JP5469482B2 - Solid baking soda dialysis agent - Google Patents

Description

  The present invention relates to a solid sodium bicarbonate dialysis agent, and more particularly to a solid sodium bicarbonate dialysis agent coated on the surface of sodium chloride particles with a mixture containing potassium chloride, calcium chloride, magnesium chloride and sodium acetate.

The dialysate used for the dialysis treatment is generally prepared by diluting, mixing, or dissolving and diluting a dialysate stock solution or a part of the dialysate solution to a predetermined concentration with dilution water. Two types of dialysate are known: an acetic acid dialysate using sodium acetate as an alkalizing agent and a sodium bicarbonate dialysate using sodium bicarbonate. Conventionally, acetic acid dialysate was common, but if the dialysis membrane was improved and the permeability increased, the amount of acetic acid transferred from the dialysate to the blood would increase, causing adverse effects on the cardiovascular system. Recently, sodium bicarbonate dialysate, which is less burdensome for living bodies, has become mainstream. However, since sodium bicarbonate causes a chemical reaction with calcium chloride and magnesium chloride and precipitates carbonate, sodium bicarbonate, potassium chloride, calcium chloride, magnesium chloride, and sodium acetate electrolyte compounds, pH An aqueous solution in which acetic acid as an adjusting agent and agent A composed of glucose added as necessary and agent B composed of powdered sodium bicarbonate or an aqueous solution thereof are each diluted and mixed are used. The compounding quantity of each component contained in 10 liter of sodium bicarbonate dialysate generally used is shown below.
Agent A Sodium chloride 1943.1 to 2238.0 g Potassium chloride 26.1 to 104.4 g Calcium chloride 25.7 to 102.9 g Magnesium chloride 17.8 to 71.2 g Sodium acetate 57.42 to 344.5 g Glucose 0.0 to 700.0 g B Agent sodium bicarbonate 588.1 to 928.0 g

  About the B agent, both the solution form and the powder form have been developed, and are appropriately selected and used. On the other hand, when the A agent is made into a powder, the content uniformity of each electrolyte compound contained cannot be obtained, so it is made into an aqueous solution in a factory and sealed in a container of about 10 liters and then transported to a hospital or the like. The A agent thus made into an aqueous solution is unfavorable in terms of transportation cost and storage location due to its large weight and volume and thus poor handling. Therefore, solidification of agent A with excellent content uniformity is currently being promoted, but the electrolyte compounds of sodium chloride, potassium chloride, calcium chloride, magnesium chloride and sodium acetate are mixed, compressed, and compressed in a dry granulator. The agent A obtained by pulverization and granulation has a wide particle size distribution, is likely to generate dust, and is mixed by foreign matter due to wear of the device, or by foreign matter or germs mixed when the device structure is an open type. There is a problem that the granulated material is easily contaminated. In addition, an aqueous solution of electrolyte other than sodium chloride is added to sodium chloride powder and kneaded, and the resulting granulated product is pushed against the screen surface of an extruding granulator and shaped and granulated. Deterioration of solubility in is observed. Furthermore, the A agent obtained by spraying each aqueous electrolyte solution other than sodium chloride on the sodium chloride powder that is flowing in the fluidized bed granulator, adhering and aggregating the particles by liquid crosslinking, Since mechanical external force cannot be applied and only the agglomeration force due to the spray droplets controls the growth of particles, it becomes a granulated product that is essentially porous, low in bulk density, and low in strength. Cheap. In this granulated product, the coating layer of the electrolyte compound coated is peeled off due to abrasion between the fluidized granulated products, and a considerable variation is recognized in the content of each electrolyte compound. In JP-A-6-178802, a suspension of potassium chloride, calcium chloride and magnesium chloride is added to sodium chloride in an agitation granulator and mixed with stirring, and the resulting mixture is mixed with sodium acetate at 50 ° C. or higher. A agent obtained by maintaining the above is introduced. However, this agent A may be peeled off due to abrasion during transportation, and pulverized, and the fine powder generated by pulverization is acidic with acetic acid and scatters during preparation of dialysate, causing a very poor working environment. Since it becomes one of the causes, it is a big problem in the medical field.

JP-A-6-178802

  It is an object of the present invention to have a uniform content of each electrolyte compound of potassium chloride, calcium chloride, magnesium chloride and sodium acetate coated on the surface of sodium chloride particles, which is a coating layer due to wear during production, storage and transportation. Is to provide a solid baking soda dialysis agent that is less likely to be peeled off and pulverized, and in which a fine powder is less scattered during the preparation of a dialysis solution.

As a result of intensive studies to solve the above problems, the present inventors have completed the present invention. That is, the present invention is obtained by spraying an aqueous solution of a mixture containing potassium chloride, calcium chloride, magnesium chloride and sodium acetate onto sodium chloride particles which are rolling and flowing in a tumbling stirred fluidized bed granulator. It is a solid baking soda dialysis agent in which the surface of sodium particles is uniformly covered with fine particles of a mixture containing potassium chloride, calcium chloride, magnesium chloride and sodium acetate. Here, when spraying an aqueous solution of a mixture containing potassium chloride, calcium chloride, magnesium chloride and sodium acetate onto sodium chloride particles in rolling flow, the rotational speed of the rolling stirring fluidized bed granulator is 20 to 1000 rpm is preferred. Moreover, it is preferable that the air volume of a rolling stirring fluidized bed granulator is 1-150 m < ³ > / min. Furthermore, it is preferable that the solid content concentration of the aqueous solution of the mixture containing potassium chloride, calcium chloride, magnesium chloride and sodium acetate sprayed on the sodium chloride particles in the rolling flow is 15 to 50% by weight.

  The solid baking soda dialysis agent of the present invention is coated with sprayed aqueous solution of a mixture containing potassium chloride, calcium chloride, magnesium chloride and sodium acetate on sodium chloride particles in rolling flow for content uniformity. The uniformity of component content is very good. In addition, the solid baking soda dialysis agent of the present invention produces less fine powder during production, and each electrolyte compound other than sodium chloride is coated very smoothly on the surface of sodium chloride particles, so that the coating layer is peeled off due to wear. Therefore, it is very effective in preventing pulverization during storage and transportation, and the amount of fine powder scattered during preparation of dialysate is reduced.

The tumbling stirring fluidized bed granulator used in the present invention can roll sodium chloride particles by the flow action by the air flow from the vicinity of the layer wall and the rolling action by the rotation of the rotor at the bottom of the apparatus, By spraying the aqueous solution of the mixture containing potassium chloride, calcium chloride, magnesium chloride and sodium acetate onto the sodium chloride particles in the rolling flow, the fine particles of the mixture can be uniformly coated on the surface of the sodium chloride particles. . Here, the rotational speed of the rotor is preferably 20 to 1000 rpm, particularly 50 to 500 rpm. If the rotational speed of the rotor is too low, the coating of the electrolyte compound on the surface of the sodium chloride particles is difficult to be uniform, and conversely, if it is too high, the coating layer will collide with the coated particles or rub against the inner wall of the device. As a result, the content and content uniformity become difficult to obtain. The air flow rate is preferably 1 to 150 m ³ / min, particularly ^{3 to} 60 m ³ / min. If the air flow rate is too low, the sodium chloride particles tend to aggregate together. Conversely, if the air flow is too high, the spray particles of the aqueous solution become spray-dried until they reach the sodium chloride particles, and they are all coated on the top of the device without being coated. Adhere to. Therefore, the coating efficiency is remarkably deteriorated. Further, the aqueous solution of the mixture containing potassium chloride, calcium chloride, magnesium chloride and sodium acetate uses an amount of water that can completely dissolve the mixture, and the solid content concentration of the mixture with respect to the water is 15 to 50%. In particular, it is preferably 25 to 40%. Even if the amount of water used is large, that is, there is no difference in the effect of the solid baking soda dialysis agent obtained even when the solid content concentration is low, the coating time can be shortened as the solid content concentration is high. Moreover, when solid content concentration becomes high too much, it will become a suspension in which the said mixture is not melt | dissolving completely in water. When spraying this suspension, there is a risk of clogging the mixture not dissolved in the spray nozzle of the apparatus, and the particle surface of the granulated product obtained by spraying this suspension onto sodium chloride particles is smooth. In addition, fine powdering due to particle surface abrasion due to collision between particles occurs, and the content uniformity of each electrolyte compound cannot be obtained. In the solid sodium bicarbonate dialysis agent of the present invention thus obtained, fine particles of a mixture containing potassium chloride, calcium chloride, magnesium chloride and sodium acetate are uniformly covered on the surface of the sodium chloride particles. The particle size of the fine particles of the mixture coated on the surface of the sodium chloride particles is 5 μm or less, preferably 0.01 to 1 μm. When the particle size of the mixture exceeds 5 μm, fine powder tends to scatter during storage and transportation.

  In the solid baking soda dialysis agent of the present invention, the mixture containing potassium chloride, calcium chloride, magnesium chloride and sodium acetate forms a uniform composition coating on the surface of sodium chloride particles. The ion concentration of each electrolyte compound in the solution obtained by dissolving the amount in a specific amount of water is always constant. Further, this solid baking soda dialysis agent has a high density, and the surface is uniformly smooth, so that the physical stability becomes very high. In addition, the solid baking soda dialysis agent of the present invention can be stored for a long time by hermetically wrapping and is very easy to handle, and only one preparation, a predetermined amount of baking soda and, if necessary, glucose are dissolved in water. The sodium bicarbonate dialysate can be prepared quickly. Furthermore, the solid baking soda dialysis agent of the present invention may contain an organic acid such as acetic acid or citric acid as a pH adjuster.

Examples of the present invention will be given below.
[Example 1] A mixture of 528.8 g of potassium chloride, 651.4 g of calcium chloride, 360.0 g of magnesium chloride and 1598.63 g of sodium acetate was completely dissolved in 7.5 liters of water so that the solid concentration would be 29.5%. Obtained. On the other hand, 14.4 kg of sodium chloride is rolled (rotation speed: 200 rpm) and flow (air flow of 8 m ³ / min or more) in a tumbling stirring fluidized bed granulator (MP-25 type, manufactured by POWREC). A granular granulated product was obtained by spraying the aqueous solution onto sodium chloride inside. 1 part by weight of acetic acid was added to 46.6 parts by weight of the obtained granular granulated product and dispersed uniformly.

[Comparative Example 1] A mixture of electrolyte compounds of 352.65 g of potassium chloride, 434.30 g of calcium chloride, 240.0 g of magnesium chloride, and 1065.75 g of sodium acetate was completely dissolved in 5.0 liters of water to a solid content concentration of 29.5% to obtain an aqueous solution. Obtained. On the other hand, 9.62 kg of sodium chloride is flowed (flow rate of 3 m ³ / min or more) in a fluidized bed granulator (flow coater, FLO-5M type, manufactured by Freund Corporation), and the aqueous solution is sprayed on the flowing sodium chloride. As a result, a granular granulated product was obtained. 1 part by weight of acetic acid was added to 46.6 parts by weight of the obtained granular granulated product and dispersed uniformly. The obtained granular granulated product was found to be scraped due to collisions between particles during the flow, and the scraped component became a fine powder and adhered to the filter at the top of the fluidized bed granulator.

[Test Example 1] 50 g of the granular granules obtained in Example 1 and Comparative Example 1 were dissolved in 500 ml of water, and the concentration of each electrolyte ion was measured. The results are shown in Table 1. As analytical methods, Na ⁺ and K ⁺ used flame photometry, Ca ²⁺ , Mg ²⁺ and CH ₃ COO ⁻ used high performance liquid chromatography, and Cl ⁻ used a titration method. As is clear from Table 1, the solid baking soda dialysis agent of the present invention sufficiently satisfied the content and content uniformity for each component, but the solid baking soda dialysis agent of Comparative Example 1 contained the content and content for each component. The content uniformity was not sufficiently satisfied.

  [Comparative Example 2] 873.3 g of sodium chloride is put into a stirring granulator (Mechanomyl MM-40N type, manufactured by Okada Seiko Co., Ltd.) and heated to around 70 ° C while stirring. Next, 21.3 g of potassium chloride, 26.3 g of calcium chloride, and 14.5 g of magnesium chloride were put into a stirring granulator and heated and mixed (rotation speed: 300 rpm). 17 ml of water was added to the contents, and 64.5 g of sodium acetate was further added, followed by heating and mixing again. After drying for 1 hour, a granular granulated product was obtained. 1 part by weight of acetic acid was added to 46.6 parts by weight of the resulting granulated granule and dispersed uniformly.

  [Test Example 2] 20 g of the granular granules obtained in Example 1 and Comparative Example 2 were collected, 20 ml of carbon tetrachloride was added thereto, and the mixture was lightly stirred, and then the supernatant was collected. Separately, 20 g of the granulated granules obtained in Example 1 and Comparative Example 2 were collected and shaken for 5 minutes. After adding 20 ml of carbon tetrachloride and stirring gently, the supernatant was collected. The absorbance of each supernatant obtained was measured at a wavelength of 660 nm, and the turbidity was measured from the absorbance of the turbidity standard solution. Table 2 shows the results of evaluating the difference in turbidity before and after shaking as the difference in the amount of fine powder produced. As is apparent from Table 2, the amount of fine powder (before shaking) of the solid baking soda dialysis agent of the present invention was very small compared to Comparative Example 1, and it was difficult to be pulverized even by physical impact (after shaking).

Claims (1)

The sodium chloride particles tumbling and flowing in the tumbling and stirring fluidized bed granulator with the rotating speed of the tumbling and stirring fluidized bed granulator are 50 to 500 rpm, and potassium chloride, calcium chloride, magnesium chloride and sodium acetate The surface of sodium chloride particles obtained by spraying an aqueous solution of a mixture containing a solid content concentration of 25 to 40% by weight with a tumbling stirring fluidized bed granulator at a flow rate of 3 to 60 m ³ / min at a time is potassium chloride. A method for producing a solid baking soda dialysis agent, which is uniformly covered with fine particles of a mixture comprising calcium chloride, magnesium chloride and sodium acetate so as to have a particle size of 5 μm or less .