1222369 玖、發明說明 【發明所屬之技術領域] 本發明有關於隱形眼鏡的單一步驟保存方法。該方法 可使元眼叙片於保存時加以消毒並隨即進行中和，從而 5不必再經清洗即可直接放入眼睛使用。 【先前技術】 、關於隱形眼鏡的保存消毒問題，通常所知借助於諸如 過氧化氫等氧化體系殺菌確實是最有效與最安全。如盥使 用含有殺菌劑(乙基汞硫代水楊酸鈉、雙氯苯雙脈己烷等) 10消毒液所發費的時間（同常為6至8小時）作比較，由儿於其 較快之消毒時間（對3%過氧化氫溶液要求15分鐘），其安 全性得以加強。 〃 隱形眼鏡一旦經過過氧化氫溶液消毒，必須再將之浸 泡於能分解（或中和）其中殘留之過氧化物的中性鹽水中。 15大部分製造商係於此等中和溶液中使用過氧化氫酶，以使 該隱形眼鏡得於15分鐘内裝置於眼睛上。 此等含有過氡化氫消毒液與中和劑溶液之傳統體系一 般稱為兩步驟體系，對使用者而言，必須繼續用中和劑替 換消毒液。 2〇 最近，Allergan使用具有相同功能之片劑以取代中和 溶液，亦即隱形眼鏡一旦使用過氧化物溶液進行消毒，即 可將所有過氧化氫失活，並將溶液轉化為與眼晴相容之介 質的片劑摻入相同之溶液中。此種新體系因有使用者介入 而也可稱之為兩步驟體系。 25回續次頁 5 1222369 發明說明續頁1222369 发明 Description of the invention [Technical field to which the invention belongs] The present invention relates to a single-step storage method for contact lenses. This method can make the Yuanyanxu disinfection during storage and then neutralize it, so that it can be used directly in the eyes without washing. [Prior art] Regarding the preservation and disinfection of contact lenses, it is generally known that sterilization by means of an oxidizing system such as hydrogen peroxide is indeed the most effective and safest. For example, if the toilet uses a disinfectant containing ethylmercury thiosalicylic acid, dichlorobenzene and dipulse hexane, etc., 10 the time spent (usually 6 to 8 hours) on the disinfection solution is compared with Faster disinfection time (requires 15% for 3% hydrogen peroxide solution), its safety is enhanced.一旦 Once the contact lenses have been sterilized with a hydrogen peroxide solution, they must be immersed in a neutral saline solution that can decompose (or neutralize) the peroxide remaining in them. 15 Most manufacturers use catalase in these neutralization solutions to get the contact lens on the eye within 15 minutes. These traditional systems containing hydrogen peroxide disinfectants and neutralizer solutions are generally called two-step systems. For users, they must continue to replace the disinfectant with a neutralizer. 2 Recently, Allergan uses tablets with the same function to replace the neutralization solution, that is, once the contact lens is sterilized with a peroxide solution, all hydrogen peroxide can be inactivated, and the solution is converted into a clear eye phase. The tablets of the contained medium are incorporated in the same solution. This new system can also be called a two-step system due to user intervention. 25Next Continued 5 1222369 Description of Invention Continued
Ciba Geigy公司已向市 氣消毒液倒入帶有能始過氧 中。該體系與前一種體系不 包含一步驟。 場推出一種體系，即將過氧化 化物失活的塗有鉑黑環之容器 同’以使用者毋庸介入，而僅 然而，鉑環一開始就馬上分解過氧化物，沒有足夠時 間以保證消毒，因此而受到嚴厲貴難。所謂單步驟體系可 見於例如EP-A-0209071 (歐洲專利申請861〇9361 $ )中，Ciba Geigy has poured commercial disinfectant into the air with a starting oxygen. This system does not include a step from the previous system. In the field, a system was introduced, in which a container coated with a black platinum ring was deactivated with the same peroxide as the user. However, the platinum ring immediately decomposed the peroxide without sufficient time to ensure disinfection. And severely expensive. The so-called single-step system can be found in, for example, EP-A-0209071 (European patent application 860099361 $),
而在其他發明中也曾提到與本案相似的體系，惟尚無申請 1〇專利提到隱形眼鏡實際上可於保存處理後直接裝置於眼晴 上。事實上，對於酸性介質提到的塗層是二甲基氨基甲基 丙缔酸酯聚合物與中性甲基丙烯酸酯，由於彼等非常刺激 眼晴，而必須徹底清洗眼鏡。至於中性介質，可參考塗覆 劑，因其刺激性或不溶性，而使得眼鏡在使用前必須再加 15清洗。於此兩種情況下，隨後清洗眼鏡乃是各該單步驟體 系之缺點。 【發明內容】In other inventions, a system similar to the present case has been mentioned, but there is no application yet. 10 The patent mentions that the contact lens can actually be directly installed on the eye after storage and treatment. In fact, the coatings mentioned for acidic media are dimethylaminomethyl acrylate polymers and neutral methacrylates, as they are very irritating to the eyes and must be washed thoroughly. As for the neutral medium, please refer to the coating agent. Because of its irritation or insolubility, the glasses must be washed for 15 more times before use. In both cases, subsequent cleaning of the spectacles is a disadvantage of the one-step system. [Summary of the Invention]
本發明所特別強調無需隨後清洗眼鏡，乃是本發明之 顯著優點與改進。而且對20人進行兩個月之測試與臨床 20觀察，顯示本發明所描述之體系與人類眼睛完全相容。 本發明之體系涉及單-步驟，由於使用人無需介入即 可處理眼睛。片劑之特性使過氧化物之消毒與中和過程不 同時進行，而是在消毒後始進行中和，此乃超越鉑環體系 之明顯優點。 25 [V]續次頁 1222369 發明說明I賣頁 本發明係關於隱形眼鏡之消毒、歷潤與中和的方法。 ^體，言:其包括於儲存隱形眼鏡之容器中，同時接人過 氧化氫/合履（消毒液）與含有活性過氧化物酶㈠蜀媒）的片 5 J 〃可在兩小時内疋成二件事:即其可將隱形目艮晴消毒、 澄潤，並且將介質轉化成為與眼晴可以完全相容之鹽水溶 液。 /精由在中和片劑表面所作之特殊塗覆，一旦眼鏡消毒 後U即開始中和、澄潤作用，以潤滑隱形眼鏡，並將 10溶液轉化成pH值為7·2:4的等渗透壓鹽水，不需要清洗 即^直接裝置於眼腈上。過氧化氫消毒劑溶液還含有防止 過虱化物分解的穩定劑（例如乙醯氨基苯乙醚）與緩沖劑 (例如磷酸單鈉）。 該片劑還含有過氧化物中和劑成分、氯化鈉（其比例 15能將1〇ml消毒液轉化成等滲透壓溶液）與磷酸單鈉（其含 里足以將ρΗ3·0的該l〇mi過氧化物消毒劑溶液轉化成7 2· 7.4 的 pH值）。 片劑塗層包括可溶於劑質的聚合物聚乙烯吡咯烷酮， 其添加量足以延遲過氧化物中和反應約1 5分鐘。塗層之 20塗覆可採用簡單的方法，諸如將聚合物喷塗在具有抽吸裝 置的谷器上；或採用諸如流化床、Accela cota、Pellegrini 等更谷易控制的方法以獲得塗層。聚合物喷塗需要使用諸 如無菌水、乙醇、異丙醇、二氯甲烷、丙酮的溶劑。 在本發明之實施方式中，片劑的塗層還包括著色劑。 25 0續次頁 7 1222369 具m吕之，所採用之著色劑是維生素β2，係一種光敏 化合物，其特徵是使溶液變成亮黃色，並通過光降解變成 無色。 5 本發明片劑中使用著色劑，係讓使用者知道何時可以 使用隱形眼鏡。具體言之，夕卜塗層中所含之著色劑可使乂其 顏色的變化檢測更容易與快速。此外，由於該著色劑^ 合物並不與核心成分緊密混合，著色劑不會被該成分降 解’以避免其對顏色檢測之干擾。10【實施方式】 本發明整個方法之實施可描述如下： 於存放隱形眼鏡之容器裝有10ml消毒劑溶液盘中和 片劑。於前10分鐘分’該溶液將眼鏡消毒，且該片劑塗 層會緩慢溶解。經過10或15分鐘後，開始少量中和反應 並在15-17分鐘後達到定導。再過10_25分鐘，即可: 全部中和反應。60分鐘後，片劑完全溶解，該隱形：鏡 於是即可取出使用。 片劑組合物 過氧化物消毒劑溶液與中和劑片劑適用之區間如下： 消毒劑溶液 2.8-3.5%w/v 過氧化氫 (U-o.3%w/v 鱗酸單鋼 χ2Η2〇 0-008-0.015O/OW/V 乙酶氨基苯乙酸 用37%鹽酸調節到pH為2.8-3 2。 25 0續次頁 劑 15 成 鲁 20 8 發明說明續頁 中和劑片劑 (對於10ml消毒劑溶液） 5 0-7 〇mg 5 6〇-i〇〇mg 2080-5400UI 60-11 Omg 〇.025-0.25mg 氯化納 磷酸二鈉 x 2H2〇 凍乾的過氧化氫酶 聚乙烯叱咯烷酮（塗層聚合物） 維生素B2 以下是實施本發明的若干實施例： 10 實施例1 消毒劑溶液 3.2%w/v 〇 .20%w/v 〇.〇13%w/v 過氧化氫 磷酸單鈉χ2Η20 乙醯氨基苯乙醚 15用37%鹽酸調節到邱為3 〇。 中和劑片劑 (對於10nU消毒劑溶液） 58m§ 氯化鈉 20 72mg 4000UI 90mg 鱗酸二鈉x 2H20 凍乾的過氧化氫酶 聚乙婦峨咯烷酮（塗層聚合物） 實施例2 消毒劑溶液 3-〇%w/v 過氧化氫 25 pi續次頁 [222369 發明說明續頁 0.22%w/v 磷酸單鈉 χ2Η20 0.009%w/v 乙醯氨基苯乙醚 用37%鹽酸調節到pH為3.0。 5 中和劑片劑 (對於1 0 m 1消毒劑溶液） 68mg 氯化鈉 75m§ 磷酸二鈉 χ2Η20 2700UI 凍乾的過氧化氫酶 10 15The particular emphasis of the present invention on the need for subsequent cleaning of the glasses is a significant advantage and improvement of the present invention. Moreover, two months of testing and clinical observation on 20 people show that the system described in the present invention is completely compatible with human eyes. The system of the present invention involves a single step because the user can handle the eyes without intervention. The characteristics of the tablet make the disinfection and neutralization of peroxides not at the same time, but the neutralization after disinfection, which is a clear advantage over the platinum ring system. 25 [V] Continued Page 1222369 Description of the Invention I Selling Page This invention relates to a method for disinfecting, aging and neutralizing contact lenses. ^ Body, language: It is included in a container for storing contact lenses, and simultaneously receives hydrogen peroxide / hypertensive (disinfectant) and a tablet containing active peroxidase (Shu media) 5 J 〃 in two hours 疋Two things: it can sterilize and moisturize the invisible eyes, and transform the medium into a saline solution that is completely compatible with the eyes. / Essence is a special coating made on the surface of the neutralizing tablet. Once the lenses are disinfected, U will start neutralizing and smoothing to lubricate the contact lenses and convert the 10 solution into a pH of 7 · 2: 4 etc. Osmotic saline does not need to be washed and is directly installed on the eye nitrile. Hydrogen peroxide disinfectant solutions also contain stabilizers (such as acetoaminophenyl ether) and buffers (such as monosodium phosphate) to prevent decomposition of lice compounds. The tablet also contains a peroxide neutralizer component, sodium chloride (a ratio of 15 can convert 10 ml of disinfection solution into an isotonic solution) and monosodium phosphate (the content of which is sufficient to convert ρΗ3.0 〇mi peroxide disinfectant solution was converted to a pH of 7 2 · 7.4). The tablet coating comprises a polymer, polyvinylpyrrolidone, which is soluble in the dosage, and is added in an amount sufficient to delay the peroxide neutralization reaction for about 15 minutes. Coating 20 can be applied by simple methods, such as spraying polymer on a trough with suction device; or by more controlled methods such as fluidized bed, Accela cota, Pellegrini, etc. to obtain the coating . Polymer spraying requires solvents such as sterile water, ethanol, isopropanol, dichloromethane, and acetone. In an embodiment of the invention, the coating of the tablet further comprises a colorant. 25 0 Continued on page 7 1222369 The coloring agent used is vitamin β2, which is a photosensitive compound that is characterized by making the solution bright yellow and colorless by photodegradation. 5 The use of coloring agents in the tablets of the present invention is to let the user know when it is possible to use contact lenses. Specifically, the coloring agent contained in the Xibu coating can make its color change detection easier and faster. In addition, since the colorant is not intimately mixed with the core component, the colorant will not be degraded by the component 'to avoid interference with color detection. [Embodiment] The implementation of the entire method of the present invention can be described as follows: The container for storing contact lenses is filled with a 10ml disinfectant solution and the tablets are neutralized. The solution sterilizes the lenses in the first 10 minutes, and the tablet coating slowly dissolves. After 10 or 15 minutes, a small amount of neutralization reaction was started and the homing was reached after 15-17 minutes. After 10_25 minutes, you can: all neutralize the reaction. After 60 minutes, the tablet is completely dissolved and the invisible: mirror is now ready for use. The application range of the tablet composition peroxide disinfectant solution and neutralizer tablet is as follows: Disinfectant solution 2.8-3.5% w / v hydrogen peroxide (Uo. 3% w / v scale acid single steel χ 2Η200- 008-0.015O / OW / V Acetylaminophenylacetic acid was adjusted to a pH of 2.8-3 with 37% hydrochloric acid. 25 0 Continuation sheet 15 Cheng Lu 20 8 Description of the invention Continuation sheet neutralizer tablets (for 10ml disinfection Agent solution) 5 0-7 〇mg 560-IO〇mg 2080-5400UI 60-11 Omg 025-0.25mg disodium sodium phosphate x 2H20 lyophilized catalase polyvinylpyrrol Alkanone (coating polymer) Vitamin B2 The following are some examples of implementing the present invention: 10 Example 1 Disinfectant solution 3.2% w / v 0.20% w / v 〇.13% w / v hydrogen peroxide Monosodium phosphate χ 2Η20 Ethylaminophenyl ether 15 Adjusted to 37 with 37% hydrochloric acid. Neutralizer tablets (for 10nU disinfectant solution) 58m§ Sodium chloride 20 72mg 4000UI 90mg Disodium linoleate x 2H20 Lyophilized Catalase polyethynone (coating polymer) Example 2 Disinfectant solution 3-0% w / v Hydrogen peroxide 25 pi Continued on page [222369 Description of the invention continued on 0.22% w / v Monosodium phosphate χ2Η20 0.009% w / v Ethylaminophenyl ether was adjusted to pH 3.0 with 37% hydrochloric acid. 5 Neutralizer tablets (for 10 m 1 disinfectant solution) 68mg sodium chloride 75m§ Disodium phosphate χ2Η20 2700UI Freeze-dried Catalase 10 15
100mg 聚乙婦吡咯烷酮（塗層聚合物） 〇_〇75mg 維生素B2 當這兩種配方對隱形眼鏡進行消毒時，在經過對於不 同人群進行兩百次試驗後，發現使用者可將眼鏡直接裝置 於眼晴上，而不會感覺到任何不適，甚至比以前用其他過 氧化物消毒體系感覺更為舒服。 罝注意者乃此等實施例係供作說明而非限制本發明，100mg polyvinylpyrrolidone (coating polymer) 〇_〇75mg Vitamin B2 When these two formulas disinfect contact lenses, after two hundred tests on different groups of people, they found that users can directly mount the glasses on Eyes clear without any discomfort, even more comfortable than before with other peroxide disinfection systems.罝 Note that these examples are provided for illustration and not for limiting the present invention,
而上述說明理當已充分描述本發明之特質。 10However, the above description should fully describe the characteristics of the present invention. 10