JPH0656601A - Electrolyte solution for organ for transplantation - Google Patents
Electrolyte solution for organ for transplantationInfo
- Publication number
- JPH0656601A JPH0656601A JP23292692A JP23292692A JPH0656601A JP H0656601 A JPH0656601 A JP H0656601A JP 23292692 A JP23292692 A JP 23292692A JP 23292692 A JP23292692 A JP 23292692A JP H0656601 A JPH0656601 A JP H0656601A
- Authority
- JP
- Japan
- Prior art keywords
- organ
- solution
- electrolyte solution
- transplantation
- transplanted
- 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.)
- Pending
Links
Abstract
Description
【０００１】[0001]
【産業上の利用分野】本発明は、移植臓器を灌流及び保
存する際に使用する電解質溶液に関するものである。BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an electrolyte solution used for perfusion and preservation of transplanted organs.
【０００２】[0002]
【従来の技術】臓器移植は、腎臓、肝臓、肺臓、膵臓及
び心臓などの臓器疾患末期症の患者に適応できる治療手
段として、近年盛んに研究が行われている。しかし、臓
器移植の成功率は、移植した臓器が機能不全に陥った場
合、きわめて低いとされている。移植臓器の保存の適否
は、臓器移植を成功させるための鍵であり、その保存方
法及び移植臓器を灌流し保存する際使用する溶液につい
て多くの検討がなされている。2. Description of the Related Art Organ transplantation has been actively studied in recent years as a therapeutic means applicable to patients with end-stage organ disease such as kidney, liver, lung, pancreas and heart. However, the success rate of organ transplantation is said to be extremely low when the transplanted organ becomes dysfunctional. The suitability of preservation of transplanted organs is the key to successful organ transplantation, and many studies have been made on the preservation method and the solution used for perfusion and preservation of transplanted organs.
【０００３】移植臓器の保存方法には、灌流後浸漬保存
法、灌流保存法、凍結法及び培養保存法などがある。こ
のなかで、灌流後浸漬保存法は、他の方法と比較して、
操作手技が簡単で、経費も安価なことから広く利用され
ている。この灌流後浸漬保存法は、移植臓器を摘出する
際に、移植臓器の動脈から約４℃に冷却した初期灌流液
を注入そして灌流した後、移植臓器を０〜１０℃の保存
液に浸漬する方法である。移植臓器の灌流及び保存の際
に用いる電解質溶液、すなわち、初期灌流液と浸漬保存
するための溶液は同一の溶液を用いることが多く、大別
すると細胞外液型の電解質溶液と、細胞内液型の電解質
溶液に分類することができる。Methods for preserving the transplanted organ include a post-perfusion immersion preservation method, a perfusion preservation method, a freezing method, and a culture preservation method. Among them, the post-perfusion soak preservation method, compared to other methods,
It is widely used because it is easy to operate and inexpensive. In this post-perfusion immersion preservation method, when the transplanted organ is removed, an initial perfusion solution cooled to about 4 ° C. is injected from the artery of the transplanted organ and perfused, and then the transplanted organ is immersed in a preservation solution at 0 to 10 ° C. Is the way. The electrolyte solution used for perfusion and preservation of the transplanted organ, that is, the same solution is often used as the initial perfusion solution and the solution for preservation by immersion, and is roughly classified into an extracellular solution type electrolyte solution and an intracellular solution. Types of electrolyte solutions.
【０００４】灌流後浸漬保存法では、移植臓器を０〜１
０℃の低温下で浸漬保存する。低温下で移植臓器を浸漬
保存することにより、移植臓器の細胞代謝を抑制し、エ
ネルギー消費を最小にとどめることができる。しかし、
細胞の代謝活動が停止すると、ＡＴＰが枯渇するため細
胞膜のナトリウムポンプが働かなくなり、細胞外液のナ
トリウムイオンと水が細胞内に流入し、カリウムイオン
及びマグネシウムイオンは細胞外に流出する。そこで、
前記初期灌流液及び保存液として、高カリウムイオン、
高マグネシウムイオン、低ナトリウムイオンの細胞内液
型の電解質溶液を利用すれば、移植臓器の浮腫発生や細
胞障害を抑制できるとした知見に基づき種々の電解質液
が提案されている。例えば、不浸透剤としてラクトビオ
ン酸アニオンとラフィノース、また、膠質浸透剤として
ヒドロキシエチル澱粉（ＨＥＳ）を含有し、約３２０mO
sm/lの浸透圧、１２５ミリグラム当量のカリウムイオ
ン、及び３５ミリグラム当量のナトリウムイオンを有す
る電解質溶液（ＵＷ液）が開発されている。（特開平１
−２４６２０１公報、特開平３−１８８００１公報）こ
のＵＷ液は、腎臓、肝臓及び膵臓の保存に有用であると
されている。また、本発明者らは、既に、前記ＵＷ液と
同様の細胞内液型の電解質溶液で、細胞変性保護作用に
優れ、安定かつ安価な電解質溶液を開示している。（特
開平４−１２８２０１号公報）In the post-perfusion soaking preservation method, the transplanted organ is 0-1
It is stored by immersion at a low temperature of 0 ° C. By immersing and storing the transplanted organ at low temperature, cell metabolism of the transplanted organ can be suppressed and energy consumption can be minimized. But,
When the metabolic activity of the cell is stopped, ATP is depleted, the sodium pump of the cell membrane does not work, sodium ion and water in the extracellular fluid flow into the cell, and potassium ion and magnesium ion flow out of the cell. Therefore,
As the initial perfusion solution and storage solution, high potassium ions,
Various electrolyte solutions have been proposed based on the finding that the use of an intracellular solution type electrolyte solution containing high magnesium ions and low sodium ions can suppress the occurrence of edema and cell damage in transplanted organs. For example, it contains lactobionate anion and raffinose as an impermeable agent, and hydroxyethyl starch (HES) as a colloidal penetrating agent.
An electrolyte solution (UW solution) having an osmotic pressure of sm / l, 125 milliequivalent potassium ion, and 35 milliequivalent sodium ion has been developed. (JP-A-1
-246201, JP-A-3-188001) This UW solution is said to be useful for preservation of kidney, liver and pancreas. In addition, the present inventors have already disclosed a stable and inexpensive electrolyte solution which is an intracellular solution type electrolyte solution similar to the UW solution and which has an excellent cell degeneration protection effect. (JP-A-4-128201)
【０００５】しかし、前記いずれの電解質溶液によって
も、なお、充分に移植臓器の生存機能を保持していると
は言えず、移植後の臓器の機能不全が懸念される。ま
た、移植臓器のなかで肝臓は、脳についで酸素欠乏に弱
い臓器で、これまで長時間の臓器保存が困難とされてい
た。この肝臓をはじめとする生存能力低い移植臓器につ
いても、長時間の臓器保存が可能で、移植後の機能不全
が少ない電解質溶液の開発が望まれている。However, it cannot be said that any of the above-mentioned electrolyte solutions still retains the survival function of the transplanted organ, and there is a concern that the organ may malfunction after transplantation. In addition, among the transplanted organs, the liver is an organ that is weak against oxygen deficiency next to the brain, and it has been difficult to preserve the organ for a long time. It is desired to develop an electrolyte solution that can preserve organs for a long period of time even in transplanted organs such as the liver with low viability and that has little malfunction after transplantation.
【０００６】[0006]
【発明が解決しようとする課題】したがって、本発明の
課題は、移植臓器の灌流及び保存に使用する電解質溶液
において、移植臓器の生存機能維持作用に優れ、長期間
の臓器保存が可能で移植後の臓器の機能不全が少ない電
解質溶液を提供することにある。Therefore, an object of the present invention is to provide an electrolyte solution used for perfusion and preservation of transplanted organs, which has an excellent effect of maintaining the survival function of the transplanted organs and enables long-term preservation of the organs. The purpose of the present invention is to provide an electrolyte solution in which the dysfunction of the organs is small.
【０００７】[0007]
【課題を解決するための手段】移植臓器の保存に関する
研究では、移植臓器を低温で保存した場合に生ずるカリ
ウムイオンの細胞外流失を防止するため、カリウムイオ
ンの高い細胞内液型の電解質溶液が移植臓器の保存に適
するとした報告がある。しかし、移植臓器の細胞内にお
けるカリウムイオンの枯渇は容易にまた急速に回復し得
るし、むしろカリウムイオンが高いと血管攣縮や血管内
皮障害を誘発するとの報告、さらに、電解質溶液の組成
を細胞内液型にすることだけで移植臓器の浮腫は防止で
きず、マンニトールやブドウ糖などを用いて浸透圧を高
める必要があり、電解質溶液の組成よりむしろ高浸透圧
の効果の方が浮腫防止に効果を発揮すると報告されてい
る。このように、移植臓器の灌流及び保存に用いる電解
質溶液に関して、その適切な組成を生み出すための統一
的な考え方は定まっていない。[Means for Solving the Problems] In studies on the preservation of transplanted organs, in order to prevent extracellular loss of potassium ions that occurs when the transplanted organs are preserved at low temperature, an intracellular solution type electrolyte solution with high potassium ions is used. There are reports that it is suitable for preservation of transplanted organs. However, depletion of potassium ions in cells of transplanted organs can be recovered easily and rapidly, and rather high potassium ions induce vasospasm and vascular endothelial damage. The edema of the transplanted organ cannot be prevented only by making it liquid type, and it is necessary to increase the osmotic pressure by using mannitol, glucose, etc., and the effect of high osmotic pressure is more effective in preventing edema than the composition of the electrolyte solution. It is reported to be effective. As described above, regarding electrolyte solutions used for perfusion and preservation of transplanted organs, no uniform idea has been established for producing the appropriate composition.
【０００８】他方、移植臓器を浸漬保存するための溶液
として細胞内液型の電解質溶液を使用すると、移植前再
灌流直前にこの溶液を洗い流す必要がある。これは、移
植手術前の操作が煩雑となり、また、急激な電解質変化
を移植臓器に与えるため好ましくない。さらに、高浸透
圧の効果により浮腫を抑制するため浸透圧調整剤の濃度
を高くすると、電解質溶液が粘稠となる。電解質溶液が
粘稠になると、初期灌流における電解質溶液の注入速度
が遅くなり、迅速な血液の洗い流しが困難となる。本発
明者らは、前記問題点を考慮して、特にナトリウム、カ
リウムの電解質組成、浸透圧調節剤、及び膠質浸透圧剤
の望ましい選択と組成範囲を鋭意研究した結果、初期の
目的を達成する本発明を完成することができた。On the other hand, when an intracellular solution type electrolyte solution is used as a solution for immersing and storing the transplanted organ, it is necessary to wash out this solution immediately before reperfusion before transplantation. This is not preferable because the operation before transplantation operation becomes complicated and a rapid change in electrolyte is given to the transplanted organ. Further, increasing the concentration of the osmotic pressure adjusting agent to suppress edema due to the effect of high osmotic pressure makes the electrolyte solution viscous. When the electrolyte solution becomes viscous, the infusion rate of the electrolyte solution in the initial perfusion becomes slow, and it becomes difficult to quickly wash out blood. In view of the above problems, the present inventors have made earnest studies on the desirable selection and composition range of the electrolyte composition of sodium and potassium, the osmotic pressure adjusting agent, and the oncotic pressure adjusting agent, and as a result, achieve the initial purpose. The present invention has been completed.
【０００９】すなわち、浸透圧が２５０〜３４０mOsm／
ｌ、ｐＨが７．０〜８．０の電解質溶液であって、下記
成分を下記の範囲内で含有することを特徴とするもので
ある。That is, the osmotic pressure is 250 to 340 mOsm /
It is an electrolyte solution having a pH of 7.0 and 8.0 and containing the following components within the following range.
【００１０】[0010]
【表２】 [Table 2]
【００１１】本発明のより好ましい実施態様の組成範囲
を示せば次の通りである。The composition range of a more preferred embodiment of the present invention is as follows.
【００１２】[0012]
【表３】 [Table 3]
【００１３】本発明の電解質溶液の製造に当たり、上記
組成中のアニオン及びカチオンを処方するための具体的
な成分としては、乳酸、酢酸、プロピオン酸、β−ヒド
ロキシ酪酸、クエン酸、グルコン酸等の有機酸及びその
塩、炭素数８以下の中鎖もしくは短鎖脂肪酸及びその
塩、並びに塩化ナトリウム、塩化カリウム、リン酸二水
素ナトリウム、リン酸二水素カリウム、リン酸水素二ナ
トリウム、リン酸水素二カリウム、炭酸水素ナトリウ
ム、炭酸水素カリウム、炭酸ナトリウム、炭酸カリウム
等が例示できる。ヒドロキシエチル澱粉は、置換度が
０．４〜０．８の範囲内のもので、平均分子量が２００
０００〜９０００００のものが好ましく、さらに好まし
くは約３５００００〜８０００００のものである。本発
明の電解質溶液は、公知の輸液剤製造方法に準拠して容
易に製造することができる。また、その使用に際して
は、活性酸素拮抗剤、細胞膜安定化剤及び微小循環系の
痙縮防止剤などの薬剤を添加することができる。In preparing the electrolyte solution of the present invention, specific components for formulating the anions and cations in the above composition include lactic acid, acetic acid, propionic acid, β-hydroxybutyric acid, citric acid, gluconic acid and the like. Organic acids and salts thereof, medium or short chain fatty acids having 8 or less carbon atoms and salts thereof, and sodium chloride, potassium chloride, sodium dihydrogen phosphate, potassium dihydrogen phosphate, disodium hydrogen phosphate, dihydrogen phosphate. Examples thereof include potassium, sodium hydrogen carbonate, potassium hydrogen carbonate, sodium carbonate, potassium carbonate and the like. Hydroxyethyl starch has a degree of substitution in the range of 0.4 to 0.8 and an average molecular weight of 200.
000-900000 are preferable, More preferably, it is about 350,000-800000. The electrolyte solution of the present invention can be easily produced according to a known method for producing an infusion agent. In addition, upon its use, agents such as an active oxygen antagonist, a cell membrane stabilizer and an antispasmodic agent for the microcirculatory system can be added.
【００１４】[0014]
実施例１ 約５０℃の蒸留水８００ｍｌにヒドロキシエチル澱粉
（平均分子量４２９０００、置換度０．５５）３０．０
ｇ、グルコン酸ナトリウム１９．６ｇ、リン酸水素二カ
リウム３．２２ｇ、リン酸二水素カリウム０．８８５ｇ
及びマンニトール７．３ｇを加えて溶解した後、炭酸水
素ナトリウム０．８４ｇ及び蒸留水を加えて全量を１ｌ
とした。これを直ちにろ過し、ガラス容器に充填、密栓
後、高圧蒸気滅菌して浸透圧２９１mOsm／ｌ、ｐＨ７．
３２の電解質溶液を製した。Example 1 Hydroxyethyl starch (average molecular weight 429000, degree of substitution 0.55) 30.0 in 800 ml of distilled water at about 50 ° C.
g, sodium gluconate 19.6 g, dipotassium hydrogen phosphate 3.22 g, potassium dihydrogen phosphate 0.885 g
And 7.3 g of mannitol were added and dissolved, and then 0.84 g of sodium hydrogen carbonate and distilled water were added to bring the total amount to 1 l.
And This was immediately filtered, filled in a glass container, sealed, and sterilized by high pressure steam to have an osmotic pressure of 291 mOsm / l and a pH of 7.
32 electrolyte solutions were prepared.
【００１５】[0015]
【試験例】本発明の有用性を調べるため、実施例１で調
製した本発明電解質溶液１ｌあたりアロプリノールを１
００ｍｇ、デキサメタゾンを４ｍｇ添加した溶液（以下
単に本発明溶液と略記する）を用いて、ウイスター系雄
性ラットの肝臓を灌流後浸漬保存法により２４時間保存
（浸漬保存温度：４℃）した。浸漬保存した前記肝臓
を、鎌田法に準じたラット肝臓移植手術により移植し、
肝臓移植後１週間目における被検動物群の生存率を調べ
た。本発明溶液の効果を明らかにするため、表４に示し
た特開平４−１２８２０１号公報の実施例１の溶液に本
発明溶液と同様の薬剤を添加した溶液（以下比較液１と
略記する）、及び表５に示すＵＷ液（以下比較液２と略
記する）を用いて、前記本発明溶液を用いて行ったと同
様の移植手術を行い、それぞれの被検動物群の生存率を
調べた。[Test Example] In order to examine the usefulness of the present invention, 1 allopurinol was added per 1 liter of the electrolyte solution of the present invention prepared in Example 1.
Using a solution containing 00 mg and 4 mg of dexamethasone (hereinafter simply referred to as the solution of the present invention), the liver of a Wistar male rat was stored for 24 hours by the immersion storage method after perfusion (immersion storage temperature: 4 ° C.). The liver soaked and preserved is transplanted by rat liver transplantation surgery according to the Kamata method,
The survival rate of the test animal group was examined one week after the liver transplantation. In order to clarify the effect of the solution of the present invention, a solution prepared by adding the same chemical agent as the solution of the present invention to the solution of Example 1 of JP-A-4-128201 shown in Table 4 (hereinafter abbreviated as Comparative Solution 1). , And the UW solution shown in Table 5 (hereinafter abbreviated as Comparative Solution 2) was used to perform the same transplantation surgery as that performed using the solution of the present invention, and the survival rate of each test animal group was examined.
【００１６】[0016]
【表４】 [Table 4]
【００１７】[0017]
【表５】 [Table 5]
【００１８】表６に各被検動物群の生存率を示した。こ
の表から、本発明溶液を使用して肝臓を灌流後浸漬保存
した場合の生存率は、２種類の比較液を使用した場合に
比べて明らかに高かく、本発明の電解質溶液は、生存能
力の低い肝臓においても、その灌流及び保存に優れた生
存機能維持作用を発揮することが認められた。Table 6 shows the survival rate of each test animal group. From this table, the survival rate when the liver was perfused with the solution of the present invention after perfusion and preserved was clearly higher than that when two types of comparative solutions were used, and the electrolyte solution of the present invention showed a viability. It was confirmed that even in a low liver, it exerts an excellent activity-maintaining action for perfusion and preservation.
【００１９】[0019]
【表６】 [Table 6]
【００２０】[0020]
【発明の効果】本発明によれば、移植臓器の長時間保存
が可能となり、また、移植後の臓器の機能不全を抑制す
ることができる。According to the present invention, the transplanted organ can be preserved for a long time, and the dysfunction of the organ after transplantation can be suppressed.
Claims (1)
が７．０〜８．０の電解質溶液であって、下記成分を下
記の範囲内で含有することを特徴とする移植臓器用の電
解質溶液。 【表１】 1. An osmotic pressure of 250 to 340 mOsm / l, pH
Is an electrolyte solution of 7.0 to 8.0, and contains the following components within the following range: An electrolyte solution for transplanted organs. [Table 1]
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP23292692A JPH0656601A (en) | 1992-08-07 | 1992-08-07 | Electrolyte solution for organ for transplantation |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP23292692A JPH0656601A (en) | 1992-08-07 | 1992-08-07 | Electrolyte solution for organ for transplantation |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| JPH0656601A true JPH0656601A (en) | 1994-03-01 |
Family
ID=16947009
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP23292692A Pending JPH0656601A (en) | 1992-08-07 | 1992-08-07 | Electrolyte solution for organ for transplantation |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JPH0656601A (en) |
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| JP2014148553A (en) * | 1997-09-23 | 2014-08-21 | Department Of Vaterans Affairs | Composition, method and device for maintaining organ |
| US9756850B2 (en) | 1997-09-23 | 2017-09-12 | The Department Of Veteran Affairs | Compositions, methods and devices for maintaining an organ |
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| US9894894B2 (en) | 2004-10-07 | 2018-02-20 | Transmedics, Inc. | Systems and methods for ex-vivo organ care and for using lactate as an indication of donor organ status |
| US10039276B2 (en) | 2005-06-28 | 2018-08-07 | Transmedics, Inc. | Systems, methods, compositions and solutions for perfusing an organ |
| US10076112B2 (en) | 2014-06-02 | 2018-09-18 | Transmedic, Inc. | Ex vivo organ care system |
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1992
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| CN109221084A (en) * | 2018-09-20 | 2019-01-18 | 中国人民解放军第二军医大学第二附属医院 | A kind of dedicated preservation liquid of pancreas and preparation method thereof |
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