CN103446177A - Cleansing solution for curing gynecological disease and preparation method thereof - Google Patents
Cleansing solution for curing gynecological disease and preparation method thereof Download PDFInfo
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- CN103446177A CN103446177A CN2013104315044A CN201310431504A CN103446177A CN 103446177 A CN103446177 A CN 103446177A CN 2013104315044 A CN2013104315044 A CN 2013104315044A CN 201310431504 A CN201310431504 A CN 201310431504A CN 103446177 A CN103446177 A CN 103446177A
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Abstract
The invention relates to sterile cleansing solution for women. The cleansing solution is composed of chitosan with a specific molecular weight and deacetylation degree, chlorhexidine, glycerol, acidifier and purified water. The cleansing solution is applied in the environment with hundred-thousand-level cleanliness, the chitosan and the purified water are mixed to form suspension liquid, acidifier is added in the suspension liquid to adjust the pH value to be within the range from 3.8 to 5.8, and chitosan gel is obtained. The chlorhexidine is additionally taken and is dissolved in the glycerol and is added in the chitosan gel, the chitosan gel is evenly stirred, degasification is conducted, filling sealing is conducted and sterilization is conducted, wherein the acidifier is lactic acid or acetic acid or the mixture of hydrochloric acid and acetic acid, and Co-60 irradiation processing or high-temperature damp and hot sterilization is conducted during the sterilization process. The invention further relates to the manufacturing method of the cleansing solution for curing the gynecological disease and the application of the cleansing solution in preparation of medicines for curing women monilial vaginitis, bacterial vaginitis, trichomonas vaginitis or cervicitis, and the sterile cleansing solution for women can be used for daily hygiene care of the vagina of a woman.
Description
Technical field
The present invention relates to the medical product field, concrete, the present invention relates to a kind of washing liquid for the treatment of gynaecopathia, it is treatment for women's monilial vaginitis, bacterial vaginitis, Combination vaginitis, cervicitis etc., there is the advantages such as good curative effect, safe, natural, good biocompatibility, the invention still further relates to its preparation method and medical applications.
Background technology
Desirable gynecological external use medical product should have the functions such as good antimicrobial antiphlogistic, safety, biocompatibility, ease of use, wants good stability simultaneously, is easy to storage, easy to use.
Chitosan (Chitosan), chemistry by name poly-(1,4)-2-amino-2-deoxidation-β-D-Glucose, it is a kind of natural biological polymer obtained after the partly or entirely de-acetyl of chitin, it is the only macromolecule alkalescence polysaccharide that nature exists, be called again soluble chitin, Chitosan, chitosan, chitosan, there is good biocompatibility, the characteristics such as abundant that have no side effect, easily are absorbed, originate, in the field such as synthetic of food industry, chemical industry, medical macromolecular materials, obtain development and application widely.
The externally used antimicrobial agent and the wound surface nursing agent that as vagina, use, although chitosan is having effect preferably aspect wound repair (for example, in wound repair and nursing), but aspect antibiotic property, especially kill aspect pathogenic bacterium obviously not enough, this form of washing liquid especially, washing vagina the time, effective ingredient in washing liquid is short in intravaginal retention time, valid density is low, simple a kind of composition of chitosan, in the treatment for serious and intractable gynaecopathia, the antibacterial action Shortcomings.
Summary of the invention
The invention provides a kind of lotion formulation of new treatment gynaecopathia, specifically a kind of woman of containing chitosan and chlorhexidine is by washing liquid and preparation method thereof, and it contains chitosan and two kinds of main constituents of chlorhexidine, has good Synergistic antimicrobial effect.
The inventor studies discovery, affects chitosan of the present invention and the chlorhexidine woman quality by washing liquid, and many factors are arranged, and direct influence factor wherein has following four factors:
The one, the stability of chitosan and chlorhexidine in washing liquid, chitosan can be water-soluble under sour environment or be become class transparent lotion shape, but chlorhexidine (normally chlorhexidine acetate, chlorhexidine gluconate, Chlorhexidine hydrochloride or citric acid chlorhexidine) poorly water-soluble, chitosan and chlorhexidine woman have material impact by formula, acidulant and the preparation technology of washing liquid to the stability of its washing liquid;
The 2nd, the molecular weight of chitosan and deacetylation, the chitosan that molecular weight is little, deacetylation is high, its anti-microbial property is better, but its washing liquid viscosity and adhesiveness are poor;
The 3rd, the pH value of washing liquid, when the pH value of washing liquid is low, viscosity and adhesion diminish, and when the pH value of washing liquid is higher, although viscosity and adhesion are preferably arranged, the less stable of washing liquid, can not form washing liquid stable, that class is transparent;
The 4th, the content of chitosan in washing liquid, the content of chitosan is for viscosity and the adhesion of washing liquid, affects greatlyr, and chitosan content is high, although the viscosity of washing liquid and adhesion are better, washing liquid is easy to occur layering and separates out the chitosan solid;
In addition, affect chitosan of the present invention and the chlorhexidine woman indirect factor by the washing liquid quality, prior have two factors:
The one, such medical product is all aseptic usually, all need to carry out sterilizing for Product Terminal, usually adopt cobalt-60 irradiation penetrate processing or carry out high-temperature heat sterilization, after adopting cobalt-60 irradiation to penetrate processing or carrying out high-temperature heat sterilization, viscosity and the adhesion of chitosan washing liquid tend to variation, while especially adopting cobalt-60 irradiation to inject capable sterilization treatment, the dosage size of radiation is crucial influence factor;
The 2nd, the selection of acidulant, under the relative rigid condition of pH value of washing liquid, with different acidulant, the washing liquid after the terminal sterilization obtained, its viscosity and adhesion, color and luster, stability, abnormal smells from the patient have difference significantly, very large by the quality influence of washing liquid to chitosan woman of the present invention.
Based on above many directly and indirectly influence factors, the invention provides a kind of woman and use washing liquid, contain chitosan 0.2%～1.5%, chlorhexidine 0.1%～0.5%, glycerol 4%～10%, acidulant and purified water, the viscosity-average molecular weight of wherein said chitosan be 2～100,000 and its deacetylation be greater than 85%, described chlorhexidine comprises chlorhexidine acetate, chlorhexidine gluconate, Chlorhexidine hydrochloride or citric acid chlorhexidine, the mixture that described acidulant is lactic acid, acetic acid or hydrochloric acid-acetic acid; And the pH value of described washing liquid is 3.8～5.8.
Preferably, the present invention selects the mixture of hydrochloric acid-acetic acid as acidulant, adopt hydrochloric acid and the glacial acetic acid that concentration is 36%～38% to using volume ratio as (1～5): 1 mixture is as acidulant, especially selects hydrochloric acid that concentration is 36%～38% and glacial acetic acid to using mixture that volume ratio is 5:1 as acidulant.
Common, the Vagina washing bottle that woman of the present invention adopts macromolecular material to make by washing liquid is packed and is sealed, and is conducive to preserve and patient's use.
One skilled in the art will appreciate that chitosan is a kind of high molecular polymer, belong to the mixture category, the assay method of molecular weight is a lot, as viscosity method is surveyed relative molecular weight, i.e. viscosity-average molecular weight (M
η); Low angle laser light scattering method check weighing average molecular weight (Mw); Size exclusion chromatography (SES) records the relative molecular weight of different component; Mass spectrography accurately records weight average molecular weight (Mw); In addition, also have end group measurement, ebulliometry, vapor-pressure osmometry.The characteristics such as wherein, viscosity method adopts Ubbelohde viscometer, has equipment simple, easy to operate are methods more commonly used at present.Because chitosan is a kind of high molecular polymer, its molecular weight is its assembly average, common, with viscosity-average molecular weight, means.
Need to particularly point out and those skilled in the art can be understood that, chitosan molecule amount of the present invention, be often referred to the relative molecular weight of measuring with viscosimetry, although molecular weight of the present invention is definite value, for the chitosan of high molecular polymer, be actually relative molecular weight, be a value range, this value range is molecular weight determined value ± 10% normally, for example, the chitosan that molecular weight is 50,000, the molecular weight ranges of in fact this chitosan is 4.5～5.5 ten thousand; The chitosan that molecular weight is 60,000, the molecular weight ranges of in fact this chitosan is 5.4～6.6 ten thousand; The chitosan that molecular weight is 100,000, the molecular weight ranges of in fact this chitosan is 9～110,000, etc.
Concrete, the invention provides a kind of woman of containing the chitosan chlorhexidine and use aseptic washing liquid, it is characterized in that:
(1) containing viscosity-average molecular weight is 2～100,000 and its deacetylation chitosan 0.2%～1.5%, chlorhexidine 0.1%～0.5%, glycerol 4%～10%, acidulant and purified water of being greater than 85%, wherein said chlorhexidine comprises chlorhexidine acetate, chlorhexidine gluconate, Chlorhexidine hydrochloride or citric acid chlorhexidine, the mixture that described acidulant is lactic acid, acetic acid or hydrochloric acid-acetic acid;
(2) pH value of described washing liquid is 3.8～5.8;
(3) the viscosity rate of change of described washing liquid after cobalt-60 irradiation is penetrated processing or carried out high-temperature heat sterilization is less than
+10%.
Preferably, the woman who the invention provides a kind of chitosan chlorhexidine uses aseptic washing liquid, it is characterized in that:
(1) containing viscosity-average molecular weight is 3～80,000 and its deacetylation chitosan 0.2%～1.2%, chlorhexidine 0.1%～0.4%, glycerol 5%～8%, acidulant and purified water of being greater than 90%, wherein said chlorhexidine comprises chlorhexidine acetate, chlorhexidine gluconate, Chlorhexidine hydrochloride or citric acid chlorhexidine, the mixture that described acidulant is lactic acid, acetic acid or hydrochloric acid-acetic acid;
(2) pH value of described washing liquid is 3.8～5.8;
(3) the viscosity rate of change of described washing liquid after cobalt-60 irradiation is penetrated processing or carried out high-temperature heat sterilization is less than
+10%.
Chitosan of the present invention also comprises the derivant of chitosan, for example include but not limited to: carboxymethyl chitosan, chitosan hydrochlorate, chitosan lactate, chitosan acetate, chitosan sulfate fat, chitosan quaternary amine, Chitosan oligosaccharide, hyaluronic acid-like chitosan or chitin, etc.
The present invention further provides the preparation method of the woman of this chitosan chlorhexidine by aseptic washing liquid.As previously mentioned, the formula of washing liquid of the present invention and preparation technology have material impact to the stability of its washing liquid, and the inventor finds, different preparation technologies, and the stability difference of resulting washing liquid is very large.
In formula range of the present invention, chlorhexidine add the mode difference, the stability difference of the washing liquid obtained is very large.
For example, according to following formula, the washing liquid that adopts different preparation technologies to obtain, its stable comparative experiments is as follows:
Table 1
| Name of material | Inventory | Percentage ratio |
| Chitosan (g) | 0.5g | 0.5% |
| Chlorhexidine acetate (g) | 0.25g | 0.25% |
| Lactic acid (ml) | In right amount | - |
| Glycerol (g) | 5g | 5% |
| Purified water (ml) | Add to 100 ml | - |
Preparation method one: chitosan and purified water are mixed in beaker and are suspension, add newborn acid for adjusting pH to 4-5, obtain the chitosan solution of clarification, separately get chlorhexidine acetate and be dissolved in glycerol, add in the lactic acid washing liquid of chitosan, stir, filling and sealing, obtain.
Preparation method two: chitosan, chlorhexidine acetate, glycerol are added in purified water successively, stir, be suspension, then add newborn acid for adjusting pH to 4-5, stir, obtain chitosan chlorhexidine washing liquid, filling and sealing, obtain.
Washing liquid obtained above is penetrated to sterilization treatment with the cobalt with 10KGy dosage-60 irradiation respectively, after the washing liquid irradiation that discover method one obtains only viscosity diminish to some extent, but the viscosity rate of change is less than
+10%, color and luster and washing liquid transparency do not change, and the washing liquid that method two obtains viscosity after irradiation diminishes to some extent, and the washing liquid appearance is muddy, and the adularescent particulate material is separated out, by after the washing liquid dilute filtration, obtain the white granular material, by analysis, this white granular material is chlorhexidine acetate, demonstrate washing liquid prepared by method two, its poor stability.
Can find out, the preparation technology of method one can obtain stability washing liquid of the present invention preferably.
Further, chitosan chlorhexidine woman of the present invention is by the preparation method of aseptic washing liquid, it is included in the environment that cleanliness factor is 100,000 grades, chitosan is mixed and is suspension with purified water, add acidulant to regulate pH to 3.8～5.8, obtain chitosan solution, separately getting chlorhexidine is dissolved in glycerol, add in chitosan solution, stir, degassed, fill is in plastic bottle or cillin bottle, sealing, sterilizing gets final product, wherein acidulant is lactic acid, the mixture of acetic acid or hydrochloric acid-acetic acid, sterilizing adopts cobalt-60 irradiation penetrate processing or carry out high-temperature heat sterilization, preferred cobalt-60 irradiation dose is 7.5～13KGy, 8KGy for example, 9KGy, 10KGy, 10.5KGy, 11KGy, 11.5KGy, 12KGy etc., perhaps further adopt 121 ℃ of moist heat sterilization 10～15min.
Concrete, chitosan chlorhexidine woman of the present invention is by the preparation method of aseptic washing liquid, and it is included in the environment that cleanliness factor is 100,000 grades, chitosan is mixed and is suspension with purified water, add acidulant to regulate pH to 3.8～5.8, obtain chitosan solution, separately getting chlorhexidine is dissolved in glycerol, add in chitosan solution, stir, degassed, fill is in plastic bottle, sealing, further penetrate processing with cobalt-60 irradiation of 7.5～13KGy dosage, obtains; Perhaps, chitosan chlorhexidine woman of the present invention is by the preparation method of aseptic washing liquid, and it is included in the environment that cleanliness factor is 100,000 grades, chitosan is mixed and is suspension with purified water, add acidulant to regulate pH to 3.8～5.8, obtain chitosan solution, separately getting chlorhexidine is dissolved in glycerol, add in chitosan solution, stir, degassed, fill is in cillin bottle, sealing, further use 121 ℃ of moist heat sterilization 10～15min, obtains.
With related experiment, related art features of the present invention is described.
One,, in the present invention, chitosan and chlorhexidine have good antibiotic synergism.By following experiment, verify.
Prepare respectively chitosan chlorhexidine washing liquid (sample 1), chitosan washing liquid (sample 2), chlorhexidine washing liquid (sample 3), main concrete composition is as follows:
Sample 1: chitosan 0.5%, chlorhexidine acetate 0.25%, glycerol 4%, all the other are purified water, lactic acid is adjusted pH to 4-5;
Sample 2: chitosan 0.5%, glycerol 4%, all the other are purified water, lactic acid is adjusted pH to 4-5;
Sample 3: chlorhexidine acetate 0.25%, glycerol 4%, all the other are purified water, lactic acid is adjusted pH to 4-5.
The anti-microbial property experiment: above-mentioned three kinds of samples are carried out respectively to the bacteriostatic experiment of Candida albicans, colon bacillus, staphylococcus aureus, and result is as follows:
During sample 1 effect 2min, the bacteriostasis rate of Candida albicans, colon bacillus, staphylococcus aureus all is greater than to 95%;
During sample 2 effect 2min, the bacteriostasis rate of Candida albicans is greater than to 70%, the bacteriostasis rate of colon bacillus, staphylococcus aureus is greater than to 65%;
During sample 3 effect 2min, the bacteriostasis rate of Candida albicans is greater than to 80%, the bacteriostasis rate of colon bacillus, staphylococcus aureus is to 85%.
By above-mentioned anti-microbial property experiment, can be found out, chitosan chlorhexidine woman of the present invention is with in washing liquid, and chitosan and chlorhexidine have good antibiotic synergism, and its antibacterial action is better than the solution of its one-component.
Two, in addition, chitosan chlorhexidine woman of the present invention is chitosan by the factor that forms the washing liquid most critical in washing liquid, and the screening study of its correlation technique factor is as follows:
(1) selection of the molecular weight of chitosan and deacetylation
Select respectively the chitosan that viscosity-average molecular weight is 20,000,30,000,40,000,60,000,80,000,100,000,120,000,140,000, the washing liquid that make content and be 0.5%, pH value is 4.5, find that the chitosan washing liquid that viscosity-average molecular weight is 120,000 has chitosan to separate out when room temperature is placed 60 days, less stable, the solution viscosity that the chitosan that molecular weight is 140,000 is made is larger, poor fluidity, cleaning effectiveness is poor
Therefore select the chitosan that viscosity-average molecular weight is 2～100,000, the chitosan that preferably viscosity-average molecular weight is 3～80,000;
Select respectively the chitosan that deacetylation is 75%, 80%, 85%, 90%, 95%, the washing liquid that make content and be 7%, pH value is 4.5, dissolubility is bad in the preparation for the chitosan that the discovery deacetylation is 75%, 80%, and the room temperature placement has chitosan particle in 6 months and separates out, that washing liquid becomes muddiness, therefore the chitosan of selecting deacetylation to be greater than 85%.Show viscosity-average molecular weight be 2～100,000 and deacetylation be greater than washing liquid of the present invention prepared by 85% chitosan and there is good stability.
(2) selection of the pH value of washing liquid
Select the chitosan that viscosity-average molecular weight is 80,000, the washing liquid that make content and be 7%, pH value is 2.5,3.5,3.8,4.5,5.5,6.0, find when pH value is less than 3.8, viscosity and the adhesion of washing liquid diminish, and the pH value of washing liquid is greater than at 6 o'clock, and the room temperature placement has chitosan particle in 6 months and separates out, make washing liquid become muddy, being attached to the pH value scope is ± 1, therefore select the pH value of washing liquid, is 3.8～5.8, and the pH value that shows washing liquid is 3.8～5.8 to have good stability.
(3) selection of chitosan content in washing liquid
Select viscosity-average molecular weight to be respectively 40,000,60,000,80,000,100,000 chitosan, making respectively content is 0.2%, 0.5%, 0.8%, 1.2%, 1.5%, 1.7%, 1.8%, and the pH value washing liquid that is 4.5, find when content is greater than 1.5%, the viscosity of washing liquid is larger, and poor fluidity can't form washing liquid; When the content of chitosan is greater than 0.2%, with chlorhexidine, there is good antibiotic synergism in addition, therefore select 0.2%～1.5% of chitosan content.
(4) selection of acidulant
Use respectively hydrochloric acid, lactic acid, the mixture of acetic acid or hydrochloric acid-acetic acid is done acidulant, select the chitosan that viscosity-average molecular weight is 80,000, making content is 0.25%, 0.8%, 1%, the washing liquid that pH value is 4.5, the washing liquid of acidulant is done in discovery with hydrochloric acid, after penetrating processing with cobalt-60 irradiation or carrying out high-temperature heat sterilization, viscosity significantly descends, viscosity becomes 70%～80% before sterilizing, may be that hydrochloric acid belongs to strong acid, crosslinked action to the chitosan washing liquid when cobalt-60 irradiation is penetrated processing or carried out high-temperature heat sterilization produces strong destruction, make viscosity decline to a great extent, therefore selection lactic acid, the mixture of acetic acid or hydrochloric acid-acetic acid is done acidulant.
(5) mixture of hydrochloric acid-acetic acid is done determining of acidulant
While with acetic acid, doing acidulant, the washing liquid obtained has strong acetic acid stink, select the mixture of the different volumes proportioning formation of acetate and hydrochloride to do acidulant, can obtain viscosity after cobalt-60 irradiation is penetrated processing or carried out high-temperature heat sterilization changes little, and the washing liquid that there is no obvious acetic acid stink, only have extremely slight acetic acid flavor.
Adopt hydrochloric acid and the glacial acetic acid that concentration is 36%～38% to using volume ratio as (1～5): 1 mixture is as acidulant, in this scope, adopt the mixture acidulant of different volume proportions, the washing liquid obtained is transparent, good stability, after penetrating processing with cobalt-60 irradiation or carrying out high-temperature heat sterilization, viscosity changes less.
Preferably, the present invention selects the mixture of hydrochloric acid-acetic acid as acidulant, especially select hydrochloric acid that concentration is 36%～38% and glacial acetic acid to using mixture that volume ratio is 5:1 as acidulant, the washing liquid clarity obtained is good, good stability, room temperature is placed 6 months, it is consistent with 0 month that the viscosity of washing liquid, pH value, color and luster homogeneous, abnormal smells from the patient all keep, washing liquid shows good stability, show that the mixture of selecting hydrochloric acid-acetic acid is as acidulant, especially select hydrochloric acid that concentration is 36%～38% and glacial acetic acid to using mixture that volume ratio is 5:1 as acidulant.
(6) sterilising conditions determines
In the environment that is 100,000 grades at cleanliness factor, the washing liquid for preparing different chitosan content, penetrate and process or moist heat sterilization by cobalt-60 irradiation, find that all washing liquids penetrate and process or with after 121 ℃ of moist heat sterilization 10～15min at cobalt-60 irradiation of 13KGy dosage, carry out immediately the bacterium inspection, result after culture period finishes is all aseptic, and after cobalt-60 irradiation of 7.5KGy dosage is penetrated processing, although the part washing liquid is carried out the bacterium inspection immediately, culture period shows the bacterium survival after finishing, but carry out the bacterium inspection after placing 3 days, result after the inspection culture period finishes is all aseptic, it may be the basic deactivation of antibacterial after cobalt-60 irradiation is penetrated processing, under the antibacterial action of washing liquid itself, make its thorough deactivation.In the environment that to show at cleanliness factor be 100,000 grades, prepare the washing liquid of different chitosan content, through cobalt-60 irradiation of 7.5～13KGy dosage, penetrate and process or with after 121 ℃ of moist heat sterilization 10～15min, obtaining aseptic washing liquid.
Further, chitosan chlorhexidine washing liquid of the present invention is as the direct administration of vagina, the application in the medicine of preparation treatment women monilial vaginitis, bacterial vaginitis, trichomonal vaginitis or cervicitis; Perhaps for the daily hygiene care of woman vagina.
the specific embodimentin implementation process of the present invention, various embodiments that those of ordinary skills produce on the basis do not departed from the scope of the present invention with spirit and modify apparent and be easily to carry out, the invention is not restricted to the scope of specific embodiment as herein described, really, various modification of the present invention, except those that narrated are to be understood by those skilled in the art from the narration of front.By the following examples, the present invention is done further and illustrates, but do not mean the embodiment limitation of the present invention.
Embodiment 1, chitosan chlorhexidine woman use washing liquid and preparation method thereof
Formula: chitosan 0.25g (viscosity-average molecular weight is 60,000, deacetylation >=90%)
Chlorhexidine acetate 0.2g
Glycerol 8g
37% hydrochloric acid and glacial acetic acid mixture (V:V=5:1) are appropriate
Purified water adds to 100g.
Preparation method: it is included in the environment that cleanliness factor is 100,000 grades, chitosan is mixed and is suspension with purified water, add hydrochloric acid and glacial acetic acid mixture, make reactant form washing liquid, and the pH value that makes washing liquid is 4～5, obtain chitosan solution, separately getting chlorhexidine acetate is dissolved in glycerol, add in the chitosan washing liquid, stir, degassed, fill is in plastic bottle or Vagina washing bottle sealing, further with cobalt-60 irradiation of 10～11KGy dosage, penetrate sterilization treatment, obtain chitosan chlorhexidine woman of the present invention and use aseptic washing liquid, washing liquid does not almost have the acetic acid flavor; Perhaps fill is in cillin bottle, and sealing, further use 121 ℃ of sterilizing 15min, obtain chitosan chlorhexidine woman of the present invention and use aseptic washing liquid, and the viscosity rate of change of described washing liquid after cobalt-60 irradiation is penetrated processing or carried out high-temperature heat sterilization is less than
+10%.
Embodiment 2, the chitosan chlorhexidine woman who fills a prescription following use washing liquid
Formula: chitosan 0.3%～0.7%,
Chlorhexidine 0.1%～0.5%,
Glycerol 5%～10%,
Acidulant is appropriate,
Purified water adds to 100g;
Wherein, chlorhexidine comprises chlorhexidine acetate, chlorhexidine gluconate, Chlorhexidine hydrochloride or citric acid chlorhexidine, the mixture that described acidulant is lactic acid, acetic acid or hydrochloric acid-acetic acid, and the viscosity rate of change of described washing liquid after cobalt-60 irradiation is penetrated processing is less than
+10%, the pH value of washing liquid is 3.8～5.8.Above-mentioned chitosan chlorhexidine woman is as follows by the preparation method of washing liquid:
It is included in the environment that cleanliness factor is 100,000 grades, chitosan is mixed and is suspension with purified water, add acidulant to regulate pH to 3.8～5.8, obtain chitosan solution, separately getting chlorhexidine is dissolved in glycerol, add in the chitosan washing liquid, stir, degassed, filling and sealing, sterilizing gets final product, wherein acidulant is lactic acid, the mixture of acetic acid or hydrochloric acid-acetic acid, sterilizing adopts cobalt-60 irradiation penetrate processing or carry out high-temperature heat sterilization, preferred cobalt-60 irradiation dose is 7.5～13KGy, 8KGy for example, 9KGy, 10KGy, 10.5KGy, 11KGy, 11.5KGy, 12KGy etc.
Embodiment 3, chitosan chlorhexidine woman use washing liquid and preparation method thereof
Formula: chitosan 0.4g (viscosity-average molecular weight is 50,000, deacetylation >=95%)
Chlorhexidine acetate 0.3g
Mentholum 0.01g
Glycerol 8g
37% hydrochloric acid and glacial acetic acid mixture (V:V=5:1) are appropriate
Purified water adds to 100g.
Preparation method: it is included in the environment that cleanliness factor is 100,000 grades, chitosan is mixed and is suspension with purified water, add hydrochloric acid and glacial acetic acid mixture, make reactant form washing liquid, and the pH value that makes washing liquid is 4～5, obtain chitosan solution, separately getting chlorhexidine acetate and Mentholum is dissolved in glycerol, add in the chitosan washing liquid, stir, degassed, fill seals in the high density polyethylene (HDPE) Vagina washing bottle, further with cobalt-60 irradiation of 10～11KGy dosage, penetrate sterilization treatment, obtain chitosan chlorhexidine woman of the present invention and use aseptic washing liquid, the viscosity rate of change of this washing liquid after cobalt-60 irradiation is penetrated processing is less than
+10%,, washing liquid does not have the acetic acid flavor, and refrigerant mint flavored is arranged.
Embodiment 4, chitosan chlorhexidine woman use washing liquid and preparation method thereof
Formula: chitosan 0.5g (viscosity-average molecular weight is 90,000, deacetylation >=85%)
Chlorhexidine gluconate 0.4g
Glycerol 7g
Lactic acid is appropriate
Purified water adds to 100g.
Preparation method: it is included in the environment that cleanliness factor is 100,000 grades, chitosan is mixed and is suspension with purified water, add lactic acid, make reactant form washing liquid, and the pH value that makes washing liquid is 4～5, obtain chitosan solution, separately getting chlorhexidine gluconate is dissolved in glycerol, add in the chitosan washing liquid, stir, degassed, fill seals in the high density polyethylene (HDPE) Vagina washing bottle, further with cobalt-60 irradiation of 10～11KGy dosage, penetrate sterilization treatment, obtain chitosan chlorhexidine woman of the present invention and use aseptic washing liquid, the viscosity rate of change of this washing liquid after cobalt-60 irradiation is penetrated processing is less than
+10%.
Embodiment 5, chitosan chlorhexidine woman use washing liquid and preparation method thereof
Formula: chitosan 0.6g (viscosity-average molecular weight is 80,000, deacetylation >=90%)
Chlorhexidine acetate 0.2g
Glycerol 6g
Lactic acid is appropriate
Purified water adds to 100g.
Preparation method: in the environment that is 100,000 grades at cleanliness factor, chitosan is mixed and is suspension with purified water, add lactic acid, make reactant form washing liquid, and the pH value that makes washing liquid is 4～5, obtain chitosan solution, separately getting chlorhexidine acetate is dissolved in glycerol, add in the chitosan washing liquid, stir, degassed, fill seals in the high density polyethylene (HDPE) Vagina washing bottle, further with cobalt-60 irradiation of 10～11KGy dosage, penetrate sterilization treatment, obtain chitosan chlorhexidine woman of the present invention and use aseptic washing liquid, the viscosity rate of change of this washing liquid after cobalt-60 irradiation is penetrated processing is less than
+10%.
Embodiment 6, chitosan chlorhexidine woman use washing liquid and preparation method thereof
Formula: chitosan 0.8g (viscosity-average molecular weight is 60,000, deacetylation >=90%)
Chlorhexidine acetate 0.15g
Glycerol 8g
Acetic acid is appropriate
Purified water adds to 100g.
Preparation method: in the environment that is 100,000 grades at cleanliness factor, chitosan is mixed and is suspension with purified water, add acetic acid, make reactant form washing liquid, and the pH value that makes washing liquid is 4～5, obtain chitosan solution, separately getting chlorhexidine acetate is dissolved in glycerol, add in the chitosan washing liquid, stir, degassed, fill seals in the high density polyethylene (HDPE) Vagina washing bottle, further with cobalt-60 irradiation of 10～11KGy dosage, penetrate sterilization treatment, obtain chitosan chlorhexidine woman of the present invention and use aseptic washing liquid, the viscosity rate of change of this washing liquid after cobalt-60 irradiation is penetrated processing is less than
+10%, washing liquid has the acetic acid abnormal flavour.
Embodiment 7, chitosan chlorhexidine woman use washing liquid and preparation method thereof
Formula: chitosan 1g (viscosity-average molecular weight is 50,000, deacetylation >=90%)
Chlorhexidine acetate 0.1g
Glycerol 8g
Lactic acid is appropriate
Purified water adds to 100g.
Preparation method: in the environment that is 100,000 grades at cleanliness factor, chitosan is mixed and is suspension with purified water, add lactic acid, make reactant form washing liquid, and the pH value that makes washing liquid is 4～5, obtain chitosan solution, separately getting chlorhexidine acetate is dissolved in glycerol, add in the chitosan washing liquid, stir, degassed, fill seals in the high density polyethylene (HDPE) Vagina washing bottle, further with cobalt-60 irradiation of 10～11KGy dosage, penetrate sterilization treatment, obtain chitosan chlorhexidine woman of the present invention and use aseptic washing liquid, the viscosity rate of change of this washing liquid after cobalt-60 irradiation is penetrated processing is less than
+10%.
Embodiment 8, chitosan chlorhexidine woman use washing liquid and preparation method thereof
Formula: chitosan 1.2g (viscosity-average molecular weight is 40,000, deacetylation >=95%)
Citric acid chlorhexidine 0.2g
Glycerol 7g
Lactic acid is appropriate
Purified water adds to 100g.
Preparation method: in the environment that is 100,000 grades at cleanliness factor, chitosan is mixed and is suspension with purified water, add lactic acid, make reactant form washing liquid, and the pH value that makes washing liquid is 4～5, obtain chitosan solution, separately getting the citric acid chlorhexidine is dissolved in glycerol, add in the chitosan washing liquid, stir, degassed, fill seals in the high density polyethylene (HDPE) Vagina washing bottle, further with cobalt-60 irradiation of 10～11KGy dosage, penetrate sterilization treatment, obtain chitosan chlorhexidine woman of the present invention and use aseptic washing liquid, the viscosity rate of change of this washing liquid after cobalt-60 irradiation is penetrated processing is less than
+10%.
Embodiment 9,
The viscosity rate of change of the viscosity of the washing liquid of embodiment 1～8 after penetrating processing through cobalt-60 irradiation or carrying out high-temperature heat sterilization all is less than
+10%, color and luster, stability all show well; And the bacteriostasis rate to Candida albicans, colon bacillus, staphylococcus aureus all is greater than 95%, and especially the bacteriostasis rate for Candida albicans reaches 100%, demonstrates stronger antibiotic property, and vaginitis is had to good therapeutical effect; As the direct administration of vagina, the application in the medicine of preparation treatment women monilial vaginitis, bacterial vaginitis, trichomonal vaginitis or cervicitis, or as the women daily gynecological's hygiene care.
Claims (10)
1. a woman uses aseptic washing liquid, it is characterized in that:
(1) containing viscosity-average molecular weight is 2～100,000 and its deacetylation chitosan 0.2%～1.5%, chlorhexidine 0.1%～0.5%, glycerol 4%～10%, acidulant and purified water of being greater than 85%, wherein said chlorhexidine comprises chlorhexidine acetate, chlorhexidine gluconate, Chlorhexidine hydrochloride or citric acid chlorhexidine, the mixture that described acidulant is lactic acid, acetic acid or hydrochloric acid-acetic acid;
(2) pH value of described washing liquid is 3.8～5.8;
(3) the viscosity rate of change of described washing liquid after cobalt-60 irradiation is penetrated processing or carried out high-temperature heat sterilization is less than
+10%.
2. a woman uses aseptic washing liquid, it is characterized in that:
(1) containing viscosity-average molecular weight is 3～80,000 and its deacetylation chitosan 0.2%～1.2%, chlorhexidine 0.1%～0.4%, glycerol 5%～8%, acidulant and purified water of being greater than 90%, wherein said chlorhexidine comprises chlorhexidine acetate, chlorhexidine gluconate, Chlorhexidine hydrochloride or citric acid chlorhexidine, the mixture that described acidulant is lactic acid, acetic acid or hydrochloric acid-acetic acid;
(2) pH value of described washing liquid is 3.8～5.8;
(3) the viscosity rate of change of described washing liquid after cobalt-60 irradiation is penetrated processing or carried out high-temperature heat sterilization is less than
+10%.
3. claim 1 or woman claimed in claim 2 use aseptic washing liquid, it is characterized in that described acidulant is that hydrochloric acid and the glacial acetic acid that concentration is 36%～38% be take volume ratio as (1～5): 1 mixture.
4. claim 1 or woman claimed in claim 2 use aseptic washing liquid, it is characterized in that described acidulant is that the concentration hydrochloric acid that is 36%～38% and glacial acetic acid be take the mixture that volume ratio is 5:1.
5. claim 1 or woman claimed in claim 2 use aseptic washing liquid, and wherein said chitosan also comprises: carboxymethyl chitosan, chitosan hydrochlorate, chitosan lactate, chitosan acetate, chitosan sulfate fat, chitosan quaternary amine or Chitosan oligosaccharide.
6. claim 1 or woman claimed in claim 2 use aseptic washing liquid, it is characterized in that being prepared into by following method:
In the environment that is 100,000 grades at cleanliness factor, chitosan is mixed and is suspension with purified water, add acidulant to regulate pH to 3.8～5.8, obtain chitosan solution, separately get chlorhexidine and be dissolved in glycerol, add in chitosan solution, stir, degassed, filling and sealing, sterilizing get final product, the mixture that wherein acidulant is lactic acid, acetic acid or hydrochloric acid-acetic acid, sterilizing adopts cobalt-60 irradiation penetrate processing or carry out high-temperature heat sterilization.
7. the preparation method of claim 1 or aseptic washing liquid claimed in claim 2, it is included in the environment that cleanliness factor is 100,000 grades, chitosan is mixed and is suspension with purified water, add acidulant to regulate pH to 3.8～5.8, obtain chitosan solution, separately getting chlorhexidine is dissolved in glycerol, add in chitosan solution, stir, degassed, filling and sealing, sterilizing get final product, the mixture that wherein acidulant is lactic acid, acetic acid or hydrochloric acid-acetic acid, and sterilizing adopts cobalt-60 irradiation penetrate processing or carry out high-temperature heat sterilization.
8. claim 1 or woman claimed in claim 2 are by the preparation method of aseptic washing liquid, and it is included in the environment that cleanliness factor is 100,000 grades, and chitosan is mixed and is suspension with purified water, add acidulant to regulate pH to 3.8～5.8, obtain chitosan solution, separately get chlorhexidine and be dissolved in glycerol, add in chitosan solution, stir, degassed, fill, in plastic bottle, seals, further with cobalt-60 irradiation of 7.5～13KGy dosage, penetrate processing, obtain.
9. claim 1 or woman claimed in claim 2 are by the preparation method of aseptic washing liquid, and it is included in the environment that cleanliness factor is 100,000 grades, and chitosan is mixed and is suspension with purified water, add acidulant to regulate pH to 3.8～5.8, obtain chitosan solution, separately get chlorhexidine and be dissolved in glycerol, add in chitosan solution, stir, degassed, fill, in cillin bottle, seals, further use 121 ℃ of moist heat sterilization 10～15min, obtain.
Claim 1 or woman claimed in claim 2 by aseptic washing liquid as the direct administration of vagina, the application in the medicine of preparation treatment women monilial vaginitis, bacterial vaginitis, trichomonal vaginitis or cervicitis; Perhaps for the daily hygiene care of woman vagina.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103920073A (en) * | 2014-04-16 | 2014-07-16 | 广西信业生物技术有限公司 | Chitosan genital tract biological antibacterial liquid and preparation method thereof |
| CN104383540A (en) * | 2014-10-08 | 2015-03-04 | 广东北罡生物科技有限公司 | Woman pudenda washing liquid capable of protecting lactics |
| CN105055439A (en) * | 2015-08-21 | 2015-11-18 | 叶元康 | Vaginal microecosystem maintenance, health care and control preparation and preparing method and application thereof |
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| CN101698101A (en) * | 2008-12-02 | 2010-04-28 | 济南宏瑞创博医药科技开发有限公司 | Medicine composite for treating vaginitis |
| CN103263525A (en) * | 2013-04-18 | 2013-08-28 | 宁波更实投资有限公司 | Gynecological cleaning fluid and preparation method thereof |
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2013
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| CN101698101A (en) * | 2008-12-02 | 2010-04-28 | 济南宏瑞创博医药科技开发有限公司 | Medicine composite for treating vaginitis |
| CN103263525A (en) * | 2013-04-18 | 2013-08-28 | 宁波更实投资有限公司 | Gynecological cleaning fluid and preparation method thereof |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103920073A (en) * | 2014-04-16 | 2014-07-16 | 广西信业生物技术有限公司 | Chitosan genital tract biological antibacterial liquid and preparation method thereof |
| CN104383540A (en) * | 2014-10-08 | 2015-03-04 | 广东北罡生物科技有限公司 | Woman pudenda washing liquid capable of protecting lactics |
| CN105055439A (en) * | 2015-08-21 | 2015-11-18 | 叶元康 | Vaginal microecosystem maintenance, health care and control preparation and preparing method and application thereof |
| CN105055439B (en) * | 2015-08-21 | 2018-04-13 | 叶元康 | A kind of microecology in vaginas maintenance, health care and prevention preparation and preparation method and application |
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|---|---|
| CN103446177B (en) | 2015-05-13 |
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