CN110025502A - A kind of hypertonic Hyaluronic Acid dimethyl-silicon alkanol complex solution - Google Patents
A kind of hypertonic Hyaluronic Acid dimethyl-silicon alkanol complex solution Download PDFInfo
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- CN110025502A CN110025502A CN201910191024.2A CN201910191024A CN110025502A CN 110025502 A CN110025502 A CN 110025502A CN 201910191024 A CN201910191024 A CN 201910191024A CN 110025502 A CN110025502 A CN 110025502A
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- hyaluronic acid
- complex solution
- hypertonic
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/695—Silicon compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/726—Glycosaminoglycans, i.e. mucopolysaccharides
- A61K31/728—Hyaluronic acid
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/14—Alkali metal chlorides; Alkaline earth metal chlorides
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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
- A61K8/19—Cosmetics or similar toiletry preparations characterised by the composition containing inorganic ingredients
- A61K8/20—Halogens; Compounds 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
- A61K8/58—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing atoms other than carbon, hydrogen, halogen, oxygen, nitrogen, sulfur or phosphorus
- A61K8/585—Organosilicon compounds
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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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/02—Nasal agents, e.g. decongestants
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/02—Drugs for genital or sexual disorders; Contraceptives for disorders of the vagina
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
- A61Q11/00—Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses
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- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Reproductive Health (AREA)
- Endocrinology (AREA)
- Gynecology & Obstetrics (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Otolaryngology (AREA)
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Abstract
Application of the composition and the composition of the present invention relates to a kind of Hyaluronic Acid dimethyl-silicon alkanol compound with hypertonic feature in preparation oral cavity, nasal cavity and vaginal care articles or medical device product.The present composition is characterized in that at least containing 5g/L~50g/L Hyaluronic Acid, the pure and mild 45g/L~110g/L sodium chloride of 0.5g/L~10g/L dimethylsilane.The present composition is used to prepare the nursing materials or medical device product of oral cavity, nasal cavity and vagina, it is provided with multiple-unit container or unit dose package product, it is used after being diluted with drinking water or purified water, it is small easy to carry with small product size, it is easy to use, the advantages of preservative acts on mucosa irritation is reduced or avoided.
Description
Technical field
The composition of the present invention relates to a kind of Hyaluronic Acid dimethyl-silicon alkanol compound with hypertonic feature and described
Application of the composition in medicine and filed of daily-use chemical industry.
Background technique
Hyaluronic Acid (hyalouronic acid, HA) also known as hyaluronic acid, are by (1- β -4) D- glucuronic acid and (1- β -
3) the chain polyanion that N- acetyl group-D- aminoglucose dissacharide units repeat connection composition sticks polysaccharide.HA is that composition skin is thin
One of main component of extracellular matrix is applied to cosmetics since the 1980s, be known as ideal natural moisture preserving because
Son.Hyaluronic Acid dimethyl-silicon alkanol compound (dimethyl silanol hyaluronate, DSHA) is HA and silanol knot
The compound of conjunction, FR2561915 and MC200122 disclose its moisturizing, eliminate glutinous wet sense, anti-degradation and prevention and repair skin
The purposes of skin damage, CN106491634, which discloses its application and preparation in mucous membrane field, improves oral cavity, nasal cavity and vaginal mucosa
The composition of function.
At present in the oral cavity of market sale, nasal cavity and vaginal care product based on multiple-unit container, product contains anti-
Rotten agent, different preservatives all has different degrees of influence to mucous membrane function, and [bibliography: Deng Qiu is raised.Nasal medicine is anti-
Influence of the rotten agent to respiratory mucosa function.International ear nose larynx Head and neck tumour magazine, 2009,33 (4): 242-246], there is product
It is provided in the form of solid powder or particle, solvent dissolution is added when use and prepares, it is possible to reduce and the influence of preservative is avoided,
But the operation of user is increased, misoperation be easy to cause the pollution of medical fluid.It is molten containing macromolecular substances for not being suitable for
Slow product is solved, which is not appropriate for.DSHA is compound of the HA in conjunction with silanol, molecular weight 150kDa with
On, DSHA molecular weight suitable for the mucous membrane solid powder at 300kDa~1800kDa [CN106491634], dissolution is not allowed
Easily dispersion, solid particle have a swelling process, and causing dissolution, slowly medical fluid is uneven, and user is inconvenient to use, therefore is not suitable for
Using solid product form, ready-to-use technical solution.In order to solve this problem, present invention exploitation has hypertonic feature
DSHA solution is used to prepare the nursing materials or medical device product of oral cavity, nasal cavity and vagina, since hypertonic solution can inhibit
The growth and breeding of microorganism, multiple-unit container product can reduce the dosage of preservative, and unit dose package product can not add
Preservative uses after being diluted with drinking water or purified water.Technical solution of the present invention has small product size small easy to carry, makes
With conveniently, the advantages of preservative acts on mucosa irritation is reduced or avoided.
Summary of the invention
The composition of the object of the present invention is to provide a kind of Hyaluronic Acid dimethyl-silicon alkanol compound with hypertonic feature,
And the composition belongs to medicine and day in the application in preparation oral cavity, nasal cavity and vaginal care articles or medical device product
Use chemical field.
The present invention provides a kind of hypertonic Hyaluronic Acid dimethyl-silicon alkanol complex solution, it is characterised in that at least containing has
Three kinds of components of certain content range, i.e. a) 5g/L~50g/L Hyaluronic Acid；B) 0.5g/L~10g/L dimethyl-silicon alkanol；And c)
45g/L~110g/L sodium chloride.In the composite solution, other than three of the above component, can add other auxiliary materials at
Point, as benzalkonium chloride, sodium benzoate, potassium sorbate, thimerosal, western pyrrole chloramines, natrium adetate, parabens, chlorohexidene,
The disinfection preservatives such as povidone iodine, triclosan (0.3% or less DP300) and polyhexamethylene guanide (PHMB and PHMG), such as the third two
The cosolvents such as alcohol, glycerine, tween and polyethylene glycol, such as Thymol, menthol, eugenol, borneol and essence corrigent.
The present invention provides a kind of hypertonic Hyaluronic Acid dimethyl-silicon alkanol complex solution, it is characterised in that specific containing having
Three kinds of components of content range, i.e. a) 5g/L~50g/L Hyaluronic Acid；B) 0.5g/L~10g/L dimethyl-silicon alkanol；And c) 45g/
L~110g/L sodium chloride, surplus are purified water.In the composite solution, other than three of the above component, do not add including
Other auxiliary materials including preservative.
Hypertonic Hyaluronic Acid dimethyl-silicon alkanol complex solution provided by the invention, wherein preferably, the content of Hyaluronic Acid
Range is 10g/L~20g/L, and the content range of dimethyl-silicon alkanol is 1g/L~4g/L, and the content range of sodium chloride is 72g/
L~110g/L.
Hypertonic Hyaluronic Acid dimethyl-silicon alkanol complex solution provided by the invention, can be provided in a manner of unit dose package,
It can also be provided in a manner of multiple-unit container.Preferably, the product for not adding preservative is provided in a manner of unit dose package, is added micro-
The product of amount preservative can be provided in a manner of multiple-unit container.
Hypertonic Hyaluronic Acid dimethyl-silicon alkanol complex solution provided by the invention, can be used for preparing oral cavity, nasal cavity and yin
Road nursing materials or medical instrument.Such as mouthwash, mouth spraying agent, oral cavity clean water to oral cavity with cleaning, disinfection, nursing role
Product or medical instrument, such as nasal wash, nasal spray, nasal mist to nasal cavity have cleaning, disinfection, nursing role production
Product or medical instrument, such as vaginal lotion, vaginal jellies, private parts nursing liquid have cleaning, disinfection, the production of nursing role to vagina
Product or medical instrument.
It is used using oral cavity, nasal cavity and the vaginal care of the hypertonic Hyaluronic Acid dimethyl-silicon alkanol complex solution preparation of the present invention
Product or medical device product make 2 to 20 times of dilutions with drinking water or purified water when in use, preferably make 5 to 10 with purified water
It dilutes again.
Hypertonic Hyaluronic Acid dimethyl-silicon alkanol complex solution provided by the invention, the Hyaluronic Acid dimethyl-silicon alkanol are multiple
The compound that object refers to one alcohol of dimethylsilane or dimethylsilane glycol and Hyaluronic Acid is closed, acquisition can use published
Preparation method will such as be obtained after glass acid solution and silanol sodium solution hybrid reaction with cation exchange resin adjustment pH compound
Silane alcohol solution and glass aqueous acid are mixed (EP0289366) in proportion, organosilicon by object aqueous solution (FR2561915)
Solvent (EP0867445) is evaporated off in compound and Hyaluronic Acid in water and ethanol solution after reaction bonded, can also use chlorosilane
Solid composite (CN103450368) is obtained through precipitating after reacting with the Hyaluronic Acid being suspended in organic solution.
Hypertonic Hyaluronic Acid dimethyl-silicon alkanol complex solution provided by the invention, the content (C) of the Hyaluronic Acid be by
Carbazole method [bibliography: Bitter T, MuirHM.Amodiffieduronic acid carbazole reaction.Anal
Biochem, 1962,4:330-333] in measurement complex solution uronic acid content (T), in terms of formula C=T/51.5%
It calculates, wherein 51.5% is that uronic acid repeats ratio shared in dissacharide units in Hyaluronic Acid.
Hypertonic Hyaluronic Acid dimethyl-silicon alkanol complex solution provided by the invention, the content of the dimethyl-silicon alkanol
It (A) is by silicon molybdenum blues photometry [bibliography: Zheng Benheng, Yuan Min.Silicon molybdenum blues photometry measurement --- the reduction of Trace Silicon in water
The research of agent.Analysis test journal, 1998,17 (5): 78-80] content (S) of silicon is measured, with formula A=S/36.8% or A=
S/30.4% is calculated, wherein 36.8% is silicon ratio shared in one alcohol of dimethylsilane, 30.4% is silicon in dimethyl-silicon
Shared ratio in alkane glycol.
Hypertonic Hyaluronic Acid dimethyl-silicon alkanol complex solution provided by the invention, the content (D) of the sodium chloride be by
Silver nitrate titration method [2015 editions Chinese Pharmacopoeias, four general rules, 3107 sodium chloride measuring method] measurement.
Specific embodiment
Following embodiment be in order to better illustrate the present invention, be not limitation the present invention.
The hypertonic Hyaluronic Acid dimethyl-silicon alkanol complex solution in 1 oral cavity of embodiment
Ingredient and content (g) in every 1000ml solution:
Preparation method: [FR2561915] Hyaluronic Acid dimethyl-silicon alkanol complex solution is prepared by existing method, chlorine is added
Change sodium, after stirring and dissolving, other auxiliary materials is added, heating stirring dissolution with a small amount of sodium hydroxide or salt acid for adjusting pH value, is cooled to
Purified water is added after room temperature to full dose, filter, sterilize after mixing evenly, be sub-packed in suitable packaging or device to get.
Application method: sample of embodiment of the present invention drinking water or purified water are made into 2 to 20 times of dilutions, gargled.
The hypertonic Hyaluronic Acid dimethyl-silicon alkanol complex solution of 2 nasal cavity of embodiment
Ingredient and content (g) in every 1000ml solution:
Preparation method: [FR2561915] Hyaluronic Acid dimethyl-silicon alkanol complex solution is prepared by existing method, chlorine is added
Change sodium, after stirring and dissolving, other auxiliary materials is added, heating stirring dissolution with a small amount of sodium hydroxide or salt acid for adjusting pH value, is cooled to
Purified water is added after room temperature to full dose, filter, sterilize after mixing evenly, be sub-packed in suitable packaging or device to get.
Application method: making 5 to 10 times of dilutions for sample of embodiment of the present invention drinking water or purified water, pour into nasal cleaner or
Spray nose bottle nasal irrigation.
The hypertonic Hyaluronic Acid dimethyl-silicon alkanol complex solution of 3 vagina of embodiment
Ingredient and content (g) in every 1000ml solution:
Preparation method: [FR2561915] Hyaluronic Acid dimethyl-silicon alkanol complex solution is prepared by existing method, chlorine is added
Change sodium, after stirring and dissolving, other auxiliary materials is added, heating stirring dissolution with a small amount of sodium hydroxide or salt acid for adjusting pH value, is cooled to
Purified water is added after room temperature to full dose, filter, sterilize after mixing evenly, be sub-packed in suitable packaging or device to get.
Application method: making 2 to 20 times of dilutions for sample of embodiment of the present invention drinking water or purified water, rinsing vulva or falls
Enter dedicated gynaecologic cleaning device, spray bottle washing vagina.
The test of 4 limit test of microbe of embodiment
The sample being sub-packed in 100ml vinyon bottle after sterilizing in 1-3 of the embodiment of the present invention is chosen, room temperature is placed in
(20 ± 5 DEG C), uncap take 10ml daily, make microbial limit by the method for Chinese Pharmacopoeia version in 2015 four 1105 and 1106
It checks, criterion of acceptability are as follows: aerobic bacteria total plate count≤100cfu/ml；Yeast and mold total plate count≤10cfu/ml；Large intestine
Angstrom uncommon bacterium, staphylococcus aureus and pseudomonas aeruginosa (1ml) must not detect.As a result it (see the table below) and show in use process
In uncap daily primary, be not added with the product limit test of microbe qualification of disinfection preservative up to 6 days or more, addition disinfection is anti-
The product limit test of microbe qualification of rotten agent was up to 28 days or more.
Note: "+" indicates qualified, and "-" indicates unqualified.
Claims (10)
1. a kind of hypertonic Hyaluronic Acid dimethyl-silicon alkanol complex solution, it is characterised in that contain a) 5g/L~50g/L Hyaluronic Acid；
B) 0.5g/L~10g/L dimethyl-silicon alkanol；And c) 45g/L~110g/L sodium chloride.
2. the complex solution of claim 1, it is characterised in that by a) 5g/L~50g/L Hyaluronic Acid；B) 0.5g/L~10g/L bis-
Methyl-monosilane alcohol；C) 45g/L~110g/L sodium chloride；And d) surplus is purified water composition.
3. the complex solution of claims 1 or 2, it is characterised in that contain 10g/L~20g/L Hyaluronic Acid.
4. the complex solution of claims 1 or 2, it is characterised in that contain 1g/L~4g/L dimethyl-silicon alkanol.
5. the complex solution of claims 1 or 2, it is characterised in that contain 72g/L~110g/L sodium chloride.
6. the complex solution of claims 1 or 2 is provided in a manner of unit dose package.
7. the complex solution of claims 1 or 2 is provided in a manner of multiple-unit container.
8. the complex solution of claims 1 or 2 is used to prepare oral care implement or medical instrument.
9. the complex solution of claims 1 or 2 is used to prepare nasal nursing articles or medical instrument.
10. the complex solution of claims 1 or 2 is used to prepare vaginal care articles or medical instrument.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910191024.2A CN110025502A (en) | 2019-03-12 | 2019-03-12 | A kind of hypertonic Hyaluronic Acid dimethyl-silicon alkanol complex solution |
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| CN201910191024.2A CN110025502A (en) | 2019-03-12 | 2019-03-12 | A kind of hypertonic Hyaluronic Acid dimethyl-silicon alkanol complex solution |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110946825A (en) * | 2019-10-24 | 2020-04-03 | 山东省药学科学院 | Saline nasal cavity care solution |
| CN113842335A (en) * | 2021-10-21 | 2021-12-28 | 山东省药学科学院 | Hair moisturizing softener and application thereof |
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| US20060182708A1 (en) * | 2003-07-21 | 2006-08-17 | Dirk Bockmuhl | Prebiotically active plant extracts |
| CN104095767A (en) * | 2014-07-31 | 2014-10-15 | 山东福瑞达生物工程有限公司 | Composition and application thereof in cosmetics |
| DE102015216610A1 (en) * | 2015-08-31 | 2017-03-02 | Henkel Ag & Co. Kgaa | Cosmetic O / W emulsion for anti-wrinkle treatment |
| WO2017037001A1 (en) * | 2015-08-31 | 2017-03-09 | Henkel Ag & Co. Kgaa | Cosmetic or dermatological composition for lightening skin |
| CN106491634A (en) * | 2016-10-31 | 2017-03-15 | 山东省药学科学院 | Hyaluronic Acid dimethyl-silicon alkanol complex and combinations thereof |
-
2019
- 2019-03-12 CN CN201910191024.2A patent/CN110025502A/en active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20060182708A1 (en) * | 2003-07-21 | 2006-08-17 | Dirk Bockmuhl | Prebiotically active plant extracts |
| CN104095767A (en) * | 2014-07-31 | 2014-10-15 | 山东福瑞达生物工程有限公司 | Composition and application thereof in cosmetics |
| DE102015216610A1 (en) * | 2015-08-31 | 2017-03-02 | Henkel Ag & Co. Kgaa | Cosmetic O / W emulsion for anti-wrinkle treatment |
| WO2017037001A1 (en) * | 2015-08-31 | 2017-03-09 | Henkel Ag & Co. Kgaa | Cosmetic or dermatological composition for lightening skin |
| CN106491634A (en) * | 2016-10-31 | 2017-03-15 | 山东省药学科学院 | Hyaluronic Acid dimethyl-silicon alkanol complex and combinations thereof |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110946825A (en) * | 2019-10-24 | 2020-04-03 | 山东省药学科学院 | Saline nasal cavity care solution |
| CN110946825B (en) * | 2019-10-24 | 2022-04-15 | 山东福瑞达生物股份有限公司 | Saline nasal cavity care solution |
| CN113842335A (en) * | 2021-10-21 | 2021-12-28 | 山东省药学科学院 | Hair moisturizing softener and application thereof |
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