TW201130524A - Compositions and methods for disinfecting contact lenses - Google Patents

Compositions and methods for disinfecting contact lenses Download PDF

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TW201130524A
TW201130524A TW99135094A TW99135094A TW201130524A TW 201130524 A TW201130524 A TW 201130524A TW 99135094 A TW99135094 A TW 99135094A TW 99135094 A TW99135094 A TW 99135094A TW 201130524 A TW201130524 A TW 201130524A
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solution
contact lens
copolymer
hydrogen peroxide
homopolymer
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TW99135094A
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Chinese (zh)
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TWI486182B (en
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Kasey Jon Minick
Manal M Gabriel
Leroy Wainaina Muya
Walter Lee Nash
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Novartis Ag
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Abstract

The present invention relates to a hydrogen peroxide solution for disinfecting contact lenses. The hydrogen peroxide solution contains an effective amount of a homopolymer or copolymer of vinylpyrrolidone to an increased residual hydrogen peroxide concentration when in the presence of a catalyst, thereby prolonging the effective life of the solution and providing greater comfort to the weather.

Description

201130524 六、發明說明: 【發明所屬之技術領域】 本發明大體上係關於用於醫療裝置之消毒及 在一較佳實施例中,本發明係關於用於同時清潔及消毒隱 形眼鏡之組合物、方法及物件。 【先前技術】 隱形眼鏡所使用之消毒溶液係技藝中所熟知及該等眼鏡 之使用包括每日消毒處理。可撓或軟性隱形眼鏡一般係自 親2聚合物製成,及此等眼鏡之經基吸引及保持塑料中 貫質買的水,從而造成在清潔及殺菌期間之困難。 隱形眼鏡消毒之兩種最常見方法係多功能溶液(其中使 用單-溶液於消毒、清潔及儲存眼鏡)及以過氧化氣為主 的系統。多功能溶液包含防腐劑但以過氧化氫為主之系統 不含防腐劑。過氧化氫係有效的微生物消毒劑,其藉由氧 化作周殺死病原體。過氧化氫系、统,特定言之3;氧化 氫溶液,係以對於所有類型的日_及長戴型水凝膠眼鏡 之首選消毒劑出現。其普遍性之主要原因係其可快速殺死 微生物污染物及其無殘餘物之特性。在過氧化氫消毒眼鏡 之後,其可轉化成與眼生理學相容之無害及天㈣副產 物’諸如〇2及水。參見Krezanoski等人,「of加 American Opt〇metric Ass〇ciati〇n」,第 59卷,第 3冊,第6 193 至 197 頁(1988)。 -般而言,過氧化氫系統包括含過氧化氫之消毒溶液, 將待消毒之隱形眼鏡置於其中及使其保持—段必需的時 I51304.doc 201130524 間。該過氧化氫可⑴將細菌中的氣化物氧化成次氣酸鹽或 (2)分解成初生氧及經基,藉此提供殺菌作用。繼該段必需 的時間之後,(例如)用鉑觸媒進行過氧化氫之有目的地去 活化。繼去活化之後,可將隱形眼鏡重新配戴至眼睛上。 可獲得大量關於過氧化氫隱形眼鏡消毒系統之專利文 獻。參照以下:201130524 VI. INSTRUCTIONS OF THE INVENTION: TECHNICAL FIELD OF THE INVENTION The present invention generally relates to sterilization for medical devices and, in a preferred embodiment, the present invention relates to compositions for simultaneously cleaning and disinfecting contact lenses, Methods and objects. [Prior Art] Disinfection solutions used in contact lenses are well known in the art and the use of such glasses includes daily disinfection treatment. Flexible or soft contact lenses are typically made from self-polymerizing 2 polymers, and the bases of such glasses attract and retain the water that is commercially available in the plastic, thereby causing difficulties during cleaning and sterilization. The two most common methods of disinfecting contact lenses are multi-functional solutions (where single-solutions are used to disinfect, clean, and store glasses) and peroxygen-based systems. The multi-functional solution contains preservatives but the system based on hydrogen peroxide contains no preservatives. Hydrogen peroxide is an effective microbial disinfectant that kills pathogens by oxidation. Hydrogen peroxide system, specifically 3; hydrogen peroxide solution, appears as the preferred disinfectant for all types of day-and long-wearing hydrogel lenses. The main reason for its universality is its ability to quickly kill microbial contaminants and their residue-free properties. After sterilizing the lens with hydrogen peroxide, it can be converted into harmless and ocular (four) by-products such as 〇2 and water that are compatible with ocular physiology. See Krezanoski et al., "of Plus American Opt〇metric Ass〇ciati〇n", Vol. 59, Vol. 3, pp. 6193-197 (1988). In general, the hydrogen peroxide system comprises a disinfecting solution containing hydrogen peroxide, which is placed between the contact lens to be sterilized and held for the period of time I51304.doc 201130524. The hydrogen peroxide can (1) oxidize the vapor in the bacteria to a hypoxanthate or (2) decompose into nascent oxygen and a meridional group, thereby providing a bactericidal action. Following the necessary time of the stage, the hydrogen peroxide is purposefully deactivated, for example, with a platinum catalyst. After deactivation, the contact lens can be re-applied to the eye. A large number of patents are available for the hydrogen peroxide contact lens disinfection system. Refer to the following:

Wintenon等人之美國專利第5,523,〇12號教示添加表面活 性劑至過氧化物消毒溶液中會增強該溶液之消毒特性。然 而,所揭示的界面活性劑全部係以〇1%以上的量存在及 由於過量的料形成而與通常用於將眼鏡消毒系統中之過 氧化氫去活化之鉑觸媒盤不相容。 等人之美國專利第5,746,972號教示用於消毒及清潔 隱形眼鏡之組合物及方法’其包括含過氧化氫之液體介質 二具有至少70重量%聚環氧乙烧之固體環氧乙院/環氧丙烧 嵌段共聚物界面活性劑。該過氧化氫係藉由釋放入溶液中 之過氧化氫酶而降解及引起「泡珠量減少」。^,當使 用銘觸媒於分解過氧化氫時,該等組合物會引起過量的泡 味形成。 -個隱形眼鏡工業中之長期以來的需求係提供一種便利 但,消毒效力之隱形眼鏡護理溶液。存在兩種類型的過氧 化氫隱形眼鏡消毒溶液及其等係:—步驟系統及兩步驟系 X兩m统包括:首先’將隱形眼鏡浸泡在具有 〇.6%至3%濃度之過氧化氫溶液中—段時間,在該段時間 内’過氧化氫濃度係幾乎恒定,及其次,將隱形眼鏡浸泡 151304.doc 201130524 入 催化=以中和殘留在隱形眼鏡中之過氧化氣+ 步驟系統已括將隱形眼鏡在設置耗銘盤之 盒中之约3%過氧化氯溶液中浸泡約6小時。:浸= 之後,殘餘過氧化氫之濃度減少 ^ 、 "、ppm,更佳為 —將該隱形眼鏡戴至眼睛上。通常,兩步射 統具有比―步驟系、统更高的料效力,因為前者在消毒處 理期間具有更高的過氧化氯濃度。然而,-步驟系統比兩 步驟糸統更方便且在隱形眼鏡使㈣中大受歡迎。 主因此,提供克服-或多個此等問題之過氧化物隱形眼鏡 消毋·〉谷液將有利。 【發明内容】 在〜樣中’本發明提供—種用於消毒隱形眼鏡之隱形 眼鏡遵理錢,其包括有效消毒量的過氧化氫及乙稀基吼 μ酮之均聚物或共聚物,其中該乙稀基料㈣之均聚 物或共聚物係以足以提供相對於在存在相㈣媒下不含乙 料料相之均聚物或共聚物之具有相同組合物之對照 /合液使蜮餘過氧化氳濃度增加至少20%之量存在;其量 足以提ί、組合物約6.〇至8.〇的阳的一或多種緩衝劑,其中 該沮σ物具有約2〇〇至約45〇 m〇sm/kg的滲透壓及在乃它下 咼至5.0厘泊的黏度。 在另態樣中,本發明提供一種消毒隱形眼鏡之方法, 其包括以下步驟: (a)使隱形眼鏡與含以下組份的水溶液接觸··有效消毒量 的k氧化氫及乙烯基°比°各啶酮之均聚物或共聚物,其 151304.doc 201130524 中該乙稀基D比17各啶_之均聚物或共聚物係以相對於在 相同觸媒存在下不含乙烯基〇比咯啶酮之均聚物或共聚 物之具有相同組合物之對照溶液’足以提供使殘餘過 氧化氫濃度增加至少20%之量存在;及其量足以提供 組合物約6.0至8.(H〇pH之一或多種緩衝劑,其中該組 °物具有約200至約mo m〇sm/kg之滲透壓及在25。〇下 兩至約5.0厘泊之黏度;及 (b)藉由將過氧化氫催化中和成水及氧氣來中和該過氧化 氫。 本發明之此等及其他態樣將自目前較佳實施例之以下描 述變得明瞭。詳細描述僅閣釋本發明且並不限制本發明之 範嗜’本發明之料係由隨附中請專利範圍及其等效物所 界定。如熟悉此項技術者所顯而易見,可在不偏離本揭示 案之新賴概念的主旨及料下,進行本發明之許多變換及 修飾。 【實施方式】 除非另収義,否則用於文中之所有技術及科學術語且 有通常如本發明之—般技術者所瞭解之相同意義。—般而 言,用於文中之名稱及實驗室步驟係眾所周知及技 用的。可將習知方法用於此等㈣,諸如彼等提供於技藏 中及各種—般參考文獻中者。當以單數形式提供-術^ :,本發明者亦涵蓋該術語之複數形式。用於文中之名稱 及以:所述之實驗室步驟係眾所周知及常用於技藝中。如 本揭帛王文所用除非另外指出,否則以下術語應理解 151304.doc 201130524 為具有以下意義。 本發明係關於-種包含過氧化氫及乙稀基㈣㈣之均 聚物或共聚物之溶液’其中該乙稀基料咬酮之均聚物或 共聚物係以相對於在相同觸媒存在下不含乙稀基料咬嗣 之均聚物或共聚物之具有相同組合物之對照溶液,足以提 供至少20。/。之增加殘餘過氧化氫濃度之量存在;;及一種 使用该溶液來消毒及/或保存隱形眼鏡,尤其係軟性隱形 〇 眼鏡之方法。本發明消毒溶液對廣範圍的微生物有效,其 包括(但不限於)金黃色葡萄球菌⑸叩知 綠腺桿菌、黏質沙雷氏菌 (Serratia marcescens、、白色念洙蛰、反職 皮條抱菌(Fusarium solani)。 消毒溶液一般係定義為一種包含一或多種活性成分(例 如,抗菌劑及/或防腐劑)之隱形眼鏡護理產品,該等成分 之濃度係足以在建議的最低浸泡時間内殺滅隱形眼鏡表面 〇 上的有害微生物。該建議的最低浸泡時間係包括在消毒溶 液之使用包裝說明書中。本發明溶液被認可為護理隱形眼 鏡之新穎物。 術语「軟性眼鏡」意指一種具有一定比例的親水性重複 單7G ’以使得該眼鏡之含水量在使用期間為至少2〇重量〇/〇 之眼鏡。術語「軟性隱形眼鏡」如文中所用一般係指彼等 在很小力量下可容易彎曲之隱形眼鏡。通常,軟性隱形眼 鏡係自具有特定比例的衍生自曱基丙烯酸羥乙酯及/或通 常利用交聯劑交聯之其他親水性單體之重複單元之聚合物 151304.doc 201130524 調配成。相對地’習知之「硬性隱形眼鏡」(其僅覆蓋眼 睛角膜之一部份)通常係由利用乙二醇二甲基丙稀酸醋交 聯之聚(甲基丙烯酸曱酯)或類似物組成,及習知之硬性透 氣性隱形眼鏡(RGP)通常係由產生更透氧性材料之含^夕單 體組成。 術語「眼科學安全」就隱形眼鏡溶液而言意指經該溶液 處理之隱形眼鏡對於不沖洗而直接放在眼睛上而言係安全 的,即該溶液對於透過隱形眼鏡每日與眼睛接觸而言係安 全的且相當舒適。眼科學安全溶液具有與眼睛相容i滲性 及PH且包括根據國際ISO標準及u,s. FDA法規係無細胞毒 性之物質及其量。 溶液 術邊「與眼睛相容」意指—種可與眼睛密切接觸报長一 ,時間’但不明顯損害眼睛及不會引起使用者明顯不適之 :語「消毒溶液」意指包含一或多種殺微生物化合物 之/谷液,其可有效地減少或 之-系列料“… 存在於隱形眼鏡上 '、"物,八可藉由用該等微生物之特定接種物击丨 激溶液或浸泡於該溶液後之隱形眼鏡而测試。如文中所用 之術語「消喜、玄、冷并π 1 乂 Τ所用 該消毒溶、夜可另外 溶液亦可用於儲存溶液或 “〜夜可另相於隱㈣鏡之每日 之可能性。 /r /无及儲存 術語「清潔 於待清潔物件 將經鬆脫固持 」意指該溶液包含-或多種其濃度足以们 = :眼鏡沉積物及其他污染物鬆脫』 …貝移除的活性成分。雖然對於本養 151304.do, 201130524 明並非必需,但使用者可能希望a 一溶液手動搓揉硭浐U 00才曰处理(例如’用 觸之辅助5 1用—攪動該溶液使其與眼鏡接 溶液。助讀(例如’-機械清潔輔助物)來使用本發明之 適用於清潔、化學消毒、儲 鏡)之溶液在文中稱為「多 /件(诸如隱形眼 L π. '合液」。該等溶液可Α「岌 工I谷液系統」或「多功能溶液包裝」之 Ο Ο 功能溶液、系統或包裝之步驟稱為「 ° :。使用^ 多功能溶液並不排除以下可能性::I ’毒方案」。 學消毒劑戋i t s '、二配戴者,例如對化 戴上==劑特別敏感之配戴者,可能偏好在 \ 則用另一溶液(例如無菌生理食鹽水)沖… 潤隱形眼鏡。術語「多功能、、容# * ㈠冲洗或濕 未每曰…… 」亦不排除以下可能性: (例如酵素清潔劑)通常係每週使用=白貝之補充清潔劑 如文中所用之聚合材料之「分子量人」,除非另外 出或除非測試條件另外指出,否則係指數量平均分子量。曰 如文中所用t增加的殘餘過氧化氫濃度J係指相對於 相同觸媒存在下不含乙婦基。比㈣酮之均聚物或共聚物 :具有相同組合物之對照溶液之增加的殘餘過氧化氫濃 又。歸㈣乙稀基対㈣之均聚物或共聚物之存 加殘餘過氧化氨濃度之百分比係定義樣…—心 物接觸30分鐘)/C對照物接觸30分鐘jjxloo之卜p^ 〜比平,L试樣接觸3〇分錄係 疋體積的具有乙稀基料。定酮之均聚物或共聚物 口 化氨溶液與適錢媒在室溫下於塑料容器中接㈣分鐘^ 151304.doc 201130524 所測得之殘餘過氧化氫濃度。 I對照物接觸30分餚係當固定妙接 的相同過氧化氫溶液(除了 U疋體積 3乙烯基吡咯啶輞之均嘮物 或共聚物外)(稱為對昭溶液彳| ,, 合'夜)與相同的適宜觸媒在室溫下於 目同塑料容器中接觸3G分鐘時所測得之殘餘過氧化氯濃 度3。該固定體積能夠使該觸媒完全浸入及係約5 em^25 ⑽,較佳為W至18-3,更佳為8‘至13咖3,甚至 :佳為9 W至U⑽3。過氧化氫溶液包括過氧化氫,及可 2用於隱形眼鏡護理溶液之其他適宜成分,例如界面活 性4、緩衝劑、渗透劑。 根據本發明’術語「觸媒」意指催化過氧化氫分解之任 何物質。該觸媒較佳為固體,及更佳為週期表之第咖 週期的過渡金屬之金屬或金屬氧化物,或鑭系元素之一 者1佳為紐,更特別為氧化紐。不同的過渡金屬在分解 過乳化氫中遵循不同的反應路徑。例如,申請人相信過氧 化物使用鉑離子作為觸媒係遵循以下的機制分解·· H202+Ptn+ -► H20+〇2+ptn+ 申》月人亦發現過氧化物可利用FentGn試劑分解,例如, 1载離子Fe被氫氧化成鐵離子Fe3+、羥基基團及氫氧根 陰離子。鐵離子卜3+隨後藉由相同的過氧化氫還原回亞鐵 離子、過氧化物基團及質子(歧化作用)。 H202+Fe2+ -► HO · +HO'+Fe3 + H2〇2+Fe3+·~~►Fe2++〇〇H . +H+ 节阿度反應性物質羥基基團可增加消毒的效力。Fenton試 劑可隨著鉑併入或單獨對分解過氧化氫起觸媒之作用。 I51304.doc 201130524U.S. Patent No. 5,523, filed on Jan. No. No. No. Nos. However, all of the disclosed surfactants are present in amounts greater than % 1% and are incompatible with platinum catalyst disks typically used to deactivate hydrogen peroxide in eyeglass disinfection systems due to excessive material formation. A composition and method for disinfecting and cleaning contact lenses is taught by U.S. Patent No. 5,746,972, which includes a liquid medium containing hydrogen peroxide and a solid epoxy epoxide/ring having at least 70% by weight of polyethylene oxide. Oxypropane block copolymer surfactant. The hydrogen peroxide is degraded by the release of catalase into the solution and causes "a decrease in the amount of beads". ^, when using a catalyst to decompose hydrogen peroxide, the compositions cause excessive foam formation. A long-standing need in the contact lens industry to provide a convenient, but effective, contact lens care solution. There are two types of hydrogen peroxide contact lens disinfecting solutions and their systems: the step system and the two-step system include: firstly, the contact lens is immersed in hydrogen peroxide having a concentration of 6%.6% to 3%. In solution - for a period of time, during which time 'the concentration of hydrogen peroxide is almost constant, and secondly, soak the contact lens 151304.doc 201130524 into the catalysis = to neutralize the peroxidation gas remaining in the contact lens + step system has The contact lens is immersed in about 3% of the chlorine peroxide solution in the box of the setting dial for about 6 hours. After dip =, the concentration of residual hydrogen peroxide is reduced ^, ", ppm, more preferably - the contact lens is worn on the eye. Typically, a two-step radiant has a higher material efficiency than a "step" system because the former has a higher concentration of chlorine peroxide during the sterilization process. However, the -step system is more convenient than the two-step system and is popular in contact lenses (4). Therefore, it is advantageous to provide a peroxide contact lens that overcomes - or a plurality of such problems. SUMMARY OF THE INVENTION In the present invention, the present invention provides a contact lens for disinfecting contact lenses, which comprises an effective disinfecting amount of hydrogen peroxide and a homopolymer or copolymer of ethylene ketone. Wherein the homopolymer or copolymer of the ethylene base (4) is sufficient to provide a control/liquid mixture having the same composition relative to the homopolymer or copolymer which does not contain the ethyl acetate phase in the presence of the phase (4) medium. An amount of at least 20% of the excess cerium peroxide concentration is present; in an amount sufficient to enhance one or more buffers of the composition of about 6. 〇 to 8. 阳 of the cation, wherein the sigma has about 2 〇〇 to The osmotic pressure of about 45 〇 m〇sm/kg and the viscosity at which it is lowered to 5.0 centipoise. In another aspect, the present invention provides a method of disinfecting a contact lens comprising the steps of: (a) contacting a contact lens with an aqueous solution containing the following components: an effective disinfecting amount of k-hydrogen peroxide and a vinyl ratio a homopolymer or copolymer of each ketone, in which the ethylene group D is more than 17 homo- or homopolymers in the presence of the same catalyst in the presence of the same catalyst in 151304.doc 201130524 A control solution of the homopolymer or copolymer of the rancidinone having the same composition is sufficient to provide an amount to increase the residual hydrogen peroxide concentration by at least 20%; and in an amount sufficient to provide a composition of about 6.0 to 8. (H〇 One or more buffers, wherein the group has an osmotic pressure of from about 200 to about mo m〇sm/kg and a viscosity of from 2 to about 5.0 centipoise at 25°; and (b) by The hydrogen peroxide catalyzes the neutralization of water and oxygen to neutralize the hydrogen peroxide. These and other aspects of the present invention will become apparent from the following description of the preferred embodiments. Limiting the scope of the present invention, the material of the present invention is covered by the scope of the patent application Many modifications and adaptations of the present invention can be made without departing from the spirit and scope of the present disclosure. All technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. In general, the names and laboratory steps used in the text are well known and used. Known methods are used in such (4), such as those provided in the art and in various references. When provided in the singular form, the inventors also cover the plural form of the term. NAME AND ITS: The laboratory procedures described are well known and commonly used in the art. As used herein, unless otherwise indicated, the following terms shall be understood to have the following meanings of 151304.doc 201130524. The present invention relates to a solution of a homopolymer or a copolymer of hydrogen peroxide and ethylene (4) (d) wherein the homopolymer or copolymer of the ethyl ketone is not present in the presence of the same catalyst a control solution having the same composition of a homopolymer or copolymer of ethylene base bite sufficient to provide an amount of at least 20% increase in residual hydrogen peroxide concentration; and a solution for disinfecting and/or A method of preserving contact lenses, especially soft invisible glasses. The disinfecting solution of the present invention is effective against a wide range of microorganisms including, but not limited to, Staphylococcus aureus (5) A. sphaeroides, Serratia serrata (Serratia) Marcescens, white chanting, Fusarium solani. Disinfecting solutions are generally defined as a contact lens care product comprising one or more active ingredients (eg, antibacterial agents and/or preservatives). The concentration of the ingredients is sufficient to kill harmful microorganisms on the surface of the contact lens during the recommended minimum soaking time. The recommended minimum soaking time is included in the package insert for the disinfection solution. The solution of the present invention is recognized as a novelty for the care of contact lenses. The term "soft spectacles" means a spectacles having a proportion of hydrophilic repeating single 7G ' such that the water content of the spectacles is at least 2 〇 〇 / 在 during use. The term "soft contact lens" as used herein generally refers to a contact lens that can be easily bent under very small forces. Typically, soft contact lenses are formulated from polymers 151304.doc 201130524 having a specific ratio of repeating units derived from hydroxyethyl methacrylate and/or other hydrophilic monomers which are typically crosslinked by a crosslinking agent. Relatively known as 'hard contact lenses' (which cover only one part of the cornea of the eye), they are usually composed of poly(methacrylate) or the like crosslinked with ethylene glycol dimethyl acrylate. And conventional rigid gas permeable contact lenses (RGP) are typically composed of a monomer containing a more oxygen permeable material. The term "ophthalmological safety" with respect to a contact lens solution means that the contact lens treated with the solution is safe for direct placement on the eye without rinsing, ie the solution is in contact with the eye daily through the contact lens. It is safe and quite comfortable. The ophthalmically safe solution has compatibility with the eye and pH and includes substances and amounts thereof that are cytotoxic according to international ISO standards and u, s. FDA regulations. Solution "being compatible with the eyes" means that the species can be in close contact with the eye for a length of time, but does not significantly damage the eyes and does not cause significant discomfort to the user: the term "disinfecting solution" means one or more a microbial compound/valley solution, which can effectively reduce or - the series of materials "...present on contact lenses", ", can be immersed in a stimulating solution by using a specific inoculum of such microorganisms The contact lens after the solution is tested. As used herein, the term "disappearing, quenching, cold, and π 1 乂Τ is used for the disinfection solution, and the night can be used for storing the solution or "~ night can be different from the hidden (4) The possibility of daily mirroring. /r / No and storage The term "cleaning the object to be cleaned will be loosely held" means that the solution contains - or a plurality of concentrations sufficient for them =: glasses deposits and other contaminants are loosened ... ... shell removed active ingredients . Although it is not necessary for the cultivar 151304.do, 201130524, the user may wish to manually treat the 一U 00 solution (for example, 'Use the touch aid 5 1 - stir the solution to connect it to the glasses Solution. A solution for aiding reading (e.g., '-mechanical cleaning aids) for use in cleaning, chemical disinfection, storage of mirrors of the present invention is referred to herein as "multiple/pieces (such as contact lenses L π. 'liquids". These solutions can be referred to as “岌 I 谷 谷 谷 ” or “multi-functional solution packaging” Ο functional solution, system or packaging steps are called “ ° :. Use of multi-functional solution does not exclude the following possibilities: I's a poisoning scheme. A disinfectant 戋its ', two wearers, such as a wearer who is particularly sensitive to wearing a == agent, may prefer to use another solution (such as sterile saline) ... contact lens. The term "multifunctional, 容# * (1) rinsing or wet not every ...... ..." does not exclude the following possibilities: (eg enzyme cleaner) is usually used weekly = white shell supplements such as "Molecular Weight Person" of the polymeric material used in the text Unless otherwise stated or unless the test conditions indicate otherwise, it refers to the number average molecular weight. For example, the residual hydrogen peroxide concentration J increased as used herein refers to the absence of an ethyl group in the presence of the same catalyst. Polymer or copolymer: an increased residual hydrogen peroxide concentration of a control solution having the same composition. The percentage of residual ammonium peroxide concentration of the homopolymer or copolymer of (4) ethylene sulfonium (iv) is defined. ... - contact with the heart for 30 minutes) / C control contact for 30 minutes jjxloo of the p ^ ~ flat, L sample contact 3 〇 entry system volume with a vinyl base. Homopolymer or copolymer of ketone The oral ammonia solution and the suitable medium are connected to the plastic container at room temperature for four minutes. 151304.doc 201130524 The residual hydrogen peroxide concentration measured. The I control is contacted with 30 minutes of the same hydrogen peroxide solution (except for the uniform or copolymer of U疋 volume 3 vinylpyrrolidinium) (referred to as the solution of 昭 彳 , | Night) The residual chlorine peroxide concentration 3 measured with the same suitable catalyst at room temperature in contact with the same plastic container for 3 G minutes. The fixed volume enables the catalyst to be fully immersed and tied to about 5 em 25 (10), preferably W to 18-3, more preferably 8' to 13 coffee 3, or even preferably 9 W to U (10) 3. The hydrogen peroxide solution includes hydrogen peroxide and may be used in other suitable components of the contact lens care solution, such as interfacial activity 4, buffers, penetrants. The term "catalyst" according to the invention means any substance which catalyzes the decomposition of hydrogen peroxide. The catalyst is preferably a solid, and more preferably a transition metal metal or metal oxide of the periodic period of the periodic table, or one of the lanthanides, preferably a oxidized nucleus. Different transition metals follow different reaction paths in decomposing peracetic acid. For example, the Applicant believes that peroxides use platinum ions as a catalyst system to decompose according to the following mechanism: H202+Ptn+ -► H20+〇2+ptn+ Shen. It has also been found that peroxides can be decomposed by FentGn reagents, for example, 1 The ion-loaded Fe is oxidized to an iron ion Fe3+, a hydroxyl group, and a hydroxide anion. Iron ion 3+ is then reduced back to ferrous ions, peroxide groups and protons (disproportionation) by the same hydrogen peroxide. H202+Fe2+ -► HO · +HO'+Fe3 + H2〇2+Fe3+·~~►Fe2++〇〇H . +H+ A degree reactive substance hydroxyl group can increase the efficacy of disinfection. The Fenton reagent can act as a catalytic catalyst for the incorporation of platinum or alone in decomposing hydrogen peroxide. I51304.doc 201130524

Fenton試劑之來源可為(例如)Ti〇2、Fe(N〇3)2、Fe(cy、The source of the Fenton reagent can be, for example, Ti〇2, Fe(N〇3)2, Fe(cy,

Fe(NH4)(S04)2或包含或能夠產生以2+或Ti3 +鐵之其他供電 子化合物。 ΟFe(NH4)(S04)2 either contains or is capable of producing other donor compounds of 2+ or Ti3 + iron. Ο

本發明大體上係關於—種過氧化氫消毒溶液。本發明係 部份基於發現:相對於在存在相同觸媒下不含乙烯基心各 啶酮之均聚物或共聚物之具有相同組合物之對照溶液,添 加乙稀基料咬酮之均聚物或共聚物可提供至少鳩,較 么至少35%或更佳至少5()%之增加的殘餘過氧化氫濃度。 本發明亦料基於發H⑽加乙烯基料咬酮之均聚 物或共聚物能夠在處理3〇分鐘時提供實質上增加的殘餘過 氧化氳’然而殘餘過氧化氫之濃度在處理6小時之後仍然 會減少至小於1GG ppm ’且經具有乙稀基吼略㈣之均聚 物或共聚物之過氧化氫溶液處理之隱形眼鏡仍然能夠舒適 地戴至目請上。本發明進__步係部份基於發現:乙烤基。比 洛咬酮之均聚物或共聚物存在於過氧化氫消毒溶液中可對 隱形眼鏡提供㈣性,其提供㈣性增加、摩擦減少、初 始舒適感及/或減少沉積物之附著至眼鏡上之未意料到的 益處,藉此提高隱形眼鏡在眼中之舒適度。 雖然本發明者並不教受任何特定理論限制,但抑乙 稀基料咬社均聚物或共聚物可對初始舒適感(在戴入 眼鏡那-刻)起作用。具有足夠大的分子量之乙稀基^各 ㈣之均聚物或共聚物可於眼鏡與角膜上皮組織之間提供 濶滑。併人乙烯基料咬酮之均聚物或共聚物可增加浸二 本發明之隱形眼鏡溶液中的隱形眼鏡之潤滑性、濕潤性 151304.doc -11 · 201130524 (特徵為接觸角減小)及/或減小摩擦。 在:樣中,本發明提供—種用於消毒隱形眼鏡之溶 液,,、匕括有效消毒量的過氧化氣及 聚物或共聚物,立中該Γ^ , 、11 烯基吡咯啶酮之均聚物或共聚物 係以相對於在存在相同觸 碉媒下不含乙烯基°比咯啶酮之均聚 物或共聚物之具有相同組合物之對照溶液,足以提供至少 20%,較佳至少35〇/〇,哎 除、 及更佳至少5〇°/〇之增加殘餘過氧化 氫農度的量存在;及置吾gThe present invention is generally directed to a hydrogen peroxide disinfecting solution. The present invention is based, in part, on the discovery that homopolymerization of a vinyl ketone is added to a control solution having the same composition in the presence of a homopolymer or copolymer of a vinyl ketone in the presence of the same catalyst. The article or copolymer can provide an increase in residual hydrogen peroxide concentration of at least 鸠, at least 35% or better by at least 5 (%). The present invention also contemplates that a homopolymer or copolymer based on H(10) plus vinyl ketone can provide substantially increased residual ruthenium peroxide upon treatment for 3 minutes. However, the residual hydrogen peroxide concentration remains after 6 hours of treatment. Contact lenses that are reduced to less than 1 GG ppm 'and treated with a hydrogen peroxide solution of a homopolymer or copolymer of ethylene (4) can still be worn comfortably. The invention is based in part on the discovery: B-bake. The presence of a homopolymer or copolymer of bilotone in a hydrogen peroxide disinfecting solution provides (four) properties to the contact lens, which provides (four) increased sexual properties, reduced friction, initial comfort and/or reduced deposit attachment to the lens. Unexpected benefits, thereby increasing the comfort of the contact lens in the eye. While the inventors do not teach any particular theoretical limitations, the Ethylene Base homopolymer or copolymer can act on initial comfort (in the case of wearing glasses). A homopolymer or copolymer having a sufficiently large molecular weight (4) provides slippage between the spectacles and the corneal epithelial tissue. The homopolymer or copolymer of vinyl ketone can increase the lubricity and wettability of the contact lens in the contact lens solution of the present invention 151304.doc -11 · 201130524 (characterized by a decrease in contact angle) / or reduce friction. In the sample, the present invention provides a solution for disinfecting contact lenses, including an effective disinfecting amount of peroxidizing gas and a polymer or copolymer, and the Γ^, 11 alkenylpyrrolidone The homopolymer or copolymer is sufficient to provide at least 20%, preferably at least 20%, relative to a control solution having the same composition in the presence of the homopolymer or copolymer of vinylpyrrolidone in the presence of the same contact medium. An amount of at least 35 〇 / 〇, 哎, and preferably at least 5 〇 ° / 〇 increase in residual hydrogen peroxide agro-amount; and

/、量足以提供組合物約6.0至8.0的pH 之一或多種緩衝劑,其中該組合物具有約至約45〇 m〇sm/kg的滲透壓及在机下高至…观泊的黏度。 根據本發明,隱形眼鏡可為習知之水凝膠隱形眼鏡(即 非聚夕氧水凝|眼鏡)或較佳為聚⑯氧水凝膠隱形眼鏡。 本發明之溶液包含濃度適用於消毒用途之過氧化氮,較 佳為約0.5重量%至約6重量%,更佳為約2重量%至約6重量 %,最佳為3重量〇/。至4重量%之間或約3重量%。 根據本發明,可將乙烯基吡咯啶酮與至少一種親水性單 體之任何共聚物用於本發明。共聚物之一較佳種類為乙烯 基吡咯啶酮與至少一種含胺基乙烯基單體之共聚物。含胺 基乙燁基單體之實例包括(但不限於)具有8至丨5個碳原子之 烷基胺基烷基曱基丙烯酸酯、具有7至15個碳原子之烷基 胺基烧基丙烯酸酯、具有8至20個碳原子之二烷基胺基烷 基曱基丙烯酸醋、具有7至20個碳原子之二烷基胺基烷基 丙烯酸酯、具有3至1 〇個碳原子之N_乙烯基烷基醯胺。較 佳的N-乙烯基烷基醯胺之實例包括(但不限於)N_乙烯基曱 151304.doc -12- 201130524 醯胺、N-乙烯基乙醯胺、Ν·乙烯基異丙醯胺、及n_乙烯 基·Ν·甲基乙酿胺。 較佳的共聚物之實 <列包括(但不限於)乙稀基吼㈣嗣與 =甲基⑮纟乙基f基丙埽酸醋<共聚&。該等較佳的共聚 物可於市面購得,例如購自Isp之共聚物845及共聚物 937 ° 乙烯基啦咯啶酮之共聚物以單位體積重量計(w/v)係以 〇 約0.02%至約5%’較佳0·^3%,更佳約〇 5%至約2%,最 佳約0 · 2 5 °/0至約1.5 %之量存在於組合物中。 本發明之組合物較佳包含一緩衝劑。該緩衝劑較佳將pH 保持在所希望的範圍内,例如在約4或約5或約6至約8或約 9或約丨0之生理上可接受範圍内。特定言之,該溶液較佳 具有約5.5至約8範圍内之ρΗβ該緩衝劑係選自無機或有機 驗’較佳為驗式醋酸鹽、磷酸鹽、硼酸鹽、檸檬酸鹽、硝 酸鹽' 硫酸鹽、酒石酸鹽、乳酸鹽、碳酸鹽、碳酸氫鹽及 Q 其混合物,更佳為鹼式磷酸鹽、硼酸鹽、檸檬酸鹽、酒石 酸鹽、碳酸鹽、碳酸氫鹽及其混合物。通常,其係以單位 體積重量計^/¥)以0.001%至2%,較佳0.01%至1%;最佳 約0.05%至約0.30%之量存在。 該緩衝劑組分較佳包括一或多種磷酸鹽緩衝劑,例如磷 酸二氫鹽、二鹼式磷酸鹽及類似物之組合。特別有用的罐 酸鹽緩衝劑係彼等選自鹼金屬及/或鹼土金屬之璘酸鹽 者。適宜的磷酸鹽緩衝劑之實例包括磷酸氣二納 (Na2HP04)、磷酸二氫鈉(NaH2P04)及磷酸二氫卸(ΚΗ2Ρ〇4) 151304.doc -13· 201130524 之一或多者。另 緩衝劑。 一較佳的緩衝劑系 統包括一或多種硼酸發 根據本發明之溶液較佳係以使其與淚液等參之方式調 配。-般應瞭解與淚液等渗之溶液係其濃度相#於〇9%氣 化納溶液(308 m〇sm/kg)之濃度之溶液。偏離此濃度亦 可。 與淚液之特性,或甚至另-所希望之等渗性,可藉由 添加影響等渗性之有機或無機物f來調節。適宜的眼睛^ 接受滲性試劑包括(但不限於)氣化鈉、氣化鉀、甘油、丙 二醇、聚乙二醇、多元醇、甘露醇、山梨糖醇、木糖醇及 其混合物。較佳地,大部份該溶液之滲性係藉由選自由包 含非歯化物之電解質(例如礙酸氯納)及非電解質化合物組 成之群之或多種化合物提供。該溶液之滲性通常係經調 節至約200至約450臺唆蔷^ , 毫夕里(m0sm),較佳約250至3 50 m〇sm 的範圍内。 本發明之組合物可包含界面活性劑或界面活性劑之混合 物。界面活性劑實際上可為任何眼睛可接受的界面活性 劑’其包括非離子性、陰離子性及兩性界面活性劑。適宜 的界面活性劑-般可描述為以—級或二級經基封端之親水 ,疏拎物之敢· ^又共聚物。該等界面活性劑之第一實例係 以級搜基封端之聚氧4申乙基/聚氧伸丙基縮合聚合物。 其可藉由控制添加環氧丙烷至丙二醇之兩個羥基中,首先 產生期望分子量的疏水物而合成。在合成之第二步驟中, '、'、氧乙燒,以將此疏水物夾於親水性基團之間。該等 15I304.doc -14- 201130524 嵌段共聚物可以商品名PLURONIC®自BASF Corporation購 得。該等界面活性劑之第二實例係以二級羥基封端之聚氧 伸乙基/聚氧伸丙基縮合聚合物。其可藉由控制添加環氧 乙烷至乙二醇中,首先產生期望分子量之親水物(聚氧伸 乙基)而合成。在合成之第二步驟中,添加環氧丙烷,以 在該分子外部產生疏水性嵌段。該等嵌段共聚物可以商品 名PLURONIC® R自BASF Corporation購得。令人滿意的 PLURONIC® R界面活性劑之特定實例包括:PLURONIC® 〇 31R1 、PLURONIC® 31R2 ' PLURONIC® 25R1 、 PLURONIC® 17R1、PLURONIC® 17R2、PLURONIC® 12R3。特別佳的結果係藉由PLURONIC® 17R4界面活性劑 獲得。 PLURONIC®字母-數字組合係用於識別該系列之不同產 品。字母符號闡釋產品之物理形式:「L」為液體,「P」為 糊料,「F」為固體形式(所有皆在20°C下)。在數字符號中 ◎ 第一個數字(三位數中之兩位)乘以3 0 0指示疏水物(聚環氧 丙烷)之大約分子量。最後的位數當乘以1 0時指示該分子 中聚環氧乙烧含量之大約百分比。 - PLURONIC® R系列之符號中間的字母「R」表示此產品 相較於PLURONIC®產品具有相反結構,即親水物(環氧乙 烷)係夾於環氧丙烷嵌段之間。當「R」之前的數字符號乘 以100時指示環氧丙烷嵌段之大約分子量。當「R」後面之 數字乘以10時指示該產品中環氧乙烷之大約重量百分比。 較佳界面活性劑之實例包括(但不限於)泊洛沙姆 151304.doc -15- 201130524 (poloxamer)(例如,Pluronic® L35、L43、L44、L62、 L62D、L62LF、L64、L92、F108、F123、F88、F98、 F68 、 F68LF 、 F127 、 F87 、 F77 、 P84 、 P85 、 P75 、 P103 、 P1 04、P1 05 及 1 7R4)、泊洛沙明(poloxamine)(例如, Tetronic® 707、11 07及13 07)、月旨肪酸之聚乙二酵酯(例 如,Tween® 20、Tween® 80)、Ci2至C!8烧烴之聚氧伸乙 基或聚氧伸丙基醚(例如Brij® 35)、聚氧伸乙基硬脂酸酯 (Myrj® 52)、聚氧伸乙基丙二醇硬脂酸酯(Atlas® G 2612) 及商品名為Mirataine®及Miranol®之兩性界面活性劑。 界面活性劑組分之量可根據(例如)所使用之一或多種特 定界面活性劑、該組合物中之其他組分及類似物之許多因 素而在廣範圍内變化。舉例而言,對於PLURONIC®系列 界面活性劑,通常界面活性劑之量係在約0.0001%或約 0.0002%至約0.03%或約0.05%或约0.08%(w/v)的範圍内。 較佳地,界面活性劑係以小於0.02% ;及最佳小於0.04%之 量存在。另一實例,非PLURONIC® R系列界面活性劑, 例如PLURONIC® R,通常界面活性劑之量係在約0.005% 或約0.01%至約0.1%或約0.5°/〇或約0.8°/〇(\¥~)的範圍内。較 佳地,該界面活性劑係以小於0.2°/。;及最佳小於0.1 %之量 存在。 本發明之隱形眼鏡溶液可包括黏度增強聚合物’其可為 水溶性纖維素衍生聚合物、水溶性聚乙烯醇(PVA)或其組 合。有用的纖維素衍生聚合物之實例包括(但不限於)纖維 素醚。示範性較佳的纖維素醚係甲基纖維素(M C )、乙基纖 151304.doc • 16· 201130524 維素(EC)、羥甲基纖維素(HMC)、羥乙基纖維素(HEC)、 每丙基纖維素(HPC)、羥丙基甲基纖維素(HpMc)或其混合 物。更佳地,纖維素醚係羥乙基纖維素(HEC)、羥丙基曱 基纖維素(HPMC)及其混合物。該纖維素醚基於該眼鏡護 理液之總量較佳係以約〇 〇〇1重量%至約〇 5重量%之量存在 於該組合物中。該眼鏡護理溶液之期望黏度係在25°C下高 至約5.0厘泊。And an amount sufficient to provide one or more buffers of the composition at a pH of from about 6.0 to 8.0, wherein the composition has an osmotic pressure of from about 4 to about 45 〇 m〇sm/kg and a viscosity as high as ... at the machine. In accordance with the present invention, the contact lens can be a conventional hydrogel contact lens (i.e., non-occupant oxygenated eyeglasses) or preferably a poly 16 oxygen hydrogel contact lens. The solution of the present invention comprises nitrogen peroxide at a concentration suitable for disinfecting purposes, preferably from about 0.5% to about 6% by weight, more preferably from about 2% to about 6% by weight, most preferably about 3% by weight. Between 4% by weight or about 3% by weight. According to the present invention, any copolymer of vinylpyrrolidone and at least one hydrophilic monomer can be used in the present invention. One preferred class of copolymers is a copolymer of vinylpyrrolidone and at least one amine-containing vinyl monomer. Examples of the amino group-containing ethylenic group-containing monomer include, but are not limited to, an alkylaminoalkylmercaptoacrylate having 8 to 5 carbon atoms, and an alkylamine group having 7 to 15 carbon atoms. An acrylate, a dialkylaminoalkylmercapto acrylate having 8 to 20 carbon atoms, a dialkylaminoalkyl acrylate having 7 to 20 carbon atoms, having 3 to 1 carbon atoms N_vinylalkylguanamine. Examples of preferred N-vinylalkylguanamines include, but are not limited to, N-vinyl hydrazine 151304.doc -12- 201130524 decylamine, N-vinylacetamide, hydrazine vinyl isopropyl amide And n_vinyl·Ν·methylethylamine. Preferred copolymers include, but are not limited to, ethylene sulfonium (tetra) hydrazine and = methyl 15 fluorene ethyl decyl acrylate vinegar < copolymerization & Such preferred copolymers are commercially available, for example, Copolymer 845 from Isp and copolymer 937 ° Vinylpyrrolidone at a basis weight per unit volume (w/v). % to about 5% 'preferably 0 · ^ 3%, more preferably from about 5% to about 2%, most preferably from about 0 · 25 ° / 0 to about 1.5 %. The compositions of the present invention preferably comprise a buffer. Preferably, the buffer maintains the pH within the desired range, e.g., within a physiologically acceptable range of from about 4 or about 5 or from about 6 to about 8 or about 9 or about 丨0. In particular, the solution preferably has a pH of from about 5.5 to about 8 and the buffer is selected from inorganic or organic tests, preferably acetate, phosphate, borate, citrate, nitrate. Sulfates, tartrates, lactates, carbonates, bicarbonates, and mixtures thereof, more preferably basic phosphates, borates, citrates, tartrates, carbonates, bicarbonates, and mixtures thereof. Usually, it is present in an amount of from 0.001% to 2%, preferably from 0.01% to 1%, optimally from about 0.05% to about 0.30% by weight per unit volume. Preferably, the buffer component comprises one or more phosphate buffers such as a combination of a dihydrogen phosphate, a dibasic phosphate, and the like. Particularly useful canister buffers are those selected from the group consisting of alkali metal and/or alkaline earth metal silicates. Examples of suitable phosphate buffers include one or more of diammonium phosphate (Na2HP04), sodium dihydrogen phosphate (NaH2P04), and dihydrogen phosphate (ΚΗ2Ρ〇4) 151304.doc -13·201130524. Another buffer. A preferred buffer system comprises one or more boric acid. The solution according to the invention is preferably formulated so as to be in the form of a tear. It is generally understood that the solution which is isotonic with tears is a solution of the concentration of the solution in the concentration of 〇 9% of the sodium hydride solution (308 m 〇 sm / kg). Deviation from this concentration is also acceptable. The properties of the tears, or even the desired isotonicity, can be adjusted by the addition of an organic or inorganic substance f which affects isotonicity. Suitable eyes^ Acceptable osmotic agents include, but are not limited to, sodium gasification, potassium glycerin, glycerin, propylene glycol, polyethylene glycol, polyols, mannitol, sorbitol, xylitol, and mixtures thereof. Preferably, most of the solution is provided by a group or compounds selected from the group consisting of non-deuterated electrolytes (e.g., acid chloride) and non-electrolyte compounds. The permeability of the solution is typically adjusted to a range of from about 200 to about 450 units, m0sm, preferably from about 250 to 3 50 m〇sm. The compositions of the present invention may comprise a mixture of surfactants or surfactants. The surfactant can be virtually any ocular acceptable surfactant' which includes nonionic, anionic, and amphoteric surfactants. Suitable surfactants - generally described as hydrophilic with a - or a secondary base, and a copolymer of dredged materials. A first example of such surfactants is a polyoxyalkylene/polyoxypropyl propylene condensation polymer terminated with a grade. It can be synthesized by controlling the addition of propylene oxide to the two hydroxyl groups of propylene glycol, first producing a hydrophobe of a desired molecular weight. In the second step of the synthesis, ',', oxyethylene is fused to sandwich the hydrophobe between the hydrophilic groups. These 15I304.doc -14- 201130524 block copolymers are commercially available from BASF Corporation under the trade name PLURONIC®. A second example of such surfactants is a secondary hydroxyl terminated polyoxyethylene/polyoxypropyl condensed polymer. It can be synthesized by controlling the addition of ethylene oxide to ethylene glycol to first produce a hydrophilic substance (polyoxyethylene) of a desired molecular weight. In the second step of the synthesis, propylene oxide is added to produce a hydrophobic block outside the molecule. Such block copolymers are commercially available from BASF Corporation under the tradename PLURONIC® R. Specific examples of satisfactory PLURONIC® R surfactants include: PLURONIC® 〇 31R1, PLURONIC® 31R2 'PLURONIC® 25R1, PLURONIC® 17R1, PLURONIC® 17R2, PLURONIC® 12R3. Particularly good results were obtained with PLURONIC® 17R4 surfactant. The PLURONIC® alpha-numeric combination is used to identify different products in the series. The alphabetic symbol explains the physical form of the product: "L" is a liquid, "P" is a paste, and "F" is a solid form (all at 20 °C). In the number sign ◎ The first number (two of the three digits) multiplied by 300 indicates the approximate molecular weight of the hydrophobe (polypropylene oxide). The last digit is multiplied by 10 to indicate an approximate percentage of the poly Ethylene Ethylene content of the molecule. - The letter "R" in the middle of the symbol of the PLURONIC® R series indicates that this product has the opposite structure as the PLURONIC® product, ie the hydrophilic (ethylene oxide) is sandwiched between the propylene oxide blocks. When the number sign before "R" is multiplied by 100, the approximate molecular weight of the propylene oxide block is indicated. When the number after "R" is multiplied by 10, it indicates the approximate weight percentage of ethylene oxide in the product. Examples of preferred surfactants include, but are not limited to, poloxamer 151304.doc -15- 201130524 (poloxamer) (eg, Pluronic® L35, L43, L44, L62, L62D, L62LF, L64, L92, F108, F123, F88, F98, F68, F68LF, F127, F87, F77, P84, P85, P75, P103, P1 04, P1 05 and 1 7R4), poloxamine (eg Tetronic® 707, 11 07) And 13 07), poly(ethylene ester) of fatty acid (for example, Tween® 20, Tween® 80), polyoxyethylene or polyoxyl propyl ether of Ci2 to C! ® 35), polyoxyethylidene stearate (Myrj® 52), polyoxyethylene ethyl propylene glycol stearate (Atlas® G 2612) and amphoteric surfactants under the trade names Mirataine® and Miranol®. The amount of surfactant component can vary widely depending upon, for example, one or more of the particular surfactants employed, other components of the composition, and the like. For example, for the PLURONIC® series of surfactants, typically the amount of surfactant is in the range of from about 0.0001% or from about 0.0002% to about 0.03% or from about 0.05% or about 0.08% (w/v). Preferably, the surfactant is present in an amount of less than 0.02%; and optimally less than 0.04%. In another example, non-PLURONIC® R series surfactants, such as PLURONIC® R, typically have a surfactant amount of from about 0.005% or from about 0.01% to about 0.1% or from about 0.5% to about 0.8% per ton ( Within the scope of \¥~). Preferably, the surfactant is less than 0.2°/. ; and the best amount is less than 0.1%. The contact lens solution of the present invention may comprise a viscosity enhancing polymer' which may be a water soluble cellulose derived polymer, a water soluble polyvinyl alcohol (PVA) or a combination thereof. Examples of useful cellulose-derived polymers include, but are not limited to, cellulosic ethers. Exemplary preferred cellulose ether methyl cellulose (MC), ethyl fiber 151304.doc • 16· 201130524 vitamin (EC), hydroxymethyl cellulose (HMC), hydroxyethyl cellulose (HEC) , perpropyl cellulose (HPC), hydroxypropyl methylcellulose (HpMc) or a mixture thereof. More preferably, the cellulose ether is hydroxyethyl cellulose (HEC), hydroxypropyl decyl cellulose (HPMC), and mixtures thereof. The cellulose ether is preferably present in the composition in an amount of from about 1% by weight to about 5% by weight based on the total amount of the lens care solution. The desired viscosity of the lens care solution is at 25 ° C up to about 5.0 centipoise.

根據本發明’該溶液可進一步包括類黏液素物質、對眼 丨青有益之物質、透明質酸及/或界面活性劑。 示範性類黏液素物質包括(但不限於)聚乙醇酸及聚乳交 I類黏液素物質可用作客體材料,其可長時間連續及緩 慢地釋放至眼睛的眼球表面,以用於治療乾眼症。該軸 液素物質較佳係以有效量存在。 示範性的對眼睛有益的物質包括(但不限於)24略咬酮_ 5-幾酸(PCA)、胺基酸(例如牛績酸、甘胺酸等)、&經基酸 (例如乙醇酸、乳酸、顏果酸、酒石酉曼、扁桃酸及檸檬酸 及其鹽等)、亞麻油酸及γ•亞麻油酸、及維生素(例如Μ、 A、Β6等)。 眼鏡可根據熟悉此項技術者所知曉之任何方法自水凝膠 眼鏡形成調配物製備。「水凝膠眼鏡形成調配物」或「: 凝料睛形成材料」係指可經熱或光化學固化(即經聚: 或父聯)以獲得經交聯/聚合之聚合材料 二 物。、眼鏡形成材料係熟悉此項技術者所熟知。通常,= 化成材枓包括可聚合/可交聯級分,例如(諸如)熟悉此項: 151304.doc 】7 201130524 術者所知曉之單體、p八 _ y — 巨刀子、預t物或其組合。眼鏡形成 材料可進步包括其他組分,諸如非可交聯親水性聚合物 (即可滤出聚合潤滑劑)、起始劑(例如光起始劑或熱起始 劑)、可見度著色劑' uv阻斷劑、感光劑、抗菌劑及類似 物。 在另心樣中,本發明提供一種消毒隱形眼鏡之方法, 其包括以下步驟: ⑷使隱形眼鏡與含以下組份的水溶液接觸:有效消毒量 的過氧化氫及乙烯基咬嘻咬綱之均聚物或共聚物,其 中乙烯基吼咯啶酮之均聚物或共聚物係以相對於在 相同觸媒存在下不含乙烯基吼〇各唆嗣之均聚物或共聚 物之具有相同紐合物之對照溶液,足以提供至少20% 之增加殘餘過氧化氫漠度之量存在,·其量足以提供組 合物約6·0至8.〇的阳之一或多種緩衝劑,其令該組合 物八有、,.勺200至約450 mOsm/kg之滲透壓及在25七下高 至約5.0厘泊之黏度;及 (b)藉由催化分解中和該過氧化氫。 先前揭示將使一般技術者能夠實施本發明。為使讀者更 好地理解其特定實施例及優勢,建議參照以下非限制性實 例。然而,以下實例不應視為限制本發明之範疇。 以下非限制性實例闡述本發明之某些態樣。 實例1 (切技術)·清除護理溶㈣購自Ciba visi〇n 藉由將個別成分摻合在-起而製備得一些以下的液體組 合物(以單位體積重量%(w/v)計)。 151304.doc 201130524 過氧化氫 3.5% 鱗酸二氫納,一水合物 0.072% 磷酸氫二鈉,無水物 0.1555% DEQUEST® 2060S 0.012% 氣化納 0.79% PLURONIC 17R4 0.05% 純淨水 補滿至容積 所得溶液係包含3.5%過氧化氫; 0.072%磷酸二氫鈉,一 ΟAccording to the present invention, the solution may further comprise a mucin-like substance, a substance beneficial to the eye phthalocyanine, hyaluronic acid and/or a surfactant. Exemplary mucin-like substances including, but not limited to, polyglycolic acid and polylactide class I mucin substances can be used as guest materials which can be continuously and slowly released to the eye surface of the eye for a long time for the treatment of dry eye syndrome. . Preferably, the axon material is present in an effective amount. Exemplary eye-friendly materials include, but are not limited to, 24 singular ketones - 5-acids (PCA), amino acids (eg, bovine acid, glycine, etc.), & basic acids (eg, ethanol) Acid, lactic acid, anaphyl, tartar, mandelic acid, citric acid and its salts, linoleic acid and gamma linoleic acid, and vitamins (eg Μ, A, Β6, etc.). The spectacles can be prepared from a hydrogel lens forming formulation according to any method known to those skilled in the art. "Hydrogel glasses forming a formulation" or ": agglomerating eye forming material" means a polymeric material which can be cured by heat or photochemistry (i.e., by poly: or parent) to obtain a crosslinked/polymerized polymeric material. Glasses forming materials are well known to those skilled in the art. In general, = chemically formed materials include polymerizable/crosslinkable fractions, such as, for example, familiar with this item: 151304.doc 】 7 201130524 The monomer known to the surgeon, p 八 y — giant knife, pre-t or Its combination. The lens forming material can be improved to include other components such as non-crosslinkable hydrophilic polymers (ie, filter out of polymeric lubricants), initiators (eg, photoinitiators or thermal initiators), visibility colorants' uv Blockers, sensitizers, antibacterial agents and the like. In another aspect, the present invention provides a method of disinfecting a contact lens comprising the steps of: (4) contacting the contact lens with an aqueous solution containing the following components: an effective disinfecting amount of hydrogen peroxide and a vinyl bite a polymer or copolymer in which the homopolymer or copolymer of vinylpyrrolidone has the same color as the homopolymer or copolymer which does not contain vinyl anthracene in the presence of the same catalyst. a control solution sufficient to provide at least 20% increase in residual hydrogen peroxide moisture, in an amount sufficient to provide one or more buffers of the composition from about 6.8 to about 8. 令, such combination The osmotic pressure of 200 to about 450 mOsm/kg and the viscosity of up to about 5.0 cps at 25:7; and (b) neutralizing the hydrogen peroxide by catalytic decomposition. The previous disclosure will enable one of ordinary skill in the art to practice the invention. In order to provide readers with a better understanding of the specific embodiments and advantages thereof, it is suggested to refer to the following non-limiting examples. However, the following examples should not be construed as limiting the scope of the invention. The following non-limiting examples illustrate certain aspects of the invention. Example 1 (cutting technique) - Scavenging treatment solution (4) Purchased from Ciba visi〇n Some of the following liquid compositions (in units of weight percent (w/v)) were prepared by blending individual ingredients. 151304.doc 201130524 Hydrogen peroxide 3.5% Dihydrogen sulphate, monohydrate 0.072% Disodium hydrogen phosphate, anhydrate 0.1555% DEQUEST® 2060S 0.012% Gasification nano 0.79% PLURONIC 17R4 0.05% Purified water to volume The solution contains 3.5% hydrogen peroxide; 0.072% sodium dihydrogen phosphate, one Ο

水合物;0.1555%磷酸氫二鈉,無水物;0.012% DEQUEST® 2060S ;及 0.79%氯化納及 0.05% PLURONIC 17R4之水溶液。 實例2 以與實例1相同的方式製備溶液,除添加1%共聚物845 至該溶液中外。共聚物845係自ISP獲得。 實例3 以與實例1相同之方式製備溶液,除添加1 %共聚物845 及0.02°/。HPMC Ε4Μ至該溶液外。共聚物845係自ISP獲 得,及HPMC Ε4Μ係自DOW獲得。 實例4 以與實例1相同之方式製備溶液,除添加1.0%共聚物845 至該溶液外。以 PLURONIC P103(0.001%;^RPLURONIC 17R4。PLURONIC P103係自 BASF獲得。 實例5 以與實例1相同之方式製備溶液,除添加0.5%共聚物845 151304.doc -19- 201130524 至該溶液外。以0.001%之PLURONIC P103替代PLURONIC 17R4 ° 實例6 以與實例1相同之方式製備溶液,除用0.64%硼酸鹽緩衝 劑替代磷酸鹽緩衝劑,及添加1.0%共聚物845及0.02% HPMC E4M至該溶液外。在30分鐘及360分鐘過氧化物中 和之後的過氧化物濃度。 (使用AOCUP及AODisc經鉑塗佈之盤系統) 表1A-對於上述實例在具有AODisc之AOCup系統中在消 毒後之特定時間點(30分鐘或360分鐘)之過氧化物含量 隱形眼鏡溶液 中和30分鐘 中和360分鐘 實例I(n=5) 1080.64 ppm 十/- 99.52 ppm 2.75 ppm +A 0.07 ppm 實例 II(n=4) 1678.33 ppm +/- 124.92 ppm 8.05 ppm +A 0.21 ppm 實例 ΙΙΙ(η=15) 2397.11 ppm +/- 297.26 ppm 12.60 ppm +/- 0.28 ppm 實例 IV(n=6)P26 2055.56 ppm +/- 186.94 ppm 9.15 ppm +/- 0.56 ppm 實例 V(n=6)P35 2385.00 ppm +/- 606.21 ppm 14.78 ppm +/-1.18 ppm 實例 VI(n=6)N35 2063.33 ppm +/- 185.53 ppm 12.85 ppm +/- 0.54 ppm 表1B -對於上述實例I、卩及111在具有AODisciA〇Cup系 統中在消毒後之特定時間點(60分鐘)之過氧化物含量 隱形眼鏡溶液 中和60分鐘 實例I(n=4) 499.5 ppm +/- 29.86 ppm 實例 II(n=2) 826 ppm +Λ 16.97 ppm 實例 ΙΙΙ(η=4) 824.0 ppm +/- 22.33 ppm 隱形眼鏡溶液之特徵分析 使用南級微滲透壓計3300塑(Advanced Micro-osmometer Model 3300)來測定實例1至6之隱形眼鏡溶液之滲透壓。 151304.doc •20- 201130524 最終結果係以對各隱形眼鏡溶液之至少三個測試結果之平 均值獲得。實例1至6之隱形眼鏡溶液之黏度係藉由使用布 魯克菲爾德(Brookfield)黏度計在特定預定速度下取三個測 量值之平均而獲得(在此情況下最佳結果係在60 rpm下獲 得)。實例1至6隱形眼鏡溶液之隱形眼鏡溶液之pH值係用 Fisher Accumet 25 pH計測定(對於各封裝溶液,對兩個獨 立試驗結果之平均值)。 表2-在於具有AODisc之AOCup系統中消毒特定時間點 (360分鐘)後之經中和實例溶液之ρΙ1、滲透壓及黏度 隱形眼鏡溶液 實例編號 PH 滲透壓 黏度 實例I (n=5) 6.69 +/- 0.01 294+/-1.00 mOsm 0.92 +A 0.02 cps 實例 II (n=30) 6.64+/-0.01 294 +/- 1.00 mOsm 1.45 +/- 0.02 cps 實例III (n=30) 6.63 +/- 0.01 297 +/- 2.1 mOsm 1.62 +Λ 0.01 cps 實例 IV(n=3) 7.05 +/- 0.01 308 +Λ 1.5 mOsm 1.33 +/- 0.02 cps 實例 V(n=l〇) 6.72 +/- 0.01 296 +Λ 2.1 mOsm 1.10 +/- 0.02 cps 實例 VI (n=3) 7.11 +/-0.01 296 +/- 1.5 mOsm 1.61 +/_ 0.02 cps 〇 所有經中和實例係在6.6 - 7.2之最佳眼睛pH舒適範圍 内,生理pH為6.8。 所有經中和實例係在280 mOsm - 320 mOsm之最佳滲性 舒適範圍内,生理滲性為29〇 m〇srn。 眼鏡特徵分析 隱形眼鏡之摩擦係數可藉由塊材上橇式滑動式(sled_on_ block)的摩擦試驗器測量如下。在特定負載(例如約4克) 下’將隱形眼鏡在指定速度下相對於生物學相關基板來回 滑動’及測量法向力切向力。隱形眼鏡之摩擦係 151304.doc •21- 201130524 數係基於方程式μ=Ι?τ/Ν計算。 、玻璃 較佳的摩擦試驗器包括:固定眼鏡夹持器 基板、水平可移動平台及複數個測力構件。 呈=定眼鏡失持器總成較佳包括「Α字形」失持器托架及 -有眼鏡支撐表面之眼鏡夾持器。該眼鏡爽持器之眼鏡支 撐表面具有-能夠適應隱形眼鏡之背(凹)面之凸面曲率。 該眼鏡夾持器較佳藉由位在「Α字形」夹持器托架中心之 一構件爽持。該「A字形」固定樣品灸持器托架之頭端係 藉由(例如)Kevlar®纖維連接至第一測力構件(例如,來自 Transducer Techniques之測力器)。「A字形」夹持器托架之 兩個腳端係連接至利用兩個1/2,,鋼拉伸彈菁附接之尼龍線。 第一測力構件及鋼拉伸彈簧係經安裝至測試器之框架上。 該水平可移動平台可為(例如)台面平台&台面),且係 在不同的速度及加速度下單軸移動。該χ_台面較佳且有 ⑹麵長及19.lmm寬之尺寸及可提供具有約14〇mm長及 約M.7 mm寬的測試面積〜台面之一實例係藉由zeta Drive C〇mpumotor(Parker Η_Πη。叩⑽u〇n)推動之 μ 型線性定位器,其係在18〇〇 mm/min的最大速度及卯⑼ mm/s2的加速度下單向操作。 在利式之如應將玻璃基板藉由用熱水沖洗繼而用異丙 醇沖洗而清潔。將附接至x_台面上之玻璃基板用5〇 μΐ的期 ㈣滑#_如’磷酸鹽緩衝鹽水溶液或眼鏡之封裝溶液) 潤滑。期望之潤滑劑應均勾地施加至玻璃基板上。 較佳地’存在三個測力構件,第一、第二及第三測力構 151304.doc -22- 201130524 件。可使用任何適宜的已知測力構件。一實例係來自 Transducer Techniques之100-克測力器。第一測力構件係 附接至樣品夾持器,以測量在兩個相反方向中之切向力 (摩擦力,FT)。第二及第三測力構件係位於x_台面下方, 以測量向下方向之法向力(N)。藉由法向測力器輸出之其 他測力器值係藉由多功能放大器/調節器(Transducer Techniques)轉化成克數。Hydrate; 0.1555% disodium hydrogen phosphate, anhydrate; 0.012% DEQUEST® 2060S; and 0.79% sodium chloride and 0.05% aqueous solution of PLURONIC 17R4. Example 2 A solution was prepared in the same manner as in Example 1, except that 1% of the copolymer 845 was added to the solution. Copolymer 845 was obtained from ISP. Example 3 A solution was prepared in the same manner as in Example 1, except that 1% copolymer 845 and 0.02 °/ were added. HPMC Ε4Μ to the outside of the solution. Copolymer 845 was obtained from ISP, and HPMC® was obtained from DOW. Example 4 A solution was prepared in the same manner as in Example 1, except that 1.0% of the copolymer 845 was added to the solution. PLURONIC P103 (0.001%; ^RPLURONIC 17R4. PLURONIC P103 was obtained from BASF. Example 5 A solution was prepared in the same manner as in Example 1, except that 0.5% copolymer 845 151304.doc -19-201130524 was added to the solution. 0.001% PLURONIC P103 instead of PLURONIC 17R4 ° Example 6 A solution was prepared in the same manner as in Example 1, except that 0.64% borate buffer was used instead of phosphate buffer, and 1.0% copolymer 845 and 0.02% HPMC E4M were added to the solution. Peroxide concentration after peroxide neutralization at 30 minutes and 360 minutes (Platinum coated disk system using AOCUP and AOSDis) Table 1A - For the above example in the AOCup system with AODisc after disinfection Peroxide content in a contact lens solution at a specific time point (30 minutes or 360 minutes) and 30 minutes in a neutral period of 360 minutes Example I (n = 5) 1080.64 ppm Ten / - 99.52 ppm 2.75 ppm + A 0.07 ppm Example II (n =4) 1678.33 ppm +/- 124.92 ppm 8.05 ppm +A 0.21 ppm Example ΙΙΙ (η=15) 2397.11 ppm +/- 297.26 ppm 12.60 ppm +/- 0.28 ppm Example IV (n=6) P26 2055.56 ppm +/- 186.94 ppm 9.15 ppm +/- 0.56 ppm Example V ( n=6)P35 2385.00 ppm +/- 606.21 ppm 14.78 ppm +/-1.18 ppm Example VI (n=6) N35 2063.33 ppm +/- 185.53 ppm 12.85 ppm +/- 0.54 ppm Table 1B - For Example I above, 卩And 111 in a AODisciA® Cup system at a specific time point (60 minutes) after disinfection in a peroxide content contact lens solution and 60 minutes Example I (n=4) 499.5 ppm +/- 29.86 ppm Example II (n =2) 826 ppm +Λ 16.97 ppm Example ΙΙΙ(η=4) 824.0 ppm +/- 22.33 ppm Characterization of contact lens solution Determination of Example 1 using a Southern Micro-osmometer Model 3300 The osmotic pressure of the contact lens solution to 6. 151304.doc •20- 201130524 The final results were obtained as the average of at least three test results for each contact lens solution. The viscosity of the contact lens solutions of Examples 1 to 6 was obtained by taking the average of three measurements at a specific predetermined speed using a Brookfield viscometer (in this case the best results were obtained at 60 rpm) . The pH values of the contact lens solutions of Examples 1 to 6 contact lens solutions were determined using a Fisher Accumet 25 pH meter (average of two independent test results for each package solution). Table 2 - Ι1, osmotic pressure and viscosity contact lens solution example number PH osmotic pressure viscosity after sterilizing a specific time point (360 minutes) in the AOCup system with AODisc Example I (n=5) 6.69 + /- 0.01 294+/-1.00 mOsm 0.92 +A 0.02 cps Example II (n=30) 6.64+/-0.01 294 +/- 1.00 mOsm 1.45 +/- 0.02 cps Example III (n=30) 6.63 +/- 0.01 297 +/- 2.1 mOsm 1.62 +Λ 0.01 cps Example IV (n=3) 7.05 +/- 0.01 308 +Λ 1.5 mOsm 1.33 +/- 0.02 cps Example V (n=l〇) 6.72 +/- 0.01 296 +Λ 2.1 mOsm 1.10 +/- 0.02 cps Example VI (n=3) 7.11 +/-0.01 296 +/- 1.5 mOsm 1.61 +/_ 0.02 cps 〇All neutralization examples are in the best eye pH comfort range of 6.6 - 7.2 The physiological pH was 6.8. All neutralized examples ranged from 280 mOsm to 320 mOsm in optimum permeability, with a physiological permeability of 29 〇 m〇srn. Analysis of the characteristics of the glasses The coefficient of friction of the contact lenses can be measured by a sled_on_block friction tester on a block as follows. The contact lens is slid back and forth relative to the biologically relevant substrate at a specified speed (e.g., about 4 grams) and the normal force tangential force is measured. The friction system of contact lenses 151304.doc •21- 201130524 The number system is based on the equation μ=Ι?τ/Ν. The preferred friction tester for the glass comprises: a fixed eyeglass holder substrate, a horizontal movable platform and a plurality of force measuring members. Preferably, the spectacles disarmer assembly includes a "Α" shaped disarmer bracket and a spectacles holder having a spectacles support surface. The lens support surface of the lens holder has a convex curvature that can accommodate the back (concave) face of the contact lens. Preferably, the eyeglass holder is held by a member positioned in the center of the "Α" shaped holder bracket. The head end of the "A-shaped" fixed sample moxibustion holder is attached to the first load cell (e.g., a force gauge from Transducer Techniques) by, for example, Kevlar® fibers. The two ends of the "A-shaped" gripper bracket are attached to a nylon thread that utilizes two 1/2, steel stretched elastomers. The first load cell and the steel tension spring are mounted to the frame of the tester. The horizontally movable platform can be, for example, a mesa platform & mesa, and is uniaxially moved at different speeds and accelerations. The χ_ countertop is preferably and has a (6) face length and a width of 19.1 mm and can provide a test area having a length of about 14 mm and a width of about M. 7 mm. - One example of a table is by zeta Drive C〇mpumotor (Parker Η_Πη.叩(10)u〇n) A push-type μ linear positioner that operates in one direction at a maximum speed of 18 mm/min and an acceleration of 卯(9) mm/s2. In the case of the formula, the glass substrate should be cleaned by rinsing with hot water followed by rinsing with isopropyl alcohol. The glass substrate attached to the x_ table is lubricated with a 5 〇 μΐ period (4) slip #_如 'phosphate buffered saline solution or a lens encapsulation solution). The desired lubricant should be applied to the glass substrate. Preferably, there are three force measuring members, the first, second and third force measuring structures 151304.doc -22- 201130524 pieces. Any suitable known force measuring member can be used. An example is a 100-gram force estimator from Transducer Techniques. The first load cell is attached to the sample holder to measure the tangential force (friction, FT) in two opposite directions. The second and third force measuring members are located below the x_ table to measure the normal force (N) in the downward direction. The other dynamometer values output by the normal dynamometer are converted to grams by means of a multi-purpose amplifier/regulator (Transducer Techniques).

摩擦係數測量係於較佳摩擦測試器上以下列步驟進行。 將隱形眼鏡置於眼鏡夾持器上,使隱形眼鏡之背面靠著眼 鏡夾持器之眼鏡支撐表面。將具有隱形眼鏡之眼鏡夾持器 與A子形」夾持器托架組合及隨後使其與經潤滑之玻璃 基板接觸。此基板係安裝至能夠在不同速度及加速度下單 軸移動之水平可移動台面平台。將約4克重量負載於眼鏡 夾持上。此負載重可代表由眼驗眨動對隱形眼鏡所施加 之力此二個測力構件(來自Transducer Techniques之3個 ^力器)同時測量法向⑼及自隱形眼鏡與經期望潤滑劑潤 滑之基板之間的相互作用產生之摩擦(FT)力。在測量隱形 眼鏡摩擦係數㈣取多個數據點。在各數據點,如下計算 摩擦係·㈣τ/Ν,其中Ft代表在玻璃基板㈣於隱形眼 ^骨動^在校正由彈簣(切向測力請提供之預負載 r '則力構件所獲得之各點處之實際數據讀數,其 二Γ克單位;_Νι與N2之和;Νι代表在基板相對 =艮鏡滑動期間在校正由測試總成(法向測 W何預負载後’由第二測力構件所獲得之各 151304.doc •23- 201130524 實際數據讀數,及其較佳具有公 相對於隱形眼鏡滑動期間在 η、在基板 权正由測試總成(法向測力器 =提供之任何預負載後,由第三測力構件所獲得之各 點處之實際數據讀數,及其較佳具有公克單位。將使用在 :數據點處之所有π平均值(μΑνε)來表示隱形 摩擦係數值。 佳地,摩擦測試器進一步包括電腦系統,該電腦系統 α控制測試器、Ε集當生物學相關基板與隱形眼鏡相互作 用之同時法向及切向力之讀數、計算摩擦係數及記錄在 測成期間在各數據點處之力(Ft&n)及摩擦係數⑻並將其 纷圖。靜摩擦係當物體靜置於基板上時該物體上之摩擦 力。為計算靜摩擦係數⑻,計算致動該物體所需之最: 力(F)及將其除以該物體上之法向力(N)。動摩擦係當物體 在基板上運動時該物體上之摩擦力。 用實例1至6之隱形眼鏡溶液所處理之皈鏡之經座滴 (sessile drop)法所測量之接觸角、動摩擦係數及靜摩擦係 數記錄於表3中。 表3_在具有AO Disc之AOCup系統中過氧化物中和(6 時)後之實例之接觸角測量(藉由座滴法)及摩擦係數測試 隱形眼鏡溶液 實例編號 ---——--- 座滴接觸角 (度)(〇asys眼鏡) — 動摩擦係數 (n=l〇 ; AirOptix __眼鏡) 0.026+/-0.001 -___^例 I 99 +/- 8 (η-10) — 60 +/- 20 (η=5) 0.018 +/- 〇 005 -- 60 +/-14 (n=30) L__^〇08 +/- 0.002 151304.doc 24· 201130524 -----— -- 30+/-12 (n=10) 0.008 +/- 0.002 ___ -foil V _ 47 +/- 22 rn=23) 0.009 +/- 0.002 49 +A 11 (n=5) 0.010+/-0.003 雖已使用特定術語、裝置及方法闡述本發明之不同實 訑例,但該描述僅用於闡釋性目的。所用詞語係非限制性 祠浯。應瞭解熟悉此項技術者可在不偏離闡述於以下申請 專利範圍中之本發明之主旨或範_下做出更換及變化。此 外,應瞭解不同實施例之態樣可整體或部份地互換。因 此’隨附申請專利範圍之主旨及範疇不應限於其中所含 較佳型式之描述。 Ο 151304.doc 25-The coefficient of friction measurement is performed on a preferred friction tester in the following steps. The contact lens is placed on the eyeglass holder such that the back of the contact lens rests against the eyeglass support surface of the eyepiece holder. The eyeglass holder with the contact lens is combined with the A-shaped "clamp holder" and subsequently brought into contact with the lubricated glass substrate. The substrate is mounted to a horizontal movable mesa platform that can be uniaxially moved at different speeds and accelerations. Approximately 4 grams of weight was loaded onto the lens holder. This load can represent the force exerted by the eye exam on the contact lens. The two force measuring members (3 from the Transducer Techniques) measure the normal direction (9) and self-contact lens and the desired lubricant lubrication. The friction (FT) force generated by the interaction between the substrates. In the measurement of the contact lens friction coefficient (four) take multiple data points. At each data point, the friction system (4) τ/Ν is calculated as follows, where Ft represents the glass substrate (4) in the invisible eye ^ bone movement ^ in the correction by the elastic 篑 (the tangential force please provide the preload r ' force component obtained The actual data reading at each point, the second gram unit; _Νι and N2; Νι represents the correction in the substrate relative to the 艮 mirror sliding during the calibration by the test assembly (normal measurement W before the preload] by the second The 151304.doc •23- 201130524 actual data readings obtained by the force-measuring members, and their preferred positive readings during contact with the contact lens at η, at the substrate weight are being tested by the test assembly (normal dynamometer = The actual data reading at each point obtained by the third load cell after any preload, and preferably in grams units. All π averages (μΑνε) at the data points are used to represent the invisible friction coefficient. Preferably, the friction tester further includes a computer system that controls the tester, collects the readings of the normal and tangential forces while calculating the interaction between the biologically relevant substrate and the contact lens, calculates the friction coefficient, and recordsThe force (Ft&n) and the coefficient of friction (8) at each data point during the formation are plotted. The static friction is the frictional force on the object when it is placed on the substrate. Calculate the static friction coefficient (8) and calculate the actuation. The most required of the object: force (F) and divide it by the normal force (N) on the object. Dynamic friction is the frictional force on the object as it moves on the substrate. Invisible with examples 1 to 6. The contact angle, dynamic friction coefficient and static friction coefficient measured by the sessile drop method of the spectacles treated by the glasses solution are recorded in Table 3. Table 3_Peroxide Neutralization in the AOCup System with AO Disc ( Contact angle measurement after 6 o'clock) (by seat drop method) and friction coefficient test contact lens solution example number --------- seat drop contact angle (degrees) (〇asys glasses) - dynamic friction coefficient ( n=l〇; AirOptix __ glasses) 0.026+/-0.001 -___^Example I 99 +/- 8 (η-10) — 60 +/- 20 (η=5) 0.018 +/- 〇005 -- 60 +/-14 (n=30) L__^〇08 +/- 0.002 151304.doc 24· 201130524 ------ -- 30+/-12 (n=10) 0.008 +/- 0.002 ___ -foil V _ 47 +/- 2 2 rn=23) 0.009 +/- 0.002 49 +A 11 (n=5) 0.010+/-0.003 Although specific examples, devices and methods have been used to illustrate different embodiments of the invention, the description is for illustrative purposes only. purpose. The words used are non-limiting. It is to be understood that those skilled in the art can make changes and variations without departing from the spirit or scope of the invention as set forth in the following claims. In addition, it should be understood that aspects of the various embodiments may be interchanged in whole or in part. Therefore, the spirit and scope of the appended claims should not be limited to the description of the preferred embodiments. 151 151304.doc 25-

Claims (1)

201130524 七、申請專利範圍: 種用於4毒隱形眼鏡之溶液,其包括有效消毒量的過 氧化氫及乙烯基吡咯啶酮之均聚物或共聚物,其中該乙 浠基比洛咬酮之均聚物或共聚物係以相對於在相同觸媒 存在下不含乙烯基咣咯啶酮之均聚物或共聚物之具有相 同組合物之對照溶液,足以提供至少20%之增加殘餘過 氧化氫濃度之量存在;及其量足以提供該組合物約6〇至 8.0的pH之一或多種缓衝劑,其中該組合物具有約2〇〇至 約450 mOsm/kg之滲透壓及在25。〇下高至約5 〇厘泊之黏 度。 2. 如清求項1之溶液,其中該溶液包括乙烯基吡咯啶酮與 至少一種含胺基乙烯系單體之共聚物,其中該含胺基乙 烯系單體係選自由具有8至15個碳原子之烷基胺基烷基 甲基丙烯酸酯、具有7至15個碳原子之烷基胺基烷基丙 稀酸酿、具有8至2〇個碳原子之二烷基胺基烷基甲基丙 烯鲛8曰、具有7至20個碳原子之二烷基胺基烷基丙烯酸 醋、及具有3至1〇個碳原子之氺乙烯基烷基醯胺組成之 群。 3. 如凊求項1之溶液,其中該隱形眼鏡係聚矽氧水凝膠隱 形眼鏡。 4. 如明求項2之溶液’其中該含胺基乙烯系單體係二甲基 月女基乙基甲基丙烯酸酯或二甲基胺基乙基丙烯酸酯。 5,如研求項1之溶液’其中該溶液在25。(:下具有高至約2.0 厘泊之黏度。 151304.doc v 201130524 6.如請求項1之溶液,其進一步包括選自由甲基纖維素 (methyl cellul〇se ; MC)、乙基纖維素、羥曱基纖維素、 經乙基纖維素(hydroxyethyl cellulose ; HEC)、經丙基纖 維素(hydroxypropylcellulose ; HPC)、經丙基甲基纖維素 (hydroxypr〇pyimethyl cellulose; HPMC)及其混合物組成 之群之增黏劑。 7. 如請求項1之溶液’其中該增黏劑之濃度以該溶液總重 量計係約0.00 1重量%至約0.5重量%。 8. 如請求項1之溶液,其進一步包括選自由磷酸鹽緩衝劑 及硼酸鹽缓衝劑組成之群之緩衝劑。 9. 如請求項1之溶液,其進一步包括選自由1 7r4 及?丨虹〇114?1〇3組成之群之界面活性劑。 10. 如請求机溶液’其中該過氧化物之濃度以該溶液總 重量計係約3%。 11.如㈣求項丨之溶液,其中該乙烯基吡咯啶_之均聚物 共聚物之濃度以3M立體積重量計係約0.1%至5%(_)。 12·如請求IM11之溶液,其巾該乙料㈣朗之均聚物 共聚物之濃度以單位體積重# 置si係約0.25% 1.50/〇(w/v) 0 13_如請求項丨之溶液’其中該經增加的殘餘過氧化5 係至少35%。 乳' 14.如請求項1之溶液,其中該經增加的殘餘 係至少50%。 1 5 —種消毒隱形眼鏡之方法,其包括 驟.(a)使隱形眼 151304.doc 201130524 與含以下組份的水溶液接觸:有效消毒量的過氧化氫與 乙烯基°比咯啶酮之均聚物或共聚物’其中該乙烯基。比咯 啶鲷之均聚物或共聚物係以相對於在相同觸媒存在下不 含乙烯基。比咯啶酮之均聚物或共聚物之具有相同組合物 之對照溶液,足以提供至少20%之增加殘餘過氧化氫濃 度之量存在;及其量足以提供該組合物約6〇至8〇的pH 之一或多種緩衝劑, 其中該組合物具有約200至約450 mOsm/kg之渗透壓及 在25°C下高至約5.0厘泊之黏度;及 (b)藉由催化分解作用中和該過氧化氫。 16. 如請求項15之消毒隱形眼鏡之方法,其中該中和步驟包 括使s亥溶液與金屬觸媒接觸。 17. 如吻求項15之方法,其中該經增加的殘餘過氧化氫濃度 係至少3 5 %。 18. 如明求項丨5之方法,其中該經增加的殘餘過氧化氫濃度 係至少5〇〇/。。 19. 如請求項16之消毒隱形眼鏡之方法,其中該金屬觸媒係 始。 20. 如請求項16之消毒隱形眼鏡之方法,其中該金屬觸媒係 Fenton試劑或鉑與Fent〇n試劑之組合。 151304.doc 201130524 四、指定代表圖: (一) 本案指定代表圖為:(無) (二) 本代表圖之元件符號簡單說明: 五、本案若有化學式時,請揭示最能顯示發明特徵的化學式: (無) 151304.doc201130524 VII. Patent Application Range: A solution for a 4-toxic contact lens comprising an effective disinfecting amount of a hydrogen peroxide and a homopolymer or copolymer of vinylpyrrolidone, wherein the ethyl thiopyrrolidone The homopolymer or copolymer is sufficient to provide at least a 20% increase in residual peroxidation relative to a control solution having the same composition as a homopolymer or copolymer of vinylpyrrolidone in the presence of the same catalyst. An amount of hydrogen concentration is present; and an amount sufficient to provide one or more buffers of the composition at a pH of from about 6 Torr to about 8.0, wherein the composition has an osmotic pressure of from about 2 Torr to about 450 mOsm/kg and at 25 . The squat is as high as about 5 〇 centipoise. 2. The solution according to claim 1, wherein the solution comprises a copolymer of vinylpyrrolidone and at least one amino group-containing vinyl monomer, wherein the amino group-containing vinyl system is selected from the group consisting of 8 to 15 Alkylaminoalkyl methacrylate of a carbon atom, alkylaminoalkyl acrylate having 7 to 15 carbon atoms, dialkylaminoalkyl group having 8 to 2 carbon atoms A group consisting of a propylene group of 8 Å, a dialkylamino acrylate acrylate having 7 to 20 carbon atoms, and a fluorenyl vinyl decylamine having 3 to 1 carbon atoms. 3. The solution of claim 1, wherein the contact lens is a polyoxygenated hydrogel contact lens. 4. The solution of claim 2, wherein the amino-containing vinyl system is monomethyl montethyl ethyl methacrylate or dimethylaminoethyl acrylate. 5. The solution of claim 1 wherein the solution is at 25. (: having a viscosity of up to about 2.0 centipoise. 151304.doc v 201130524 6. The solution of claim 1, further comprising a solution selected from the group consisting of methyl cellulose (MC), ethyl cellulose, Hydroxymethyl cellulose, hydroxyethyl cellulose (HEC), hydroxypropylcellulose (HPC), hydroxypr〇pyimethyl cellulose (HPMC) and mixtures thereof 7. A tackifier. The solution of claim 1 wherein the concentration of the tackifier is from about 0.001% to about 0.5% by weight based on the total weight of the solution. 8. The solution of claim 1 further A buffer selected from the group consisting of a phosphate buffer and a borate buffer. 9. The solution of claim 1, further comprising a group selected from the group consisting of: 17r4 and 丨 rainbow 〇 114 〇 1 〇 3 Surfactant 10. If the machine solution is requested, the concentration of the peroxide is about 3% based on the total weight of the solution. 11. (4) The solution of the solution, wherein the vinyl pyrrolidine _ homopolymer The concentration of the copolymer is based on the weight of 3M About 0.1% to 5% (_). 12. If the solution of IM11 is requested, the concentration of the homopolymer of the material of the material (4) is in the unit volume and the weight is about 0.25% 1.50/〇 (w/ v) 0 13_ as the solution of the claim ' 'where the increased residual peroxidation 5 is at least 35%. Milk ' 14. The solution of claim 1 wherein the increased residue is at least 50%. - A method of disinfecting a contact lens, comprising the steps of: (a) contacting the contact lens 151304.doc 201130524 with an aqueous solution containing the following components: an effective disinfecting amount of hydrogen peroxide and a homopolymer of vinylpyrrolidone Or a copolymer wherein the vinyl group. The homopolymer or copolymer of the pyridinium is the same as the homopolymer or copolymer of the pyrrolidone in the absence of a vinyl group in the presence of the same catalyst. a control solution sufficient to provide at least a 20% increase in residual hydrogen peroxide concentration; and an amount sufficient to provide one or more buffers of the composition at a pH of from about 6 to 8 Torr, wherein the composition has about An osmotic pressure of from 200 to about 450 mOsm/kg and a viscosity of up to about 5.0 centipoise at 25 ° C; (b) neutralizing the hydrogen peroxide by catalytic decomposition. 16. The method of disinfecting a contact lens of claim 15, wherein the neutralizing step comprises contacting the s-hai solution with a metal catalyst. The method of 15, wherein the increased residual hydrogen peroxide concentration is at least 35 %. 18. The method of claim 5, wherein the increased residual hydrogen peroxide concentration is at least 5 Å. . 19. The method of disinfecting a contact lens of claim 16, wherein the metal catalyst is initiated. 20. The method of disinfecting a contact lens of claim 16, wherein the metal catalyst is a Fenton reagent or a combination of platinum and Fent〇n reagent. 151304.doc 201130524 IV. Designated representative map: (1) The representative representative of the case is: (none) (2) The symbol of the symbol of the representative figure is simple: 5. If there is a chemical formula in this case, please reveal the best indication of the characteristics of the invention. Chemical formula: (none) 151304.doc
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