WO2014114124A1 - Corneal contact lens nursing composition containing trehalose quaternary ammonium salt - Google Patents

Corneal contact lens nursing composition containing trehalose quaternary ammonium salt Download PDF

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Publication number
WO2014114124A1
WO2014114124A1 PCT/CN2013/086855 CN2013086855W WO2014114124A1 WO 2014114124 A1 WO2014114124 A1 WO 2014114124A1 CN 2013086855 W CN2013086855 W CN 2013086855W WO 2014114124 A1 WO2014114124 A1 WO 2014114124A1
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quaternary ammonium
ammonium salt
contact lens
chloride
agent
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PCT/CN2013/086855
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French (fr)
Chinese (zh)
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何坚
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江苏海伦隐形眼镜有限公司
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Publication of WO2014114124A1 publication Critical patent/WO2014114124A1/en

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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
    • A61K9/0048—Eye, e.g. artificial tears
    • A61K9/0051—Ocular inserts, ocular implants
    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N47/00—Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom not being member of a ring and having no bond to a carbon or hydrogen atom, e.g. derivatives of carbonic acid
    • A01N47/40—Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom not being member of a ring and having no bond to a carbon or hydrogen atom, e.g. derivatives of carbonic acid the carbon atom having a double or triple bond to nitrogen, e.g. cyanates, cyanamides
    • A01N47/42—Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom not being member of a ring and having no bond to a carbon or hydrogen atom, e.g. derivatives of carbonic acid the carbon atom having a double or triple bond to nitrogen, e.g. cyanates, cyanamides containing —N=CX2 groups, e.g. isothiourea
    • A01N47/44—Guanidine; Derivatives thereof
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Definitions

  • the present invention relates to a composition for contact lens care.
  • the composition is a contact lens care composition comprising a trehalose quaternary ammonium salt.
  • Contact lenses can be divided into hard, semi-rigid and soft.
  • Hard contact lenses are made of polymethyl methacrylate (PMMA) which is substantially impermeable to oxygen and siloxane and acrylate copolymerizable with oxygen.
  • the semi-rigid contact lens is made of silicone rubber that is permeable to oxygen and maintains normal breathing on the surface of the cornea.
  • a special wetting solution is used to maintain wetting to meet comfort and physiological requirements;
  • Soft contact lenses the most commonly used are lenses made of polyhydroxyethyl methacrylate (HEMA).
  • HEMA polyhydroxyethyl methacrylate
  • the HEMA molecule is a network structure, which makes the lens have the function of adsorbing and releasing low molecular liquid. The looser the lens network structure and the higher the water content, there are now more than a dozen soft contact lens lenses.
  • the existing soft contact lens has high hydrophilicity. Because the contact lens is worn in the eye, it is placed in front of the cornea, which hinders the contact of the cornea with the air and causes corneal hypoxia. In addition, the tear is wet except for the cornea. In addition to the conjunctiva, the lens is also wetted, resulting in a lack of tears, causing the lens wearer's eyes to dry up and sore.
  • Trehalose ( ct -D-glucopyranosyl - a -D-glucopyra-noside) is a stable non-reducing disaccharide composed of two pyranose glucose molecules linked to 1, 1-glycosidic bonds. Because trehalose is a non-reducing sugar composed of special disaccharide molecules, it is very stable and can form a special protective film on the cell surface under the harsh conditions of high temperature, cold, dryness and water loss, effectively protecting the biomolecular structure. Destroyed to maintain the life process and biological characteristics of the living body. Because trehalose has unique biological properties that protect biological cells and active substances from damage under adverse conditions such as drying, foreign researchers are actively studying trehalose derivatives and using them in contact lens care compositions. feasibility.
  • a contact lens care composition which is an aqueous solution comprising an isotonicity adjusting agent, a buffering agent, a complexing agent, a trehalose quaternary ammonium salt, a surfactant, and an antimicrobial agent. Storage, disinfection, cleaning, lubrication, moisturization and rewetting of the lens of the contact lens.
  • the contact lens is stored in the composition at the time of use or the above composition is added dropwise onto the contact lens or directly into the eye.
  • a contact lens care composition containing a trehalose quaternary ammonium salt which comprises, by weight percent, consisting of the following components:
  • the quaternary ammonium salt of the trehalose is 0. 001 - 2%, the isotonicity adjusting agent is 0.01 - 2%, the surfactant is 0. 05 - 2%, the complexing agent is 0.01-1%, and the buffering agent is 0. 01— 3%, the antimicrobial compound is 0. 00001—1%, and the water is 89-99. 91899%.
  • the above isotonicity adjusting agent is at least one of sodium chloride, potassium chloride, calcium chloride, magnesium chloride, monosaccharide of glucose, propylene glycol, glycerin, sorbitol, and mannitol.
  • the above surfactants may be Poloxamer, Poloxamines, Tylo Xa pol, polysorbate, sodium lauroyl glutamate, lauryl propyl hydroxy sulfoyl. At least one of betaine.
  • the above complexing agent is at least one of ethylenediaminetetraacetic acid, 2-amino-2-methyl-1-propanol (AMP-95), and N-dodecylamethylenediaminetriacetic acid.
  • the above buffering agent is at least one of boric acid, borax, disodium hydrogen phosphate, sodium dihydrogen phosphate, citric acid, sodium citrate, and tromethamine (TRIS AMINO).
  • the above antimicrobial agents are Polyquaternium-1, polyhexamethylene biguanide ( P), polyaminopropyl biguanide (PAPB), and alexidine (Alexidine). And at least one of benzalkonium chloride, benzethonium chloride, cetylpyridinium chloride, and sorbic acid.
  • the method for preparing the care solution composition of the present invention is: putting the above components into water in order of weight percentage Dissolve, adjust the pH with NaOH and hydrochloric acid at 6.5-7.8, osmotic pressure at 260-340 mosm/Kg* 3 ⁇ 40, and sterilize the solution through a 0.22 ⁇ m pore size membrane filter.
  • the invention has the functions of storage, disinfection, cleaning, lubrication, moisturizing and anti-drying of the contact lens, which is effective for relieving dryness and soreness of the eye, reducing the mortality of the corneal epithelial cells in a dry environment, promoting the corneal epithelium and Repair of intradermal cells.
  • the killing rate of each composition against Escherichia coli, Pseudomonas aeruginosa and Staphylococcus aureus was more than 99.9%, and the killing rate against Candida albicans and Fusarium solani was greater than 90.0%.
  • a contact lens care composition containing a trehalose quaternary ammonium salt consisting of the following components by weight: trehalose quaternary ammonium salt content 0.001-2%, isotonicity adjusting agent content 0.01-2%, surfactant The content is 0.05-2%, the complexing agent content is 0.01-1%, the buffering agent content is 0.01-3%, the antimicrobial compound content is 0.00001-1%, and the water is 89-99.91899%.
  • isotonicity adjusting agent sodium chloride 0.36%
  • surfactant poloxamer 0.2%
  • complexing agent disodium edetate 0.1%
  • Buffer 0.64% boric acid
  • antimicrobial agent polyhexamethylene biguanide (PHMB) 0.000018%
  • water 96 ⁇ 569992% water 96 ⁇ 569992%.
  • the osmotic pressure is 260-340 mosm/Kg.
  • the osmotic pressure is 260-340 mosm/Kg.
  • the osmotic pressure is 260-340 mosm/Kg. * 0,
  • the solution was sterilized by a membrane filter of 0.22 ⁇ m pore size.
  • the contact lens is immersed in the composition during use or the above composition is added dropwise onto the contact lens or directly into the eye.
  • compositions of different schemes have been tested, indicating that the compositions containing different levels of trehalose quaternary ammonium salt have a moisturizing and anti-drying effect proportional to the amount used.
  • 001— 8 % ( Indeed, the preferred amount of trehalose quaternary ammonium salt in the composition of the present invention is 0.001 - 8 %.
  • the compositions of the present invention are suitable for disinfecting a soaked contact lens, and thus the preferred composition further comprises at least one antimicrobial agent. Since the contact lens of the composition is placed directly into the eye, the antimicrobial agent should be in good biocompatibility with the eye. In conventional contact lens soaking and disinfecting solutions, the antimicrobial is present in an amount effective to disinfect the contact lens, and the preferred amount of disinfection is to reduce the microbial load at a certain logarithmic level over time.
  • the bactericidal efficiency was tested for different compositions prepared according to the method, and the bactericidal efficiency tests were carried out on Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans, and Fusarium solani. As a result, each composition was against Escherichia coli.
  • the killing rate of Pseudomonas aeruginosa and Staphylococcus aureus is greater than 99.0%, and the killing rate of Candida albicans and Solanum blazei is greater than 90.0%.
  • the pH of the composition of the present invention is compatible with the eye, a suitable pH of about 6. 5 - 7. 8, preferably in the 6. 8-7.
  • the composition of the present invention is suitable for contact lens cleaning, disinfection, lubrication, moisturizing, storage, relieving dry eyes and soreness, effectively reducing the mortality of corneal cells in a dry environment, and promoting Repair of corneal epithelium and intradermal cells.
  • a complexing agent is added to the composition of the present invention, and the complexing agent is combined with heavy metal ions.
  • the composition of the present invention needs to be a solution which is isotonic with eye liquid.
  • the composition has an osmotic pressure of about 260 - 340 mosm / Kg * H 2 0 , more preferably an osmotic pressure of 280 - 320 mosm / Kg * H 2 0.
  • composition of the present invention comprises an anti-drying humectant, and the anti-drying humectant is a trehalose quaternary ammonium salt to ensure that the eye dryness and soreness are alleviated during use.
  • the quaternary ammonium salt of trehalose is very stable in chemical properties, and has great research progress in eye liquid preparation, dry eye treatment, corneal preservation and the like.
  • composition of the present invention comprises a surfactant, which may be a cationic surfactant, an anionic surfactant, a nonionic surfactant, an amphoteric surfactant, which surfactant is not irritated to the eye, and has good Eye compatibility, this substance primarily removes contaminants from contact lenses.
  • a surfactant which may be a cationic surfactant, an anionic surfactant, a nonionic surfactant, an amphoteric surfactant, which surfactant is not irritated to the eye, and has good Eye compatibility, this substance primarily removes contaminants from contact lenses.
  • the animal test of the present invention shows that the composition of the present invention is biocompatible, has no systemic toxicity and is irritating to animal conjunctiva and iris and corneal tissue.

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Abstract

A corneal contact lens nursing composition containing trehalose quaternary ammonium salt comprises the following components by weight percentage: trehalose quaternary ammonium salt of 0.001-2%, isotonic regulator of 0.01-2%, surfactant of 0.05-2%, complexing agent of 0.01-1%, buffer of 0.01-3%, antimicrobial compound of 0.00001-1% and water of 89-99.91899%. The composition is used for storing, sterilizing, cleaning, lubricating, and hydrating corneal contact lenses, has a drought resistant function, is effective for relieving dryness and stiffness of eyes, can reduce a death rate of corneal epithelial cells in a dry environment, and promotes repairing of corneal epithelial and endothelial cells. A kill rate of each composition to escherichia coli, pseudomonas aeruginosa and staphylococcus aureus is greater than 99.9%, and a kill rate to candida albicans and solanaceae fusarium is greater than 90.0%.

Description

含海藻糖季铵盐的角膜接触镜护理组合物  Contact lens care composition containing trehalose quaternary ammonium salt
技术领域 Technical field
本发明涉及一种角膜接触镜护理的组合物。具体的说， 该组合物是一种包括海 藻糖季铵盐的角膜接触镜护理组合物。  The present invention relates to a composition for contact lens care. In particular, the composition is a contact lens care composition comprising a trehalose quaternary ammonium salt.
背景技术 Background technique
角膜接触镜可分为硬性、半硬性和软性三种， 硬性角膜接触镜是由基本上不能 透过氧的聚甲基丙烯酸甲脂（PMMA)以及可渗透氧的硅氧烷和丙烯酸酯共聚物制成； 半硬性角膜接触镜则是由可渗透氧和可维持角膜表面正常呼吸的硅橡胶制成，需使 用专用的润湿溶液来保持润湿， 以满足舒适性和生理上的要求； 软性角膜接触镜， 最常用的是由聚甲基丙烯酸羟乙酯 (HEMA)制成的镜片。 HEMA分子是网状结构， 使 镜片具有吸附和释放低分子液体的功能， 镜片网状结构越松大， 含水量越高， 现在 已经有了十几种规格的软性角膜接触镜。  Contact lenses can be divided into hard, semi-rigid and soft. Hard contact lenses are made of polymethyl methacrylate (PMMA) which is substantially impermeable to oxygen and siloxane and acrylate copolymerizable with oxygen. The semi-rigid contact lens is made of silicone rubber that is permeable to oxygen and maintains normal breathing on the surface of the cornea. A special wetting solution is used to maintain wetting to meet comfort and physiological requirements; Soft contact lenses, the most commonly used are lenses made of polyhydroxyethyl methacrylate (HEMA). The HEMA molecule is a network structure, which makes the lens have the function of adsorbing and releasing low molecular liquid. The looser the lens network structure and the higher the water content, there are now more than a dozen soft contact lens lenses.
现有的软性角膜接触镜， 具有较高的亲水性， 由于角膜接触镜戴入眼睛， 其遮 在眼角膜前， 阻碍了角膜与空气的接触而造成角膜缺氧， 另外泪液除了湿润角膜、 结膜外， 还要湿润镜片， 造成泪液缺乏， 引起镜片配戴者的眼部干涩、 酸胀。  The existing soft contact lens has high hydrophilicity. Because the contact lens is worn in the eye, it is placed in front of the cornea, which hinders the contact of the cornea with the air and causes corneal hypoxia. In addition, the tear is wet except for the cornea. In addition to the conjunctiva, the lens is also wetted, resulting in a lack of tears, causing the lens wearer's eyes to dry up and sore.
海藻糖 ( ct -D-glucopyranosyl - a -D-glucopyra-noside) ， 是一种稳定的非还原性双糖， 由两个吡喃环葡萄糖分子与 1， 1-糖苷键连结而成。 由于海藻糖是由特殊双糖分子构成的非还原性糖， 性质非常稳定， 能够在高温、 高 寒、干燥失水等恶劣的条件下在细胞表面形成特殊的保护膜， 有效的保护生物分子 结构不被破坏， 从而维持生命体的生命过程和生物特征。 由于海藻糖具有保护生物 细胞和活性物质在干燥等不良环境下活性不受破坏的独特生物学性质，国外研究人 员正在积极研究海藻糖的衍生物， 并将其用于角膜接触镜护理组合物的可行性。 发明内容 本发明的目的是提供一种角膜接触镜护理组合物，该组合物是包含有等渗调整 剂、 缓冲剂、 络合剂、 海藻糖季铵盐、 表面活性剂、 抗微生物剂的水溶液， 用于角 膜接触镜镜片的贮存、 消毒、 清洁、 润滑、 保湿和镜片的再润湿。 使用时将角膜 接触镜保存在组合物中或在角膜接触镜上滴加上述组合物或直接滴入眼内。 Trehalose ( ct -D-glucopyranosyl - a -D-glucopyra-noside) is a stable non-reducing disaccharide composed of two pyranose glucose molecules linked to 1, 1-glycosidic bonds. Because trehalose is a non-reducing sugar composed of special disaccharide molecules, it is very stable and can form a special protective film on the cell surface under the harsh conditions of high temperature, cold, dryness and water loss, effectively protecting the biomolecular structure. Destroyed to maintain the life process and biological characteristics of the living body. Because trehalose has unique biological properties that protect biological cells and active substances from damage under adverse conditions such as drying, foreign researchers are actively studying trehalose derivatives and using them in contact lens care compositions. feasibility. Summary of the invention It is an object of the present invention to provide a contact lens care composition which is an aqueous solution comprising an isotonicity adjusting agent, a buffering agent, a complexing agent, a trehalose quaternary ammonium salt, a surfactant, and an antimicrobial agent. Storage, disinfection, cleaning, lubrication, moisturization and rewetting of the lens of the contact lens. The contact lens is stored in the composition at the time of use or the above composition is added dropwise onto the contact lens or directly into the eye.
本发明的技术方案是通过以下方式实现的：含海藻糖季铵盐的角膜接触镜护理 组合物， 按重量百分比， 由以下组分组成：  The technical solution of the present invention is achieved by a contact lens care composition containing a trehalose quaternary ammonium salt, which comprises, by weight percent, consisting of the following components:
海藻糖季铵盐为 0. 001— 2 %， 等渗调整剂为 0.01— 2%， 表面活性剂为 0. 05 —2% , 络合剂为 0. 01— 1%， 缓冲剂为 0. 01— 3%， 抗微生物化合物为 0. 00001— 1 %、 水 89-99. 91899 %。  The quaternary ammonium salt of the trehalose is 0. 001 - 2%, the isotonicity adjusting agent is 0.01 - 2%, the surfactant is 0. 05 - 2%, the complexing agent is 0.01-1%, and the buffering agent is 0. 01— 3%, the antimicrobial compound is 0. 00001—1%, and the water is 89-99. 91899%.
上述的等渗调整剂是氯化钠、 氯化钾、 氯化钙、 氯化镁、 葡萄糖的单糖、 丙二醇、 甘油、 山梨醇、 甘露醇中的至少一种。  The above isotonicity adjusting agent is at least one of sodium chloride, potassium chloride, calcium chloride, magnesium chloride, monosaccharide of glucose, propylene glycol, glycerin, sorbitol, and mannitol.
上述表面活性剂可以是泊洛沙姆（Poloxamer)、泊洛沙敏（Poloxamines)、 泰洛沙泊 （TyloXapol )、 聚山梨酯、 月桂酰谷氨酸钠、 月桂酰胺丙基羟磺基甜菜 碱中的至少一种。 The above surfactants may be Poloxamer, Poloxamines, Tylo Xa pol, polysorbate, sodium lauroyl glutamate, lauryl propyl hydroxy sulfoyl. At least one of betaine.
上述的络合剂是乙二胺四乙酸、 2-氨基 -2-甲基 -1-丙醇 （AMP— 95)、 N-十 二烷基乙二胺三乙酸中的至少一种。  The above complexing agent is at least one of ethylenediaminetetraacetic acid, 2-amino-2-methyl-1-propanol (AMP-95), and N-dodecylamethylenediaminetriacetic acid.
上述的缓冲剂是硼酸、 硼砂、 磷酸氢二钠、 磷酸二氢钠、 柠檬酸、 柠檬酸 钠、 氨丁三醇 （TRIS AMINO) 中的至少一种。  The above buffering agent is at least one of boric acid, borax, disodium hydrogen phosphate, sodium dihydrogen phosphate, citric acid, sodium citrate, and tromethamine (TRIS AMINO).
上述的抗微生物剂是聚季铵盐 -1 ( Polyquaternium-1 ) , 聚六亚甲基双胍 (polyhexamethylene biguanide , ΡΗΜΒ)、 聚氨基丙基双狐 (polyaminopropyl biguanide ， PAPB)、 阿来西定 （Alexidine )、 苯扎氯铵、 苄索氯铵、 西吡氯 铵、 山梨酸中的至少一种。  The above antimicrobial agents are Polyquaternium-1, polyhexamethylene biguanide ( P), polyaminopropyl biguanide (PAPB), and alexidine (Alexidine). And at least one of benzalkonium chloride, benzethonium chloride, cetylpyridinium chloride, and sorbic acid.
制备本发明的护理液组合物的方法为：按重量百分比将上述组分依次放入水中 溶解，用氢氧化钠和盐酸调整 pH在 6.5-7.8，渗透压在 260— 340 mosm/Kg* ¾0， 溶液经 0.22 μ m孔径的薄膜过滤器除菌过滤， 即可。 The method for preparing the care solution composition of the present invention is: putting the above components into water in order of weight percentage Dissolve, adjust the pH with NaOH and hydrochloric acid at 6.5-7.8, osmotic pressure at 260-340 mosm/Kg* 3⁄40, and sterilize the solution through a 0.22 μm pore size membrane filter.
本发明， 具有角膜接触镜镜片的贮存、 消毒、 清洁、 润滑、 保湿、 抗干燥功 能， 对缓解眼睛的干涩和酸胀非常有效， 降低角膜上皮细胞在干燥环境中的死亡 率， 促进角膜上皮和皮内细胞的修复。 各组合物对大肠杆菌、 绿脓杆菌、 金黄色葡 萄球菌的杀灭率大于 99.9%， 对白色念珠菌、茄科镰刀霉菌的杀灭率大于 90.0%。 具体实施方式  The invention has the functions of storage, disinfection, cleaning, lubrication, moisturizing and anti-drying of the contact lens, which is effective for relieving dryness and soreness of the eye, reducing the mortality of the corneal epithelial cells in a dry environment, promoting the corneal epithelium and Repair of intradermal cells. The killing rate of each composition against Escherichia coli, Pseudomonas aeruginosa and Staphylococcus aureus was more than 99.9%, and the killing rate against Candida albicans and Fusarium solani was greater than 90.0%. detailed description
含海藻糖季铵盐的角膜接触镜护理组合物， 按重量百分比， 由以下组分组成： 海藻糖季铵盐含量为 0.001— 2%，等渗调整剂含量为 0.01— 2%，表面活性剂 含量为 0.05— 2%， 络合剂含量为 0.01—1%， 缓冲剂含量为 0.01—3%， 抗微生 物化合物含量为 0.00001— 1%、 水 89-99.91899%。  A contact lens care composition containing a trehalose quaternary ammonium salt, consisting of the following components by weight: trehalose quaternary ammonium salt content 0.001-2%, isotonicity adjusting agent content 0.01-2%, surfactant The content is 0.05-2%, the complexing agent content is 0.01-1%, the buffering agent content is 0.01-3%, the antimicrobial compound content is 0.00001-1%, and the water is 89-99.91899%.
实施例 1: Example 1:
海藻糖季铵盐 2%， 等渗调整剂： 氯化钠 0.36%、氯化钾 0.04%， 表面活性剂： 泊洛沙姆 0.2%， 络合剂： 乙二胺四乙酸二钠 0.1%， 缓冲剂： 硼酸 0.64%、 硼砂 0.09%, 抗微生物剂： 聚六亚甲基双胍 (PHMB) 0.000018%、 水 96· 569992%。 实施例 2:  Trehalose quaternary ammonium salt 2%, isotonicity adjusting agent: sodium chloride 0.36%, potassium chloride 0.04%, surfactant: poloxamer 0.2%, complexing agent: disodium edetate 0.1%, Buffer: 0.64% boric acid, 0.09% borax, antimicrobial agent: polyhexamethylene biguanide (PHMB) 0.000018%, water 96·569992%. Example 2:
海藻糖季铵盐 1%， 等渗调整剂： 氯化钠 0.5%， 表面活性剂： 泊洛沙姆 0.2%， 络合剂： 乙二胺四乙酸二钠 0.1%， 缓冲剂： 硼酸 0.64%、 硼砂 0.09%， 抗微生 物剂： 聚六亚甲基双胍 0.000018%, 水 97.46009%。  Trehalose quaternary ammonium salt 1%, isotonicity adjusting agent: sodium chloride 0.5%, surfactant: poloxamer 0.2%, complexing agent: disodium edetate 0.1%, buffer: boric acid 0.64% Borax 0.09%, antimicrobial agent: polyhexamethylene biguanide 0.00018%, water 97.46009%.
实施例 3: Example 3:
海藻糖季铵盐 0.5%， 等渗调整剂： 氯化钠 0.6%， 表面活性剂： 月桂酰谷氨酸 钠 0. 15%, 络合剂： 乙二胺四乙酸二钠 0.1%， 缓冲剂： 磷酸氢二钠 0.17%、 磷 酸二氢钠 0.03%， 抗微生物剂： 聚六亚甲基双胍 0.00001 %、 阿来西定 (Alexidine) 0.00004%, 水 98· 45%。 Trehalose quaternary ammonium salt 0.5%, isotonicity adjusting agent: sodium chloride 0.6%, surfactant: sodium lauroyl glutamate 0. 15%, complexing agent: disodium edetate 0.1%, buffer : disodium hydrogen phosphate 0.17%, sodium dihydrogen phosphate 0.03%, antimicrobial agent: polyhexamethylene biguanide 0.00001%, alexidine (Alexidine) 0.00004%, water 98. 45%.
实施例 4: Example 4:
海藻糖季铵盐 0.5%、 等渗调整剂： 氯化钠 0.6%， 表面活性剂： 月桂酰胺丙基 羟磺基甜菜碱 0.3%、 络合剂： 乙二胺四乙酸二钠 0.1%、 缓冲剂： 磷酸氢二钠 0.17%、 磷酸二氢钠 0.03%， 抗微生物剂： 聚六亚甲基双胍 0.000015%、 西吡 氯铵 0.0002%, 水 98.3  Trehalose quaternary ammonium salt 0.5%, isotonicity adjusting agent: sodium chloride 0.6%, surfactant: lauric acid propyl hydroxy sulfobetaine 0.3%, complexing agent: disodium edetate 0.1%, buffer Agent: disodium hydrogen phosphate 0.17%, sodium dihydrogen phosphate 0.03%, antimicrobial agent: polyhexamethylene biguanide 0.000015%, cetylpyridinium chloride 0.0002%, water 98.3
实施例 5: Example 5
海藻糖季铵盐 0.8%， 等渗调整剂： 氯化钠 0.6%， 表面活性剂： 月桂酰胺丙基 羟磺基甜菜碱 0.3%， 络合剂： 乙二胺四乙酸二钠 0.1%， 缓冲剂： 磷酸氢二钠 0.17%、 磷酸二氢钠 0.03%， 抗微生物剂： 聚六亚甲基双胍 0.000015%、 西吡 氯铵 0.0002%, 水 98.0%。  Trehalose quaternary ammonium salt 0.8%, isotonicity adjusting agent: sodium chloride 0.6%, surfactant: lauric amido propyl hydroxy sulfobetaine 0.3%, complexing agent: disodium edetate 0.1%, buffer Agent: disodium hydrogen phosphate 0.17%, sodium dihydrogen phosphate 0.03%, antimicrobial agent: polyhexamethylene biguanide 0.000015%, cetylpyridinium chloride 0.0002%, water 98.0%.
实施例 6: Example 6:
海藻糖季铵盐 0.8%， 等渗调整剂： 氯化钠 0.2%， 络合剂： 乙二胺四乙酸二 钠 0.1%， 表面活性剂： 泊洛沙姆 0.2%、 缓冲剂： 硼酸 1.6%、 硼砂 0.09%、 柠 檬酸钠 0.4%、 氨丁三醇 0.6%， 抗微生物剂： 聚六亚甲基双胍 0.000015%、 西吡 氯铵 0.0002%, 水 96.01%。  Trehalose quaternary ammonium salt 0.8%, isotonicity adjusting agent: sodium chloride 0.2%, complexing agent: disodium edetate 0.1%, surfactant: poloxamer 0.2%, buffer: boric acid 1.6% Borax 0.09%, sodium citrate 0.4%, tromethamine 0.6%, antimicrobial agent: polyhexamethylene biguanide 0.000015%, cetylpyridinium chloride 0.0002%, water 96.01%.
实施例 7: Example 7
海藻糖季铵盐 0.3%， 等渗调整剂： 氯化钠 0.3%， 表面活性剂： 月桂酰胺丙基 羟磺基甜菜碱 0.3%,络合剂：乙二胺四乙酸二钠 0.1%，缓冲剂：氨丁三醇 0.3%、 磷酸二氢钠 0.5%， 抗微生物剂： 聚六亚甲基双胍 0.000012%、 聚季铵盐 Trehalose quaternary ammonium salt 0.3%, isotonicity adjusting agent: sodium chloride 0.3%, surfactant: lauramide propyl hydroxy sulfobetaine 0.3%, complexing agent: disodium edetate 0.1%, buffer Agent: tromethamine 0.3%, sodium dihydrogen phosphate 0.5%, antimicrobial agent: polyhexamethylene biguanide 0.00012%, polyquaternium
(Polyquaternium-1 ) 0.001%, 纯水 98.2%。 (Polyquaternium-1) 0.001%, pure water 98.2%.
实施例 8: Example 8
海藻糖季铵盐 0.8%， 等渗调整剂： 氯化钠 0.2%， 表面活性剂： 月桂酰胺丙基 羟磺基甜菜碱 0.3%,络合剂：乙二胺四乙酸二钠 0.1%，缓冲剂：氨丁三醇 0.3%、 硼酸 1.2%， 抗微生物剂： 聚六亚甲基双胍 0.000015%、 西吡氯铵 0.0002%， 纯 水 97· 1 %。 Trehalose quaternary ammonium salt 0.8%, isotonicity adjusting agent: sodium chloride 0.2%, surfactant: lauramide propyl Hydroxysulfobetaine 0.3%, complexing agent: disodium edetate 0.1%, buffer: tromethamine 0.3%, boric acid 1.2%, antimicrobial agent: polyhexamethylene biguanide 0.000015%, west The pyridinium chloride is 0.0002%, and the pure water is 97. 1%.
实施例 9: Example 9
海藻糖季铵盐 0.5%， 等渗调整剂： 氯化钠 0.2%， 表面活性剂： 月桂酰胺丙基 羟磺基甜菜碱 0.3%,络合剂：乙二胺四乙酸二钠 0.1%，缓冲剂：氨丁三醇 0.3%、 硼酸 1.2%， 抗微生物剂： 聚六亚甲基双胍 0.000015%、 西吡氯铵 0.00002%， 纯水 97.4%。  Trehalose quaternary ammonium salt 0.5%, isotonicity adjusting agent: sodium chloride 0.2%, surfactant: lauramide propyl hydroxysultaine 0.3%, complexing agent: disodium edetate 0.1%, buffer Agent: tromethamine 0.3%, boric acid 1.2%, antimicrobial agent: polyhexamethylene biguanide 0.000015%, cetylpyridinium chloride 0.00002%, pure water 97.4%.
实施例 10: Example 10
海藻糖季铵盐 0.5%， 等渗调整剂： 氯化钠 0.6%， 表面活性剂： 月桂酰胺丙基 羟磺基甜菜碱 0.3%， 络合剂： 乙二胺四乙酸二钠 0.1%， 缓冲剂： 硼酸 0.64%、 硼砂 0.09%， 抗微生物剂： 聚六亚甲基双胍 0.000015%、 西吡氯铵 0.00003%， 纯水 97.77%。  Trehalose quaternary ammonium salt 0.5%, isotonicity adjusting agent: sodium chloride 0.6%, surfactant: lauramide propyl hydroxy sulfobetaine 0.3%, complexing agent: disodium edetate 0.1%, buffer Agent: boric acid 0.64%, borax 0.09%, antimicrobial agent: polyhexamethylene biguanide 0.000015%, cetylpyridinium chloride 0.00003%, pure water 97.77%.
实施例 11: Example 11
海藻糖季铵盐 0.8%， 等渗调整剂： 氯化钠 0.4%， 表面活性剂： 月桂酰胺丙基 羟磺基甜菜碱 0.3%， 络合剂： N-十二烷基乙二胺三乙酸 0.2%， 缓冲剂： 氨丁三 醇 0.2%、 磷酸二氢钠 0.4%， 抗微生物剂： 聚六亚甲基双胍 0.000015%、 西吡氯 铵 0.00003%, 纯水 97.7%o  Trehalose quaternary ammonium salt 0.8%, isotonicity adjusting agent: sodium chloride 0.4%, surfactant: lauric acid propyl hydroxy sulfobetaine 0.3%, complexing agent: N-dodecyl ethylenediamine triacetic acid 0.2%, Buffer: tromethamine 0.2%, sodium dihydrogen phosphate 0.4%, antimicrobial agent: polyhexamethylene biguanide 0.000015%, cetylpyridinium chloride 0.00003%, pure water 97.7% o
实施例 12: Example 12:
海藻糖季铵盐 0.3%， 等渗调整剂： 氯化钠 0.4%， 表面活性剂： 月桂酰胺丙基 羟磺基甜菜碱 0.3%， 络合剂： N-十二烷基乙二胺三乙酸 0.2%， 缓冲剂： 氨丁三 醇 0.2%、 磷酸二氢钠 0.4%， 抗微生物剂： 聚六亚甲基双胍 0.000015%、 西吡氯 铵 0.0002%, 纯水 98.2%o 制备本发明的护理液组合物的方法依次为：将上述组合物放入纯水中溶解， 用 氢氧化钠和盐酸调整 pH在 6. 5— 7. 8， 渗透压在 260— 340 mosm/Kg* 0， 溶液 经 0. 22 μ πι孔径的薄膜过滤器除菌过滤。 使用时将角膜接触镜浸泡在组合物 中或在角膜接触镜上滴加上述组合物或直接滴入眼内。 Trehalose quaternary ammonium salt 0.3%, isotonicity adjusting agent: sodium chloride 0.4%, surfactant: lauric acid propyl hydroxy sulfobetaine 0.3%, complexing agent: N-dodecyl ethylenediamine triacetic acid 0.2%, Buffer: tromethamine 0.2%, sodium dihydrogen phosphate 0.4%, antimicrobial agent: polyhexamethylene biguanide 0.000015%, cetylpyridinium chloride 0.0002%, pure water 98.2% o The osmotic pressure is 260-340 mosm/Kg. The osmotic pressure is 260-340 mosm/Kg. The osmotic pressure is 260-340 mosm/Kg. * 0, The solution was sterilized by a membrane filter of 0.22 μm pore size. The contact lens is immersed in the composition during use or the above composition is added dropwise onto the contact lens or directly into the eye.
不同方案的组合物经过试用， 表明使用不同含量海藻糖季铵盐的组合物， 保湿润滑及抗干燥效果与使用量成正比， 海藻糖季铵盐量越多， 保湿润滑及 抗干燥效果越强， 本发明组合物中海藻糖季铵盐优选量为 0. 001— 8 % (确。  The compositions of different schemes have been tested, indicating that the compositions containing different levels of trehalose quaternary ammonium salt have a moisturizing and anti-drying effect proportional to the amount used. The more the quaternary ammonium salt of trehalose, the stronger the moisturizing and anti-drying effect. 001— 8 % ( Indeed, the preferred amount of trehalose quaternary ammonium salt in the composition of the present invention is 0.001 - 8 %.
根据不同的优选实施方案， 本发明组合物适用于将浸泡的隐形眼镜进行 消毒， 因此该优选组合物中还包含至少一种抗微生物剂。 由于该组合物护理 的隐形眼镜直接放入眼睛， 因此该抗微生物剂应是与眼睛具有良好生物相容 性。 在常规的隐形眼镜浸泡和消毒溶液中， 抗微生物以有效消毒隐形眼镜的 量而存在， 优选的消毒量是在一定时间以一定对数级降低微生物负载量。按实 施方法制备的不同组合物， 测试杀菌效率， 各实施对大肠杆菌、 绿脓杆菌、 金黄色 葡萄球菌和白色念珠菌、 茄科镰刀霉菌的杀菌效率试验， 其结果， 各组合物对大肠 杆菌、 绿脓杆菌、 金黄色葡萄球菌的杀灭率大于 99. 9 %， 对白色念珠菌、 茄科镰 刀霉菌的杀灭率大于 90. 0 %。  According to various preferred embodiments, the compositions of the present invention are suitable for disinfecting a soaked contact lens, and thus the preferred composition further comprises at least one antimicrobial agent. Since the contact lens of the composition is placed directly into the eye, the antimicrobial agent should be in good biocompatibility with the eye. In conventional contact lens soaking and disinfecting solutions, the antimicrobial is present in an amount effective to disinfect the contact lens, and the preferred amount of disinfection is to reduce the microbial load at a certain logarithmic level over time. The bactericidal efficiency was tested for different compositions prepared according to the method, and the bactericidal efficiency tests were carried out on Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans, and Fusarium solani. As a result, each composition was against Escherichia coli. The killing rate of Pseudomonas aeruginosa and Staphylococcus aureus is greater than 99.0%, and the killing rate of Candida albicans and Solanum blazei is greater than 90.0%.
本发明的组合物的 pH值需与眼睛相容， 适合的 pH值约为 6. 5— 7. 8， 优 选的在 6. 8-7. 5。  5。 The pH of the composition of the present invention is compatible with the eye, a suitable pH of about 6. 5 - 7. 8, preferably in the 6. 8-7.
根据不同的优选实施方案， 本发明组合物适用于角膜接触镜清洁、 消毒、 润滑、 保湿、 贮存， 缓解眼部干涩、 酸胀， 有效地降低角膜上眼细胞在干燥环境 中的死亡率， 促进角膜上皮和皮内细胞的修复。  According to various preferred embodiments, the composition of the present invention is suitable for contact lens cleaning, disinfection, lubrication, moisturizing, storage, relieving dry eyes and soreness, effectively reducing the mortality of corneal cells in a dry environment, and promoting Repair of corneal epithelium and intradermal cells.
为保持该组合物的稳定性， 本发明的组合物中添加了络合剂， 络合剂与 重金属离子结合。 本发明的组合物需是一个与眼液等渗的溶液， 优选的该组合物的渗透压 约为 260— 340mosm/Kg* H20， 更优选的渗透压为 280-320 mosm/Kg* H20。 To maintain the stability of the composition, a complexing agent is added to the composition of the present invention, and the complexing agent is combined with heavy metal ions. The composition of the present invention needs to be a solution which is isotonic with eye liquid. Preferably, the composition has an osmotic pressure of about 260 - 340 mosm / Kg * H 2 0 , more preferably an osmotic pressure of 280 - 320 mosm / Kg * H 2 0.
本发明的组合物包含抗干燥保湿剂， 抗干燥保湿剂为海藻糖季铵盐， 以 保证在使用时缓解眼部干涩、 酸胀。 海藻糖季铵盐化学性质十分稳定， 在眼液制 剂、 干眼症治疗、 角膜保存等方面有较大的研究进展。  The composition of the present invention comprises an anti-drying humectant, and the anti-drying humectant is a trehalose quaternary ammonium salt to ensure that the eye dryness and soreness are alleviated during use. The quaternary ammonium salt of trehalose is very stable in chemical properties, and has great research progress in eye liquid preparation, dry eye treatment, corneal preservation and the like.
本发明的组合物包含表面活性剂， 该组份可以是阳离子表面活性剂、 阴 离子表面活性剂、 非离子表面活性剂、 两性表面活性剂， 该表面活性剂需与 眼睛没有剌激， 具有良好与眼睛相容性， 该物质主要清除隐形眼镜上的污染 物。  The composition of the present invention comprises a surfactant, which may be a cationic surfactant, an anionic surfactant, a nonionic surfactant, an amphoteric surfactant, which surfactant is not irritated to the eye, and has good Eye compatibility, this substance primarily removes contaminants from contact lenses.
本发明经过动物试验表明， 本发明的组合物生物相容性好， 无全身毒性 反应和对动物结膜和虹膜及角膜组织的剌激性。  The animal test of the present invention shows that the composition of the present invention is biocompatible, has no systemic toxicity and is irritating to animal conjunctiva and iris and corneal tissue.

Claims

O 2014/114124 权 禾 |J 要 求 书 PCT/CN2013/086855 O 2014/114124 Quanhe|J Letter of Request PCT/CN2013/086855
1、 含海藻糖季铵盐的角膜接触镜护理组合物， 按重量百分比， 其特征在于： 由以 下组分组成： 海藻糖季铵盐为 0.001— 2%， 等渗调整剂为 0.01— 2%， 表面活性剂 为 0.05—2%， 络合剂为 0.01—1%， 缓冲剂为 0.01—3%， 抗微生物化合物为 0.00001—1%、 水 89-99.91899%; 1. A contact lens care composition containing trehalose quaternary ammonium salt, characterized by weight percentage: consisting of the following components: 0.001-2% trehalose quaternary ammonium salt, 0.01-2% isotonicity adjusting agent , surfactant is 0.05-2%, complexing agent is 0.01-1%, buffer is 0.01-3%, antimicrobial compound is 0.00001-1%, water 89-99.91899%;
上述的等渗调整剂是氯化钠、 氯化钾、 氯化钙、 氯化镁、 葡萄糖的单糖、 丙 二醇、 甘油、 山梨醇、 甘露醇中的至少一种； 表面活性剂可以是泊洛沙姆 (Poloxamer)、 泊洛沙敏 （Poloxamines)、 泰洛沙泊 （Tyloxapol)、 聚山梨 酯、 月桂酰谷氨酸钠、 月桂酰胺丙基羟磺基甜菜碱中的至少一种； The above-mentioned isotonic adjuster is at least one of sodium chloride, potassium chloride, calcium chloride, magnesium chloride, glucose monosaccharide, propylene glycol, glycerol, sorbitol, and mannitol; the surfactant can be a poloxamer At least one of (Poloxamer), Poloxamines, Tyloxapol, polysorbate, sodium lauroyl glutamate, and laurolamidopropyl hydroxysulfobetaine;
上述的络合剂是乙二胺四乙酸、 2-氨基 -2-甲基 -1-丙醇 （AMP— 95)、 N-十二烷 基乙二胺三乙酸中的至少一种； The above-mentioned complexing agent is at least one of ethylenediaminetetraacetic acid, 2-amino-2-methyl-1-propanol (AMP-95), and N-dodecylethylenediaminetriacetic acid;
上述的缓冲剂是硼酸、 硼砂、 磷酸氢二钠、 磷酸二氢钠、 柠檬酸、 柠檬酸钠、 氨丁三醇 （TRIS AMINO) 中的至少一种； The above buffering agent is at least one of boric acid, borax, disodium hydrogen phosphate, sodium dihydrogen phosphate, citric acid, sodium citrate, and tromethamine (TRIS AMINO);
上述的抗微生物剂是聚季铵盐 -1 (Polyquaternium-1), 聚六亚甲基双胍 (polyhexamethylene biguanide , ΡΗΜΒ)、 聚氨基丙基双狐 (polyaminopropyl biguanide， PAPB)、 阿来西定 （Alexidine)、 苯扎氯铵、 苄索氯铵、 西吡氯 铵、 山梨酸中的至少一种。 The above-mentioned antimicrobial agents are polyquaternium-1 (Polyquaternium-1), polyhexamethylene biguanide (PHMB), polyaminopropyl biguanide (PAPB), Alexidine ), at least one of benzalkonium chloride, benzethonium chloride, cetylpyridinium chloride, and sorbic acid.
2、 一种制备权利要求 1所述的角膜接触镜护理组合物的方法： 其特征在于： 按重 量百分比将海藻糖季铵盐为 0.001— 2%，等渗调整剂为 0.01— 2%，表面活性剂为 0.05— 2%，络合剂为 0.01—1%,缓冲剂为 0.01—3%,抗微生物化合物为 0.00001 — 1% 水 89-99.91899%； 依次放入水中溶解， 用氢氧化钠和盐酸调整 pH在 6.5 -7.8, 渗透压在 260— 340 mosm/Kg*H20， 溶液经 0.22 μ m孔径的薄膜过滤器 除菌过滤， 即可。 2. A method for preparing the contact lens care composition according to claim 1: It is characterized in that: the trehalose quaternary ammonium salt is 0.001-2%, the isotonicity adjusting agent is 0.01-2% by weight, and the surface The active agent is 0.05-2%, the complexing agent is 0.01-1%, the buffer is 0.01-3%, the antimicrobial compound is 0.00001-1% water 89-99.91899%; put it into water to dissolve in turn, use sodium hydroxide and Adjust the pH to 6.5-7.8 with hydrochloric acid and the osmotic pressure to 260-340 mosm/Kg*H 2 0. The solution is sterilized and filtered through a membrane filter with a pore size of 0.22 μm.
PCT/CN2013/086855 2013-01-23 2013-11-11 Corneal contact lens nursing composition containing trehalose quaternary ammonium salt WO2014114124A1 (en)

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