CN103446177B - 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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- CN103446177B CN103446177B CN201310431504.4A CN201310431504A CN103446177B CN 103446177 B CN103446177 B CN 103446177B CN 201310431504 A CN201310431504 A CN 201310431504A CN 103446177 B CN103446177 B CN 103446177B
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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 medical product field, concrete, the present invention relates to a kind of washing liquid for the treatment of gynaecopathia, it is the treatment etc. for women's monilial vaginitis, bacterial vaginitis, Combination vaginitis, cervicitis, 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, be easy to storage, easy to use.
Chitosan (Chitosan), chemistry by name poly-(1,4)-2-amino-2-deoxidation-β-D-Glucose, a kind of natural biological polymer being chitosan moiety or obtaining after all taking off acetyl, it is the only macromolecule alkaline polysaccharide that nature exists, also known as making soluble chitin, Chitosan, chitosan, chitosan, there is good biocompatibility, have no side effect, easily absorbed, the feature such as abundance, obtain development and application widely in the field such as synthesis of food industry, chemical industry, medical macromolecular materials.
The externally used antimicrobial agent used as vagina and wound surface nursing agent, although chitosan has good effect in wound repair (such as in wound repair and nursing), but in antibiotic property, especially kill in pathogenic bacterium obviously not enough, especially this form of washing liquid, washing vagina time, effective ingredient in washing liquid is short in intravaginal retention time, valid density is low, a kind of composition of chitosan alone, in the treatment of serious and intractable gynaecopathia, antibacterial action Shortcomings.
Summary of the invention
The invention provides a kind of lotion formulation for the treatment of gynaecopathia newly, specifically a kind of woman's washing liquid containing chitosan and chlorhexidine and preparation method thereof, it contains chitosan and chlorhexidine two kinds of main constituents, has good Synergistic antimicrobial effect.
The present inventor studies discovery, affects the quality of chitosan of the present invention and chlorhexidine woman washing liquid, has many factors, wherein direct influence factor, has four factors below:
One is the stability of chitosan and chlorhexidine in washing liquid, chitosan energy under sour environment is water-soluble or become class transparent lotion shape, but chlorhexidine (normally chlorhexidine acetate, chlorhexidine gluconate, Chlorhexidine hydrochloride or citric acid chlorhexidine) poorly water-soluble, the formula of chitosan and chlorhexidine woman washing liquid, acidulant and the stability of preparation technology to its washing liquid have material impact;
Two is molecular weight and deacetylations of chitosan, the chitosan that molecular weight is little, deacetylation is high, and its anti-microbial property is better, but its washing liquid viscosity and adhesiveness poor;
Three is pH value of washing liquid, and when the pH value of washing liquid is lower, viscosity and adhesion diminish, and when the pH value of washing liquid is higher, although have good viscosity and adhesion, the less stable of washing liquid, can not form stable, that class is transparent washing liquid;
Four is the content of chitosan in washing liquid, and the content of chitosan is for the viscosity of washing liquid and adhesion, and impact is comparatively large, and chitosan content is high, although the viscosity of washing liquid and adhesion better, washing liquid is easy to layering occurs and separates out chitosan solid;
In addition, affect chitosan of the present invention and the chlorhexidine woman indirect factor by washing liquid quality, prior have two factors:
One be such medical product is all aseptic usually, Product Terminal is all needed to carry out sterilizing, usual employing cobalt-60 spoke treatment with irradiation or carry out high-temperature heat sterilization, in employing cobalt-60 spoke treatment with irradiation or after carrying out high-temperature heat sterilization, viscosity and the adhesion of chitosan washing liquid are often deteriorated, when especially adopting cobalt-60 irradiation to inject row sterilization treatment, the dosage size of radiation is crucial influence factor;
Two is selections of acidulant, under the relative rigid condition of the 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 to the quality influence of chitosan woman washing liquid of the present invention.
Based on many directly and indirectly influence factors above, the invention provides a kind of woman's washing liquid, containing 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 is 2 ~ 100,000 and its deacetylation is greater than 85%, described chlorhexidine comprises chlorhexidine acetate, chlorhexidine gluconate, Chlorhexidine hydrochloride or citric acid chlorhexidine, and described acidulant is the mixture of 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 concentration be 36% ~ 38% hydrochloric acid and glacial acetic acid be (1 ~ 5) using volume ratio: the mixture of 1 as acidulant, especially selection concentration be 36% ~ 38% hydrochloric acid and glacial acetic acid be that the mixture of 5:1 is as acidulant with volume ratio.
Common, woman of the present invention packs with the Vagina washing bottle that washing liquid adopts macromolecular material to make and seals, and is conducive to preserving and patient's use.
One skilled in the art will appreciate that chitosan is a kind of high molecular polymer, belong to mixture category, the assay method of molecular weight is a lot, as viscosity method surveys 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, end group measurement, ebulliometry, vapor-pressure osmometry is also had.The features such as wherein, viscosity method adopts Ubbelohde viscometer, has equipment simple, easy to operate are methods comparatively conventional at present.Because chitosan is a kind of high molecular polymer, its molecular weight is its assembly average, common, represents with viscosity-average molecular weight.
Need particularly point out and those skilled in the art it is understood that, chitosan molecule amount of the present invention, be often referred to the relative molecular weight measured with viscosimetry, although molecular weight of the present invention is the value determined, 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, such as, molecular weight is the chitosan of 50,000, and the molecular weight ranges of in fact this chitosan is 4.5 ~ 5.5 ten thousand; Molecular weight is the chitosan of 60,000, and the molecular weight ranges of in fact this chitosan is 5.4 ~ 6.6 ten thousand; Molecular weight is the chitosan of 100,000, and the molecular weight ranges of in fact this chitosan is 9 ~ 110,000, etc.
Concrete, the invention provides a kind of woman containing chitosan chlorhexidine and use aseptic washing liquid, it is characterized in that:
(1) be 2 ~ 100,000 containing viscosity-average molecular weight and its deacetylation be greater than 85% chitosan 0.2% ~ 1.5%, chlorhexidine 0.1% ~ 0.5%, glycerol 4% ~ 10%, acidulant and purified water, wherein said chlorhexidine comprises chlorhexidine acetate, chlorhexidine gluconate, Chlorhexidine hydrochloride or citric acid chlorhexidine, and described acidulant is the mixture of lactic acid, acetic acid or hydrochloric acid-acetic acid;
(2) pH value of described washing liquid is 3.8 ~ 5.8;
(3) described washing liquid is less than through cobalt-60 spoke treatment with irradiation or the viscosity B coefficent rate after carrying out high-temperature heat sterilization
+10%.
Preferably, the woman that the invention provides a kind of chitosan chlorhexidine uses aseptic washing liquid, it is characterized in that:
(1) be 3 ~ 80,000 containing viscosity-average molecular weight and its deacetylation be greater than 90% chitosan 0.2% ~ 1.2%, chlorhexidine 0.1% ~ 0.4%, glycerol 5% ~ 8%, acidulant and purified water, wherein said chlorhexidine comprises chlorhexidine acetate, chlorhexidine gluconate, Chlorhexidine hydrochloride or citric acid chlorhexidine, and described acidulant is the mixture of lactic acid, acetic acid or hydrochloric acid-acetic acid;
(2) pH value of described washing liquid is 3.8 ~ 5.8;
(3) described washing liquid is less than through cobalt-60 spoke treatment with irradiation or the viscosity B coefficent rate after carrying out high-temperature heat sterilization
+10%.
Chitosan of the present invention also comprises the derivant of chitosan, such as 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.
Invention further provides the preparation method of woman by aseptic washing liquid of this chitosan chlorhexidine.As previously mentioned, the formula of washing liquid of the present invention and the stability of preparation technology to its washing liquid have material impact, and inventor finds, different preparation technologies, the stability difference of the washing liquid obtained is very large.
In formula range of the present invention, the feed postition of chlorhexidine is different, and the stability difference of the washing liquid obtained is very large.
Such as, according to formula below, adopt the washing liquid that different preparation technologies obtains, 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 being mixed in beaker is suspension, adds newborn acid for adjusting pH to 4-5, obtains the chitosan solution clarified, separately getting chlorhexidine acetate is dissolved in glycerol, adds in the lactic acid washing liquid of chitosan, stirs, filling and sealing, to obtain final product.
Preparation method two: chitosan, chlorhexidine acetate, glycerol are added successively in purified water, stir, in suspension, then add newborn acid for adjusting pH to 4-5, stir, obtain chitosan chlorhexidine washing liquid, filling and sealing, to obtain final product.
By washing liquid obtained above respectively to penetrate sterilization treatment with cobalt-60 irradiation of 10KGy dosage, after the washing liquid irradiation that discover method one obtains, only viscosity diminishes to some extent, but viscosity B coefficent rate 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 washing liquid occurs muddy, and adularescent particulate material is separated out, after washing liquid dilute filtration, obtain 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 the good washing liquid of the present invention of stability.
Further, chitosan chlorhexidine woman of the present invention is by the preparation method of aseptic washing liquid, it is included in cleanliness factor is in the environment of 100,000 grades, chitosan is mixed in suspension with purified water, add acidulant and 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, wherein acidulant is lactic acid, the mixture of acetic acid or hydrochloric acid-acetic acid, sterilizing adopts cobalt-60 spoke treatment with irradiation or carries out high-temperature heat sterilization, preferred cobalt-60 irradiation dose is 7.5 ~ 13KGy, such as 8KGy, 9KGy, 10KGy, 10.5KGy, 11KGy, 11.5KGy, 12KGy etc., or adopt 121 DEG C of moist heat sterilization 10 ~ 15min further.
Concrete, chitosan chlorhexidine woman of the present invention is by the preparation method of aseptic washing liquid, and it is included in cleanliness factor is in the environment of 100,000 grades, chitosan is mixed with purified water in suspension, add acidulant and 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, uses cobalt-60 spoke treatment with irradiation of 7.5 ~ 13KGy dosage further, to obtain final product; Or chitosan chlorhexidine woman of the present invention is by the preparation method of aseptic washing liquid, and it is included in cleanliness factor is in the environment of 100,000 grades, chitosan is mixed with purified water in suspension, add acidulant and 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, uses 121 DEG C of moist heat sterilization 10 ~ 15min further, to obtain final product.
With related experiment, related art features of the present invention is described.
One, in the present invention, chitosan and chlorhexidine have good antibacterial synergism.Verified by experiment below.
Prepare chitosan chlorhexidine washing liquid (sample 1), chitosan washing liquid (sample 2), chlorhexidine washing liquid (sample 3) respectively, main concrete composition is as follows:
Sample 1: chitosan 0.5%, chlorhexidine acetate 0.25%, glycerol 4%, all the other are purified water, and lactic acid adjusts pH to 4-5;
Sample 2: chitosan 0.5%, glycerol 4%, all the other are purified water, and lactic acid adjusts pH to 4-5;
Sample 3: chlorhexidine acetate 0.25%, glycerol 4%, all the other are purified water, and lactic acid adjusts pH to 4-5.
Anti-microbial property is tested: the bacteriostatic experiment above-mentioned three kinds of samples being carried out respectively to Candida albicans, colon bacillus, staphylococcus aureus, and result is as follows:
When sample 1 acts on 2min, all 95% is greater than to the bacteriostasis rate of Candida albicans, colon bacillus, staphylococcus aureus;
When sample 2 acts on 2min, 70% is greater than to the bacteriostasis rate of Candida albicans, 65% is greater than to the bacteriostasis rate of colon bacillus, staphylococcus aureus;
When sample 3 acts on 2min, 80% is greater than to the bacteriostasis rate of Candida albicans, 85% is to the bacteriostasis rate of colon bacillus, staphylococcus aureus.
Tested as can be seen from above-mentioned anti-microbial property, in chitosan chlorhexidine woman washing liquid of the present invention, chitosan and chlorhexidine have good antibacterial synergism, and its antibacterial action is better than the solution of its one-component.
Two, in addition, the factor forming washing liquid most critical in chitosan chlorhexidine woman washing liquid of the present invention is chitosan, and the screening study of its correlation technique factor is as follows:
(1) molecular weight of chitosan and the selection of deacetylation
Select respectively viscosity-average molecular weight be 20,000,30,000,40,000,60,000,80,000,100,000,120,000,140,000 chitosan, make that content is 0.5%, pH value is the washing liquid of 4.5, find viscosity-average molecular weight be 120,000 chitosan washing liquid have chitosan to separate out when room temperature places 60 days, less stable, molecular weight be 140,000 the solution viscosity made of chitosan larger, poor fluidity, cleaning effectiveness is poor
Therefore selection viscosity-average molecular weight is the chitosan of 2 ~ 100,000, preferred viscosity-average molecular weight is the chitosan of 3 ~ 80,000;
Select respectively deacetylation be 75%, 80%, 85%, 90%, 95% chitosan, make that content is 7%, pH value is the washing liquid of 4.5, find deacetylation be 75%, 80% chitosan dissolubility is bad in the preparation, and room temperature is placed and within 6 months, is had chitosan particle precipitation, be that washing liquid becomes muddy, therefore select deacetylation to be greater than the chitosan of 85%.Show that viscosity-average molecular weight is 2 ~ 100,000 and washing liquid of the present invention prepared by the chitosan that deacetylation is greater than 85% has good stability.
(2) selection of the pH value of washing liquid
Select viscosity-average molecular weight be 80,000 chitosan, make the washing liquid that content is 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 when the pH value of washing liquid is greater than 6, room temperature is placed and within 6 months, had chitosan particle precipitation, washing liquid is made to become muddy, being attached to pH value range is ± 1, therefore selects the pH value of washing liquid to be 3.8 ~ 5.8, shows that the pH value of washing liquid is 3.8 ~ 5.8 have good stability.
(3) selection of washing liquid mesochite glycan content
Select viscosity-average molecular weight to be respectively the chitosan of 40,000,60,000,80,000,100,000, making content is respectively 0.2%, 0.5%, 0.8%, 1.2%, 1.5%, 1.7%, 1.8%, and pH value is the washing liquid of 4.5, find when content is greater than 1.5%, the viscosity of washing liquid is comparatively large, and poor fluidity, cannot form washing liquid; In addition when the content of chitosan is greater than 0.2%, with chlorhexidine, there is good antibacterial synergism, therefore select 0.2% ~ 1.5% of chitosan content.
(4) selection of acidulant
Use hydrochloric acid respectively, lactic acid, the mixture of acetic acid or hydrochloric acid-acetic acid does acidulant, select viscosity-average molecular weight be 80,000 chitosan, making content is 0.25%, 0.8%, 1%, pH value is the washing liquid of 4.5, find the washing liquid doing acidulant with hydrochloric acid, by cobalt-60 spoke treatment with irradiation or after carrying out high-temperature heat sterilization, viscosity significantly declines, viscosity becomes 70% ~ 80% before sterilizing, may be that hydrochloric acid belongs to strong acid, in cobalt-60 spoke treatment with irradiation or when carrying out high-temperature heat sterilization, strong destruction is produced to the crosslinked action of chitosan washing liquid, viscosity is declined to a great extent, therefore selection lactic acid, the mixture of acetic acid or hydrochloric acid-acetic acid does acidulant.
(5) mixture of hydrochloric acid-acetic acid does the determination of acidulant
When doing acidulant with acetic acid, the washing liquid obtained has strong acetic acid stink, the mixture selecting the different volumes proportioning of acetate and hydrochloride to be formed does acidulant, can obtain cobalt-60 spoke treatment with irradiation or after carrying out high-temperature heat sterilization viscosity B coefficent little, and there is no the washing liquid of obvious acetic acid stink, only have extremely slight acetic acid taste.
Adopt concentration be 36% ~ 38% hydrochloric acid and glacial acetic acid be (1 ~ 5) using volume ratio: the mixture of 1 is as acidulant, within the scope of this, adopt the mixture acidulant of different volume proportions, the washing liquid obtained is transparent, good stability, by cobalt-60 spoke treatment with irradiation or after carrying out high-temperature heat sterilization, viscosity B coefficent is less.
Preferably, the present invention selects the mixture of hydrochloric acid-acetic acid as acidulant, especially select concentration be 36% ~ 38% hydrochloric acid and glacial acetic acid be that the mixture of 5:1 is as acidulant with volume ratio, the washing liquid clarity obtained is good, good stability, room temperature places 6 months, the viscosity of washing liquid, pH value, color and luster are homogeneous, abnormal smells from the patient all keeps consistent with 0 month, washing liquid shows good stability, show to select the mixture of hydrochloric acid-acetic acid as acidulant, especially select concentration be 36% ~ 38% hydrochloric acid and glacial acetic acid be that the mixture of 5:1 is as acidulant with volume ratio.
(6) determination of sterilising conditions
Be in the environment of 100,000 grades at cleanliness factor, prepare the washing liquid of different chitosan content, by cobalt-60 spoke treatment with irradiation or moist heat sterilization, find all washing liquids cobalt-60 spoke treatment with irradiation of 13KGy dosage or with 121 DEG C of moist heat sterilization 10 ~ 15min after, carry out bacterium inspection immediately, result after culture period terminates is all aseptic, and after cobalt-60 spoke treatment with irradiation of 7.5KGy dosage, although part washing liquid carries out bacterium inspection immediately, bacterium survival is shown after culture period terminates, but carry out bacterium inspection in placement after 3 days, result after inspection culture period terminates is all aseptic, it may be the basic deactivation of antibacterial after cobalt-60 spoke treatment with irradiation, under the antibacterial action of washing liquid itself, make its thorough deactivation.Show that at cleanliness factor be in the environment of 100,000 grades, prepare the washing liquid of different chitosan content, through cobalt-60 spoke treatment with irradiation of 7.5 ~ 13KGy dosage or aseptic washing liquid can be obtained with after 121 DEG C of moist heat sterilization 10 ~ 15min.
Further, chitosan chlorhexidine washing liquid of the present invention, as the direct administration of vagina, treats the application in the medicine of women's monilial vaginitis, bacterial vaginitis, trichomonal vaginitis or cervicitis in preparation; Or for the daily hygiene care of woman vagina.
detailed description of the inventionin implementation process of the present invention, those of ordinary skill in the art are not departing from the scope of the present invention various embodiment that the basis with spirit produces and are modifying apparent and be easily carry out, the invention is not restricted to the scope of specific embodiment as herein described, really, various modification of the present invention, except describe those be can from above describe understood by those skilled in the art.By the following examples the present invention done and illustrate further, but do not represent embodiment limitation of the present invention.
Embodiment 1, chitosan chlorhexidine woman 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
The hydrochloric acid of 37% and glacial acetic acid mixture (V:V=5:1) are in right amount
Purified water adds to 100g.
Preparation method: it is included in cleanliness factor is in the environment of 100,000 grades, chitosan is mixed in suspension with purified water, add hydrochloric acid and glacial acetic acid mixture, reactant is made to form washing liquid, and make the pH value of washing liquid 4 ~ 5, obtain chitosan solution, separately getting chlorhexidine acetate is dissolved in glycerol, add in chitosan washing liquid, stir, degassed, fill is in plastic bottle or Vagina washing bottle sealing, penetrate sterilization treatment with cobalt-60 irradiation of 10 ~ 11KGy dosage further, obtain chitosan chlorhexidine woman of the present invention and use aseptic washing liquid, washing liquid does not almost have acetic acid taste; Or fill is in cillin bottle, sealing, uses 121 DEG C of sterilizing 15min further, namely obtain chitosan chlorhexidine woman of the present invention and use aseptic washing liquid, and described washing liquid is less than through cobalt-60 spoke treatment with irradiation or the viscosity B coefficent rate after carrying out high-temperature heat sterilization
+10%.
The chitosan chlorhexidine woman washing liquid that embodiment 2, formula are following
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, and described acidulant is the mixture of lactic acid, acetic acid or hydrochloric acid-acetic acid, and the viscosity B coefficent rate of described washing liquid after cobalt-60 spoke treatment with irradiation is less than
+10%, the pH value of washing liquid is 3.8 ~ 5.8.The preparation method of above-mentioned chitosan chlorhexidine woman washing liquid is as follows:
It is included in cleanliness factor is in the environment of 100,000 grades, chitosan is mixed in suspension with purified water, add acidulant and regulate pH to 3.8 ~ 5.8, obtain chitosan solution, separately getting chlorhexidine is dissolved in glycerol, add in chitosan washing liquid, stir, degassed, filling and sealing, sterilizing, wherein acidulant is lactic acid, the mixture of acetic acid or hydrochloric acid-acetic acid, sterilizing adopts cobalt-60 spoke treatment with irradiation or carries out high-temperature heat sterilization, preferred cobalt-60 irradiation dose is 7.5 ~ 13KGy, such as 8KGy, 9KGy, 10KGy, 10.5KGy, 11KGy, 11.5KGy, 12KGy etc.
Embodiment 3, chitosan chlorhexidine woman 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
The hydrochloric acid of 37% and glacial acetic acid mixture (V:V=5:1) are in right amount
Purified water adds to 100g.
Preparation method: it is included in cleanliness factor is in the environment of 100,000 grades, chitosan is mixed in suspension with purified water, add hydrochloric acid and glacial acetic acid mixture, reactant is made to form washing liquid, and make the pH value of washing liquid 4 ~ 5, obtain chitosan solution, separately get chlorhexidine acetate and Mentholum is dissolved in glycerol, add in chitosan washing liquid, stir, degassed, fill seals in high density polyethylene (HDPE) Vagina washing bottle, sterilization treatment is penetrated further with cobalt-60 irradiation of 10 ~ 11KGy dosage, obtain chitosan chlorhexidine woman of the present invention and use aseptic washing liquid, the viscosity B coefficent rate of this washing liquid after cobalt-60 spoke treatment with irradiation is less than
+10%, washing liquid does not have acetic acid taste, has cool peppermint taste.
Embodiment 4, chitosan chlorhexidine woman 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 cleanliness factor is in the environment of 100,000 grades, chitosan is mixed in suspension with purified water, add lactic acid, reactant is made to form washing liquid, and make the pH value of washing liquid 4 ~ 5, obtain chitosan solution, separately getting chlorhexidine gluconate is dissolved in glycerol, add in chitosan washing liquid, stir, degassed, fill seals in high density polyethylene (HDPE) Vagina washing bottle, sterilization treatment is penetrated further with cobalt-60 irradiation of 10 ~ 11KGy dosage, obtain chitosan chlorhexidine woman of the present invention and use aseptic washing liquid, the viscosity B coefficent rate of this washing liquid after cobalt-60 spoke treatment with irradiation is less than
+10%.
Embodiment 5, chitosan chlorhexidine woman 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: be in the environment of 100,000 grades at cleanliness factor, chitosan is mixed in suspension with purified water, add lactic acid, reactant is made to form washing liquid, and make the pH value of washing liquid 4 ~ 5, obtain chitosan solution, separately getting chlorhexidine acetate is dissolved in glycerol, add in chitosan washing liquid, stir, degassed, fill seals in high density polyethylene (HDPE) Vagina washing bottle, penetrate sterilization treatment with cobalt-60 irradiation of 10 ~ 11KGy dosage further, obtain chitosan chlorhexidine woman of the present invention and use aseptic washing liquid, the viscosity B coefficent rate of this washing liquid after cobalt-60 spoke treatment with irradiation is less than
+10%.
Embodiment 6, chitosan chlorhexidine woman 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: be in the environment of 100,000 grades at cleanliness factor, chitosan is mixed in suspension with purified water, add acetic acid, reactant is made to form washing liquid, and make the pH value of washing liquid 4 ~ 5, obtain chitosan solution, separately getting chlorhexidine acetate is dissolved in glycerol, add in chitosan washing liquid, stir, degassed, fill seals in high density polyethylene (HDPE) Vagina washing bottle, penetrate sterilization treatment with cobalt-60 irradiation of 10 ~ 11KGy dosage further, obtain chitosan chlorhexidine woman of the present invention and use aseptic washing liquid, the viscosity B coefficent rate of this washing liquid after cobalt-60 spoke treatment with irradiation is less than
+10%, washing liquid has acetic acid abnormal flavour.
Embodiment 7, chitosan chlorhexidine woman 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: be in the environment of 100,000 grades at cleanliness factor, chitosan is mixed in suspension with purified water, add lactic acid, reactant is made to form washing liquid, and make the pH value of washing liquid 4 ~ 5, obtain chitosan solution, separately getting chlorhexidine acetate is dissolved in glycerol, add in chitosan washing liquid, stir, degassed, fill seals in high density polyethylene (HDPE) Vagina washing bottle, penetrate sterilization treatment with cobalt-60 irradiation of 10 ~ 11KGy dosage further, obtain chitosan chlorhexidine woman of the present invention and use aseptic washing liquid, the viscosity B coefficent rate of this washing liquid after cobalt-60 spoke treatment with irradiation is less than
+10%.
Embodiment 8, chitosan chlorhexidine woman 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: be in the environment of 100,000 grades at cleanliness factor, chitosan is mixed in suspension with purified water, add lactic acid, reactant is made to form washing liquid, and make the pH value of washing liquid 4 ~ 5, obtain chitosan solution, separately getting citric acid chlorhexidine is dissolved in glycerol, add in chitosan washing liquid, stir, degassed, fill seals in high density polyethylene (HDPE) Vagina washing bottle, sterilization treatment is penetrated further with cobalt-60 irradiation of 10 ~ 11KGy dosage, obtain chitosan chlorhexidine woman of the present invention and use aseptic washing liquid, the viscosity B coefficent rate of this washing liquid after cobalt-60 spoke treatment with irradiation is less than
+10%.
Embodiment 9,
The viscosity of the washing liquid of embodiment 1 ~ 8 is all being less than through cobalt-60 spoke treatment with irradiation or the viscosity B coefficent rate after carrying out high-temperature heat sterilization
+10%, color and luster, stability all show well; And be all greater than 95% to the bacteriostasis rate of Candida albicans, colon bacillus, staphylococcus aureus, the bacteriostasis rate especially for Candida albicans reaches 100%, demonstrates stronger antibiotic property, has good therapeutical effect to vaginitis; 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 daily gynecological's hygiene care of women.
Claims (3)
1. a chitosan chlorhexidine woman washing liquid, its formula is as follows:
Viscosity-average molecular weight is 60,000, the chitosan 0.25g of deacetylation >=90%,
Chlorhexidine acetate 0.2g,
Glycerol 8g,
37% hydrochloric acid of V:V=5:1 and the mixture of glacial acetic acid are appropriate,
Purified water adds to 100g;
Its preparation method comprises: be in the environment of 100,000 grades at cleanliness factor, mixed with purified water by chitosan in suspension, add hydrochloric acid and glacial acetic acid mixture, regulates liquid pH value is 4 ~ 5, obtain chitosan solution, separately getting chlorhexidine acetate is dissolved in glycerol, joins in chitosan solution, stirs, degassed, fill, in plastic bottle or Vagina washing bottle sealing, is penetrated sterilization treatment with cobalt-60 irradiation of 10 ~ 11KGy dosage, to be obtained final product.
2. a chitosan chlorhexidine woman washing liquid, its formula is as follows:
Viscosity-average molecular weight is 50,000, the chitosan 0.4g of deacetylation >=95%,
Chlorhexidine acetate 0.3g,
Mentholum 0.01g,
Glycerol 8g,
37% hydrochloric acid of V:V=5:1 and the mixture of glacial acetic acid are appropriate,
Purified water adds to 100g;
Its preparation method comprises: be in the environment of 100,000 grades at cleanliness factor, mixed with purified water by chitosan in suspension, add hydrochloric acid and glacial acetic acid mixture, the pH value of regulates liquid is 4 ~ 5, obtain chitosan solution, separately get chlorhexidine acetate and Mentholum is dissolved in glycerol, join in chitosan solution, stir, degassed, fill, in the sealing of high density polyethylene (HDPE) Vagina washing bottle, is penetrated sterilization treatment with cobalt-60 irradiation of 10 ~ 11KGy dosage, to be obtained final product.
3. a chitosan chlorhexidine woman washing liquid, its formula is as follows:
Viscosity-average molecular weight is 60,000, the chitosan 0.3% ~ 0.7% of deacetylation >=90%,
Chlorhexidine 0.1% ~ 0.5%,
Glycerol 5% ~ 10%,
Acidulant is appropriate,
Purified water adds to 100%;
Wherein, described chlorhexidine comprises chlorhexidine acetate, chlorhexidine gluconate, Chlorhexidine hydrochloride or citric acid chlorhexidine, described acidulant is lactic acid, the mixture of acetic acid or hydrochloric acid-acetic acid, and its preparation method comprises: be in the environment of 100,000 grades at cleanliness factor, chitosan is mixed in suspension with purified water, add acidulant and regulate pH to 3.8 ~ 5.8, obtain chitosan solution, separately getting chlorhexidine is dissolved in glycerol, add in chitosan washing liquid, stir, degassed, filling and sealing, sterilization treatment is penetrated with cobalt-60 irradiation of 7.5 ~ 13KGy dosage, obtain.
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| CN103920073B (en) * | 2014-04-16 | 2015-10-28 | 东莞市达庆医疗器械有限公司 | A kind of chitosan reproductive tract biological antibiotic 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 |
| 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 |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
Non-Patent Citations (1)
| Title |
|---|
| Chitosan films and hydrogels of chlorhexidine gluconate for oral mucosal delivery;S. Senel等;《International Journal of Pharmaceutics》;20001231;第193卷;197-203 * |
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Effective date of registration: 20180716 Address after: 100071 Beijing Fengtai District East blacksmith battalion horizontal 31 No. 6 Building 3 floor 0319. Patentee after: Beijing Zhong run Qi source Biotechnology Co., Ltd. Address before: 350008 Jinshan Industrial Concentration Zone, 6 Lane Road, Jianxin Town, Cangshan District, Fuzhou, Fujian, two, Cangshan, 25. Patentee before: Fuzhou Qianzheng Pharmaceutical Co., Ltd. |
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