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WO2020140365A1 - Composition hydratante et lubrifiante contenant de la gomme xanthane et son utilisation - Google Patents

Composition hydratante et lubrifiante contenant de la gomme xanthane et son utilisation Download PDF

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Publication number
WO2020140365A1
WO2020140365A1 PCT/CN2019/087856 CN2019087856W WO2020140365A1 WO 2020140365 A1 WO2020140365 A1 WO 2020140365A1 CN 2019087856 W CN2019087856 W CN 2019087856W WO 2020140365 A1 WO2020140365 A1 WO 2020140365A1
Authority
WO
WIPO (PCT)
Prior art keywords
xanthan gum
composition
moisturizing
osmotic pressure
care solution
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CN2019/087856
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English (en)
Chinese (zh)
Inventor
凌沛学
邵新田
边玲
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Shandong Academy of Pharmaceutical Sciences
Original Assignee
Shandong Academy of Pharmaceutical Sciences
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Shandong Academy of Pharmaceutical Sciences filed Critical Shandong Academy of Pharmaceutical Sciences
Publication of WO2020140365A1 publication Critical patent/WO2020140365A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • C—CHEMISTRY; METALLURGY
    • C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D1/00—Detergent compositions based essentially on surface-active compounds; Use of these compounds as a detergent
    • C11D1/66—Non-ionic compounds
    • C11D1/722—Ethers of polyoxyalkylene glycols having mixed oxyalkylene groups; Polyalkoxylated fatty alcohols or polyalkoxylated alkylaryl alcohols with mixed oxyalkylele groups
    • C—CHEMISTRY; METALLURGY
    • C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D3/00—Other compounding ingredients of detergent compositions covered in group C11D1/00
    • C11D3/02—Inorganic compounds ; Elemental compounds
    • C11D3/04—Water-soluble compounds
    • C—CHEMISTRY; METALLURGY
    • C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D3/00—Other compounding ingredients of detergent compositions covered in group C11D1/00
    • C11D3/16—Organic compounds
    • C11D3/26—Organic compounds containing nitrogen
    • C11D3/33—Amino carboxylic acids
    • C—CHEMISTRY; METALLURGY
    • C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D3/00—Other compounding ingredients of detergent compositions covered in group C11D1/00
    • C11D3/16—Organic compounds
    • C11D3/37—Polymers
    • C—CHEMISTRY; METALLURGY
    • C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D3/00—Other compounding ingredients of detergent compositions covered in group C11D1/00
    • C11D3/48—Medical, disinfecting agents, disinfecting, antibacterial, germicidal or antimicrobial compositions

Definitions

  • the invention belongs to the field of medical equipment, and particularly relates to a moisturizing and lubricating composition containing xanthan gum and its application.
  • the commonly used moisturizing and lubricating factors are mainly hyaluronic acid (HA), sodium pyrrolidone carboxylate (PCA), polyvinylpyrrolidone (PVP), polyvinyl alcohol (PVA), glycerin, propylene glycol, sorbitol and so on.
  • PCA is a moisturizing factor that naturally exists in the skin.
  • the moisturizing and hygroscopic properties are significantly better than glycerin, propylene glycol, and sorbitol.
  • the moisturizing effect of PCA must be in a high humidity environment. When the air humidity is low, it makes the skin more dry.
  • PVP and PVA are high-molecular compounds. Although they are both water-soluble substances, the degree of stretch of their molecular chains in aqueous solution is not ideal, and PVA has a stimulating effect on the eyes.
  • HA is an acidic mucopolysaccharide, which is also a component of the human body.
  • HA has good water absorption and moisturizing properties, its production cost is high, and there are many factors affecting the moisturizing and lubricating properties, such as pH enzymes, reducing substances, ultraviolet rays, etc., and its stability is very poor. The difference in technology has a significant impact on the effect.
  • Xanthan gum is a kind of microbial extracellular polysaccharide produced by fermentation using sugar as the main raw material. In 1969, xanthan gum was first approved by the US FDA for use in foods and medicines. It is now used as a pharmaceutical excipient in the 2010 version of China Pharmacopoeia has good biological safety. The literature has confirmed that xanthan gum can be used to treat eye diseases and increase the bioavailability of ophthalmic drugs.
  • xanthan gum solutions have higher viscosity at low concentrations and are used as thickeners, suspending agents, emulsifiers, and stabilizers in liquid and semi-solid formulations.
  • the high viscosity of xanthan gum makes it easier for external preparations to be coated, and not easy to fall off from the skin, which helps to improve the bioavailability of the drug and increase the comfort of the drug.
  • xanthan gum is used as an eye drop aid to prolong the contact time between the drug and the site of application. Due to the nature of its pseudoplastic fluid, the shear force generated during blinking can rapidly reduce its viscosity without causing discomfort to the eyes.
  • Eye drops prepared by mixing xanthan gum, chondroitin sulfate, and sodium hyaluronate can protect corneal epithelial cells and accelerate cell regeneration.
  • the ophthalmic gel prepared with xanthan gum as the gel matrix is uniform, stable, and has good gel strength. It has a good bioadhesive effect on the corneal surface, can significantly prolong the drug residence time and improve the efficacy, and delay the drug release.
  • the research results show that xanthan gum is more stable than sodium hyaluronate, is not easily degraded by enzymes and free radicals in the body, and has a longer residence time.
  • Chinese invention patent application with publication number 106860903A discloses a contact lens care solution, including sodium pyrrolidone carboxylate, quaternary ammonium salt chitosan, vitamin B 6 , plant extract, etc., wherein the moisturizer is quaternary ammonium salt chitosan .
  • Quaternary ammonium salt chitosan has good biocompatibility, no immunogenicity and inflammation, no toxicity to eye tissue, no harmful degradation products, but it does not have a lubricating effect, and its moisturizing properties are not as good as hyaluronic acid.
  • the Chinese invention patent application with publication number CN1390606A discloses a composition for treating contact lenses and its application.
  • the composition contains sodium hyaluronate 0.001-0.5%, nonionic surfactant 0.001-10%, chelate Mixture 0.01-10%, buffer 0.05-2.5%, tonicity agent, bactericide, water, in which the moisturizing agent is sodium hyaluronate.
  • sodium hyaluronate Although sodium hyaluronate has good water absorption and moisturizing properties, its production cost is high, and there are many factors affecting the moisturizing and lubricating properties, such as pH enzymes, reducing substances, ultraviolet rays, etc., the stability is very poor, and also because of the source of raw materials And the difference in manufacturing technology has a significant impact on the effect.
  • the present invention provides a moisturizing and lubricating composition containing xanthan gum.
  • the composition includes: xanthan gum 0.005%-2.5%, buffer 0.005%-15 %, surfactant 0.0005%-10%, chelating agent 0.0005%-5%, bacteriostatic agent 0.00005%-0.005%, osmotic pressure regulator 0.005%-5%, and the rest is water for injection.
  • the composition includes: xanthan gum 0.01%-2%, buffer 0.01%-10%, surfactant 0.001%-5%, chelating agent 0.001%-3%, bacteriostatic Agent 0.00005%-0.002%, osmotic pressure regulator 0.01%-4%.
  • mass-volume ratio of xanthan gum is 0.1%-1.0%.
  • the mass-volume ratio of xanthan gum is selected from 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1.0%, 1.2%, 1.5%, 2.0% .
  • the molecular weight of the xanthan gum is 10-20 million, preferably 1-5 million, more preferably 1 million, 2 million, 3 million, 4 million, 5 million.
  • the pH range of the composition is 6-8, preferably 7-7.5, more preferably 7.4.
  • the osmotic pressure of the composition is 220-350 mOsm/(Kg ⁇ H2O), preferably 290 mOsm/(Kg ⁇ H2O).
  • the osmotic pressure of the composition is adjusted by an osmotic pressure regulator, wherein the osmotic pressure regulator is one selected from sodium chloride, glucose, boric acid, and borax, preferably sodium chloride.
  • the osmotic pressure regulator is one selected from sodium chloride, glucose, boric acid, and borax, preferably sodium chloride.
  • the buffering agent is selected from a mixture of any one or more of phosphate, carbonate, borate and citrate, preferably borate buffering agent.
  • the above buffering agent not only has a buffering effect, but also can assist sterilization, and has low toxicity.
  • the bacteriostatic agent is selected from the group consisting of sorbic acid, polyhexamethylene biguanide hydrochloride (PHMB), polyaminopropyl biguanide (PAPB), and iodine, preferably polyhexamethylene Biguanide hydrochloride.
  • PHMB polyhexamethylene biguanide hydrochloride
  • PAPB polyaminopropyl biguanide
  • iodine preferably polyhexamethylene Biguanide hydrochloride.
  • the chelating agent is selected from ethylenediaminetetraacetic acid (EDTA) and its sodium salt, glycine, citric acid, succinic acid, tartaric acid, boric acid, phosphate, or any combination thereof, preferably ethylenediaminetetraacetic acid diacetate Sodium (EDTA-2Na).
  • EDTA ethylenediaminetetraacetic acid
  • the above chelating agent is used to bind metal ions to prevent the metal ions from reacting with the protein accumulated on the lens and assist in sterilization.
  • the surfactant is a mixture of one or more selected from poloxamers, polyethylene glycol, glycerides, glucose esters, polysorbates, alkyl glycosides, and polysiloxanes, preferably poloxamers , More preferably Poloxamer 407.
  • poloxamers polyethylene glycol, glycerides, glucose esters, polysorbates, alkyl glycosides, and polysiloxanes, preferably poloxamers , More preferably Poloxamer 407.
  • the above surfactants not only have a cleaning effect on the deposits on contact lenses, but also can remove proteins, lipids and debris on the surface of the lens. They also have good biocompatibility and are non-irritating to the eyes.
  • the present invention also provides the use of the above composition in the treatment of contact lenses.
  • the composition is used for cleaning, lubricating and/or storing contact lenses.
  • the present invention also provides the application of xanthan gum in the preparation of contact lens care solution, wherein the contact lens care solution includes: xanthan gum 0.005%-2.5%, buffer 0.005%-15%, surfactant 0.0005 %-10%, chelating agent 0.0005%-5%, bacteriostatic agent 0.00005%-0.005%, osmotic pressure regulator 0.005%-5%, the rest is water for injection; the molecular weight of the xanthan gum is 10-20 million.
  • the present invention also provides the application of the above composition in the preparation of contact lens care solution.
  • the present invention also provides a contact lens care solution comprising the above composition having moisturizing and lubricating properties.
  • composition provided by the present invention using xanthan gum with a certain mass fraction and molecular weight as a moisturizing lubricant, shows excellent lubricating and moisturizing properties, and can be used as a contact lens care solution to clean, lubricate and store contact lenses According to the test data, the lubricity and moisturizing properties of xanthan gum in contact lens care solution are better than hyaluronic acid, which can effectively reduce the wear between contact lens and cornea and improve the wearing comfort.
  • the contact lens treated with the composition provided by the present invention can avoid the decrease of lubricity caused by tearing; keep the liquid filling between the corneal cells and the contact lens for a long time to moisturize the eye for a long time; very stable to acid and alkali , Its properties are not affected at a pH between 5 and 10, including lubricity; the humidity retention and comfort when worn are improved, and xanthan gum also has a protective effect on corneal epithelial cells.
  • the corneal damage caused has a repairing effect.
  • the contact lens care solution provided by the present invention composed of the composition provided by the present invention, has higher biological safety. Compared with the hyaluronic acid as the lubricant care solution, it can provide better lubrication and moisturizing effect, even It can also be used to moisturize the eye when not wearing glasses.
  • xanthan gum was obtained by fermentation of Xanthomonas, the remaining raw material components were purchased commercially, and the four-ball friction and wear test machine used in the lubrication effect experiment was purchased from the Jinan test machine Factory, model is MRS-1J.
  • the water used is water for injection.
  • the water used is water for injection.
  • the water used is water for injection.
  • the water used is water for injection.
  • the water used is water for injection.
  • the water used is water for injection.
  • the water used is water for injection.
  • the water used is water for injection.
  • the water used is water for injection.
  • the water used is water for injection.
  • compositions obtained in Examples 1-9 can be applied to contact lens care solutions.
  • method of using the composition provided by the present invention as a contact lens care solution is as follows:
  • Example 4 0.139 1.50
  • Example 5 0.113 1.32
  • Example 6 0.085 1.06
  • Example 7 0.107 1.23
  • Example 8 0.081 0.94
  • Examples 1-9 showed a lower friction coefficient and a smaller wear scar diameter, indicating the lubricating of the contact lens care solution of xanthan gum in each molecular weight segment and concentration The performance is significantly better than hyaluronic acid.
  • the friction coefficients of Examples 6, 8 and 9 are smaller than those of other examples. Among them, the friction coefficient of Example 9 is the smallest, which is 0.062, indicating that the greater the concentration of xanthan gum, the greater the molecular weight , The lower the friction coefficient.
  • Test 2 Use comfort and humidity retention test
  • the composition provided by the present invention uses xanthan gum with a certain mass fraction and molecular weight as a moisturizing lubricant, shows excellent lubricating and moisturizing properties, and can be used as a contact lens care solution to clean and lubricate contact lenses 3.
  • the lubricity and moisturizing properties of xanthan gum in contact lens care solution are better than hyaluronic acid, which can effectively reduce the wear between contact lens and cornea and improve the wearing comfort.
  • hyaluronic acid When used as a contact lens care solution, it has high biological safety. Compared with hyaluronic acid as a lubricant care solution, it can provide better lubrication and moisturizing effect.

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  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Wood Science & Technology (AREA)
  • Organic Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Cosmetics (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

L'invention concerne une composition hydratante et lubrifiante contenant de la gomme xanthane, comprenant les composants suivants en pourcentages massiques : 0,005 à 2,5% de gomme xanthane, 0,005 à 15% d'un agent tampon, 0,0005 à 10% d'un tensioactif, 0,0005 à 5% d'un agent chélatant, 0,00005 à 0,005% d'un agent antimicrobien, 0,005 à 5% d'un régulateur de pression osmotique, le reste étant constitué d'eau pour injection; et la composition peut être utilisée pour traiter des lentilles de contact en tant que solution d'entretien pour lentilles de contact.
PCT/CN2019/087856 2019-01-03 2019-05-21 Composition hydratante et lubrifiante contenant de la gomme xanthane et son utilisation Ceased WO2020140365A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201910004049.7 2019-01-03
CN201910004049.7A CN109722347B (zh) 2019-01-03 2019-01-03 一种含有黄原胶的保湿润滑组合物及其应用

Publications (1)

Publication Number Publication Date
WO2020140365A1 true WO2020140365A1 (fr) 2020-07-09

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PCT/CN2019/087856 Ceased WO2020140365A1 (fr) 2019-01-03 2019-05-21 Composition hydratante et lubrifiante contenant de la gomme xanthane et son utilisation

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CN (1) CN109722347B (fr)
WO (1) WO2020140365A1 (fr)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110755465A (zh) * 2019-11-04 2020-02-07 海昌隐形眼镜有限公司 一种眼部护理液及其制备方法与应用
CN111518627A (zh) * 2020-05-09 2020-08-11 华熙生物科技股份有限公司 一种隐形眼镜护理液以及制备方法

Citations (2)

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Publication number Priority date Publication date Assignee Title
CN103120703A (zh) * 2013-01-06 2013-05-29 王峥 鼻腔清洗护理液及相关组合物
CN107789657A (zh) * 2016-08-30 2018-03-13 欧普康视科技股份有限公司 一种硬性接触镜护理液

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JPS57186733A (en) * 1981-05-13 1982-11-17 Toyo Contact Lens Co Ltd Agent for use in contact lenses
EP1069913B1 (fr) * 1998-04-07 2003-07-23 Alcon Laboratories, Inc. Compositions ophtalmiques gelifiantes, contenant de la gomme de xanthanne
CN101574537B (zh) * 2009-06-01 2012-10-10 海昌隐形眼镜有限公司 一种含薄荷隐形眼镜护理液的组合物及其制备方法
CN103083710A (zh) * 2013-01-23 2013-05-08 江苏海伦隐形眼镜有限公司 含海藻糖季铵盐的角膜接触镜护理组合物
CN103656726A (zh) * 2013-12-06 2014-03-26 东南大学 一种季铵盐壳聚糖在隐形眼镜护理液中的应用

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103120703A (zh) * 2013-01-06 2013-05-29 王峥 鼻腔清洗护理液及相关组合物
CN107789657A (zh) * 2016-08-30 2018-03-13 欧普康视科技股份有限公司 一种硬性接触镜护理液

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CN109722347A (zh) 2019-05-07
CN109722347B (zh) 2020-12-29

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