Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Reexamination Certificate
1999-05-21
2001-04-10
Lee, Howard C. (Department: 1623)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
C514S002600, C514S053000, C514S054000
Reexamination Certificate
active
06214802
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a peritoneal dialysis fluid. More particularly, it relates to a peritoneal dialysis fluid that can suppress occurrence of peritonitis resulting from peritoneal dialysis.
BACKGROUND OF THE INVENTION
In the event of renal failure, it becomes difficult to excrete the final nitrogen metabolites and the like from the human body and they accumulate within the body to cause dysfunction to various organs. For this reason, a medical treatment by artificial dialysis is conducted in order to excrete the accumulated metabolites outside the body. Artificial dialysis is roughly classified into haemodialysis and peritoneal dialysis.
The aim of haemodialysis is to excrete excess water, unwanted solutes, small molecular weight substances like urea and creatinine and other uremic substances in order to correct their levels. Therefore, the usual procedure is that blood is withdrawn from a patient and is passed through a dialyser outside the body using a dialysis fluid. Recently a dialysis fluid mainly containing sodium bicarbonate which is an alkaline agent is used. This haemodialysis treatment is capable of being combined with blood absorption or plasma separation procedures, which is frequently adopted. This treatment has an advantage that it can be applied to patients for a long term period, whereas it has such defects that use of the dialysis apparatus requires a great deal of cost, that patients must have a surgical procedure to provide blood access for blood extracorporeal circulation, that its application is limited to patients who have cardiopulmonary functions strong enough to endure extracorporeal circulation, and so on.
On the other hand, peritoneal dialysis is a method for exchanging solutes and water in capillary vessels of a patient's peritoneal with hypertonic solution which is injected within the peritoneal cavity. The principle of this method is diffusion of solutes which are transferred according to the concentration gradient and water migration due to the osmotic differences. Azotemia, and imbalance of water and electrolytes are corrected by this principle. This method has many advantages such that no special apparatus is commonly required and it gives less influence on the hemodynamics because extracorporeal circulation of the patient's blood is not necessary, and further the peritoneal dialysis is similar to the physiological function of the kidney.
Peritoneal dialyses are usually classified as Continuous Ambulatory Peritoneal Dialysis(CAPD), Intermittent Peritoneal Dialysis (IPD) or Continuous Cyclic Peritoneal Dialysis(CCPD).
The dialysis fluid used for peritoneal dialysis is an aqueous solution which comprises an osmotic agent such as glucose and the like, electrolytes such as sodium, potassium, calcium, magnesium, and organic acid salts such as sodium lactate. These peritoneal dialysis fluids are determined according to the components so as to control the levels of electrolytes or acid-base equilibrium, remove the waste materials and efficiently carry out ultrafiltration.
However, peritoneal dialysis fluids have heretofore been maintained at acidic pH, 4.5 to 5.5, for their compositional stability and their osmotic pressure has been rendered hypertonic for dialyzing effects, that is the osmotic pressure ratio to physiological saline is about 1.1 to 1.6. Clinically, dialysis fluids which are unsuitable for the human body are intraperitoneally injected in large amounts, for instance about 10 L/human/day and pooled in the peritoneal cavity for several hours, for instance 2 to 24 hours. Accordingly, there is a defect that patients who are subjected to dialysis tend to suffer peritonitis, etc., accompanied by clinical symptoms such as stomach ache, and finally peritoneal sclerosis, etc. (Wakabayashi, Y. and Kawaguchi, Y.; “Peritoneal Dialysis and Sclerosing Encapsulating Peritonitis”, Igaku No Ayumi (Progress in Medical Science), 183, 363-367, 1997). Occurrence of peritoneal sclerosis decreases the degree of effectiveness of dialysis, which makes it difficult for patients suffering kidney diseases to use peritoneal dialysis for a long term period. Further there are defects that plasma proteins are lost and the period of dialysis is very long and so on.
Under these circumstances, the present invention has been made and, therefore, an object of the present invention is to provide a peritoneal dialysis fluid that can suppress the occurrence of peritonitis.
SUMMARY OF THE INVENTION
As a result of intensive research by the present inventors in view of solving the above-described problems, it has now been found that an addition of a suitable amount of albumin to a peritoneal dialysis fluid considerably suppresses the occurrence of peritonitis, thus completing the present invention. That is, the present invention relates to a peritoneal dialysis fluid containing 0.1 to 30 g/L of albumin.
Conventionally albumin is known to be used in dialysis fluid as an osmotic agent (for instance, Japanese Patent Publication No.63-3871, Japanese Patent Publication No.1-313061, Artificial Organ, 1995, 19(4), 307-314). However, because the albumin shows a less osmotic effect than that of lower molecular weight substances as a dialysis osmotic agent, extremely high amounts of albumin are necessary to excrete high amounts of water, that is, ultrafiltration. For instance, the amount of the albumin as an osmotic agent is about 75 g per one liter of dialysis fluid which is relatively high. The high amounts of albumin cause an uptake into the living body and the increased amount of albumin in the body causes a disorder of serum osmolarity. The present invention is characterized by the use of smaller amounts of albumin than when used as conventional osmotic agents.
The dialysis fluid in the present invention comprises electrolytes, an osmotic agent not including albumin, physiologically acceptable pH solution and 0.1 to 30 g/L of human serum albumin.
The osmotic pressure of the peritoneal dialysis fluid in the present invention, that is, the ratio of the osmotic pressure of the dialysis fluid to that of physiological saline, is 1.0 to 3.0, preferably 1.1 to 1.6. The physiologically acceptable pH is 4.0 to 8.0, preferably 4.5 to 7.5, most preferably 5.0 to 7.4.
Albumin which can be used in the present invention is that derived from mammals such as humans, bovines and the like, or manufactured by chemical synthesis or genetic techniques. Preferably, human serum albumin including that manufactured by the genetic techniques is used.
Here, the amount of albumin is 0.1 to 30 g/L, preferably 0.1 to 5 g/L. An amount of less than 0.1 g/L of albumin exhibits a low peritonitis suppressing effect while use of an amount of more than 30 g/L of albumin results in increased water migration from the body to the peritoneal dialysis fluid. Substantially more than 30 g/L of albumin causes an increased level of serum albumin so as to change serum osmolarity, such as shown in rats in Example 5 described below.
The peritoneal dialysis fluid may contain sodium N-acetyltryptophan, sodium caprylate, etc., as an albumin stabilizer. The amount of the albumin stabilizer is 5 to 50 mg per 1 gram of albumin.
The osmotic agent in the present invention is one or two or more compounds selected from the group consisting of glycerol, monosaccharides, disaccharides, polysaccharides, sugar alcohols, gelatin and amino acids. The monosaccharides can include glucose, fructose, galactose, etc., and disaccharides can include sucrose, maltose, trehalose, etc. The polysaccharides can include dextrin, starch, polyglucose, hydroxyethylstarch and other carbohydrates and the sugar alcohols can include xylytol, mannitol, sorbitol, etc. Additionally, other useful high molecular weight substances include gelatin, hyaluronic acid, etc. The amount of the osmotic agent is generally about 5 to 200 g/L. Specifically, about 10 to 70 g/L of monosaccharide, about 20 to 140 g/L of disaccharide or about 30 to 100 g/L of polysaccharide can be used. The amino acids can be a mixture of essential amino aci
Kikuchi Takeo
Nakamura Yukio
Tsutsui Yasuhiro
Yamaguchi Shiho
Kubovcik & Kubovcik
Lee Howard C.
Nissho Corporation
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