CN100457084C - Nanometer silver type external use antibiotic gel for female external use and its prepn. method - Google Patents
Nanometer silver type external use antibiotic gel for female external use and its prepn. method Download PDFInfo
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- CN100457084C CN100457084C CNB2006100199097A CN200610019909A CN100457084C CN 100457084 C CN100457084 C CN 100457084C CN B2006100199097 A CNB2006100199097 A CN B2006100199097A CN 200610019909 A CN200610019909 A CN 200610019909A CN 100457084 C CN100457084 C CN 100457084C
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Abstract
An exterior-applied antibacterial nano-Ag gel for treating the infection of vagina, cervix uteri and skin of woman is proportionally prepared from Ag nanoparticles, carbomer, triethanolamine, hydroxyphenyl ethylester, propanediol, alcohol and water through mixing.
Description
Technical field
The present invention relates to a kind of preparation method of antimicrobial medicine for external use, be mainly used in the infection of woman vagina mucosa and uterus neck or body surface.
Background technology
Women's lower genital tract infection mainly is cervical erosion, cervicitis, all kinds of vaginitis (monilial vaginitis, bacterial vaginitis, trichomonal vaginitis, senile vaginitis, vagina mixed infection etc.) and leucorrhea abnormal, and sickness rate is higher.The treatment medicine for external use has:
Silver has clear and definite wide spectrum antimicrobial, promotes the function of wound healing, nanometer silver is that simple substance silver is made nanoparticle about the about 25nm of particle diameter, be adsorbed on the carrier gel, can fully contact pathogen and rotten to the corn tissue surface, effects such as the broad-spectrum sterilization that performance silver itself is had, convergence, promotion wound healing, treatment cervical erosion.
Number of patent application: the 200410029794.0 (nano silver antimicrobial gels of treatment women ' s genital tract infection, preparation method and application), a kind of externally used antimicrobial nano silver gel of the women's of treatment lower genital tract infection is disclosed, described externally used antimicrobial nano silver gel contains, nano silver colloid, pharmaceutically acceptable excipient, diluent, the particle diameter of described nanometer silver are the 2-25 nanometer.
Though the treatment product is more on the market, the total effective rate of general treatment is undesirable.
Summary of the invention
The object of the present invention is to provide a kind of preparation method for the treatment of the high nanometer silver type external use antibiotic gel for female external use of effective percentage.
To achieve these goals, technical scheme of the present invention is: the preparation method of nanometer silver type external use antibiotic gel for female external use is characterized in that it comprises the steps:
1). by the proportion relation between each raw material be: nanometer silver: carbomer: triethanolamine: ethyl hydroxybenzoate: propylene glycol: 95% ethanol: water=0.1g: 9-11g: 10-12g: 0.9-1.1g: 95-105ml: 190-210ml: 685-715ml chooses nanometer silver, carbomer, triethanolamine, ethyl hydroxybenzoate, propylene glycol, 95% second alcohol and water raw material, and is standby;
2). get carbomer and add 95% ethanol and soak into after 24 hours, add the water logging bubble of (3.9-4.1)/7, become gel substrate after carbomer is fully expanded, leave standstill the final vacuum deaeration;
3). the speed with clockwise 100-130r/min in the gel substrate after vacuum defoamation adds oxybenzene second fat and propylene glycol while stirring, make it uniform mixing after, add triethanolamine neutralization while stirring with identical speed again, gel;
4). get again after purified water that nanometer silver powder adds (1.5-1.7)/7 fully stirs 20 minutes with clockwise 100-130r/min, obtain homodisperse nanometer silver solution, and placed 10 minutes;
5). again with 4) in resulting nanometer silver solution divide in the gel of pouring step 3) for 3 times into, be 3 minutes each blanking time, speed with low speed 110r/min adds while stirring at every turn, add remaining water at last again, governing speed fully stirs with the speed of 120r/min and to make nanometer silver type external use antibiotic gel for female external use after 45 minutes.
The therapeutical effect principle of nanometer silver: silver has clear and definite wide spectrum antimicrobial, promotes the function of wound healing, concrete mechanism is as follows: (1) silver combines with sulfydryl enzyme in the microbial body and makes latter's inactivation, the energy metabolism and the cell wall of blocking-up microorganism are synthetic, play the effect of kill bacteria, virus and eukaryotic microorganisms.(2) silver combines with the metalloproteases that contains sulfydryl, reduces the wound surface zinc ion, increases the wound surface calcium ion, promotes epithelium regeneration and tissue repair, thereby promotes wound and rotten to the corn healing.Nanometer silver is a nanoparticle of simple substance silver being made particle diameter 1-50nm, makes gel and directly injects, and can fully contact pathogen and rotten to the corn tissue surface, effects such as the broad-spectrum sterilization that performance silver itself is had, convergence, promotion wound healing.
Carbomer has good thickening property, gelation, cohesive, emulsibility, suspension and film property, as slow-release material, carrier matrix.Triethanolamine has hygroscopicity, as emulsifying agent.Ethyl hydroxybenzoate uses as antibacterial.Organic solvent propylene glycol Carboxymethyl Chitin makes after the nanometer silver type external use antibiotic gel for female external use external nice and cool lubricated.Ethanol is good organic solvent, and has stronger osmosis, and nanometer silver (disinfectant) is dissolved in the ethanol, and bactericidal action can strengthen.
The present invention adopts and is mixed into gel by nanometer silver, carbomer, triethanolamine, ethyl hydroxybenzoate, propylene glycol, second alcohol and water raw material stirring, directly act on the human body affected part, can form the inhibition of one deck antimicrobial protection film at positions such as infection and inflammation and kill the pathogenic microorganism, thereby reach antibiotic and therapeutic purposes that diminish inflammation; Compared with prior art, percdation of the present invention (subcutaneous 4mm), thoroughly elimination is not recurred, treatment effective percentage height, therapeutic effect is remarkable.
Using method: local topical, after gel makes, can divide to install in the injector every 2-10g.Tear packing before the use, take out the injector (as Fig. 1) that antibacterial gel is housed.After cleaning pudendum before sleeping every night, take medicated cap 1 earlier, the protecgulum 5 of injector front end is taken off, insert the injector rear end and promote piston 2 as piston push rod the wicked women externally used antimicrobial gels of the nanometer silver in the gel chamber 4 of body 3 are released; Adopt dorsal position, knee bends is slowly inserted vagina with the injector that is loaded with nanometer silver type external use antibiotic gel for female external use, promotes piston push rod with forefinger, and nanometer silver type external use antibiotic gel for female external use is pushed vagina, has injected the back and has extracted injector out, abandons it.Each 2-10g, once a day, 6 days is a course of treatment.
Antibiotic classification: staphylococcus aureus, escherichia coli, Candida albicans, fungus etc. are had very strong antibacterial action.
Cure mainly: be used for the treatment of cervical erosion, cervicitis, all kinds of vaginitis (monilial vaginitis, bacterial vaginitis, trichomonal vaginitis, senile vaginitis, vagina mixed infection etc.) and leucorrhea abnormal; And the infection of body surface.
Points for attention: 1. the silver allergy sufferers is forbidden.
2. this product only is for external application antibioticly, please don't take orally.
3. share with the product that contains vaseline, chlorine, iodine, hydrogen peroxide, antibacterial efficacy can weaken.
4. anemia of pregnant woman and women breast-feeding their children's safety is not established as yet, so Ying Shen
5. forbidding when this product character changes.
6. the child must use under adult's monitoring.
7. please this product is placed on the place that the child can not contact.
Description of drawings
Fig. 1 is the structural representation of injector of the present invention
Among the figure: 1-medicated cap, 2-piston, 3-body, 4-gel chamber, 5-protecgulum.
The specific embodiment
In order to understand the present invention better, further illustrate content of the present invention below in conjunction with embodiment, but content of the present invention not only is confined to the following examples.
Embodiment 1:
Nanometer silver type external use antibiotic gel for female external use, it mainly is mixed into gel by nanometer silver, carbomer, triethanolamine, ethyl hydroxybenzoate, propylene glycol, second alcohol and water raw material stirring, and the proportion relation between each raw material is: nanometer silver: carbomer: triethanolamine: ethyl hydroxybenzoate: propylene glycol: ethanol: water=0.1g: 9g: 10g: 0.9g: 95ml: 190ml: 715ml.Water is deionized water or distilled water (purified water).
The preparation of above-mentioned nanometer silver type external use antibiotic gel for female external use, it comprises the steps:
A. get carbomer 9g and add 190ml 95% ethanol and soak into after 24 hours, the purified water that adds 400ml is soaked, and becomes gel substrate after carbomer is fully expanded, and leaves standstill the final vacuum deaeration;
B. the speed with 100-130r/min (clockwise) adds 0.9g oxybenzene second fat and 95ml propylene glycol while stirring in the gel substrate after vacuum defoamation, make it uniform mixing after, add 10g triethanolamine neutralization while stirring with identical speed again;
C. get nanometer silver powder 0.1g again, after the purified water that adds 160ml fully stirs 20 minutes with 100-130r/min (clockwise), obtain homodisperse nanometer silver solution, and place 10 minutes no silver particles and separate out and be the best;
D. more resulting nanometer silver solution among the c is divided 3 times (are 3 minutes each blanking time) to pour in the gel, sneak into too much bubble for avoiding vigorous stirring.At every turn the speed with low speed 110r/min adds while stirring, adds remaining purified water at last again, and governing speed fully stirs with the speed about 120r/min and to make nanometer silver type external use antibiotic gel for female external use after 45 minutes.
Embodiment 2:
The wicked women externally used antimicrobial gel of nanometer silver, it mainly is mixed into gel by nanometer silver, carbomer, triethanolamine, ethyl hydroxybenzoate, propylene glycol, second alcohol and water raw material stirring, and the proportion relation between each raw material is: nanometer silver: carbomer: triethanolamine: ethyl hydroxybenzoate: propylene glycol: ethanol: water=0.1g: 10g: 11g: 1g: 100ml: 200ml: 700ml.Water is deionized water or distilled water (purified water).
The preparation of above-mentioned nanometer silver type external use antibiotic gel for female external use, it comprises the steps:
A. get carbomer 10g and add 200ml 95% ethanol and soak into after 24 hours, the purified water that adds 400ml is soaked, and becomes gel substrate after carbomer is fully expanded, and leaves standstill the final vacuum deaeration; (annotating: in the existing gel bubble is arranged);
B. the speed with 100-130r/min (clockwise) adds 1g oxybenzene second fat and 100ml propylene glycol while stirring in the gel substrate after vacuum defoamation, make it uniform mixing after, add 11g triethanolamine neutralization while stirring with identical speed again, gel;
C. get nanometer silver powder 0.1g again, after the purified water that adds 160ml fully stirs 20 minutes with 100-130r/min (clockwise), obtain homodisperse nanometer silver solution, and place 10 minutes no silver particles and separate out and be the best;
(annotate: prior art is difficult to solve the agglomeration problem of nanomorphic material, mainly be fully and evenly to stir, the present invention is by a large amount of analysis of experimentss, draw above rotating speed and time, through the resulting nanometer silver solution of this mode is the most stable, thereafter after it being joined gel, the easier nanometer silver that makes is uniformly dispersed, the feasible gel nanometer silver concentration unanimity that is used for human body at last.)
D. more resulting nanometer silver solution among the c is divided 3 times (are 3 minutes each blanking time) to pour in the gel, sneak into too much bubble for avoiding vigorous stirring, speed with low speed 110r/min adds while stirring at every turn, add remaining purified water at last again, governing speed fully stirs with the speed about 120r/min and to make nanometer silver type external use antibiotic gel for female external use after 45 minutes.
(annotate: the present invention is after test of many times is analyzed, the mode of this adding nanometer silver solution that forms and the rotating speed and the time of stirring, only its medicament contg of antibacterial gel of gained is the most uniform after measured under this mixed prescription formula, also has only and just can avoid entering in the gel bubble in this manner)
Annotate: as containing bubble, can cause in the gel:
1. storage is recommended in the process and is raise as temperature, gel Peng is expanded overflow, and causes the seal failure of powder charge utensil, may cause external microbial to pollute.
2. if any bubble, in use dosage is inaccurate inconsistent with local drug concentration can to cause the patient, causes the thorough or delay treatment of sterilization.
Because the material of nanomorphic is coalescent easily, so be difficult to be uniformly dispersed, therefore the present invention is dispersed in the stable solution of formation in the pure water with nanometer silver powder earlier, reuse nanometer silver solution dispersing nanometer silver is in gel, this directly adds nanometer silver powder in the gel than domestic many enterprises and stirs, and the concentration of resulting gel nanometer silver is more even.This might be initiative at home!
Rotating speed in the technology that the present invention is found out from the mass production process and time and reinforced method (comprise interval, number of times) the antibacterial gel character of gained is the most stable, nanometer silver concentration is the most even, gel outward appearance the most nice (no bubble, color and luster is even, and----is faint yellow)
Embodiment 3:
Nanometer silver type external use antibiotic gel for female external use, it mainly is mixed into gel by nanometer silver, carbomer, triethanolamine, ethyl hydroxybenzoate, propylene glycol, second alcohol and water raw material stirring, and the proportion relation between each raw material is: nanometer silver: carbomer: triethanolamine: ethyl hydroxybenzoate: propylene glycol: ethanol: water=0.1g: 11g: 12g: 1.1g: 105ml: 210ml: 685ml.
Its preparation is substantially the same manner as Example 2, just the proportion relation difference between each raw material.
The foregoing description 2 prepared nanometer silver type external use antibiotic gel for female external use are used for the treatment clinical observation of cervical erosion:
1, object: the cervical erosion person that outpatient service is gone to a doctor is totally 205 examples, 20-45 year.The temporary dwelling palace jugular sclerite is got rid of canceration, and the vaginal secretions smear is got rid of infusorian, monilial infection.
2, diagnostic criteria:
Be divided into slight erosion according to rotten to the corn area: rotten to the corn area is less than 1/3 of the cervix uteri area; The moderate erosion: rotten to the corn area accounts for the 1/3-2/3 of the cervix uteri gross area; Heavily fill erosion: rotten to the corn area is less than 2/3 of the cervix uteri gross area.Be divided into three types according to the rotten to the corn degree of depth, simple type: erosion has smooth; Granular pattern: the uneven graininess that presents of rotten to the corn face; Nipple type: the uneven papillary that is of rotten to the corn face.
3, this group case classification, typing see Table 1.
Table 1, the classification of 205 routine cervical erosion, typing
Simple type | Granular pattern | The nipple type | Add up to | |
Slightly | 23 | 10 | 20 | 53 |
Moderate | 27 | 44 | 52 | 123 |
Severe | 15 | 8 | 6 | 29 |
Add up to | 65 | 62 | 78 | 205 |
4, clean 3 days afterwash pudendums of patient's menstruation, the injector that is loaded with nanometer silver type external use antibiotic gel for female external use is slowly inserted vagina, promote piston push rod with forefinger, nanometer silver type external use antibiotic gel for female external use is pushed vagina, go into 1 before sleeping every night, 6 times is 1 course of treatment, shared 1 course of treatment, prohibits sexual life during the treatment.
5, curative effect judging standard
Recovery from illness: symptom and sign disappears, rotten to the corn face healing, and cervix uteri is smooth.Produce effects: symptom and sign is clearly better, and rotten to the corn area dwindles more than 1/2, and moderate transfers to slightly, severe transfers moderate to.Effectively: symptom and sign has improvement slightly, or rotten to the corn area dwindle<1/2, or the mastoid process type transfers granular pattern to, granular pattern transfers simple type to.Invalid: symptom and sign does not have improvement, rotten to the corn area no change.Cure rate=routine the number of fully recovering/total on the same group routine number * 100%.Obvious effective rate=(the routine number of fully recovering+produce effects example number)/total on the same group routine number * 100%.Effective percentage=(recovery from illness+produce effects+effective routine number)/total on the same group routine number * 100%.
6, observe the visible nanometer silver type external use antibiotic gel for female external use of medication result's 1 course of treatment to the symptom of cervical erosion as: leucorrhoea grow in quantity, pruritus vulvae, lower abdomen weigh down and expand and the total effective rate of contact bleeding can be up to 100%; Total effective rate to slight, moderate, the rotten to the corn treatment of severe is respectively 100%, 99.19%, 93.10%.
Claims (1)
1. the preparation method of nanometer silver type external use antibiotic gel for female external use is characterized in that it comprises the steps:
1). by the proportion relation between each raw material be: nanometer silver: carbomer: triethanolamine: ethyl hydroxybenzoate: propylene glycol: 95% ethanol: water=0.1g: 9-11g: 10-12g: 0.9-1.1g: 95-105ml: 190-210ml: 685-715ml chooses nanometer silver, carbomer, triethanolamine, ethyl hydroxybenzoate, propylene glycol, 95% second alcohol and water raw material, and is standby;
2). get carbomer and add 95% ethanol and soak into after 24 hours, add the water logging bubble of (3.9-4.1)/7, become gel substrate after carbomer is fully expanded, leave standstill the final vacuum deaeration;
3). the speed with clockwise 100-130r/min in the gel substrate after vacuum defoamation adds oxybenzene second fat and propylene glycol while stirring, make it uniform mixing after, add triethanolamine neutralization while stirring with identical speed again, gel;
4). get again after purified water that nanometer silver powder adds (1.5-1.7)/7 fully stirs 20 minutes with clockwise 100-130r/min, obtain homodisperse nanometer silver solution, and placed 10 minutes;
5). again with 4) in resulting nanometer silver solution divide in the gel of pouring step 3) for 3 times into, be 3 minutes each blanking time, speed with low speed 110r/min adds while stirring at every turn, add remaining water at last again, governing speed fully stirs with the speed of 120r/min and to make nanometer silver type external use antibiotic gel for female external use after 45 minutes.
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CN1169529C (en) * | 2001-04-20 | 2004-10-06 | 朱红军 | Nanometer silver antimicrobial inflammation-relieving gel for curing prostatitis and its industrial production process |
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