CN106215250A - A kind of recombination human source I-type collagen gel stent for slack vagina and preparation method thereof - Google Patents
A kind of recombination human source I-type collagen gel stent for slack vagina and preparation method thereof Download PDFInfo
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- CN106215250A CN106215250A CN201610729309.3A CN201610729309A CN106215250A CN 106215250 A CN106215250 A CN 106215250A CN 201610729309 A CN201610729309 A CN 201610729309A CN 106215250 A CN106215250 A CN 106215250A
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- vagina
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- 210000001215 vagina Anatomy 0.000 title claims abstract description 44
- 230000006798 recombination Effects 0.000 title claims abstract description 34
- 238000005215 recombination Methods 0.000 title claims abstract description 34
- 239000000512 collagen gel Substances 0.000 title claims abstract description 16
- 238000002360 preparation method Methods 0.000 title claims description 10
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims abstract description 44
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 26
- 230000000694 effects Effects 0.000 claims abstract description 24
- 108010035532 Collagen Proteins 0.000 claims abstract description 22
- 102000008186 Collagen Human genes 0.000 claims abstract description 19
- 229920001436 collagen Polymers 0.000 claims abstract description 19
- 229920001983 poloxamer Polymers 0.000 claims abstract description 18
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims abstract description 17
- 229910052708 sodium Inorganic materials 0.000 claims abstract description 17
- 239000011734 sodium Substances 0.000 claims abstract description 17
- QCDWFXQBSFUVSP-UHFFFAOYSA-N 2-phenoxyethanol Chemical compound OCCOC1=CC=CC=C1 QCDWFXQBSFUVSP-UHFFFAOYSA-N 0.000 claims abstract description 14
- 150000002148 esters Chemical class 0.000 claims abstract description 14
- 229960005323 phenoxyethanol Drugs 0.000 claims abstract description 14
- 241000259759 Cassida nobilis Species 0.000 claims abstract description 13
- 239000008367 deionised water Substances 0.000 claims abstract description 11
- 229910021641 deionized water Inorganic materials 0.000 claims abstract description 11
- YWIVKILSMZOHHF-QJZPQSOGSA-N sodium;(2s,3s,4s,5r,6r)-6-[(2s,3r,4r,5s,6r)-3-acetamido-2-[(2s,3s,4r,5r,6r)-6-[(2r,3r,4r,5s,6r)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2- Chemical compound [Na+].CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 YWIVKILSMZOHHF-QJZPQSOGSA-N 0.000 claims abstract description 11
- 238000003756 stirring Methods 0.000 claims description 19
- CTKXFMQHOOWWEB-UHFFFAOYSA-N Ethylene oxide/propylene oxide copolymer Chemical compound CCCOC(C)COCCO CTKXFMQHOOWWEB-UHFFFAOYSA-N 0.000 claims description 10
- 229920001993 poloxamer 188 Polymers 0.000 claims description 10
- 229940044519 poloxamer 188 Drugs 0.000 claims description 10
- 238000005070 sampling Methods 0.000 claims description 5
- 239000011265 semifinished product Substances 0.000 claims description 5
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- 238000001816 cooling Methods 0.000 claims 1
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- 208000004483 Dyspareunia Diseases 0.000 abstract description 7
- 210000003756 cervix mucus Anatomy 0.000 abstract description 5
- RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical compound C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 abstract description 4
- 206010047791 Vulvovaginal dryness Diseases 0.000 abstract description 4
- 239000000203 mixture Substances 0.000 abstract description 4
- 229960000502 poloxamer Drugs 0.000 abstract description 4
- 230000008439 repair process Effects 0.000 abstract description 4
- 206010061218 Inflammation Diseases 0.000 abstract description 3
- 208000003251 Pruritus Diseases 0.000 abstract description 3
- 238000001035 drying Methods 0.000 abstract description 3
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- 206010002198 Anaphylactic reaction Diseases 0.000 abstract 1
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- 239000002253 acid Substances 0.000 description 3
- 239000002671 adjuvant Substances 0.000 description 3
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- 239000003814 drug Substances 0.000 description 3
- 239000000835 fiber Substances 0.000 description 3
- 239000000463 material Substances 0.000 description 3
- 210000003205 muscle Anatomy 0.000 description 3
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- 230000008313 sensitization Effects 0.000 description 2
- 208000024891 symptom Diseases 0.000 description 2
- 206010003694 Atrophy Diseases 0.000 description 1
- 102000012422 Collagen Type I Human genes 0.000 description 1
- 108010022452 Collagen Type I Proteins 0.000 description 1
- 208000005156 Dehydration Diseases 0.000 description 1
- 241000162403 Deloyala guttata Species 0.000 description 1
- 241000283973 Oryctolagus cuniculus Species 0.000 description 1
- 208000002193 Pain Diseases 0.000 description 1
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- 239000008280 blood Substances 0.000 description 1
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- 238000001514 detection method Methods 0.000 description 1
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- 239000004744 fabric Substances 0.000 description 1
- 210000003754 fetus Anatomy 0.000 description 1
- 210000004392 genitalia Anatomy 0.000 description 1
- 229940088597 hormone Drugs 0.000 description 1
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- 239000000314 lubricant Substances 0.000 description 1
- 238000005461 lubrication Methods 0.000 description 1
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- 238000005259 measurement Methods 0.000 description 1
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- 210000004877 mucosa Anatomy 0.000 description 1
- 229920005615 natural polymer Polymers 0.000 description 1
- 231100000252 nontoxic Toxicity 0.000 description 1
- 230000003000 nontoxic effect Effects 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- 230000032696 parturition Effects 0.000 description 1
- 210000003899 penis Anatomy 0.000 description 1
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- 238000003786 synthesis reaction Methods 0.000 description 1
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- 210000004291 uterus Anatomy 0.000 description 1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/04—Macromolecular materials
- A61L31/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/39—Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0034—Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/04—Macromolecular materials
- A61L31/042—Polysaccharides
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/04—Macromolecular materials
- A61L31/043—Proteins; Polypeptides; Degradation products thereof
- A61L31/044—Collagen
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- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/145—Hydrogels or hydrocolloids
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/18—Materials at least partially X-ray or laser opaque
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Abstract
The present invention relates to a kind of recombination human source I-type collagen gel stent for slack vagina and its production and use, each component that wherein said gel stent comprises following mass concentration: recombination human source dissolvable high activity I-type collagen is 0.002 0.5%, poloxamer is 407 15 25%, PLURONICS F87 is 1 8%, glycerol is 2 6%, hyaluronate sodium is 0.5 2.5%, Nepal's tortoise beetle ester sodium is 0.02 2%, and phenoxyethanol is 0.3 1%, deionized water surplus.The present invention, in addition to having and being obviously improved treatment slack vagina effect, also can repair the pruritus caused by vagina drying, scorching hot, the problem such as chap, and has that increase vagina is elastic, alleviate dyspareunia, improve sexual intercourse satisfaction；Increase vaginal secretions, reduce vagina inflammatory reaction, improve vaginal microenvironment wettability, improving vaginal dryness state, safeguard vaginal microenvironment pH, this compositions is without pessimal stimulation anaphylaxis and immunity rejection, can be used for being prepared as suppository dressing, gel dressing and lotion etc., clinic is promoted.
Description
Technical field
The present invention relates to medical gel technical field, a kind of recombination human source type i collagen egg for slack vagina
White gel support, its preparation method, and its purposes in improving slack vagina treatment.
Background technology
Vagina, the flesh pipeline being made up of mucosa, muscle layer and adventitia, rich extensibility, connect uterus and external genitalia.It
It is the sexual intercourse organ of women, is also to discharge menstruation and the pipeline of fetus of giving birth to.Slack vagina is that women goes out with advancing age
Existing a kind of physiological situation, main population is women in puerperal.Slack vagina severe patient can reduce love life quality, along with the modern times
The gradually change of people's understanding, slack vagina paid attention to by increasing women, and koro product is the most increasingly by joyous
Meet.The reason causing vagina lax in life has a variety of, and most commonly seen reason is given birth to exactly, and natural labor also results in the moon
Road relaxes.During slack vagina, owing to vagina is loose so that during sexual life, " holding " ability of penis is declined by original vagina,
Carnal abuse is the most just difficult to reach abundant, thus causes sexual intercourse satisfaction to decline.
Slack vagina refers to that the tension force of pelvic muscle group declines, and causes that perivaginal is of flaccid muscles, vagina broadens.Puerperal is cloudy
The main cause that road is lax is to cause the fracture of collagen fabric when spontaneous labor, and puerperal cannot clear-cutting forestland.Existing rank
The restoration methods of section slack vagina is mainly by methods such as clear-cutting forestland, reinforcement exercises, but there is DeGrain, recovery time
The shortcomings such as length, the recombination human source I-type collagen gel stent in the present invention has promotion vagina collagen fiber and network fiber bullet
Property fiber formation, the secretion of regulation vaginal secretions, maintain moisture and electrolyte metabolism in vagina tissue, improve atrophy
The exsiccosis of vagina, moistens and repairs vagina tissue, by the effect to vascular endothelial cell, promotes that vagina tissue is constantly formed
New blood capillary, thus reach to improve the purpose for the treatment of slack vagina, there is the most significant effect.The present invention is my company
Doctor Wei research team of associating Harvard University, doctor Yu research team of Shandong Agricultural University, China biological medicine academy,
Guangdong medical insurance pharmaceutcal corporation, Ltd, the joint research exploitation of Hong Kong Pharmaceuticals Ltd.The present invention is obviously improved treatment the moon except having
Outside road relaxing effect, also can repair the pruritus owing to vagina drying causes, scorching hot, the problem such as chap, and there is increase vagina bullet
Property, alleviate dyspareunia, improve sexual intercourse satisfaction；Increase vaginal secretions, reduce vagina inflammatory reaction, improve vagina micro-loop
Border wettability, improves vaginal dryness state, safeguards vaginal microenvironment pH, and without bad irritant reaction, clinic is promoted.
Summary of the invention
The present invention is to solve vagina relax treatment aspect be correlated with medicine lack problem, one aspect of the present invention provide
A kind of recombination human source I-type collagen gel stent for slack vagina, comprises the various components of following mass concentration:
The present invention also provides for the preparation method of above-mentioned recombination human source I-type collagen gel stent, it is characterised in that comprise
Following steps:
Deionized water is added material-compound tank, logical steam, it is heated to water temperature 85 DEG C, is incubated 30min sterilizing；By above-mentioned dosage to
Material-compound tank adds poloxamer188, PLURONICS F87, glycerol interval homogenizing stirring 5min to being uniformly dispersed；By above-mentioned dosage
Add hyaluronate sodium, close cover, open vacuum pump, while stirring interval homogenizing 10min, to being uniformly dispersed；Logical condensed water
It is cooled to feed temperature 40 DEG C, closes condensed water, add recombination human source dissolvable high activity I-type collagen, limit by above-mentioned dosage
Stirring limit interval homogenizing 3min, to being uniformly dispersed；By above-mentioned dosage add Nepal tortoise beetle ester sodium, phenoxyethanol while stirring between
Have a rest homogenizing 3min, to being uniformly dispersed；PH is surveyed in semi-finished product sampling, adjusts PH to 3.8.
Preparing in the gel stent of slack vagina additionally, the present invention also provides for recombination human source I-type collagen
Purposes, it is characterised in that this gel stent also includes poloxamer188, PLURONICS F87, glycerol, hyaluronate sodium, Nepal
Tortoise beetle ester sodium, phenoxyethanol and deionized water.
The recombination human source I-type collagen gel stent using the inventive method to prepare has the advantages that gel
Scaffold component formula is clear and definite, quality controllable, is suitable for industrially scalable growth；Gel stent main component is to have biocompatibility
With the natural polymer of biodegradability or synthesis macromolecule this, safety non-toxic, it is to avoid in prior art other
The side effect that frame component or hormone preparation are brought；Gel stent clinical practice is extensive, has and is obviously improved treatment slack vagina
Symptom, can repair the pruritus owing to vagina drying causes, scorching hot, the problem such as chap, and also has that increase vagina is elastic, alleviate sexual intercourse
Pain, raising sexual intercourse satisfaction；Increase vaginal secretions, reduce vagina inflammatory reaction, improve vaginal microenvironment wettability, change
Kind vaginal dryness state, safeguards vaginal microenvironment pH, without bad irritant reaction.
Detailed description of the invention
Below in conjunction with embodiment, the present invention is elaborated further, but not limitation of the present invention, all according to this
Any equivalent of this area that disclosure of the invention content is done, belongs to protection scope of the present invention.
Embodiment 1
A kind of recombination human source dissolvable high activity I-type collagen gene dressing, calculates in parts by mass, and composition includes: restructuring
People source dissolvable high activity I-type collagen 0.5%；Poloxamer188 25%；PLURONICS F87 8%；Glycerol 6%；Transparent
Matter acid sodium 2.5%；Nepal's tortoise beetle ester sodium 0.02%；Phenoxyethanol 1%；Deionized water surplus.
As a example by preparation 100kg gene adjuvant, recombination human source dissolvable high activity I-type collagen 0.5%, i.e. 100kg applies
Dissolvable high activity I-type collagen 500g Han recombination human source in material, poloxamer188 25kg；PLURONICS F87 8kg；Glycerol
6kg；Hyaluronate sodium 2.5kg；Nepal tortoise beetle ester sodium 20g；Phenoxyethanol 1kg；Concrete technology is as follows: added by deionized water
Material-compound tank, logical steam, it is heated to water temperature 85 DEG C, is incubated 30min sterilizing；In material-compound tank, poloxamer is added by above-mentioned dosage
407, PLURONICS F87, glycerol interval homogenizing stirring 5min are to being uniformly dispersed；Add hyaluronate sodium by above-mentioned dosage, close
Cover, opens vacuum pump, while stirring interval homogenizing 10min, to being uniformly dispersed；Logical condensed water is cooled to feed temperature 40 DEG C,
Close condensed water, add recombination human source dissolvable high activity I-type collagen, while stirring interval homogenizing 3min by above-mentioned dosage,
To being uniformly dispersed；Nepal's tortoise beetle ester sodium, phenoxyethanol interval homogenizing 3min while stirring is added, to dispersion all by above-mentioned dosage
Even；PH is surveyed in semi-finished product sampling, adjusts PH to 3.8.
Embodiment 2
A kind of recombination human source dissolvable high activity I-type collagen gene dressing, calculates in parts by mass, and composition includes: restructuring
People source dissolvable high activity I-type collagen 0.05%；Poloxamer188 20%；PLURONICS F87 5%；Glycerol 3%；Transparent
Matter acid sodium 1.5%；Nepal's tortoise beetle ester sodium 0.05%；Phenoxyethanol 0.08%；Deionized water surplus.
As a example by preparation 100kg gene adjuvant, recombination human source dissolvable high activity I-type collagen 0.1%, i.e. 100kg applies
Dissolvable high activity I-type collagen 100g Han recombination human source in material, poloxamer188 20kg；PLURONICS F87 5kg；Glycerol
3kg；Hyaluronate sodium 1.5kg；Nepal tortoise beetle ester sodium 50g；Phenoxyethanol 0.8kg；Concrete technology is as follows: added by deionized water
Enter material-compound tank, logical steam, it is heated to water temperature 85 DEG C, is incubated 30min sterilizing；In material-compound tank, poloxamer is added by above-mentioned dosage
407, PLURONICS F87, glycerol interval homogenizing stirring 5min are to being uniformly dispersed；Add hyaluronate sodium by above-mentioned dosage, close
Cover, opens vacuum pump, while stirring interval homogenizing 10min, to being uniformly dispersed；Logical condensed water is cooled to feed temperature 40 DEG C,
Close condensed water, add recombination human source dissolvable high activity I-type collagen, while stirring interval homogenizing 3min by above-mentioned dosage,
To being uniformly dispersed；Nepal's tortoise beetle ester sodium, phenoxyethanol interval homogenizing 3min while stirring is added, to dispersion all by above-mentioned dosage
Even；PH is surveyed in semi-finished product sampling, adjusts PH to 3.8.
Embodiment 3
A kind of recombination human source dissolvable high activity I-type collagen gene dressing, calculates in parts by mass, and composition includes: restructuring
People source dissolvable high activity I-type collagen 0.05%；Poloxamer188 15%；PLURONICS F87 5%；Glycerol 3%；Transparent
Matter acid sodium 1.5%；Nepal's tortoise beetle ester sodium 0.05%；Phenoxyethanol 0.08%；Deionized water surplus.
As a example by preparation 100kg gene adjuvant, recombination human source dissolvable high activity I-type collagen 0.1%, i.e. 100kg applies
Dissolvable high activity I-type collagen 100g Han recombination human source in material, poloxamer188 10kg；PLURONICS F87 5kg；Glycerol
3kg；Hyaluronate sodium 1.5kg；Nepal tortoise beetle ester sodium 50g；Phenoxyethanol 0.8kg；Concrete technology is as follows: added by deionized water
Enter material-compound tank, logical steam, it is heated to water temperature 85 DEG C, is incubated 30min sterilizing；In material-compound tank, poloxamer is added by above-mentioned dosage
407, PLURONICS F87, glycerol interval homogenizing stirring 5min are to being uniformly dispersed；Add hyaluronate sodium by above-mentioned dosage, close
Cover, opens vacuum pump, while stirring interval homogenizing 10min, to being uniformly dispersed；Logical condensed water is cooled to feed temperature 40 DEG C,
Close condensed water, add recombination human source dissolvable high activity I-type collagen, while stirring interval homogenizing 3min by above-mentioned dosage,
To being uniformly dispersed；Nepal's tortoise beetle ester sodium, phenoxyethanol interval homogenizing 3min while stirring is added, to dispersion all by above-mentioned dosage
Even；PH is surveyed in semi-finished product sampling, adjusts PH to 3.8.
Embodiment 4: the pharmacology detection of recombination human source collagen gel support
4.1 gel stents mensuration to skin irritation index
Being measured by the closed sensitization test (STT) method of GB/T16886.10-2000 regulation, testing result sees table 1.
Table 1: gel stent is to skin irritation index measurement result
| Test event | Embodiment 1 | Embodiment 2 | Embodiment 3 | Embodiment 4 | Embodiment 5 |
| Skin irritation index | 0 | 0 | 0 | 0 | 0 |
| Sensitization of skin | Nothing | Nothing | Nothing | Nothing | Nothing |
As it can be seen from table 1 the recombination human source I-type collagen gel stent that the present invention prepares is all without skin irritation and skin
Skin sensitivity response.
4.2 biocompatibility experiment
Being injected separately in white rabbit body by the recombination human source collagen gel of embodiment 1-5, timing is observed, continuous 8 days bodies
Weight, feed, body temperature, movable without exception.Illustrate that the recombination human source I-type collagen gel that the present invention prepares has good biology
The compatibility.
Embodiment 5: clinical application effect
The present invention has carried out experimental study to clinical application effect, and selected patient is OPD of Obs & Gyn patient, age
Between 40 55 years old, sexual intercourse women exists that vagina detail relaxes, lacks flexibility, dry and astringent, dyspareunia, secretions are reduced to
Main clinical symptoms, selected 60 example patients, this test completes 58 examples altogether.Wherein slack vagina, lack flexibility patient 20 example, dry
Few patient 20 example of puckery, dyspareunia patient 20 example, secretions.
Before and after table 2, test, slack vagina, the patients symptomatic that lacks flexibility improve situation analysis
By table 2 can be seen that recombination human source I-type collagen gel stent to slack vagina, lack flexibility patients symptomatic
Tool improves significantly, and tests 20 days effective percentage and reaches 60%, tests 30 days effective percentage and reach 75%.
Before and after table 3, test, dry and astringent, dyspareunia patients symptomatic improves situation analysis
| Natural law | Dry and astringent, dyspareunia | Less lubricant | The most with lubricator | Effective percentage |
| 0 | 20 | 0 | 0 | 0 |
| 5 | 10 | 3 | 7 | 50% |
| 10 | 5 | 4 | 11 | 75% |
| 15 | 3 | 3 | 14 | 85% |
Can be seen that recombination human source I-type collagen gel stent is to vaginal dryness, dyspareunia patients symptomatic by table 3
Tool improves significantly, and tests 10 days effective percentage and reaches 75%, tests 15 days effective percentage and reach 85%.
Before and after table 4, test, the few patients symptomatic of secretions improves situation analysis
| Natural law | Secretions is few | Lubrication | Effective percentage |
| 0 | 20 | 0 | 0 |
| 5 | 8 | 10 | 55.6% |
| 10 | 5 | 13 | 72.2% |
| 15 | 2 | 16 | 88.9% |
Can be seen that recombination human source I-type collagen gel stent patients symptomatic few to vaginal secretions has by table 4
Significantly improve, test 10 days effective percentage and reach 72.2%, test 15 days effective percentage and reach 88.9%.
All above-mentioned primary these intellectual properties of enforcement, do not set this new product of enforcement limiting other forms
And/or new method.Those skilled in the art will utilize this important information, and foregoing is revised, to realize similar execution feelings
Condition.But, all modifications or transformation belong to the right of reservation based on new product of the present invention.
Claims (3)
1. the recombination human source I-type collagen gel stent for slack vagina, it is characterised in that comprise following quality dense
The various components of degree:
2. the preparation method of the recombination human source I-type collagen gel stent for slack vagina as claimed in claim 1, its
It is characterised by comprising the steps of
Deionized water is added material-compound tank, logical steam, it is heated to water temperature 85 DEG C, is incubated 30min sterilizing；By above-mentioned dosage to dispensing
Tank adds poloxamer188, PLURONICS F87, glycerol interval homogenizing stirring 5min to being uniformly dispersed；Add by above-mentioned dosage
Hyaluronate sodium, closes cover, opens vacuum pump, while stirring interval homogenizing 10min, to being uniformly dispersed；Logical condensed water cooling
To feed temperature 40 DEG C, closing condensed water, add recombination human source dissolvable high activity I-type collagen by above-mentioned dosage, limit is stirred
Limit interval homogenizing 3min, to being uniformly dispersed；Nepal's tortoise beetle ester sodium, phenoxyethanol interval while stirring is added all by above-mentioned dosage
Matter 3min, to being uniformly dispersed；PH is surveyed in semi-finished product sampling, adjusts PH to 3.8.
3. recombination human source I-type collagen purposes in preparation is used for the gel stent of slack vagina, it is characterised in that described
Gel stent also includes poloxamer188, PLURONICS F87, glycerol, hyaluronate sodium, Nepal's tortoise beetle ester sodium, phenoxyethanol
And deionized water.
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| CN113730557A (en) * | 2021-09-03 | 2021-12-03 | 山西锦波生物医药股份有限公司 | Application of recombinant I-type humanized collagen in pelvic floor repair |
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