483934 經濟部中央標準局貝工消費合作社印^ A7 B7 五、發明説明(1 ) 本發明係有關一種單一步驟的隱形眼鏡淸潔消毒方 法,及其延釋性過氧化物破壞劑組成物’尤指一種可同時 顯示中和反應起始點之消毒方法,及其延釋性氧化物破壞 組成物。 隱形眼鏡必須經常的淸潔及消毒,以防止因爲配戴隱 形眼鏡所引起的感染。不適當的消毒會引起細菌及黴菌的 污染。一般而言,因細菌污染所引起的眼睛病變,可由最 輕微的紅眼症至最嚴重的失明。Pseudomonas aeroginosa是一般最常引起眼睛感染的細菌,因它可穿 過受損的眼角膜而造成角膜潰瘍。這種細菌所造成的角膜 感染,約佔因配戴隱形眼鏡所造成角膜潰瘍的2 / 3〜3 / 4左 右。 目前有二種方式可用於軟式隱形眼鏡的消毒上。第一 種爲”熱式消毒法",此法是使用加熱的方式來消毒隱形眼 鏡。另一種爲”冷式化學消毒法’’,是使用化學消毒劑來達 致殺菌的效果。在冷式化學消毒法中,因爲過氧化氫的特 殊化學特性,可被分解爲氧氣及水,而値得我們特別硏 究。若過氧化氫未被完全中和或破壞,則殘留在隱形眼鏡 上的過氧化氫會對眼睛造成刺痛,而引起燒灼感、眼睛紅 腫,甚至造成眼球受損。所以隱形眼鏡消毒後,過氧化氫 必須要完全的被破壞掉,以確保使用者的舒適、安全,除 此之外,其他例如操作的簡易程度及過氧化氫的破壞有效 程度都會影響到配戴者的使用依從性。是故發展一種簡易 的單一步驟過氧化氫消毒法乃有其必要性,以增進使用者 本紙張尺度適用中國國家標準(CNS ) Α4規格(210Χ 297公釐) (請先閱讀背面之注意事項再填寫本頁) -483934 Printed by the Shellfish Consumer Cooperative of the Central Bureau of Standards, Ministry of Economic Affairs ^ A7 B7 V. Description of the invention (1) The present invention relates to a single-step disinfection method for contact lenses, and its extended release peroxide destroyer composition. Refers to a disinfection method that can simultaneously show the starting point of a neutralization reaction, and its extended release oxide destroying composition. Contact lenses must be cleaned and disinfected frequently to prevent infections caused by contact lenses. Improper disinfection can cause bacterial and mold contamination. Generally speaking, eye lesions caused by bacterial contamination can range from the slightest red eye to the most severe blindness. Pseudomonas aeroginosa is the most common bacteria that cause eye infections. It can penetrate the damaged cornea and cause corneal ulcers. Corneal infections caused by this kind of bacteria account for about 2-3 to 3/4 of corneal ulcers caused by wearing contact lenses. There are currently two ways to disinfect soft contact lenses. The first is "thermal disinfection method", which uses heat to disinfect contact lenses. The other is "cold chemical disinfection method", which uses a chemical disinfectant to achieve a sterilization effect. In the cold chemical disinfection method, because of the special chemical properties of hydrogen peroxide, it can be decomposed into oxygen and water, which made us special research. If the hydrogen peroxide is not completely neutralized or destroyed, the hydrogen peroxide remaining on the contact lenses can cause tingling in the eyes, causing burning sensation, redness and swelling of the eyes, and even damage to the eyes. Therefore, after disinfection of contact lenses, hydrogen peroxide must be completely destroyed to ensure the comfort and safety of the user. In addition, other factors such as the ease of operation and the effectiveness of the destruction of hydrogen peroxide will affect the wearing Use compliance. Therefore, it is necessary to develop a simple single-step hydrogen peroxide disinfection method to improve the user's standard. This paper applies the Chinese National Standard (CNS) A4 specification (210 × 297 mm). (Please read the precautions on the back first. (Fill in this page)-
、1T 483934 A7 _____B7 五、發明説明(2 ) 的方便及安全,從而提高他的使用依從習性。 (請先閱讀背面之注意事項再填寫本頁) 已知之單一步驟過化氫消毒方法,例如美國專利第 4568517、4767559 ' 5011661 和 5145644 號專利, 唯該等專利均係採用覆膜式錠劑(coated tablet)作爲具 有延釋功能之過氧化氫破壞劑。該等技術之共通缺點爲: 1·製造過程較複雜,係經製錠程序(tableting process)將原料製成裸錠,再經覆膜程序(co a ting process)製成覆膜式錠劑,爲二步驟製程。 2 .成本較高。 3.易因製程或品管不當或疏忽,保存期間或使用前/ 使用中使用不當,造成針孔/裂痕/缺角等,使覆膜不 全,形成延釋功能不足或喪失。 基於傳統覆膜式錠劑的缺點,發明人改採一般打錠 劑。本發明之錠劑,係由原料,經單一程序(製錠程序)直 接製成錠劑,由此製程相對較簡單,成本較低,也不會有 上述覆膜式錠劑因爲針孔/裂痕/缺角所造成之延釋功能 不足或喪失等缺點。 經濟部中央標準局員工消費合作社印掣 本發明打錠劑之延釋成分係均勻分佈在整個錠劑,而 傳統覆膜式銳劑,主要係藉由外層之覆膜(coating)作爲 阻滯劑,二者爲不同之設計理念,其依循之釋出模式亦不 相同。 本發明之一目的,在提供一種兼具中和反應起始點顯 示功能之單一步驟隱形眼鏡淸潔消毒方法。 本發明之另一目的,在提供一種兼具中和反應起始點 一 4 - 本紙張尺度適用中國國家標準(CNS ) Α4規格(210Χ297公釐) 經濟部中央標準局貝工消費合作社印^ A7 B7 1、發明説明(3 ) 顯示功能和延釋功效的過氧化物破壞劑、片劑、錠劑或九 劑。 本發明的隱性眼鏡淸潔消毒方法,係採用傳統的冷式 化學消毒法,以含適當量過氧化物的隱形眼鏡淸潔消毒 液,對隱形眼鏡進行淸潔、消毒和殺菌,並在鏡片置入淸 潔消毒液時,實質上同時加入一具有延釋功效的過氧化物 破壞劑之錠劑、片劑或九劑,其特徵在該錠劑、片劑或九 劑爲一般打錠劑/片劑/九劑,且其中含著色劑作爲中和 反應起始點顯示劑。 上述含當量過氧化物的隱形眼鏡淸潔消毒液,可爲購 自市面上或自已配製,含過氧化物的隱形眼鏡淸潔消毒 液、其混合液或稀釋液,由購自市面上的隱形眼鏡淸潔消 毒粉劑、片劑、錠劑、九劑或類似固態產品所配製的溶 液,或以適當量的過氧化物,配合適當的各種單劑配製而 成的隱形眼鏡淸潔消毒液,其過氧化物的含量,以能達到 淸潔消毒效果爲準,一般而言,過氧化物含量以能在3小 時內減少9 0 %以上微生物負荷較佳,以能在1小時內減 9 0 %微生物負荷爲更佳,以能在1 〇分鐘內減少9 0 %微生 物負荷爲尤佳。 上述過氧化物的種類,爲適用於隱形眼鏡淸潔消毒用 途的任意過氧化物,例如雙氧水、溫氧化鈉、過氧醋酸 (peracetic)等 〇 上述所謂”實質上同時加入”,意指同時加入成幾乎同 時加入。若含過氧化物之隱形眼鏡淸潔消毒液係由粉劑、 本紙張尺度適用中國國家標準(CNS ) A4規格(210X297公釐) (請先閱讀背面之注意事項再填寫本頁)1T 483934 A7 _____B7 V. The convenience and safety of the invention description (2), thereby improving his usage and compliance. (Please read the notes on the back before filling this page) Known single-step hydrogen sterilization methods, such as U.S. Pat. Nos. 4,568,517, 4,767,559, 5011661, and 5,145,644, but these patents are all coated tablets ( coated tablet) as a hydrogen peroxide destroying agent with a delayed release function. The common disadvantages of these technologies are: 1. The manufacturing process is more complicated. The raw materials are made into bare ingots through the tabletting process, and then the coated tablets are made through the co a ting process. For a two-step process. 2. Higher cost. 3. Due to improper or negligent manufacturing process or quality control, improper use during storage or before / during use, resulting in pinholes / cracks / notches, etc., causing incomplete film, resulting in insufficient or loss of extended release function. Based on the disadvantages of the traditional film-coated tablets, the inventors switched to general tablets. The lozenges of the present invention are directly made into lozenges from a raw material through a single process (ingot making process), so the manufacturing process is relatively simple, the cost is low, and the film-covered lozenges described above will not have pinholes / cracks. / Inadequate or loss of extended function caused by missing corners. The Consumers' Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs of the People's Republic of China printed the extended release ingredients of the tableting agent of the present invention uniformly distributed throughout the tablet, while the traditional film-type sharpening agent mainly uses the outer coating as a retarder. The two are different design concepts, and the release models they follow are also different. It is an object of the present invention to provide a single-step method for cleaning and disinfecting contact lenses which has a function of displaying the neutralization reaction starting point. Another object of the present invention is to provide a neutralization reaction starting point 4-This paper size is applicable to the Chinese National Standard (CNS) A4 specification (210 × 297 mm) Printed by the Bayer Consumer Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs ^ A7 B7 1. Description of the invention (3) Peroxide destroying agent, tablet, lozenge, or nine doses showing function and extended release effect. The contact lens cleaning and disinfection method of the present invention adopts a traditional cold chemical disinfection method to clean, disinfect and sterilize contact lenses with a contact lens cleaning and disinfecting solution containing an appropriate amount of peroxide, and applies the contact lens to the lens. When the sanitary disinfection solution is placed, a tablet, tablet or nine tablets of a peroxide-breaking agent with a delayed release effect are substantially added at the same time, which is characterized in that the tablets, tablets or nine tablets are ordinary tabletting tablets / Tablet / nine, and contains a colorant as a neutralization reaction starting point indicator. The above contact lens cleaning solution containing equivalent peroxide can be purchased from the market or self-made. The contact lens cleaning solution containing peroxide, its mixed solution or diluent can be purchased from the contact lens on the market. Contact lens cleaning and disinfecting solution prepared by spectacle disinfection powder, tablet, lozenge, nine doses or similar solid products, or a suitable amount of peroxide and appropriate various single agents, The content of peroxide is subject to the effect of disinfection. Generally speaking, the content of peroxide is preferably to reduce the microbial load by more than 90% in 3 hours, and to reduce 90% in 1 hour. The microbial load is more preferable, and the microbial load can be reduced by 90% in 10 minutes. The type of the peroxide is any peroxide suitable for use in cleaning and disinfecting contact lenses, such as hydrogen peroxide, warm sodium oxide, peracetic acid, etc. The above-mentioned "substantially simultaneous addition" means simultaneous addition Cheng joined almost simultaneously. If the peroxide-containing contact lens cleaning solution is made of powder, the paper size applies the Chinese National Standard (CNS) A4 specification (210X297 mm) (Please read the precautions on the back before filling this page)
、1T 483934, 1T 483934
瑣請委負: ,否§::,:32.原實質内容 經濟部中央標隼局貝工消費合作社印聚 片劑、錠劑、九劑等類似固態產品配製成溶液時,則以配 製成溶液時爲準。 上述所謂π過氧化物破壞劑”,意指可破壞過氧化物的 試劑或ι4,諸如過氧化物還氧劑,例如硫代硫酸鹽類、亞 硫酸鹽類、硫代甘油(thiogiycero1)或其鹼金屬鹽類、 硫代尿素(thiourea)、維生素 C(Ascorbic acid)、異 維生素C(iso-ascorbic acid)、N -乙醯基半胱胺酸(N-acetylcystenine)、乙醛酸(glyoxylic acid)等;去 過氧化物_(Peroxidase)、例如過氧化氫_(catalase) 等,或其混合物或組成物。 上述過氧化物破壞劑之劑量,以能在釋出後的預定時 間內,將隱形眼鏡淸潔消毒液中殘存的過氧化物破壞掉爲 準,因此,其用量依所用的隱形眼鏡淸潔消毒液中過氧化 物的含量而定,一般而言,過氧化物破壞劑的濃度(以過 氧化氫爲例),以約1 〇 〇至約 250I.U./%(W/V)H2〇2/ml 爲較佳,以約 150 至約 2 0 0Ι·υ·/%(〜/乂)112〇2/1111爲更佳。 若將上述過氧化物破壞劑,直接和含過氧化物的隱形 眼鏡淸潔消毒液混合,則該等過氧化物破壞劑立刻和過氧 代物反應,使隱形眼鏡淸潔消毒液中的過氧化物分解而不 再具有淸潔消毒功能。因此,傳統方法係使隱形眼鏡鏡片 在含過氧化物的淸潔消毒液中浸泡一段時間(達到淸潔消 毒目的)後,再加入過氧化物破壞劑,對使用者而言,相 當不方便。據此,發明人提出一種具有延釋功能的片劑、 一 6 - (請先閲讀背面之注意事項再填寫本頁) #1衣· 、-ιτ 本紙張尺度適用中國國家標準(CNS>A4規格(210Χ297公# ) 483934 A7 B7__ 五、發明説明(5 ) 綻劑或或九劑組成物,讓使用者在配好隱形眼鏡淸潔消毒 液,置入隱形鏡片時,實質上同時加入本發明具有延釋功 能的片劑、錠劑或九劑。利用片劑、錠劑或九劑的崩散時 間達到延釋功能。亦即讓本發明的片劑、錠劑或九劑,在 隱形鏡片在含過氧化物的淸潔消毒液中達到淸潔消毒效果 時,才崩散並釋出其中所含的過氧化物破壞劑,開始分解 淸潔消毒液中殘存的過氧化物,同時,由溶出之著色劑之 顏色,顯示中和反應(即破壞過氧化物反應)開始。 爲達成過氧化物破壞劑在隱形眼鏡淸潔液中的延釋功 效,可將上述過氧化物破壞劑,和賦形劑、黏合劑 (binders)及/或崩散劑(disintegrants)混合製成錠 劑、片劑或九劑。必要時,尙可加入適當量的稀釋劑 (d i 1 u e n t s )、潤滑劑(1 u b r i c a n t s )、隱形眼鏡用淸潔 劑、潤混保養齊!l(wetting/conditioning agents)、滲 透壓調整劑(tonicity agents)、冒泡劑(effervescent reagents)、酸驗度緩衝劑等。 經濟部中央標準局貝工消費合作社印製 (請先閱讀背面之注意事項再填寫本頁) 上述賦形劑、黏合劑和崩散劑的含量依所需的崩散時 間而定。崩散時間則依隱形眼鏡淸潔液配方而定。若淸潔 消毒液中,過氧化物含量高,則淸潔消毒效果可以迅速達 成,因此延釋時間應該比較短,亦即黏合劑的含量相對較 低或崩散劑約含量相對較高,同時,因爲殘有的過氧化物 含量較高,因此過氧化物破壞劑含量應該較高。反之,若 淸潔消毒液中,過氧化物含量較低,則延釋時間應較長, 亦即黏合劑含量應較高或崩散劑含量較低,而殘存的過氧 一 飞 一 本紙張尺度適用中國國家標隼(CNS) A4規格(21〇X297公釐) 483934 A7 B7 五、發明説明(6 ) 化物含量較低,所以過氧化物破壞劑含量宜較低。一般而 言,淸潔消毒時間爲一分鐘至十二小時,以五分鐘至二小 時爲較佳,最常見的是十分鐘到的二十分鐘。本發明之片 劑、錠劑或九劑之崩散時間即依上述而時而定。 稀釋劑用以降低本發明片劑、錠劑或九劑中過氧化物 破壞劑的含量比例。潤滑劑用以增進打片時的顆粒流動 性,以利片劑、錠劑或九劑之製備。潤濕保養劑用以增進 隱形眼鏡淸潔消毒液的潤混保養功能,滲透壓調劑用以調 整鏡片對眼球的滲透壓,使其能達成平衡而致於有不舒服 的感覺。 本發明特徵之一爲加入一些著色劑,以葉綠素爲較 佳。這些著色劑本身應不會對鏡片、鏡片材質或是人體造 成任何不良影響或傷害。這些著色劑隨著錠劑在過氧化氫 的水溶液中崩散而釋出後,能夠提供使用者一種指標,表 示過氧化氫開始被分解。 冒泡劑(Effervescent reagents)亦可使用於本 經濟部中央標準局員工消費合作社印聚 (請先閲讀背面之注意事項再填寫本頁) 發明中,以加速錠劑的崩散及增進淸潔的效果;一般最常 使用的是碳酸氫納。冒泡劑在水溶液中隨著錠劑的崩散會 產生二氧化碳,從而造成一些亂流,因此能夠加速水溶液 中的成份混合,同時亦能幫忙使鏡片上的沉積物剝落。 酸鹼度緩衝劑亦可加入本發明中的成份內,來調整水 溶液中最後的酸鹼度,以期使用者不需再經過最後一次的 沖洗步驟,便能馬上戴入眼內。任何足以維持酸鹼度在5 到9中的酸鹼緩衝劑均可用於本發明中,茲舉一例:磷酸 一 8 - 本紙张尺度適用中國國家標準(CNS ) A4規格(2l〇X297公楚) 483934 經濟部中央標準局貝工消費合作社印製 A7 B7 五、發明説明(7 ) 鹽類便可使用。然而更適當者爲那些不但具備有酸鹼緩衝 能力,本身亦具備有殺菌防腐作用的緩衝劑,譬如硼酸鹽 類便爲其中一例。 任何可溶於水而又具備有粘合劑功能的材質均可與本 發明一起使用,可完全溶於水中的材質尤佳。這類材質最 好能含有一種聚合物在內;這種聚合物或聚合物的組成可 佔錠劑總重的一大部份而無妨。一般常用聚合物的材質如 下:聚乙嫌醋酸酯(polyvinylacetate)、聚乙燒四氫外匕 咯酮(polyvingylpyrrolidone)、聚乙嫌醇 (polyvinylalcohol)、纖維素醚(cellnlose ethers)、其衍生物,或其混合物。上述聚合物僅爲本發 明中可採用的一部分,其他具備有相同功能性的聚合物均 在本發明適用範圍之內。 本發明之組成物可製成片劑、錠劑或九劑,以錠劑爲 較佳。製粒方法可採用任何習知方法,只要使該片劑、錠 劑或九劑的硬度大於約5 k g即可,以大於約8 k g爲較佳, 以大於約10 kg爲更佳,其脆度則應少於1 %。若其硬度 小於5 k g及/或脆度大於1 % ,則無法在預定時間崩散的目 的。 爲達成上述目的,稀釋劑之用量應爲1 0 %〜9 0 % ,以 1 5 %〜6 0 %爲較佳,3 0 %〜5 0 %以爲更佳;著色劑用量爲 0 · 0 2 %〜3 · 0 %爲較佳,以〇 · 1 %〜2 · 0爲更佳;黏合劑之用 量應爲0 · 5 %〜4 0 % ,以1 %〜2 5 %爲較佳,以2 · 5 %〜1 0 % 爲更佳。而崩散劑用量應爲0 %〜2 0 % ,以0 %〜5 %爲較 本紙張尺度適用中國國家標準(CNS) A4说格(210X297公釐) (請先閱讀背面之注意事項再填寫本頁)Please bear in mind: , No § ::,: 32. When the original substance is printed into tablets, tablets, nine tablets, and other similar solid products by the Central Standards Bureau of the Ministry of Economy When making solution, prevail. The above-mentioned π-peroxide destroying agent "means an agent or ι4 that can destroy peroxides, such as a peroxide reducing agent, such as thiosulfates, sulfites, thiogiycero1 or thiogiycero1 Alkali metal salts, thiourea, Ascorbic acid, iso-ascorbic acid, N-acetylcystenine, glyoxylic acid ), Etc .; Peroxidase, such as hydrogen peroxide (catalase), etc., or a mixture or composition thereof. The dosage of the above peroxide destroying agent can be within a predetermined time after release, will be The residual peroxide in the contact lens disinfection solution shall be destroyed. Therefore, the amount depends on the content of the peroxide in the contact lens disinfection solution. Generally speaking, the concentration of the peroxide destroying agent (Taking hydrogen peroxide as an example), about 1000 to about 250 I.U./%(W/V)H2O2/ml is more preferable, and about 150 to about 20,000 · υ · /% ( ~ / 乂) 112〇2 / 1111 is more preferred. If the above peroxide destroying agent is directly When the lens cleaning solution is mixed, the peroxide destroying agent immediately reacts with the peroxygen, so that the peroxide in the contact lens cleaning solution is decomposed and no longer has the function of cleaning and disinfecting. Therefore, the traditional method is to use It is quite inconvenient for the user to add the peroxide destroying agent after immersing the contact lens in the disinfectant solution containing peroxide for a period of time (to achieve the disinfection purpose). According to this, the inventor proposed A tablet with a delayed release function, a 6- (Please read the precautions on the back before filling this page) # 1 衣 ·, -ιτ This paper size applies to Chinese national standards (CNS > A4 specifications (210χ297 公 #) 483934 A7 B7__ 5. Description of the invention (5) The floss or nine-dose composition allows the user to add the tablet with the extended release function of the present invention at the same time when the contact lens is cleaned and disinfected and the contact lens is placed. , Lozenge or nine. Use the disintegration time of tablets, lozenges or nine to achieve a delayed release function. That is, let the tablets, lozenges or nine of the present invention in the contact lens in a peroxide-containing tincture. Clean and disinfect When it reaches the disinfection effect, it will disintegrate and release the peroxide destroyer contained in it, and begin to decompose the peroxide remaining in the disinfection solution. At the same time, the color of the dissolving colorant will show neutrality. The reaction (that is, the peroxide destroying reaction) begins. In order to achieve the extended release effect of the peroxide destroying agent in the contact lens cleaning solution, the above peroxide destroying agent, and excipients, binders and / Or disintegrants mixed into tablets, tablets or nine. When necessary, you can add appropriate amounts of diluents, lubricants, cleaning agents for contact lenses, wetting / conditioning agents, tonicity agents), effervescent reagents, acid test buffers, etc. Printed by Shellfish Consumer Cooperative, Central Bureau of Standards, Ministry of Economic Affairs (please read the notes on the back before filling this page) The content of the above excipients, binders and dispersants depends on the required disintegration time. The disintegration time depends on the formula of the contact lens cleaning solution. If the content of peroxide in the disinfection solution is high, the disinfection effect can be achieved quickly, so the extended release time should be relatively short, that is, the content of the binder is relatively low or the content of the dispersant is relatively high. At the same time, Because the residual peroxide content is higher, the peroxide destroyer content should be higher. Conversely, if the peroxide content in the Sanitizer disinfectant solution is low, the extended release time should be longer, that is, the binder content should be higher or the dispersant content should be lower, and the remaining peroxide will fly to the paper size. Applicable to China National Standard (CNS) A4 specification (21 × 297 mm) 483934 A7 B7 V. Description of the invention (6) The content of compounds is low, so the content of peroxide destroyer should be low. Generally speaking, the sanitizing time is 1 minute to 12 hours, preferably 5 minutes to 2 hours, and the most common is 10 minutes to 20 minutes. The disintegration time of the tablets, lozenges or nine agents of the present invention depends on the above. The diluent is used to reduce the content of the peroxide destroying agent in the tablet, lozenge or nine doses of the present invention. Lubricants are used to improve the fluidity of the granules during tableting, so as to facilitate the preparation of tablets, lozenges, or nine doses. Wetting and maintenance agents are used to enhance the maintenance and maintenance of contact lens cleaning and disinfecting solution, and osmotic pressure regulators are used to adjust the osmotic pressure of the lens on the eyeball, so that it can reach a balance and cause uncomfortable feeling. One of the features of the invention is the addition of some colorants, preferably chlorophyll. These colorants should not cause any adverse effects or harm to the lenses, lens materials or the human body. These colorants are released as the tablets disintegrate in an aqueous solution of hydrogen peroxide, and can provide users with an indicator that hydrogen peroxide is starting to decompose. Effervescent reagents can also be used for printing and gathering of employees' cooperatives in the Central Bureau of Standards of the Ministry of Economic Affairs (please read the precautions on the back before filling out this page). In the invention, to accelerate the disintegration of tablets and improve the cleanliness Effect; sodium bicarbonate is most commonly used. The effervescent agent in the aqueous solution will generate carbon dioxide with the disintegration of the tablets, which will cause some turbulence. Therefore, it can accelerate the mixing of the components in the aqueous solution, and also help to peel off the deposits on the lens. A pH buffering agent can also be added to the ingredients of the present invention to adjust the final pH in the aqueous solution, so that the user can immediately put on the eyes without going through the last rinsing step. Any acid-base buffer sufficient to maintain a pH between 5 and 9 can be used in the present invention, for example: Phosphoric acid-8-This paper is in accordance with the Chinese National Standard (CNS) A4 specification (21 × 297) Chu 483934 Economy A7 B7 printed by the Shell Standard Consumer Cooperative of the Ministry of Standards of the People's Republic of China 5. Description of the invention (7) The salt can be used. However, the more suitable ones are those that not only have the ability to buffer acid and alkali, but also have a bactericidal and antiseptic effect, such as borate is one of them. Any material that is soluble in water and has the function of an adhesive can be used with the present invention, and a material that is completely soluble in water is particularly preferred. This type of material preferably contains a polymer; the polymer or polymer composition can make up a large portion of the total weight of the lozenge without any problem. The materials of commonly used polymers are as follows: polyvinylacetate, polyvingylpyrrolidone, polyvinylcohol, cellnlose ethers, and derivatives thereof, Or a mixture thereof. The above-mentioned polymers are only a part that can be adopted in the present invention, and other polymers having the same functionality are all within the scope of the present invention. The composition of the present invention can be made into tablets, lozenges or nine doses, and lozenges are preferred. The granulation method can adopt any conventional method, as long as the hardness of the tablet, lozenge, or nine is greater than about 5 kg, preferably greater than about 8 kg, more preferably greater than about 10 kg, and its brittleness The degree should be less than 1%. If its hardness is less than 5 kg and / or its brittleness is greater than 1%, it cannot be disintegrated for a predetermined time. To achieve the above purpose, the amount of diluent should be 10% ~ 90%, more preferably 15% ~ 60%, more preferably 30% ~ 50%; the amount of colorant is 0. 0 2 % ~ 3 · 0% is better, more preferably 0.1% ~ 2 · 0; the amount of adhesive should be 0.5% ~ 40%, more preferably 1% ~ 25%, 2 · 5% to 10% is more preferable. The dispersant dosage should be 0% ~ 20%, with 0% ~ 5% as the standard of this paper. Chinese National Standard (CNS) A4 (210X297 mm) is applicable (please read the precautions on the back before filling in this page)
、1T 483934 Α7 Β7 五、發明説明(8 ) 佳,以0 °/。〜2 %爲更佳。 隱形眼鏡鏡片淸潔消毒後,殘存的過氧化物,宜在8 小時內被分解,以在2小時內被分解爲較佳,以在3 0分鐘 內被分解爲更佳。爲達成此目的,本發明之片劑、錠劑或 九劑中,過氧化物破壞劑的含量爲1 %〜3 0 %。 茲以較佳的實施例進一步說明本發明,唯該等實施例 並非用以限制本發明的申請專利範圍。 實施例1 : 以下列成份製成錠劑: 過氧化氣給(Catalase) 3500 I.U. 磷酸三鈉(Sodium Phosphate,Tribasic) 1.2 mg 甘露醇(Mannitol 52.0 mg 氫氧丙基-甲基-纖維素(HPMC) 26.2 mg 聚乙基乙二醇(P.E.C.6000) 20.0 mg 葉綠素 0.6 mg 經濟部中央標準局員工消費合作社印¾ (請先閱讀背面之注意事項再填寫本頁) 一溶器內,加入1 〇 m 1含3 % Η 2 Ο 2市售隱形眼鏡淸潔 消毒液,再置入上述打好的錠片,測定溶液中過氧氫濃度 的變化: -10- 本紙张尺度適用中國國家標準(CNS) Α4規格(210Χ297公釐) 483934 A7 B7 五、發明説明(9 ) 經济部中央標準局員工消費合作社印^ 時間(分鐘) 0 15 3 0 6 0 9 0 12 0 240 水溶液中過氧化氫濃度(Ρ Ρ Π1 ) 3 0 0 0 0 1 2 5 0 0 5 0 0 0 5 0 0 2 0.2 0 由實驗數據顯示,本錠劑確具延釋效果,其延釋時間 約爲4至5小時。其中過氧化氫濃度,係以默克公司 (Merck)產品過氧化氫試紙(Merckoquant 1 . 1 0 0 1 1 · 0 0 0 1 )測得。 實施例2 : 製備如實施例1的錠劑,但其中過氧化氫Μ含量如下 表所示,分別測定使3 %雙氧水中過氧化物含量降0 ρ p m 所需時間如下表: 過氧化氫岭含量(I.U·/錠) 2 0 0 0 3 5 0 0 所需時間 1 2 - 1 6小時 4 - 5小時 由上表可知:過氧化氫岭含量高,則過氧化氫的分解 速度增快。 11 本紙張尺度適用中國國家標準(CNS ) A4規格(210X297公釐) 請 先 閱 讀 背 之 注 意 事 項 再 483934 A7 B7 五、發明説明(1 〇 ) 實施例3 : 依下述配方製備錠劑: 過氧化氫_(Catalase) 35001.U. 氫氧丙基-甲基-纖維素(HPMC) 23.8 mg 磷酸三納 1.8 mg 花楸醒Sorbitol 67.4 mg 聚乙嫌四氫,叱咯酮(Polyvinyl Pyrrolidone) 6.5 mg 葉綠素 0.5 mg (讀先閱讀背面之注意事項再填寫本頁) 經濟部中央標隼局貝工消費合作社印1i 發明其在3 %過氧化氫溶液中,維持1 0分鐘不溶離(即 延釋時間),同時在2 4 0分鐘內,使過氧化氫完全分解。 -12- 本紙張尺度適用中國國家標準(CNS ) A4規格(210X 297公釐〉1T 483934 Α7 Β7 V. Description of the invention (8) The best is 0 ° /. ~ 2% is better. After cleaning and disinfecting the contact lens, the residual peroxide should be decomposed within 8 hours, preferably within 2 hours, and more preferably within 30 minutes. In order to achieve this, the content of the peroxide destroying agent in the tablets, lozenges or nine agents of the present invention is 1% to 30%. The present invention is further described with preferred embodiments, but these embodiments are not intended to limit the scope of patent application of the present invention. Example 1: A lozenge was prepared with the following ingredients: Catalase 3500 IU Sodium Phosphate (Tribasic) 1.2 mg Mannitol 52.0 mg Hydroxypropyl-methyl-cellulose (HPMC ) 26.2 mg Polyethylene Glycol (PEC6000) 20.0 mg Chlorophyll 0.6 mg Printed by the Consumers' Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs (Please read the precautions on the back before filling this page) Add 1 〇m to a container 1 Contains 3% Η 2 〇 2 Commercially available contact lens cleaning and disinfecting solution, and then insert the above-mentioned prepared tablets to determine the change in the concentration of hydrogen peroxide in the solution: -10- This paper size applies to Chinese National Standards (CNS) Α4 specification (210 × 297 mm) 483934 A7 B7 V. Description of the invention (9) Printed by the Consumer Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs ^ Time (minutes) 0 15 3 0 6 0 9 0 12 0 240 Hydrogen peroxide concentration in aqueous solution (P Ρ Π1) 3 0 0 0 0 1 2 5 0 0 5 0 0 5 0 0 2 0.2 0 The experimental data show that this tablet has a delayed release effect, and its extended release time is about 4 to 5 hours. Hydrogen oxide concentration is based on Merck's hydrogen peroxide test paper (Merckoq uant 1. 1 0 0 1 1 · 0 0 0 1). Example 2: Preparation of the tablets as in Example 1, but the content of hydrogen peroxide M is shown in the table below. The time required to reduce the oxide content by 0 ρ pm is as follows: Hydrogen peroxide content (IU · / ingot) 2 0 0 0 3 5 0 0 The time required is 1 2-1 6 hours 4-5 hours. If the content of hydrogen peroxide ridge is high, the decomposition rate of hydrogen peroxide will increase. 11 This paper size applies Chinese National Standard (CNS) A4 specification (210X297 mm). Please read the precautions in the back first, and then 483934 A7 B7. 5. Description of the invention (10) Example 3: Preparation of lozenges according to the following formula: Hydrogen peroxide (Catalase) 35001.U. Hydroxypropyl-methyl-cellulose (HPMC) 23.8 mg Trina phosphate 1.8 mg Sorbitol 67.4 mg Polyvinyl Pyrrolidone 6.5 mg Chlorophyll 0.5 mg (Read the precautions on the back before filling out this page) Printed by 1i from the Shellfish Consumer Cooperative of the Central Bureau of Standards of the Ministry of Economic Affairs % Hydrogen peroxide solution for 10 minutes without dissolution (ie extended release time), It is within 240 minutes to complete decomposition of the hydrogen peroxide. -12- This paper size is applicable to China National Standard (CNS) A4 (210X 297mm>