CN108210448A - Fenticonazole nitrate suppository and its application - Google Patents
Fenticonazole nitrate suppository and its application Download PDFInfo
- Publication number
- CN108210448A CN108210448A CN201810310045.7A CN201810310045A CN108210448A CN 108210448 A CN108210448 A CN 108210448A CN 201810310045 A CN201810310045 A CN 201810310045A CN 108210448 A CN108210448 A CN 108210448A
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- CN
- China
- Prior art keywords
- fenticonazole nitrate
- parts
- powder
- mixed
- suppository
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4164—1,3-Diazoles
- A61K31/4174—Arylalkylimidazoles, e.g. oxymetazolin, naphazoline, miconazole
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/75—Rutaceae (Rue family)
- A61K36/752—Citrus, e.g. lime, orange or lemon
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0034—Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/02—Suppositories; Bougies; Bases therefor; Ovules
Abstract
The invention belongs to pharmaceutical technology fields, disclose a kind of fenticonazole nitrate suppository, are prepared according to following technique：Fenticonazole nitrate is sieved with 100 mesh sieve, takes sieve powder；Prepare dried orange peel extracts；780 parts of 100 parts of fenticonazole nitrate powder, 30 parts of dried orange peel extracts, 90 parts of lanolin and mixed fatty glycerides are weighed in mass ratio；Lanolin and mixed fatty glycerides are uniformly mixed, addition fenticonazole nitrate powder ground and mixed is uniform after being heated to 45 DEG C of fusings；It is cooled to 38 DEG C to be poured into the bolt mould for being coated with lubricant, the outer redundance of mould be scraped off after solidifying, suppository is made in depanning.
Description
Technical field
The invention belongs to pharmaceutical technology fields, and in particular to fenticonazole nitrate suppository and its application.
Background technology
Fenticonazole nitrate, English language Chemical name: 1-[2-(2,4-dichlorophenyl)-2-[[4-(phenylthio)
phenyl] methoxy] ethyl- 1H-imidazole mononitrate.Chinese chemical name:1- [2- (2,4 dichloro benzenes
Base) -2- [[4- (benzene is thio) phenyl] methoxyl group] ethyl -1H- imidazole nitrates；Molecular formula is C24H20Cl2N2OSHNO3.
The suppository of fenticonazole nitrate, according to《Drug registration management method》Pertinent regulations, this product belong to chemicals
3.1 class.It is write according to Chinese Pharmacopoeia Commission《Chinese adopted drug name》This product is named as " nitric acid sweet smell by nomenclature principle
Ticonazole bolt ".Fenticonazole nitrate (Fenticonazole Nitrate, LomexinTM) it is the big medicines of Italy RECORDATI
The imidazoles broad-spectrum antifungal medicine of factory's genuine exploitation, for treating superficial mycosis and vaginal Candida infection.The medicine was in 1986
It goes through to list in Italy, dosage form has cream, spray and vaginal suppository.Its mechanism of action is by inhibiting fungi thin
The hydroxylation of the cytochrome P-450 of born of the same parents makes the Phospholipids of its cell wall unstable state be presented, and then make fungal cell
Rupture and necrosis, therefore, fenticonazole nitrate not only have the bacteriostasis of general antifungal agent, more can reach the effect of sterilization
Fruit, thus it is low using the antimycotic recurrence rate of fenticonazole nitrate.
Fenticonazole nitrate has a broad antifungal spectrum to dermatophyte, saccharomycete and causes other fungies of dermatomycosis to have
Effect, there is bacteriostasis in low concentration, and there is bactericidal effect in when high concentration.It can be clinically used for treatment baldness tinea, tinea glabrosa, jock itch, foot
Tinea, the tinea manuum, face tinea, tinea capitis, onychomycosis bacterium, the monilial infection (monilial infection of perineum and scrotum) of reproductive organs, face tinea,
Intertrigo ani, beads cheilisis, onychia and paronychia etc..Fenticonazole nitrate vaginal preparation for treating vulvovaginal candida
Disease, it is only necessary to which 1~3 day drug treatment phase can reach 92% curative effect once a day, be that similar product is incomparable.
The fungal infection of the mankind can be divided into 3 kinds：Superficial mycoses, deep mycosis and systemic mycoses (Systemic
Fungal Infection).Most serious, can the fungal infection of threat to life be systemic mycoses.Systemic mycoses are invaded
Violate internal organs and blood skeletal system, harmfulness is very big, and prognostic capabilities are very poor, and case fatality rate is high.In recent years, with wide spectrum
Commonly used and AIDS the sprawling of antimicrobial, glucocorticoid and immunosuppressor, various Catheter Interventional Therapies so that
Systemic fungal infection increases severely.Only 1979~2000 years fungal septicemias in the U.S. increase 20.7%, relevant statistics money
Material shows that China's systemic fungal infection rate rises 40 times.Domestic whole body antifungal drug market was in continuous over the past two years
The trend of growth, the consumption sum of the whole body antifungal drug of 2004 increase to 2 times of 1999.Antifungal drug is complete
The 3rd is arranged in ball anti-infectious agent market, total sales volume is about 40~4,200,000,000 dollars.Fenticonazole nitrate is systemic fungal
Disease antifungal drug, suitable for vagina candidiasis infection (by candidal infection), and vagina is read
The infection of pearl bacterium disease greatly compromises the health of women, and candida albicans may be present in the skin of normal person, mucous membrane (such as oral cavity, the moon
Road), in alimentary canal and other organs, the candida albicans at above-mentioned position can mutual phase transmission.The normal women vagina of about 10%-20%
Inside there is a small amount of Candida albicans, but do not cause symptom.When vaginal epithelial cell glycogen increases, genital tract resistance reduces, machine
During body flora imbalance, candida albicans, which can breed rapidly, causes inflammation, various symptoms occurs, thus be common in pregnant woman, diabetic and
Receive patient and prolonged application broad-spectrum antibiotic, the corticosteroid hormone and immunosuppressor person of estrin treatment.Chinese mugwort
It grows patient and monilial infection also easily occurs.And medication amount currently on the market for this disease is less and effect is general, nitric acid
The listing of Fenticonazole bolt not only it is benefited for patient, can also bring incomparable economic benefit to society.
It is very inconvenient since injection patient must often go hospital's ability medication, and oral preparation is long due to medication time
And amount is more, easily causes patient's digestive discomfort and the toxic side effect of other systemic administrations.And fenticonazole nitrate bolt uses vagina
Approach administration can avoid the first pass effect of liver and easy to use, more applicable for drying property vaginitis patient.
Invention content
The object of the present invention is to provide a kind of fenticonazole nitrate suppository and its applications.
The present invention is achieved by the following technical solution：
A kind of fenticonazole nitrate suppository is prepared according to following technique：
1), fenticonazole nitrate is sieved with 100 mesh sieve, takes sieve powder；
2) dried orange peel, is taken, is crushed, 200 mesh sieve is crossed, obtains tangerine peel powder, be placed in reaction kettle, then add the 85% of five times of weight
Three times, each 6h is then combined with leaching liquor three times to alcohol steep, is concentrated under reduced pressure into no alcohol, and last frozen drying crushes,
It sieves with 100 mesh sieve, obtains dried orange peel extracts；
3）It is sweet that 100 parts of fenticonazole nitrate powder, 30 parts of dried orange peel extracts, 90 parts of lanolin and fatty acid mixed are weighed in mass ratio
780 parts of grease；
4), lanolin and mixed fatty glycerides are uniformly mixed, fenticonazole nitrate powder is added in after being heated to 45 DEG C of fusings
Ground and mixed is uniform；
5) 38 DEG C, are cooled to be poured into the bolt mould for being coated with lubricant, the outer redundance of mould is scraped off after solidifying, bolt is made in depanning
Agent.
The invention also discloses application of the suppository in vaginitis is treated.
Specific embodiment
In order to make those skilled in the art better understand the technical solutions in the application, have below in conjunction with the application
Body embodiment more clearly and completely describes the present invention, it is clear that described embodiment is only the application one
Divide embodiment, instead of all the embodiments.Based on the embodiment in the application, those of ordinary skill in the art are not making
All other embodiments obtained under the premise of creative work should all belong to the scope of protection of the invention.
Embodiment 1
A kind of fenticonazole nitrate suppository is prepared according to following technique：
1), fenticonazole nitrate is sieved with 100 mesh sieve, takes sieve powder；
2) dried orange peel, is taken, is crushed, 200 mesh sieve is crossed, obtains tangerine peel powder, be placed in reaction kettle, then add the 85% of five times of weight
Three times, each 6h is then combined with leaching liquor three times to alcohol steep, is concentrated under reduced pressure into no alcohol, and last frozen drying crushes,
It sieves with 100 mesh sieve, obtains dried orange peel extracts；
3）It is sweet that 100 parts of fenticonazole nitrate powder, 30 parts of dried orange peel extracts, 90 parts of lanolin and fatty acid mixed are weighed in mass ratio
780 parts of grease；
4), lanolin and mixed fatty glycerides are uniformly mixed, fenticonazole nitrate powder is added in after being heated to 45 DEG C of fusings
Ground and mixed is uniform；
5) 38 DEG C, are cooled to be poured into the bolt mould for being coated with lubricant, the outer redundance of mould is scraped off after solidifying, bolt is made in depanning
Agent.
Comparative example 1
A kind of fenticonazole nitrate suppository is prepared according to following technique：
1), fenticonazole nitrate is sieved with 100 mesh sieve, takes sieve powder；
2) 780 parts of 130 parts of fenticonazole nitrate powder, 90 parts of lanolin and mixed fatty glycerides, are weighed in mass ratio；
3), lanolin and mixed fatty glycerides are uniformly mixed, fenticonazole nitrate powder is added in after being heated to 45 DEG C of fusings
Ground and mixed is uniform；
4) 38 DEG C, are cooled to be poured into the bolt mould for being coated with lubricant, the outer redundance of mould is scraped off after solidifying, bolt is made in depanning
Agent.
Mouse experiment shows that the effect of embodiment 1 and comparative example 1 is not significantly different.
Embodiment 2, quality standard
【Character】Fenticonazole nitrate suppository is off-white color to yellowish bolt.
【Differentiate】In the chromatogram recorded under assay item, the retention time of test solution main peak should be with reference substance
The retention time of solution main peak is consistent.
【It checks】Related substance takes this product, and chopping takes appropriate (being approximately equivalent to fenticonazole nitrate 10mg), accurately weighed,
It puts in 50ml measuring bottles, add flowing phased soln and is diluted to scale, shake up, filter, take subsequent filtrate as test solution；It is accurate
1ml is measured, puts in 200ml measuring bottles, mobile phase is added to be diluted to scale, shake up, as contrast solution (a), it is molten that precision measures control
Liquid (a) 10ml puts in 25ml measuring bottles, mobile phase is added to be diluted to scale, shakes up, and as contrast solution (b), precision measures control
Solution (a) 1ml puts in 10ml measuring bottles, mobile phase is added to be diluted to scale, shakes up, and as contrast solution (c), precision measures control
Solution (a) 1ml puts in 100ml measuring bottles, mobile phase is added to be diluted to scale, shakes up, as contrast solution (d), according to assay
Chromatographic condition under takes 20 μ l of contrast solution (b), injects liquid chromatograph, adjusts detection sensitivity, makes principal component chromatography
The peak height at peak is about the 10% of full scale；Contrast solution (c) and (d) each 20 μ l are taken respectively, are injected separately into liquid chromatograph, it is right
It should be able to be detected according to solution (d), contrast solution (c) signal-to-noise ratio should be greater than 5, then accurate measurement test solution and contrast solution (a)
Each 20 μ l, are injected separately into liquid chromatograph, 5.5 times of record chromatogram to principal component peak retention time.The color of test solution
If any impurity peaks (in addition to nitric acid peak) in spectrogram, single impurity peak area is not greater than contrast solution (a) main peak area
(0.5%).Each impurity peak area is not greater than 2 times (1.0%) of contrast solution (a) main peak area.Less than contrast solution (c)
The chromatographic peak of main peak area can be neglected.
Microbial limit takes test sample 10g, puts in sterilizing conical flask, adds in appropriate pH7.0 sterile NaCls-peptone
Buffer solution puts 45 DEG C of water-baths heat preservation 10min, adds in sterile polyoxyethylene sorbitan monoleate 8ml, and shaking is allowed to emulsify, then add pH7.0 without
Bacterium sodium chloride-peptone buffer agent to 100ml, shakes up, as 1: 10 test liquid.1: 10 test liquid 10ml is taken to add in
In sterile NaCl-peptone buffer agent of 100mlpH7.0, after membrane-filter procedure processing, with the peptone of 800ml0.1%
Aqueous solution rinses filter membrane, and point 8 flushings, each 100ml, according to microbial decolorization, (China's coastal port two is attached
Record XI J) membrane-filter procedure is checked under check item, regulation should be met.
Other should meet every regulation (two annex I D of China's coastal port) related under suppository item.
【Assay】
It is measured according to high performance liquid chromatography (two annex V D of China's coastal port).
Chromatographic condition is filler with octadecylsilane chemically bonded silica with system suitability；With acetonitrile-phosphate
Buffer solution (takes potassium dihydrogen phosphate 3.4g, is dissolved in water and is diluted to 1000ml, add triethylamine 10ml, with phosphorus acid for adjusting pH value extremely
3.0) (70: 30) are mobile phase；Detection wavelength is 229nm.Number of theoretical plate is calculated by Fenticonazole peak not less than 2000.
Measuring method takes this product 10, accurately weighed, and chopping makes to be uniformly mixed, and precision weighs (is approximately equivalent to nitric acid sweet smell in right amount
Ticonazole 10mg), it puts in 50ml measuring bottles, adds flowing phased soln and be diluted to scale, shake up, filter, precision measures subsequent filtrate
5ml is put in 25ml measuring bottles, is diluted to scale with mobile phase, is shaken up, and precision measures 20 μ l, injects liquid chromatograph, records chromatography
Figure；Separately take fenticonazole nitrate reference substance appropriate, it is accurately weighed, it is measured in the same method.By external standard method with calculated by peak area to get.
Above-mentioned data have carried out the specific embodiment of the present invention detailed description, but not to the limit of the scope of the present invention
System, those skilled in the art should understand that, based on the technical solutions of the present invention, those skilled in the art do not need to pay
Go out various modifications or changes that creative work can be made still within protection scope of the present invention.
Claims (2)
1. a kind of fenticonazole nitrate suppository is prepared according to following technique：
1), fenticonazole nitrate is sieved with 100 mesh sieve, takes sieve powder；
2) dried orange peel, is taken, is crushed, 200 mesh sieve is crossed, obtains tangerine peel powder, be placed in reaction kettle, then add the 85% of five times of weight
Three times, each 6h is then combined with leaching liquor three times to alcohol steep, is concentrated under reduced pressure into no alcohol, and last frozen drying crushes,
It sieves with 100 mesh sieve, obtains dried orange peel extracts；
3）It is sweet that 100 parts of fenticonazole nitrate powder, 30 parts of dried orange peel extracts, 90 parts of lanolin and fatty acid mixed are weighed in mass ratio
780 parts of grease；
4), lanolin and mixed fatty glycerides are uniformly mixed, fenticonazole nitrate powder is added in after being heated to 45 DEG C of fusings
Ground and mixed is uniform；
5) 38 DEG C, are cooled to be poured into the bolt mould for being coated with lubricant, the outer redundance of mould is scraped off after solidifying, bolt is made in depanning
Agent.
2. application of the suppository described in claim in vaginitis is treated.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810310045.7A CN108210448A (en) | 2018-04-09 | 2018-04-09 | Fenticonazole nitrate suppository and its application |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810310045.7A CN108210448A (en) | 2018-04-09 | 2018-04-09 | Fenticonazole nitrate suppository and its application |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN108210448A true CN108210448A (en) | 2018-06-29 |
Family
ID=62658002
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201810310045.7A Pending CN108210448A (en) | 2018-04-09 | 2018-04-09 | Fenticonazole nitrate suppository and its application |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN108210448A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP4096655A4 (en) * | 2020-01-31 | 2024-02-28 | Exeltis Ilac Sanayii Ve Ticaret Anonim Sirketi | Pharmaceutical composition suitable for vaginal delivery |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2010079373A1 (en) * | 2009-01-09 | 2010-07-15 | EGIS GYOGYSZERGYAR, Nyilvánosan, Müködö | Improved pharmaceutical formulation |
| CN101933895A (en) * | 2009-06-30 | 2011-01-05 | 严洁 | Fenticonazole nitrate vaginal suppository composition |
| CN102028652A (en) * | 2010-11-29 | 2011-04-27 | 林凡友 | Method for preparing fenticonazole nitrate suppository |
-
2018
- 2018-04-09 CN CN201810310045.7A patent/CN108210448A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2010079373A1 (en) * | 2009-01-09 | 2010-07-15 | EGIS GYOGYSZERGYAR, Nyilvánosan, Müködö | Improved pharmaceutical formulation |
| CN101933895A (en) * | 2009-06-30 | 2011-01-05 | 严洁 | Fenticonazole nitrate vaginal suppository composition |
| CN102028652A (en) * | 2010-11-29 | 2011-04-27 | 林凡友 | Method for preparing fenticonazole nitrate suppository |
Non-Patent Citations (2)
| Title |
|---|
| 李晓芳等: "陈皮的研究进展", 《江西中医药》 * |
| 郭力等: "《中药化学 供中药学、药学及相关专业使用》", 31 August 2015, 北京：中国医药科技出版社 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP4096655A4 (en) * | 2020-01-31 | 2024-02-28 | Exeltis Ilac Sanayii Ve Ticaret Anonim Sirketi | Pharmaceutical composition suitable for vaginal delivery |
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Application publication date: 20180629 |