JP2002282354A - Liquid for peritoneal dialysis - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a liquid for peritoneal dialysis with high biocompatibility with which absorption of glucose into blood and elimination thereof from blood are small in amount. SOLUTION: This invention is the liquid for peritoneal dialysis characterized by containing at least one kind of trehalose or raffinose and glucose in the liquid.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a peritoneal dialysis solution applied to patients with renal insufficiency, and more particularly to a biocompatible peritoneal dialysis solution containing trehalose, raffinose and the like as osmotic agents. .

[0002]

2. Description of the Related Art Peritoneal dialysis is a therapy for exchanging or removing wastes, water and the like in capillaries of a patient's peritoneum with a dialysate injected into a patient's abdominal cavity. Is an important therapy. Compared to hemodialysis, which is another typical therapy for renal failure, a large-scale device
It is widely accepted by patients who wish to reintegrate into society or who have difficulty in visiting medical facilities due to remote locations because of the advantages that do not necessarily require equipment and the assistance of doctors and nurses.

[0003] However, peritoneal dialysis therapy has several disadvantages, as listed below. First, most peritoneal dialysis solutions currently on the market use glucose as an osmotic agent, so that various problems have arisen. For example, absorption of glucose into the patient's body, which causes an increase in blood sugar level and abnormal lipid metabolism. There are also problems associated with adjusting the pH of the dialysate.
With the current peritoneal dialysis solution, it is necessary to adjust the dialysate to the acidic side in order to maintain the stability of the glucose in the dialysate during autoclaving. Is not preferred for peritoneal or peritoneal epithelial cells.

[0004] Further, even after the acid solution is adjusted to the acidic side, glucose decomposition products harmful to the human body are generated in the peritoneal dialysate due to high-pressure steam sterilization or long-term storage. The glucose decomposition products are AGE (final saccharification reaction product). It has been shown to be unfavorable for living organisms in terms of the production of atherosclerosis and the like. For this reason, methods for reducing the production of this glucose decomposition product have been conventionally studied. For example, a method for removing the decomposition product from the liquid, a sterilization method, a change in sterilization conditions, and the like. However, as long as glucose is present during dialysis as a major osmotic agent, it is not possible to drastically reduce glucose degradation products in the dialysate.

[0005] Therefore, attempts have been made to use other than osmotic agents other than glucose. For example, a glucose polymer which is a hydrolyzate of an amino acid or starch is used. However, the above-mentioned osmotic agents are not yet fully utilized at present because of their high cost and insufficient confirmation of biological safety in long-term use.

On the other hand, 2-3 saccharides such as trehalose, sucrose and raffinose (referred to as polysaccharides having 2-3 glucose units) have been proposed and developed as osmotic agents. The osmotic agent is more stable in the neutral region than glucose, so that the dialysate using the osmotic agent can have a pH around neutral. Thereby, a favorable state can be created for the peritoneum and peritoneal epithelial cells. Further, since the degradation products of glucose released into the dialysate are reduced, the dialysate having high compatibility with the living body is obtained. Further, since the dialysate does not contain glucose, absorption of glucose into blood can be prevented. Furthermore, since the osmotic agent has a higher molecular weight than glucose, it also has the advantage of increasing the amount of water removed and extending the water removal time.

However, it has been found that the dialysis solution containing the osmotic agent alone has the following problems as compared with the conventional one. That is, when peritoneal dialysis is performed using the above dialysate, glucose in the blood is removed because the dialysate does not contain glucose.
This is a phenomenon that occurs because the glucose concentration in the dialysate is extremely lower than the glucose concentration contained in the blood.

[0008]

SUMMARY OF THE INVENTION Accordingly, an object of the present invention is to provide a highly biocompatible peritoneal dialysis solution, and furthermore, a dialysis in which the absorption of glucose into the blood and the removal from the blood are small. Providing a liquid.

[0009]

According to the present invention, at least one of trehalose or raffinose is used as an osmotic agent.
The above-mentioned problem has been solved by a peritoneal dialysis solution characterized by containing a type and glucose in the solution. Further, the present invention can obtain the following advantages by taking the following embodiments.

The above-mentioned peritoneal dialysis solution containing as an osmotic agent a 2-3 saccharide other than the above-mentioned trehalose or raffinose. With the above configuration, the osmotic pressure can be adjusted at low cost. Further, depending on the type of the osmotic agent to be added, it is possible to change or adjust the water removal performance and the water removal time.

Alternatively, the glucose concentration is 0.01 to 2.
The peritoneal dialysis solution according to the above, wherein at least one of trehalose or raffinose is added to the peritoneal dialysis solution so as to have a 5% W / V and an osmotic pressure of 300 to 800. More preferably, the glucose concentration is 0.05 to
The peritoneal dialysis solution having a osmotic pressure of 300 to 400 at 0.2% W / V. The dialysate with these components reduces glucose degradation products generated during autoclaving.
It is possible to obtain a dialysate in which glucose can be prevented from being absorbed into blood or removed from blood.

In the peritoneal dialysate, the above-mentioned peritoneal dialysate adjusted to pH 3 to 9 is preferable, and the peritoneal dialysate adjusted to pH 6.0 to 7.0 is more preferable. By adjusting the peritoneal dialysate within the above range, the production of glucose degradation products can be suppressed as compared with the existing peritoneal dialysate. In addition, since the dialysate can be simultaneously shifted to the neutral region side, damage to the peritoneum and peritoneal mesothelial cells can be further reduced.

[0013]

[Example 1] α, α-trehalose 4.3
4g, glucose 0.2, sodium chloride 0.567
g, sodium lactate 3.92 g, calcium chloride 0.
294 g and magnesium chloride 0.103 g were dissolved in distilled water, and pH was adjusted using sodium hydroxide 0.294 g.
Was adjusted to about 7.5, and the total amount was adjusted to 1000 ml with distilled water.
And The solution was filtered through a 0.2 μm membrane filter, filled in a polyvinyl chloride resin (PVC) bag, and subjected to high-pressure steam sterilization at 121 ° C. for 20 minutes.
At this time, the osmotic pressure was 400 m0sm / kg, and the pH was 6.5. In addition, instead of the above sodium lactate,
Other buffers (such as sodium bicarbonate) may be used.

[Embodiment 2] In the embodiment 1, α, α-
5. Raffinose instead of 4.34 g trehalose
A solution prepared by dissolving 82 g in distilled water was filled into a bag made of PVC after filtration, and subjected to high-pressure steam sterilization. (Same conditions as in Example 1) At this time, the osmotic pressure was 400 m0 sm / kg.
And the pH was 6.5.

[Measurement] Coloring of the dialysate obtained above was visually confirmed. Further, the pH of the dialysate was measured.
Further, in order to confirm the production of 5-hydroxymethylfurfural, which is one of glucose degradation products, 28
The absorbance at 4 nm [A284] was measured.

[Results] The peritoneal dialysis solutions prepared in Examples 1 and 2 were all colorless and clear and colorless.
Further, the absorbance at 284 nm of the above two dialysates is 0.09, which is lower than the absorbance (284 nm) of the dialysate using only glucose as an osmotic agent (284 nm) 0.9.
It was confirmed that it was significantly (about 1/10) lower. Furthermore, the pH of the peritoneal dialysis solution prepared in Examples 1 and 2 is suppressed from shifting to the acidic side and is favorably maintained in the neutral region as compared with the conventional dialysis solution as shown below. It is estimated that there is little damage to. (1) pH immediately after preparation of the peritoneal dialysate of Examples 1 and 2 and after a predetermined period (24 hr) pH 7.5 (immediately after preparation) → pH 6.5 (after 24 hr) (2) Immediately after preparation of conventional dialysate and PH after predetermined period pH 7.5 (immediately after preparation) → pH 6.5 (after 24 hours)

[0017]

According to the constitution of the present invention, firstly, a dialysate having high biocompatibility can be obtained. In other words, since the production of glucose degradation products can be reduced, a peritoneal dialysis solution containing less harmful substances to the living body can be obtained. In addition, dialysate pH
Can be transferred to the neutral side, and a dialysate with less damage to biological membranes and peritoneal cells can be obtained. Secondly, it is possible to obtain a dialysate having less influence on the blood concentration of glucose (such as absorption of glucose into blood or loss from blood). Third, since the added osmotic agent has a higher molecular weight than glucose, it is possible to increase the amount of water removed and extend the time for removing water.

Claims (4)

[Claims] 1. A peritoneal dialysis solution comprising at least one of trehalose or raffinose and glucose in the solution. 2. The peritoneal dialysis solution according to claim 1, wherein the osmotic agent comprises at least one kind of 2-3 saccharides other than trehalose or raffinose. 3. The peritoneal dialysis solution having a glucose concentration of 0.0
1-2.5% W / V, osmotic pressure 300-800m
The peritoneal dialysate according to claim 1, wherein at least one of trehalose and raffinose is added to the peritoneal dialysate so as to be Osm / Kg. 4. The peritoneal dialysis solution according to claim 1, wherein the pH of the dialysis solution is adjusted to 3 to 9.