JP4293742B2 - Dialysis agent and method for producing the same - Google Patents

Description

表１に示されるように、本実施例においては、５−ハイドロキシメチルフルフラール類に相当する吸光度が試験開始時から２ヶ月経過後までの間０．００を維持されている。したがって、本実施例では、ブドウ糖がほとんど変質していないことが分かる。
【００３１】
これに対して比較例では、１ヶ月経過した時点での吸光度が０．３５まで急激に増加し、２ヶ月経過時点では、１．２９まで増加している。したがって、比較例では、ブドウ糖の変質が急速に生じていることが分かる。
【００３２】
以上より、本発明にかかる透析用剤は、極めて高い保存安定性があることが分かる。
【００３３】
【発明の効果】
以上説明したように、本発明によれば、電解質成分とブドウ糖との接触面積を小さくでき、透析用剤の保存安定性を大きく向上することができる。[0001]
BACKGROUND OF THE INVENTION
The present invention relates to an improvement of a dialysis agent and a production method thereof.
[0002]
[Prior art]
The dialysis agent is a drug for preparing a dialysis solution. Dialysis fluid is used to remove the waste products of body fluids in place of the functions that the kidneys originally perform by artificial kidney, hemodialysis, peritoneal dialysis, etc., and in some cases is used to supplement the necessary components in the blood. It is an aqueous solution having a close electrolyte composition. As the dialysis solution, a sodium bicarbonate dialysis solution using sodium bicarbonate as an alkalizing agent is physiologically preferable, and its demand is increasing.
[0003]
Such a dialysis agent is a conventional liquid agent, but its volume and weight are large, and there is a problem that it is inconvenient for storage, transportation and handling during use. As this powder agent, a three-part type, a two-part type, and a one-part type are generally known.
[0004]
As a three-part powder dialysis agent, for example, a granulated product of an electrolyte component, glucose and sodium bicarbonate are individually packaged, for example. However, in the case of this three-part dialysis agent, since it is necessary to dissolve and mix three kinds of medicines in water, the preparation work of the dialysis solution becomes complicated, and human error is likely to occur. there were. If a human error occurs, the patient may experience serious health problems such as increased blood pressure, sudden decrease in blood pressure, numbness in the extremities, increased heartbeat, intrathoracic distress, and disturbance of consciousness. That is.
[0005]
In addition, the one-part dialysis agent is one in which the above-described electrolyte component, glucose, and sodium bicarbonate are all packaged in one container, which can reduce human error, but depends on sodium bicarbonate and the electrolyte component. There was a problem that insoluble salts were easily formed.
[0006]
Therefore, it is conceivable to use a two-dialysis dialysis agent in which a granulated product composed of an electrolyte component and glucose and sodium bicarbonate are separately packaged. An example of such a two-part dialysis agent is disclosed in Japanese Patent No. 2751933.
[0007]
[Problems to be solved by the invention]
However, the conventional two-part dialysis agent has a problem that the glucose in the granulated product composed of the electrolyte component and glucose is denatured and the stability against long-term storage is not sufficient.
[0008]
This alteration occurs due to the water-mediated degradation reaction between the electrolyte component and glucose in contact with each other in the granulated product, so that the drug content must be thoroughly dried to improve the storage stability. Need to be low. However, for that purpose, a large amount of dry air is required, and there is a problem that the manufacturing cost is high and it is not economical.
[0009]
The present invention has been made in view of the above-described conventional problems, and an object thereof is to provide a two-agent dialysis agent with improved storage stability and a method for producing the same.
[0010]
[Means for Solving the Problems]
In order to achieve the above object, the present invention provides a dialysis agent comprising a granulated product and glucose containing an electrolyte component excluding sodium bicarbonate and a pH adjuster among electrolytes required for a sodium bicarbonate dialysate. It consists of A agent with which the airtight container was filled, and B agent containing sodium bicarbonate.
[0011]
In the dialysis agent, the average particle size of the granulated product is 0.1 mm to 10 mm, preferably 0.3 mm to 2 mm, and the average particle size of glucose is 0.02 mm to 2 mm, preferably 0.05 mm to It is characterized by being 1 mm.
[0012]
In addition, a method for producing a dialysis agent, wherein a granule containing an electrolyte component excluding sodium bicarbonate and a pH adjuster among electrolytes necessary for a sodium bicarbonate dialysis solution is produced, and the granule and glucose Is packed in an airtight container to prepare agent A, and agent B containing sodium bicarbonate is packaged separately from agent A.
[0013]
According to each of the above configurations, the granule containing the electrolyte component excluding sodium bicarbonate and the pH adjuster and glucose are filled in the airtight container, but the contact area between the electrolyte component and glucose is reduced. Therefore, the alteration of glucose can be suppressed, and the storage stability of the dialysis agent can be improved.
[0014]
DETAILED DESCRIPTION OF THE INVENTION
Hereinafter, embodiments of the present invention (hereinafter referred to as embodiments) will be described.
[0015]
As a result of various studies by the present inventors to improve the storage stability of a two-part dialysis agent, among electrolytes required for a sodium bicarbonate dialysis solution, an electrolyte component excluding sodium bicarbonate and a pH adjuster It has been found that it is effective to fill the granulated product (A1 agent) and glucose (A2 agent) contained in an airtight container into an A agent.
[0016]
Here, the pH adjuster is not limited as long as it is a pharmacologically acceptable liquid acid or solid acid. Examples of the liquid acid include hydrochloric acid and acetic acid. Examples of the solid acid include citric acid and malic acid.
[0017]
The average particle size of the granulated product is 0.1 mm to 10 mm, preferably 0.3 mm to 2 mm. The average particle size of the glucose is preferably 0.02 mm to 2 mm, preferably 0.05 mm to 1 mm. By setting the average particle size of the granulated product in such a range, the specific surface area can be controlled and the storage stability can be improved.
[0018]
The B agent containing sodium bicarbonate is packaged separately from the A agent.
[0019]
As described above, the dialysis agent according to this embodiment is a two-agent dialysis agent consisting of agent A and agent B in appearance, but is actually in an airtight container filled with agent A. It is configured to be filled with two agents, A1 agent and A2 agent. Therefore, the electrolyte component which is A1 agent and the glucose which is A2 agent are contacting in an airtight container.
[0020]
However, since the electrolyte component (A1 agent) in the agent A is a granulated product, even if the same airtight container is filled with glucose (A2 agent), the A1 agent and the A2 agent are in the granulated product. Compared with the case where they are in contact with each other, the contact area between the two can be reduced. For this reason, the alteration rate of glucose which is A2 agent can be suppressed, and stability with respect to long-term storage can be improved. In addition, when filling A1 agent and A2 agent in an airtight container, if A1 agent is filled first and A2 agent is filled on it, the contact area of both can further be reduced.
[0021]
In addition, since the contact area between the electrolyte component and glucose is reduced, it is not necessary to dry the drug as well as the conventional example, and it is not necessary to spend extra cost for drying. For this reason, manufacturing cost can also be reduced.
[0022]
Furthermore, as described above, this embodiment is formally a two-agent system, and the entire amount of the drug (A1, A2, and B agent) in the airtight container is dissolved and used. Therefore, the dialysate preparation work is not complicated, and the risk of human error can be reduced.
[0023]
Specific examples of the present embodiment described above will be described below as examples.
[0024]
Example.
Mixing sodium chloride 222.7kg, potassium chloride 5.31kg, calcium chloride dihydrate 6.54kg, magnesium chloride hexahydrate 3.62kg, anhydrous sodium acetate 23.36kg, 50% particle size about 40 microns Grind to become. In addition, each electrolyte described here is an example of the electrolyte component except the sodium bicarbonate concerning this invention.
[0025]
Next, the pulverized product is tumbled and granulated and dried in a fluidized tank to obtain a granulated product having a particle size of 0.355 mm (42 mesh) or more and 1.7 mm (10 mesh) or less. 4.75 kg of glacial acetic acid is added to the granulation and mixed. An airtight container is filled with 2355.4 g of this granulated product and 315 g of glucose to obtain agent A according to the present invention. In this case, the average particle size of glucose was 0.17 mm.
[0026]
Comparative example.
50% granules of sodium chloride 222.7kg, potassium chloride 5.31kg, calcium chloride dihydrate 6.54kg, magnesium chloride hexahydrate 3.62kg, anhydrous sodium acetate 23.36kg, glucose 11.868kg Grind to a diameter of about 40 microns.
[0027]
Next, the pulverized product is tumbled and granulated and dried in a fluidized tank to obtain a granulated product having a particle size of 0.355 mm (42 mesh) or more and 1.7 mm (10 mesh) or less. 4.75 kg of glacial acetic acid is added to the granulation and mixed. An airtight container is filled with 2670.4 g of this granulated product.
[0028]
Storage stability test.
The stability test of the chemical | medical agent manufactured by the said Example and comparative example was performed on 40 degreeC conditions. Collect 20.8 g of specimen from each drug. In the embodiment, since the granule (A1 agent) and glucose (A2 agent) are filled in the container, the sample is collected after the medicine filled in the container is uniformly mixed. Next, water is added to the collected specimen and dissolved to make exactly 100 ml. The absorbance of this liquid at a wavelength of 284 nm was measured as 5-hydroxymethylfurfural by an absorbance measurement method. When glucose is altered by contact between the electrolyte component and glucose, the 5-hydroxymethylfurfurals increase.
[0029]
The results of the above test are shown in Table 1.
[0030]
[Table 1]

As shown in Table 1, in the present example, the absorbance corresponding to 5-hydroxymethylfurfural is maintained at 0.00 from the start of the test until 2 months have passed. Therefore, it turns out that glucose has hardly changed in this Example.
[0031]
On the other hand, in the comparative example, the absorbance at the time when one month elapses rapidly increases to 0.35, and at the time when two months elapse, it increases to 1.29. Therefore, it can be seen that in the comparative example, the alteration of glucose occurs rapidly.
[0032]
From the above, it can be seen that the dialysis agent according to the present invention has extremely high storage stability.
[0033]
【The invention's effect】
As described above, according to the present invention, the contact area between the electrolyte component and glucose can be reduced, and the storage stability of the dialysis agent can be greatly improved.

Claims (3)

Among the electrolytes required for the sodium bicarbonate dialysate, from the A agent in which an airtight container is filled with a granulated product containing an electrolyte component excluding sodium bicarbonate and a pH adjuster and glucose, and the B agent containing sodium bicarbonate A dialysis agent characterized by comprising: The dialysis agent according to claim 1, wherein the granulated product has an average particle size of 0.1 mm to 10 mm, preferably 0.3 mm to 2 mm, and the glucose has an average particle size of 0.02 mm to 2 mm, preferably A dialysis agent characterized by being 0.05 mm to 1 mm. Among the electrolytes required for the sodium bicarbonate dialysate, a granulated product containing an electrolyte component excluding sodium bicarbonate and a pH adjuster is produced, and the granulated product and glucose are filled in an airtight container to prepare an agent A,
A method for producing a dialysis agent, wherein the B agent containing sodium bicarbonate is packaged separately from the A agent.