JP3635653B2 - Method for producing solid dialysis agent - Google Patents

Description

【０００９】
【発明の効果】
以上説明してきたことから明らかなように、本発明は、湿潤状態では反応性を有する塩化カルシウムおよび塩化マグネシウムの層をクエン酸および／または塩化カリウムの層で被覆し、また、湿潤状態ではクエン酸と反応性を有するブドウ糖および炭酸水素ナトリウムを核粒子として混合しているので、得られた透析用剤は長期保存に対して安定であり、また、使用時の透析液調製に際して炭酸塩を生ずることがない。
【図面の簡単な説明】
【図１】 塩化ナトリウムの立方晶粒子の電子顕微鏡写真（２００倍）である。
【図２】 塩化ナトリウム粒子の表面に塩化カリウム、塩化カルシウム、塩化マグネシウムおよびクエン酸を付着させた粒子の電子顕微鏡写真（２００倍）である。
【図３】 図３に示す粒子にブドウ糖粒子および炭酸水素ナトリウム粒子を複数個結合させた状態を示す電子顕微鏡写真（２００倍）である。[0001]
BACKGROUND OF THE INVENTION
The present invention relates to a solid bicarbonate-type dialysis agent and a method for producing the same. The dialysis agent of the present invention contains all necessary components in one agent.
[0002]
[Prior art]
A bicarbonate type dialysis agent generally used as a dialysis agent is composed of an A agent composed of an electrolyte, glucose and an acid, and a B agent composed of sodium hydrogen carbonate. The dosage forms of both agent A and agent B may be aqueous solutions and solids, and there are two types of solid agent A, one-drug type and two-drug type.
When both the A and B agents are aqueous solutions, they are generally called A and B solutions, and are sold in a state where a concentrated solution of about 10 L is filled in a polyethylene container. The dialysate is made by adding water and diluting to mix. On the other hand, when agent A or agent B is solid, it is usually necessary to dissolve in water once to prepare a concentrated solution called solution A or solution B.
As a bicarbonate type dialysis agent, one having the following composition is generally used.
Na ⁺ 130 to 150 mEq / L
K ⁺ 1.0 to 3.0 mEq / L
Ca ⁺ 2.0 to 4.0 mEq / L
Mg ⁺ 0 to 2.0 mEq / L
Cl ^- 100 to 125 mEq / L
^{_{HCO 3 - 20 ~ 40 mEq /}} L
^{_{CH 3 COO - 2 ~ 12 mEq}} / L
Glucose 0-2.0 mEq / L
[0003]
The liquid bicarbonate type dialysis agent is inconvenient to transport and store due to its large weight and volume, and requires excessive labor in handling when preparing the dialysate. There is also a problem of disposal of a large amount of large polyethylene tank after use.
If both agent A and agent B are solid, the above problem can be solved, but it is necessary to prepare the solution once before preparing the dialysate, so the two-agent or three-agent container must be opened and dissolved. I must. Therefore, if the number of patients in the hospital is large, the opening operation is complicated, and there is a high risk of mistakenly dissolving the quantity.
Therefore, it is conceivable that the dialysis agent is a solid and one agent. In this case, since the raw material used contains a liquid acid such as acetic acid or hydrochloric acid, the liquid acid reacts with sodium hydrogen carbonate. There is a problem in that the generated water is used as a medium to cause degradation of glucose or to generate carbonate insoluble in water.
[0004]
[Problems to be solved by the invention]
The present invention has been made in view of the above circumstances, and is a one-part solid dialysis agent that is stable for long-term storage, does not produce carbonate during dialysis solution preparation, and is easy to handle. It is an object to provide a method for producing a product efficiently and with high yield.
[0005]
[Means for Solving the Problems]
As a result of intensive studies to solve the above-mentioned problems, the present inventors have made sodium chloride, glucose and sodium hydrogen carbonate as core particles, so that the pH adjuster (citric acid) can be easily combined with sodium hydrogen carbonate. The present invention has been completed by conceiving that contact can be avoided. That is, the present invention includes (1) a step of spraying and drying a mixed aqueous solution of calcium chloride and magnesium chloride on sodium chloride as a core particle, and (2) spraying a mixed aqueous solution of potassium chloride and citric acid on the product of step (1). It is a manufacturing method of the agent for solid dialysis which comprises each process of the process dried and (3) The process of mixing glucose and sodium hydrogencarbonate with the product of process (2). The present invention also includes (1) a step of spraying and drying a mixed aqueous solution of potassium chloride, calcium chloride and magnesium chloride on sodium chloride as a core particle, and (2) spraying an aqueous solution of citric acid on the product of step (1). It is a manufacturing method of the agent for solid dialysis which comprises each process of the process dried and (3) the process which mixes glucose and sodium hydrogencarbonate with the product of process (2). Furthermore, the present invention includes (1) a step of spraying and drying a mixed aqueous solution of calcium chloride and magnesium chloride on sodium chloride as a core particle, and (2) spraying and drying an aqueous solution of citric acid on the product of step (1). (3) a step of mixing glucose and sodium hydrogen carbonate with the product of step (2), (4) a step of spraying an aqueous solution of potassium chloride to the mixture of step (3) and drying. It is a manufacturing method of the solid dialysis agent which consists of these. Further, the present invention further comprises a step of spraying and drying a sodium acetate or sodium citrate aqueous solution on the mixture obtained by each of the above methods .
[0006]
DETAILED DESCRIPTION OF THE INVENTION
The method for producing a solid dialysis agent of the present invention comprises (1) a step of spraying and drying a mixed aqueous solution of calcium chloride and magnesium chloride on sodium chloride as a core particle (see FIG. 1), and (2) formation of step (1). The step comprises spraying an aqueous solution of potassium chloride and citric acid onto the product and drying, and (3) mixing glucose and sodium bicarbonate with the product of step (2) (see FIG. 2). However, potassium chloride may be mixed with the aqueous solution of step (1) without being mixed with the aqueous solution of step (2), and as the step (4), an aqueous solution of potassium chloride is sprayed on the product of step (3). And may be dried.
The solid dialysis agent produced by the method of the present invention is of a one-part type as shown in FIG. 3, and if there is a dissolution tank, it can be easily dissolved and diluted by simply adding water to dilute the bicarbonate-type dialysate. Can be adjusted.
The dialysis agent may be prepared by adding water thereto to dissolve it once to prepare a concentrated solution, and diluting it at a predetermined ratio at the time of use to prepare a bicarbonate type dialysate. However, in this case, it is necessary to keep the ratio of the solid dialysis agent closed to the entire dialysate to 10 W / V% or less so as not to generate insoluble carbonate.
[0007]
[Example 1]
Put 96.1 kg of sodium chloride with an average particle diameter of about 0.4 mm in a tumbling fluidized drying apparatus (multiplex, MP-01 type, manufactured by Paulex), and under conditions of an intake air temperature of 80 ° C., calcium chloride 2 Sprayed 11 L of a mixed aqueous solution of 0.9 kg and 1.6 kg of magnesium chloride for 70 minutes and simultaneously dried.
Next, 20 L of a mixed aqueous solution of 2.35 kg of potassium chloride and 2.74 kg of citric acid was sprayed for 130 minutes, simultaneously dried, and further dried for 60 minutes.
Next, 15.75 kg of glucose and 37.1 kg of sodium bicarbonate were mixed, and then 20 L of an aqueous sodium acetate solution was sprayed for 170 minutes and simultaneously dried. After the completion of spraying, the mixture was further dried for 60 minutes and then cooled for 60 minutes to obtain a final granulated product.
The obtained granulated product was arbitrarily taken 3 times, 10.5 g was taken, and water was added to this to melt, and when the component content was measured for 1000 mL of liquid, stable results as shown in Table 1 were obtained. It was.
Also, two 10.5 g samples were arbitrarily taken from the obtained granulated material, one was sealed in a gas barrier bag under dry conditions, and stored for 3 months in an atmosphere of 40 ° C. and 75% RH. However, there was no change in coloring or content of each component. Moreover, the liquid was clear and the change of pH was not recognized.
[0008]
[Table 1]

[0009]
【The invention's effect】
As can be seen from the above description, the present invention covers a layer of calcium chloride and magnesium chloride that is reactive in the wet state with a layer of citric acid and / or potassium chloride, Glucose and sodium hydrogen carbonate, which are reactive with each other, are mixed as core particles, so that the resulting dialysis agent is stable for long-term storage, and also produces carbonate when preparing dialysate for use. There is no.
[Brief description of the drawings]
FIG. 1 is an electron micrograph (200 ×) of cubic particles of sodium chloride.
FIG. 2 is an electron micrograph (200 ×) of particles having potassium chloride, calcium chloride, magnesium chloride and citric acid attached to the surface of sodium chloride particles.
3 is an electron micrograph (200 ×) showing a state in which a plurality of glucose particles and sodium hydrogen carbonate particles are bound to the particles shown in FIG. 3. FIG.

Claims (3)

The manufacturing method of the agent for solid dialysis which comprises the process of following (1)-( 4 ).
(1) A step of spraying and drying a mixed aqueous solution of calcium chloride and magnesium chloride on sodium chloride as a core particle.
(2) A step of spraying and drying a mixed aqueous solution of potassium chloride and citric acid on the product of step (1).
(3) A step of mixing glucose and sodium hydrogen carbonate with the product of step (2).
(4) A step of spraying and drying an aqueous solution of sodium acetate or sodium citrate on the mixture of step (3). The manufacturing method of the agent for solid dialysis which comprises the process of following (1)-(4).
(1) A step of spraying and drying a mixed aqueous solution of potassium chloride, calcium chloride and magnesium chloride on sodium chloride as a core particle.
(2) A step of spraying and drying an aqueous solution of citric acid on the product of step (1).
(3) A step of mixing glucose and sodium hydrogen carbonate with the product of step (2).
(4) A step of spraying and drying an aqueous solution of sodium acetate or sodium citrate on the mixture of step (3). The manufacturing method of the agent for solid dialysis which comprises the process of following (1)-(5).
(1) A step of spraying and drying a mixed aqueous solution of calcium chloride and magnesium chloride on sodium chloride as a core particle.
(2) A step of spraying and drying an aqueous solution of citric acid on the product of step (1).
(3) A step of mixing glucose and sodium hydrogen carbonate with the product of step (2).
(4) A step of spraying and drying an aqueous solution of potassium chloride on the mixture of step (3).
(5) A step of spraying and drying an aqueous solution of sodium acetate or sodium citrate on the product of step (4).

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