JPH09301875A - Hemodialysis preparation - Google Patents
Hemodialysis preparationInfo
- Publication number
- JPH09301875A JPH09301875A JP11622996A JP11622996A JPH09301875A JP H09301875 A JPH09301875 A JP H09301875A JP 11622996 A JP11622996 A JP 11622996A JP 11622996 A JP11622996 A JP 11622996A JP H09301875 A JPH09301875 A JP H09301875A
- Authority
- JP
- Japan
- Prior art keywords
- preparation
- lactate
- agent
- ion
- dialysis
- 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.)
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Description
【０００１】[0001]
【発明の属する技術分野】本発明は、腎不全等の患者に
対する血液浄化を目的として行われる血液透析（人工透
析）に用いる透析剤であり、特にアルカリ化剤として重
炭酸イオンを用いる改良された重炭酸透析用製剤に関す
るものである。TECHNICAL FIELD The present invention relates to a dialysis agent used in hemodialysis (artificial dialysis) performed for the purpose of blood purification for patients with renal failure and the like. In particular, it has been improved by using bicarbonate ion as an alkalizing agent. It relates to a preparation for bicarbonate dialysis.
【０００２】[0002]
【従来の技術】慢性腎不全患者等に対して行われる血液
浄化療法の最もポピュラーな療法の一つとして血液透析
療法（人工透析療法）がある。2. Description of the Related Art Hemodialysis (artificial dialysis) is one of the most popular blood purification therapies for patients with chronic renal failure.
【０００３】この療法は、１９１４年アベル（Ａｂｅ
ｌ）によって血液透析により尿毒症起因物質を除去する
ことが提唱され、その後改良を積み重ねて現在のような
療法となっている。現在、日本国内でも１４万人にのぼ
る患者がこの治療を受けていると言われている。このよ
うな透析治療における目的としては、老廃物の除去、除
水を行うほかに、血清電解質濃度の改善、酸塩基平衡の
是正等を挙げることができる。This therapy was used in 1914 by Abe.
It has been proposed by 1) to remove the uremia-causing substance by hemodialysis, and thereafter improvements have been accumulated to obtain the current therapy. Currently, it is said that 140,000 patients in Japan are receiving this treatment. The purpose of such dialysis treatment is to remove waste products, remove water, and improve serum electrolyte concentration and correct acid-base balance.
【０００４】透析剤におけるアルカリ剤は、特に酸性血
となりやすい透析患者のアシドーシス改善のために作用
するが、血液透析製剤ではその用いるアルカリ剤により
重炭酸透析と酢酸透析の２つに大別されている。Alkaline agents in dialysis agents act to improve acidosis in dialysis patients who are particularly prone to acid blood. In hemodialysis preparations, they are roughly classified into bicarbonate dialysis and acetic acid dialysis according to the alkaline agents used. There is.
【０００５】人間の血液中のアルカリ剤は、通常、その
ほとんどが重炭酸イオンとして存在しているが、酢酸、
クエン酸、コハク酸および乳酸等もクレブス（Ｋｒｅｂ
ｓ）回路を経て重炭酸イオンに変換されることから、同
様のアルカリ剤として取り扱われている。Most of the alkaline agents in human blood usually exist as bicarbonate ions, but acetic acid,
Krebs (Kreb, citric acid, succinic acid, lactic acid, etc.)
s) Since it is converted to bicarbonate ions through the circuit, it is treated as a similar alkaline agent.
【０００６】血液透析にあたっては、上述のようにヒト
血液成分である重炭酸イオンを利用した重炭酸透析が行
われてきたが、重炭酸イオンは他の重要な電解質成分で
あるカルシウムイオンおよびマグネシウムイオンと不溶
性の沈殿を生成することから、製剤として一剤化するこ
とが不可能であった。そのため、カルシウムイオンおよ
びマグネシウムイオンを含む製剤（Ａ剤）と重炭酸イオ
ンを含む製剤（Ｂ剤）の２剤組合せ製剤としてしか提供
出来ず、用時混合希釈して使用する製剤が提供されてき
た。In hemodialysis, bicarbonate dialysis using bicarbonate ion, which is a human blood component, has been performed as described above, but bicarbonate ion is another important electrolyte component, calcium ion and magnesium ion. Since it produces an insoluble precipitate, it was impossible to form a single preparation as a preparation. Therefore, it can be provided only as a two-drug combination preparation of a preparation containing calcium ion and magnesium ion (agent A) and a preparation containing bicarbonate ion (agent B), and a preparation to be used by mixing and diluting before use has been provided. .
【０００７】これに対して、アルカリ剤として酢酸を用
いる酢酸透析製剤は一剤化が可能であり、また、常に安
定した透析液を提供できることから、その後、酢酸透析
が広く一般的に普及することとなった。On the other hand, acetic acid dialysis preparations that use acetic acid as an alkaline agent can be made into a single preparation and can always provide a stable dialysate, so that acetic acid dialysis becomes widely popular thereafter. Became.
【０００８】しかしながら、近年のダイアライザー性能
の向上に伴って酢酸が代謝速度以上に過度に負荷され、
特に透析直後の血中の酢酸濃度が高くなることにより、
心筋抑制作用や血管拡張による血圧低下などいわゆる循
環器に悪い影響を与えるようになり、アセテート不耐症
をはじめとする種々の不都合が表面化してきた。そのた
め現在では、アルカリ剤として炭酸水素ナトリウムを用
いた重炭酸透析が再び主流となってきているが、製剤と
して一剤化することは不可能なままである。However, with the recent improvement in the dialyzer performance, acetic acid is excessively loaded above the metabolic rate,
Especially, because the concentration of acetic acid in the blood immediately after dialysis becomes high,
The so-called cardiovascular effects such as myocardial depressant action and blood pressure decrease due to vasodilation have been adversely affected, and various inconveniences such as acetate intolerance have come to the surface. Therefore, at present, bicarbonate dialysis using sodium hydrogencarbonate as an alkaline agent is becoming mainstream again, but it is still impossible to make it into a single formulation.
【０００９】[0009]
【発明が解決しようとする課題】血液透析治療において
は、老廃物の除去、除水および血清電解質濃度の改善の
他に、酸塩基平衡の是正も行うことから、使用時におけ
る人工透析製剤のｐＨは正常血液ｐＨとほぼ等しいこと
が必要であり、通常、７．０〜７．８程度に調整されて
いる。In hemodialysis treatment, in addition to removal of waste products, removal of water and improvement of serum electrolyte concentration, acid-base equilibrium is also corrected. Needs to be approximately equal to the normal blood pH, and is usually adjusted to about 7.0 to 7.8.
【００１０】また、重炭酸透析製剤においては重炭酸イ
オンに緩衝作用がないことから、透析液の安定性を保つ
ために、透析液もしくは透析液調製用の高濃度製剤のｐ
Ｈ調整剤として使用する酸に緩衝作用をもたせ上記のよ
うなｐＨに調整される。In addition, since bicarbonate ion does not have a buffering effect in the bicarbonate dialyzed preparation, in order to maintain the stability of the dialysate, the p-type of the dialysate or a highly concentrated preparation for preparation of the dialysate is used.
The acid used as the H adjuster has a buffering effect and is adjusted to the above pH.
【００１１】重炭酸透析は血中の酢酸濃度の増加という
酢酸透析の欠点をカバーするために行われていることが
多いにもかかわらず、現行の重炭酸透析製剤ではｐＨ調
整剤および／または緩衝剤として酢酸−酢酸塩緩衝系が
用いられ、重炭酸透析製剤中には３〜１５ｍＥｑ／Ｌの
酢酸が含有されている。Despite the fact that bicarbonate dialysis is often carried out to cover the disadvantage of acetic acid dialysis, that is, the increase in acetic acid concentration in blood, the present bicarbonate dialysis preparations have pH adjusting agents and / or buffers. An acetic acid-acetate buffer system is used as an agent, and the bicarbonate dialysis preparation contains 3 to 15 mEq / L of acetic acid.
【００１２】酢酸は元来生体内にほとんど存在しないた
め（０．１ｍＥｑ／Ｌ以下）、透析中における頭痛、血
圧低下等の臨床症状の発現が問題となっており、特に近
年のダイアライザー性能の向上に伴って酢酸が過度に負
荷され循環器に悪い影響を与えるようになり、アセテー
ト不耐症をはじめとする種々の不都合が表面化してきて
おり、酢酸を含まない透析製剤の開発が求められてい
る。Since acetic acid originally does not exist in the living body (0.1 mEq / L or less), the occurrence of clinical symptoms such as headache during dialysis and lowering of blood pressure has become a problem, and particularly in the recent improvement of dialyzer performance. Acetic acid has been overloaded and adversely affects the circulatory system, and various inconveniences such as acetate intolerance have come to the fore, and development of a dialysis preparation containing no acetic acid is required.
【００１３】[0013]
【課題を解決するための手段】本発明はこのような問題
点を解決するために鋭意検討した結果完成されたもので
あって、血液透析に使用する人工透析用製剤として、酢
酸を含まないことを特徴とする製剤を提供するものであ
る。更に詳しくは、本発明は、(1) アルカリ化剤として
重炭酸イオンを用いる重炭酸透析製剤において、ｐＨ調
整剤として乳酸−乳酸塩系緩衝剤を用いることを特徴と
する人工透析製剤、(2) 腎不全患者等に対する血液透析
に用いる製剤として、ナトリウムイオン、カリウムイオ
ン、カルシウムイオンおよびマグネシウムイオンを含有
するＡ剤および炭酸水素ナトリウムを含有するＢ剤から
なる組合せ製剤で構成する重炭酸透析製剤において、ｐ
Ｈ調整剤として乳酸−乳酸塩系緩衝剤を主体に用いるこ
とを特徴とする人工透析製剤、(3) 透析用固体電解質、
炭酸水素ナトリウムおよびブドウ糖を含有する血液透析
用製剤において、緩衝剤として乳酸−乳酸塩系を用いる
ことを特徴とする人工透析製剤、(4) 乳酸塩として乳酸
カルシウムを主体とすることを特徴とする人工透析製
剤、(5) 乳酸−乳酸塩系の緩衝剤に使用する乳酸と乳酸
塩とのモル比が１：１〜５であることを特徴とする人工
透析製剤、(6) 使用時の濃度として乳酸イオンの含有量
が３〜１０ｍＥｑ／Ｌであることを特徴とする人工透析
製剤、に関するものである。Means for Solving the Problems The present invention has been completed as a result of extensive studies in order to solve such problems, and does not contain acetic acid as an artificial dialysis preparation used for hemodialysis. The present invention provides a pharmaceutical preparation characterized by: More specifically, the present invention is (1) a bicarbonate dialysis preparation using bicarbonate ion as an alkalizing agent, wherein an artificial dialysis preparation characterized by using a lactic acid-lactate buffer as a pH adjuster, (2 ) A bicarbonate dialysis preparation comprising a combination preparation comprising an agent A containing sodium ions, potassium ions, calcium ions and magnesium ions and a agent B containing sodium hydrogen carbonate as a preparation used for hemodialysis for patients with renal failure, etc. , P
An artificial dialysis preparation characterized by mainly using a lactic acid-lactate buffer as an H regulator, (3) a solid electrolyte for dialysis,
A hemodialysis preparation containing sodium hydrogen carbonate and glucose, an artificial dialysis preparation characterized by using a lactic acid-lactate system as a buffer, (4) characterized by mainly comprising calcium lactate as a lactate. Artificial dialysis preparation, (5) Artificial dialysis preparation characterized in that the molar ratio of lactic acid and lactate used in the lactic acid-lactate buffer is 1: 1 to 5, (6) Concentration during use As a lactate ion content of 3 to 10 mEq / L.
【００１４】[0014]
【発明の実施の形態】本発明における重炭酸透析製剤と
しては、ヒト血清電解質に存在するイオン種が用いら
れ、その含有量は、ヒト血清における電解質濃度にほぼ
等しい濃度とすることが望ましい。例えば、用時希釈後
の濃度として、ナトリウムイオン；１３０〜１４５ｍＥ
ｑ／Ｌ、カリウムイオン；１〜４ｍＥｑ／Ｌ、カルシウ
ムイオン；２〜４ｍＥｑ／Ｌ、マグネシウムイオン；０
〜２ｍＥｑ／Ｌ及びブドウ糖；０〜２００ｍｇ／ｄＬ等
を含有し、更に、炭酸水素イオンおよび乳酸イオン等の
アルカリ化剤の総含有量として２８〜４０ｍＥｑ／Ｌ程
度配合させることが出来る。BEST MODE FOR CARRYING OUT THE INVENTION As the bicarbonate dialysis preparation of the present invention, an ionic species present in human serum electrolyte is used, and the content thereof is preferably approximately equal to the electrolyte concentration in human serum. For example, as the concentration after dilution before use, sodium ion; 130 to 145 mE
q / L, potassium ion; 1-4 mEq / L, calcium ion; 2-4 mEq / L, magnesium ion; 0
˜2 mEq / L and glucose; 0 to 200 mg / dL and the like, and further can be added in a total amount of about 28 to 40 mEq / L as a total content of alkalizing agents such as hydrogen carbonate ion and lactate ion.
【００１５】本発明においては、透析液の安定性を保つ
ために、透析液もしくは透析液調製用の高濃度製剤ｐＨ
調整剤として、乳酸−乳酸塩系緩衝剤を採用する。乳酸
塩を構成する金属としては、ナトリウム、カリウム、カ
ルシウム、マグネシウム、亜鉛等を挙げることが出来
る。In the present invention, in order to maintain the stability of the dialysate, the dialysate or a highly concentrated preparation pH for preparing the dialysate is used.
A lactic acid-lactate buffer is used as a regulator. Examples of the metal constituting the lactate include sodium, potassium, calcium, magnesium, zinc and the like.
【００１６】乳酸−乳酸塩緩衝剤に用いる乳酸と乳酸塩
の比率としては、用いる金属によっても異なるが、好ま
しくはモル比で１：１〜５の範囲内、モル比で２：３〜
８の範囲内であることが特に好ましく、更には１：２〜
３の範囲内が好ましい。The ratio of lactic acid to lactate used in the lactic acid-lactate buffer varies depending on the metal used, but is preferably in the range of 1: 1 to 5 in molar ratio, and 2: 3 to in molar ratio.
It is particularly preferable that it is within the range of 8, and further 1: 2 to 2.
The range of 3 is preferable.
【００１７】含有させる乳酸イオンの量としては、用時
希釈後の濃度として３〜１２ｍＥｑ／Ｌになるような範
囲の量、特に好ましくは４〜１０ｍＥｑ／Ｌになるよう
な範囲の量で配合される。また、本発明のｐＨ調整剤と
しては乳酸緩衝剤を主とし、必要に応じて少量の塩酸、
酢酸、シュウ酸、コハク酸、クエン酸等を併用した緩衝
剤・ｐＨ調整剤とすることもできる。The amount of lactate ion to be contained is such that the concentration after dilution before use is in the range of 3 to 12 mEq / L, particularly preferably in the range of 4 to 10 mEq / L. It The pH adjusting agent of the present invention is mainly a lactate buffer, and if necessary, a small amount of hydrochloric acid,
It is also possible to use a buffering agent / pH adjusting agent in which acetic acid, oxalic acid, succinic acid, citric acid and the like are used in combination.
【００１８】これらは、不溶性の炭酸カルシウムの沈殿
を生成させないために、ナトリウム、カリウム、カルシ
ウムおよびマグネシウムを含む製剤（Ａ剤）と炭酸水素
イオンを含む製剤（Ｂ剤）の２つからなる組合せ製剤と
し、用時混合希釈して使用するのが好ましい。These are combination preparations consisting of two preparations containing sodium, potassium, calcium and magnesium (agent A) and bicarbonate ion preparations (agent B) in order to prevent the formation of insoluble calcium carbonate precipitates. It is preferable to mix and dilute before use.
【００１９】組合せ製剤とした場合の用時における混合
希釈方法としては、例えば、Ｂ剤１容と水２６容を混合
してＢ剤希釈液とし、このＢ剤希釈液３４容をＡ剤１容
と混合することにより使用時の血液透析製剤とすること
が出来る。これらの血液透析製剤のｐＨとしては、用時
希釈後のｐＨがヒト正常血液に近いｐＨとなるように調
整する。As a method for mixing and diluting the combined preparation at the time of use, for example, 1 volume of agent B and 26 volumes of water are mixed to prepare a diluent solution for agent B, and 34 volumes of the diluent solution for agent B are used for 1 volume of agent A. A hemodialysis preparation at the time of use can be prepared by mixing with. The pH of these hemodialysis preparations is adjusted so that the pH after dilution before use will be close to that of normal human blood.
【００２０】また、本発明の透析剤は用時に溶解して調
製する粉末製剤または固形製剤であっても良い。例え
ば、粉末製剤の場合、ナトリウム、カリウム、カルシウ
ム、マグネシウム、乳酸および乳酸塩を含むＡ剤を造粒
して顆粒剤とすることもできる。この場合には、炭酸水
素ナトリウムから成る粉末Ｂ剤を組み合わせた組合せ製
剤とし、使用時に透析現場にてそれぞれ溶解し、混合希
釈して使用する。Further, the dialysis agent of the present invention may be a powder preparation or a solid preparation prepared by dissolving at the time of use. For example, in the case of a powder formulation, the agent A containing sodium, potassium, calcium, magnesium, lactic acid and lactate can be granulated to give granules. In this case, a combined preparation is prepared by combining powder B agents made of sodium hydrogen carbonate, which are each dissolved at the dialysis site at the time of use, mixed and diluted before use.
【００２１】このようなＡ剤粉末製剤に配合する乳酸塩
としては、通常、粉末として提供される乳酸カルシウム
等を主体として使用することがすることが望ましい。ま
た、これらの粉末製剤にはブドウ糖をＡ剤および／また
はＢ剤に添加した製剤にすることもでき、また、ブドウ
糖を別剤として用時に同時に溶解する３剤の組合せ製剤
とすることもできる。As the lactate salt to be added to the powder preparation of the agent A, it is desirable to use calcium lactate, which is usually provided as a powder, as a main component. Further, these powder preparations may be prepared by adding glucose to agent A and / or agent B, or may be a combination preparation of three agents in which glucose is dissolved as a separate agent at the same time before use.
【００２２】[0022]
〔実施例１〕表１に示す処方量（処方１〜６）の薬剤を
それぞれ量り、Ａ剤は７Ｌの水に溶解した後、１０Ｌに
メスアップして製し、Ｂ剤は１０Ｌの水に溶解した後、
１２．６Ｌにメスアップして所望の処方（表２）の人工
透析製剤を得た。（表中に記載した量は１００％換算の
理論値である。使用した乳酸ナトリウムの規格は局外
規、乳酸及び塩酸の規格は局方品である。）[Example 1] Each of the drugs in the prescribed amounts (prescriptions 1 to 6) shown in Table 1 was weighed, the agent A was dissolved in 7 L of water and then made up to 10 L, and the agent B was added to 10 L of water. After melting
The artificial dialysis preparation having the desired formulation (Table 2) was obtained by increasing the volume to 12.6 L. (Amounts shown in the table are theoretical values in terms of 100% conversion. Standards of sodium lactate used are external standards, and standards of lactic acid and hydrochloric acid are pharmacopoeial products.)
【表１】 [Table 1]
【表２】 [Table 2]
【００２３】Ｂ剤１容と水２６容を混合してＢ剤希釈液
とし、このＢ剤希釈液３４容をＡ剤１容と混合して用時
の透析剤を調製した。用時調製後のｐＨ変動および沈殿
生成の観察を行った結果、表３に示すようにｐＨ変動は
少なく、また沈殿生成もない安定した製剤であった。
（−：沈殿生成無し、±：判定不能、＋：沈殿生成）1 volume of the agent B and 26 volumes of water were mixed to prepare a diluted solution of the agent B, and 34 volume of the diluted solution of the agent B was mixed with 1 volume of the agent A to prepare a dialysis agent for use. As a result of observing pH fluctuation and precipitation formation after preparation at the time of use, as shown in Table 3, the preparation was stable with little pH fluctuation and no precipitation formation.
(-: No precipitation is generated, ±: Judgment is impossible, +: Precipitation is generated)
【表３】 [Table 3]
【００２４】〔実施例２〕塩化ナトリウム２３５２０
ｇ、塩化カリウム５２０ｇ、塩化マグネシウム３６０
ｇ、乳酸カルシウム１６２０ｇおよびブドウ糖３５００
ｇをとり撹拌混合した後、乳酸９５ｇおよび水を噴霧し
て練合造粒した。その後、乾燥機で乾燥して所望のＡ剤
粉末製剤を得た。（処方７）[Example 2] Sodium chloride 23520
g, potassium chloride 520g, magnesium chloride 360
g, calcium lactate 1620 g and glucose 3500
After taking g and mixing with stirring, 95 g of lactic acid and water were sprayed to knead and granulate. Then, it dried with the dryer and obtained the desired A agent powder formulation. (Prescription 7)
【００２５】得られたＡ剤粉末製剤を別々の５箇所から
３０４７ｇを量り、水に溶解して１０Ｌとした液を製剤
原液として、この原液を３５倍に希釈した液について各
成分の含量測定を行った結果、表４に示すように各成分
含量のばらつきは少なく、分散性のよい粉末製剤であっ
た。Each of the obtained powder preparations of agent A was weighed at 3047 g from five different locations and dissolved in water to make 10 L, and a stock solution was prepared. The stock solution was diluted 35 times to determine the content of each component. As a result of the experiment, as shown in Table 4, the content of each component was small, and the powder preparation had good dispersibility.
【表４】 [Table 4]
【００２６】〔実施例３〕表５に掲げる処方量（処方８
〜１０）について、実施例２と同様にＡ剤粉末透析製剤
を製した結果、同様に、各成分含量のばらつきが少ない
分散性のよい粉末製剤が得られた。[Example 3] Prescription amounts listed in Table 5 (prescription 8
10), a powdered dialysis preparation of agent A was produced in the same manner as in Example 2, and as a result, a powdered preparation with good dispersibility and little variation in content of each component was obtained.
【表５】 [Table 5]
【００２７】また、実施例２（処方７）および実施例３
（処方８〜１０）により得られた粉末透析剤をそれぞれ
３０４７ｇ、２９８７ｇ、３０６６ｇおよび３１０４ｇ
を量り、水に溶解して１０Ｌとした液をＡ剤とし、組み
合わせるＢ剤として８２４ｇの炭酸水素ナトリウム粉末
を量り、水に溶解して１２．６Ｌとした（用時希釈濃度
として、ＣＯ3 -濃度＝２８ｍＥｑ／Ｌ）。In addition, Example 2 (formulation 7) and Example 3
3047 g, 2987 g, 3066 g and 3104 g of the powdered dialysate obtained by (Formulations 8 to 10), respectively.
The weighed, liquid was 10L was dissolved in water and the agent A, weighed sodium bicarbonate powder 824g as B agent to be combined, as it was 12.6L was dissolved in water (dilution before use, CO 3 - Concentration = 28 mEq / L).
【００２８】Ｂ剤１容と水２６容を混合したＢ剤希釈液
３４容を、Ａ剤１容と混合した透析液について、用時調
製後のｐＨ変動および沈殿生成の観察を行った結果、表
６に示すようにｐＨ変動は少なく、また沈殿生成もない
安定した製剤であった。（−：沈殿生成無し、±：判定
不能、＋：沈殿生成）As a result of observing pH fluctuation and precipitation formation after preparation, a dialysate prepared by mixing 1 volume of the B agent with 26 volumes of water and 34 volumes of the B agent diluted solution was mixed with 1 volume of the A agent. As shown in Table 6, the pH of the preparation was stable and there was no precipitation. (-: No precipitate is generated, ±: Undecidable, +: Precipitate is generated)
【表６】 [Table 6]
【００２９】[0029]
【発明の効果】このように本発明における人工透析用製
剤では酢酸を含まないことから、酢酸を原因とする臨床
症状を起こさない、極めて優れた重炭酸透析製剤を提供
することができる。また、揮発性でない乳酸−乳酸塩系
緩衝剤を使用することから、長期間保存してもｐＨ変動
のない安定な透析用製剤を提供することが出来る。とく
に粉末製剤として製する場合、揮発成分を含まないこと
から、長期保存によってもｐＨ変動のない安定した透析
製剤を提供することが出来る。As described above, since the preparation for artificial dialysis according to the present invention does not contain acetic acid, it is possible to provide an extremely excellent bicarbonate dialysis preparation that does not cause clinical symptoms caused by acetic acid. Further, since a volatile lactate-lactate buffer is used, it is possible to provide a stable dialysis preparation that does not fluctuate in pH even when stored for a long period of time. In particular, when manufactured as a powder formulation, since it does not contain volatile components, it is possible to provide a stable dialysis formulation that does not fluctuate in pH even after long-term storage.
Claims (6)
製剤であり、アルカリ剤として重炭酸イオンを用いる重
炭酸透析製剤において、緩衝剤として乳酸−乳酸塩系を
用いることを特徴とする人工透析製剤。1. An artificial dialysis preparation for use in hemodialysis for patients with renal failure, wherein the preparation is a bicarbonate dialysis preparation using bicarbonate ion as an alkaline agent, wherein a lactic acid-lactate system is used as a buffering agent. .
製剤であり、ナトリウムイオン、カリウムイオン、カル
シウムイオンおよびマグネシウムイオンを含有するＡ剤
および炭酸水素ナトリウムを含有するＢ剤からなる組合
せ製剤で構成する重炭酸透析製剤において、緩衝剤とし
て乳酸−乳酸塩系を用いることを特徴とする請求項１記
載の人工透析製剤。2. A preparation for use in hemodialysis for patients with renal failure or the like, which is composed of a combination preparation comprising agent A containing sodium ion, potassium ion, calcium ion and magnesium ion and agent B containing sodium hydrogen carbonate. The artificial dialysis preparation according to claim 1, wherein a lactic acid-lactate system is used as a buffer in the bicarbonate dialysis preparation.
びブドウ糖を含有する血液透析用粉末製剤において、緩
衝剤として乳酸−乳酸塩系を用いることを特徴とする請
求項１記載の人工透析製剤。3. The artificial dialysis preparation according to claim 1, wherein a lactic acid-lactate system is used as a buffering agent in a hemodialysis powder preparation containing a dialysis electrolyte, sodium hydrogen carbonate and glucose.
とを特徴とする請求項１〜３記載の人工透析製剤。4. The artificial dialysis preparation according to claim 1, wherein the lactate is mainly composed of calcium lactate.
あることを特徴とする請求項１〜４記載の人工透析製
剤。5. The artificial dialysis preparation according to claim 1, wherein the molar ratio of lactic acid to lactate is 1: 1 to 5.
〜１０ｍＥｑ／Ｌであることを特徴とする請求項１〜５
記載の人工透析製剤。6. The content of lactate ion at the time of use is 3
10 to 10 mEq / L.
The described artificial dialysis preparation.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP11622996A JP3867174B2 (en) | 1996-05-10 | 1996-05-10 | Hemodialysis preparation |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP11622996A JP3867174B2 (en) | 1996-05-10 | 1996-05-10 | Hemodialysis preparation |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPH09301875A true JPH09301875A (en) | 1997-11-25 |
| JP3867174B2 JP3867174B2 (en) | 2007-01-10 |
Family
ID=14682035
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP11622996A Expired - Fee Related JP3867174B2 (en) | 1996-05-10 | 1996-05-10 | Hemodialysis preparation |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JP3867174B2 (en) |
Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| WO2008149788A1 (en) | 2007-05-31 | 2008-12-11 | Ajinomoto Co., Inc. | Solid dialysis preparation |
| 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 |
-
1996
- 1996-05-10 JP JP11622996A patent/JP3867174B2/en not_active Expired - Fee Related
Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7011855B2 (en) | 1994-07-01 | 2006-03-14 | Baxter International Inc. | Biochemically balanced peritoneal dialysis solutions |
| 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 |
| WO2008149788A1 (en) | 2007-05-31 | 2008-12-11 | Ajinomoto Co., Inc. | Solid dialysis preparation |
| KR20150110832A (en) | 2007-05-31 | 2015-10-02 | 아지노모토 가부시키가이샤 | Solid dialysis preparation |
| 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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| Publication number | Publication date |
|---|---|
| JP3867174B2 (en) | 2007-01-10 |
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