CN102872159A - Nano-silver chitosan gel foam preparation for treating vaginal bacterial inflammation, and preparation method thereof - Google Patents
Nano-silver chitosan gel foam preparation for treating vaginal bacterial inflammation, and preparation method thereof Download PDFInfo
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- CN102872159A CN102872159A CN2012103730929A CN201210373092A CN102872159A CN 102872159 A CN102872159 A CN 102872159A CN 2012103730929 A CN2012103730929 A CN 2012103730929A CN 201210373092 A CN201210373092 A CN 201210373092A CN 102872159 A CN102872159 A CN 102872159A
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Abstract
The invention relates to a nano-silver chitosan gel foam preparation for treating vaginal bacterial inflammation, and a preparation method thereof, and belongs to the technical field of the foam preparation production. The preparation is composed of a nano-drug, a gel matrix, a surfactant, a cosurfactant, an oil phase, a foaming agent, an antiseptic, a solvent and a propellent. The preparation method comprises the steps of dissolving the gel matrix in deionized water to fully swell into a flow liquid; adding the surfactant and the cosurfactant in residue deionized water; adding the chitosan; stirring and heating to make the chitosan fully dissolved; mixing the above two solutions, adding the antiseptic, adding the nano-silver sol liquid after the mixture becomes uniform, stirring uniformly; weighing the oil phase and the foaming agent, adding the oil phase and the foaming agent to the above liquid, making into an emulsion solution via ultrasonic emulsification; loading the emulsion solution in a pressure bottle; adding the propellent to make the finished product of the nano-silver chitosan gel foam preparation. The gel foam preparation can kill bacteria quickly, is convenient for administration, is low in drug dosage, can decrease side effects, and eliminates potential safety risks caused by large application amount of the nano-silver.
Description
Technical field
The present invention relates to a kind of gel preparation, be specifically related to a kind of nano silver shell polysaccharide gel foam preparation for the treatment of the vaginal bacteria inflammation and preparation method thereof, relate to a kind of new gel rubber system both nano silver shell polysaccharide gel foam preparation and method for making thereof, belong to the gel preparation production technical field.
Background technology
Women's bacterial vaginitis is the common disease of gynecological's reproductive tract infection, has a strong impact on women's physical and mental health.Cause the reason of bacterial vaginitis disease morbidity a lot of as, the body drag of health descends, easily cause infection, also has plenty of the antibiotics abuse, cause bacterial drug resistance, the a lot of female patients of what is more important are through washing liquid commonly used, and the destruction of causing the vagina environment is more easily caused the infection chance of vagina.
Because vagina inflammation sickness rate is very high, so it is very many such as suppository, gel, washing liquid, disintegrating tablet, granule etc. to be used for the treatment of on the market the external medicine preparation of women vaginitis.These dosage forms are more or less in and have defective on the administering mode.The reason of the physiological structure of vagina, generally about long 8cm, patient oneself examines finger and is difficult to suppository and tablet are filled in the vagina depths, contact range occurs little and antibiotic incomplete.Granule will be dissolved into solution, adopts to fill with as the washing liquid sample and rushes formula, and the patient generally adopts sitting posture and crouching formula, because position, liquid also is difficult to fully contact antibacterial at once toward dirty.Because the administrator innovation, a lot of common gels can reach the vagina depths, but oneself's operation is very inconvenient, because position also still is difficult on earth lyra of vagina place.Infect the existing defective of vaginitis in order to overcome above-mentioned preparation for treating women antibacterial, we have invented nano silver shell polysaccharide gel foam preparation, preparation of the present invention has been selected the verified drug resistance that do not have, the nanometer silver medicine that gynecological's antibacterial vaginitis is had good therapeutical effect, selected and had antibacterial action, has again biocompatibility material chitosan as the stabilizing material of gel-type vehicle and foam, application surface activating agent and foaming agent consist of foaming system, the propellant of using environment-friendly type is as the medicine thrust power, that is to say that what the present invention relates to is the drug-supplying system of a gel foam, the preparation that is formed by this system, medicine can be formed the full whole vaginal wall of bubble, rapid kill bacteria, convenient drug administration, no matter what position you adopt, the patient is administration easily.
The gel foam that the present invention produces by the full vagina of form of foam, because foam surface is long-pending large, is attached in whole vaginal wall and the gauffer by the strength of propellant, and foam stabilization formed gel at last at 10-30 minute.Anti-inflammation is effective, and dosage is little, can reduce side effect.
Patent CN101491541B has introduced a kind of thermosensitive gel type nano silver foam aerosol, the nanometer silver concentration that the said preparation system is selected is up to 300-400ppm, the gel temperature sensing material of selecting is poloxamer, the propellant of selecting is dimethyl ether, because nano silver colloid and the easy layering of other liquid of system, in this patent, lack foaming agent and foam stabiliser etc., after actual tinning, can occur spraying blow weak and foam is unstable.The nanometer silver consumption of this patent is too large, may bring safety hidden danger.Nano silver shell polysaccharide gel foam of the present invention because selected low molecular weight water-soluble shitosan, has obvious antibacterial action, with the nanometer silver synergism, can greatly lower the consumption of nanometer silver.Adopt surface activity and cosurfactant, and the emulsifying oil phase, form stable Emulsion, adds certain foaming agent and suitable propellant, the gel foam of formation stablize with froth breaking after form gel.Bioadhesive and bactericidal effect all reach the purpose of preparation.
Summary of the invention
The objective of the invention is to overcome the deficiencies in the prior art, a kind of nano silver shell polysaccharide gel foam preparation for the treatment of the vaginal bacteria inflammation is provided, said preparation can form medicine the full whole vaginal wall of bubble, rapid kill bacteria, convenient drug administration, no matter what position you adopt, the patient is administration easily, said preparation can greatly reduce the consumption of nanometer silver simultaneously, has eliminated the potential safety hazard that the nanometer silver application quantity brings greatly.
For realizing the purpose of foregoing invention, the technical scheme that the present invention takes is as follows:
What the present invention relates to is a nano silver shell polysaccharide gel foam drug-supplying system, comprising: medicine, gel-type vehicle, and surfactant, cosurfactant, oil phase, foaming agent, antiseptic, propellant forms;
Nano silver shell polysaccharide gel foam drug-supplying system medicine of the present invention is the nanometer silver sol solution, the solubility in the prescription: 10ppm-50ppm (% W/W), wherein nanometer silver particle diameter 25-50nm scope;
Nano silver shell polysaccharide gel foam drug-supplying system gel-type vehicle of the present invention comprises: chitosan (molecular weight distribution 2000-5000, deacetylation is more than 95%) accounts for 5-10%(W/W in the prescription); Carbomer 01-0.5% (W/W);
Nano silver shell polysaccharide gel foam drug-supplying system surfactant of the present invention comprises: tween 80, and Octoxinol and tween 80 and Arlacel-80 mixture (5:1), the accounting example is 0.2-2%(W/W in prescription);
Cosurfactant in the nano silver shell polysaccharide gel foam drug-supplying system of the present invention: glycerol, PEG400,0.1-1%(W/W in the prescription);
Foaming agent in the nano silver shell polysaccharide gel foam drug-supplying system of the present invention: sodium lauryl sulphate (SLS), ratio 0.1-1% in the prescription, (W/W);
Antiseptic in the nano silver shell polysaccharide gel foam drug-supplying system of the present invention: the mixture of benzalkonium bromide or methyl hydroxybenzoate or methyl hydroxybenzoate and ethyl hydroxybenzoate, ratio is 0.1-1% in the prescription; The proportioning of the mixture of methyl hydroxybenzoate and ethyl hydroxybenzoate is methyl hydroxybenzoate: the mixture=1:1 of ethyl hydroxybenzoate.
Oil phase material in the nano silver shell polysaccharide gel foam drug-supplying system of the present invention: oleic acid, aloe, Oleum Ricini or paraffin oil, ratio 5-10%(W/W in prescription);
Propellant in the nano silver shell polysaccharide gel foam drug-supplying system of the present invention: iso-butane or tetrafluoroethane or iso-butane and tetrafluoroethane mist (1:1), according to the 100g amount of liquid medicine, the ratio that adds propellant is the 100:10-20(amount of liquid medicine: propellant W/W);
Solvent is deionized water in the nano silver shell polysaccharide gel foam drug-supplying system of the present invention, and its content is surplus.
Nano silver shell polysaccharide gel foam preparation of the present invention becomes nanoscale gel foam 50-100nm..
Another object of the present invention provides a kind of preparation method for the treatment of the nano silver shell polysaccharide gel foam preparation of vaginal bacteria inflammation, comprises the steps:
(1) gel-type vehicle preparation: take by weighing the carbomer of recipe quantity, be dissolved in the deionized water, fully swelling 20-30 hour, A was for subsequent use for Cheng Liuzhuan liquid;
(2) surfactant and cosurfactant are joined in the deionized water, add the recipe quantity chitosan, stir, heat the 60-100 degree, fully dissolve to get B liquid, for subsequent use;
(3) A, B liquid are mixed, after the adding antiseptic is even, add the nano silver colloidal sol liquid of recipe quantity, the C liquid that stirs to get, for subsequent use;
(4) take by weighing recipe quantity oil phase, foaming agent, join respectively in the C liquid, made emulsified solution in ultrasonic emulsification 20-30 minute; In the fill pressure bottle, add propellant, be prepared into nano silver shell polysaccharide gel foam preparation finished product.
The invention has the beneficial effects as follows:
1. preparation of the present invention has been selected the verified drug resistance that do not have, the nanometer silver medicine that gynecological's antibacterial vaginitis is had good therapeutical effect, selected and had antibacterial action, has again biocompatibility material chitosan as the stabilizing material of gel-type vehicle and foam, application surface activating agent and foaming agent consist of foaming system, the propellant of using environment-friendly type is as the medicine thrust power, the preparation that is formed by this system, medicine can be formed the full whole vaginal wall of bubble, rapid kill bacteria, convenient drug administration, no matter what position you adopt, the patient is administration easily;
2. the gel foam produced of the present invention, by the full vagina of form of foam, because foam surface is long-pending large, strength by propellant is attached in whole vaginal wall and the gauffer, foam stabilization formed gel at last at 10-30 minute, and anti-inflammation is effective, and dosage is little, can reduce side effect;
3. nano silver shell polysaccharide gel foam of the present invention because selected low molecular weight water-soluble shitosan, has obvious antibacterial action, with the nanometer silver synergism, can greatly lower the consumption of nanometer silver.Adopt surface activity and cosurfactant, and the emulsifying oil phase, form stable Emulsion, adds certain foaming agent and suitable propellant, the gel foam of formation stablize with froth breaking after form gel, bioadhesive and bactericidal effect all reach the purpose of preparation.
Description of drawings
Fig. 1 is gel foamable composition and ordinary gel, the comparison of suppository, effervescent tablet physical behavior, and wherein A is gel foamable composition of the present invention, B aerosol, C gel, D suppository;
Fig. 2 is the particle diameter projection Electronic Speculum figure of microemulsion medicament under the Electronic Speculum;
Fig. 3 is the particle size distribution figure that the laser particle analyzer is measured.
The specific embodiment
Below by example the present invention is described in further details, these examples only are used for illustrating the present invention, do not limit the scope of the invention.
Embodiment 1
Each component contain scale:
| Component | Act in the | Consumption | 100% |
| Nanometer silver | Medicine | The 10ppm(5g solution amount) | |
| Chitosan | Antibiotic and gel-type vehicle | 5.0g | |
| Carbomer | Gel-type vehicle | 0.1g | |
| Tween 80 | Surfactant | 0.2g | |
| Glycerol | Cosurfactant | 0.1g | |
| SLS | Foaming agent | 0.2g | |
| Benzalkonium bromide | The corrosion-proof and sterilization agent | 1.0 | |
| Paraffin oil | Oil phase emulsifier | 5.0g | |
| Deionized water | Solvent | 83.5g |
The gel-type vehicle preparation: take by weighing the carbomer 0.1g of recipe quantity, be dissolved among the deionized water 30g, fully swelling is 24 hours, and A is for subsequent use for Cheng Liuzhuan liquid; Superficiality agent Tween 80 0.2g, cosurfactant glycerol 0.1g joins (53.5g) in the remaining deionized water, adds recipe quantity chitosan 5g, stirs, heats 80 degree, fully dissolves to get B liquid; Adding mixes A, B liquid, after adding antiseptic benzalkonium bromide 1g is even, adds the nano silver colloidal sol liquid 5g of recipe quantity, and C liquid stirs to get; Take by weighing oil phase paraffin oil 5g, foaming agent SLS 0.2g joins respectively in the C liquid, and ultrasonic emulsification was made emulsified solution in 30 minutes.100g in the fill pressure bottle adds propellant 10g (proportionally regulate the foam situation of spraying, regulate the amount of filling propellant, in the general preferred 100:10-20 scope), is prepared into the silver-colored chitosan gel rubber foam formulations of nanometer (50-100nm) finished product.
Embodiment 2
Each component contain scale:
| | Effect | Consumption | 100% |
| Nanometer silver | Medicine | The 20ppm(5g solution amount) | |
| Chitosan | Antibiotic and gel-type vehicle | 10g | |
| Carbomer | Gel-type vehicle | 0.3g | |
| Tween 80 | Surfactant | 0.5g | |
| Glycerol | Cosurfactant | 0.5g | |
| SLS | Foaming agent | 0.5g | |
| Benzalkonium bromide | The corrosion-proof and sterilization agent | 1.0g | |
| Paraffin oil | Oil phase emulsifier | 10g | |
| Deionized water | Solvent | 80g |
Preparation method is with reference to embodiment 1 preparation method.
Embodiment 3
Each component contain scale:
| | Effect | Consumption | 100% |
| Nanometer silver | Medicine | The 50ppm(5g solution amount) | |
| Chitosan | Antibiotic and gel-type vehicle | 10g | |
| Carbomer | Gel-type vehicle | 0.5g | |
| Tween 80 and Arlacel-80 mixture | Surfactant | 1.0g | |
| Glycerol | Cosurfactant | 1.0g | |
| SLS | Foaming agent | 1.0g | |
| Benzalkonium bromide | The corrosion-proof and sterilization agent | 1.0g | |
| Oleum Ricini | Oil phase emulsifier | 10g | |
| Deionized water | Solvent | 80g |
Preparation method is with reference to embodiment 1 preparation method.
Embodiment 4
Each component contain scale:
| | Effect | Consumption | 100% |
| Nanometer silver | Medicine | The 50ppm(5g solution amount) | |
| Chitosan | Antibiotic and gel-type vehicle | 5.0g | |
| Carbomer | Gel-type vehicle | 0.5g | |
| Hot menthylphenoxypolyethoxy ethanol | Surfactant | 1.0g | |
| PEG400 | Cosurfactant | 1.0g | |
| SLS | Foaming agent | 0.5g | |
| Methyl hydroxybenzoate, | Antiseptic | 0.1g | |
| Ethyl hydroxybenzoate | Antiseptic | 0.1g | |
| Paraffin oil | Emulsifying agent | 10g | |
| Deionized water | Solvent | 78g |
Preparation method is with reference to embodiment 1 preparation method.
Embodiment 5
Each component contain scale:
| | Effect | Consumption | 100% |
| Nanometer silver | Medicine | The 50ppm(5g solution amount) | |
| Chitosan | Antibiotic and gel-type vehicle | 10g | |
| Carbomer | Gel-type vehicle | 0.5g | |
| Tween 80 and Arlacel-80 mixture | Surfactant | 2.0g | |
| PEG400 | Cosurfactant | 0.5g | |
| SLS | Foaming agent | 1.0g | |
| Methyl hydroxybenzoate, | Antiseptic | 0.1g | |
| Ethyl hydroxybenzoate | Antiseptic | 0.1g | |
| Oleic acid | Emulsifying agent | 10g | |
| Deionized water | Solvent | 78g |
Preparation method is with reference to embodiment 1 preparation method.
Embodiment 6
Each component contain scale:
| | Effect | Consumption | 100% |
| Nanometer silver | Medicine | The 10ppm(5g solution amount) | |
| Chitosan | Antibiotic and gel-type vehicle | 8g | |
| Carbomer | Gel-type vehicle | 0.5g | |
| Tween 80 and Arlacel-80 mixture | Surfactant | 2.0g | |
| PEG400 | Cosurfactant | 0.5g | |
| SLS | Foaming agent | 1.0g | |
| Benzalkonium bromide | The corrosion-proof and sterilization agent | 0.5g | |
| Oleic acid | Emulsifying agent | 10g | |
| Deionized water | Solvent | 73g |
Preparation method is with reference to embodiment 1 preparation method.
Embodiment 7
Each component contain scale:
| Component | Effect | Consumption |
| Nanometer silver | Medicine | The 30ppm(5g solution amount) |
| Chitosan | Antibiotic and gel-type vehicle | 8g |
| Carbomer | Gel-type vehicle | 0.5 |
| Tween | ||
| 80 and Arlacel-80 mixture | Surfactant | 1.0g |
| Glycerol | Cosurfactant | 0.5g |
| SLS | Foaming agent | 1.0g |
| Benzalkonium bromide | The corrosion-proof and sterilization agent | 1.0g |
| Oleum Ricini | Emulsifying agent | 8.0 |
| Deionized water | Solvent | 75g |
Preparation method is with reference to embodiment 1 preparation method.
Embodiment 8
Finished product inspection:
| Inspection item | Critical field |
| Nanometer silver | 10—50 ppm |
| Foam density is held time | Fine and smooth, continue 30 minutes |
| Foam viscosity | Foam glues hands |
| Gel behind the froth breaking | Gel behind the froth breaking, |
Embodiment 9
Gel foamable composition extracorporeal disinfecting experimental result of the present invention:
100 times of every group of dilutions, extracorporeal disinfecting experiment expression, nanometer silver solubility is higher, sterilize faster, gel foamable composition of the present invention, when lacking 3-10 times with listing gel and suppository dosage, but bactericidal effect the same (P〉0.05).
100 times of every group of dilutions, extracorporeal disinfecting experiment expression, nanometer silver solubility is higher, sterilize faster, gel foamable composition of the present invention, when lacking 3-10 times with listing gel and suppository dosage, but bactericidal effect the same (P〉0.05).
100 times of every group of dilutions, extracorporeal disinfecting experiment expression, nanometer silver solubility is higher, sterilize faster. when gel foamable composition of the present invention lacks 3-10 times with listing gel and suppository nanometer silver dosage, but bactericidal effect the same (P〉0.05).
Enforcement 10 and ordinary gel, the comparison of suppository, effervescent tablet physical behavior
As can be seen from Figure 1 gel foam can fill whole tract and wall (A gel foamable composition of the present invention, B aerosol, C gel, D suppository).
Claims (6)
1. nano silver shell polysaccharide gel foam preparation for the treatment of the vaginal bacteria inflammation is characterized in that: this foam formulations is by medicine, gel-type vehicle, surfactant, cosurfactant, oil phase, foaming agent, antiseptic, propellant and solvent composition;
Described medicine is the nanometer silver sol solution, and its solubility is 10ppm-50ppm (% W/W), nanometer silver particle diameter 25-50nm scope;
Described gel-type vehicle is chitosan and carbomer, wherein chitosan be molecular weight distribution at 2000-5000, deacetylation is more than 95%, content is 5-10%(W/W), carbomer content is 0.1-0.5% (W/W);
Described surfactant is tween 80, Octoxinol or tween 80 and Arlacel-80 mixture, and the content of surfactant is 0.2-2%(W/W);
Described cosurfactant: glycerol or PEG400, the content in the prescription are 0.1-1%(W/W);
Described oil phase is oleic acid, aloe, Oleum Ricini or paraffin oil, and the ratio in prescription is 5-10%(W/W);
Described foaming agent is sodium lauryl sulphate (SLS), and the ratio in the prescription is 0.1-1%(W/W);
Described antiseptic is the mixture of benzalkonium bromide or methyl hydroxybenzoate or methyl hydroxybenzoate and ethyl hydroxybenzoate, and its content is 0.1-1%;
Described propellant be iso-butane or tetrafluoroethane or iso-butane and tetrafluoroethane mist according to the 100g amount of liquid medicine, the ratio that adds propellant is amount of liquid medicine: propellant=100:10-20(W/W);
Described solvent is deionized water, and content is surplus.
2. a kind of nano silver shell polysaccharide gel foam preparation for the treatment of the vaginal bacteria inflammation according to claim 1, it is characterized in that: described nano silver shell polysaccharide gel foam preparation becomes nanoscale gel foam 50-100nm.
3. a kind of nano silver shell polysaccharide gel foam preparation for the treatment of the vaginal bacteria inflammation according to claim 1, it is characterized in that: the ratio of described tween 80 and Arlacel-80 mixture is tween 80: Arlacel-80=5:1.
4. a kind of nano silver shell polysaccharide gel foam preparation for the treatment of the vaginal bacteria inflammation according to claim 1, it is characterized in that: the ratio of described iso-butane and tetrafluoroethane mist is iso-butane: tetrafluoroethane=1:1.
5. a kind of nano silver shell polysaccharide gel foam preparation for the treatment of the vaginal bacteria inflammation according to claim 1, it is characterized in that: the proportioning of the mixture of described methyl hydroxybenzoate and ethyl hydroxybenzoate is methyl hydroxybenzoate: the mixture=1:1 of ethyl hydroxybenzoate.
6. one kind for the preparation of a kind of nano silver shell polysaccharide gel foam preparation for the treatment of the vaginal bacteria inflammation claimed in claim 1, it is characterized in that: comprise the steps:
(1) gel-type vehicle preparation: take by weighing the carbomer of recipe quantity, be dissolved in the deionized water, fully swelling 20-30 hour, A was for subsequent use for Cheng Liuzhuan liquid;
(2) surfactant and cosurfactant are joined in the deionized water, add the recipe quantity chitosan, stir, heat the 60-100 degree, fully dissolve to get B liquid, for subsequent use;
(3) A, B liquid are mixed, after the adding antiseptic is even, add the nano silver colloidal sol liquid of recipe quantity, the C liquid that stirs to get, for subsequent use;
(4) take by weighing recipe quantity oil phase, foaming agent, join respectively in the C liquid, made emulsified solution in ultrasonic emulsification 20-30 minute; In the fill pressure bottle, add propellant, be prepared into nano silver shell polysaccharide gel foam preparation finished product.
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| CN103520107A (en) * | 2013-10-11 | 2014-01-22 | 徐克之 | Foaming agent for vaginal packing |
| CN103655459A (en) * | 2013-12-19 | 2014-03-26 | 中国药科大学 | Multifunctional microemlusion gel preparation and preparation process thereof |
| CN111603440A (en) * | 2020-06-28 | 2020-09-01 | 南京东万生物技术有限公司 | Gynecological gel foaming agent and preparation method thereof |
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| CN111603440A (en) * | 2020-06-28 | 2020-09-01 | 南京东万生物技术有限公司 | Gynecological gel foaming agent and preparation method thereof |
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Application publication date: 20130116 |