JP3442842B2 - Processing method of permselective membrane - Google Patents
Processing method of permselective membraneInfo
- Publication number
- JP3442842B2 JP3442842B2 JP35291393A JP35291393A JP3442842B2 JP 3442842 B2 JP3442842 B2 JP 3442842B2 JP 35291393 A JP35291393 A JP 35291393A JP 35291393 A JP35291393 A JP 35291393A JP 3442842 B2 JP3442842 B2 JP 3442842B2
- Authority
- JP
- Japan
- Prior art keywords
- membrane
- weight
- present
- polyvinylpyrrolidone
- processing method
- 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 - Fee Related
Links
Landscapes
- Separation Using Semi-Permeable Membranes (AREA)
Description
【発明の詳細な説明】
【０００１】
【産業上の利用分野】本発明は、ポリサルホンとポリビ
ニルピロリドンよりなる選択透過性膜の放射線処理方法
であって、特に選択透過性膜をモジュール化した血液透
析器中に充填液を充填した状態でγ線滅菌処理を行う際
に、充填液の酸性化を抑制する方法に関するものであ
る。
【０００２】
【従来の技術】特開昭６３−９７２０５号公報及び特開
平４−３００６３６号公報にはポリサルホンとポリビニ
ルピロリドンよりなる選択透過性膜に放射線処理を施
し、ポリビニルピロリドンの選択透過性膜からの溶出を
少なくする技術が開示されている。
【０００３】
【発明が解決しようとする課題】しかしながら前記選択
透過性膜を水中または湿潤中で放射線処理を行うと放射
線の影響により水のｐＨが酸性側に大きく変化する。こ
のため血液の透析膜として使用時に、ｐＨ変化による支
障を生じるとともに、膜成分に分解を生じ溶出量が増加
する原因となる。更に長期間保存した場合に膜成分並び
に充填液中の溶存成分変化による膜の劣化が進行し膜が
性能面で変化することが考えられる。このような膜の変
化は患者に与える影響も大きく好ましくない。
【０００４】さらに特開平４−３３８２２３号では、ピ
ロ亜硫酸ナトリウム、アセトンソジウムバイサルファイ
ト等の抗酸化剤の水溶液中でγ線処理を行う方法が開示
されている。しかしこれらの方法では選択透過性膜をモ
ジュール化した人工腎臓、血漿分離器等の医療用具とし
て使用する場合、抗酸化剤の残留とこれらが人体に与え
る影響等を解決し安全性を確保する必要がある。そこで
本発明は以上の課題を解決するために鋭意検討を重ねた
結果次の発明に到達した。
【０００５】
【課題を解決するための手段】本発明は、ポリサルホン
とポリビニルピロリドンよりなる選択透過性膜をｐＨ緩
衝液中でγ線滅菌処理する選択透過性膜の処理方法を提
供する。本発明に使用されるポリサルホンとポリビニル
ピロリドンは公知のものを使用することができ選択透過
性膜も公知の方法により製造したものを使用することが
できる。
【０００６】本発明に使用されるｐＨ緩衝液とは、例え
ばリン酸二水素カリウム及びリン酸水素二ナトリウムの
混合水溶液、リン酸二水素カリウム及び水酸化ナトリウ
ムの混合水溶液、クエン酸ナトリウム及び水酸化ナトリ
ウムの混合水溶液、グリシン、塩化ナトリウム及び水酸
化ナトリウムの混合水溶液、リン酸水素二ナトリウム及
びクエン酸の混合水溶液等が使用される。各ｐＨ緩衝液
のｐＨ及び濃度は各成分の量を適宜調製することにより
どのようにも設定することができる。
【０００７】本発明に使用される製膜原液濃度は、ポリ
サルホンは10〜25重量％、好ましくは12〜20％、ポリビ
ニルピロリドンは1〜15重量％で、好ましくは2〜10％
で、製膜においてはポリサルホン90〜99重量％、ポリビ
ニルピロリドン10〜1重量％にするのが好ましい。
【０００８】またｐＨ緩衝液中の溶質の濃度はγ線の線
量により異なるが、2.5Ｍｒａｄのγ線を照射する場合
は、0.02〜0.1重量％に調製するのが望ましい。濃度が
0.01重量％より低いと照射後の充填液の酸性化を押さえ
ることができず、他方濃度が1.0重量％より高いと中空
糸内に溶質の残留の可能性がある。
【０００９】次に本発明の実施例について説明する。ポ
リサルホン15重量％、ポリビニルピロリドン（分子量4
0、000）9重量％、ジメチルアセトアミド30重量％、ジ
メチルスルホキシド45重量％、および水１重量％を含有
する湿式紡糸重合体溶液を調製した。この溶液から未溶
解物を除き、製膜して得た中空糸7000本を用いて有効膜
面積1.25ｍ2の人工腎臓モジュールを作成し、表１から
表７に記載したｐＨ緩衝液、ＵＦ水をモジュール中に充
填し2.5Ｍｒａｄのγ線を照射した。
【００１０】これらについて透析膜の溶出物試験（透析
型人工腎臓装置承認基準）（表１、表２参照）、血液側
充填液に関する試験（表３から表７）を行った。
【表１】
【表２】【表３】
【表４】
【表５】【表６】
【表７】
【００１１】表１から表３の結果より本発明の実施例１
から２のＵＶ値は、基準値以下であった。また表４の結
果よりｐＨ緩衝液中の溶質濃度を高くすることにより充
填液が酸性に変化するのを防止することができることが
わかる。また表６の結果により比較例のＵＦ水（ｐＨ緩
衝剤等を含まないもの）の場合は白濁したのに対して本
発明の実施例１から２のｐＨ緩衝液を充填したものは無
色澄明か若干着色するのみであった。また表７の結果よ
り比較例の場合は、ｐＨが低いため溶血性試験は不合格
であったが、本発明の実施例１は全ての生物学的試験に
合格であった。
【００１２】
【発明の作用効果】以上説明したように本発明では充
填液の酸性化を抑えることができ、膜の分解、性能の低
下を防ぐことができる。膜の分解による溶出物を抑え
ることができる。、より臨床において膜を安全に
使用することができる。Description: BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a method for radiation treatment of a selectively permeable membrane comprising polysulfone and polyvinylpyrrolidone, and more particularly to a hemodialysis method in which the selectively permeable membrane is modularized. The present invention relates to a method for suppressing acidification of a filling liquid when performing γ-ray sterilization in a state in which the filling liquid is filled in a vessel. 2. Description of the Related Art JP-A-63-97205 and JP-A-4-300636 disclose that a selectively permeable membrane composed of polysulfone and polyvinylpyrrolidone is subjected to radiation treatment, and that a selectively permeable membrane of polyvinylpyrrolidone is used. There is disclosed a technique for reducing the elution of phenol. [0003] However, when the selectively permeable membrane is subjected to radiation treatment in water or wet, the pH of the water greatly changes to the acidic side due to the influence of radiation. For this reason, when used as a dialysis membrane for blood, there is a problem due to a change in pH, and the components of the membrane are decomposed to increase the amount of elution. Further, when stored for a long period of time, it is conceivable that deterioration of the membrane due to changes in the membrane components and the dissolved components in the filling liquid progresses, and the membrane changes in terms of performance. Such a change in the membrane greatly affects the patient, which is not preferable. Further, Japanese Patent Application Laid-Open No. 4-338223 discloses a method of performing gamma ray treatment in an aqueous solution of an antioxidant such as sodium pyrosulfite, acetone sodium bisulfite, or the like. However, in these methods, when used as medical devices such as artificial kidneys and plasma separators with modular permselective membranes, it is necessary to ensure the safety by solving the residual antioxidants and their effects on the human body. There is. Thus, the present invention has conducted intensive studies in order to solve the above problems, and as a result, has arrived at the following invention. SUMMARY OF THE INVENTION The present invention provides a method for treating a selectively permeable membrane comprising polysulfone and polyvinylpyrrolidone by γ-ray sterilization in a pH buffer. As the polysulfone and polyvinylpyrrolidone used in the present invention, known ones can be used, and a selectively permeable membrane produced by a known method can also be used. The pH buffer used in the present invention includes, for example, a mixed aqueous solution of potassium dihydrogen phosphate and disodium hydrogen phosphate, a mixed aqueous solution of potassium dihydrogen phosphate and sodium hydroxide, sodium citrate and hydroxide A mixed aqueous solution of sodium, a mixed aqueous solution of glycine, sodium chloride and sodium hydroxide, a mixed aqueous solution of disodium hydrogen phosphate and citric acid, and the like are used. The pH and concentration of each pH buffer can be set in any manner by appropriately adjusting the amount of each component. The concentration of the stock solution used in the present invention is 10 to 25% by weight, preferably 12 to 20% for polysulfone, 1 to 15% by weight for polyvinylpyrrolidone, and preferably 2 to 10%.
In the film formation, it is preferable that the content be 90 to 99% by weight of polysulfone and 10 to 1% by weight of polyvinylpyrrolidone. [0008] The concentration of the solute in the pH buffer varies depending on the dose of γ-rays. When irradiating with 2.5 Mrad of γ-rays, the concentration is preferably adjusted to 0.02 to 0.1% by weight. Concentration
When the concentration is less than 0.01% by weight, the acidification of the filling liquid after irradiation cannot be suppressed, and when the concentration is more than 1.0% by weight, there is a possibility that a solute may remain in the hollow fiber. Next, an embodiment of the present invention will be described. Polysulfone 15% by weight, polyvinylpyrrolidone (molecular weight 4
A wet-spun polymer solution containing 9% by weight (0,000), 30% by weight of dimethylacetamide, 45% by weight of dimethylsulfoxide, and 1% by weight of water was prepared. An undissolved substance was removed from this solution, and an artificial kidney module having an effective membrane area of 1.25 m 2 was prepared using 7000 hollow fibers obtained by forming a membrane. The pH buffer and UF water described in Tables 1 to 7 were prepared. Was filled in a module and irradiated with 2.5 Mrad of γ-rays. With respect to these, a dialysis membrane eluate test (dialysis type artificial kidney apparatus approval standard) (see Tables 1 and 2) and a test on the blood side filling solution (Tables 3 to 7) were performed. [Table 1] [Table 2] [Table 3] [Table 4] [Table 5] [Table 6] [Table 7] From the results of Tables 1 to 3, the first embodiment of the present invention is shown.
2 of UV values from, equal to or smaller than the reference value. Also, from the results in Table 4, it can be seen that increasing the solute concentration in the pH buffer solution can prevent the filling solution from changing to acidic. According to the results shown in Table 6, the UF water (containing no pH buffer or the like) of the comparative example became cloudy, whereas the UF water filled with the pH buffer of Examples 1 and 2 of the present invention was colorless and clear. It was only slightly colored. Also, from the results in Table 7, in the case of the comparative example, the hemolytic test failed because of low pH, but Example 1 of the present invention passed all the biological tests. As described above, according to the present invention, the acidification of the filling liquid can be suppressed, and the decomposition of the membrane and the deterioration of the performance can be prevented. Eluted substances due to membrane decomposition can be suppressed. The membrane can be used more safely in clinical practice.
───────────────────────────────────────────────────── フロントページの続き (58)調査した分野(Int.Cl.7，ＤＢ名) B01D 65/02 - 71/68 ──────────────────────────────────────────────────続 き Continued on the front page (58) Field surveyed (Int.Cl. 7 , DB name) B01D 65/02-71/68
Claims (1)
なる選択透過性膜をｐＨ緩衝液中でγ線滅菌処理するこ
とを特徴とする選択的透過性膜の処理方法。(57) Claims 1. A method for treating a selectively permeable membrane, comprising subjecting a selectively permeable membrane comprising polysulfone and polyvinylpyrrolidone to γ-ray sterilization in a pH buffer.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP35291393A JP3442842B2 (en) | 1993-12-28 | 1993-12-28 | Processing method of permselective membrane |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP35291393A JP3442842B2 (en) | 1993-12-28 | 1993-12-28 | Processing method of permselective membrane |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPH07194949A JPH07194949A (en) | 1995-08-01 |
| JP3442842B2 true JP3442842B2 (en) | 2003-09-02 |
Family
ID=18427313
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP35291393A Expired - Fee Related JP3442842B2 (en) | 1993-12-28 | 1993-12-28 | Processing method of permselective membrane |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JP3442842B2 (en) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2001036072A1 (en) | 1999-11-17 | 2001-05-25 | Asahi Medical Co., Ltd. | Blood treating membrane, blood treating container and process for producing the same |
| JPWO2013187396A1 (en) | 2012-06-11 | 2016-02-04 | 旭化成メディカル株式会社 | Separation membrane for blood treatment and blood treatment device incorporating the membrane |
-
1993
- 1993-12-28 JP JP35291393A patent/JP3442842B2/en not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| JPH07194949A (en) | 1995-08-01 |
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