acid, Arabic gelatin, Lac, guar gum, agar or the sodium cellulosate.
Above-mentioned plasticizer is a multicomponent alcoholics compound.
Above-mentioned film material lytic agent is distilled water or dehydrated alcohol.
Above-mentioned antiseptic is an ethyl hydroxybenzoate, a kind of in benzyl alcohol or the benzoic acid.
Above-mentioned multicomponent alcoholics compound is a kind of in glycerol, propylene glycol or the Macrogol 600.
The preparation method of above-mentioned miconazole nitrate film is characterized in that preparation process is as follows: the first step: it is an amount of to get filmogen blooming material lytic agent, and the back that stirs is placed fully and expanded, and is standby; Second step: will make its dissolving in the film material lytic agent adding miconazole nitrate, and add the plasticizer stirring again and make its clarification, standby; The 3rd goes on foot: the filmogen after the first step is expanded is put in the water-bath and heated, and adds an amount of plasticizer and antiseptic and stirs, and is standby; The 4th step: dissolved principal agent of second step is added in the 3rd film material that obtain of step, put in the water-bath heating and stir, above-mentioned medicine slurry evenly is laid on the glass plate dry back film forming with the scraper plate method.
In the 4th step of above-mentioned preparation method with 70 ℃ of forced air drying 5-10min.
Miconazole nitrate film of the present invention is a kind of new dosage form, it is compared with the existing various dosage forms of miconazole nitrate, have that volume is little, the characteristics of light weight, easy to use, safe, good stability and have long-lasting and quick-acting, and preparation technology is simple, workable, show that through pharmacological tests the female genital tract fungal infection is had significant curative effect.
The specific embodiment
Embodiment 1
(1) weighing polyvinyl alcohol 3g is standby; The 20ml distilled water is slowly added in the polyvinyl alcohol at normal temperatures, and the limit edged stirs and prevents its caking, places 30min until the back that stirs and makes its abundant swelling, and is standby;
(2) the 4ml dehydrated alcohol added in the 1g miconazole nitrate stir, add glycerol 1g again and stir, after leave standstill 10min;
(3) polyvinyl alcohol of step (1) is put into 65 ℃ of water-bath heated and stirred, and can be warming up to 75 ℃ gradually it is dissolved fully, the ethyl hydroxybenzoate that adds 0.8g glycerol and 0.005g again continues to stir, the miconazole nitrate solution of step (2) is slowly poured in the above-mentioned film material that makes, put in 80 ℃-85 ℃ the water-bath heating and stir, standby;
(4) the medicine slurry with above-mentioned steps (3) is poured on the glass plate of four smooth 10cm*20cm of cleaning, manual system film 800cm
2,, put in 70 ℃ the constant temperature blast drier and take out behind the 10min, film is taken off getting final product.
Embodiment 2
(1) it is standby to take by weighing Arabic gelatin 5g, and the 25ml distilled water is added in the Arabic gelatin, stirs, and places 30min and makes its abundant swelling;
(2) will the 6ml dehydrated alcohol add in the 1g miconazole nitrate and stir, add glycerol 1.5g again and stir and leave standstill 10min after making it become clear shape liquid;
(3) the Arabic gelatin of step (1) is put into 65 ℃ of water-bath heated and stirred, and can be warming up to 70 ℃ gradually it is dissolved fully, the benzoic acid that adds 1g glycerol and 0.005g again continues to stir, the miconazole nitrate solution of step (2) is slowly poured in the above-mentioned film material that makes, put in 80 ℃-85 ℃ the water-bath heating and stir;
(4) the medicine slurry with above-mentioned steps (3) is poured on the glass plate of four smooth 10cm*20cm of cleaning, manual system film 800cm
2, put in 70 ℃ the constant temperature blast drier and take out behind the 10min, film is taken off getting final product.
Embodiment 3
(1) it is standby to take by weighing chitosan hydrochlorate 2g, and the 40ml distilled water is added in the chitosan hydrochlorate, stirs, and places 20min and makes its abundant swelling;
(2) the 7ml dehydrated alcohol added in the 1g miconazole nitrate stir, add propylene glycol 1.5g again and stir, after leave standstill 10min;
(3) chitosan hydrochlorate of step (1) is put into 65 ℃ of water-bath heated and stirred, and can be warming up to 75 ℃ gradually it is dissolved fully, the benzyl alcohol that adds 1.5g propylene glycol and 0.002g again continues to stir, the miconazole nitrate solution of step (2) is slowly poured in the above-mentioned film material that makes, put in 80 ℃-85 ℃ the water-bath heating and stir;
(4) the medicine slurry with above-mentioned steps (3) is poured on the glass plate of four smooth 10cm*20cm of cleaning, manual system film 800cm
2,, put in 70 ℃ the constant temperature blast drier and take out behind the 10min, film is taken off getting final product.
Embodiment 4
(1) it is standby to take by weighing sodium cellulosate 9g, and the 35ml distilled water is added in the sodium cellulosate, stirs, and places 30min and makes its abundant swelling;
(2) the 8ml dehydrated alcohol is added the 1g miconazole nitrate and also make its dissolving in the stirring.Adding Polyethylene Glycol-6002g again stirs and leaves standstill 10min after making it become clear shape liquid;
(3) sodium cellulosate of step (1) is put into 65 ℃ of water-bath heated and stirred, and can be warming up to 80 ℃ gradually it is dissolved fully, the ethyl hydroxybenzoate that adds 2g Polyethylene Glycol-600 and 0.002g again continues to stir, the miconazole nitrate solution of step (2) is slowly poured in the above-mentioned film material that makes, put in 80 ℃-85 ℃ the water-bath heating and stir;
(4) the medicine slurry with above-mentioned steps (3) is poured on the glass plate of four smooth 10cm*20cm of cleaning, manual system film 800cm
2, put in 70 ℃ the constant temperature blast drier and take out behind the 10min, film is taken off getting final product.
Embodiment 5
(1) weighing polyvinyl alcohol 6g is standby, and the 25ml distilled water is slowly added in the polyvinyl alcohol at normal temperatures, and the limit edged stirs and prevents its caking, places 30min until the back that stirs and makes its abundant swelling;
(2) the 6ml dehydrated alcohol added in the 1g miconazole nitrate stir, add glycerol 1.3g again and stir, after leave standstill 10min;
(3) polyvinyl alcohol of step (1) is put into 65 ℃ of water-bath heated and stirred, and can be warming up to 75 ℃ gradually it is dissolved fully, the ethyl hydroxybenzoate that adds 1g glycerol and 0.001g again continues to stir, the miconazole nitrate solution of step (2) is slowly poured in the above-mentioned film material that makes, put in 80 ℃-85 ℃ the water-bath heating and stir;
(4) the medicine slurry with above-mentioned steps (3) is poured on the glass plate of four smooth 10cm*20cm of cleaning, manual system film 800cm
2, put in 70 ℃ the constant temperature blast drier and take out behind the 10min, film is taken off getting final product.
Embodiment 6: pharmacology embodiment
1) laboratory animal: healthy ICR mice, female, age (25 ± 3g) in 8-10 week
Derive from Nanjing University of Traditional Chinese Medicine zoopery center
2) experiment medicine: miconazole nitrate suppository (trade name: miconazole 200mg/ piece) Xian-Janssen Pharmaceutical Ltd.'s preparation of the present invention (Nanjing University of Traditional Chinese Medicine pharmacological experiment chamber provides)
3) experimental technique: 60 of ICR mices, be divided into 4 groups at random, every group 15: miconazole nitrate film high-dose therapy group (60mg/ opens) (A group), miconazole nitrate film low dose therapy group (40mg/ opens) (B group), miconazole matched group (200mg/ piece) (C group) and blank group (D group), every mice 6d before inoculation begins subcutaneous injection and contains 0.1mg estradiol benzoate oil preparation 0.05ml, later every 2d injection 1 time.With the inoculation of separation and purification on the liquid base that contains 1% peptone and 0.1% glucose, 25 ℃ of water-bath shaken cultivation 16-18h.During inoculation be that (Candida albicans spore inoculating amount is 5*10 to the 2.5*106/L bacteria suspension 20ul that is dissolved in PBS with density
4Individual) inoculating day intravaginal of all mices of injection.The time of drawing materials is respectively postvaccinal the 2nd, 4,7,14, and 21 days, each lavation day, with 100ul PBS lavation vagina, irrigating solution placed the cleaning sterile pipe earlier 5 mices of every group of picked at random.The abundant mixing of irrigating solution is got 40ul and is added in the 1ml Sterile Saline and dilute, after be seeded on the husky fort glucose agar medium, cultivate 72h for 30 ℃, carry out cfu counting (being colony-forming units, is unit in individual bacterium colony/L).2 of irrigating solution smear for microscopic examination: a smear adds microscopy behind the heat fixation, observes mycelia and blastopore and generates situation; Wright's staining after another smear drying, at 4 visual field counting macrophages, PMN (polymorphonuclear granulocyte), lymphocyte and other (basophil, eosinophilic granulocyte, mastocyte etc.) leukocyte, the cell number in each visual field is represented with the percent that this cell accounts for total cell under * 400 mirrors.After putting to death not 2 of lavation mices each lavation day, win its vagina tissue for every group in addition, place 10% formalin fixed, stay and do histopathology.The vagina tissue pathological examination: the specimen tissue carries out paraffin embedding, and HE dyeing and PAS dyeing are carried out in 0.5 μ m section.Per vaginam the irrigating solution smear for microscopic examination shows: from beginning in the 2nd day, each is organized promptly high-caliber cfu to the vaginal douche fungus carrying capacity of different periods behind the mouse inoculation candidiasis (with the expression of cfu counting) in the mouse vagina, and continued to the observation end of term.Vaginal douche smear staining result shows: infect successful mice from the 4th day, can see more blastopore and pseudohypha in the smear.Played visible agglomerating mycelia on the 7th day.Histopathology is the result prove: observing the end of term blastopore or hypha body appearred in the vaginal canal on the 4th day and continued in the inoculation back.Three check result proof monilial infection vaginal mucosas, the modeling success.
Second day each group after the modeling success begins administration simultaneously.Miconazole nitrate film high dose group and low dose group 1 administration every day knead film and fill in the mouse vagina depths, successive administration 7 days; The administration once a day of miconazole matched group, 50mg/, continuous 7 days; Continuous 7 days of blank group is irritated the normal saline volume with the oral matched group of terbinafine, respectively after administration 2,3,4,6,8 days, observe vaginal secretions, the mucosa injury recovery, and 2,3,4,6, carried out lavation in 8 days, each respectively organizes 3 of equal picked at random more than lavation day, with phosphate buffer (PBS) 100 μ L liquid lavation vaginas, put irrigating solution in cleaning sterile 1.5mL EP pipe earlier.Disconnected neck is put to death and is won its vagina tissue, is divided into two parts and places-70 ℃ of refrigerators to preserve, and stays and does histopathological examination.
Each organizes the irrigating solution smear for microscopic examination, observes mycelia and blastopore and generates situation, and contrasts before the administration.Other gets and respectively organizes irrigating solution 20 μ L and add among the PBS liquid 480 μ L and be mixed into diluent, is inoculated on the husky fort glucose agar medium, cultivates 48h for 30 ℃, and counting is respectively organized colony-forming units (cfu), and contrasts before the administration.Histopathological examination: get and respectively organize vagina tissue and carry out paraffin embedding, 0.4 μ m section, PAS dyeing is also taken pictures, and contrasts before the administration.
Different time points mouse vagina irrigating solution fungus carrying capacity after each group group administration (* 104cfu, x ± s)
Compare * P＜0.05, * * P＜0.01, * * * P＜0.001 with blank group (D group)
With positive controls (C group) comparison ▲ P＜0.05, △ P＜0.01, ★ P〉0.05
Last table as seen, miconazole nitrate film high and low dose treatment group with but the miconazole matched group all can obviously reduce mouse vagina irrigating solution fungus carrying capacity, relatively there were significant differences with the blank group.Compare with the miconazole matched group, the fungus carrying capacity of miconazole nitrate film high and low dose group and its all do not have significant difference, and wherein high dose group and miconazole group are more approaching.Simultaneously: find in the irrigating solution smear for microscopic examination: A, B, the mycelia that C is three groups and blastopore compare before generating situation and administration, and minimizing is in various degree all arranged, and that the D group changes is little.Histopathological examination shows: medication is after 6 days, A, and B, the mycelia of three groups of vaginal mucosa tissues of C adheres to, the intrusion situation disappears or reduce, and the inflammatory cell infiltration number vaginal mucosa and mucosa under reduces, and the D group is slightly increase then.
Conclusion: prove that by above effect experiment preparation of the present invention has therapeutical effect preferably to monilial vaginitis, on the improvement of symptom and fungus clearance rate, identical curative effect is arranged with miconazole.
Claims (9)
1, a kind of miconazole nitrate film that is used for the treatment of the female genital fungal infection is characterized in that it is made by following materials of weight proportions:
Miconazole nitrate, filmogen, plasticizer, film material lytic agent and antiseptic are 1:3～9:1.5～4:24～43:0.0002～0.02 by weight.
2, miconazole nitrate film according to claim 1 is characterized in that described filmogen is a kind of in polyvinyl alcohol, chitosan hydrochlorate, alginic acid, Arabic gelatin, Lac, guar gum, agar or the sodium cellulosate.
3, miconazole nitrate film according to claim 1 is characterized in that described plasticizer is a multicomponent alcoholics compound.
4, miconazole nitrate film according to claim 1 is characterized in that described film material lytic agent is dehydrated alcohol or distilled water.
5, miconazole nitrate film according to claim 1 is characterized in that described antiseptic is a kind of in ethyl hydroxybenzoate, benzyl alcohol or the benzoic acid.
6, miconazole nitrate film according to claim 3 is characterized in that described multicomponent alcoholics compound is a kind of in glycerol, propylene glycol or the Macrogol 600.
7, a kind of method for preparing the described miconazole nitrate film of claim 1 is characterized in that preparation process is as follows:
The first step: it is an amount of to get filmogen blooming material lytic agent, and the back that stirs is placed fully and expanded, and is standby;
Second step: will make its dissolving in the film material lytic agent adding miconazole nitrate, and add the plasticizer stirring again and make its clarification, standby;
The 3rd goes on foot: the filmogen after the first step is expanded is put in the water-bath and heated, and adds an amount of plasticizer and antiseptic and stirs, and is standby;
The 4th step: dissolved principal agent of second step is added in the 3rd film material that obtain of step, put in the water-bath heating and stir, above-mentioned medicine slurry evenly is laid on the glass plate dry back film forming with the scraper plate method.
8, preparation method according to claim 7 is characterized in that in the 4th step with 70 ℃ of forced air drying 5-10min.
9, the application of miconazole nitrate film as claimed in claim 1 in preparation treatment female genital fungal infection medicine.
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| CNA2008102431976A CN101422448A (en) | 2008-12-10 | 2008-12-10 | Miconazole nitrate film and preparation method and pharmacy use thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106266037A (en) * | 2016-08-19 | 2017-01-04 | 吉安市御美丽健康产业股份有限公司 | A kind of liquid gel and preparation method thereof |
| CN111329846A (en) * | 2020-04-24 | 2020-06-26 | 云南伦扬科技有限公司 | Vaginal sterilization adhesive film and preparation method thereof |
-
2008
- 2008-12-10 CN CNA2008102431976A patent/CN101422448A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106266037A (en) * | 2016-08-19 | 2017-01-04 | 吉安市御美丽健康产业股份有限公司 | A kind of liquid gel and preparation method thereof |
| CN106266037B (en) * | 2016-08-19 | 2020-09-29 | 吉安市御美丽健康产业股份有限公司 | Liquid gel and preparation method thereof |
| CN111329846A (en) * | 2020-04-24 | 2020-06-26 | 云南伦扬科技有限公司 | Vaginal sterilization adhesive film and preparation method thereof |
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