CN108354952A - Vagina infusion and its mixing arrangement set group and application method - Google Patents
Vagina infusion and its mixing arrangement set group and application method Download PDFInfo
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- CN108354952A CN108354952A CN201810027429.8A CN201810027429A CN108354952A CN 108354952 A CN108354952 A CN 108354952A CN 201810027429 A CN201810027429 A CN 201810027429A CN 108354952 A CN108354952 A CN 108354952A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/66—Microorganisms or materials therefrom
- A61K35/74—Bacteria
- A61K35/741—Probiotics
- A61K35/744—Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
- A61K35/747—Lactobacilli, e.g. L. acidophilus or L. brevis
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/66—Microorganisms or materials therefrom
- A61K35/74—Bacteria
- A61K35/741—Probiotics
- A61K35/744—Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
- A61K35/745—Bifidobacteria
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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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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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
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2210/00—Anatomical parts of the body
- A61M2210/005—Anatomical parts of the body used as an access side to the body
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2210/00—Anatomical parts of the body
- A61M2210/14—Female reproductive, genital organs
- A61M2210/1475—Vagina
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- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Abstract
For the present invention about a kind of vagina infusion and its mixing arrangement set group and application method, medial vagina infusion includes the first component and the second component；Mixing arrangement set group includes above-mentioned vagina infusion, two extrusion type syringes and a linker, first component and the second component can be respectively contained in each extrusion type syringe, and linker is set among two extrusion type syringes the cylinder to be connected to two extrusion type syringes and forms confined space；Application method includes traction or pushes the piston core pin of each extrusion type syringe, the first component and the second component is set to be mixed to form mixture, and for injecting intravaginal, and make lactic acid bacteria play its in vagina due function to reach restore and persistently maintain vagina Tiny ecosystem be in equilibrium state, with the health of sharp vagina and health care.
Description
Technical field
The present invention is about a kind of infusion, espespecially a kind of infusion suitable for vagina；The present invention includes separately about one kind
The mixing arrangement set group of above-mentioned infusion includes espespecially the mixing arrangement set group of two extrusion type syringes and a linker；This hair
It is bright separately about a kind of application method of above-mentioned mixing arrangement set group.
Background technology
It is lactic acid bacteria to analyze its most important flora in the vagina of healthy women, and unhealthy period vaginal flora is then to add
Moral receives bacterium (Gardnerella), mycoplasma (Mycoplasma), Candida albicans (Candida), Escherichia coli
(Escherichia), it is clear that as it can be seen that lactic acid bacteria plays the part of epochmaking role on vaginal health.Female child is cloudy in parent
Road is sterile.A few hours after birth, newborn's intravaginal can turn out bacterium.To puberty with the development of ovary
The gradually increasing of mature women's hormone (hormone) release can facilitate vaginal epithelial cell and reaching maturity for body of gland and help point
The secretion of secretion forms a group " normal vagina bacterium because being helped containing glycogen (glycogen) in secretion in normal vagina
Group ", there are about fifties kinds of bacterium symbiosis, wherein being again that " dominant bacteria " quantity is most with lactic acid bacteria, there are about 10 in every milliliter of secretion7
Colony Forming Unit (colony forming unit, cfu).
Because the candy former (glycogen) that lactic acid bacteria can decompose intravaginal generates organic acid, and vagina is made to become weakly acidic environment
PH-value also can release antibiotics such as about 3.8 to 4.5：Hydrogen peroxide (H2O2), class bacteriocin, biological surface
Activating agent, lectin molecule etc. make to be adapted to the pathogenic bacteria of weakly alkaline environment such as：It is Gardnerella, mycoplasma, Candida albicans, big
Enterobacteria is suppressed in growth in attachment, and the Tiny ecosystem of vagina is made to be in equilibrium state, not by pathogenic bacterial infection, and is in
Existing health.
When vagina " lactic acid bacteria " quantity is reduced so that original microecological balance wrecks, and is caused present in vagina
Germ will become dominant bacteria, and vagina infection problem will occur at this time.Microecological balance in vagina is subjected to antibiolics
Object use, Vaginal lavages, sexual behaviour influence make vagina alkalization, aging that estrogen be made to reduce and influence the secretion of secretion, weather
Bored wet, immunologic hypofunction, disease such as diabetes etc., and vagina infection problem is made to annoying numerous female friends.Therefore such as
What restore and persistently maintain vagina Tiny ecosystem be in equilibrium state by be vagina health Main way, wherein and with increasing
Add the lactic acid bacteria in vagina mostly important.
Vagina infection and the mode of vagina health care have at present：1, antibiotic usage：The main side of vaginitis is treated for doctor
Method is such as：Nitromethyl azole (metronidazole), clindamycin (clindamycin), Tinidazole (tinidazole),
Fluconazole (fluconazole) etc..Dosage form has injection, capsule, pastille, vagina suppository, ointment etc., and occupation mode has injection, mouth
Oral dosage form, vagina fill in, dermal application etc..Although its therapeutic effect is quickly and clear, antibiotic usage often makes people denounce
The problem of being the generation and side effect of drug resistance, and because the Tiny ecosystem of vagina can not be made to restore with lactic acid bacteria as main vaginal environment,
Therefore the regular generation of repeatability infection and up to 50% or more, and the therapeutic modality of antibiotic is made still to be apparent not enough.2, detergent
It is used with fungicide：It is produced with gel for the cleaning and the vagina of lavation or the ingredient containing bactericidal of vagina inside and external genital
Product, though pathogenic bacteria and peculiar smell and discomfort in vagina can be reduced rapidly, its duration is very short (because secretion can continue
Secretion and having wash away and dilution phenomenon) and because in excessive physical and intervention chemically not only vagina Tiny ecosystem flora without
Method is established and is restored and mucous membrane tissue is also damaged, in the unhealthy lower risk increasing for probably causing virus to infect of long-term vaginal mucosa
Add.3, lactic acid bacteria uses：The candy that lactic acid bacteria can decompose intravaginal in vagina originates in raw organic acid, and vagina is made to become faintly acid
Environment pH-value about 3.8 to 4.5, while also can release antibiotics, the pathogenic bacteria for being adapted to weakly alkaline environment made to exist
Growth is suppressed in attachment, and the Tiny ecosystem of vagina is made to be in equilibrium state, not by pathogenic bacterial infection, and health is presented.
This is the defense mechanism that host gets up with environmental microorganism co-architecture.Simultaneously as lactic acid bacteria is applied to the clinic of vagina infection
Document is constantly delivered and its is acted on machine and turns also increasingly to understand a kind of most natural no pair for already becoming treatment or health care under trend
The option of effect.
In the prior art, China Patent Publication No. CN106177270A discloses a kind of vagina inhibiting-bacteria preparation and its preparation side
Method, though disclosing lactobacillus and gel, used lactobacillus is Lactobacillus rhamnosus (Lactobacillus
Rhamnosus Rosell-11) and lactobacillus plantarum HA-119 (Lactobacillus plantarum HA-119), and simultaneously
It is undisclosed how to avoid outside contamination hybrid mode.
Lactic acid bacteria living, which is applied to vagina infection and its dosage form in vagina health care, at present capsule, pulvis and suppository, mainly
The mode of giving has to take orally directly to be administered with vagina, however lactic acid bacteria living still has many restrictions in use, such as oral to pass through
The destruction of hydrochloric acid in gastric juice, choline, and eating habit is for example thermophilic eats irritation, pungent, high fatty foods etc. and intestinal condition such as constipation etc.
It is influenced in the proliferation of enteron aisle and is transmitted to vagina；The direct administration of vagina is commonly considered as most directly transmitting lactic acid bacteria road vagina most
Good mode has powdered object being fills up to the occupation mode being directly plugged into again in capsule in vagina, but is subjected to regulation at present
Limitation, the inconvenience of administering merging and uncomfortable, hard shape foreign matter are placed in the sense of discomfort of vagina, need enough secretion by its capsule
Molten open dissolves with powder, is easily sliding out vagina etc., still there is many places ideal not to the utmost.Moreover the lactic acid of work in liquid form
Bacterium product also often has the limitation of goods shelf storage phase, although lactic acid bacteria living its accretion rate under dried powder state is extremely low therefore
Can meet the needs of frame storage phase, but when Environmental Water gradually increases the decline speed that its accretion rate is consequently increased lactic acid bacteria
Degree can also be accelerated eventually to complete death, Yoghourt such as containing lactic acid bacteria living and fermented beverage its storage life about only 2 weeks and needs exist
It is stored in low temperature environment, exactly loses its commodity value because lactic acid bacteria is become feeble and die, therefore lactic acid bacteria living is to deposit in a liquid
Form or there are commercial applications are unable to reach in vagina in aqueous gel form, this makes lactic acid bacteria living expand
The application for opening the function of market and its vaginal treatment and health care is above extremely limited.
Invention content
The object of the present invention is to provide a kind of lactobacteria-containing vagina infusion and its mixing arrangements, its purpose is that making lactic acid
Bacterium can be to meet the demand of room temperature and the storage of long-term frame and can transmit breast in such a way that liquid or gel is directly injected into vagina
Sour bacterium enters in vagina, to reach recovery and persistently the Tiny ecosystem of vagina is maintained so that lactic acid bacteria is played it in equilibrium state
The due function in vagina, with the health of sharp vagina and health care.
The technical problem to be solved in the present invention is that the prior art is fills up to powdered object in capsule and is directly plugged into the moon again
Disadvantage in road has the sense of discomfort of the inconvenience that administering is placed in and uncomfortable, hard shape foreign matter merging vagina, needs enough secretion
By its capsule it is molten open the shortcomings of being easily sliding out vagina with powder dissolving, capsule, the lactic acid bacteria product of work in liquid form has again
Goods shelf stores up the shortcomings of limitation of phase.In order to solve the above technical problem, the present invention provides a kind of lactobacteria-containing vaginas to inject
Object and its mixing arrangement, its purpose is that enabling lactic acid bacteria to meet demand that room temperature is stored up with long-term frame and can be with liquid or solidifying
Glue is directly injected into vagina mode and enters in vagina to transmit lactic acid bacteria, to reach the Tiny ecosystem for restoring and persistently maintaining vagina
Lactic acid bacteria is set to play its due function in vagina in equilibrium state, with the health of sharp vagina and health care.
In order to achieve the above objectives, the present invention provides a kind of vagina infusion comprising：
First component includes Lactobacillus bacterium (Lactobacillus sp.), powdered prebiotic matter and pharmaceutically can
The excipients of receiving；And
Second component includes the liquid of sterilized processing.
Preferably, the bacterium of the Lactobacillus be any, wantonly two or multiple combinations be selected from by
L.acidophilus、L.acidophilus RC-14(ATCC 55845)、L.acidophilus(ATCC 4357)、
L.acidophilus F-1(BCRC 910469)、L.acidophillus Rosell-52、L.bifidum、L.brevis、
L.buchneri、L.casei、L.casei RC-17、L.casei RC-36、L.casei NRC 430、L.casei(ATCC
7469)、L.cellobiosis、L.collinoides、L.crispatus、L.crispatus LCRP190、
L.delbrueckii、L.fermentum、L.fermentum A-60(ATCC 55896)、L.fermentum B-54(ATCC
55884)、L.gasseri、L.helveticus、L.iners、L.jensenii、L.jensenii RC-14(ATCC
55920)、L.johnsonii、L.paracasei、L.paracasei LP201、L.plantarum、L.plantarum RC-6
(ATCC 55894)、L.plantarum RC-20(ATCC 55883)、L.plantarum LP142、L.plantarum LP-
143、L.plantarum HA-199、L.reuteri、L.reuteri RC-14(ATCC 55845)、L.reuteri TE-33
(BCRC 910441)、L.reuteri HA-188(ATCC PTA6475)、L.rhamnosus、L.rhamnosus GR-1
(ATCC 55826)、L.rhamnosus GR-2(ATCC55915)、L.rhamnosus GR-3(ATCC55917)、
L.rhamnosus GR-4(ATCC 55916)、L.rhamnosus RC-6、L.rhamnosus GR-17(ATCC55825)、
L.rhamnosus Lcr 35、L.rhamnosus RC-12(ATCC 55895)、L.rhamnosus CT-53(BCRC
910468)、L.rhamnosus Rosell-11、L.rhamnosus、L.rogosae、L.salivarius、L.salivarius
The group that LS160, L.salivarius AP-32 (BCRC 910437) and L.vaginalis are formed.
It is furthermore preferred that the Lactobacillus bacterium is L.rhamnosus GR-1 (ATCC 55826) and L.reuteri
RC-14(ATCC 55845)。
Preferably, in first component, L.rhamnosus GR-1 (ATCC 55826) and L.reuteri RC-14
The bacterium number ratio of (ATCC 55845) is 40：60 to 60：40, and total 1 × 107 to 5 × 1010 Colony Forming Unit of lactic acid bacteria bacterium number
(colony forming unit, cfu).
Preferably, the vagina infusion further includes Bifidobacterium bacterium, and wherein Bifidobacterium bacterium is any, wantonly two
Or multiple combinations are selected from the group being made of B.bifidum, B.breve, B.adolescentis and B.longum.
Preferably, first component is solid, powder or capsule shape.It is furthermore preferred that being by the powder of the first component
Capsule, aluminium foil bag or sealing are filled in not by outside contamination and moisture-proof packaging.
Preferably, second component is liquid and is packaged in the container of sealing not by external environmental.
Preferably, the powdered prebiotic matter includes, but are not limited to synanthrin or galactooligosacchari(es.
Preferably, the vagina infusion further includes powdered functional materials comprising, but be not limited to estrogen or
Cranberry extract.
Preferably, the pharmaceutically receptible excipient includes the filler for contributing to capsule charge comprising,
But it is not limited to microcrystalline cellulose or maltodextrin.
It is furthermore preferred that the pharmaceutically receptible excipient includes that the powder of the first component is contributed to form glue
Or the thickener of liquid comprising, but it is not limited to carragheen (carrageenan), carbomer (carbomer) or Xanthan gum
(xanthan gum)。
Preferably, the liquid of the sterilized processing includes, but are not limited to the water or normal saline solution of sterilized processing.
Preferably, the weight ratio of the liquid of the thickener in first component and the second component is 1：5 to 1:300
Between.
The present invention separately provides a kind of mixing arrangement set group including aforementioned vagina infusion, including：
The vagina infusion；
Two extrusion type syringes, each extrusion type syringe includes a cylinder and a piston core pin, wherein two
A cylinder can load first component or second component respectively, and the piston core pin can live in the cylinder
It moves to draw or push first component or second component；
One linker for hollow cylinder and is respectively equipped with two openings being connected in both ends, is set by the linker
The centre of the two extrusion type syringes is placed in be connected to the cylinder of the two extrusion type syringes and form confined space.
Preferably, each cylinder of each extrusion type syringe includes head and tail portion, makes the first component or second
Component can be entered by head or tail portion in cylinder, and make the first component or the second component that can be discharged by tail portion, and tail portion can be set
There are screw thread or non-threaded.
Preferably, the diameter on the head of each extrusion type syringe is more than the diameter of tail portion.
Preferably, the linker includes, but are not limited to Lu's terminal lug.
It is furthermore preferred that the linker is Lu's terminal lug is equipped with a stage casing between two openings, the stage casing it is straight
Diameter is less than or equal to the diameter of two openings, and in another embodiment, and the opposite sides in stage casing is equipped with handle；Another preferred
Embodiment in, the opposite sides in stage casing does not set handle.
Preferably, two openings of the linker are respectively equipped with screw thread, can be set with tail portion by the screw thread of linker
Threaded extrusion type syringe is connected.
Preferably, the outer wall of wherein one end of the linker is equipped with screw thread, and the other end does not have screw thread.
Preferably, the diameter of the tail portion of the cylinder of the extrusion type syringe is more than the diameter of the opening of linker, makes
The both ends for being fixed on linker can be arranged respectively by obtaining the tail portion of the cylinder of each extrusion type syringe.
Preferably, the diameter of the tail portion of the cylinder of the extrusion type syringe is less than the diameter of opening so that each to push
The tail portion of the cylinder of formula syringe can be respectively contained in the opening of linker, i.e., the tail portion quilt of the cylinder of each extrusion type syringe
The both ends of linker are arranged.
The present invention more provides a kind of application method of the mixing arrangement set group, including：
Filling step：First component and second component are respectively placed in two extrusion type syringes；
Assembling steps：It is set among the two extrusion type syringes by the linker to be connected to two extrusion types
The cylinder of syringe simultaneously forms confined space；
Mixing step：The piston core pin of the extrusion type syringe comprising second component is pushed with by described second
Component is moved by the linker towards the extrusion type syringe comprising first component, then is pushed comprising described first group
Part the extrusion type syringe the piston core pin with will first component by the linker direction comprising described
The extrusion type syringe of second component moves, and repeats to push for several times to mix first component with second component
Mixture is formed, and the mixture is placed in the wherein one extrusion type syringe；And
Injection step：The extrusion type syringe equipped with the mixture is detached with linker, and by pushing institute
Piston core pin is stated so that the mixture is injected receptor intravaginal.
Preferably, must pull out the piston core pin of each extrusion type syringe in the filling step makes itself and cylinder point
From, then the first component and the second component be respectively placed in extrusion type syringe.
Compared with prior art, the invention has the characteristics that and advantage：
Vagina infusion of the present invention includes Lactobacillus bacterium, prebiotic matter and second group by the first component
Part, and so that lactic acid bacteria is played its due function in vagina and restore and the Tiny ecosystem of vagina is persistently maintained to be in balance to reach
State can more meet the demand of room temperature and the storage of long-term frame with the health of sharp vagina and health care；And compared to the prior art
Lactic acid bacteria (such as lactobacillus plantarum Lactobacillus plantarum HA-119 or Lactobacillus rhamnosus
Lactobacillus rhamnosus Rosell-11) it is different bacterial strains.Lactic bacteria strain L.rhamnosus GR-1 (ATCC
55826) and L.reuteri RC-14 (ATCC 55845) are that World Health Organization expert consulting meeting is recommended to have and clearly improved
The two strains of lactic acid bacteria category bacterial strain of urogenital health.
In addition, the second component be sterilized processing water or normal saline solution, compared to the prior art used in aloe
Glue is relatively easy in acquirement and at low cost；And pre-configured Aloe Vera Gel used in the prior art is to make not by micro- life
Object pollution need to be through high-temperature sterilization or addition preservative (i.e. fungicide), therefore the prior art can also inhibit breast simultaneously using Aloe Vera Gel
Sour bacterium growth.
Mixing arrangement set group advantage of the present invention is to connect close to be formed by linker two extrusion type syringes of connection
The pipeline closed, and mix the first component with the second component by piston core pin is pushed, it can avoid polluting and improving
Antipollution protective capacities.
By by the first component and when the advantages of application method of mixing arrangement set group of the present invention, is to need
Two components are respectively placed in extrusion type syringe and mix the first component and the second component by piston core pin is pushed and formed
Mixture enables its mixture to transmit lactic acid bacteria in injection vagina in such a way that liquid or gel is directly injected into vagina,
The method can not only solve the sense of discomfort of prior art hardness foreign matter merging vagina, enough secretion is needed to open its capsule is molten and powder
End dissolving limits, is easily sliding out the shortcomings of vagina, can more solve the lactic acid bacteria frame storage of the work of liquid form in the prior art
Phase is short and the shortcomings that needing low-temperature storage, and can avoid polluting and improving antipollution protective capacities.
Description of the drawings
Attached drawing described here is only used for task of explanation, and is not intended to limit model disclosed by the invention in any way
It encloses.In addition, the shape and proportional sizes etc. of each component in figure are only schematical, it is used to help the understanding of the present invention, and
It is not the specific shape and proportional sizes for limiting each component of the present invention.Those skilled in the art under the teachings of the present invention, can
Implement the present invention to select various possible shapes and proportional sizes as the case may be.
Figure 1A-Fig. 1 E are the stereo appearance figures of the mixing arrangement set group comprising vagina infusion of the present invention.
Fig. 2 is the use state diagram of the mixing arrangement set group of the present invention.
Fig. 3 is the stereo appearance figure of the first embodiment of the linker of the mixing arrangement set group of the present invention.
Fig. 4 is the stereo appearance figure of the second embodiment of the linker of the mixing arrangement set group of the present invention.
Fig. 5 is the stereo appearance figure of the 3rd embodiment of the linker of the mixing arrangement set group of the present invention.
Fig. 6 is the stereo appearance figure of the fourth embodiment of the linker of the mixing arrangement set group of the present invention.
The reference numerals are as follows：
The first components of 10-, the second components of 20-, 30- extrusion type syringes, 31- cylinders, the heads 311-, the tail portions 312-,
32- piston rods, 40- linkers, 40A- linkers, 40B- linkers, 40C- linkers, 40D- linkers, 41- are open, in 42-
Section, 43- handles, 45- screw threads.
Specific implementation mode
With reference to the drawings and the description of the specific embodiments of the present invention, the details of the present invention can clearly be understood.But
It is the specific implementation mode of invention described herein, is only used for explaining the purpose of the present invention, and cannot understands in any way
At being limitation of the present invention.Under the teachings of the present invention, technical staff is contemplated that the arbitrary possible change based on the present invention
Shape, these are regarded as belonging to the scope of the present invention.
Coordinate schema and presently preferred embodiments of the present invention below, the present invention is further explained to reach predetermined goal of the invention institute
The technological means taken.
A to Fig. 1 E is please referred to Fig.1, vagina infusion of the present invention includes the first component 10 and the second component 20,
In the first component 10 include Lactobacillus bacterium (Lactobacillus sp.), Bifidobacterium bacterium (Bifidobacterium
Sp.), powdered prebiotic matter (prebiotic), powdered functional materials and pharmaceutically acceptable excipients；Wherein institute
The Lactobacillus bacterium stated is L.rhamnosus GR-1 (ATCC 55826) and L.reuteri RC-14 (ATCC 55845),
And the bacterium number ratio of L.rhamnosus GR-1 (ATCC 55826) and L.reuteri RC-14 (ATCC 55845) is 40：60 to
60：40, total lactic acid bacteria bacterium number is 1 × 107 to 5 × 1010 Colony Forming Unit (colony forming unit, cfu)；It is described
Bifidobacterium bacterium be any, wantonly two or multiple combinations be selected from by B.bifidum, B.breve, B.adolescentis and
The group that B.longum is formed.The powdered prebiotic matter includes synanthrin or galactooligosacchari(es.The powdered functionality
Substance includes estrogen or Cranberry extract.The pharmaceutically acceptable excipient includes thickener comprising glue
Former albumen, hyaluronic acid, carragheen (carrageenan), carbomer (carbomer) or Xanthan gum (xanthan gum).The
Two components 20 include the liquid of sterilized processing, wherein the liquid of sterilized processing includes the water or physiological saline of sterilized processing
Water.Specifically, the weight ratio of the liquid of thickener and the second component in the first component is 1：5 to 1：Between 300.
Specifically, the weight of the first component is about 280 milligrams (mg) to 330 milligrams (mg), including 30mg
The maltodextrin of L.rhamnosus GR-1 (ATCC 55826) and L.reuteri RC-14 (ATCC55845), 150mg, and
The thickener of 100mg to 150mg, wherein L.rhamnosus GR-1 (ATCC 55826) and L.reuteri RC-14 (ATCC
55845) bacterium number ratio is 1：1, and total lactic acid bacteria bacterium number is 5 × 109 Colony Forming Unit (CUF)；Second component is 3 milliliters
(ml) sterile water.
Mixing arrangement set group of the present invention comprising aforementioned vagina infusion is in addition to including the first component 10 above-mentioned
And second except component 20, further includes two extrusion type syringes 30 and a linker 40.Each extrusion type syringe
30 include a cylinder 31 and a piston core pin 32, wherein each cylinder 31 can load the first component 10 or the second component 20 respectively,
And piston core pin 32 can be in activity in cylinder 31 to draw or push the first component 10 or the second component 20.More specifically, respectively
Cylinder 31 includes head 311 and tail portion 312, and the first component 10 or the second component 20 can be entered by head 311 or tail portion 312
In cylinder 31.In the particular embodiment, the diameter on head 311 is more than the diameter of tail portion 312, the first component 10 or the second component
20 can be discharged cylinder 31 by tail portion 312.In another specific embodiment, the tail portion 312 of each extrusion type syringe 30 is equipped with
Lid locks.
The linker 40 is hollow cylinder and is equipped with two openings 41 being connected in both ends, is arranged by linker 40
In the centre of the tail portion 312 of two extrusion type syringes 30 to be connected to the cylinder 31 of two extrusion type syringes 30 and form confined air
Between.More specifically, the diameter of the tail portion 312 of the cylinder 31 of each extrusion type syringe 30 is more than the diameter of opening 41 so that each
The tail portion 312 of the cylinder 31 of extrusion type syringe 30 can be sheathed on the opening 41 of linker 40 respectively.Yet another specific implementation
In example, the diameter of the tail portion 312 of the cylinder 31 of each extrusion type syringe 30 is less than the diameter of opening 41 so that each extrusion type injection
The tail portion 312 of the cylinder 31 of device 30 can be respectively contained in the opening 41 of linker 40.
The present invention is when implementing, referring to FIG. 2, including step used below：
Filling step：First component 10 and the second component 20 are respectively placed in two extrusion type syringes 30；
Assembling steps：The tail portion 312 of the cylinder 31 of each extrusion type syringe 30 can respectively with 41 phase of the opening of linker 40
Connection, and be set among two extrusion type syringes 30 by linker 40 to be connected to the cylinder 31 of two extrusion type syringes 30 simultaneously
Form confined space；
Mixing step：The piston core pin 32 of the extrusion type syringe 30 comprising the second component 20 is pushed with by the second component 20
It is moved towards the extrusion type syringe 30 comprising the first component 10 through linker 40, then pushes the pushing for including the first component 10
The piston core pin 32 of formula syringe 30 towards the extrusion type comprising the second component 20 to note the first component 10 through linker 40
Emitter 30 moves, and repeats to push for several times the first component 10 and the second component 20 are mixed to form mixture, and mixture is held
It is placed in one in an extrusion type syringe 30；And
Injection step：Extrusion type syringe 30 equipped with mixture is detached with linker 40, and is mixed by pushing to be equipped with
The piston core pin 32 of the extrusion type syringe 30 of object is closed to inject the mixture into receptor intravaginal.
In specific implementation steps, the first component 10 can be put into extrusion type by the head 311 of extrusion type syringe 30
In syringe 30, the second component 20 is placed in the tail portion 312 of extrusion type syringe 30, then piston core pin 32 is pulled to make the second component 20
It is towed and is placed in the cylinder 31 of extrusion type syringe 30 by tail portion 312.In another specific implementation steps, extrusion type note
The tail portion 312 of emitter 30 locks equipped with lid, therefore can the pull-out of the piston core pin 32 of each extrusion type syringe 30 be made itself and cylinder
After body 31 detaches, then the first component 10 and the second component 20 be respectively put into each extrusion type syringe 30, and the first component 10
Lock without being flowed out from tail portion 312 because the tail portion 312 of extrusion type syringe 30 is equipped with lid with the second component 20；When needing to carry out
When assembling steps and linker 40 assemble, after first lid is removed, then by the tail portion 312 of the cylinder 31 of each extrusion type syringe 30
It is connected respectively with the opening of linker 40 41.
There are many patterns for linker 40 of the present invention, in the first preferred embodiment, referring to FIG. 3, linker
40A is Lu's terminal lug.In the second preferred embodiment, referring to FIG. 4, linker 40B is the deformation of Lu's terminal lug, and two
A stage casing 42 is equipped between opening 41, the diameter in the stage casing 42 is less than the diameter of two openings 41, and in the opposite of stage casing 42
Both sides are equipped with handle 43.In third preferred embodiment, please refer to Fig.1 and Fig. 5, linker 40C two opening 41 at set respectively
There is screw thread 45, threaded extrusion type syringe 30 can be set with tail portion 312 by the screw thread 45 of linker 40C and be connected；Specifically
For, the diameter of each opening 41 of linker 40C is less than the diameter of the tail portion 312 of extrusion type syringe 30 so that linker 40C
The tail portion 312 of the extrusion type syringe 30 that can be provided with screw thread of each opening 41 be arranged.In the 4th preferred embodiment, it please join
Fig. 1 and Fig. 6 is examined, the outer wall of wherein one end of linker 40D is equipped with screw thread 45, and the other end does not have screw thread 45, that is to say, that its chain
Threaded extrusion type syringe 30 can be set with tail portion 312 and be connected through screw thread by connecing one end of device 40D, and linker 40D's is another
End can be connect with not having threaded 30 phase of extrusion type syringe to be arranged.
1 soundness test of embodiment
Capsule containing lactic acid bacteria powder 165mg and 15mg carbomer (is included into Lactobacillus rhamnosus GR-
1＆Lactobacillus reuteri RC-14) as a control group, totally two groups, respectively A1, A2 include with of the present invention
The vagina infusion of first component and the second component (as experimental group, two groups, is divided totally using the aforementioned mixture formed using step
Wei B1, B2) carry out soundness test：By experimental group and control group be positioned over 25 DEG C of room temperature and in the 0th day, the 3rd day, the 7th day,
Its lactic acid bacteria bacterium number is measured respectively within 14th day, the 28th day.
1 soundness test of table is compared
Such as table 1 the results show that a ten thousandth (difference nearly 4 log that the bacterium number of experimental group was reduced to control group at the 28th day
Value), stability of the display bacterial strain in having water or liquid is bad, therefore it is not recommended that be commercialized with admixture (gel), and
It is applied in 14 days even to be suggestion subject when needing to use exist side by side according to abovementioned steps mixing again.
2 bacteriostatic test of embodiment
In the present embodiment, the first component is that the capsule containing lactic acid bacteria powder 165mg and 15mg carbomer (includes
Lactobacillus rhamnosus GR-1&Lactobacillus reuteri RC-14)；Second component is 3 milliliters (ml)
Normal saline solution.And it is in gelatinous mixture to mix the first component and the second component in aforementioned step method；And strictly according to the facts
Example 1 is applied to place respectively the 0th day, the 3rd day, the 7th day and the 14th day (as processing group).
By Escherichia coli (E.coli, BCRC 11549) (ATCC 11229) bacterial strain and staphylococcus aureus
(Staphylococcus aureus, BCRC 12154) (ATCC 6538) is incubated at NB culture mediums (nutrient broth),
Be coated later on NA culture dishes (nutrient agar) and with 1ml tip in digging five holes on NA culture mediums, wherein intermediate
Hole be put into normal saline solution (as a control group), remaining 4 hole is put into 50 μ l processing group (2 samples of different number of days above-mentioned
Originally it is repeated 2 times, totally 4 holes), it is placed in after being cultivated 48 hours at 37 DEG C and observes inhibition zone as a result, this can be observed within wherein the 3rd day
Invention first component and the second component are mixed in gelatinous mixture in aforementioned step method respectively for large intestine bar
Bacterium has significant inhibition with staphylococcus aureus.
3 comfort level of embodiment tests (one)
The suppository for being commercially available for treatment vaginitis or urethral infection is mostly capsule form or suppository (being all solid-state), so
And for the thin subject of vaginal fluid, it may cause to be difficult to solid tablet or suppository because of secretion deficiency
Fill in vagina；In addition, for the too many subject of vaginal fluid, may because secretion is too many cause solid tablet or
It is to easily slide out vagina when suppository fills in vagina and cause to be not easy merging or sense of discomfort.
This experiment will have vaginal fluid thin and measure mostly and have to be divided at random using 12 people of subject of vagina suppository experience
At two groups and questionnaire survey is carried out, wherein capsule (control group) is placed in vagina (group number is 1) by 6 people before sleeping,
Other 6 people is before sleep by vagina infusion of the present invention in the form of colloidal mixture (experimental group) and by step above-mentioned
Rapid mode is injected in vagina (group number is 2)；Wherein questionnaire is divided into four projects：(1) complexity of merging vagina can divide
For：1. it is difficult to be easy 2. not smooth 3.；(2) comfort can be divided into 1. comfortable 2. no foreign body sensations 3. and have foreign body sensation after being placed in vagina；
(3) form of the merging object of early morning observation every other day can be divided into：1. being completely dissolved 2. is partly dissolved the slippage of 3. capsules；And (four) are whole
Body-sensing is felt：1. it is dissatisfied to be satisfied with 2. fine 3..
Accordingly, for (one) is placed in the project of the complexity of vagina, if the higher expression subject of score is more difficult to be placed in
Vagina.For the project of comfort after (two) merging vagina, if the higher expression subject of score is more uncomfortable.Every other day with regard to (three)
For the project of early morning observation merging object form, if the higher expression merging object of score cannot more be absorbed via vaginal mucosa.Just
(4) for the project of overall feeling, if the higher expression merging object of score is not satisfied with by subject.
2 comfort test result of table
As shown in table 2, for the subject that vaginal fluid is thin or amount is more, just (one) is placed in the difficulty or ease journey of vagina
Degree as a result, by capsule (control group) be placed in vagina in subject mostly feels be placed in it is not smooth；After just (two) are placed in vagina
For the result of comfort, the subject that capsule (control group) is placed in vagina is felt under the weather mostly；Just (three) are clear every other day
For the result of morning observation merging object form, capsule (control group) is placed in the subject in vagina, and feeling cannot be via the moon mostly
Mucous membrane is by acceptor absorbance；For the result of (four) overall feeling, the subject that capsule (control group) is placed in vagina is big
It is feel dissatisfied more.Accordingly, vagina infusion of the present invention be placed in the form of colloidal mixture vagina allow subject compared with
For it is comfortable, be easier to merging and trap is preferable.
4 comfort level of embodiment tests (two)
The suppository for being commercially available for treatment vaginitis or urethral infection is mostly capsule form or suppository (being all solid-state), so
And for the subject of vaginal dryness after menopause, it may cause solid tablet or suppository plug because of secretion deficiency
Sense of discomfort is generated when entering vagina.
This experiment divides the subject of vaginal dryness after menopause and having using 12 people of subject of vagina suppository experience at random
At two groups and questionnaire survey is carried out, wherein capsule (control group) is placed in vagina (group number is 1) by 6 people before sleeping,
Other 6 people is before sleep by vagina infusion of the present invention in the form of colloidal mixture (experimental group) and by step above-mentioned
Rapid mode is injected in vagina (group number is 2)；Wherein questionnaire is divided into four projects：(1) complexity of merging vagina can divide
For：1. it is difficult to be easy 2. not smooth 3.；(2) comfort can be divided into after being placed in vagina：1. comfortable 2. no foreign body sensation 3. has foreign matter
Sense；(3) form of the merging object of early morning observation every other day can be divided into：1. being completely dissolved 2. is partly dissolved the slippage of 3. capsules；And (four)
Overall feeling：1. it is dissatisfied to be satisfied with 2. fine 3..
As described in embodiment 3, the higher representative of the score of projects be more difficult to merging vagina, more have foreign body sensation (uncomfortable),
It cannot more be absorbed and subject is more dissatisfied.
3 comfort test result of table
As shown in table 3, for the subject of vaginal dryness after menopause, just (one) is placed in the knot of the complexity of vagina
The subject that capsule (control group) is placed in vagina is felt to be difficult to be placed in by fruit mostly；Just comfort after (two) merging vagina
As a result for, the subject that capsule (control group) is placed in vagina is felt under the weather mostly；Just (three) early morning observation every other day is set
For the result for entering object form, capsule (control group) is placed in the subject in vagina, and feeling cannot be via vaginal mucosa quilt mostly
Acceptor absorbance；For the result of (four) overall feeling, capsule (control group) is placed in the subject in vagina and is felt mostly not
It is satisfied.
Accordingly, vagina infusion of the present invention not only allows subject to be easily put into the moon by after mixing for gel form
Road and receptor is allowed to feel relatively comfortable；Still further capsule (control group), compared to the prior art, the moon of the present invention
Road infusion makes its easy Via vagina mucous membrane be absorbed by subject by after mixing for gel form, therefore the moon of the present invention
Road infusion can more allow subject to be satisfied with by after mixing for the capsule of gel form compared to the prior art.
The above is only presently preferred embodiments of the present invention, not does limitation in any form to the present invention, though
So the present invention has been disclosed as a preferred embodiment, and however, it is not intended to limit the invention, any technology people for being familiar with this profession
Member, in the range of not departing from technical solution of the present invention, when the technology contents using the disclosure above make a little change or repair
Decorations are the equivalent embodiment of equivalent variations, as long as being the content without departing from technical solution of the present invention, technology according to the present invention is real
Any simple modification, equivalent change and modification made by confrontation above example still fall within the range of technical solution of the present invention
It is interior.
For explaining in detail for the respective embodiments described above, purpose, which is only that, explains the present invention, in order to be able to
More fully understand the present invention, still, these descriptions cannot with any explanation at being limitation of the present invention, in particular,
Each feature described in different embodiments mutually can also be combined arbitrarily, to form other embodiment, in addition to having
Opposite description is specified, these features should be understood to can be applied in any one embodiment, and be not limited merely to
Described embodiment.
Claims (23)
1. a kind of vagina infusion, which is characterized in that the vagina infusion includes：
First component comprising Lactobacillus bacterium (Lactobacillus sp.), powdered prebiotic matter and can pharmaceutically connect
The excipients received；And
Second component comprising the liquid of sterilized processing.
2. vagina infusion according to claim 1, which is characterized in that the bacterium of the Lactobacillus be it is any,
Wantonly two or multiple combinations be selected from by L.acidophilus, L.acidophilus RC-14 (ATCC 55845),
L.acidophilus(ATCC 4357)、L.acidophilus F-1(BCRC 910469)、L.acidophillus
Rosell-52、L.bifidum、L.brevis、L.buchneri、L.casei、L.casei RC-17、L.casei RC-36、
L.casei NRC 430、L.casei(ATCC 7469)、L.cellobiosis、L.collinoides、L.crispatus、
L.crispatus LCRP190、L.delbrueckii、L.fermentum、L.fermentum A-60(ATCC 55896)、
L.fermentum B-54(ATCC 55884)、L.gasseri、L.helveticus、L.iners、L.jensenii、
L.jensenii RC-14(ATCC 55920)、L.johnsonii、L.paracasei、L.paracasei LP201、
L.plantarum、L.plantarum RC-6(ATCC 55894)、L.plantarum RC-20(ATCC 55883)、
L.plantarum LP142、L.plantarum LP-143、L.plantarum HA-199、L.reuteri、L.reuteri
RC-14(ATCC 55845)、L.reuteri TE-33(BCRC 910441)、L.reuteri HA-188(ATCC
PTA6475)、L.rhamnosus、L.rhamnosus GR-1(ATCC 55826)、L.rhamnosus GR-2
(ATCC55915)、L.rhamnosus GR-3(ATCC55917)、L.rhamnosus GR-4(ATCC 55916)、
L.rhamnosus RC-6、L.rhamnosus GR-17(ATCC55825)、L.rhamnosus Lcr 35、L.rhamnosus
RC-12(ATCC 55895)、L.rhamnosus CT-53(BCRC 910468)、L.rhamnosus Rosell-11、
L.rhamnosus、L.rogosae、L.salivarius、L.salivarius LS160、L.salivarius AP-32(BCRC
And the groups that are formed of L.vaginalis 910437).
3. vagina infusion according to claim 2, which is characterized in that wherein Lactobacillus bacterium is L.rhamnosus
GR-1 (ATCC 55826) and L.reuteri RC-14 (ATCC 55845).
4. vagina infusion according to claim 2, which is characterized in that in first component, L.rhamnosus
The bacterium number ratio of GR-1 (ATCC 55826) and L.reuteri RC-14 (ATCC 55845) is 40：60 to 60：40, and total lactic acid
Bacterium bacterium number is 1 × 107 to 5 × 1010 Colony Forming Unit.
5. vagina infusion according to claim 1, which is characterized in that the vagina infusion further includes Bifidobacterium
Belong to bacterium (Bifidobacterium sp.), wherein Bifidobacterium bacterium be any, wantonly two or multiple combinations selected from by
The group that B.bifidum, B.breve, B.adolescentis and B.longum are formed.
6. vagina infusion according to claim 1, which is characterized in that first component is solid, powder or glue
Capsule.
7. vagina infusion according to claim 1, which is characterized in that the powdered prebiotic matter includes synanthrin or half
Newborn oligosaccharides.
8. vagina infusion according to claim 1, which is characterized in that the vagina infusion further includes powdered work(
Energy property substance comprising estrogen or Cranberry extract.
9. vagina infusion according to claim 1, which is characterized in that the pharmaceutically receptible excipient packet
Include filler comprising microcrystalline cellulose or maltodextrin.
10. vagina infusion according to claim 1, which is characterized in that the pharmaceutically receptible excipient
Including thickener comprising collagen, hyaluronic acid, carragheen, carbomer or Xanthan gum.
11. vagina infusion according to claim 10, which is characterized in that the thickener in first component and institute
The weight ratio for stating the liquid of the second component is 1：5 to 1：Between 300.
12. vagina infusion according to claim 1, which is characterized in that the liquid of the sterilized processing includes warp
The water of sterilization treatment or the normal saline solution of sterilized processing.
13. a kind of mixing arrangement set group of vagina infusion according to any one of claim 1 to 12, including：
The vagina infusion；
Two extrusion type syringes, each extrusion type syringe include a cylinder and a piston core pin, two of which institute
First component or second component can be loaded respectively by stating cylinder, and the piston core pin can the cylinder body activity with
Draw or push first component or second component；
One linker for hollow cylinder and is respectively equipped with two openings being connected in both ends, is set to by the linker
To be connected to the cylinder of the two extrusion type syringes and form confined space among the two extrusion type syringes.
14. mixing arrangement set group according to claim 13, which is characterized in that the cylinder of each extrusion type syringe
Body includes head and tail portion, and the tail portion is equipped with screw thread or non-threaded.
15. mixing arrangement set group according to claim 13, which is characterized in that the diameter on head described in the cylinder is big
Diameter in the tail portion.
16. mixing arrangement set group according to claim 13, which is characterized in that the linker includes Lu's terminal lug.
17. mixing arrangement set group according to claim 13, which is characterized in that the both ends of institute's linker are equipped with Lu Erjie
Head, is equipped with a stage casing between two openings, and the diameter in the stage casing is less than or equal to the diameter of two openings, and in
The opposite sides in the stage casing can be respectively equipped with handle.
18. mixing arrangement set group according to claim 13, which is characterized in that two openings of the linker
It is respectively equipped with screw thread, setting the threaded extrusion type syringe by the screw thread and the tail portion of the linker is connected.
19. mixing arrangement set group according to claim 13, which is characterized in that the outer wall of one end of the linker is set
There are screw thread, the other end there is no screw thread.
20. mixing arrangement set group according to claim 13, which is characterized in that the cylinder of the extrusion type syringe
The diameter of the tail portion of body is more than the diameter of the opening of the linker, the cylinder of two extrusion type syringes
The tail portion can be arranged the both ends for being fixed on the linker respectively.
21. mixing arrangement set group according to claim 13, which is characterized in that the institute of each extrusion type syringe
The diameter for stating the tail portion of cylinder is respectively less than the diameter of the opening so that the institute of the cylinder of two extrusion type syringes
Stating tail portion can be respectively contained in two openings of the linker.
22. a kind of application method of mixing arrangement set group according to any one of claim 13 to 21, including：
Filling step：First component and second component are respectively placed in two extrusion type syringes；
Assembling steps：It is set among the two extrusion type syringes by the linker to be connected to the two extrusion type injections
The cylinder of device simultaneously forms confined space；
Mixing step：The piston core pin of the extrusion type syringe comprising second component is pushed with by the second component
By the linker towards the extrusion type syringe movement comprising first component, then push comprising described first group
Part the extrusion type syringe the piston core pin with will first component by the linker direction comprising described
The extrusion type syringe of second component moves, and repeats to push for several times to mix first component with second component
Mixture is formed, and the mixture is placed in the wherein one extrusion type syringe；And
Injection step：The extrusion type syringe equipped with the mixture is detached with the linker, and by pushing institute
Piston core pin is stated so that the mixture is injected receptor intravaginal.
23. application method according to claim 22, which is characterized in that must be by each pushing in the filling step
The piston core pin pull-out of formula syringe makes it be detached with the cylinder, then first component and second component are divided
It is not placed in the two extrusion type syringes.
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|---|---|---|---|
| CN201710057511 | 2017-01-26 | ||
| CN2017100575110 | 2017-01-26 |
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Cited By (3)
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| CN110656060A (en) * | 2019-08-09 | 2020-01-07 | 四川厌氧生物科技有限责任公司 | Multi-linked lactobacillus composition and application thereof in female vaginal health |
| CN110777087A (en) * | 2019-08-09 | 2020-02-11 | 四川厌氧生物科技有限责任公司 | Lactobacillus johnsonii and application thereof |
| RU2819717C1 (en) * | 2023-04-07 | 2024-05-23 | Татьяна Юрьевна Малинина | High-viscosity solution in the form of volumetric additive to intercellular matrix, used for rehabilitation, prevention and elimination of vulvovaginal and intrauterine diseases in women |
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Application publication date: 20180803 |