JPH0759846A - Agent for disalysis and its production - Google Patents
Agent for disalysis and its productionInfo
- Publication number
- JPH0759846A JPH0759846A JP5209361A JP20936193A JPH0759846A JP H0759846 A JPH0759846 A JP H0759846A JP 5209361 A JP5209361 A JP 5209361A JP 20936193 A JP20936193 A JP 20936193A JP H0759846 A JPH0759846 A JP H0759846A
- Authority
- JP
- Japan
- Prior art keywords
- agent
- sodium
- powder
- dialysis
- hydrogen carbonate
- 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.)
- Granted
Links
Abstract
Description
【０００１】[0001]
【産業上の利用分野】本発明は、透析用剤及びその製造
方法に関するものである。TECHNICAL FIELD The present invention relates to a dialysis agent and a method for producing the same.
【０００２】[0002]
【従来の技術】透析用剤は、透析液を作成するための薬
剤である。透析液は、人工腎臓、血液透析、腹膜透析な
どにより本来腎臓が行なう機能に代わり、体液の老廃物
を取り去り、場合によっては血液中に必要な成分を補う
ために用いられるもので、体液に近い電解質組成を有す
る水溶液である。透析液としては、アルカリ化剤として
炭酸水素ナトリウムを用いる重曹透析液が生理的に好ま
しく、その需要が増加してきている。2. Description of the Related Art A dialysis agent is a drug for preparing a dialysate. The dialysate replaces the function originally performed by the kidney by artificial kidneys, hemodialysis, peritoneal dialysis, etc., and is used to remove waste products of the body fluid and, in some cases, to supplement the necessary components in the blood. It is an aqueous solution having an electrolyte composition. As the dialysate, a sodium bicarbonate dialysate using sodium hydrogen carbonate as an alkalizing agent is physiologically preferable, and its demand is increasing.
【０００３】重曹透析液としては、通常、以下に示すよ
うな電解質イオン組成を有するものが用いられている。
使用時のｐＨは酢酸または塩酸により７．２〜７．４に
調整されている。さらに必要に応じて、ブドウ糖を０〜
２５０ｍｇ／デシリットル含有させる。 Ｎａ+ １２０〜１５０ｍＥｑ／リットル Ｋ+ ０．５〜３．０ｍＥｑ／リットル Ｃａ2+ １．５〜４．５ｍＥｑ／リットル Ｍｇ2+ ０〜２．０ｍＥｑ／リットル Ｃｌ- ９０〜１３５ｍＥｑ／リットル ＣＨ3 ＣＯＯ- ５〜 ３５ｍＥｑ／リットル ＨＣＯ3 - ２０〜 ３５ｍＥｑ／リットルAs the sodium bicarbonate dialysate, one having an electrolyte ionic composition as shown below is usually used.
The pH at the time of use is adjusted to 7.2 to 7.4 with acetic acid or hydrochloric acid. Furthermore, if necessary, add 0 to glucose.
It contains 250 mg / deciliter. Na + 120 to 150 mEq / liter K + 0.5 to 3.0 mEq / liter Ca 2+ 1.5 to 4.5 mEq / liter Mg 2+ 0 to 2.0 mEq / liter Cl - 90 to 135 mEq / liter CH 3 COO - 5~ 35mEq / liter HCO 3 - 20~ 35mEq / liter
【０００４】従来、重曹透析液は、炭酸水素ナトリウム
以外の必要電解質及びブドウ糖を溶解した濃厚液と、炭
酸水素ナトリウム溶液とに分けて調製され、透析時に両
者を希釈混合して用いられる。炭酸水素ナトリウム溶液
については、粉末状にて保存あるいは輸送して使用の直
前に溶解することもある。Conventionally, a sodium bicarbonate dialysate is prepared by separately preparing a concentrated solution in which necessary electrolytes other than sodium hydrogen carbonate and glucose are dissolved, and a sodium hydrogen carbonate solution, and both are diluted and mixed during dialysis. The sodium hydrogen carbonate solution may be stored or transported in powder form and dissolved immediately before use.
【０００５】このように、炭酸水素ナトリウム以外の必
要電解質及びブドウ糖と炭酸水素ナトリウムとを溶液の
形で調製する場合は、これを濃厚な原液として調製して
も、かなりの容積と重量になり、貯留や運搬や使用時の
取扱いに不便をきたすという問題がある。この問題を避
けるため、Ａ剤成分を粉体化した透析用剤が種々提案さ
れている（特公昭５８−２７２４６号公報、特開平２−
３１１４１８号公報、特開平４−２５７５２２号公報等
参照）。As described above, when the necessary electrolytes other than sodium hydrogencarbonate and glucose and sodium hydrogencarbonate are prepared in the form of a solution, even if this is prepared as a concentrated stock solution, the volume and weight are considerably large. There is a problem that it causes inconvenience in storage, transportation and handling during use. In order to avoid this problem, various dialysis agents in which the component A component has been powdered have been proposed (JP-B-58-27246, JP-A-2-).
31118, Japanese Patent Laid-Open No. 4-257522, etc.).
【０００６】[0006]
【発明が解決しようとする課題】重曹透析用剤は、ｐＨ
調整のために、酢酸や塩酸などの酸を含有させる必要が
あるが、これらの酸は他の成分に比較して揮散しやす
く、保存安定性の点で問題がある。そこで、本発明で
は、取扱いが容易で、かつ保存安定性に優れた粉末状の
重曹透析用剤を提供することを目的とする。Problems to be Solved by the Invention
For adjustment, it is necessary to add an acid such as acetic acid or hydrochloric acid, but these acids are more likely to volatilize than other components, and there is a problem in storage stability. Therefore, an object of the present invention is to provide a powdery sodium bicarbonate dialysis agent that is easy to handle and has excellent storage stability.
【０００７】[0007]
【課題を解決するための手段】本発明は、重曹透析液に
必要な電解質のうち、炭酸水素ナトリウム以外の成分及
び酢酸を含有する粉末（Ａ剤）、並びに、炭酸水素ナト
リウムを含有する粉末（Ｂ剤）とからなる透析用剤であ
って、Ａ剤中の酢酸が実質的にナトリウムジアセテート
として含有する透析用剤である。The present invention relates to a powder (agent A) containing components other than sodium hydrogen carbonate and acetic acid among electrolytes required for a sodium bicarbonate dialysate, and a powder containing sodium hydrogen carbonate ( (B agent), which is a dialysis agent containing acetic acid in agent A as substantially sodium diacetate.
【０００８】透析液に必要な電解質は、溶解したときに
前記のようなイオン組成を与えるものであれば種々の組
み合わせが可能であり、例えばカリウムイオンを与える
ために、炭酸水素カリウム、酢酸カリウム、水酸化カリ
ウムのような電解質を１種または２種以上混合して使用
することもできる。しかし、原料調製の容易さや価格な
どを考慮すると、実際上は、塩化ナトリウム、塩化カリ
ウム、塩化マグネシウム、塩化カルシウム、酢酸ナトリ
ウム、炭酸水素ナトリウムを使用するのが適当である。The electrolyte necessary for the dialysate can be variously combined so long as it gives the above-mentioned ionic composition when dissolved, and for example, potassium hydrogen carbonate, potassium acetate, It is also possible to use one kind or a mixture of two or more kinds of electrolytes such as potassium hydroxide. However, considering the easiness of preparation of raw materials and the price, it is practically appropriate to use sodium chloride, potassium chloride, magnesium chloride, calcium chloride, sodium acetate, or sodium hydrogen carbonate.
【０００９】以下、電解質として塩化ナトリウム、塩化
カリウム、塩化マグネシウム、塩化カルシウム、酢酸ナ
トリウム、炭酸水素ナトリウムを使用する場合を例にし
て説明を行う。これらの電解質は、患者の要求に応じて
配合量が種々変更され、場合によってはまったく配合さ
れない場合もあるが、本発明はこのような場合を排除す
るものではない。また、本発明の透析用剤には、患者の
状態に応じてさらに他の電解質やブドウ糖などの成分を
配合することも可能である。これらの塩は、無水塩ある
いは含水塩を適宜選択して使用できる。Hereinafter, the case where sodium chloride, potassium chloride, magnesium chloride, calcium chloride, sodium acetate, or sodium hydrogen carbonate is used as the electrolyte will be described as an example. The amount of these electrolytes to be added may be variously changed depending on the needs of the patient and may not be added at all in some cases, but the present invention does not exclude such cases. In addition, the dialysis agent of the present invention may further contain other components such as electrolytes and glucose depending on the patient's condition. An anhydrous salt or a hydrous salt can be appropriately selected and used as these salts.
【００１０】本発明の透析用剤は、電解質のうち炭酸水
素ナトリウム以外の成分からなる粉末（Ａ剤）と、炭酸
水素ナトリウムを含有する粉末（Ｂ剤）とからなる。The dialysis agent of the present invention comprises a powder (agent A) containing components other than sodium hydrogen carbonate in the electrolyte and a powder (agent B) containing sodium hydrogen carbonate.
【００１１】Ａ剤は、主に透析液に必要な電解質を供給
するものであり、塩化ナトリウム、塩化カリウム、塩化
カルシウム、塩化マグネシウム、酢酸ナトリウム、酢酸
を含有する。これらの電解質のうち、塩化ナトリウム、
塩化カリウム、酢酸ナトリウムについては、その一部ま
たは全部をＢ剤に配合することも可能である。Ａ剤中に
は、一般的にｐＨ調整剤として酢酸が含有されるが、本
発明では、酢酸を酢酸ナトリウムと結合したナトリウム
ジアセテートのかたちで含有させることを特徴としてい
る。The agent A mainly supplies an electrolyte necessary for the dialysate and contains sodium chloride, potassium chloride, calcium chloride, magnesium chloride, sodium acetate and acetic acid. Of these electrolytes, sodium chloride,
With regard to potassium chloride and sodium acetate, part or all of them can be blended with the agent B. Although acetic acid is generally contained in the agent A as a pH adjuster, the present invention is characterized by containing acetic acid in the form of sodium diacetate bound to sodium acetate.
【００１２】ナトリウムジアセテートは、酢酸ナトリウ
ム１モルに対して酢酸１モルが結合した複合結晶（固体
酢酸あるいは粉末酢酸ともよばれる）である。酢酸と酢
酸ナトリウムとを撹拌混合することにより得られるが、
酢酸ナトリウムが固体であるので、通常の酢酸ナトリウ
ム粉末に等モルの酢酸を加えて撹拌混合すると、シャー
ベット状の生成物（おそらく、ナトリウムジアセテー
ト、酢酸ナトリウム、酢酸の混合物）が得られ、完全に
反応した粉末状のナトリウムジアセテートが得られない
場合もある。あらかじめ酢酸ナトリウムを粉砕して表面
積を大きくすると、よく反応して、粉末状のナトリウム
ジアセテートが得られるので好ましい。Sodium diacetate is a complex crystal (also called solid acetic acid or powdered acetic acid) in which 1 mol of acetic acid is bonded to 1 mol of sodium acetate. It can be obtained by stirring and mixing acetic acid and sodium acetate,
Sodium acetate is a solid, so adding equimolar acetic acid to normal sodium acetate powder and stirring and mixing gives a sherbet-like product (probably a mixture of sodium diacetate, sodium acetate, acetic acid), In some cases, the reacted powdery sodium diacetate cannot be obtained. It is preferable to pulverize sodium acetate in advance to increase the surface area because it reacts well and powdery sodium diacetate is obtained.
【００１３】通常の透析用剤の場合、酢酸１モルに対し
て酢酸ナトリウムが２〜４モル処方されるので、透析用
剤に必要な酢酸ナトリウムの１部分を使用することで、
酢酸をナトリウムジアセテートとして固体化することが
可能である。酢酸ナトリウムを過剰量使用する場合は、
遊離の酢酸の量が減少し、酢酸がさらに揮散しにくくな
るので、透析用剤に必要な酢酸ナトリウムの全量をあら
かじめ酢酸と混合しておくことが好ましい。この場合、
ナトリウムジアセテートと酢酸ナトリウムとの混合粉末
が得られるので、これを使用してＡ剤を製造する。In the case of an ordinary dialysis agent, 2 to 4 moles of sodium acetate are prescribed for 1 mole of acetic acid. Therefore, by using one part of sodium acetate necessary for the dialysis agent,
It is possible to solidify acetic acid as sodium diacetate. When using an excess amount of sodium acetate,
Since the amount of free acetic acid decreases and the acetic acid becomes more difficult to volatilize, it is preferable to premix the total amount of sodium acetate required for the dialysis agent with acetic acid. in this case,
Since a mixed powder of sodium diacetate and sodium acetate is obtained, this is used to manufacture Part A.
【００１４】酢酸は、溶解時にｐＨが７．２〜７．４の
範囲になるように配合する必要がある。そして、希釈後
の透析液として、２ｍＥｑ／リットル程度になるように
使用するのが適当である。Acetic acid must be blended so that the pH will be in the range of 7.2 to 7.4 when dissolved. Then, it is suitable to use the diluted dialysate so as to have a concentration of about 2 mEq / liter.
【００１５】Ａ剤は、Ａ剤成分のうち電解質（塩化ナト
リウム、塩化カリウム、塩化マグネシウム、塩化カルシ
ウムなど）と、必要に応じてブドウ糖に、あらかじめナ
トリウムジアセテート粉末を配合し、造粒して製造する
のが好ましい。The agent A is produced by blending an electrolyte (sodium chloride, potassium chloride, magnesium chloride, calcium chloride, etc.) among the ingredients of the agent A, and optionally glucose with sodium diacetate powder in advance and granulating. Preferably.
【００１６】造粒方法としては、特に限定されず種々の
方法が採用できる。ナトリウムジアセテートが造粒の途
中で溶解すると本発明の効果が減少するので、乾式の造
粒方法が好ましいが、造粒特性または造粒物の特性を向
上させるために、小量の水を添加することは可能であ
る。水の添加量が５重量％以下の場合には、造粒工程に
おける酢酸の揮発は実質上生じない。水の添加量が２〜
４重量％の場合は、造粒が良好でかつ酢酸の揮発が少な
いので、特に好ましい。ただし、水の最適添加量は、電
解質などの粒径分布に依存するため、実際には用いる原
料の粒径分布を考慮して決定しなければならない。The granulating method is not particularly limited, and various methods can be adopted. Since the effect of the present invention is reduced when sodium diacetate is dissolved during granulation, a dry granulation method is preferable, but a small amount of water is added to improve granulation characteristics or characteristics of the granulated material. It is possible to do so. When the amount of water added is 5% by weight or less, volatilization of acetic acid does not substantially occur in the granulation step. The amount of water added is 2
When the content is 4% by weight, the granulation is good and the volatilization of acetic acid is small, so that it is particularly preferable. However, the optimum amount of water to be added depends on the particle size distribution of the electrolyte, etc., so that it must be determined in consideration of the particle size distribution of the raw material actually used.
【００１７】造粒方法として具体的には、押し出し造
粒、転動造粒、圧縮造粒、流動層造粒、撹拌造粒などの
方法が好ましく採用できる。As the granulation method, specifically, extrusion granulation, rolling granulation, compression granulation, fluidized bed granulation, stirring granulation and the like can be preferably adopted.
【００１８】造粒に際しては、Ａ剤の各成分の粒子径は
積算分布曲線における９０％径（ｄ 90）として２５０μ
ｍ以下、好ましくは１８０μｍ以下、特に好ましくは１
００μｍ以下が適している。粒子径が２５０μｍを超え
る場合には、造粒物の機械的強度が不十分となり、粉化
しやすくなり、また、溶解速度も遅くなるので好ましく
ない。粒径の大きな電解質を原料として用いる場合は、
適宜粉砕を行ってから造粒するのが好ましい。At the time of granulation, the particle size of each component of the agent A is
90% diameter in integrated distribution curve (d 90) As 250μ
m or less, preferably 180 μm or less, particularly preferably 1
A size of 00 μm or less is suitable. Particle size exceeds 250 μm
If the granules have insufficient mechanical strength, they will be pulverized.
It is preferable because it is easy to dissolve and the dissolution rate is slow.
Absent. When using an electrolyte with a large particle size as a raw material,
It is preferable to granulate after appropriately pulverizing.
【００１９】Ａ剤造粒物の粒径は、０．１〜１０ｍｍ程
度にするのが好ましい。粒径が０．１ｍｍに満たない場
合は、造粒物の流動性が阻害されたり、粉化して飛散す
るなど取扱いが困難になるおそれがある。逆に、粒径が
１０ｍｍを超える場合は、造粒物の機械的強度が不十分
となり、粉化しやすくなり、また、溶解速度も遅くなる
おそれがあるので好ましくない。The particle size of the granules of agent A is preferably about 0.1 to 10 mm. If the particle size is less than 0.1 mm, the flowability of the granulated product may be impaired, or the granulated product may scatter and become difficult to handle. On the contrary, if the particle size exceeds 10 mm, the mechanical strength of the granulated product becomes insufficient, the powder tends to be pulverized, and the dissolution rate may be slowed, which is not preferable.
【００２０】造粒工程の後、必要に応じて乾燥操作を行
う。ナトリウムジアセテートは水のない状態では、１５
０℃以下の温度で安定であるが、水があると反応して酢
酸が揮発しやすくなるので、乾燥温度は３０〜９０℃の
範囲で行うのが好ましい。乾燥の方法として具体的に
は、バンド乾燥器、円盤乾燥器、通気乾燥器、回転乾燥
器等を使用することにより、高強度で溶解性の良好な造
粒物を得ることができる。ナトリウムジアセテートの分
解防止の目的で、乾燥の雰囲気として、酢酸雰囲気を採
用することもできる。After the granulation step, a drying operation is performed if necessary. Sodium diacetate is 15
Although it is stable at a temperature of 0 ° C. or lower, acetic acid is likely to volatilize in the presence of water, so that the drying temperature is preferably in the range of 30 to 90 ° C. As a drying method, specifically, a band dryer, a disk dryer, a ventilation dryer, a rotary dryer, or the like can be used to obtain a granulated product having high strength and good solubility. For the purpose of preventing decomposition of sodium diacetate, an acetic acid atmosphere can be adopted as a drying atmosphere.
【００２１】本発明においては、ナトリウムジアセテー
ト以外のＡ剤成分を上記のような方法で造粒した後、ナ
トリウムジアセテートを混合することにより、造粒物表
面にナトリウムジアセテートを付着させることも可能で
ある。この場合、他の成分の造粒の際に酢酸が揮発する
ことがないので、湿式の造粒方法も採用することが可能
であり、乾燥時により高い温度を採用できるという利点
があるが、造粒物の表面にナトリウムジアセテートに富
む層が形成されるので、やや固結しやすくなるので、注
意が必要である。In the present invention, the agent A component other than sodium diacetate may be granulated by the above method and then mixed with sodium diacetate to adhere the sodium diacetate to the surface of the granulated product. It is possible. In this case, since acetic acid does not volatilize during granulation of other components, it is possible to employ a wet granulation method, which has the advantage that a higher temperature can be employed during drying. Care should be taken because a layer rich in sodium diacetate is formed on the surface of the granules, so that the granules are likely to be consolidated.
【００２２】本発明の透析用剤において、Ｂ剤は炭酸水
素ナトリウムを含有する粉末である。炭酸水素ナトリウ
ム単独であってもよいが、Ａ剤に含まれる電解質成分の
うちカルシウム塩またはマグネシウム塩以外の電解質成
分（塩化ナトリウム、塩化カリウム、酢酸ナトリウム）
の一部又は全部、さらには、ブドウ糖を含有させても差
し支えない。Ｂ剤を造粒物にすると、流動性及び溶解性
が良好になるので好ましい。Ｂ剤が、炭酸水素ナトリウ
ムと他の電解質あるいはブドウ糖との混合造粒物にする
と、溶解速度が大きな造粒物が得られる。In the dialysis agent of the present invention, the agent B is a powder containing sodium hydrogen carbonate. Sodium hydrogen carbonate may be used alone, but electrolyte components other than calcium salt or magnesium salt among electrolyte components contained in agent A (sodium chloride, potassium chloride, sodium acetate)
Part or all, and further glucose may be contained. When the B agent is a granulated product, the fluidity and the solubility are improved, which is preferable. When the agent B is a mixed granulated product of sodium hydrogen carbonate and another electrolyte or glucose, a granulated product having a high dissolution rate can be obtained.
【００２３】Ｂ剤を造粒する場合、その方法は特に限定
されず種々の方法を採用することができる。Ａ剤の造粒
と同様、炭酸水素ナトリウムと必要に応じて他の電解質
及び／又はブドウ糖を混合し、好ましくは小量の水を添
加して造粒する方法が採用できる。このときの水の添加
量は、Ａ剤よりやや多い１〜２５重量％が好ましい。水
添加量が１重量％に満たない場合には、粒子強度が低く
なり粉化しやすくなるので好ましくない。逆に、２５重
量％を超える場合には造粒が困難となるおそれがあるの
で好ましくない。When granulating the agent B, the method is not particularly limited, and various methods can be adopted. As in the case of granulation of the agent A, a method of mixing sodium hydrogen carbonate with other electrolyte and / or glucose as needed and preferably adding a small amount of water for granulation can be adopted. The amount of water added at this time is preferably 1 to 25% by weight, which is slightly higher than that of the agent A. If the amount of water added is less than 1% by weight, the particle strength becomes low and powdering is likely to occur, which is not preferable. On the other hand, if it exceeds 25% by weight, granulation may become difficult, which is not preferable.
【００２４】Ｂ剤の成分も、造粒の際にはＡ剤と同様
に、粒子径はｄ90として２５０μｍ以下、好ましくは１
８０μｍ以下、特に好ましくは１００μｍ以下の微粉末
であることが好ましい。粒子径が２５０μｍを超える場
合は、造粒物の機械的強度が不十分となり、粉化しやす
くなり、また、溶解速度が遅くなるので好ましくない。
粒径の大きな電解質を原料として用いる場合は、適宜粉
砕を行ってから造粒するのが好ましい。The component of the agent B also has a particle size d 90 of 250 μm or less, preferably 1 at the time of granulation, similar to the agent A.
It is preferably a fine powder having a particle size of 80 μm or less, particularly preferably 100 μm or less. When the particle diameter exceeds 250 μm, the mechanical strength of the granulated product becomes insufficient, the powder is easily pulverized, and the dissolution rate becomes slow, which is not preferable.
When an electrolyte having a large particle size is used as a raw material, it is preferable to appropriately crush and then granulate.
【００２５】Ｂ剤造粒物の粒径は、０．１〜１０ｍｍ程
度にするのが好ましい。粒径が０．１ｍｍに満たない場
合には、造粒物の流動性が阻害されたり、粉化して飛散
するなどして、取扱いが困難になるおそれがあるので好
ましくない。逆に、粒径が１０ｍｍを超える場合は、造
粒物の機械的強度が不十分となり、粉化しやすくなり、
また、溶解速度が遅くなるおそれがあるので好ましくな
い。The particle size of the B agent granulated product is preferably about 0.1 to 10 mm. If the particle size is less than 0.1 mm, the fluidity of the granulated product may be impaired, or it may become powdered and scattered, which makes handling difficult, which is not preferable. On the other hand, when the particle size exceeds 10 mm, the mechanical strength of the granulated product becomes insufficient, and it becomes easy to pulverize,
In addition, the dissolution rate may slow down, which is not preferable.
【００２６】Ｂ剤を造粒した後、必要に応じて乾燥を行
う。その際、炭酸水素ナトリウムの分解防止のため、炭
酸ガス雰囲気を用いるのが好ましい。炭酸ガス濃度とし
ては５％程度以上を採用するのが好ましい。乾燥は３０
〜９０℃において行なうのが適当であり、具体的乾燥手
段としては例えば、バンド乾燥機、円板乾燥機、通気乾
燥機、回転乾燥機等を採用することにより、高強度及び
易溶性で均一で組成安定性の良好な顆粒を得ることが可
能となる。After granulating the agent B, it is dried if necessary. At that time, in order to prevent decomposition of sodium hydrogen carbonate, it is preferable to use a carbon dioxide gas atmosphere. It is preferable to adopt a carbon dioxide concentration of about 5% or more. Dry 30
It is suitable to carry out at ~ 90 ° C, and as a concrete drying means, for example, a band dryer, a disk dryer, an aeration dryer, a rotary dryer or the like can be used to obtain high strength and easy solubility and uniformity. It becomes possible to obtain granules having good composition stability.
【００２７】本発明の重曹透析用剤を用いて、透析液を
作製するには、Ａ剤およびＢ剤を必要な濃度になるよう
に溶解して混合すればよい。Ａ剤中に酢酸が含有されて
いるので、特にｐＨの調整を行わなくても、所定のｐＨ
の透析液が得られ、かつ、カルシウムまたはマグネシウ
ム成分の沈澱も生じない。To prepare a dialysate using the sodium bicarbonate dialysis agent of the present invention, the agents A and B may be dissolved and mixed so as to have a required concentration. Since acetic acid is contained in agent A, it does not require a specific pH adjustment
As a result, a dialysate of the same is obtained, and precipitation of calcium or magnesium components does not occur.
【００２８】[0028]
（実施例１）あらかじめ粉砕機（ボールミル）でｄ90が
１００μｍ以下に粉砕した無水酢酸ナトリウム１２．６
０８ｋｇに氷酢酸２．５６３６ｋｇを加え、混合機内で
均一に混合し、酢酸ナトリウムとナトリウムジアセテー
トとの混合物からなる粉末を得た。この粉末に、塩化ナ
トリウム１１９．１２９ｋｇ、塩化カリウム２．８６４
ｋｇ、塩化カルシウム・２水塩４．２３６ｋｇ、塩化マ
グネシウム・６水塩１．９５３ｋｇ、ブドウ糖１９．２
１ｋｇの粉砕混合物を添加し、加湿・混練後、押出し造
粒機にて造粒した。得られた造粒物を酢酸ガス雰囲気
下、７３℃、１０〜１５分の通風乾燥を行い乾燥粉末状
組成物（Ａ剤）を得た。(Example 1) Anhydrous sodium acetate 12.6 crushed in advance with a crusher (ball mill) to a d 90 of 100 μm or less
2.5636 kg of glacial acetic acid was added to 08 kg and uniformly mixed in a mixer to obtain a powder consisting of a mixture of sodium acetate and sodium diacetate. To this powder, 119.129 kg of sodium chloride and 2.864 potassium chloride.
kg, calcium chloride dihydrate 4.236 kg, magnesium chloride hexahydrate 1.953 kg, glucose 19.2
1 kg of the pulverized mixture was added, humidified and kneaded, and then granulated by an extrusion granulator. The obtained granulated product was dried under ventilation in an acetic acid gas atmosphere at 73 ° C. for 10 to 15 minutes to obtain a dry powdery composition (agent A).
【００２９】（実施例２）あらかじめ粉砕機（ボールミ
ル）でｄ90が１００μｍ以下に粉砕した無水酢酸ナトリ
ウム１２．６０８ｋｇに氷酢酸２．５６３６ｋｇを加
え、混合機内で均一に混合し、酢酸ナトリウムとナトリ
ウムジアセテートとの混合物からなる粉末を得た。一
方、塩化ナトリウム１１９．１２９ｋｇ、塩化カリウム
２．８６４ｋｇ、塩化カルシウム・２水塩４．２３６ｋ
ｇ、塩化マグネシウム・６水塩１．９５３ｋｇ、ブドウ
糖１９．２１ｋｇの粉砕混合物を、加湿・混練後、押出
し造粒機にて造粒した。得られた造粒物を、流動層中で
８０℃、５〜１０分加熱しながら、上記の酢酸ナトリウ
ムとナトリウムジアセテートとの混合物からなる粉末を
添加して、さらに造粒して乾燥粉末状組成物（Ａ剤）を
得た。(Example 2) 2.5636 kg of glacial acetic acid was added to 12.608 kg of anhydrous sodium acetate which had been previously pulverized to a d 90 of 100 μm or less by a pulverizer (ball mill), and the mixture was uniformly mixed in a mixer to prepare sodium acetate and sodium. A powder consisting of a mixture with diacetate was obtained. On the other hand, sodium chloride 119.129kg, potassium chloride 2.864kg, calcium chloride dihydrate 4.236k
A pulverized mixture of g, magnesium chloride hexahydrate 1.953 kg, and glucose 19.21 kg was moistened and kneaded, and then granulated by an extrusion granulator. The obtained granulated product was heated in a fluidized bed at 80 ° C. for 5 to 10 minutes, and the powder consisting of the above mixture of sodium acetate and sodium diacetate was added to the resulting granulated product to obtain a dry powder. A composition (agent A) was obtained.
【００３０】〔試験例〕実施例１及び２で得られた粉末
状組成物（Ａ剤）の一部を、それぞれ所定量の水に溶解
し、乾燥粉末中の各成分の含有率を測定した。結果を乾
燥粉末に対する各成分の量を重量％として表１に示す。
目標値とは、配合した成分が粉末中に均一に配合され、
損失がないとした場合の値である。なお、分析法として
は、Ｎａ + およびＫ+ はイオン電極法で、Ｃａ2+、Ｍｇ
2+、Ｃｌ- は滴定法で、ブドウ糖および酢酸は高速液体
クロマトグラフィーで測定した。[Test Example] Powders obtained in Examples 1 and 2
Part of the liquid composition (agent A) is dissolved in a predetermined amount of water.
Then, the content of each component in the dry powder was measured. Dry results
The amount of each component relative to the dry powder is shown in Table 1 as wt%.
The target value is that the blended ingredients are uniformly blended in the powder,
It is the value when there is no loss. As an analytical method
Is Na +And K+Is the ion electrode method, Ca2+, Mg
2+, Cl-Is a titration method, glucose and acetic acid are high-performance liquids
It was measured by chromatography.
【００３１】[0031]
【表１】 [Table 1]
【００３２】実施例１及び２はともに、重曹透析液を得
るためのＡ剤として十分な均一性を有していた。これら
のＡ剤は、所定のＢ剤と配合することにより、重曹透析
液を得ることができた。また、これらのＡ剤は、酢酸の
揮発が少なく、長期の保存が可能であった。Both Examples 1 and 2 had sufficient homogeneity as the agent A for obtaining the sodium bicarbonate dialysate. By mixing these agents A with the prescribed agent B, a sodium bicarbonate dialysate could be obtained. In addition, these agents A were able to be stored for a long period of time because acetic acid was less volatile.
【００３３】[0033]
【発明の効果】本発明の透析用剤は容易に水に溶解して
均質な水溶液になり簡単に透析液を得ることができる。
また、本透析用剤は、体積が小さくでき、貯留時に粉化
したりあるいは難溶性の化合物が生成したりせず、保存
並びに輸送に有利である。さらに、流動性に優れている
ので、取り扱いが容易である。The dialysis agent of the present invention can be easily dissolved in water to form a homogeneous aqueous solution, and a dialysate can be easily obtained.
Further, the dialysis agent of the present invention can be reduced in volume, does not powder when stored, or does not form a hardly soluble compound, and is advantageous for storage and transportation. Furthermore, since it has excellent fluidity, it is easy to handle.
【００３４】本発明の透析用剤は、Ａ剤中に酢酸が安定
なかたちで配合され、含有されているので、経時的安定
性が優れている。The dialysis agent of the present invention is excellent in stability over time because acetic acid is contained and contained in the agent A in a stable form.
───────────────────────────────────────────────────── フロントページの続き (51)Int.Cl.6 識別記号 庁内整理番号 ＦＩ 技術表示箇所 Ａ６１Ｋ 31:185 31:70） ─────────────────────────────────────────────────── ─── Continuation of the front page (51) Int.Cl. 6 Identification code Office reference number FI technical display area A61K 31: 185 31:70)
Claims (10)
水素ナトリウム以外の成分及び酢酸を含有する粉末（Ａ
剤）、並びに、炭酸水素ナトリウムを含有する粉末（Ｂ
剤）とからなる透析用剤であって、Ａ剤中の酢酸を実質
的にナトリウムジアセテートとして含有する透析用剤。1. A powder (A) containing acetic acid and components other than sodium hydrogen carbonate among electrolytes necessary for a sodium bicarbonate dialysate.
Agent) and powder containing sodium hydrogen carbonate (B
A dialysis agent comprising the agent A) and the dialysis agent substantially containing the acetic acid in the agent A as sodium diacetate.
剤。2. The dialysis agent according to claim 1, wherein the agent A is a granulated product.
または請求項２の透析用剤。3. A glucose solution is added to the agent A. 1.
Alternatively, the dialysis agent according to claim 2.
又は、炭酸水素ナトリウムと血液透析用製剤に含まれる
他の電解質及び／又はブドウ糖との混合造粒物である請
求項１〜３のいずれか１の透析用剤。4. The agent B is a granulated product of sodium hydrogen carbonate,
Alternatively, the dialysis agent according to any one of claims 1 to 3, which is a mixed granulation product of sodium hydrogen carbonate and another electrolyte and / or glucose contained in the hemodialysis preparation.
水素ナトリウム以外の成分の粉末と、ナトリウムジアセ
テート粉末を混合し、造粒して透析用剤のＡ剤を製造す
ることを特徴とする上記Ａ剤と、炭酸水素ナトリウムを
含有する粉末（Ｂ剤）とからなる透析用剤の製造方法。5. Among the electrolytes required for a baking soda dialysate, powders of components other than sodium hydrogen carbonate and sodium diacetate powder are mixed and granulated to produce a dialysis agent A agent. A method for producing a dialysis agent, which comprises the above-mentioned agent A and a powder (agent B) containing sodium hydrogen carbonate.
５の透析用剤の製造方法。6. The method for producing a dialysis agent according to claim 5, wherein glucose is mixed with the granules of agent A.
燥工程を設けた請求項５又は請求項６の透析用剤の製造
方法。7. The method for producing a dialysis agent according to claim 5, wherein a drying step under an acetic acid atmosphere is provided during the granulating step of the agent A.
水素ナトリウム以外の電解質の粉末を造粒した後、ナト
リウムジアセテート粉末を混合してＡ剤を製造すること
を特徴とする上記Ａ剤と炭酸水素ナトリウムを含有する
粉末（Ｂ剤）とからなる透析用剤の製造方法。8. The agent A prepared by granulating powders of electrolytes other than sodium hydrogen carbonate among the electrolytes necessary for the sodium bicarbonate dialysate and mixing the sodium diacetate powder to produce the agent A. And a powder (agent B) containing sodium hydrogen carbonate, which is a method for producing a dialysis agent.
８の透析用剤の製造方法。9. The method for producing a dialysis agent according to claim 8, wherein glucose is blended with the granules of agent A.
酢酸ナトリウム粉末との混合粉末を用いる請求項５〜９
のいずれか１の透析用剤の製造方法。10. A sodium diacetate powder,
A mixed powder with sodium acetate powder is used, wherein the mixed powder is used.
1. A method for producing a dialysis agent according to any one of 1.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP20936193A JP3433979B2 (en) | 1993-08-24 | 1993-08-24 | Dialysis agent and method for producing the same |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP20936193A JP3433979B2 (en) | 1993-08-24 | 1993-08-24 | Dialysis agent and method for producing the same |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPH0759846A true JPH0759846A (en) | 1995-03-07 |
| JP3433979B2 JP3433979B2 (en) | 2003-08-04 |
Family
ID=16571670
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP20936193A Expired - Fee Related JP3433979B2 (en) | 1993-08-24 | 1993-08-24 | Dialysis agent and method for producing the same |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JP3433979B2 (en) |
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