CN106492267B - Human-like collagen anorectal mucosa repair gel - Google Patents
Human-like collagen anorectal mucosa repair gel Download PDFInfo
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- CN106492267B CN106492267B CN201611055725.6A CN201611055725A CN106492267B CN 106492267 B CN106492267 B CN 106492267B CN 201611055725 A CN201611055725 A CN 201611055725A CN 106492267 B CN106492267 B CN 106492267B
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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
- A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
- A61L26/0061—Use of materials characterised by their function or physical properties
- A61L26/008—Hydrogels or hydrocolloids
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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
- A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
- A61L26/0009—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form containing macromolecular materials
- A61L26/0014—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form containing macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
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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
- A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
- A61L26/0009—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form containing macromolecular materials
- A61L26/0023—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
- A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
- A61L26/0009—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form containing macromolecular materials
- A61L26/0028—Polypeptides; Proteins; Degradation products thereof
- A61L26/0033—Collagen
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L89/00—Compositions of proteins; Compositions of derivatives thereof
Abstract
The invention relates to a human-like collagen anorectal mucosa repair gel. The human-like collagen anorectal mucosa repair gel comprises 0.1-1 wt% of human-like collagen, 0.75-0.85 wt% of carbomer, 20-25 wt% of glycerin, 0.001-0.01 wt% of sodium hyaluronate, 0.12-0.2 wt% of sodium hydroxide, 0.1-0.5 wt% of ethylparaben, 0.2-1 wt% of chitosan and the balance of water. When the human-like collagen gel is applied to anorectal epidermis with damaged mucosa, the transdermal absorption speed of the human-like collagen can be remarkably increased. Therefore, the human-like collagen gel can provide better nourishment, stimulate the regeneration of mucosal cells and promote the repair of damaged anorectal mucosa.
Description
Technical Field
The invention relates to a human-like collagen dressing, in particular to a gel containing human-like collagen, which is particularly suitable for anorectal mucosa repair and belongs to the field of health care/medical appliances.
Background
The Human-like Collagen is invented by the teaching of the Van-David of the university of northwest China (see the Chinese patent application publication No. CN1371919A), and is also called Van's recombinant Collagen or Van's Human-like Collagen (FHLC). Human-like collagen is a recombinant collagen with high biocompatibility, and is widely applied to the field of medical treatment or cosmetology at present.
On the other hand, when the collagen dressing product is used for moisturizing and protecting mucosa of nasal cavity, anorectal and gynecological parts, the collagen dressing product is often used indoors (for example, otorhinology, anorectal and gynecological department in hospitals), and a user of the collagen dressing product wants to finish the use in a short time (the time for medical treatment which can be accepted by the user is usually about 30 minutes), and the medical treatment occupies a large amount of time of the user of the collagen dressing product due to the extension of the action time, so that the application range and market competitiveness of the collagen dressing product are reduced. From this point of view, a collagen dressing product with a high transdermal absorption speed is needed. Unfortunately, the related studies have focused more on the transdermal absorption rate of collagen, and have not focused on the transdermal absorption rate of collagen.
In view of the above, the present inventors have invented a human-like collagen mucosal repair gel, which can accelerate the transdermal absorption of human-like collagen by constituting a suitable microenvironment, as described in chinese patent application publication No. CN 105709267A. The patent document also discloses that the human-like collagen mucosa repair gel can be used for repairing nasal mucosa, anorectal mucosa or gynecological part mucosa.
Disclosure of Invention
However, the inventors of the present invention have conducted further research and found that, in the development of the above-mentioned human collagen mucosal repair gel, the skin is only used as a site for examining the transdermal absorption rate of human collagen, and the local microenvironment of the actual application site of the human collagen mucosal repair gel is not considered, so that the transdermal absorption rate of human collagen is improved, but not as good as possible.
In view of the above problems in the prior art, the present invention aims to provide a gel which is particularly suitable for anorectal mucosa repair and can promote the rapid transdermal absorption of human-like collagen.
Namely, the present invention is as follows.
1. A human collagen-like anorectal mucosa repair gel comprising:
2. use of the human-like collagen gel according to item 1 in the preparation of a medical dressing for anorectal mucosal repair.
3. A method of preparing the human-like collagen gel of claim 1, comprising:
step A: preparing phase A, wherein the phase A consists of 0.75-0.85 wt% of carbomer, 5-10 wt% of glycerin, 0.001-0.01 wt% of sodium hyaluronate and the balance of water;
and B: preparing a phase B, wherein the phase B is a sodium hydroxide aqueous solution consisting of 0.12-0.2 wt% of sodium hydroxide and 1-3 wt% of water;
and C: preparing a phase C, wherein the phase C is a mixture of 0.1-0.5 wt% of ethylparaben and 20-10 wt% of glycerol;
step D: preparing a phase D, wherein the phase D is 0.2-1 wt% of chitosan;
step E: preparing an E phase which is human-like collagen liquid and comprises human-like collagen with the content of the human-like collagen in the human-like collagen anorectal mucosa repair gel being 0.1-1 wt%, wherein the medium is water, and the weight ratio of the human-like collagen to the water is 1: 1-20; and
step F: adding the phase D into the phase A and stirring uniformly, then adding the phase B and stirring uniformly, then adding the phase C and the phase E and stirring uniformly, preserving heat at 80-85 ℃ for 60-120 minutes, stirring uniformly after heat preservation, and cooling to room temperature;
the total weight of the human-like collagen gel is taken as 100 wt%.
The invention achieves the following technical effects: when the human-like collagen gel is applied to anorectal epidermis with damaged mucosa, the transdermal absorption speed of the human-like collagen can be remarkably increased. Therefore, the human-like collagen gel can provide better nourishment, stimulate the regeneration of mucosal cells and promote the repair of damaged anorectal mucosa.
Detailed Description
The present invention will be described in detail with reference to specific embodiments.
The invention provides a human-like collagen anorectal mucosa repair gel (human-like collagen gel of the invention), which comprises:
in the present specification, the human-like collagen anorectal mucosa repair gel means a gel suitable for anorectal mucosa repair containing human-like collagen as an active ingredient.
In the present specification, the human-like collagen is the recombinant collagen according to claim 1 of chinese patent application publication CN1371919A, and can be prepared by, for example, the genetic engineering expression method disclosed in chinese patent application publication CN 1371919A. The Human-like Collagen is invented by the teaching of the Van-Dynasty university of North-West China, and is also called Van's recombinant Collagen or Van's Human-like Collagen (FHLC).
Carbomers are synthetic high molecular polymers of acrylic acid with allyl sucrose or allyl pentaerythritol ether. There is No particular limitation on the carbomer, and those commonly used in cosmetic or medical dressings by those skilled in the art can be used, for example, carbomer manufactured by cantonese hanpu pharmaceutical co ltd, guan, usa No: 9003-01-4.
The glycerin is not particularly limited, and those commonly used in cosmetic or medical dressings by those skilled in the art may be used, and for example, glycerin manufactured by Hunan Erkang pharmaceutical Co., Ltd, CAS No: 56-81-5.
There is no particular limitation on the sodium hyaluronate, and those commonly used in cosmetic or medical dressings by those skilled in the art may be used, for example, sodium hyaluronate manufactured by Huaxifurida biomedical Co., Ltd, product code: HA-T.
The chitosan is not particularly limited, and those commonly used in cosmetic or medical dressings by those skilled in the art may be used, for example, chitosan manufactured by Zhejiang gold Chitosan industries, Ltd, CAS No: 9012-76-4.
The ethylparaben is not particularly limited, and those conventionally used in cosmetic or medical dressings by those skilled in the art may be used, and for example, ethylparaben manufactured by Hunan Erkang pharmaceutical Co., Ltd, CAS No: 120-47-8.
When the human-like collagen gel is applied to the damaged part of the anorectal tract, the transdermal absorption speed of the human-like collagen is accelerated, and the 30-minute transdermal absorption rate of the human-like collagen is further remarkably improved (even exceeds 50 percent) on the basis of the existing product, which is probably because a more suitable microenvironment is formed.
It should be noted that the present inventors found that the human-like collagen gel of the present invention cannot contain polysorbates, such as polysorbate 80. The polysorbates may significantly reduce the transdermal absorption effect of the human-like collagen gel of the present invention.
The human-like collagen gel is particularly suitable for anorectal mucosa repair in the medical/health care field. When the human-like collagen gel is used for anorectal mucosa repair in the medical/health care field, the human-like collagen gel can be used as a dressing, and can also be combined with other carriers or auxiliary materials to prepare other types of dressings or other dosage forms (such as suppositories and the like).
The preparation method of the human-like collagen gel of the present invention is not particularly limited, and the preparation method may include:
step A: preparing phase A, wherein the phase A consists of 0.75-0.85 wt% of carbomer, 5-10 wt% of glycerin, 0.001-0.01 wt% of sodium hyaluronate and the balance of water;
and B: preparing a phase B, wherein the phase B is a sodium hydroxide aqueous solution consisting of 0.12-0.2 wt% of sodium hydroxide and 1-3 wt% of water;
and C: preparing a phase C, wherein the phase C is a mixture of 0.1-0.5 wt% of ethylparaben and 20-10 wt% of glycerol;
step D: preparing a phase D, wherein the phase D is 0.2-1 wt% of chitosan;
step E: preparing an E phase which is human-like collagen liquid and comprises human-like collagen with the content of the human-like collagen in the human-like collagen anorectal mucosa repair gel being 0.1-1 wt%, wherein the medium is water, and the weight ratio of the human-like collagen to the water is 1: 1-20; and
step F: adding the phase D into the phase A and stirring uniformly, then adding the phase B and stirring uniformly, then adding the phase C and the phase E and stirring uniformly, preserving heat at 80-85 ℃ for 60-120 minutes, stirring uniformly after heat preservation, and cooling to room temperature;
the total weight of the human-like collagen gel is taken as 100 wt%.
Herein, the human-like collagen liquid includes an aqueous solution of human-like collagen and an aqueous dispersion of human-like collagen.
Here, the order of the step A, B, C, D, E is not particularly limited, and may be performed sequentially or simultaneously in any order.
Preferably, the phase a is prepared by dispersing carbomer and hyaluronic acid with glycerol, adding to water, and stirring until completely dissolved.
Here, the stirring method is not particularly limited as long as uniform stirring is possible.
The human-like collagen gel of the present invention may be placed in a packaging container. There is no particular limitation on the material constituting the packaging container, which includes, but is not limited to, ceramics, glass, metal, plastics, and the like. The packaging container may or may not be hermetically sealed, but is preferably hermetically sealed.
Examples
The present invention will be described more specifically with reference to the following examples, but the present invention is not limited to these examples.
The human-like collagen used in the following examples and comparative examples was Van's human-like collagen (consisting of the amino acid sequence shown in SEQ ID NO: 1) prepared according to the method described in Chinese patent application publication CN1371919A, and was confirmed to have a molecular weight of 90 kDa.
In order to observe the transdermal absorption behavior of human-like collagen, it was fluorescently labeled with FITC (fluorescein isothiocyanate) using a conventional method.
In the following description, "%" means "% by weight" unless otherwise specified.
Example 1 human-like collagen of the inventionPreparation of protein anorectal mucosa repair gel
The components: carbomer 0.8%, glycerin 22%, sodium hyaluronate 0.005%, sodium hydroxide 0.15%, ethylparaben 0.2%, chitosan 0.5%, human-like collagen 0.5%, and water in balance.
The process operation comprises the following steps:
firstly, carbomer, sodium hyaluronate and glycerol (8 weight percent) are added into water, and then the chitosan is slowly added and continuously stirred until the carbomer, the sodium hyaluronate and the glycerol are completely dispersed.
Secondly, adding a sodium hydroxide aqueous solution into the solution, stirring uniformly, slowly adding a mixed solution of ethylparaben and glycerol and a human-like collagen liquid, stirring uniformly, keeping the temperature at 82 ℃ for 90 minutes, stirring uniformly after keeping the temperature, and cooling to room temperature.
Comparative example 1 preparation of other human collagen anorectal mucosa repair gels
The components: carbomer 1.5%, glycerin 22%, sodium hyaluronate 0.005%, sodium hydroxide 0.15%, ethylparaben 0.2%, chitosan 2%, human-like collagen 0.5%, and water in balance.
The process operation comprises the following steps:
firstly, carbomer, sodium hyaluronate and glycerol (8 weight percent) are added into water, and then the chitosan is slowly added and continuously stirred until the carbomer, the sodium hyaluronate and the glycerol are completely dispersed.
Secondly, adding a sodium hydroxide aqueous solution into the solution, stirring uniformly, slowly adding a mixed solution of ethylparaben and glycerol and a human-like collagen liquid, stirring uniformly, keeping the temperature at 82 ℃ for 90 minutes, stirring uniformly after keeping the temperature, and cooling to room temperature.
Comparative example 2 preparation of other human collagen anorectal mucosa repair gels
The components: carbomer 0.8%, glycerin 22%, sodium hyaluronate 0.005%, sodium hydroxide 0.15%, ethylparaben 0.2%, chitosan 0.5%, human-like collagen 0.5%, tween-800.5%, and water in balance.
The process operation comprises the following steps:
firstly, carbomer, sodium hyaluronate and glycerol (8 weight percent) are added into water, and then the chitosan is slowly added and continuously stirred until the carbomer, the sodium hyaluronate and the glycerol are completely dispersed.
Secondly, adding a sodium hydroxide aqueous solution into the solution, stirring uniformly, slowly adding a mixed solution of ethylparaben and glycerol and a human-like collagen liquid, stirring uniformly, keeping the temperature at 82 ℃ for 90 minutes, stirring uniformly after the temperature is kept, adding polysorbate 80, stirring uniformly, and cooling to room temperature.
Comparative example 3 preparation of other human collagen anorectal mucosa repair gels
The components: carbomer 1%, glycerin 22%, sodium hyaluronate 0.005%, sodium hydroxide 0.09%, ethylparaben 0.2%, chitosan 0.5%, human-like collagen 0.5%, and water in balance.
The process operation comprises the following steps:
firstly, carbomer, sodium hyaluronate and glycerol (8 weight percent) are added into water, and then the chitosan is slowly added and continuously stirred until the carbomer, the sodium hyaluronate and the glycerol are completely dispersed.
Secondly, adding a sodium hydroxide aqueous solution into the solution, stirring uniformly, slowly adding a mixed solution of ethylparaben and glycerol and a human-like collagen liquid, stirring uniformly, keeping the temperature at 82 ℃ for 90 minutes, stirring uniformly after keeping the temperature, and cooling to room temperature.
Determination of 30-minute transdermal absorption rate of collagen
Rats that had been adapted to a breeding environment in a laboratory were fasted for 1 day, anesthetized, placed in the rectum with a 4% acetic acid cotton swab through the anus of the rat for 1 minute with an insertion depth of 3 cm, and a model group rat acute rectal mucosal injury model was prepared (refer to rosy chard et al, morphological observation of acetic acid-induced establishment of rat acute rectal mucosal injury model, vol.23, No. 2, 4/2015). The human-like collagen anorectal mucosa repair gel of the embodiment and the comparative example is injected into rat rectum in the same amount, the rat rectum is normally raised after the completion of the injection, 5 rats in each group are killed at 0.5h, the test tissue part is cut off and cleaned, and the collagen in the cleaning solution is quantitatively analyzed by a fluorescence enzyme labeling instrument, namely the collagen which cannot be permeated through skin.
Wherein, the skin penetration rate is calculated as follows: skin penetration rate (total amount of collagen injected-amount of collagen that failed to penetrate skin)/total amount of collagen injected.
The average values of the results of the above-described permeability tests are shown in table 1 below for the human-like collagen anorectal mucosa repair gels of each example and comparative example.
TABLE 1 transdermal absorption Rate of each collagen gel
| No | 30-minute transdermal absorption rate of collagen |
| Example 1 | 65％ |
| Comparative example 1 | 43％ |
| Comparative example 2 | 39％ |
| Comparative example 3 | 31％ |
Industrial applicability
According to the present invention, a human-like collagen gel particularly suitable for anorectal mucosa repair can be provided.
Claims (2)
1. Use of a human-like collagen anorectal mucosa repair gel comprising:
and the human collagen anorectal mucosa repair gel does not contain polysorbates.
2. The use according to claim 1, wherein the human collagen-like anorectal mucosa repair gel is prepared by a process comprising:
step A: preparing phase A, wherein the phase A consists of 0.75-0.85 wt% of carbomer, 5-10 wt% of glycerin, 0.003-0.007 wt% of sodium hyaluronate and the balance of water;
and B: preparing a phase B, wherein the phase B is a sodium hydroxide aqueous solution consisting of 0.13-0.17 wt% of sodium hydroxide and 1-3 wt% of water;
and C: preparing a phase C, wherein the phase C is a mixture of 0.1-0.3 wt% of ethylparaben and 20-10 wt% of glycerol;
step D: preparing a phase D, wherein the phase D is 0.3-0.7 wt% of chitosan;
step E: preparing an E phase which is human-like collagen liquid and comprises human-like collagen with the content of the human-like collagen in the human-like collagen anorectal mucosa repair gel being 0.1-1 wt%, wherein the medium is water, and the weight ratio of the human-like collagen to the water is 1: 1-20; and
step F: adding the phase D into the phase A and stirring uniformly, then adding the phase B and stirring uniformly, then adding the phase C and the phase E and stirring uniformly, preserving heat at 80-85 ℃ for 60-120 minutes, stirring uniformly after heat preservation, and cooling to room temperature;
the total weight of the human collagen-like anorectal mucosa repair gel is taken as 100 percent by weight.
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105169374A (en) * | 2015-10-23 | 2015-12-23 | 东莞市达庆医疗器械有限公司 | Recombinant human collagen gel and preparation method thereof |
| CN105709266A (en) * | 2015-12-04 | 2016-06-29 | 陕西巨子生物技术有限公司 | Scar-repairing silica gel containing human-like collagen |
| CN105983131A (en) * | 2015-02-13 | 2016-10-05 | 陕西巨子生物技术有限公司 | Hydrogel collagen dressing especially suitable for oily skins |
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| US6645948B2 (en) * | 1998-03-24 | 2003-11-11 | George D. Petito | Nutritional composition for the treatment of connective tissue |
| CN105709216B (en) * | 2015-12-04 | 2019-03-12 | 陕西巨子生物技术有限公司 | A kind of human-like collagen oral mucosa reparation liquid |
| CN105709267B (en) * | 2015-12-04 | 2018-10-12 | 陕西巨子生物技术有限公司 | A kind of human-like collagen cell migration gel |
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| CN105983131A (en) * | 2015-02-13 | 2016-10-05 | 陕西巨子生物技术有限公司 | Hydrogel collagen dressing especially suitable for oily skins |
| CN105169374A (en) * | 2015-10-23 | 2015-12-23 | 东莞市达庆医疗器械有限公司 | Recombinant human collagen gel and preparation method thereof |
| CN105709266A (en) * | 2015-12-04 | 2016-06-29 | 陕西巨子生物技术有限公司 | Scar-repairing silica gel containing human-like collagen |
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