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CN105999224B - A kind of biomimetic type gynaecologic washing lotion and preparation method thereof - Google Patents

A kind of biomimetic type gynaecologic washing lotion and preparation method thereof Download PDF

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CN105999224B
CN105999224B CN201610316286.3A CN201610316286A CN105999224B CN 105999224 B CN105999224 B CN 105999224B CN 201610316286 A CN201610316286 A CN 201610316286A CN 105999224 B CN105999224 B CN 105999224B
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washing lotion
vagina
biomimetic type
gynaecologic washing
manual simulation
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CN105999224A (en
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陈松彬
易萍
张爱萍
倪彦艳
吴纯玲
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Guangdong Kewei Biological Technology Co Ltd
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Guangdong Kewei Biological Technology Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/702Oligosaccharides, i.e. having three to five saccharide radicals attached to each other by glycosidic linkages
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin

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Abstract

The invention belongs to personal cleanliness's articles for use field, specifically related to a kind of biomimetic type gynaecologic washing lotion and preparation method thereof, the gynaecologic washing lotion includes manual simulation's vaginal secretion that house fly antibiotic peptide, xylo-oligosaccharide, xanthans and pH are 3.3~4.8, and the content of the house fly antibiotic peptide, xylo-oligosaccharide and xanthans in manual simulation's vaginal secretion is respectively 0.1~10.0g/L, 5~10.0g/L and 0.05~0.15g/L.The invention provides a kind of biomimetic type gynaecologic washing lotion with sterilized, regulation vaginal flora and reparation vagina function, it has significant curative effect to different types of vaginitis.

Description

A kind of biomimetic type gynaecologic washing lotion and preparation method thereof
Technical field
The invention belongs to personal cleanliness's articles for use field, and in particular to a kind of biomimetic type gynaecologic washing lotion and preparation method thereof.
Background technology
Vaginitis is the inflammation of connective tissue under vagina mucosa and mucous membrane, is the most common disease of gynaecology.Normal health Women, due to anatomy and biochemical characteristics, intrusion of the vagina to pathogen has natural defense function, when preventing naturally for vagina Imperial function is destroyed, then pathogen can take advantage of the occasion to invade, and cause the generation of colpitis.According to statistics, China's Status of Married Child-bearing aged Women In there is more than 80% to be annoying by this disease is light or heavy.
Vaginitis causes mainly due to the flora imbalance of intravaginal, i.e., normally colonize in the microecological balance of intravaginal (flora) is lacked of proper care, and the beneficial bacterium such as ability of Lactobacillus in human vagina is reduced and other bacterium amount reproductions, and anaerobic bacteria breeding produces amine simultaneously Class material, alkalize vagina, increases vaginal fluid and has stink.Therefore the normal vaginal flora balance of regulation patient is prevention With the key for the treatment of vaginitis.
At present, the product for the treatment of vaginitis is mainly based on sterilization, one side common antibiotics and various with antibacterial The washing lotion of effect.So while pathogenic microorganisms is killed, leading flora (Bacillus acidi lactici, vagina bifid bar have also been killed Bacterium), although symptom has been alleviated during medication, once being discontinued other miscellaneous bacterias quickly and can grow rapidly, makes inflammation alternately and repeatedly Occur.Long-term use antibiotic, antimicrobial can also make various pathogen produce drug resistance, and the flora for aggravating intravaginal is unbalance.Separately On the one hand, existing washing lotion constitutes entirely different with vaginal secretion, and lavation vagina can accelerate the aging of vagina repeatedly, easily make Vaginal dryness.
Chinese patent application 201310062784.6 discloses a kind of bionic gynecologic care solution and preparation method thereof, described Gynecologic care solution includes the artificial vagina juice of antibacterial peptide and pH 3.3~4.4, and the antibacterial peptide is in artificial vagina juice In content be 0.1~10.0g/L;The artificial vagina juice includes artificial body fluid and thickener, and the thickener is in institute It is 0.5~5.0g/L to state the content in artificial body fluid.The invention bionic gynecologic care solution uses Bionic Design, with prosthesis Liquid adds thickener and adjusts its viscosity as solvent, with its pH value of acid-base accommodation, obtain with the vaginal secretion of human body into Point, the close artificial vagina juice of viscosity, pH, then do not have chemical bactericide chronic as bactericide from antibacterial peptide The drawbacks of corroding vagina viscosity, will not excessively change the physiological equilibrium of vaginal microenvironment and destruction vagina, can be used to treat obstinate Property vaginitis and daily vagina health care diseases prevention.Applicant is it has been investigated that the product has the following disadvantages:1. it is due to prosthesis The hypersaline environment of liquid reduces the bioactivity of antibacterial peptide, ultimately results in its anti-microbe ability and is obviously reduced;2. it is that this is artificial The composition of body fluid and human vagina's juice still has larger difference, is not truly bionical, therefore itself and the moon Road compatibility is poor;3. it is the main purpose that treatment vaginitis is reached to kill vagina harmful bacteria of the product, but it is to vagina The effect that flora is not balanced, and it can not repair the infringement that vaginitis is caused to vagina, therefore cause vaginitis easily multiple Hair, the crowd for having vaginitis medical history is still the group of people at high risk of vaginitis;4. it is because washing lotion is shorter in the intravaginal residence time Cause antibacterial peptide action time too short, therefore need to repeat lavation vagina in order to reach preferable antibacterial effect, when using every time, Multiple relation is easily destroyed vagina inside microenvironment.
Therefore, it is necessary to develop a kind of biomimetic type gynaecology with sterilized, regulation vaginal flora, reparation vagina function wash Liquid.
The content of the invention
Defect it is an object of the invention to overcome above-mentioned prior art, there is provided one kind has sterilized, regulation vaginal flora With the biomimetic type gynaecologic washing lotion for repairing vagina function, it has significant curative effect to different types of vaginitis.
It is the invention provides a kind of biomimetic type gynaecologic washing lotion, including house fly antibiotic peptide, xylo-oligosaccharide, xanthans and pH 3.3~4.8 manual simulation's vaginal secretion, the house fly antibiotic peptide, xylo-oligosaccharide and xanthans are in manual simulation's vagina Content in juice is respectively 0.1~10.0g/L, 5~10.0g/L and 0.05~0.15g/L.
Preferably, the content of the house fly antibiotic peptide, xylo-oligosaccharide and xanthans in manual simulation's vaginal secretion Respectively 0.1g/L, 6.0g/L and 0.1g/L.
Preferably, manual simulation's vaginal secretion is composed of the following components:5~10g/L of NaCl, KC l 0.3~ 0.5g/L、CaClZ0.1~0.2g/L, NaHCO30.3~0.45g/L, MgCl2·6H20.006~0.015g/L of O, MgSO4·7H20.04~0.08g/L of O, KH2PO40.05~0.08g/L, Na2HPO4·12H20.05~0.08g/L of O, Portugal 0.1~2.5g/L of grape sugar, 0.5~3g/L of urea, 0.001~0.003g/L of gram positive bacterial cell fragment and surplus are gone Ionized water.
Preferably, manual simulation's vaginal secretion is composed of the following components:NaCl 8.0g/L、KCl 0.45g/L、 CaCl2 0.15g/L、NaHCO3 0.4g/L、MgCl2·6H2O 0.015g/L、MgSO4·7H2O 0.05g/L、KH2PO4 0.06g/L、Na2HPO4·12H2OO 0.06g/L, glucose 2g/L, urea 1.5g/L, gram positive bacterial cell fragment 0.002g/L and balance deionized water.
Preferably, the gram positive bacterial cell fragment is by bifidobacterium cells fragment and lactobacillus cell fragment By 1:1 weight is than composition.
Preferably, the biomimetic type gynaecologic washing lotion also includes vagina renovation agent, and the vagina renovation agent is in the artificial mould It is 0.1~2g/L to intend the content in vaginal secretion, and the vagina renovation agent is selected from water solubility VE, NMF and dissociates One or more in amino acid.
Preferably, the vagina renovation agent presses 1 by water-soluble VE, NMF and free amino acid:0.5~1:1 ~2 weight is than composition.
Preferably, the vagina renovation agent presses 1 by water-soluble VE, NMF and free amino acid:0.5:1 weight Amount is than composition.
Preferably, the free amino acid is selected from the one kind or several in glycine, alanine, asparatate and serine Kind.
Correspondingly, present invention also offers the preparation method of above-mentioned biomimetic type gynaecologic washing lotion, comprise the following steps:
A 5~10g/L of NaCl, 0.3~0.5g/L of KCl, CaCl) are taken20.1~0.2g, NaHCO30.3~0.45g/L, MgCl2·6H20.006~0.015g/L of O, MgSO4·7H20.04~0.08g/L of O, KH2PO40.05~0.08g/L, Na2HPO4·12H20.05~0.08g/L of O, 0.1~2.5g/L of glucose, 0.5~3g/L of urea and gram-positive bacterium 0.001~0.003g/L of cell fragment is dissolved in deionized water, is uniformly mixed, constant volume, and regulation pH is 3.3~4.8, is obtained final product Manual simulation's vaginal secretion;
B) take 0.05~0.15g/L xanthans to be dissolved in deionized water, stir, be configured to xanthan gum solution, plus Enter 5~10.0g/L house fly antibiotic peptides, continue to stir 10~15min, add 0.1~10.0g/L xylo-oligosaccharides, stirring obtains one and mixes Close liquid;
C) step A is added toward above-mentioned mixed liquor) gained manual simulation's vaginal secretion, to stir, homogenization is obtained final product bionical Type gynaecologic washing lotion.
Preferably, the step B) in be additionally included in addition house fly antibiotic peptide after add vagina renovation agent.
The present invention to the full extent simulate human vagina's juice composition, on the basis of artificial body fluid add urea and Gram positive bacterial cell fragment, is preferably added to bifidobacterium cells fragment and lactobacillus cell fragment, and it can induce the moon The generation of Bifidobacterium and Bacillus acidi lactici in road, adds xylo-oligosaccharide specifically to promote beneficial bacterium Bacillus acidi lactici and the dry bacterium of bifid Amount reproduction, the Bacillus acidi lactici of breeding and Bifidobacterium can be colonized by occupy-place, competition nutrition, secretion H2O2With bacteriocin etc. Antibacterial substance and suppress in vagina and enteron aisle in middle pathogenic microorganisms growth and breeding, additionally by Bacillus acidi lactici and bifid Bacillus produces a large amount of SCFA such as acetic acid, propionic acid and butyric acid etc. to adjust the acidity of vagina, two using xylo-oligosaccharide fermentation Person's Synergistic, can be quick, active balance vaginal flora and regulation vagina acidity.
Because antibacterial peptide is under high salt concentration, anti-microbe ability can be obviously reduced, it is contemplated that manual simulation's vaginal secretion The hypersaline environment of liquid, it is found by the applicant that house fly antibiotic peptide remains to maintain excellent bioactivity in high salt concentration, and its heat is steady It is qualitative good, beneficial to the carrying out of subsequent high temperature disinfecting action;Because washing lotion is short in the intravaginal residence time, antibacterial peptide action time It is short, therefore need to repeat lavation vagina in order to reach preferable antibacterial effect, when using every time, it is found by the applicant that first by xanthan Glue is coupled with antibacterial peptide, using the bioadhesive of xanthans itself, can be attached on mucous membrane and cell for a long time, and extension is anti- The action time of bacterium peptide, and then lavation number of times is reduced, both cooperate with the fungistatic effect that increased washing lotion.
In view of the damage that vaginitis is caused to vagina, it is aided with water-soluble VE, NMF and free amino acid, swims Isolated amino acid has powerful moisture-retaining capacity, and it can keep the moisture of vagina inner skin, makes vagina skin lubrication, flexible. In sum, the present invention greatly improves antibacterial effect while reducing lavation number of times using the coupling of house fly antibiotic peptide xanthans, Cooperate with xylo-oligosaccharide strong again using the generation of gram positive bacterial cell fragment induction intravaginal Bifidobacterium and Bacillus acidi lactici The function of big regulation vaginal flora and vagina acidity, is finally aided with the solvent close with human vagina's secretory component and to vagina Composition with repair, each component compatibility rationally, is made a distinction between the important and the lesser one, and composition one has sterilized, balance vaginal flora, vagina concurrently The stabilising system of acidity and reparation vaginal injury function.
Compared with prior art, bionical gynaecologic washing lotion of the invention has the advantage that:
1) biomimetic type gynaecologic washing lotion of the present invention uses Bionic Design, on vaginal microenvironment and vagina physiological equilibrium influence compared with It is small, will not make cell produce drug resistance, its compared with existing gynaecologic washing lotion, with prominent bactericidal effect, to bacillary the moon Road inflammation, monilial vaginitis, trichomonas vaginitis and Combination vaginitis are respectively provided with significant therapeutic effect.
2) present invention greatly improves antibacterial effect while reducing lavation time using the coupling of house fly antibiotic peptide xanthans Number, xylo-oligosaccharide is cooperateed with using the generation of gram positive bacterial cell fragment induction intravaginal Bifidobacterium and Bacillus acidi lactici again The function of powerful regulation vaginal flora and vagina acidity, is finally aided with the solvent close with human vagina's secretory component and to the moon Road has the composition of repair, and each component compatibility rationally, is made a distinction between the important and the lesser one, and composition one has sterilized, balance vaginal flora, the moon concurrently The stabilising system of road acidity and reparation vaginal injury function.
3) present component safety non-toxic, preparation method is simple.
Specific embodiment:
Below by way of the description of specific embodiment, the invention will be further described, but this is not to limit of the invention System, those skilled in the art's basic thought of the invention, various modifications may be made or improves, but without departing from this The basic thought of invention, within the scope of the present invention.
The preparation method bibliography of present inventor's diptercin:Zhou Yiwen, Yin Yibing, apply and plant the house fly antibiotic peptides such as light Primary Study [J] China antibiotic magazine of antibacterial activity and antibacterial mechanisms, 2004,5 (29) remaining each raw material sources are in city Sell, such as antibacterial peptide derives from Hai Na rivers medicine company in comparative example 1.
Embodiment 1, a kind of biomimetic type gynaecologic washing lotion
The biomimetic type gynaecologic washing lotion of the present embodiment 1 is composed of the following components:House fly antibiotic peptide 0.1g, xylo-oligosaccharide 6.0g, Huang Virgin rubber 0.1g, NaCl 8.0g, KCl 0.45g, CaCl2 0.15g、NaHCO3 0.4g、MgCl2·6H2O 0.015g、MgSO4· 7H2O 0.05g、KH2PO4 0.06g、Na2HPO4·12H2O 0.06g, glucose 1.0g, urea 1.5g, gram-positive bacterium Cell fragment 0.002g, 1L is settled to deionized water, wherein, the growth factor is by recombinant human epidermal growth factor and restructuring Human alkaline fibroblast growth factor presses 1:, than composition, the gram positive bacterial cell fragment is by bifid bar for 1 weight Bacterium cell fragment and lactobacillus cell fragment press 1:1 weight is than composition.
Preparation method:
A) by NaCl, KCl, CaCl2、NaHCO3、MgCl2·6H2O、MgSO4·7H2O、KH2PO4、Na2HPO4·12H2O、 Urea, gram positive bacterial cell fragment and glucose are dissolved in 800ml deionized waters, are uniformly mixed, and are added water to 1000ml, regulation pH is 3.4, obtains final product manual simulation's vaginal secretion;
B) take xanthans to be dissolved in deionized water, stir, be configured to xanthan gum solution, add house fly antibiotic peptide, Continue to stir 10min, add xylo-oligosaccharide, stirring obtains a mixed liquor;
C) step A is added toward above-mentioned mixed liquor) gained manual simulation's vaginal secretion, to stir, homogenization is obtained final product bionical Type gynaecologic washing lotion.
Embodiment 2, a kind of biomimetic type gynaecologic washing lotion
The biomimetic type gynaecologic washing lotion of the present embodiment 2 is composed of the following components:House fly antibiotic peptide 0.1g, xylo-oligosaccharide 6.0g, Huang Virgin rubber 0.1g, NaCl 8.0g, KCl 0.45g, CaCl2 0.15g、NaHCO3 0.4g、MgCl2·6H2O 0.015g、MgSO4· 7H2O 0.05g、KH2PO4 0.06g、Na2HPO4·12H2O 0.06g, glucose 1.0g, urea 1.5g, gram-positive bacterium Cell fragment 0.002g, water solubility VE0.4g, NMF 0.2g and free amino acid 0.4g, are settled to deionized water 1L, wherein, the growth factor presses 1 by recombinant human epidermal growth factor and recombination human basic fibroblast growth factor:1 Weight presses 1 than composition, the free amino acid by glycine, alanine, asparatate and serine:1:1:1 weight Than composition, the gram positive bacterial cell fragment presses 1 by bifidobacterium cells fragment and lactobacillus cell fragment:1 Weight is than composition.
Preparation method reference implementation example 1.
Embodiment 3, a kind of biomimetic type gynaecologic washing lotion
The biomimetic type gynaecologic washing lotion of the present embodiment 3 is composed of the following components:House fly antibiotic peptide 0.2g, xylo-oligosaccharide 5.0g, Huang Virgin rubber 0.1g, NaCl 8.0g, KCl 0.45g, CaCl2 0.15g、NaHCO3 0.4g、MgCl2·6H2O 0.015g、MgSO4· 7H2O 0.05g、KH2PO4 0.06g、Na2HPO4·12H2O 0.06g, glucose 1.0g, urea 1.5g, gram-positive bacterium Cell fragment 0.001g, water solubility VE 0.4g, NMF 0.2g and free amino acid 0.4g, use deionized water constant volume To 1L, wherein, the growth factor presses 1 by recombinant human epidermal growth factor and recombination human basic fibroblast growth factor:1 Weight than composition, the free amino acid by glycine, alanine, asparatate and serine press 1:1:1:1 weight Amount presses 1 than composition, the gram positive bacterial cell fragment by bifidobacterium cells fragment and lactobacillus cell fragment:1 Weight than composition.
Comparative example 1, a kind of biomimetic type gynaecologic washing lotion
Remove component gram positive bacterial cell fragment, remaining component and its consumption such as embodiment 2.
Preparation method reference implementation example 2.
Comparative example 2, a kind of biomimetic type gynaecologic washing lotion
Remove component urea, remaining component and its consumption such as embodiment 2.
Preparation method reference implementation example 2.
Comparative example 3, a kind of biomimetic type gynaecologic washing lotion
The biomimetic type gynaecologic washing lotion of this comparative example 3 is composed of the following components:House fly antibiotic peptide 0.1g, xylo-oligosaccharide 6.0g, Huang Virgin rubber 0.2g, NaCl 8.0g, KCl 0.45g, CaCl2 0.15g、NaHCO3 0.4g、MgCl2·6H2O 0.015g、MgSO4· 7H2O 0.05g、KH2PO4 0.06g、Na2HPO4·12H2O 0.06g, glucose 1.0g, urea 1.5g, gram-positive bacterium Cell fragment 0.002g, water solubility VE0.4g, NMF 0.2g and free amino acid 0.4g, are settled to deionized water 1L, wherein, the growth factor presses 1 by recombinant human epidermal growth factor and recombination human basic fibroblast growth factor:1 Weight presses 1 than composition, the free amino acid by glycine, alanine, asparatate and serine:1:1:1 weight Than composition, the gram positive bacterial cell fragment presses 1 by bifidobacterium cells fragment and lactobacillus cell fragment:1 Weight is than composition.
Preparation method reference implementation example 2.
Comparative example 3 and the difference of embodiment 2 are the consumption that increased xanthans.
Test example one, stability test
1st, trial target:The embodiment of the present invention 1~3 and the biomimetic type gynaecologic washing lotion of comparative example 1~3.
2nd, test method:By above-mentioned each group washing lotion, constant temperature is placed two weeks at 45 DEG C, then observes each gynaecologic washing lotion proterties Change, test result see the table below 1.
The stability test result of table 1
As shown in Table 1, embodiment 1~3 and the biomimetic type washing lotion of comparative example 1~2 constant temperature at through 45 DEG C place two weeks There is not muddiness, lamination, with good stability, and the constant temperature at 45 DEG C of comparative example 3 has muddy product after placing two weeks Raw, its stability is not so good as remaining each group.
Performance test
Experiment 1, gynaecologic washing lotion of the present invention to gonococcus, staphylococcus aureus, Candida albicans bactericidal effect
1.1 trial targets:The embodiment of the present invention 1~3 and the biomimetic type gynaecologic washing lotion of comparative example 1~2.
1.2 test methods:
(1) aseptic filter paper piece is taken, the every embodiment of the present invention 1~3 and the gynaecologic washing lotion of comparative example 1~2 that 20 μ l are added dropwise will Filter paper is lain against in sterilized petri dishes, is uncapped, standby after spontaneously drying at room temperature;
(2) concentration is 7 × 105The gonococcus of cfu/ml, staphylococcus aureus, Candida albicans bacteria suspension it is each 100 μ l move to nutrient agar planar surface, and uniform application is covered, cultivated at room temperature;
(3) filter paper is placed on the above-mentioned nutrient agar flat board for scribbling different strain, the training of each nutrient agar Support be placed with base flat board 5 respectively drop there is embodiment 1~3 and the cleaning fluid for gynecology filter paper of comparative example 1~2,1 drop to have sterilized water Filter paper (blank group), at a distance of more than 20mm between each filter paper center, and with more than the border 10mm of flat board.Post Afterwards with the light press filtration scraps of paper of tweezers, it is adjacent to, covered;3 repetitions are set per test group, each nutrient agar flat board is placed in Cultivated 24 hours in 37 DEG C of insulating boxs, observe the antibacterial circle diameter size of each group cleaning fluid, take 3 cell means, statistics is shown in Table 2 below.
The bacteriostasis property test result of table 2
As shown in Table 2,1~3 group of embodiment is respectively provided with to staphylococcus aureus, staphylococcus aureus and gonococcus Excellent killing effect, particularly 2 groups of embodiment;Compared with 2 groups of embodiment, it is to three kinds of killings of germ for comparative example 1 and 2 groups Effect decreases.
Trichomonas vaginalis experiment is killed in experiment 2, gynaecologic washing lotion of the present invention
2.1 trial drugs:The embodiment of the present invention 1~3 and the biomimetic type gynaecologic washing lotion of comparative example 1~2 are taken, trial drug is high After pressure sterilizing, the aseptic doubling dilution of difference, highest dilution is 1:16, embodiment 1~3 and the dilution of comparative example 1~2 are obtained, point Do not take in the above-mentioned dilution addition test tubes of 2ml, mark is good standby.
2.2 supply test worm kind:Trichomonas vaginalis, the vagina hair drop provided by clinical hospitals gynemetrics of Chinese Medical Sciences University the 3rd The 30 worms strain being separately cultured in worm patient's vaginal fluid.
2.3 culture mediums:Trichomonas vaginalis culture medium, matches somebody with somebody with reference to clinical medical inspection handbook (publication of Jilin Science Press) Hepar-peptone-glucose medium processed.
2.4 worm kind cultures:Take above-mentioned trichomonas vaginalis and be inoculated in culture medium, per the passage of 3d transferred speciess, stabilization 3 generations of culture are carried out Experiment.
2.5 test methods:Take respectively during the nutrient solution 0.05ml after Secondary Culture 48h adds above-mentioned dilution test tube, gently Jog is even, then toward aseptic hepar-peptone-glucose medium 8ml is added in above-mentioned test tube, 37 DEG C of incubator cultures is placed in, every 24h suction pipes Bottom culture microscopy, even inspection three days, observe polypide survival condition after light liquid is acted on and count the trichomonad death rate, statistics knot respectively Really, such as table 3.
The result of the test of table 3
As shown in Table 3, when trial drug dilution factor is 1:When 1, each group has preferable killing effect to pubes trichomonad, kills Trichomonad effect of going out is ordered as from high to low:The > comparative examples 1 of 1 > comparative examples of embodiment 2 > embodiments, 3 > embodiments 2;Work as investigational agent Thing dilution factor reaches 1:When 16, embodiment 1~3 has the trichomonad of more than half to be killed after dosing 72h, still, and comparative example 1~ 2 after dosing 72h the trichomonad death rate be only 32% and 38%, this explanation 1~3 pair of pubes trichomonad of the embodiment of the present invention have it is excellent Killing effect, wherein it is most notable to have been carried out the killing effect of example 2.
Clinical test
1.1 clinical datas
The voluntary patient of vagina 560 that in May, 2012~2014 year July goes to a doctor in institute of traditional Chinese medicine of Zixing City of Hunan Province, wherein Bacterial vaginitis 160, monilial vaginitis 200, trichomonas vaginitis 80, Combination vaginitis 120.Patient 21~62 years old age, average age 34.6 years old.Medical patient is with different degrees of pruritus vulvue burn feeling, vaginal fluid Increase, waist abdomen pain, leucorrhea increasing proterties change etc. symptom.
1.2 packets and treatment method
All types of vaginitis patients are divided into the treatment group of embodiment 1~3 and routine medication control group, treatment group at random The gynaecologic washing lotion lavation vulva of example 1~3, vagina 5min are applied in receiving, and once a day, 7d is a course for the treatment of.Monilial vagina in control group After inflammation is with 3% sodium bicarbonate solution rinsing vulva, vagina, 200mg Gyno-Daktarins are placed in intravaginal;Bacterial vaginitis with After 1% compound iodine rinsing vulva, vagina, 500mg Flagyl suppositories are placed in intravaginal;Trichomonas vaginitis is rushed with 0.5% acetic acid After washing vulva, vagina, 400mg metronidazole suppositories are placed in intravaginal;Combination vaginitis then uses drug combination.All treatments are equal Once a day, continuous 7d is a course for the treatment of.Respectively before the treatment, 7d checks patient clinical symptom, sign and the moon after the course for the treatment of terminates The change of road secretion.Observation index includes:Vulva is uncomfortable, leukorrhea amount, smell and proterties, and vulva/vagina is congested, oedema, cloudy Road cleannes, pH value, vagina etiological examination etc..
1.3 curative effect determinate standards
4 grades of standards are divided into according to patient symptom, sign and vaginal fluid testing result.1. cure:Through treating clinical condition Shape and Signs are wholly absent, and vaginal fluid etiological examination is negative.2. it is effective:Substantially mitigate through treating clinical symptoms, sign It is clearly better, but is not wholly absent, vaginal fluid etiological examination is negative.3. it is effective:Have through treating clinical symptoms and sign Improved, vaginal fluid etiological examination is negative or positive.3. it is invalid:Even add without improvement through treating clinical symptoms and sign Weight, vaginal fluid etiological examination is the positive.To cure+effective patient's number of cases calculating total effective rate.
2. result is as follows
The bacterial vaginitis therapeutic effect of table 4
The monilial vaginitis therapeutic effect of table 5
The trichomonas vaginitis therapeutic effect of table 6
The Combination vaginitis treatment effect of table 7
Consolidated statement 4~7 understand, through the above-mentioned 4 kinds of vaginitis of 1~3 group for the treatment of of embodiment after, failing to respond to any medical treatment does not occur in patient Situation, and through the gynaecologic washing lotion of the embodiment of the present invention 1~3 cure patient be discontinued after no relapse;Wherein, 1~3 group of embodiment The cure rate for the treatment of bacterial vaginitis, monilial vaginitis, trichomonas vaginitis and Combination vaginitis reaches More than 80%, total effective rate reaches more than 90.0%, significantly larger than control group;Wherein, it is different types of with 2 groups of treatments of embodiment Vaginitis best results, and 2 groups for the treatment of trichomonal vaginitis total effective rates of embodiment are up to 100%, this explanation embodiment of the present invention 1 ~3 pairs of bacterial vaginitis, monilial vaginitis, trichomonas vaginitis and Combination vaginitis are respectively provided with significant treatment Effect.

Claims (8)

1. a kind of biomimetic type gynaecologic washing lotion, it is characterised in that including house fly antibiotic peptide, xylo-oligosaccharide, xanthans and pH be 3.3 ~4.8 manual simulation's vaginal secretion, the house fly antibiotic peptide, xylo-oligosaccharide and xanthans are in manual simulation's vaginal secretion Content in liquid is respectively 0.1~10.0g/L, 5~10.0g/L and 0.05~0.15g/L;Manual simulation's vaginal secretion It is composed of the following components:5~10g/L of NaCl, 0.3~0.5g/L of KCl, CaCl20.1~0.2g/L, NaHCO30.3~ 0.45g/L、MgCl2·6H20.006~0.015g/L of O, MgSO4·7 H20.04~0.08g/L of O, KH2PO40.05~ 0.08g/L、Na2HPO4·12 H20.05~0.08g/L of O, 0.1~2.5g/L of glucose, 0.5~3g/L of urea, gram sun Property 0.001~0.003g/L of bacterial cellular debris and balance deionized water;The gram positive bacterial cell fragment is by double Discrimination bacilli-cell fragment and lactobacillus cell fragment press 1:1 weight is than composition.
2. biomimetic type gynaecologic washing lotion as claimed in claim 1, it is characterised in that the house fly antibiotic peptide, xylo-oligosaccharide and Content of the xanthans in manual simulation's vaginal secretion is respectively 0.1g/L, 6.0g/L and 0.1g/L.
3. biomimetic type gynaecologic washing lotion as claimed in claim 1, it is characterised in that manual simulation's vaginal secretion is by following Component is constituted:NaCl 8.0g/L、KCl 0.45g/L、CaCl2 0.15g/L、NaHCO3 0.4g/L、MgCl2·6H2O 0.015g/L、MgSO4·7H2O 0.05g/L、KH2PO4 0.06g/L、Na2HPO4·12H2O 0.06g/L, glucose 2g/L, Urea 1.5g/L, gram positive bacterial cell fragment 0.002g/L and balance deionized water.
4. biomimetic type gynaecologic washing lotion as claimed in claim 1, it is characterised in that the biomimetic type gynaecologic washing lotion also includes vagina Renovation agent, content of the vagina renovation agent in manual simulation's vaginal secretion is 0.1~2g/L, the vagina reparation Agent is selected from one or more in water solubility VE, NMF and free amino acid.
5. biomimetic type gynaecologic washing lotion as claimed in claim 4, it is characterised in that the vagina renovation agent is by water-soluble VE, day Right moisturizing factor and free amino acid press 1:0.5~1:1~2 weight is than composition.
6. the biomimetic type gynaecologic washing lotion as described in claim 4 or 5, it is characterised in that the free amino acid be selected from glycine, One or more in alanine, asparatate and serine.
7. a kind of preparation method for preparing biomimetic type gynaecologic washing lotion as claimed in claim 1, it is characterised in that including following step Suddenly:
A 5~10g/L of NaCl, 0.3~0.5g/L of KCl, CaCl) are taken20.1~0.2g, NaHCO30.3~0.45g/L, MgCl2·6H20.006~0.015g/L of O, MgSO4·7H20.04~0.08g/L of O, KH2PO40.05~0.08g/L, Na2HPO4·12H20.05~0.08g/L of O, 0.1~2.5g/L of glucose, 0.5~3g/L of urea and gram-positive bacterium 0.001~0.003g/L of cell fragment is dissolved in deionized water, is uniformly mixed, constant volume, and regulation pH is 3.3~4.8, is obtained final product Manual simulation's vaginal secretion;
B) take 0.05~0.15g/L xanthans to be dissolved in deionized water, stir, be configured to xanthan gum solution, add 5~ 10.0g/L house fly antibiotic peptides, continue to stir 10~15min, add 0.1~10.0g/L xylo-oligosaccharides, and stirring obtains a mixed liquor;
C) step A is added toward above-mentioned mixed liquor) gained manual simulation's vaginal secretion, to stir, homogenization obtains final product biomimetic type woman Section's washing lotion.
8. the preparation method of biomimetic type gynaecologic washing lotion as claimed in claim 7, it is characterised in that the step B) in be additionally included in Vagina renovation agent is added after adding house fly antibiotic peptide.
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