CN114224773A - Medical gel containing recombinant humanized collagen and preparation method thereof - Google Patents
Medical gel containing recombinant humanized collagen and preparation method thereof Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
- A61K8/64—Proteins; Peptides; Derivatives or degradation products thereof
- A61K8/65—Collagen; Gelatin; Keratin; Derivatives or degradation products thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
- A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
- A61K8/34—Alcohols
- A61K8/345—Alcohols containing more than one hydroxy group
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
- A61K8/40—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing nitrogen
- A61K8/41—Amines
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
- A61K8/73—Polysaccharides
- A61K8/735—Mucopolysaccharides, e.g. hyaluronic acid; Derivatives thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
- A61K8/81—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds obtained by reactions involving only carbon-to-carbon unsaturated bonds
- A61K8/8141—Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by only one carboxyl radical, or of salts, anhydrides, esters, amides, imides or nitriles thereof; Compositions of derivatives of such polymers
- A61K8/8147—Homopolymers or copolymers of acids; Metal or ammonium salts thereof, e.g. crotonic acid, (meth)acrylic acid; Compositions of derivatives of such polymers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
- A61Q19/00—Preparations for care of the skin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
- A61Q19/00—Preparations for care of the skin
- A61Q19/005—Preparations for sensitive skin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
- A61K2800/40—Chemical, physico-chemical or functional or structural properties of particular ingredients
- A61K2800/59—Mixtures
- A61K2800/592—Mixtures of compounds complementing their respective functions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
- A61K2800/80—Process related aspects concerning the preparation of the cosmetic composition or the storage or application thereof
- A61K2800/85—Products or compounds obtained by fermentation, e.g. yoghurt, beer, wine
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Abstract
The invention discloses a medical gel containing recombinant humanized collagen and a preparation method thereof. The medical gel comprises the following components in percentage by weight: 0.1-1% of recombinant humanized collagen, 10-40% of glycerol, 1-5% of 1, 2-pentanediol, 0.1-0.5% of hydrolyzed sodium hyaluronate, 0.2-0.6% of carbomer, 0.1-0.3% of aminomethyl propanol and the balance of water. The medical gel containing the recombinant humanized collagen is mild in components, and by utilizing the compounding of the recombinant humanized collagen and the hydrolyzed sodium hyaluronate, the effects of moisturizing, permeating and repairing the recombinant humanized collagen are better exerted, the phenomena of sensitive skin, red skin removal and unsmooth skin repairing can be instantly relieved, and the sensitive skin is effectively improved.
Description
Technical Field
The invention belongs to the field of medical instruments, and relates to a medical gel containing recombinant humanized collagen and a preparation method thereof.
Background
In general, sensitive skin, also known as sensitive skin syndrome, i.e., skin that is highly reactive, poorly tolerated, or susceptible to allergy, is a skin condition that describes subjective sensory symptoms induced by susceptibility to a variety of factors. The clinical manifestations are subjective symptoms, including tightness, irritation, burning, pain and pruritus, etc., the skin appearance is normal or accompanied by mild desquamation, erythema and dryness, and the skin is sensitive to many slight conventional external stimuli, belonging to a skin subclinical state. Sensitive skin is mainly caused by two reasons: 1) a genetic factor; 2) external factors such as over-stimulated product usage, long overnight stay, improper skin care, etc.
The treatment of general sensitive skin firstly avoids the re-stimulation and reduces the cosmetic measures of face steaming, massage, cutin removal and the like as much as possible. The cosmetic designed for sensitive skin can be selected, and it often contains vitamin B5, carboxymethyl beta-glucan, etc. Since the skin is relatively dry, a moisturizing product containing lipids in a suitable ratio may be used. For patients with serious subjective symptoms and daily life influence, antihistamine medicines can be orally taken, and non-hormone anti-inflammatory medicines can be externally used to relieve symptoms.
Sensitive skin should be made as simple as possible with little or no cosmetic substances and irritants. In daily skin care, the following three basic principles are adhered to: mild and non-irritant cleaning agents and humectants are used; moisture for maintaining the function of healthy stratum corneum of the skin; skin oils are replenished to strengthen the skin barrier.
The recombinant humanized collagen is obtained by taking a human collagen gene as a template, preferably optimizing and transforming, introducing pichia pastoris and performing fermentation, induction, separation and purification. The recombinant humanized collagen is highly consistent with human collagen, has good skin affinity and tissue compatibility, and has good repairing capability.
Disclosure of Invention
The invention provides a medical gel containing recombinant humanized collagen and a preparation method thereof.
The medical gel containing the recombinant humanized collagen comprises the following components in percentage by weight: 0.1-1% of recombinant humanized collagen, 10-40% of glycerol, 1-5% of 1, 2-pentanediol, 0.1-0.5% of hydrolyzed sodium hyaluronate, 0.2-0.6% of carbomer, 0.1-0.3% of aminomethyl propanol and the balance of water.
In the invention, the adopted recombinant humanized collagen is produced by fermenting Pichia pastoris with the preservation number of CGMCC No. 5021.
In the specific embodiment of the invention, the medical gel containing the recombinant humanized collagen comprises the following components in percentage by weight: 0.5% of recombinant humanized collagen, 10% of glycerol, 5% of 1, 2-pentanediol, 0.15% of hydrolyzed sodium hyaluronate, 0.4% of carbomer, 0.2% of aminomethyl propanol and the balance of water.
The invention also provides a preparation method of the medical gel containing the recombinant humanized collagen, which comprises the following steps:
adding carbomer, hydrolyzed sodium hyaluronate and glycerol into water according to a certain proportion, heating to 65 +/-2 ℃, uniformly stirring, cooling to below 45 ℃, adding 1, 2-pentanediol and the recombinant humanized collagen, uniformly stirring until the materials are completely dissolved, adding aminomethyl propanol, and continuously uniformly stirring until medical gel is formed.
Compared with the prior art, the invention has the following advantages:
the medical gel containing the recombinant humanized collagen has mild components, the used recombinant humanized collagen is derived from microbial fermentation, and the medical gel is safe and reliable, has good compounding performance with other raw materials, and cannot generate the problems of precipitation, color change, precipitation and the like. The recombinant humanized collagen and the hydrolyzed sodium hyaluronate are compounded for use, so that the moisturizing, permeating and repairing effects of the recombinant humanized collagen are better exerted, the phenomena of sensitive muscles, redness removal and unsmooth skin repairing can be immediately relieved, and the sensitive skin is effectively improved.
Drawings
Fig. 1 is a report of skin texture analysis of a human subject after 0 day, 3 days, and 7 days of use.
Fig. 2 is a report of skin hemoglobin analysis of a human subject at 0 day, 3 days, and 7 days after use.
Detailed Description
The present invention will be described in further detail with reference to the following examples and the accompanying drawings.
The recombinant humanized collagen adopted by the invention is produced by fermenting Pichia pastoris with the preservation number of CGMCC No.5021, and is fully disclosed in Chinese patent ZL 201110327865.5.
Example 1
The medical gel containing the recombinant humanized collagen comprises the following components in percentage by weight: 0.5% of recombinant humanized collagen, 10% of glycerol, 5% of 1, 2-pentanediol, 0.15% of hydrolyzed sodium hyaluronate, 0.4% of carbomer, 0.2% of aminomethyl propanol and the balance of water.
Is prepared by the following steps:
adding carbomer, hydrolyzed sodium hyaluronate and glycerol into water according to a certain proportion, heating to 65 +/-2 ℃, uniformly stirring, cooling to below 45 ℃, adding 1, 2-pentanediol and the recombinant humanized collagen, uniformly stirring until the materials are completely dissolved, adding aminomethyl propanol, and continuously uniformly stirring until medical gel is formed.
Test examples
1. Test samples: each vial contained 30 g of the recombinant humanized collagen-containing medical gel prepared in example 1.
2. The test purpose is as follows: open 10-day test, instrumental and photographic tests were performed to assess changes in texture and hemoglobin efficacy 10 days after product use.
3. The subject claims:
(3.1) inclusion criteria
(1) Chinese female
(2) Age 22-55 years old
(3) Dry or semi-dry skin
(4) Slightly sensitive or sensitive person for face research
(5) The subject should be insensitive to common cosmetics
(6) Subjects did not participate in additional clinical studies for the last 3 months
(3.2) exclusion criteria
(1) The antihistamine is administered in a week or the immunosuppressant is administered in a month
(2) Any anti-inflammatory drug is used on the tested part in nearly 2 months
(3) Insulin dependent diabetic patients
(4) Patients suffering from respiratory diseases undergoing therapy
(5) Women in lactation or pregnancy
(6) People with allergic constitution or allergic dermatitis have a history of skin diseases or diseases
(7) A person undergoing dermatological treatment, or a subject taking within one month hydroxy-acids, whitening and anti-aging drugs.
(8) The test area has the influences of large-area birthmarks, scratch marks, white spots, pigmented nevi, pimples, scars and the like, the skin characterization of the experiment is carried out, and in addition, the person in charge of the experiment judges that the person is not suitable for the crowd as the experimental object.
(3.3) matters of restrictions
(1) During the test, the treatment for the effect test on the skin to be tested is prohibited.
(2) During the test, retesting with other skin care products and other products that affect the test was prohibited.
(3) During the test period, daily products such as bath foam, soap, shampoo and the like are consistent with those used before the test is started, and replacement is prohibited.
4. The number of experimental targets: eligible subjects were enrolled for 35, ensuring a final completion of 30.
5. Testing an instrument:
(1) antera3D skin tester (Ireland)
(2) Canon E600 camera
6. And (3) testing environment: the temperature is 21 ℃ plus or minus 1 ℃, the humidity is 50 percent plus or minus 5 percent, and the light ray is ensured to be unchanged every time.
7. The experimental process comprises the following steps:
(1) at the first visit, subjects were instructed to perform the trial and signed an informed consent.
(2) Screening the test subjects according to the test requirements, screening 35 subjects in the test group, and finally ensuring more than 30 subjects.
(3) Screening qualified subjects can not use any cosmetics in the morning, after the faces are cleaned with clear water, the faces are smeared in a constant-temperature constant-humidity room for rest for 30 minutes, and after 30 minutes, the faces are tested.
(4) And (3) carrying out use instructions on the testee after the test is finished, dispensing the product after the testee listens to the instructions, using the test sample by the testee for 10 days continuously at home, carrying out return visit of the appointed place after 3 days and 7 days of continuous use of the product according to the instruction of the test, and carrying out the face test according to the step (3).
(5) The amount of product used was confirmed at the beginning and end of the test.
8. And (3) observing test items:
the subjects were subjected to instrumental testing 0 days before use, 3 days after use and 3 times after 7 days after use.
(1) Skin heme: wrinkle analysis with antera3D combined with canon camera image acquisition.
And (4) judging a result: the hemoglobin was analyzed by photographing with antera 3D.
(2) Skin texture: texture was analyzed with antea 3D in conjunction with canon camera image acquisition.
And (4) judging a result: the texture was analyzed by photographing with antera 3D.
(3) Pores in the skin: texture was analyzed with antea 3D in conjunction with canon camera image acquisition.
And (4) judging a result: the skin was photographed with antera3D and the pores were analyzed.
(4) Introduction description of the test apparatus:
antera3D is an imaging device used for skin analysis and evaluation.
Based on advanced optical technology, the skin, epidermis and true skin with 2 and 3 dimensions can be observedMultispectral analysis of the skin.
Wrinkle measurement: wrinkle depth [ mm ], wrinkle width [ mm ], wrinkle indentation [ mm ], overall size [ a.u ].
And (3) texture measurement: average roughness Ra [ a.u ], root mean square roughness Rq [ a.u ], and elevation span Rspan [ mm ].
Pore measurement: total volume [ mm3]Index, count [ number of pores]Density [ number of pores/mm2]Average pore volume [ mm3]Area affected [ mm ]2]Maximum depth [ mm ]]。
Volume measurement: height volume [ mm ]3]Maximum peak height, Rp [ mm]Affected elevation area [ mm ]2]And the amount of recess [ mm ]3]Maximum valley depth Rv [ mm ]]Affected depressed area [ mm ]2]。
And (3) melanin measurement: average concentration [ arbitrary unit ], variation [ arbitrary unit ], relative variation [ arbitrary unit ], high-concentration [ arbitrary unit ], low-concentration [ arbitrary unit ].
And (3) hemoglobin measurement: average concentration [ arbitrary unit ], variation [ arbitrary unit ], relative variation [ arbitrary unit ], high-concentration [ arbitrary unit ], low-concentration [ arbitrary unit ].
And (3) colorimetric measurement: average CIE L a b value, color change Δ E.
Single L a b varies- Δ L, Δ a, Δ b.
High variation region [ mm2 ]: relative high variable regions expressed as percentages.
9. The statistical method of the test results comprises the following steps:
TABLE 1 whether example Classification Table is adopted
TABLE 2 sample usage determination of whether to use case classification
| Status of use | Whether to employ data |
| During the test period, more than 3/4 are used | By using |
| During the test, the general method | By using |
| Less than half of the test period | Conference for others |
| Is not substantially used | Without using |
| Otherwise, the usage and dosage do not comply with | Conference for others |
The data statistical analysis method comprises the following steps: the SPSS software is used to make descriptive statistics on the various measurements, including quantity, mean, standard deviation, minimum, maximum, etc. And (3) carrying out significance test on normal distribution of data improvement values by using Shapiro-wilk test (Charcot-Wilk test), wherein if Sig is more than 0.01 (double sides), the data are normally distributed, carrying out T test, and taking a significance difference level alpha as 0.05. If weak Sig (both sides) <0.01, the distribution is abnormal, Wilcoxon test is carried out, the significance difference level alpha is 0.05, the significance difference level is P value <0.05, which shows that statistical difference exists, P <0.01, and the statistical difference is obvious.
10. Data summary analysis
Table 3 shows gel efficacy data for 0, 3 and 7 days of testing, calculated as the average of the values corresponding to each time point tested for the population of test subjects.
Table 3 gel efficacy test data for 0, 3 and 7 days
*P≤0.05，**P≤0.01
The test results in table 3 show that the test population of this experiment had a total of 30 persons, 3 days and 7 days after the use of the medical gel containing recombinant humanized collagen:
(1) safety: by the end of the test, 30 people have no allergy, itching, redness and other discomfort symptoms.
(2) The efficacy is as follows: skin heme: compared with the prior art, the improvement rate of D3 skin heme is 30.58% (P is less than or equal to 0.01), and the improvement rate of D7 skin heme is 29.05% (P is less than or equal to 0.01).
(3) Skin texture: compared with the prior art, the skin texture improving rate of D3 is 19.03% (P is less than or equal to 0.05), and the skin texture improving rate of D7 is 20.18% (P is less than or equal to 0.05).
In conclusion, through the comparison between the front and the back of the human body efficacy test, after the tested person uses the gel containing the recombinant humanized collagen, the red blood streak and the skin texture of the skin are improved, the improvement rate P is less than or equal to 0.05, and the statistical significance is achieved.
Claims (3)
1. The medical gel containing the recombinant humanized collagen is characterized by comprising the following components in percentage by weight: 0.1-1% of recombinant humanized collagen, 10-40% of glycerol, 1-5% of 1, 2-pentanediol, 0.1-0.5% of hydrolyzed sodium hyaluronate, 0.2-0.6% of carbomer, 0.1-0.3% of aminomethyl propanol and the balance of water; the recombinant humanized collagen is produced by fermenting Pichia pastoris with the preservation number of CGMCC No. 5021.
2. The medical gel containing the recombinant humanized collagen according to claim 1, which is characterized by comprising the following components in percentage by weight: 0.5% of recombinant humanized collagen, 10% of glycerol, 5% of 1, 2-pentanediol, 0.15% of hydrolyzed sodium hyaluronate, 0.4% of carbomer, 0.2% of aminomethyl propanol and the balance of water.
3. The method for preparing the medical gel containing the recombinant humanized collagen according to claim 1 or 2, comprising the steps of:
adding carbomer, hydrolyzed sodium hyaluronate and glycerol into water according to a certain proportion, heating to 65 +/-2 ℃, uniformly stirring, cooling to below 45 ℃, adding 1, 2-pentanediol and the recombinant humanized collagen, uniformly stirring until the materials are completely dissolved, adding aminomethyl propanol, and continuously uniformly stirring until medical gel is formed.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN116874587A (en) * | 2023-06-30 | 2023-10-13 | 广东英腾生物科技有限公司 | Recombinant collagen hydrogel and preparation method thereof |
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| CN107714504A (en) * | 2017-08-01 | 2018-02-23 | 杭州惠博士健康产业有限公司 | A kind of same human-like collagen composition and its applied in cosmetics |
| CN112587436A (en) * | 2020-12-25 | 2021-04-02 | 浙江诸暨聚源生物技术有限公司 | Medical dressing containing recombinant collagen and preparation method thereof |
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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 |
| CN107714504A (en) * | 2017-08-01 | 2018-02-23 | 杭州惠博士健康产业有限公司 | A kind of same human-like collagen composition and its applied in cosmetics |
| CN112587436A (en) * | 2020-12-25 | 2021-04-02 | 浙江诸暨聚源生物技术有限公司 | Medical dressing containing recombinant collagen and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN116874587A (en) * | 2023-06-30 | 2023-10-13 | 广东英腾生物科技有限公司 | Recombinant collagen hydrogel and preparation method thereof |
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