CN106580981A - Pharmaceutical composition for treating gynecologic inflammations as well as preparation method and application thereof - Google Patents
Pharmaceutical composition for treating gynecologic inflammations as well as preparation method and application thereof Download PDFInfo
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- fibrauretin
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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
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4412—Non condensed pyridines; Hydrogenated derivatives thereof having oxo groups directly attached to the heterocyclic ring
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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
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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
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/4353—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
- A61K31/4375—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a six-membered ring having nitrogen as a ring heteroatom, e.g. quinolizines, naphthyridines, berberine, vincamine
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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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
- A61K31/7056—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing five-membered rings with nitrogen as a ring hetero atom
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- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
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- 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
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- 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
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
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Abstract
The invention relates to a pharmaceutical composition for treating gynecologic inflammations. The pharmaceutical composition comprises ciclopirox olamine, palmatine and clindamycin or secnidazole serving as active pharmaceutical ingredients, wherein a synergistic effect is achieved among the three active pharmaceutical ingredients. The preferable preparation form of the pharmaceutical composition is gel. The product is uniform, fine and smooth in texture and appropriate in thickness. The pharmaceutical composition can be used for effectively treating mixed infectious diseases, particularly mixed infective vaginitis.
Description
Technical field
The invention belongs to pharmaceutical technology field, in particular it relates to a kind of pharmaceutical composition and its system for treating gynecological inflammation
Preparation Method and purposes.
Background technology
Gynecological inflammation is primarily referred to as a series of infection of female reproductive system appearance or non-infectious inflammation, modal woman
Section's inflammation includes vaginitiss, and cardinal symptom is pudendum and vagina itching, redness, pain, leucorrhoea grow in quantity, and patient's vulva prurituss are difficult
Bear, fall ill repeatedly after treatment, have a strong impact on women's work and sleep, endanger it physically and mentally healthy.
Gynecological inflammation problem is mainly subject to the invasion of four kinds of problems and is formed, and is respectively：Antibacterial, funguses, infusorian and disease
The infection of poison.Mixed infective vaginitis are most commonly seen vaginitiss, and in the regional prevalence of sanitary condition difference 70% is up to.
And staphylococcus aureuses, colon bacillus, Candida albicans, trichomonas vaginitises are the common pathogen of vagina.Have at present
Although the medicine of anti-infective effect is a lot, commonly single, drug, majority can only targetedly to anti-trichomonal, antibacterial
Or fungal infection, and some broad-spectrum antiseptics such as clotrimazole, miconazole, penicillin etc. are in the treatment to internal deep, external table
Shallow mixed infectious disease therapeutic effect is undesirable.Meanwhile, widely using for existing conventional treatment drug has caused one
A little pathogen produce drug resistance to it.If additionally, two kinds of medicines are used simultaneously together, not investigating them each other
Effect, easily causes untoward reaction or potential safety hazard.Research and development novel compound vagina preparation is accordingly, there exist, it is improved to mixing sense
The needs of the therapeutic effect of infectious diseases.
In addition, the medicine of existing gynecological inflammation mainly has suppository, unguentum, effervescent tablet etc., but there is therapeutic effect
Not good enough problem, main reason is that：Suppository will melt by body temperature, work slower；Unguentum is oleaginous base, affects skin to glue
The normal function of film, and it is little with the contact surface of mucosa, short in intravaginal effective time of staying, so as to affect the treatment；Effervescent tablet
Need to absorb moisture ability disintegrate, there is burn feeling to vagina drying patient, and drug residence time is short, drug absorption effect is poor.
Therefore, it is necessary to develop antiinflammatory, the antibacterials dosage form for being suitable for vagina administration.
The content of the invention
For the problem and shortage for overcoming existing treatment gynaecological inflammation disease to exist, the invention provides a kind of compounding is controlled
Treat the pharmaceutical composition of gynecological inflammation, particularly treat the pharmaceutical composition of gynecological mixed infectious disease, its pharmaceutically active into
/ there is synergistic function, to gynecological's mixed infectious disease clear curative effect, consumption is little, low cost, application are convenient, and
On the focus mucosa that homogeneous, fine and smooth, denseness is suitable, be easy to be coated on vagina, with especially excellent pharmaceutical property for example
Drug substance stable performance.
Technical scheme is as follows：
A kind of pharmaceutical composition for treating gynecological inflammation, it includes ciclopirox olamine and fibrauretin, and also comprising gram
Woods mycin or secnidazole.
In one embodiment, the mass ratio of ciclopirox olamine, fibrauretin and clindamycin or secnidazole is 10-1:
10-1: 1-10, preferred mass ratio is 5-1: 5-1: 1-5, and especially preferred mass ratio is 4-1: 4-1: 1-4, preferred matter
Amount, than being 2-1: 2-1: 1-2, can be 1: 1: 1,4: 1: 1,1: 4: 1,1: 1: 4,4: 4: 1,2: 2: 1 specifically.
When described pharmaceutical composition is prepared, as removing between three kinds of compositions of active constituents of medicine above-mentioned compounding is met
Outside proportionate relationship, the content in pharmaceutical composition can be controlled respectively in 0.1-10% (weight).In other words, every 100 weight portion
Pharmaceutical composition in, ciclopirox olamine 0.1-10 parts, fibrauretin 0.1-10 parts, clindamycin or secnidazole 0.1- can be included
10 parts, remaining is excipient substance.The content of each drug component can be preferably 0.2-2 part/100 weight portion, especially can be 0.2-1
Part/100 weight portions.
In one embodiment, the dosage form of described pharmaceutical composition is gel.
The composition of the gel can be ciclopirox olamine, fibrauretin, clindamycin or secnidazole, carbomer, sweet
Oil, shitosan, triethanolamine, Polyethylene Glycol, pH adjusting agent, purified water.
Wherein, described pH adjusting agent is or the combination in pH adjusting agent acid or in alkalescence；At one
In embodiment, described is selected from hydrochloric acid, phosphoric acid, nitric acid, lactic acid, acetic acid, citric acid, tartaric acid etc. in acid pH adjusting agent
Or its combination.In one embodiment, the described pH adjusting agent in alkalescence selected from sodium hydroxide, sodium carbonate, sodium bicarbonate,
Potassium hydroxide, sodium phosphate, potassium phosphate etc. or its combination.
In one embodiment, every 100 weight portion of the gel is included：
Another object of the present invention also resides in a kind of method for preparing described pharmaceutical composition of offer, and the preparation method is such as
Under：
A) by ciclopirox olamine, fibrauretin, clindamycin or secnidazole by weight crushing after mixing, sieving for standby；
B) by weight glycerol, Polyethylene Glycol, shitosan is added in the crushing medicine prepared in step a, stirring mixing is equal
It is even that to obtain mixture standby；
C) carbomer is mixed with the 60-80% of purification water inventory, places 2-3 days with fully naturally swelling, add three second
Hydramine stirs, and adds pH adjusting agent to adjust pH, makes substrate；
D) mixture in step b is added gradually in substrate made by step c under agitation, adds the purification of surplus
Water, makes gel；
E) to take and obtain gel products after the gel subpackage packaging that step d is obtained.
Another object of the present invention is also resided in and provides a kind of purposes of described pharmaceutical composition, and it is used to prepare anti-infective
Medicine.
In one embodiment, the infection is gynecological inflammation, particularly mixed infective vaginitis.
Ciclopirox olamine：Also known as ciclopiroxolamin, Loprox, business's famous-object：Loprox, is broad-spectrum antifungal medicine.Ring pyrrole
Ketoamine solution, emulsifiable paste (ointment) are used for treatment and are used for the tinea manuum, tinea pedis, tinea corporis, tinea cruris, tinea unguium and tinea versicolor, also can be used for skin
With vulvovaginal candida infection and tinea unguium.Vaginal ointment and vaginal suppository are used to treat fungoids (monilial) vagina
Disease.
Fibrauretin：Also known as Palmatine, Fibranine, hydrochloride Palmatine, Palmatine Hydrochloride, Palmatine, belong to clear
Pyrolysis poison, with the effect for strengthening leukocytes phagocytic ability.Can be used for treat gynecological inflammation, surgical infection, bacillary dysentery, enteritis,
The disease such as respiratory tract and urinary tract infection, eye conjunctivitis.
Clindamycin：Also known as clindamycin, it is Bacterioprotein biosynthesis inhibitor, with very strong antibacterial activity, clinically
It is mainly used in the microbial abdominal cavity of anaerobism and gynecological infection.
Secnidazole：Belong to 5- nitro glyoxaline compounds, clinically for treating various acute and chronic liver sausage amebiasiss
And the trichomoniasis such as urethra, vagina, male prostate.
Beneficial effect
The pharmaceutical composition of the present invention is by the broad-spectrum antiseptic component, antifungal component and antibacterial components/anti-trichomonal
The synergism of component, improves anti-infective therapy's effect, so as to solving that traditional gynecological inflammation drug treatment regimen is narrow, controlling
Treat thoroughly and easily recurrence and to mixed infection without remarkable result the shortcomings of.
The present inventor has found first：Ciclopirox olamine, fibrauretin and clindamycin, or ciclopirox olamine, fibrauretin and plug gram
Nitre azoles is made by a certain percentage compound preparation and is used, and when gynecological inflammation is treated, treats except being played by respective mechanism of action
Outside effect, it also produces each other synergistic function, can greatly improve antibacterial, antiinflammatory action, improves women's reproduction sense
The cure rate of dye, shortens treatment course, reduces toxicity, reduces medicine local irritant effect.Antibacterial activity in vitro test display, will
Ciclopirox olamine, fibrauretin and clindamycin are shared, or ciclopirox olamine, fibrauretin and secnidazole are shared increased medicine pair
Candida albicans, the antibacterial action of staphylococcus aureuses and range of application；Rat test shows, by ciclopirox olamine, fibrauretin
Share with clindamycin, or ciclopirox olamine, fibrauretin and secnidazole are shared can effectively improve mixed infection vagina
Scorching cure rate, the Shorten the Treatment Process time, and its relapse rate is reduced, toxic and side effects are low, safe and reliable.It can be seen that, ciclopirox olamine, Huang
Good synergism is shown between rattan element and clindamycin or secnidazole.
Additionally, this invention takes particular substrate supplementary product kind and ratio so that obtained gel is homogeneous, thin
On the focus mucosa that greasy, denseness is suitable, be easy to be coated on vagina, with especially excellent pharmaceutical property such as medicine stability
Energy.
Specific embodiment
The present invention is described below in more detail to contribute to the understanding of the present invention.
It should be appreciated that the term for using in the specification and in the claims or word be not construed as have
In dictionary limit implication, and be interpreted as on the basis of following principle have and its implication one in the context of the present invention
The implication of cause：The concept of term can suitably by inventor in order to the present invention best illustration and limit.
Test example 1：Antibacterial activity in vitro is tested
1.1 under test medicines
The raw material anhydrous alcohol for medical use of ciclopirox olamine, fibrauretin and clindamycin or secnidazole is prepared into 1% concentration, examination
The concentration of 50 μ g/ml is diluted to before testing with RPMI RPMI-1640s, later each pipe doubling dilution, concentration (μ g/ml).
1.2 study subject
Test bacterial strain uses therefor includes Candida albicans and staphylococcus aureuses.
1.3 result of the test
Table 1, ciclopirox olamine/fibrauretin/inhibition (μ of the clindamycin compound preparation (mass ratio) to Candida albicans
g/ml)
Note：Compared with ciclopirox olamine group, five kinds of ciclopirox olamine/fibrauretin/clindamycin compound preparations of the invention
MIC scopes, MIC50And MIC90P ＜ 0.01；Similar, compared with fibrauretin group and compared with clindamycin group, according to
Five kinds of ciclopirox olamine/fibrauretin/MIC scopes of clindamycin compound preparation, MIC of the present invention50And MIC90P ＜ 0.01
Suppression of the table 2, ciclopirox olamine/fibrauretin/clindamycin compound preparation (mass ratio) to staphylococcus aureuses is imitated
Really (μ g/ml)
Note：Compared with ciclopirox olamine group, five kinds of ciclopirox olamine/fibrauretin/clindamycin compound preparations of the invention
MIC scopes, MIC50And MIC90P ＜ 0.01；Similar, compared with fibrauretin group and compared with clindamycin group, according to
Five kinds of ciclopirox olamine/fibrauretin/MIC scopes of clindamycin compound preparation, MIC of the present invention50And MIC90P ＜ 0.01
Table 3, ciclopirox olamine/fibrauretin/inhibition (μ of the secnidazole compound preparation (mass ratio) to Candida albicans
g/ml)
Note：Compared with ciclopirox olamine group, five kinds of ciclopirox olamine/fibrauretin/secnidazole compound preparations of the invention
MIC scopes, MIC50And MIC90P ＜ 0.01；It is similar, compared with fibrauretin group and secnidazole group is compared, according to this
Five kinds of ciclopirox olamine/fibrauretin/MIC scopes of secnidazole compound preparation, MIC of invention50And MIC90P ＜ 0.01
Suppression of the table 4, ciclopirox olamine/fibrauretin/secnidazole compound preparation (mass ratio) to staphylococcus aureuses is imitated
Really (μ g/ml)
Note：Compared with ciclopirox olamine group, five kinds of ciclopirox olamine/fibrauretin/secnidazole compound preparations of the invention
MIC scopes, MIC50And MIC90P ＜ 0.01；It is similar, compared with fibrauretin group and secnidazole group is compared, according to this
Five kinds of ciclopirox olamine/fibrauretin/MIC scopes of secnidazole compound preparation, MIC of invention50And MIC90P ＜ 0.01
From table 1- tables 4, ciclopirox olamine/fibrauretin/clindamycin or secnidazole (1: 1: 1,4: 1: 1,1: 4: 1,1:
1: 4,4: 4: the external antifungal of compound preparation 1), bacterial activity and ciclopirox olamine, fibrauretin, clindamycin, secnidazole
Folk prescription medicine more has the raising of significance degree.Wherein, ciclopirox olamine/fibrauretin/clindamycin compound preparation suppresses white to read
Activity (the MIC of pearl bacterium50) be folk prescription medicine 3-44 times (p ＜ 0.01), suppress staphylococcus aureuses activity (MIC50) it is single
3-13 times (p ＜ 0.01) of square medicine；Ciclopirox olamine/fibrauretin/secnidazole compound preparation suppresses the activity of Candida albicans
(MIC50) be folk prescription medicine 3-20 times (p ＜ 0.01), suppress staphylococcus aureuses activity (MICs0) be folk prescription medicine 2-9
Again (p ＜ 0.01)；In all of compound preparation, the weight ratio of ciclopirox olamine, fibrauretin, clindamycin or secnidazole is 1:
Fungistatic effect when 1: 1 is best.The above results show the compound preparation of ciclopirox olamine/fibrauretin/clindamycin or secnidazole
With folk prescription medicine phases ratio, in terms of funguses and antibacterial is suppressed, the effect of Synergistic is achieved.
Test example 2：Treatment to rat vagina mixed infection
2.1 test medicine
Embodiment group：(weight compares 1: 1: 1 to ciclopirox olamine/fibrauretin/clindamycin compound gel agent, drug level 0.25-
1%), ciclopirox olamine/fibrauretin/secnidazole compound gel (weight compares 1: 1: 1, drug level 0.25-1%), 1%- is high
Dosage group, 0.5%- middle dose groups, 0.25%- low dose groups.
Matched group：Including ciclopirox olamine, fibrauretin, clindamycin, secnidazole folk prescription medicine group, metronidazole,clotrimazole and chlorhexidine acetate suppositorieses positive drug
Group, drug level is 1%, and blank control group then adopts adjuvant.
The general preparative methods of gel：
A) by active constituents of medicine by weight crushing after mixing, sieving for standby；
B) 20g glycerol, 4g Polyethylene Glycol, 0.8g shitosans are added in the crushing medicine prepared in step a, stirring mixing is equal
It is even that to obtain mixture standby；
C) 2g carbomers are mixed with the 60-80% of purification water inventory, places 2-3 days with fully naturally swelling, added
1.5g triethanolamine stirs, and adds pH adjusting agent to adjust pH to 5-6, makes substrate；
D) mixture in step b is added gradually in substrate made by step c under agitation, adds the purification of surplus
It is 100g that water causes the total amount of preparation, makes gel；
E) to take and obtain gel products after the gel subpackage packaging that step d is obtained.
2.2 study subject：180 female rat, 0.235～0.260kg of body weight.
2.3 method of testing
Vagina mixed infection is carried out to rat with Candida albicans, staphylococcus aureuses, trichomonas vaginitises, will be made with cotton balls
Standby Candida albicans bacteria suspension (104Cfu/ml), staphylococcus aureuses suspension (106) and trichomonas vaginitises suspension is each cfu/ml
0.4ml applies vagina, once a day, continuous 2 days.Infection takes rat vagina secretions pathogenic examination after 3-5 days be chronic, and
On naked eyes and histopathologic examination there is hyperemia, edema, bleeding or infiltration person to infect successfully in mucosa.By the rat of infection
Random GP TH.
2.4 result
After infection 7 days (before treatment) and treatment after 3,7 and 14 days, taking animal secretions carries out pathogen culture and mirror
Inspection, is compared by pathogen culture and microscopy animals showing positive number with matched group, folk prescription medicine group, metronidazole,clotrimazole and chlorhexidine acetate suppositorieses positive drug group, is as a result seen
Table 5.It is the positive when there are one or more pathogenic growths, is feminine gender during asepsis growth.
Table 5
Note：Compare with folk prescription medicine*P ＜ 0.05,**P ＜ 0.01；Compare with positive controlaP ＜ 0.05,bP ＜ 0.01
From the pathogen culture result of table 5, ciclopirox olamine/fibrauretin/clindamycin or secnidazole drug level
0.25-1% has certain therapeutical effect to rat vagina funguses, antibacterial and infusorian mixed infection, and its pathogen culture is turned out cloudy animal
Number increases with dosage and increases, and shows good dose-effect relationship.Compare with folk prescription medicine group with metronidazole,clotrimazole and chlorhexidine acetate suppositorieses positive drug group,
The number of turning out cloudy of high, middle dose group is significantly improved (p ＜ 0.05-0.01), turn out cloudy number of the low dose group after treating 7,14 days
It is also obviously improved.The above results show that ciclopirox olamine/fibrauretin/clindamycin or secnidazole compound gel are for mixed
Close infective vaginitis and there is excellent curative effect, and with folk prescription medicine phases ratio, achieve the effect of Synergistic.
Test example 3：Anxious poison research and long term toxicity research
3.1 anxious poison researchs
Test medicine：With the embodiment group of embodiment 2.
Study subject：50 female rat, 0.235～0.260kg of body weight.
Tested scheme：Test medicine was administered respectively according to high, medium and low three dosage in 7 days after infection, is observed 7 days.It is main
Observation index is wanted to be the activity of animal, feed, defecation, fur, vagina outward appearance, whether there is edema, hyperemia, ulceration and secretions whether there is
It is abnormal etc..
Cervical dislocation puts to death rat after last dose, and dissecting pelvic cavity perusal reproductive system and surrounding tissue organ has
Without abnormal phenomenas such as edema, hyperemia, erosions；Dissect vagina perusal vaginal walls color, edema, hyperemia, erosion, ulcer etc.
ANOMALOUS VARIATIONS；Winning Some Animals vagina carries out pathological section.
As a result during finding administration and observing, subject body weight, breathing, heart rate Non Apparent Abnormality, activity, feed, row
Just wait without exception.Vaginal anatomy perusal is shown without the abnormal phenomena such as congested, swelling and surrounding tissue adhesion, also without exception
Pathological change.Anatomic observation kidney, liver all goes well, and does not exist abnormal or damages.
3.2 long term toxicities are studied
Test medicine：Ibid
Study subject：Ibid
Tested scheme：Test medicine was administered respectively according to high, medium and low three dosage in 7 days after infection, Continuous Observation 30
My god.
As a result show that study subject whole body and vagina local are showed no toxic reaction and local irritation；Section film-making shows
Micro mirror observation also has no pathological change, shows that three dosage group medicines do not have pathogenic effects to each layer of vagina.
In sum, ciclopirox olamine/fibrauretin/clindamycin of the invention or secnidazole compound gel are being controlled
Treat than each curative effect of medication is used alone significantly on mixed infective vaginitis, and it is safe and reliable.
The preferred embodiment for the present invention is the foregoing described, so it is not limited to the present invention.Those skilled in the art couple
Embodiment disclosed herein can carry out the improvement and change without departing from scope and spirit.
Claims (10)
1. a kind of pharmaceutical composition for treating gynecological inflammation, it includes ciclopirox olamine and fibrauretin, and also comprising crin
Mycin or secnidazole.
2. pharmaceutical composition according to claim 1, it is characterised in that the ciclopirox olamine, fibrauretin and clindamycin
Or the mass ratio of secnidazole is 10-1: 10-1: 1-10, preferred mass ratio is 5-1: 5-1: 1-5, especially preferred quality
Than for 4-1: 4-1: 1-4, preferred mass ratio is 2-1: 2-1: 1-2, can be 1: 1: 1,4: 1: 1,1: 4: 1,1 specifically:
1∶4、4∶4∶1、2∶2∶1。
3. pharmaceutical composition according to claim 1, it is characterised in that the ciclopirox olamine, fibrauretin and clindamycin
Or gross weight content of the secnidazole in described pharmaceutical composition is 0.1-10%.
4. the pharmaceutical composition according to any one of claim 1-3, it is characterised in that the preparation of described pharmaceutical composition
Form is gel.
5. pharmaceutical composition according to claim 4, it is characterised in that the composition of the gel include ciclopirox olamine,
It is fibrauretin, clindamycin or secnidazole, carbomer, glycerol, shitosan, triethanolamine, Polyethylene Glycol, pH adjusting agent, pure
Change water.
6. pharmaceutical composition according to claim 5, it is characterised in that the pH adjusting agent is in acid or in alkalescence
PH adjusting agent, or combination.
7. the pharmaceutical composition according to any one of claim 4-6, it is characterised in that every 100 weight of the gel
Part includes：
8. a kind of method of the pharmaceutical composition prepared according to any one of claim 5-7, the preparation method is as follows：
A) by ciclopirox olamine, fibrauretin, clindamycin or secnidazole by weight crushing after mixing, sieving for standby；
B) it is uniformly mixed by weight glycerol, Polyethylene Glycol, shitosan is added in the crushing medicine prepared in step a
It is standby to mixture；
C) carbomer is mixed with the 60-80% of purification water inventory, places 2-3 days with fully naturally swelling, add triethanolamine
Stir, add pH adjusting agent to adjust pH, make substrate；
D) mixture in step b is added gradually in substrate made by step c under agitation, adds the purified water of surplus,
Make gel；
E) to take and obtain gel products after the gel subpackage packaging that step d is obtained.
9. the purposes of the pharmaceutical composition according to any one of claim 1-7, it is characterised in that it is used to prepare anti-sense
The medicine of dye.
10. purposes according to claim 9, it is characterised in that the infection is gynecological inflammation, particularly mixed infection
Vaginitiss.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710062523.2A CN106580981B (en) | 2017-01-23 | 2017-01-23 | A kind of pharmaceutical composition and its preparation method and application for treating gynaecological imflammation |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN201710062523.2A CN106580981B (en) | 2017-01-23 | 2017-01-23 | A kind of pharmaceutical composition and its preparation method and application for treating gynaecological imflammation |
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| CN101116656A (en) * | 2006-08-03 | 2008-02-06 | 上海汇伦生命科技有限公司 | Ciclopirox olamine gelling agent, method for preparing the same and pharmaceutical use thereof |
| CN101721353A (en) * | 2009-07-08 | 2010-06-09 | 济南宏瑞创博医药科技开发有限公司 | Stable thermosensitive gelatin composite |
| CN101744833A (en) * | 2008-12-02 | 2010-06-23 | 济南宏瑞创博医药科技开发有限公司 | Medicinal composition for treating bacterial vaginitis |
| CN103040728A (en) * | 2013-02-03 | 2013-04-17 | 福州乾正药业有限公司 | Chitosan gel for women as well as preparation method and medical application thereof |
| CN104546690A (en) * | 2015-01-07 | 2015-04-29 | 北京紫光制药有限公司 | Medicine composition containing palmatine |
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Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101116656A (en) * | 2006-08-03 | 2008-02-06 | 上海汇伦生命科技有限公司 | Ciclopirox olamine gelling agent, method for preparing the same and pharmaceutical use thereof |
| CN101744833A (en) * | 2008-12-02 | 2010-06-23 | 济南宏瑞创博医药科技开发有限公司 | Medicinal composition for treating bacterial vaginitis |
| CN101721353A (en) * | 2009-07-08 | 2010-06-09 | 济南宏瑞创博医药科技开发有限公司 | Stable thermosensitive gelatin composite |
| CN103040728A (en) * | 2013-02-03 | 2013-04-17 | 福州乾正药业有限公司 | Chitosan gel for women as well as preparation method and medical application thereof |
| CN104546690A (en) * | 2015-01-07 | 2015-04-29 | 北京紫光制药有限公司 | Medicine composition containing palmatine |
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