JPH03195561A - Manufacture of glucose-containing steam-sterilized liquid and tool used therefor - Google Patents

Manufacture of glucose-containing steam-sterilized liquid and tool used therefor

Info

Publication number
JPH03195561A
JPH03195561A JP1337914A JP33791489A JPH03195561A JP H03195561 A JPH03195561 A JP H03195561A JP 1337914 A JP1337914 A JP 1337914A JP 33791489 A JP33791489 A JP 33791489A JP H03195561 A JPH03195561 A JP H03195561A
Authority
JP
Japan
Prior art keywords
glucose
liquid
steam
containers
container
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
Application number
JP1337914A
Other languages
Japanese (ja)
Inventor
Yoji Kawaguchi
川口 洋司
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Nippon Medical Supply Corp
Original Assignee
Nippon Medical Supply Corp
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Nippon Medical Supply Corp filed Critical Nippon Medical Supply Corp
Priority to JP1337914A priority Critical patent/JPH03195561A/en
Publication of JPH03195561A publication Critical patent/JPH03195561A/en
Pending legal-status Critical Current

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  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)

Abstract

PURPOSE:To obtain a steam-sterilized glucose-containing liquid by separately storing the first liquid containing glucose and the second liquid containing a component accelerating the heat decomposition of glucose in two containers, sealing and steam-sterilizing them, and removing a bulkhead from the outside of a pipe to sterilely mix both liquids. CONSTITUTION:A liquid containing glucose is stored in the first container 1, a liquid containing citrate or phosphate accelerating the heat decomposition of glucose is stored in the second container 2, two containers 1, 2 are connected with a pipe 3, a bulkhead 4 removable from the outside is provided in the pipe 3 so that the liquids in two containers are not mixed, and the combination of containers 1, 2 are steam-sterilized. Steam sterilization is performed under the conditions normally employed for the sterilization of medical articles. After sterilization is completed, the bulkhead 4 of the pipe 3 is removed to communicate two containers 1, 2, and the liquid is moved from the second container 2 to the first container 1 to mix both liquids. The pipe 3 is sealed and cut at the position 5, and a steam-sterilized liquid containing glucose stored in the container 1 and also containing citrate or phosphate can be obtained.

Description

【発明の詳細な説明】 1産業上の利用分野〕 本発明は、グルコースを含有する蒸気滅菌された液を得
るための方法に関する。さらに詳しくは、グルコースの
熱分解を促進する成分を含む蒸気滅菌されたグルコース
溶液を得るための方法とそのための用具に関する。
DETAILED DESCRIPTION OF THE INVENTION 1. Field of Industrial Application The present invention relates to a method for obtaining a steam-sterilized liquid containing glucose. More specifically, the present invention relates to a method for obtaining a steam-sterilized glucose solution containing a component that promotes the thermal decomposition of glucose, and a device therefor.

〔従来の技術〕[Conventional technology]

グルコースは、輸液剤、腹膜透析液、血液保存液など多
くの液状薬剤に成分の1つとして含まれている。これら
の液状薬剤は、ハソグや瓶に封入され、通常は蒸気滅菌
が施されている。
Glucose is contained as one of the ingredients in many liquid drugs such as infusion solutions, peritoneal dialysis solutions, and blood preservation solutions. These liquid drugs are sealed in gaskets or bottles and are usually steam sterilized.

〔発明が解決しようとする課題〕[Problem to be solved by the invention]

現在市販されているグルコース含有液状薬剤は、蒸気滅
菌を行ってもグルコースの分解はあまり起こらないので
、そのまま蒸気滅菌することが可能である。しかし、本
発明者らが新しい組成のグルコース含有液を蒸気滅菌し
たところ、大量のグルコースが分解してしまい、滅菌後
のグルコース濃度が大きく低下してしまった。そこでそ
の原因を追求したところ、組成の一部にグルコースの熱
分解を促進する成分があることをつきとめた。グルコー
スの熱分解が激しいと、滅菌後のグルコース濃度が変動
するために品質管理上問題があるばかりでなく、滅菌後
の液に多量の分解生成物が存在することになるので好ま
しくない。本発明者らが検討したところでは、このグル
コース分解は液のpHを酸性にすることによっである程
度抑制することができたが、基本的に中性領域にある生
体に対して酸性の液を使用するのは好ましいことではな
い。
Glucose-containing liquid medicines currently on the market can be steam sterilized without much decomposition of glucose even after steam sterilization. However, when the present inventors steam-sterilized a glucose-containing liquid with a new composition, a large amount of glucose was decomposed, and the glucose concentration after sterilization was significantly reduced. In pursuit of the cause, they discovered that part of the composition contained a component that promoted the thermal decomposition of glucose. If the thermal decomposition of glucose is severe, the glucose concentration after sterilization will fluctuate, causing problems in terms of quality control, and a large amount of decomposition products will be present in the liquid after sterilization, which is undesirable. According to the studies conducted by the present inventors, this glucose decomposition could be suppressed to some extent by making the pH of the solution acidic. It is not desirable to use it.

本発明の目的は、このようなグルコースの熱分解を促進
する成分を含む蒸気滅菌されたグルコース含有液を、液
のpH調整を行うことなく且つ多量のグルコースの分解
を伴うことなく製造する方法を提供することにある。ま
た本発明の他の目的は、そのような方法において使用す
る用具を提供するものである。
The object of the present invention is to provide a method for producing a steam-sterilized glucose-containing liquid containing a component that promotes the thermal decomposition of glucose without adjusting the pH of the liquid and without decomposing a large amount of glucose. It is about providing. Another object of the invention is to provide a device for use in such a method.

〔課題を解決するだめの手段〕[Failure to solve the problem]

本発明においては、グルコースの熱分解を促進する成分
をグルコースから分離した状態で蒸気滅菌し、滅菌後に
両者を密閉状態で混合することによって上記の目的を達
成した。
In the present invention, the above object was achieved by steam sterilizing a component that promotes the thermal decomposition of glucose in a state separated from glucose, and then mixing the two in a sealed state after sterilization.

すなわち第1の発明は、グルコースを含有する第1の液
と、グルコースの熱分解を促進する成分を含有する第2
の液とを、外部より除去可能な隔壁を内部に有する導管
で接続された2つの容器にそれぞれ別個に収納して密封
し、次いで蒸気滅菌を行い、しかる後に前記隔壁を導管
外部から除去して第1の液と第2の液とを無菌的に混合
することを特徴とする蒸気滅菌されたグルコース含有液
の製造方法である。
That is, the first invention includes a first liquid containing glucose and a second liquid containing a component that promotes thermal decomposition of glucose.
and the liquid are stored separately in two containers connected by a conduit having a partition wall inside which can be removed from the outside and sealed, then steam sterilized, and then the partition wall is removed from the outside of the pipe. This is a method for producing a steam-sterilized glucose-containing liquid, which is characterized by aseptically mixing a first liquid and a second liquid.

また第2の発明は、グルコース含有液を収納するための
第1の容器と、グルコースの熱分解を促進する成分を含
有する液を収納するための第2の容器と、これら2つの
容器を連結する導管と、該導管内に設けられた外部から
除去可能な隔壁とを有することを特徴とするグルコース
含有蒸気滅菌液の製造用具である。
The second invention also provides a first container for storing a glucose-containing liquid, a second container for storing a liquid containing a component that promotes thermal decomposition of glucose, and a method for connecting these two containers. This is a device for producing a glucose-containing steam sterilization solution, characterized by having a conduit for the purpose of sterilization, and a partition wall provided in the conduit and removable from the outside.

(作  用〕 本発明によれば、グルコースは熱分解を促進する成分か
ら隔離された状態で蒸気滅菌されるので分解はほとんど
起こらず、その後に熱分解を促進する成分と混合するこ
とによって最終的な溶液を得ることができる。そして、
混合は密閉状態で行うので、滅菌状態を維持することが
できる。また、液を混合した後に導管をシールして切断
することにより2つの容器を分離すれば、単独の容器に
収納された蒸気滅菌液を得ることができる。
(Function) According to the present invention, glucose is steam sterilized while being isolated from components that promote thermal decomposition, so that almost no decomposition occurs, and the glucose is then mixed with components that promote thermal decomposition to produce the final product. You can obtain a solution with
Since the mixing is done in a sealed state, sterilization can be maintained. Additionally, if the two containers are separated by sealing and cutting the conduit after mixing the liquids, a steam sterilization liquid contained in a single container can be obtained.

〔実施例〕〔Example〕

本発明の対象となるグルコースを含有する液としては、
各種の輸液剤、腹膜透析液および血液保存液などをあげ
ることができる。そして、これらの液におけるグルコー
スの濃度には特に制限はない。以下、血液保存液を例に
とって本発明をさらに具体的に説明する。
The glucose-containing liquid targeted by the present invention includes:
Examples include various infusion agents, peritoneal dialysis solutions, and blood preservation solutions. There is no particular restriction on the concentration of glucose in these solutions. Hereinafter, the present invention will be explained in more detail by taking a blood preservation solution as an example.

全血または赤血球製剤の保存期間を延長するために、種
々の血液保存液が使用されるが、血液保存液は、血液バ
ッグに充填・密封したものを蒸気滅菌して使用に供する
。従来使用されている保存液には、塩化ナトリウム5ア
デニン、マンニトールおよびグルコースなどの成分が含
まれており、蒸気滅菌によってわずかにグルコースが分
解することがあるが、問題になるようなものではなかっ
た。ところが、保存性の改善のためにこれにクエン酸塩
やリン酸塩をさらに添加して蒸気滅菌を行うと、大量の
グルコースが分解してしまう。
Various blood preservation solutions are used to extend the storage period of whole blood or red blood cell preparations, and blood preservation solutions are used after filling and sealing blood bags and steam sterilizing them. Conventionally used storage solutions contain ingredients such as sodium chloride 5-adenine, mannitol, and glucose, and while steam sterilization may slightly degrade glucose, this was not a problem. . However, when citrate or phosphate is further added to this and steam sterilized to improve its shelf life, a large amount of glucose decomposes.

この問題を解決するために、本発明においては、第1図
に示すように、前述したグルコースを含む組成の液を第
1の容器1(塩化ビニル樹脂製バッグ)に入れ、クエン
酸塩やリン酸塩を含む液を第2の容器2(塩化ビニル樹
脂製バッグ)に入れる。
In order to solve this problem, in the present invention, as shown in FIG. The solution containing the acid salt is placed in the second container 2 (vinyl chloride resin bag).

そして、2つの容器を導管3(塩化ビニル製チューブ)
で連結し、導管内には外部から除去可能な隔壁4を設け
て、2つの容器内の溶液が混合しないようにしてお(。
Then, connect the two containers to conduit 3 (vinyl chloride tube).
A partition wall 4 that can be removed from the outside is provided inside the conduit to prevent the solutions in the two containers from mixing.

そしてこの容器連結体を蒸気滅菌する。蒸気滅菌の条件
は、通常医薬品の滅菌等に採用されている条件で問題な
〈実施できる。
This container assembly is then steam sterilized. Steam sterilization can be carried out under the conditions normally used for sterilizing pharmaceutical products.

滅菌が終了したならば、導管の隔壁4を除去して2つの
容器を連通状態にし、第2の容器から第1の容器に液を
移動させて両者を混合する。そして最後に導管を5の位
置でシールして切断すれば、容器1内に収納されたグル
コース含有液であってクエン酸塩やリン酸塩をも含む蒸
気滅菌済の液を得ることができる。また、混合した液を
一方の容器に全量収納するかわりに、半量ずつを2つの
容器に分割して収納し、導管をシールして容器同士を分
離するようにすれば、同時に滅菌済の液を収納した2つ
の容器を得るごとができる。
Once sterilization has been completed, the septum 4 of the conduit is removed to bring the two containers into communication, and the liquid is transferred from the second container to the first container to mix them. Finally, by sealing and cutting the conduit at position 5, the steam-sterilized glucose-containing liquid contained in the container 1, which also contains citrate and phosphate, can be obtained. Also, instead of storing the entire amount of the mixed liquid in one container, it is possible to divide half the amount into two containers and separate the containers by sealing the conduit, allowing the sterilized liquid to be stored at the same time. It is possible to obtain two stored containers.

導管内に設ける隔壁としては、第2図に示すような連通
筒6が好適である。図に示すように、連通筒6は小径部
7と大径部8より構成されており、小径部は中実で大径
部は中空構造になっている。
A communication tube 6 as shown in FIG. 2 is suitable as the partition wall provided in the conduit. As shown in the figure, the communication tube 6 is composed of a small diameter part 7 and a large diameter part 8, the small diameter part being solid and the large diameter part having a hollow structure.

連通筒は全体が硬質樹脂から形成されており、大径部外
表面は導管3の内表面に固着され、大径部と小径部の境
界付近には薄肉部9が設けられている。この状態では、
容器1ど容器2の内容液は完全に隔離されている。蒸気
滅菌が終了した後、導管を外部から折り曲げて連通筒の
薄肉部9の位置で破断すると、小径部は分離され大径部
の先端が開口して、2つの容器は連通状態となる。この
とき、分離した小径部7が容器1内に流れていかないよ
うにするために、連通筒を設けた位置よりも左側の導管
3゛は、内径が小径部7の外径より小さくしである。こ
のような構造の隔壁を設けることによって、簡便かつ確
実に本発明を実施することができる。なお、隔壁を設け
る位置は、導管の任意の位置でよい。
The entire communication tube is made of hard resin, the outer surface of the large diameter portion is fixed to the inner surface of the conduit 3, and a thin wall portion 9 is provided near the boundary between the large diameter portion and the small diameter portion. In this state,
The contents of containers 1 and 2 are completely isolated. After steam sterilization is completed, when the conduit is bent from the outside and broken at the thin wall portion 9 of the communication tube, the small diameter portion is separated and the tip of the large diameter portion is opened, so that the two containers are in communication. At this time, in order to prevent the separated small diameter part 7 from flowing into the container 1, the inner diameter of the conduit 3' on the left side of the position where the communicating tube is provided is smaller than the outer diameter of the small diameter part 7. . By providing a partition wall having such a structure, the present invention can be carried out easily and reliably. Note that the partition wall may be provided at any position on the conduit.

次に、本発明の効果を試験例によってさらに具体的に説
明する。
Next, the effects of the present invention will be explained in more detail using test examples.

試隻曇 表1に示す4種類の組成の液を調製し、これを容it 
300dの塩化ビニル樹脂製バッグに1oadずつ充填
して121°Cで20分間蒸気滅菌を行った。滅菌後に
グルコースの濃度を測定し、滅菌による減少率を求めた
。結果を表1に併せて示す。
Prepare liquids with the four types of compositions shown in Table 1, and add
1 oad each was filled into a 300 d vinyl chloride resin bag and steam sterilized at 121°C for 20 minutes. After sterilization, the glucose concentration was measured and the rate of decrease due to sterilization was determined. The results are also shown in Table 1.

(以下余白) 表  1 次に、組成2〜4のものについて、塩化ナトリウム、ア
デニン、マンニトールおよびグルコースを含む第1の液
と、クエン酸ナトリウム単独(組成2)またはクエン酸
ナトリウム、リン酸2水素ナトリウムおよびリン酸水素
2ナトリウムを含む(組成3および4)第2の液とを、
第1の液60mと第2の液40dを混合したときに表1
の組成になるように調製し、第1図に示すのと同様のハ
ングシステムの2つのハングに、それぞれを別々に充填
して蒸気滅菌を行った。そして滅菌後に隔壁を除去して
両者を混合し、グルコース濃度を測定してグルコースの
減少率を求めた。結果を表2に示す。
(Margin below) Table 1 Next, for compositions 2 to 4, the first liquid containing sodium chloride, adenine, mannitol, and glucose, and sodium citrate alone (composition 2) or sodium citrate and dihydrogen phosphate. a second liquid containing sodium and disodium hydrogen phosphate (compositions 3 and 4);
When 60 m of the first liquid and 40 d of the second liquid were mixed, Table 1
The composition was prepared to have the following composition, and the two hangs of a hang system similar to that shown in FIG. 1 were filled separately and steam sterilized. After sterilization, the septum was removed, the two were mixed, and the glucose concentration was measured to determine the glucose reduction rate. The results are shown in Table 2.

表  2 1記の結果から明らかなように、クエン酸ナトリウムや
リン酸2水素ナトリウムおよびリン酸水素2ナトリウム
を含む組成2〜4の場合には、グルコースの分解が非常
に顕著である。
As is clear from the results shown in Table 2-1, in compositions 2 to 4 containing sodium citrate, sodium dihydrogen phosphate, and disodium hydrogen phosphate, the decomposition of glucose is extremely significant.

表2の結果から明らかなように、本発明によればグルコ
ースの分解はほとんど起こらない。表1の結果と比較す
ると、発明の効果が一目瞭然である。
As is clear from the results in Table 2, according to the present invention, glucose decomposition hardly occurs. When compared with the results in Table 1, the effects of the invention are obvious.

また、参考のために組成2〜4の液について、塩酸を添
加して液のpHを下げて羊−の液で蒸気滅菌を行うと、
pHの低Fとともにグルコースの分解が起きにくくなり
、5.5以下ではいずれの組成のものもグルコースの減
少率を5%以tにすることができた。しかし、本発明に
比べて効果がやや劣るものであった。
Also, for reference, if you add hydrochloric acid to lower the pH of the liquid and steam sterilize it with sheep's liquid,
As the pH decreases, glucose decomposition becomes less likely to occur, and at a pH of 5.5 or lower, glucose reduction rates of 5% or more were achieved for all compositions. However, the effect was slightly inferior to that of the present invention.

〔発明の効果〕〔Effect of the invention〕

本発明によれば、グルコースの熱分解を促進する成分を
含むグルコース含有液の蒸気滅菌法製品を、グルコース
の熱分解を最小限に抑えた状態で得ることができる。し
たがって、所定のグルコースを含有する滅菌法の液を再
現性よく製造することができる。また、液のp Hを酸
性にする必要がなく、滅菌された液に多量のグルコース
分解生成物が含まれることもないので、安全性の面でも
好ましい。
According to the present invention, a steam sterilization product of a glucose-containing liquid containing a component that promotes the thermal decomposition of glucose can be obtained with the thermal decomposition of glucose being minimized. Therefore, a sterilization solution containing a predetermined glucose can be produced with good reproducibility. Furthermore, it is preferable from the viewpoint of safety, since there is no need to make the pH of the liquid acidic and the sterilized liquid does not contain a large amount of glucose decomposition products.

【図面の簡単な説明】[Brief explanation of drawings]

第1図は、本発明の方法を実施するための用具の実施例
を示す簡略化された正面図であり、第2図は、その実施
例において導管内に設ける隔壁の実施例を示す部分断面
図である。 ■、第1のバッグ  2.第2のバッグ3、導管   
   4.隔壁
1 is a simplified front view of an embodiment of a device for carrying out the method of the invention, and FIG. 2 is a partially cross-sectional view of an embodiment of a septum provided in a conduit in that embodiment; FIG. It is a diagram. ■, 1st bag 2. Second bag 3, conduit
4. bulkhead

Claims (2)

【特許請求の範囲】[Claims] (1)グルコースを含有する第1の液と、グルコースの
熱分解を促進する成分を含有する第2の液とを、外部よ
り除去可能な隔壁を内部に有する導管で接続された2つ
の容器にそれぞれ別個に収納して密封し、次いで蒸気滅
菌を行い、しかる後に前記隔壁を導管外部から除去して
第1の液と第2の液とを無菌的に混合することを特徴と
する蒸気滅菌されたグルコース含有液の製造方法。
(1) A first liquid containing glucose and a second liquid containing a component that promotes thermal decomposition of glucose are placed in two containers connected by a conduit that has a partition inside that can be removed from the outside. A method of steam sterilization characterized in that the first liquid and the second liquid are individually stored and sealed, then steam sterilized, and then the partition wall is removed from the outside of the conduit and the first liquid and the second liquid are mixed aseptically. A method for producing a glucose-containing liquid.
(2)グルコース含有液を収納するための第1の容器と
、グルコースの熱分解を促進する成分を含有する液を収
納するための第2の容器と、これら2つの容器を連結す
る導管と、該導管内に設けられた外部から除去可能な隔
壁とを有することを特徴とするグルコース含有蒸気滅菌
液の製造用具。
(2) a first container for storing a glucose-containing liquid, a second container for storing a liquid containing a component that promotes thermal decomposition of glucose, and a conduit connecting these two containers; 1. A device for producing a glucose-containing steam sterilization liquid, comprising a partition wall provided in the conduit and removable from the outside.
JP1337914A 1989-12-26 1989-12-26 Manufacture of glucose-containing steam-sterilized liquid and tool used therefor Pending JPH03195561A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP1337914A JPH03195561A (en) 1989-12-26 1989-12-26 Manufacture of glucose-containing steam-sterilized liquid and tool used therefor

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
JP1337914A JPH03195561A (en) 1989-12-26 1989-12-26 Manufacture of glucose-containing steam-sterilized liquid and tool used therefor

Publications (1)

Publication Number Publication Date
JPH03195561A true JPH03195561A (en) 1991-08-27

Family

ID=18313182

Family Applications (1)

Application Number Title Priority Date Filing Date
JP1337914A Pending JPH03195561A (en) 1989-12-26 1989-12-26 Manufacture of glucose-containing steam-sterilized liquid and tool used therefor

Country Status (1)

Country Link
JP (1) JPH03195561A (en)

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999009953A1 (en) * 1997-08-22 1999-03-04 Shimizu Pharmaceutical Co., Ltd. Glucose-containing preparation
US6475529B2 (en) 1999-09-10 2002-11-05 Baxter International Inc. Bicarbonate-based solution in two parts for peritoneal dialysis or substitution in continuous renal replacement therapy
US7011855B2 (en) 1994-07-01 2006-03-14 Baxter International Inc. Biochemically balanced peritoneal dialysis solutions
US7122210B2 (en) 2002-01-11 2006-10-17 Baxter International Inc. Bicarbonate-based solutions for dialysis therapies
US7445801B2 (en) 2002-06-07 2008-11-04 Baxter International Inc. Stable bicarbonate-based solution in a single container
US8052631B2 (en) 2005-01-28 2011-11-08 Fresenius Medical Care Holdings, Inc. Systems and methods for delivery of peritoneal dialysis (PD) solutions
US10842714B2 (en) 2010-10-14 2020-11-24 Fresenius Medical Care Holdings, Inc. Systems and methods for delivery of peritoneal dialysis (PD) solutions with integrated inter chamber diffuser

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7011855B2 (en) 1994-07-01 2006-03-14 Baxter International Inc. Biochemically balanced peritoneal dialysis solutions
WO1999009953A1 (en) * 1997-08-22 1999-03-04 Shimizu Pharmaceutical Co., Ltd. Glucose-containing preparation
US6475529B2 (en) 1999-09-10 2002-11-05 Baxter International Inc. Bicarbonate-based solution in two parts for peritoneal dialysis or substitution in continuous renal replacement therapy
US7122210B2 (en) 2002-01-11 2006-10-17 Baxter International Inc. Bicarbonate-based solutions for dialysis therapies
US7445801B2 (en) 2002-06-07 2008-11-04 Baxter International Inc. Stable bicarbonate-based solution in a single container
US8052631B2 (en) 2005-01-28 2011-11-08 Fresenius Medical Care Holdings, Inc. Systems and methods for delivery of peritoneal dialysis (PD) solutions
US8328784B2 (en) 2005-01-28 2012-12-11 Fresenius Medical Care Holdings, Inc. Systems and methods for delivery of peritoneal dialysis (PD) solutions
US9180069B2 (en) 2005-01-28 2015-11-10 Fresenius Medical Care Holdings, Inc. Systems and methods for delivery of peritoneal dialysis (PD) solutions
US10842714B2 (en) 2010-10-14 2020-11-24 Fresenius Medical Care Holdings, Inc. Systems and methods for delivery of peritoneal dialysis (PD) solutions with integrated inter chamber diffuser

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