CN1672689A - Nano silver antiseptic gel for treating women's genital tract infection and its prepn and application - Google Patents
Nano silver antiseptic gel for treating women's genital tract infection and its prepn and application Download PDFInfo
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Abstract
The present invention discloses one kind of nanometer antiseptic silver gel for external application to treat women's genital tract infection. The nanometer antiseptic silver gel contains nanometer silver colloid of silver particles in size 1-20 nm, pharmaceutically acceptable excipient and diluent. The present invention also discloses the preparation process and application of the gel. The product of the present invention is applied through vagina to treat vaginitis, cervicitis or mixed infection, and may be used as externally applied medicine for treating skin infection and surgical infection and as the antiseptic component in cosmetics.
Description
Technical field
The present invention relates to a kind of medicine of the women's of treatment lower genital tract infection, specifically a kind of externally used antimicrobial nano silver gel for the treatment of women's lower genital tract infection.The invention still further relates to the preparation method and the application of this medicine.
Background technology
Women's lower genital tract infection mainly is vaginitis and cervicitis, and sickness rate is higher, physical and mental health to women and kinsfolk thereof affects greatly, and at present, the treatment product is more on the market, be divided into direct administration or indirect administration type, but its active ingredient is the antibiotic of common broad-spectrum antiseptic, and life-time service is easy to generate Drug resistance, and can have side effects to human body, so the general treatment effect is bad, treatment cycle is long, and the relapse rate height.
Dermatosis also is that a kind of morbidity is wider, the bigger disease of treatment difficulty, and a lot of dermatosiss lack the specific antibacterial medicine.
At present, the nanometer silver of prior art is a kind of of nano material.Mostly all with the nanometer silver material attached on the fabric, form antibiotic fabric, be applied to various antibiotic occasions again.
In Chinese invention patent application CN01110767.7, a kind of antimicrobial nano argentum powder is disclosed, mainly be to be attached with ultra micron silver between the fiber element method of natural porous crack vegetable material with on the fiber, its particle diameter is the 1-100 nanometer, the top layer of this ultra micron silver is the silver oxide of 2-8 nanometer, and core is an elemental silver.The particle diameter distribution broad of described nanometer silver.
Disclosing with above-mentioned antimicrobial nano silver powder in Chinese invention patent application CN01129507.4 is active ingredient, the nanometer silver antimicrobial inflammation-relieving gel for curing prostatitis of making, because described nanometer silver is a powdery, so in the feedstock production process, will add surfactant, dispersant, composition are complicated, and in the course of processing, need heating, technology is complicated.
Korean Patent PCT/KR2003/002855 discloses a kind of nano silver colloid, its nanoparticle size is the 1-20 nanometer, colloidal carrier is a silica gel, the silver content of described nano silver colloid can reach 1000-50000ppm, the anti-microbial property of this nano silver colloid is better, be applied on various fibers or the article of everyday use,, but openly be not applied to treat the situation of women's lower genital tract infection as the composition of antibiotic and sterilizing.
Summary of the invention
The present invention has overcome the shortcoming of prior art, and a kind of externally used antimicrobial nano silver gel of the women's of treatment lower genital tract infection is provided.
The present invention also provides the preparation method of above-mentioned externally used antimicrobial nano silver gel.
The present invention also provides above-mentioned externally used antimicrobial nano silver gel in the application as treatment women lower genital tract infection medicine.
The present invention also provides above-mentioned externally used antimicrobial nano silver gel at conduct treatment department of dermatologry, or the application of the medicine of surgical infection.
The present invention also provides above-mentioned externally used antimicrobial nano silver gel in the application as the antibiotic composition in the cosmetics.
In order to achieve the above object, the antimicrobial nano silver gel among the present invention contains nano silver colloid, and pharmaceutically acceptable excipient and diluent, the particle diameter of described nanometer silver are the 1-20 nanometer.
Described antimicrobial nano silver gel also comprises dispersant 1-5ppm, and described dispersant is a medicinal surfactant, as: dodecyl sodium sulfate.
Described antimicrobial nano silver gel also comprises wetting agent 1% (percentage by weight), and described wetting agent can be a glycerol.
The content of the nanometer silver in the described nano silver gel is 10ppm-2000ppm, preferred 10-800ppm.
Described excipient comprises carbomer, Polycarbophil or Polyethylene Glycol, or at least a in the above material, but also several mix and use.The content of described excipient is weight percentage and is 1%-5%.
Also comprise diluent in the described nano silver gel, described diluent can be a water, such as: deionized water or distilled water, perhaps acceptable diluent on other medical science or the cosmetics makes the content of nanometer silver reach desired amount.
The externally used antimicrobial nano silver gel of the treatment women lower genital tract infection among the present invention, its preparation method is: will contain nano silver colloid that the nanometer silver particle diameter is the 1-20 nanometer and excipient, diluent, add in the agitator, stirring at normal temperature 30 minutes to 6 hours, mix, form gel; Promptly form antimicrobial nano silver gel of the present invention, packing gets final product then.
If in the prescription dispersant and wetting agent are arranged, can add together with other raw materials, mix.
After gel makes, can divide to install to in the gel device, described is special to gel device, similar to ordinary syringe, just use in order to be fit to vagina administration, its external diameter is thinner, and length is longer, mainly by blocking a shot, give gel body, push rod three parts to form, giving the gel body is a hollow circular cylinder, and block of drive end bearing bracket is equipped with the antimicrobial nano silver gel in the gel body, be inserted with push rod in the middle of giving the gel body, can the antimicrobial nano silver gel directly be pushed into the vagina deep by push rod.
After gel makes, also can divide to install in the plastic-aluminum pipe, be used for department of dermatologry or surgical infection.
Antibiotic mechanism of the present invention is as follows:
Nanometer silver by in the enzyme of depending on for existence in the thalline-the SH group converts to-SAg, makes the enzyme loss of activity, cause pathogenic bacteria death, and its product is enzyme-2SAg and H
2There is not the secondary paathogenic factor in O.
2. the Peptidoglycan combination on nanometer silver and the bacteria cell wall, blocking-up oxygen enters outside bacterial cell in the cell, makes the antibacterial can't metabolism death.
3. the DNA combination of nanometer silver and pathogen, the dna double chain separates when stoping pathogenic bacteria to be duplicated, thereby kills pathogen.
Product of the present invention, to treatment women lower genital tract infection, as: vaginitis, cervicitis or mixed infection etc., have excellent curative effect, can pass through the direct administration of vagina, because the particle diameter of nano silver particles of the present invention is little, the particle diameter of nanometer silver is the 1-20 nanometer, narrowly distributing, specific surface area is big, so that be in the atomic number of surface layer and increase sharply, cause former coordination deficiency, unsaturated bond exposes and increases, and the surface energy of atom increases, so have extremely strong chemism, add that particle diameter is little, so good penetrability can directly act on the affected part, broad-spectrum antiseptic, to gram-positive bacterium, gram negative bacteria, fungus, multiple pathogen such as infusorian all has stronger inhibition or killing action, and avirulence, no anaphylaxis, nonirritant.So product of the present invention is rapid-action, good effect has no side effect, and does not influence vagina normal flora and vagina acid-base value, and bactericidal action is not influenced by pH value.
Product of the present invention, preparation method is simple, and product can be encased in in the gel device, is directly used in patient part, uses simple, convenient.
Product of the present invention is except being used for the treatment of women's lower genital tract infection; also can be used for infection such as department of dermatologry, surgery are treated; can also be used for cosmetics; play antibacterial action; protection skin; for example: vermiform mite dermatitis and acne vulgaris are common skin diseases, and very the nanometer silver of low concentration all has very strong inhibition or killing action to vermiform mite, propionibacterium acnes, pityrosporum furfur, staphylococcus epidermidis.A small amount of nanometer silver infiltrates skin, and the reaction that reduces inflammation promotes the skin lesion healing.Nano silver gel is easy to use, and skin is not had zest.The human body skin contact test proves this gel to the human body skin nonirritant, and has high-efficiency antimicrobial, so for the infection of department of dermatologry and surgery and the protection of skin more significantly effect is arranged all.
The experiment of chmice acute oral toxicity: oral administration is observed after 14 days after taking the nanometer silver of 5000mg/kg body weight for 10 mices (each 5 of male and female), and all mices all survive, and body weight gain is normal.
Description of drawings
Fig. 1 structural representation of giving gel device of the present invention.
The specific embodiment
In conjunction with experimental data, will be described in detail the specific embodiment of the present invention.
One of raw material in the present embodiment: nano silver colloid can be outsourcing, and manufacturer is a Korea S NANUX.INC company, and this product is accredited as food grade products by U.S. food and FAD (FDA) inspection center.Other raw materials are pharmaceutically acceptable raw material.
Embodiment 1
Ingredients: nano silver colloid: contain nanometer silver particle diameter 1-20 nanometer, content of nanometer silver 35000ppm, 10g;
Polyethylene Glycol: 10g
Glycerol: 10g
Deionized water: 970g
Dodecyl sodium sulfate: 0.005g
Above raw material is added in the agitator, stirred 2 hours, make its mix homogeneously, form gel; Divide then to install to, add outer package, obtain containing the gel of nanometer silver 350ppm, whenever give dress 3g product in the gel device in the gel device.The described gel device of giving, as shown in Figure 1, mainly by block 1, forms for gel body 2, push rod 3 three parts, are hollow circular cylinders to gel body 2, long is 10-12cm, external diameter is 11mm, and front end is a spherical surface, and a hole is arranged on spherical surface, at block 1 of hole loam cake, the antimicrobial nano silver gel is housed in the gel body 2, in the middle of giving gel body 2, is inserted with push rod 3, can gel be released by push rod 3.
Embodiment 2
Ingredients: nano silver colloid: contain nanometer silver particle diameter 1-20 nanometer, content of nanometer silver 4000ppm, 10g;
Polycarbophil: 20g
Glycerol: 10g
Deionized water: 960g
Dodecyl sodium sulfate: 0.003g
Other conditions are with embodiment 1, and just mixing time is 1 hour, obtains containing the gel of nanometer silver 40ppm.
Embodiment 3
Ingredients: nano silver colloid: contain nanometer silver particle diameter 1-20 nanometer, content of nanometer silver 1000ppm, 10g;
Carbomer: 30g
Glycerol: 10g
Deionized water: 950g
Dodecyl sodium sulfate: 0.001g
Other conditions are with embodiment 1.Just mixing time is 0.5 hour, obtains containing the gel of nanometer silver 10ppm.
Embodiment 4
Ingredients: nano silver colloid: contain nanometer silver particle diameter 1-20 nanometer, content of nanometer silver 20000ppm, 100g;
Polyethylene Glycol: 40g
Glycerol: 10g
Deionized water: 850g
Dodecyl sodium sulfate: 0.005g
Other conditions are with embodiment 1.Just mixing time is 3 hours, divides then to install in the plastic-aluminum pipe, adds outer package, obtains containing the gel of nanometer silver 2000ppm.
Embodiment 5
Ingredients: nano silver colloid: contain nanometer silver particle diameter 1-20 nanometer, content of nanometer silver 1000ppm, 50g;
Polyethylene Glycol: 20g
Glycerol: 10g
Deionized water: 920g
Dodecyl sodium sulfate: 0.002g
Other conditions are with embodiment 1.Just mixing time is 2 hours, divides then to install in the plastic-aluminum pipe, adds outer package, obtains containing the gel of nanometer silver 50ppm.
Embodiment 6
Ingredients: nano silver colloid: contain nanometer silver particle diameter 1-20 nanometer, content of nanometer silver 8000ppm, 100g;
Polyethylene Glycol: 20g
Glycerol: 10g
Deionized water: 870g
Dodecyl sodium sulfate: 0.004g
Other conditions are with embodiment 1.Just mixing time is 3 hours, divides then to install in the plastic-aluminum pipe, adds outer package, obtains containing the gel of nanometer silver 800ppm.
Effect example 1
Zhujiang Hospital, No.1 Military Medical Univ. doctor religion portion provides clinical experiment, and used product be the product of embodiment 1, and the patient of use product is 92 examples, vaginitis 47 examples wherein, cervicitis 42 examples, mixed infection 3 examples.Experimental technique is: utilize every night to gel device antibacterial gel is pushed into the vagina deep, 1 every night, logotype 6 days was a course of treatment, finished check in back 7 days.Resulting the results are shown in Table 1 and table 2 shown in.
The externally used antimicrobial nano silver gel of table 1 embodiment 1 is treated colpitic effect
| Type | Total routine number | Routine hundreds of proportion by subtraction % fully recovers | Produce effects | Take a turn for the better | Invalid | Effective percentage % | |
| Monilial vaginitis | ???20 | ????16 | ???80.0 | ????3 | ???1 | ????0 | ???95.0 |
| Bacterial vaginitis | ???16 | ????13 | ???81.3 | ????2 | ???1 | ????0 | ???93.8 |
| Trichomonal vaginitis | ???11 | ????9 | ???81.8 | ????2 | ???0 | ????0 | ???100.0 |
| Add up to | ???47 | ????38 | ???80.9 | ????7 | ???2 | ????0 | ???95.7 |
The effect of the externally used antimicrobial nano silver gel treatment cervicitis of table 2 embodiment 1
| Type | Total routine number | Recovery from illness | Produce effects | Effectively | Invalid | Effective percentage % | |
| Slightly | Simple type | ????15 | ???12 | ????2 | ???0 | ???1 | ???93.3 |
| Granular pattern | ????0 | ???0 | ????0 | ???0 | ???0 | ???- | |
| Moderate | Simple type | ????11 | ???3 | ????8 | ???0 | ???0 | ???100.0 |
| Granular pattern | ????6 | ???0 | ????2 | ???1 | ???3 | ???50.0 | |
| Severe | Simple type | ????3 | ???2 | ????1 | ???0 | ???0 | ???100.0 |
| Granular pattern | ????7 | ???0 | ????3 | ???2 | ???2 | ???71.4 | |
| Add up to | ????42 | ???17 | ????16 | ???3 | ???6 | ???85.7 | |
For the patient of 3 routine mixed infections, wherein 1 example suffers from bacterial vaginitis, trichomonal vaginitis, moderate cervical erosion simultaneously, and through the treatment of 1 course of treatment, bacterial vaginitis produce effects, trichomonal vaginitis recovery from illness, moderate cervical erosion transfer to slightly; 1 example is the patient of bacterial vaginitis, monilial vaginitis, moderate and severe cervical, and through the treatment of 1 course of treatment, bacillary cloudy recovery from illness, candidiasis are turned out cloudy, the rarely seen hyperemia of cervix uteri; 1 routine patient has infected trichomonal vaginitis and mycoplasma simultaneously in addition, and through the treatment of 1 course of treatment, infusorian and mycoplasma all transfer the moon to.
Effect example 2
By new medicament screen key lab of Inst. of Medicinal Biological Technology, Chinese Academy of Medical Sciences country the product of embodiment 1 is carried out the in-vitro antibacterial test, result of the test is as shown in table 3.
The externally used antimicrobial nano silver gel in-vitro antibacterial result of the test of table 3 embodiment 1
| Test strain | Antibacterial circle diameter (mm) | |||
| Experimental result | Meansigma methods | |||
| Staphylococcus aureus | ???17.0 | ???16.6 | ????16.5 | ????16.7 |
| Escherichia coli | ???15.2 | ???15.1 | ????15.9 | ????15.4 |
| Bacillus pyocyaneus | ???16.2 | ???15.3 | ????15.7 | ????15.7 |
| Candida albicans | ???16.5 | ???17.1 | ????17.1 | ????16.9 |
As seen, antimicrobial nano silver gel of the present invention is to staphylococcus aureus, escherichia coli, and bacillus pyocyaneus, Candida albicans all has comparatively obvious suppression effect.
Effect example 3
Product to embodiment 2 carries out the in-vitro antibacterial test, and result of the test is as shown in table 4.
The externally used antimicrobial nano silver gel in-vitro antibacterial result of the test of table 4 embodiment 2
| Strain name | Action time | ||
| The former bacterium amount that connects | Act on bacterium amount after 2 minutes | Act on bacterium amount after 5 minutes | |
| Staphylococcus aureus (CFU/ml) | ????6.5×10 6 | ????5.5×10 3 | ????3.0×10 3 |
| Escherichia coli (CFU/ml) | ????7.7×10 6 | ????6.0×10 3 | ????4.0×10 2 |
| Bacillus pyocyaneus (CFU/ml) | ????1.8×10 6 | ????2.3×10 3 | ????9.0×10 |
As seen, antimicrobial nano silver gel of the present invention all has comparatively obvious suppression effect to staphylococcus aureus, escherichia coli, bacillus pyocyaneus.
Effect example 4
Product to embodiment 3 carries out the in-vitro antibacterial test, and result of the test is as shown in table 5.
The externally used antimicrobial nano silver gel in-vitro antibacterial result of the test of table 5 embodiment 3
| Action time | |||
| Strain name | The former bacterium amount that connects | Act on bacterium amount after 10 minutes | Blank |
| Staphylococcus aureus (CFU/ml) | ????1.4×10 5 | ??????＜10 | ????3.6×10 5 |
| Erichsen escherichia coli (CFU/ml) | ????1.5×10 5 | ??????＜10 | ????2.7×10 5 |
As seen, antimicrobial nano silver gel of the present invention is to staphylococcus aureus, and the Erichsen escherichia coli all have comparatively obvious suppression effect.
Effect example 5
Product to embodiment 5 carries out human body skin contact experiment, and 20 routine objects do not have skin irritation, and the contact skin result of experiment is all negative.
Effect example 6
Zhujiang Hospital, No.1 Military Medical Univ.'s department of dermatologry provides clinical experiment, treats the curative effect of acne vulgaris and the clinical experiment of safety with the product of embodiment 1, and MethodsThe cases enrolled is totally 30 examples, wherein male 14 examples, women 16 examples, 15～34 years old age, average 21 years old, the shortest 2 weeks of the course of disease, the longest 10 years; Patient's skin lesion mainly is positioned at facial area, several 30 of average skin lesion.Experimental technique is: the proper amount of nano silver gel is applied in the affected part, every day 3～4 times, used continuously for 2～4 weeks (or to skin lesion disappear fully).Treatment finishes back 1 week check, observes skin lesion and changes and the itemized record untoward reaction.Experimental result is as shown in table 6 below:
The curative effect of the externally used antimicrobial nano silver gel treatment acne vulgaris of table 6 embodiment 1
| Calibration | The example number | Base more | Produce effects | Take a turn for the better | Invalid | Effective percentage (%) |
| ???I | ???12 | ????2 | ???9 | ???1 | ????0 | ????92 |
| ???II | ???17 | ????1 | ???13 | ???3 | ????0 | ????82 |
| ???III | ???1 | ????0 | ???1 | ???0 | ????0 | ????1/1 |
| Add up to | ???30 | ????3 | ???23 | ???4 | ????0 | ????87 |
By above result as can be known, nano silver gel is to the treatment acne vulgaris, and effect is very obvious.
There is not 1 routine patient any untoward reaction to occur in the therapeutic process.
Effect example 7
Zhujiang Hospital, No.1 Military Medical Univ.'s department of dermatologry provides clinical experiment, treats the curative effect of vermiform mite dermatitis and the clinical experiment of safety with the product of embodiment 1, and MethodsThe cases enrolled is totally 31 examples, wherein male 17 examples, women 14 examples, 15～48 years old age, The median age 23 years old, the shortest 1 week of the course of disease.Experimental technique is: the proper amount of nano silver gel is applied in the affected part, and every day 3～4 times, 2～4 weeks were a course of treatment.Treatment finishes back 1 week check, observes skin lesion and changes and the itemized record untoward reaction.Experimental result is as shown in table 7 below:
The curative effect of the externally used antimicrobial nano silver gel treatment vermiform mite dermatitis of table 7 embodiment 1
| Calibration | The example number | Base more | Produce effects | Effectively | Invalid | Effective percentage (%) |
| ??I | ???18 | ????1 | ???13 | ????4 | ????0 | ?????77 |
| ??II | ???13 | ????1 | ???10 | ????2 | ????0 | ?????85 |
| Add up to | ???31 | ????2 | ???23 | ????6 | ????0 | ?????81 |
By above result as can be known, nano silver gel is to treatment vermiform mite dermatitis, and effect is very obvious.There is not 1 routine patient any untoward reaction to occur in the therapeutic process.
Claims (12)
1, a kind of externally used antimicrobial nano silver gel for the treatment of women's lower genital tract infection contains nano silver colloid, pharmaceutically acceptable excipient, diluent, and the particle diameter of described nanometer silver is the 1-20 nanometer.
2, externally used antimicrobial nano silver gel according to claim 1, the content that it is characterized in that the nanometer silver in described nano silver gel is 10ppm-2000ppm.
3, externally used antimicrobial nano silver gel according to claim 1 and 2 is characterized in that described excipient comprises carbomer, Polycarbophil or Polyethylene Glycol, or at least a in the above material.
4, externally used antimicrobial nano silver gel according to claim 3, the content that the it is characterized in that described excipient 1%-5% that is weight percentage.
5, externally used antimicrobial nano silver gel according to claim 1 and 2 is characterized in that described diluent is deionized water or distilled water.
6, externally used antimicrobial nano silver gel according to claim 1 and 2 is characterized in that containing dispersant 1-5ppm in the described nano silver gel, and described dispersant is a medicinal surfactant.
7, externally used antimicrobial nano silver gel according to claim 1 and 2 is characterized in that containing wetting agent in the described nano silver gel.
8, the preparation method of the externally used antimicrobial nano silver gel of the arbitrary described treatment women lower genital tract infection of claim 1 to 7, may further comprise the steps: will contain the nano silver colloid that the nanometer silver particle diameter is the 1-20 nanometer, excipient, diluent, add in the agitator, mix, form gel.
9, the preparation method of externally used antimicrobial nano silver gel according to claim 8 is characterized in that, also comprises described gel branch is installed in the container.
10, the preparation method of externally used antimicrobial nano silver gel according to claim 9 is characterized in that, described container is that external use for woman is given gel device or plastic-aluminum pipe.
11, the application of the externally used antimicrobial nano silver gel of the arbitrary described treatment women lower genital tract infection of claim 1 to 7 is characterized in that, can pass through vagina administration, as treatment gynecology colpitis, the medicine of cervicitis or mixed infection.
12, the application of the externally used antimicrobial nano silver gel of the arbitrary described treatment women lower genital tract infection of claim 1 to 7 is characterized in that described gel is used for the medicine as treatment department of dermatologry or surgical infection, perhaps as the antimicrobial component in the cosmetics.
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| CN106074364A (en) * | 2016-07-20 | 2016-11-09 | 国家纳米科学中心 | A kind of antibacterial gel containing nanometer gold |
| CN107281095A (en) * | 2017-06-26 | 2017-10-24 | 尚蒙科技无锡有限公司 | A kind of gynaecology conserves gel with antibacterial |
| CN110625130A (en) * | 2019-10-11 | 2019-12-31 | 深圳埃米迦医药生物科技有限公司 | Eimeria silver, external gel of Eimeria silver, preparation method and application |
| CN110625130B (en) * | 2019-10-11 | 2022-03-18 | 深圳埃米迦医药生物科技有限公司 | Eimeria silver, external gel of Eimeria silver, preparation method and application |
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