JPH087336B2 - Method for manufacturing storage / cleaning solution for soft contact lenses - Google Patents
Method for manufacturing storage / cleaning solution for soft contact lensesInfo
- Publication number
- JPH087336B2 JPH087336B2 JP21694389A JP21694389A JPH087336B2 JP H087336 B2 JPH087336 B2 JP H087336B2 JP 21694389 A JP21694389 A JP 21694389A JP 21694389 A JP21694389 A JP 21694389A JP H087336 B2 JPH087336 B2 JP H087336B2
- Authority
- JP
- Japan
- Prior art keywords
- dissolved oxygen
- physiological saline
- inert gas
- contact lenses
- rays
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
Links
Landscapes
- Eyeglasses (AREA)
- Detergent Compositions (AREA)
Description
本発明は、長期保存可能ソフトコンタクトレンズの保
存・洗浄液を製造するための改良方法に関するものであ
る。The present invention relates to an improved method for producing a preservative / cleaning solution for long-term storable soft contact lenses.
ソフトコンタクトレンズを保存したり洗浄するために
は従来から生理食塩水（食塩濃度0.85〜0.95W/V％の食
塩水）が使用されており、かような生理食塩水に各種の
保存料や殺菌剤等を添加して長期保存可能にする方法も
採用されている。 しかしながら、保存・洗浄液中に添加した保存料や殺
菌剤等に目に刺激を与える為に保存料や殺菌剤の使用は
好ましくないという観点から、生理食塩水にコバルト60
によりγ線を照射して滅菌処理する方法が提案されてい
る（特公昭59−39139号）。Conventionally, physiological saline (saline having a salt concentration of 0.85 to 0.95 W / V%) has been used to store and clean soft contact lenses, and various preservatives and sterilizers are used for such physiological saline. A method of adding a drug or the like to enable long-term storage is also adopted. However, from the viewpoint that the use of preservatives and bactericides is not preferable because they irritate the preservatives and bactericides added to the preservative / washing solution, cobalt-60 is added to physiological saline.
Has proposed a method of sterilizing by irradiating γ rays (Japanese Patent Publication No. 59-39139).
上記したコバルト60のγ線を照射する方法は、生理食
塩水の滅菌効果の点では有効である。しかしながら、生
理食塩水中には酸素が溶存しており、溶存酸素を含む水
にγ線が照射されると放射線分解により少量ではあるが
過酸化水素等の酸化種が生成される。かような過酸化水
素を含む生理食塩水は目に刺激を与えるためにソフトコ
ンタクトレンズの保存・洗浄液として使用するのは好ま
しくない。 そこで本発明の目的は、目に刺激を与えるような物質
を含むことがなくしかも長期保存可能なソフトコンタク
トレンズ用保存・洗浄液の製造方法を提供することであ
る。The above-described method of irradiating cobalt 60 with γ-rays is effective in terms of the sterilizing effect of physiological saline. However, oxygen is dissolved in physiological saline, and when water containing dissolved oxygen is irradiated with γ-rays, a small amount of oxidizing species such as hydrogen peroxide is generated by radiolysis. Such a physiological saline solution containing hydrogen peroxide is not preferable to be used as a storage / washing solution for soft contact lenses because it causes irritation to the eyes. Therefore, an object of the present invention is to provide a method for producing a preservative / cleaning solution for soft contact lenses, which does not contain a substance that irritates the eyes and can be preserved for a long period of time.
すなわち本発明によるソフトコンタクトレンズ用保存
・洗浄液の製造方法は、生理食塩水中の溶存酸素を除去
する工程と、溶存酸素を除去した生理食塩水に電離放射
線を照射して滅菌する工程とからなることを特徴とする
ものである。 上述のように本発明においては、電離放射線の照射に
先立って、生理食塩水中の溶存酸素を除去するようにし
たから、溶存酸素を含む水の放射線分解による過酸化水
素等の酸化種の生成を抑制することができる。 本発明を実施するに際しては、先ず精製水（蒸溜水あ
るいはイオン交換樹脂処理した純水）に局方食塩を溶解
して0.85〜0.95W/V％の生理食塩水を調整し、これを容
器に入れる。次いで容器内の食塩水中に窒素ガスのごと
き不活性ガスを約30分間吹込み、食塩水中の溶存酸素を
窒素ガスにより置換することによって溶存酸素を除去
し、さらに食塩水の水面と容器開口部との間の空隙部も
窒素ガスで満たした後、容器開口部を密封する。この状
態で容器内の食塩水に電離放射線を照射して滅菌処理を
施す。 この時の電離放射線の照射線量は５〜30kGyとするこ
とが好ましい。5kGyより少ないと所望の滅菌効果が得ら
れないし、30kGyより多く照射した場合には、過酸化水
素濃度はその放射線分解のためほぼ一定に保たれ特に不
都合はないが、滅菌の目的達成の後に過剰に放射線を照
射することを経済的に好ましくない。 食塩水中の溶存酸素を除去する方法としては、上記し
た方法以外に、食塩水中に３〜7kg/cm2の圧力で不活性
ガスを圧入してその後大気圧に戻す操作を３〜５回繰り
返し行う方法や、食塩水を減圧して溶存酸素を除去した
後不活性ガスを吹込んで大気圧に戻す操作を３〜５回繰
り返し行う方法が挙げられる。また、食塩水を減圧して
溶存酸素を除去した後、容器を密封して滅圧状態を保持
しておく方法も採用できる。しかしながら、不活性ガス
を圧入したり、容器内を減圧したりする場合には、加圧
状態あるいは減圧状態に耐える圧力容器を使用する必要
がある。さらには、食塩水を沸騰させることによって
も、溶存酸素の除去は可能である。 不活性ガスとしては、窒素ガスのほかに、ヘリウムや
アルゴンなどの希ガス類も使用できる。 なお、食塩水を入れる容器は、そのまま商品として市
場に流通させることができる比較的小さい容量の最終容
器を用い、この中に食塩水を入れて溶存酸素除去工程お
よび電離放射線照射工程を施すことができる。あるいは
また、比較的容量の大きい大型容器に食塩水を入れて溶
存酸素除去工程および電離放射線照射工程を施した後、
処理後の食塩水を小型の最終容器に無菌的に移し変えて
もよい。 電離放射線としては、従来と同様にコバルト60のγ線
を使用することができるが、コバルト60は常時γ線を放
出しながら減衰し、その半減期は、5.2年であるため、
定期的にコバルト60を補充する必要がある。 コバルト60のγ線以外に、本発明で使用できる電離放
射線としては、エネルギー10MeV以下の電子線およびエ
ネルギー5MeV以下のＸ線が挙げられる。 電子線は、最近５〜10MeVの電子線発生装置が進歩し
工業的な照射装置として普及してきたため、本発明にお
いてもγ線と同等の照射効果を有する電離放射線として
手軽に利用することができる。 一方、Ｘ線もγ線と照射効果が同じであることが知ら
れており、5MeV程度の高エネルギー電子線をタンタル等
の重金属ターゲットに照射してそこから発生するエネル
ギースペクトルの最大値が5MeV、平均エネルギー２〜3M
eV程度の高エネルギー変換Ｘ線を利用する技術が発達
し、産業用に広く利用できるようになった。特に5MeV程
度の高エネルギーＸ線を照射する場合には、コバルト60
のγ線による照射滅菌処理時の1.5倍程度の厚さを有す
る被処理食塩水に照射しても、Ｘ線が食塩水に十分に透
過し、効果的な滅菌効果を行うことができる。 かような電子線やＸ線を電離放射線として使用する場
合には、コバルト60のような放射性同位体を使用してい
ないため、線源の減衰もなく従って線源の補充の必要も
ない。また、電子線発生装置の電源スイッチを入切する
だけでいたって簡便に照射工程を行うことができるとい
う利点もある。 なお、本発明で使用する電子線のエネルギーを10MeV
以下、Ｘ線のエネルギーを5MeV以下とした理由は、これ
らを食品に対して照射する場合の国際規格（“照射食品
に関する国際一般規格”）で定められた数値であり、安
全性の面から本発明においてもこの数値を採用したもの
である。That is, the method for producing a preservative / cleaning solution for soft contact lenses according to the present invention comprises a step of removing dissolved oxygen in physiological saline and a step of sterilizing physiological saline from which dissolved oxygen is removed by irradiating with ionizing radiation. It is characterized by. As described above, in the present invention, since the dissolved oxygen in the physiological saline is removed prior to the irradiation with ionizing radiation, the generation of oxidizing species such as hydrogen peroxide by the radiolysis of water containing dissolved oxygen is performed. Can be suppressed. In carrying out the present invention, first, the pharmacopoeial salt is dissolved in purified water (distilled water or pure water treated with ion exchange resin) to prepare 0.85 to 0.95 W / V% physiological saline solution, and this is put in a container. Put in. Then, an inert gas such as nitrogen gas was blown into the saline solution in the container for about 30 minutes to remove the dissolved oxygen by replacing the dissolved oxygen in the saline solution with nitrogen gas. After filling the voids between them with nitrogen gas, the container opening is sealed. In this state, the saline solution in the container is irradiated with ionizing radiation for sterilization. The irradiation dose of ionizing radiation at this time is preferably 5 to 30 kGy. If it is less than 5 kGy, the desired sterilization effect is not obtained, and if it is irradiated more than 30 kGy, the hydrogen peroxide concentration is kept almost constant due to its radiolysis, but there is no particular inconvenience, but it is excessive after the purpose of sterilization is achieved. It is economically unfavorable to irradiate them with radiation. As a method for removing dissolved oxygen in saline, in addition to the method described above, the operation of injecting an inert gas into saline at a pressure of 3 to 7 kg / cm 2 and then returning to atmospheric pressure is repeated 3 to 5 times. Examples include a method of depressurizing the saline solution to remove dissolved oxygen, and then blowing an inert gas to return the pressure to atmospheric pressure, which is repeated 3 to 5 times. Further, it is also possible to adopt a method in which the saline is depressurized to remove the dissolved oxygen, and then the container is sealed to keep the depressurized state. However, when injecting an inert gas or depressurizing the inside of the container, it is necessary to use a pressure container that can withstand a pressurized state or a depressurized state. Furthermore, the dissolved oxygen can be removed by boiling the saline solution. In addition to nitrogen gas, rare gases such as helium and argon can be used as the inert gas. As the container for the saline solution, use a final container with a relatively small volume that can be distributed as a product to the market as it is, and the saline solution may be put into this container to carry out the dissolved oxygen removal step and the ionizing radiation irradiation step. it can. Alternatively, after putting a saline solution in a large container having a relatively large capacity and performing a dissolved oxygen removing step and an ionizing radiation irradiation step,
The treated saline may be aseptically transferred to a small final container. As ionizing radiation, γ-rays of cobalt 60 can be used as in the past, but cobalt 60 always decays while emitting γ-rays, and its half-life is 5.2 years,
Cobalt-60 needs to be replenished regularly. In addition to the γ-ray of cobalt 60, the ionizing radiation that can be used in the present invention includes an electron beam having an energy of 10 MeV or less and an X-ray having an energy of 5 MeV or less. Since electron beam generators of 5 to 10 MeV have been recently developed and have spread as industrial irradiation devices, electron beams can be easily used as ionizing radiation having an irradiation effect equivalent to that of γ-rays in the present invention. On the other hand, it is known that X-rays have the same irradiation effect as γ-rays, and the maximum value of the energy spectrum generated from irradiating a heavy metal target such as tantalum with a high energy electron beam of about 5 MeV is 5 MeV, Average energy 2-3M
The technology of using high energy conversion X-rays of about eV has been developed and can be widely used for industrial purposes. Especially when irradiating with high energy X-rays of about 5 MeV, cobalt 60
Even when the saline solution to be treated having a thickness of about 1.5 times that of the sterilization treatment with γ-rays is irradiated, the X-rays sufficiently penetrate into the saline solution and an effective sterilization effect can be achieved. When such an electron beam or X-ray is used as the ionizing radiation, no radioactive isotope such as cobalt 60 is used, so that the source is not attenuated and therefore the source need not be replenished. Further, there is also an advantage that the irradiation process can be easily performed simply by turning on / off the power switch of the electron beam generator. The energy of the electron beam used in the present invention is 10 MeV.
Hereinafter, the reason why the energy of X-rays is set to 5 MeV or less is the numerical value determined by the international standard for irradiating these with food (“International General Standard for Irradiated Food”). The present invention also employs this numerical value.
イオン交換樹脂処理した純水に局方食塩を0.9W/V％と
なるように溶解して生理食塩水を調製した。複数のポリ
エチレン製容器の各々に上記の生理食塩水を200cc宛入
れ、各容器内の食塩水中に窒素ガスを30分間吹き込んで
溶存酸素を窒素ガスで置換して除去した後、容器の開口
部を密栓した。次いで、コバルト60からのγ線を各容器
に各々5,10,15kGyとなるように照射した後、容器内の食
塩水中の過酸化水素濃度と菌数を測定した。 なお比較のために、窒素ガス置換せずにγ線照射しな
い場合、および窒素ガス置換せずにγ線照射した場合に
ついて同様に過酸化水素濃度と菌数を測定した。結果を
下表にまとめて示す。 なお、過酸化水素濃度の測定および菌数の測定は次の
ような方法で行った。 過酸化水素濃度の測定方法： 「衛生試験法，飲食物試験法，ヨウ素法による定量」に
のっとり、検液50mlを200ml共栓フラスコにとり、10％
硫酸10mlおよび10％ヨウ化カリウム溶液10mlを加え、直
ちに３％モリブデン酸アンモニウム溶液を２〜３滴加え
て振り混ぜ、10分間暗所に放置した後0.02Nチオ硫酸ナ
トリウム溶液で滴定する。 菌数の測定方法： 〈未照射試料の菌数測定〉 「衛生試験法，飲食物試験法，微生物試験」にのっと
り、下記条件の寒天平板塗末法による。 培養条件 培地 トリプチケース ソイ アガー （BBL） 温度 30〜32℃ 時間 ２日間 〈照射試料の菌数測定〉 「日本薬局方，無菌試験」にのっとり、下記条件の無
菌試験法による 培養条件 培地 チオグレコレート培地 温度 30〜32℃ 時間 ７日間Physiological saline was prepared by dissolving pharmacopoeia in 0.9 W / V% in pure water treated with an ion exchange resin. Put 200 cc of the above-mentioned physiological saline in each of a plurality of polyethylene containers, blow nitrogen gas into the saline in each container for 30 minutes to replace the dissolved oxygen with nitrogen gas, and then remove the opening of the container. It was sealed. Next, after irradiating each container with γ-rays from cobalt 60 at 5, 10, and 15 kGy, the hydrogen peroxide concentration and the number of bacteria in the saline solution in the container were measured. For comparison, the hydrogen peroxide concentration and the number of bacteria were similarly measured in the case of not γ-irradiating without nitrogen gas replacement and in the case of γ-irradiating without nitrogen gas replacement. The results are summarized in the table below. The hydrogen peroxide concentration and the number of bacteria were measured by the following methods. Measuring method of hydrogen peroxide concentration: According to "hygiene test method, food and drink test method, quantification by iodine method", put 50 ml of test solution in a 200 ml stoppered flask and 10%
10 ml of sulfuric acid and 10 ml of 10% potassium iodide solution are added, and immediately 2 to 3 drops of 3% ammonium molybdate solution are added and shaken. The mixture is left for 10 minutes in the dark and titrated with 0.02N sodium thiosulfate solution. Method of measuring the number of bacteria: <Measurement of the number of bacteria in non-irradiated samples> According to the "hygiene test method, food and drink test method, microbial test", the agar plate coating method under the following conditions is used. Culture conditions Medium Trypticase Soy agar (BBL) Temperature 30-32 ° C Time 2 days <Measurement of bacterial count of irradiated sample> In accordance with the "Japanese Pharmacopoeia, Sterility test", the sterility test method under the following conditions is used. Rate medium Temperature 30-32 ℃ Time 7 days
上記した実施例からもわかるように、本発明において
は食塩水中の溶存酸素を除去した後電離放射線を照射し
て滅菌処理を施しているため、溶存酸素を除去せずに電
離放射線を照射する従来の方法に比べて、照射中の過酸
化水素の発生を少なくすることができる。 従って、本発明により製造したソフトコンタクトレン
ズ用保存・洗浄液は、目に対して刺激がなく、しかも滅
菌効果も従来と同様に得ることができるため長期保存も
可能となる。As can be seen from the above-mentioned examples, in the present invention, since the dissolved oxygen in the saline solution is irradiated and then sterilized by irradiation with ionizing radiation, irradiation with ionizing radiation without removing dissolved oxygen is conventionally performed. It is possible to reduce the generation of hydrogen peroxide during irradiation as compared with the above method. Therefore, the storage / washing solution for soft contact lenses produced according to the present invention is not irritating to the eyes, and since the sterilizing effect can be obtained as in the conventional case, it can be stored for a long time.
Claims (7)
と、溶存酸素を除去した生理食塩水に電離放射線を照射
して滅菌する工程とからなることを特徴とするソフトコ
ンタクトレンズ用保存・洗浄液の製造方法。1. A preservative / cleaning solution for soft contact lenses, which comprises a step of removing dissolved oxygen in a physiological saline solution and a step of irradiating ionized radiation to the physiological saline solution from which the dissolved oxygen is removed to sterilize it. Manufacturing method.
に不活性ガスを吹き込んで溶存酸素を不活性ガスで置換
することによって行う請求項１記載の方法。2. The method according to claim 1, wherein the step of removing dissolved oxygen is performed by blowing an inert gas into physiological saline to replace the dissolved oxygen with the inert gas.
に不活性ガスを圧入した後、大気圧に戻すことによって
行う請求項１記載の方法。3. The method according to claim 1, wherein the step of removing dissolved oxygen is performed by injecting an inert gas into a physiological saline solution and then returning to atmospheric pressure.
減圧して溶存酸素を除去した後、不活性ガスを吹き込ん
で大気圧に戻すことによって行う請求項１記載の方法。4. The method according to claim 1, wherein the step of removing dissolved oxygen is performed by decompressing physiological saline to remove dissolved oxygen, and then blowing in an inert gas to restore the atmospheric pressure.
して窒素ガスを使用する請求項１記載の方法。5. The method according to claim 1, wherein nitrogen gas is used as an inert gas in the step of removing dissolved oxygen.
y照射して行う請求項１記載の方法。6. The sterilization step is performed with ionizing radiation of 5 to 30 kG.
The method according to claim 1, which is carried out by irradiation with y.
コバルト60のγ線、エネルギー10MeV以下の電子線、ま
たはエネルギー5MeV以下のＸ線を用いる請求項１記載の
方法。7. The ionizing radiation irradiated in the sterilization step is
The method according to claim 1, wherein gamma rays of cobalt 60, electron beams having an energy of 10 MeV or less, or X-rays having an energy of 5 MeV or less are used.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP21694389A JPH087336B2 (en) | 1989-08-23 | 1989-08-23 | Method for manufacturing storage / cleaning solution for soft contact lenses |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP21694389A JPH087336B2 (en) | 1989-08-23 | 1989-08-23 | Method for manufacturing storage / cleaning solution for soft contact lenses |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPH0380215A JPH0380215A (en) | 1991-04-05 |
| JPH087336B2 true JPH087336B2 (en) | 1996-01-29 |
Family
ID=16696365
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP21694389A Expired - Lifetime JPH087336B2 (en) | 1989-08-23 | 1989-08-23 | Method for manufacturing storage / cleaning solution for soft contact lenses |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JPH087336B2 (en) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB2406854A (en) * | 2003-09-03 | 2005-04-13 | Frederick Pearson | Method and apparatus for sterilising a material or treating carbonaceous material |
| US9017622B2 (en) * | 2012-04-10 | 2015-04-28 | Lightship Medical Limited | Calibrator for a sensor |
-
1989
- 1989-08-23 JP JP21694389A patent/JPH087336B2/en not_active Expired - Lifetime
Also Published As
| Publication number | Publication date |
|---|---|
| JPH0380215A (en) | 1991-04-05 |
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