JPH04257522A - Dialyzing agent for sodium bicarbonate - Google Patents

Abstract

PURPOSE:To provide the title powdered agent advantageous for reservation or transportation, without the need for any additional pH adjusting ingredient, capable of giving a dialyzing solution of desired pH value by simply dissolution in water without causing any precipitation. CONSTITUTION:The objective dialyzing agent comprising electrolyte components, made up of a group A consisting of at least one ingredient (in the form of granulated particles containing an acid as pH adjusting agent) other than sodium bicarbonate and a group B consisting mainly of sodium bicarbonate.

Description

[Detailed description of the invention]

0001

[Industrial Field of Application] The present invention relates to a sodium bicarbonate dialysis agent.

0002

BACKGROUND OF THE INVENTION A dialysis agent is a drug used to prepare a dialysate. Dialysis fluid is used in artificial kidneys, hemodialysis, peritoneal dialysis, etc. to replace the functions normally performed by the kidneys, remove waste products from body fluids, and supplement necessary components in the blood, and is used as an alkalizing agent. Demand for sodium bicarbonate dialysis agents using sodium bicarbonate is increasing because they are physiologically preferred.

[0003] As a sodium bicarbonate dialysate, one having an electrolyte ion composition as shown below is used, and the pH at the time of use is
is adjusted to 7.2 to 7.4. Na+ 120 ~ 15
0 mEq/lK +
0.5 to 3.0 mEq/lCa++
1.5 to 4.5 mEq/lM
g++ 0 ~ 2.0
mEq/lCl-
90 to 135 mEq/lCH3COO-
5 to 35 mEq/lHCO3-
20-35 mEq/l glucose 0-250
g/l

Normally, baking soda dialysate contains necessary electrolytes and glucose components (hereinafter referred to as A) other than baking soda due to solubility.
It is called a drug. ) is added to about 2.5 kg of water to make a stock solution with a volume of about 10 liters, and during dialysis, this stock solution is mixed with an aqueous sodium bicarbonate solution as an alkaline agent to dilute the total volume to 350 liters. Baking soda may be stored or transported in powder form and dissolved immediately before use.

[0005] As mentioned above, when the solution of Part A and the aqueous sodium bicarbonate solution are prepared in advance, even if they are made into a concentrated stock solution, they take up a considerable volume and weight, making it difficult to store, transport, and use them. There is a drawback that it is inconvenient to handle. To avoid this drawback, when storing or transporting agent A as a powder,
There is a problem in that when agent A is dissolved and mixed with baking soda, the calcium component or magnesium component contained therein tends to form a precipitate. In order to avoid such problems or to adjust the pH of the dialysate to a physiologically favorable value, an acid such as acetic acid or hydrochloric acid is usually added.

[0006]

[Problems to be Solved by the Invention] When Agent A is an aqueous solution, it is sufficient to add a pH adjusting component to the aqueous solution, but when Agent A is a powder, the pH adjusting component is usually added as a separate agent. It is necessary to mix this pH adjusting component in advance with the pure water in which it will be dissolved. For this reason, extra care is required in terms of safety and quality control when handling, transporting, and storing the pH-adjusting component, which reduces the advantage of solidifying Part A.

An object of the present invention is to provide a solid dialysis agent that is convenient for storage and transportation, does not require a separate pH adjusting component, and is free from segregation or caking. It is.

[0008]

[Means for Solving the Problems] The present invention provides a group (agent A) consisting of one or more electrolyte components other than sodium bicarbonate among the electrolyte components contained in a sodium bicarbonate dialysis agent, and a compound containing sodium bicarbonate as a main component. A sodium bicarbonate dialysis agent that is divided into a group (Agent B) and used by mixing Agents A and B at the time of use, where Agent A is granulated particles and contains an acid as a pH regulator within the particles. The present invention provides a sodium bicarbonate dialysis agent characterized by the following.

In the present invention, since agent A is a granulated particle, it has good fluidity, generates little dust, and is easy to handle. Since the particles contain an acid as a pH adjuster, it is possible to obtain agent A which has a predetermined pH of 7.2 to 7.4 upon dissolution and does not generate precipitates of calcium or magnesium components. Furthermore, since the pH adjuster is contained within the granulated particles, segregation and caking do not occur.

[0010] Various acids such as acetic acid, hydrochloric acid, and lactic acid can be used as the pH adjuster, but acetic acid or lactic acid is preferable from the viewpoint of safety during handling, and acetic acid is particularly preferable. The amount of acid used is preferably such that the pH of the dialysate falls within the range of 7.0 to 8.0. A more preferable range of pH of the dialysate is 7.2 to 7.4. The pH adjusting component of acetic acid or lactic acid may be added to agent A in an amount to give a concentration of about 2 mEq/l to the dialysate when used for artificial dialysis. When using acetic acid as a pH adjuster, it is preferable to add acetic acid in an amount of 1.0 to 2.0% by weight based on the total amount of A agent so as to maintain the pH within this range. In the case of lactic acid, 1.5 of the total amount of A agent
It is preferable to add up to 3.0% by weight. The acid need not be limited to a single type, and a mixture of multiple types of acids can be used.

In the A agent of the present invention, the pore volume of the granules is preferably 0.03 to 0.2 cc/g. If the pore volume is less than 0.03 cc/g, the dissolution rate may become slow, which is not preferable. If the pore volume exceeds 0.2 cc/g, it is not preferable because the strength of the granulated product may decrease and dust generation may occur. When the pore volume is 0.04 to 0.1 cc/g,
This is preferable because the effect of granulation is most effectively expressed.

The method for granulating agent A of the present invention is not particularly limited, but it is preferable to use the following method because it is easy to obtain a granulated product having the above-mentioned preferred pore volume. first,
The particle size of the component powder of Part A is adjusted, water is added so that the moisture content becomes 1 to 25% by weight, and the mixture is thoroughly mixed. After granulation using an extrusion granulator or the like, the powder is dried to obtain a granulated product. If the moisture content is less than 1% by weight during granulation, the particle strength will be low and it will be easier to powder, while if it exceeds 25% by weight, granulation may become difficult, so both are preferred. do not have.

[0013] The particle size of the powder of the component A before granulation is suitably 250 μm or less, preferably 180 μm or less, and more preferably 100 μm or less. If the particle size exceeds 250 μm, the mechanical strength of the granulated product as a final product will be insufficient, it will be easily powdered, and the dissolution rate will be slow, which is not preferable.

[0014] The particle size of the granulated agent A particles is from 0.1 to
It is preferable to set it to about 10 mm. If the particle size is less than the above range, the fluidity may be inhibited or the particle may become powdered and scatter, making it difficult to handle.On the other hand, if the particle size exceeds the above range, the mechanical strength of the particle may decrease. Both are unfavorable since they may take a long time to dissolve. It is more preferable that the particle size of the agent A particles is 0.5 to 10 mm.

[0015] When part A contains glucose, the glucose tends to turn yellow when heated to a high temperature. Therefore, in order to prevent the progress of this coloring, it is desirable to dry at a lower temperature for a short time. During drying in the granulation step, it is preferable to use air that has been dehumidified and then heated. Drying is suitably carried out at 30 to 90°C. As specific drying means, for example, by adopting a band dryer, disk dryer, ventilation dryer, rotary dryer, etc., it is possible to obtain granules with high strength, easy solubility, uniformity, and good compositional stability. It becomes possible.

The pH adjusting component in the present invention is preferably added after the A agent component is granulated and dried. It is preferable that the pH-adjusting component is added uniformly into the granulated A-agent particles, and specific means for uniformly adding the pH-adjusting component to the A-agent include, for example, adjusting the pH while stirring the A-agent. By spraying the ingredients, the pH is adjusted to the A agent.
One example is a method of uniformly impregnating the adjusting component.

The B agent of the present invention may contain only sodium bicarbonate, or may be a mixture of baking soda and a portion of the A agent components. When adding glucose to Agent B, care must be taken as bacteria are likely to proliferate.

To prepare a dialysis solution using the sodium bicarbonate dialysis agent of the present invention, agents A and B may be dissolved and mixed to a required concentration. A dialysate having a predetermined pH can be obtained without particularly adjusting the pH, and no precipitate of calcium or magnesium components is generated.

[0019]

[Example] (Example 1) Sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, sodium acetate anhydrous and glucose of the Japanese Pharmacopoeia were each ground to an average particle size of about 50 μm. The following ratios were mixed, and 1.5% by weight of water on a dry basis was added and mixed. NaCl 74.7110
Weight% KCl 1
．． 7943 wt%CaCl2.2H2O
2.2839 wt%MgCl2.6H2O
1.2408 wt% CH3 COONa
7.9296 weight% glucose
12.0404% by weight

This mixture was granulated using an extrusion granulator with a screen diameter of 0.5 mm to obtain 100 kg of cylindrical particles with a diameter of 0.5 mm and a length of 1 to 10 mm. Next, the temperature was raised to 50°C while blowing in air that had been dehumidified to a relative humidity of 50% in advance.
The particles were placed in a batch type box dryer adjusted to dry for 3 hours. While stirring the dried granules, spray glacial acetic acid 1.
6% by weight was sprayed to obtain agent A of the present invention. This A agent was in the form of granules, and the pore volume measured by a mercury intrusion porosimeter was 0.08 cc/g.

[0021] 97.6% by weight of sodium bicarbonate and 2.4% by weight of sodium chloride were mixed and granulated in the same manner as Part A to obtain Part B.

A solution of 2,654 g of agent A dissolved in pure water to make 9 liters is called solution A, and a solution of 678 g of agent B dissolved in pure water to make 11.34 liters is called solution B.
．． A solution obtained by mixing 1 liter of solution A with 26 liters of solution made by adding pure water to make 34 liters is a solution with a concentration used for artificial dialysis. No precipitation occurred during dilution mixing. The pH of this diluted mixed solution was 7.3. Furthermore, the content of glacial acetic acid in Part A can be determined by acid-alkali titration using phenolphthalein as an indicator.

(Examples 2 to 5) Agent A, which was pulverized, mixed, and granulated in the same manner as in Example 1, was placed in a batch-type box dryer adjusted to a temperature of 50°C, and then dried. Glacial acetic acid at 0.9, 1.1, 1.7 and 2.
Examples 2, 3, 4 and 5 were obtained by adding 1% by weight. pH of the solution obtained by diluting and mixing in the same manner as in Example 1
and pore volume are shown in Table 1. No precipitation occurred during dilution mixing.

(Example 6) Part A, which was pulverized, mixed, and granulated in exactly the same manner as in Example 1, was placed in a batch-type box dryer adjusted to a temperature of 50°C, and after drying, lactic acid was added to ．．
4% by weight was added, and this was designated as Example 6. Table 1 shows the pH and pore volume of the solution obtained by diluting and mixing in the same manner as in Example 1. No precipitation occurred during dilution mixing.

[0025]

[Table 1]

[0026]

Effects of the Invention The dialysis agent of the present invention dissolves in water to form a homogeneous aqueous solution, and a dialysate can be obtained safely and easily without the need to separately add a pH adjusting component during use. A
Since the agent is granulated, it has excellent fluidity and is easy to handle. Furthermore, the present dialysis agent is solidified and can be made smaller in volume than conventional solution-type artificial dialysis agents. The dialysis agent of the present invention is advantageous in storage and transportation since it does not turn into powder or generate poorly soluble compounds during storage.

Claims (3)

[Claims] Claim 1: A group consisting of one or more electrolyte components other than sodium bicarbonate among the electrolyte components contained in the sodium bicarbonate dialysis agent (agent A), and a group containing baking soda as the main component (agent B). , in a sodium bicarbonate dialysis agent that uses a mixture of agent A and agent B during use,
A sodium bicarbonate dialysis agent characterized in that agent A is granulated particles and contains an acid as a pH regulator in the particles. 2. The sodium bicarbonate dialysis agent according to claim 1, wherein the acid is acetic acid, lactic acid, or a mixture of acetic acid and lactic acid. Claim 3: The pore volume of agent A is 0.03 to 0.2 cc/
The sodium bicarbonate dialysis agent according to claim 1 or 2, which is