CN103316033A - Gel and use thereof - Google Patents
Gel and use thereof Download PDFInfo
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- CN103316033A CN103316033A CN2013102756254A CN201310275625A CN103316033A CN 103316033 A CN103316033 A CN 103316033A CN 2013102756254 A CN2013102756254 A CN 2013102756254A CN 201310275625 A CN201310275625 A CN 201310275625A CN 103316033 A CN103316033 A CN 103316033A
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Abstract
The invention belongs to the technical field of medicines, and discloses a gel and a use thereof. The gel comprises a chitosan polymer, a hyaluronic acid matter, a lactic acid matter, a gel matrix, a wetting agent and a diluter. The gel has the advantages of good antibacterial effect, wide antibacterial spectrum (comprising high risk HPV (Human Papilloma Virus), physical antibacterial effect, no tolerance, biodegradability, safety and environment-friendliness and lasting effect for a long time, and has the functions of nourishing, lubricating, whitening, repairing skins or mucosal tissues, and removing spots and inhibiting cicatrisation for skins or mucosal tissues.
Description
Technical field
The invention belongs to medical technical field, be specifically related to a kind of gel and uses thereof.
Background technology
Vaginitis and cervicitis are a kind of persistence inflammation of female genital tract, usually betide the Female in reproduction period, are the modal diseases of gynecological, and the Chang Yinqi treatment is not thorough, or not for the pathogen treatment, make due to the protracted inflammation.Modern medicine confirms, antibacterial, viral infection are the one of the main reasons of vaginitis, cervicitis and cervical erosion, common pathogen has: staphylococcus, streptococcus, escherichia coli, anaerobe, candidiasis, human papillomavirus (HPV), chlamydia trachomatis (CT), herpes simplex virus (HSV-n) etc., wherein HPV occupies an leading position in numerous causes of disease.And HPV and cervical intraepithelial neoplasia (CIN) (CIN) and cervical cancer are closely related, by CIN, can develop into cervical cancer by cervical erosion.
Cervical polyp also is one of modal disease of woman uterus pathological changes, with colpitis, chronic cervicitis (cervical erosion), is particularly infected relevant by HPV, HSV with Epstein-Barr virus (nerpes vinrus hominis) for a long time.
More for the treatment product on above-mentioned common female genital tract infection (containing high-risk HPV infects), cervicitis, the cervical erosion market, but therapeutic effect is unsatisfactory, and relapse rate is higher.
Summary of the invention
Purpose of the present invention provides a kind of new gel, and this gel has good anti-bacterial effect, and has a broad antifungal spectrum, does not produce drug resistance at physical antibacterial, biodegradable, safety and environmental protection, and duration of efficacy is long, tissue is had nourish function lubricated, that repair.
Another object of the present invention is to provide a kind of chitosan transparent matter yogurt acid gel agent in preparation treatment female lower genital tract infection (containing high-risk HPV infects), cervicitis, cervical erosion, wound healing, hemostasis and pain-relieving, antipruritic behind promotion cervix uteri or the vagina operation, nourish lubricated reproductive tract epithelial cell or mucosa, enhancing vagina elasticity, alleviate dry and astringent, burn, use in the vaginal atrophy symptom medicine such as pruritus.Alleviate bleeding hemorrhoids in preparation, pendant is swollen, use in the hemorrhoid mucous hyperemia edema, anal fissure pain symptom medicine; In the dermatitis that preparation Acne treatment, burn, scald, decubital ulcer infect and other scytitis such as tinea manus and pedis, mite infection cause; Suppress the cutaneous pigmentation that wound surface or inflammation cause, promote the laser beautifying postoperative to cause in the various traumatic infection medicines such as the reparation of the little damage of skin or the dressing and use.
Particularly, the invention provides:
A kind of gel comprises chitosan base polymer, hyalomitome acids material, lactic acid class material, gel-type vehicle, wetting agent, diluent.
A kind of gel also comprises be used to the hydrotropy acid of dissolving water-insoluble chitosan base polymer.
Described chitosan base polymer is one or more in chitin, water-soluble chitosan, carboxymethyl chitosan, acylation chitosan, alkylated chitosan, hydroxylating chitosan, chitosan quaternary ammonium salt, Chitosan oligosaccharide, the sulfated chitosan.
Described lactic acid class material is one or more of lactic acid, sodium lactate, calcium lactate, zinc lactate, aluctyl., ferrous lactate.
Described hyalomitome acids material is one or more in the chemical compound that forms of the sugar of hyaluronic acid, its cationic salts or itself and amino-contained.
Described hyalomitome acids material is among a kind of or several in hyaluronate sodium, potassium hyaluronate, calcium hyauronate, hyaluronic acid ammonium, hyaluronic acid, hyaluronic acid magnesium, hyaluronic acid TBuA, the deacetylate hyaluronic acid.
Described gel-type vehicle is one or more of carbomer, Polycarbophil, alginate, tragakanta, gelatin, cellulose and derivant thereof, Polyethylene Glycol, sodium polyacrylate, polyvinylpyrrolidone and derivant thereof.
Described wetting agent is one or more of glycerol, propylene glycol, sorbitol.
Described diluent is purified water or distilled water.
Described hydrotropy acid is acetic acid, phosphoric acid, citric acid, formic acid, hydrochloric acid, one or more of 1,2,3,4-BTCA.
Described gel raw material comprises: the chitosan base polymer is 3～28 weight portions; Hyalomitome acids material is 0.2～3.5 weight portion; Lactic acid class material is 0.4～50 weight portion, gel-type vehicle 0.6～1.2 weight portion, wetting agent 5～15 weight portions, hydrotropy acid 0.4-1.2 weight portion, water 55.4-86.1 weight portion.Perhaps described chitosan base polymer is 3～28 weight portions; Hyalomitome acids material is 0.2～3.5 weight portion; Lactic acid class material is 0.4～50 weight portion, gel-type vehicle 0.6～1.2 weight portion, wetting agent 5～15 weight portions, water 55.4-86.1 weight portion.
A kind of preparation method of gel may further comprise the steps:
1. chitosan polymer is dissolved in the diluent of pH3～7.5, fully stand-by after the swelling;
2. hyalomitome acids material is added in the diluent, fully add stand-by after the swelling;
3. gel-type vehicle is dissolved in an amount of diluent, fully adds stand-by after the swelling;
4. with step 1. with step 2. the solution of gained add in the same container, fully stirring and evenly mixing is stand-by;
5. with step 3. the gel-type vehicle of gained join in the container of step described in 4. abundant stirring and evenly mixing;
6. 5. add lactic acid class material in the solution of gained to step, and abundant stirring and evenly mixing;
7. 6. add wetting agent, diluent in the solution of gained to step, fully stir evenly mixedly, and get final product.
A kind of preparation method of gel may further comprise the steps:
Diluent, hyalomitome acids material, gel-type vehicle, lactic acid class material, diluent, the wetting agent of chitosan polymer, pH3～7.5 are added in the container, fully mix, make it to form gel after the abundant swelling, and get final product.
Above-mentioned chitosan transparent matter yogurt acid gel is in preparation treatment female lower genital tract infection (containing high-risk HPV infects), cervicitis, cervical erosion, wound healing, hemostasis and pain-relieving, antipruritic behind promotion cervix uteri or the vagina operation, nourish lubricated reproductive tract epithelial cell or mucosa, enhancing vagina elasticity, alleviate dry and astringent, burn, use in the vaginal atrophy symptom medicine such as pruritus.
Above-mentioned chitosan transparent matter yogurt acid gel is alleviated bleeding hemorrhoids in preparation, pendant is swollen, the application in the hemorrhoid mucous hyperemia edema, anal fissure pain medication.
Above-mentioned chitosan transparent matter yogurt acid gel is in preparation Acne treatment, burn, scald, decubital ulcer infect and other scytitis such as tinea manus and pedis, mite infection cause dermatitis; The cutaneous pigmentation that inflammation causes, laser beautifying postoperative cause the reparation of the little damage of skin and suppress to be used in the various traumatic infection medicines such as cicatrization or the dressing.
The present invention compared with prior art has the following advantages and good effect:
1, product of the present invention all has higher inhibition killing action to antibacterial, fungus, virus (containing high-risk HPV infects) or parasite; Except treatment women lower genital tract infection, also can alleviate bleeding hemorrhoids, symptom and the various infection for the treatment of human body skin such as pendant is swollen, hemorrhoid mucous hyperemia edema, anal fissure pain.Also can be used for cosmetic field, chitosan and hyaluronic acid can generate cationic membrane at skin surface under solutions of weak acidity, have significant moisture absorption, moisturizing, whitening, light speckle effect, antimicrobial antiphlogistic, to the skin nonirritant, can treat the skin of face inflammation that acarid etc. causes.
2, product of the present invention belongs to physical antibacterial, does not have drug resistance, can also be degradable, and be the green product of safety and environmental protection.
3, product safety of the present invention is nontoxic, has effect antibiotic, that repair, moisten, regulate vagina or skin microecological balance.
The specific embodiment
Below the invention will be further described for the description by the specific embodiment, but this is not to be limitation of the present invention, those skilled in the art are according to basic thought of the present invention, can make various modifications or improvement, but only otherwise break away from basic thought of the present invention, all within the scope of the present invention.
Described chitin, water-soluble chitosan, carboxymethyl chitosan, acylation chitosan, alkylated chitosan, hydroxylating chitosan, chitosan quaternary ammonium salt, Chitosan oligosaccharide, sulfated chitosan are available from Xingcheng, Nantong biological factory; Described lactic acid, sodium lactate, calcium lactate, zinc lactate, aluctyl., ferrous lactate are available from Zhengzhou Tian Run lactic acid company limited; Described hyaluronate sodium, potassium hyaluronate, calcium hyauronate, hyaluronic acid ammonium, hyaluronic acid, hyaluronic acid magnesium, hyaluronic acid TBuA, deacetylate hyaluronic acid are available from Qufu City sea sunrise Industrial Co., Ltd.; Described carbomer is available from Nanjing WeiEr chemical engineering Co., Ltd; Described glycerol, propylene glycol, sorbitol are available from Xi'an San Pu chemical reagent company limited; Described acetic acid, phosphoric acid, citric acid, formic acid, hydrochloric acid, 1,2,3,4-BTCA is available from sky, Yixing roc Fine Chemical Co., Ltd.
Test example
Test example 1: the effect I of anti-HPV
Test reagent: HPV nucleic acid amplification (PCR) fluorescence detection reagent kit (comprising DNA extraction liquid 1, DNA extraction liquid 2, PCR reactant liquor, Taq enzyme, UNG).Other reagent are analytical pure.
Trial drug:
Test 1 group: the 88mg chitosan.
Test 2 groups: the 25mg hyaluronic acid.
Test 3 groups: 28mg lactic acid.
Test 4 groups: 88mg chitosan+25mg hyaluronic acid.
Test 5 groups: 88mg chitosan+25mg hyaluronic acid+28mg lactic acid.
Test 6 groups: 150mg chitosan+25mg hyaluronic acid+28mg lactic acid.
Test method:
HPV infected specimen preparation: make a definite diagnosis HPV from hospital outpatient and infect the specimen of taking (the HPV type is 6,42 mixed types, belong to the mucosa low risk), focus in 1 centrifuge tube, 30mg weighs, use glass homogenizer homogenate, add the 5ml normal saline, be made into the stripped suspension of 6mg/ml, for subsequent use.
Sample treatment: draw 25 μ l sample liquid and 25 μ l specimen suspensions to the 15ml centrifuge tube with liquid-transfering gun, jolting is even, and sample and specimen can fully be acted on, and puts in 37 ℃ of water baths and cultivates,, respectively get 1 group and carry out following test after 1 day, 3 days, 5 days, 7 days in the sample treatment specimen.
The extraction of HPV-DNA: from water bath, take out the specimen suspension through sample treatment, extract DNA by the test kit step: add 50 μ l normal saline, add 100 μ l DNA extraction liquid behind the mixing, jolting is even, the centrifugal 10min of 1200r/min again, abandoning supernatant, add again 25 μ l DNA extraction liquid 2, abundant mixing, 100 ℃ of boiling water boiling 10min, the centrifugal 10min of 1200r/min, supernatant is the HPV-DNA template very.
DNA cloning: get the PCR reactant liquor 37.6 μ l in the detection kit, Taq archaeal dna polymerase 0.4 μ l, UNG0.03 μ l are adding HPV-DNA template 2 μ l in the PCR reaction tube, and button strict control lid places quantitative PCR instrument cocycle amplification.HPV-DNA carries out cyclic amplification through high-temperature denatured, process annealing and extension, and cyclic program is set to: 37 ℃, and 5min; 94 ℃, 1min; 95 ℃, 5sec; 60 ℃, 30sec circulates 40 times.
Amount standard curve: detect quantitatively with fluorescent probe, according to the detection kit requirement, set up the quantitative positive criteria product of HPV-DNA of 4 series concentration, be followed successively by 5 * 10
7/ ml, 5 * 10
6/ ml, 5 * 10
5/ ml, 5 * 10
4/ ml, (its detection sensitivity is 1 * 10 through the PCR detection
3/ ml, the result is judged to be feminine gender less than this concentration person).Take the natural logrithm of initial copy number as abscissa, the circulation threshold is vertical coordinate, and the regression straight line that obtains is standard curve, accordingly the amplification times of sample is carried out quantitatively.
Result of the test: see Table 1.
Table 1: the DNA exercising result that the different tests medicine infects HPV
Annotate: one represents feminine gender.
Test example 2: the effect II of anti-HPV
Test reagent: HPV nucleic acid amplification (PCR) fluorescence detection reagent kit (comprising DNA extraction liquid 1, DNA extraction liquid 2, PCR reactant liquor, Taq enzyme, UNG).Other reagent are analytical pure.
Trial drug:
Test 1 group: the 88mg chitosan.
Test 2 groups: the 25mg hyaluronic acid.
Test 3 groups: 28mg lactic acid.
Test 4 groups: 88mg chitosan+25mg hyaluronic acid.
Test 5 groups: 88mg chitosan+25mg hyaluronic acid+28mg lactic acid.
Test 6 groups: 150mg chitosan+25mg hyaluronic acid+28mg lactic acid.
Test method:
HPV infected specimen preparation: make a definite diagnosis HPV from hospital outpatient and infect the specimen of taking (the HPV type is 16,18 mixed types, belong to the mucosa high-risk-type), focus in 1 centrifuge tube, 30mg weighs, use glass homogenizer homogenate, add the 5ml normal saline, be made into the stripped suspension of 6mg/ml, for subsequent use.
Sample treatment: draw 25 μ l sample liquid and 25 μ l specimen suspensions to the 15ml centrifuge tube with liquid-transfering gun, jolting is even, and sample and specimen can fully be acted on, and puts in 37 ℃ of water baths and cultivates,, respectively get 1 group and carry out following test after 1 day, 3 days, 5 days, 7 days in the sample treatment specimen.
The extraction of HPV-DNA: from water bath, take out the specimen suspension through sample treatment, extract DNA by the test kit step: add 50 μ l normal saline, add 100 μ l DNA extraction liquid behind the mixing, jolting is even, the centrifugal 10min of 1200r/min again, abandoning supernatant, add again 25 μ l DNA extraction liquid 2, abundant mixing, 100 ℃ of boiling water boiling 10min, the centrifugal 10min of 1200r/min, supernatant is the HPV-DNA template very.
DNA cloning: get the PCR reactant liquor 37.6 μ l in the detection kit, Taq archaeal dna polymerase 0.4 μ l, UNG0.03 μ l are adding HPV-DNA template 2 μ l in the PCR reaction tube, and button strict control lid places quantitative PCR instrument cocycle amplification.HPV-DNA carries out cyclic amplification through high-temperature denatured, process annealing and extension, and cyclic program is set to: 37 ℃, and 5min; 94 ℃, 1min; 95 ℃, 5sec; 60 ℃, 30sec circulates 40 times.
Amount standard curve: detect quantitatively with fluorescent probe, according to the detection kit requirement, set up the quantitative positive criteria product of HPV-DNA of 4 series concentration, be followed successively by 5 * 10
7/ ml, 5 * 10
6/ ml, 5 * 10
5/ ml, 5 * 10
4/ ml, (its detection sensitivity is 1 * 10 through the PCR detection
3/ ml, the result is judged to be feminine gender less than this concentration person).Take the natural logrithm of initial copy number as abscissa, the circulation threshold is vertical coordinate, and the regression straight line that obtains is standard curve, accordingly the amplification times of sample is carried out quantitatively.
Result of the test: see Table 1.
Table 2: the DNA exercising result that the different tests medicine infects HPV
Annotate: one represents feminine gender.
The HPV infected specimen changed into be diagnosed as HPV from hospital outpatient and infect the isolated preparation take (the HPV type is the mixed type of HPV1 and HPV12, belong to the skin low risk), test according to above-mentioned identical condition and method, test 5 groups of results that cultivate 5 days, 7 days all negative; Test 6 groups of results that cultivate 3 days, 5 days, 7 days all negative.
The HPV infected specimen changed into be diagnosed as HPV from hospital outpatient and infect the isolated preparation take (the HPV type is the mixed type of HPV8 and HPV36, belong to the skin high-risk-type), test according to above-mentioned identical condition and method, test 5 groups of results that cultivate 5 days, 7 days all negative; Test 6 groups of results that cultivate 3 days, 5 days, 7 days all negative.
The HPV infected specimen changed into be diagnosed as HPV from hospital outpatient and infect the isolated preparation take (the HPV type is the mixed type of HPV11 and HPV53, belong to the mucosa low risk), test according to above-mentioned identical condition and method, test 5 groups of results that cultivate 5 days, 7 days all negative; Test 6 groups of results that cultivate 3 days, 5 days, 7 days all negative.
Conclusion (of pressure testing): above-mentioned result of the test shows that pharmaceutical composition of the present invention has good inhibitory action to the DNA that different subtype HPV infects.
Test example 3: to the inhibition test of bacterial growth
The standard tube dilution method that test method: U.S. Clinical and Laboratory Standards Institute (CLSI) recommends)
1, with microbionation in fresh MH body fluid culture medium, 37 ℃ of overnight incubation.
2, bacterium liquid is proofreaied and correct to 0.5 Maxwell bacterial concentration than turbid standard with fresh MH fluid medium, dilute by 1: 200 with the MH fluid medium again, in every test tube, add 1ml, add the product of the present invention (solvent DMSO final concentration preserves 1%) of 1ml, cultivated 18 hours for 37 ℃.With the 1%DMSO+ antibacterial in contrast, take aseptic culture medium as blank.
3, taking-up and blank compare, and the pipe that the concentration that antibacterial does not grow is minimum is minimal inhibitory concentration.
The result shows that gel of the present invention (compositions that polysaccharide base polymer, hyalomitome acids material and lactic acid class material form) has obvious inhibitory action to several staphylococcus epidermidiss and staphylococcus aureus growth, and its minimum inhibitory concentration sees Table 3.
Table 3 the present invention is to the inhibitory action of aureus growth
Test example 3: In vitro Bactericidal Experiments
Adopt the continuous doubling dilution of trace to measure the pharmaceutical composition of the embodiment of the invention 1 to colon bacillus, staphylococcus aureus, Pseudomonas aeruginosa, staphylococcus epidermidis, proteus vulgaris, streptococcus faecalis, mark bacterial strain and the colon bacillus of gonococcus, staphylococcus aureus, Pseudomonas aeruginosa, staphylococcus epidermidis, proteus vulgaris, streptococcus faecalis, the minimal inhibitory concentration of gonococcus clinical separation strain (MIC) adopts dull and stereotyped infection protocol to measure pharmaceutical composition of the present invention to the minimal bactericidal concentration (MBC) of above-mentioned antibacterial.Colon bacillus, staphylococcus aureus, Pseudomonas aeruginosa, staphylococcus epidermidis, proteus vulgaris, vagina Gartner bacterium are inoculated in MH meat soup, put 37 ℃ of common incubators and cultivate 24h; Streptococcus faecalis is inoculated in TPY meat soup (anaerobe nutrient broth), puts 37 ℃ of anaerobic culture boxes and cultivates 48h; Gonococcus is inoculated in the MH meat soup of antiperspirant 5% calf serum, puts 5%CO
237 ℃ of cultivations of cultivation property 48h.
Table 4 embodiment 3 products are to MIC and the MBC of reference culture
As seen from the above table, gel of the present invention (compositions that polysaccharide base polymer, hyalomitome acids material and lactic acid class material form) all has obvious inhibition and deactivation to the clinical Reference Strains that separates of mark bacterial strain and vagina Gartner bacterium of testing selected colon bacillus, staphylococcus aureus, Pseudomonas aeruginosa, staphylococcus epidermidis, proteus vulgaris, streptococcus faecalis, gonococcus, and its MBC is 2～4 times of MIC.
Table 5 embodiment 3 products are to 405 strain clinical isolates strains
MIC, MIC
50, MIC
99And MBC (the mg compositions/ml)
| Bacterial strain | The strain number | MIC | MIC 50 | MIC 99 | MBC |
| Escherichia coli | 120 | 6.25～50 | 18.1693 | 22.7543 | 25～100 |
| Bacillus proteus | 100 | 12.5～50 | 25.682 | 33.0179 | 25～100 |
| Gonococcus | 24 | 0.195～0.39 | 0.2174 | 0.2457 | 0.195～0.78 |
| Vagina Gartner bacterium | 11 | 0.39～1.56 | 0.7354 | 0.9241 | 0.78～1.56 |
As seen from the above table, gel of the present invention (compositions that polysaccharide base polymer, hyalomitome acids material and lactic acid class material form) all has certain inhibition and deactivation to testing 405 selected strain clinical isolates strains, and its MBC is 2～4 times of MIC.
Annotate: compositions described above is: the compositions that polysaccharide base polymer, hyalomitome acids material and lactic acid class material form.
Preparation Example
Embodiment 1
Prescription
Preparation method
1., the carboxylic chitin is dissolved in the aqueous acetic acid of pH4.0, fully stand-by after the swelling;
2., hyaluronate sodium is added in the suitable purified water, fully add after the swelling stand-by;
3., carbomer is dissolved in an amount of purified water, fully add after the swelling stand-by;
4., with step 1. with step 2. the solution of gained add in the same container, fully stirring and evenly mixing is stand-by;
5., with step 3. the carbomer aqueous solution of gained join in the container of step described in 4. abundant stirring and evenly mixing;
6., 5. add lactic acid in the solution of gained to step, and abundant stirring and evenly mixing;
7., 6. add glycerol, purified water in the solution of gained to step, fully stir evenly mixed, fill, and get final product.
Embodiment 2
Prescription
Preparation method
After placing agitator fully to stir swelling the above-mentioned raw materials, obtain chitosan transparent matter yogurt acid gel agent.
Embodiment 3
Prescription
After placing agitator fully to stir swelling the above-mentioned raw materials, fill obtains chitosan transparent matter yogurt acid gel agent.
Embodiment 4
Prescription
1., chitosan is dissolved in the aqueous hydrochloric acid solution of pH4.0, fully stand-by after the swelling;
2., the hyaluronic acid ammonium is added in the suitable distilled water, fully add stand-by after the swelling;
3., the tragakanta is dissolved in an amount of distilled water, fully add after the swelling stand-by;
4., with step 1. with step 2. the solution of gained add in the same container, fully stirring and evenly mixing is stand-by;
5., 3. step is joined in the container of step described in 4. the tragakanta of gained, abundant stirring and evenly mixing;
6., 5. add zinc lactate in the solution of gained to step, and abundant stirring and evenly mixing;
7., 6. add sorbitol, distilled water in the solution of gained to step, fully stir evenly mixed, fill, and get final product.
Embodiment 5
Prescription
Preparation method
After placing agitator fully to stir swelling the above-mentioned raw materials, fill namely gets chitosan transparent matter yogurt acid gel agent.
Embodiment 6
Prescription
Preparation method
After placing agitator fully to stir swelling the above-mentioned raw materials, fill namely gets chitosan transparent matter yogurt acid gel agent.
Embodiment 7
Prescription
Preparation method
After placing agitator fully to stir swelling the above-mentioned raw materials, fill namely gets chitosan transparent matter yogurt acid gel agent.
Embodiment 8
Prescription
Preparation method
After placing agitator fully to stir swelling the above-mentioned raw materials, fill, i.e. chitosan transparent matter yogurt acid gel agent.
Embodiment 9
Prescription
Preparation method
After placing agitator fully to stir swelling the above-mentioned raw materials, fill namely gets chitosan transparent matter yogurt acid gel agent.
Embodiment 10
Prescription
Preparation method
1. carboxymethyl chitosan is dissolved in the aqueous acetic acid of pH4.5, fully stand-by after the swelling;
2., hyaluronate sodium is added in the suitable purified water, fully add after the swelling stand-by;
3., carbomer, Polyethylene Glycol are dissolved in an amount of purified water, fully add after the swelling stand-by;
4., with step 1. with step 2. the solution of gained add in the same container, fully stirring and evenly mixing is stand-by;
5., with step 3. the carbomer aqueous solution of gained join in the container of step described in 4. abundant stirring and evenly mixing;
6., 5. add lactic acid in the solution of gained to step, and abundant stirring and evenly mixing;
7., 6. add Polyethylene Glycol, glycerol, purified water in the solution of gained to step, fully stir evenly mixed, fill, and get final product.
Test case 1:
According to GB/T14223.2-2005 medical infusion, blood transfusion, instrument used for injection method of inspection second portion: biological test method; GB/T16886.1-2001 BiologicalEvaluationofMedicalDevice part 1: estimate and test; GB/T16886.5-2003 BiologicalEvaluationofMedicalDevice the 5th part: vitro cytotoxicity test; GB/T16886.10-2005 BiologicalEvaluationofMedicalDevice the 10th part: stimulate and the delayed hypersensitivity test, the product of embodiment 1～4 is carried out the bio-safety property testing, experimental result is as shown in table 5 as a result:
The biological property of table 5 embodiment 1～4 and physicochemical property assay
Claims (10)
1. a gel is characterized in that gel comprises chitosan base polymer, hyalomitome acids material, lactic acid class material, gel-type vehicle, wetting agent, diluent.
2. a kind of gel according to claim 1 is characterized in that comprising the hydrotropy acid be used to dissolving water-insoluble chitosan base polymer.
3. a kind of gel according to claim 1 is characterized in that described chitosan base polymer is one or more in chitin, water-soluble chitosan, carboxymethyl chitosan, acylation chitosan, alkylated chitosan, hydroxylating chitosan, chitosan quaternary ammonium salt, Chitosan oligosaccharide, the sulfated chitosan; Described lactic acid class material is one or more of lactic acid, sodium lactate, calcium lactate, zinc lactate, aluctyl., ferrous lactate.
4. a kind of gel according to claim 1; it is characterized in that, described hyalomitome acids material is one or more in hyaluronate sodium, potassium hyaluronate, calcium hyauronate, hyaluronic acid ammonium, hyaluronic acid, hyaluronic acid magnesium, hyaluronic acid TBuA, the deacetylate hyaluronic acid.
5. a kind of gel according to claim 1, it is characterized in that: described gel-type vehicle is one or more of carbomer, Polycarbophil, alginate, tragakanta, gelatin, cellulose and derivant thereof, Polyethylene Glycol, sodium polyacrylate, polyvinylpyrrolidone and derivant thereof; Described wetting agent is one or more of glycerol, propylene glycol, sorbitol.
6. a kind of gel according to claim 2, wherein hydrotropy acid is acetic acid, phosphoric acid, citric acid, formic acid, hydrochloric acid, one or more of 1,2,3,4-BTCA.
7. a kind of gel according to claim 1, it is characterized in that: described gel is: the chitosan base polymer is 3～28 weight portions; Hyalomitome acids material is 0.2～3.5 weight portion; Lactic acid class material is 0.4～50 weight portion, and gel-type vehicle 0.6～1.2 weight portion, wetting agent 5～15 weight portions add or do not add hydrotropy acid 0.4-1.2 weight portion, water 55.4-86.1 weight portion.
8. the preparation method of a gel is characterized in that may further comprise the steps:
1. chitosan polymer is dissolved in the diluent of pH3～7.5, fully stand-by after the swelling;
2. hyalomitome acids material is added in the diluent, fully add stand-by after the swelling;
3. gel-type vehicle is dissolved in an amount of diluent, fully adds stand-by after the swelling;
4. with step 1. with step 2. the solution of gained add in the same container, fully stirring and evenly mixing is stand-by;
5. with step 3. the gel-type vehicle of gained join in the container of step described in 4. abundant stirring and evenly mixing;
6. 5. add lactic acid class material in the solution of gained to step, and abundant stirring and evenly mixing;
7. 6. add wetting agent, diluent in the solution of gained to step, fully stir evenly mixedly, and get final product.
9. want the preparation method of 8 described a kind of gels according to right, it is characterized in that may further comprise the steps:
Diluent, hyalomitome acids material, gel-type vehicle, lactic acid class material, diluent, the wetting agent of chitosan polymer, pH3～7.5 are added in the container, fully mix, make it to form gel after the abundant swelling, and get final product.
10. each described a kind of gel is in preparation treatment female lower genital tract infection, HPV infection, cervicitis, cervical erosion according to claim 1-7, wound healing, hemostasis and pain-relieving, antipruritic behind promotion cervix uteri or the vagina operation, nourish lubricated reproductive tract epithelial cell or mucosa, enhancing vagina elasticity, alleviate dry and astringent, burn, the vaginal atrophy symptom such as pruritus, alleviate bleeding hemorrhoids, pendant is swollen, hemorrhoid mucous hyperemia edema, anal fissure pain, the dermatitis that Acne treatment, burn, scald, decubital ulcer infect and other scytitis such as tinea manus and pedis, mite infection cause; Suppress the cutaneous pigmentation that wound surface or inflammation cause, the laser beautifying postoperative causes the reparation of the little damage of skin and suppresses to be used in the various traumatic infection medicines such as cicatrization or the dressing.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310275625.4A CN103316033B (en) | 2013-07-03 | 2013-07-03 | Gel and use thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310275625.4A CN103316033B (en) | 2013-07-03 | 2013-07-03 | Gel and use thereof |
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| Publication Number | Publication Date |
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| CN103316033A true CN103316033A (en) | 2013-09-25 |
| CN103316033B CN103316033B (en) | 2015-07-15 |
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Cited By (19)
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| CN110664733A (en) * | 2019-10-09 | 2020-01-10 | 华欧研创生物科技(深圳)有限公司 | Hyaluronic acid nanoemulsion gel for nursing female vagina |
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| WO2021051685A1 (en) * | 2019-09-20 | 2021-03-25 | 江西善行生物科技有限公司 | Compound formulation for removing hpv |
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Inventor after: Xu Yang Inventor before: Kang Xiaofei |
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Effective date of registration: 20170731 Address after: 2, 570216 factory building, United States industrial village, 100 Nanhai Avenue, Hainan, Haikou Patentee after: Hainan World Health Care Technology Co., Ltd. Address before: No. 27 A District 570311 Zihyuan Hainan province Haikou City Xiuying District West Coast Changyi Road 5 Building Room 502 Patentee before: Kang Xiaofei |