Use of succinylated gelatin in preparing peritoneal dialysis solution and peritoneal dialysis solution containing succinylated gelatin and sodium citrate

By using succinyl gelatin as a penetrant and sodium citrate as a buffer in peritoneal dialysate, the problem of acidosis caused by glucose exposure and amino acids in the existing peritoneal dialysate is solved, achieving better biocompatibility and The effect of dialysis delays the structural and functional changes of the peritoneum.

CN118976116BActive Publication Date: 2025-01-24WEST CHINA HOSPITAL SICHUAN UNIV
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Patent Information

Application Number
CN202411472422.9
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2024-10-22
Publication Date
2025-01-24
Estimated Expiration
2044-10-22

AI Technical Summary

Technical Problem

During the use of existing peritoneal dialysate, metabolic disorders caused by glucose exposure, acidosis caused by amino acid peritoneal dialysate, and potential damage to the peritoneum, affecting the dialysis effect and patient health.

Method used

Succinyl gelatin is used as the penetrating agent of peritoneal dialysate, and sodium citrate is used as a buffer to form an isotonic and neutral peritoneal dialysate, which avoids the absorption of glucose and acidosis caused by amino acids, while providing stable Colloidal osmotic pressure to maintain ultrafiltration.

Benefits of technology

The peritoneal dialysate has better biocompatibility, delays changes in peritoneal structure and function, avoids metabolic disorders and acidosis, improves dialysis effect, reduces the risk of peritonitis, and protects peritoneal function.

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Abstract

The present invention provides the use of succinylated gelatin in preparing peritoneal dialysis fluid and a peritoneal dialysis fluid containing succinylated gelatin and sodium citrate, and belongs to the field of medicine. In the peritoneal dialysis fluid of the present invention, 20 to 80 g of succinylated gelatin is contained in every 1000 ml. The peritoneal dialysis fluid of the present invention uses succinylated gelatin as an osmotic agent. As a colloidal macromolecule, it can continuously provide a stable osmotic pressure, and has good biocompatibility, can protect the peritoneal structure and function, and delay the occurrence of peritoneal fibrosis. At the same time, the present invention uses sodium citrate as a buffer, and the increase of calcium ion level is closely related to the occurrence of inflammatory response, and citric acid can chelate part of calcium ions, which can reduce the risk of peritonitis to a certain extent, protect the peritoneal function, and provide a new choice for clinical peritoneal dialysis fluid.
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Description

Technical Field

[0001] The invention relates to application of succinylated gelatin in preparing peritoneal dialysis solution and peritoneal dialysis solution containing succinylated gelatin and sodium citrate, belonging to the field of medicine. Background Art

[0002] Peritoneal dialysis (PD) is a common form of renal replacement therapy. There is an osmotic pressure gradient between the peritoneal dialysis fluid injected into the abdominal cavity and the plasma in the human body. Using this principle, excess water in the body can enter the abdominal cavity through the pores on the peritoneum, reducing water retention in the body. After the peritoneal dialysis fluid remains in the abdomen for a period of time, high concentrations of toxins in the plasma, such as creatinine and urea, enter the abdominal cavity through diffusion and convection to achieve toxin exchange, and are then excreted from the body through the peritoneal dialysis fluid.

[0003] Peritoneal dialysis fluid usually consists of three parts: osmotic agents such as glucose, polysaccharides, amino acids, etc., with glucose being the most commonly used. The main function of osmotic agents is to remove excess water from the patient's body; buffers such as bicarbonate, lactate, acetate, etc. The main function of buffers is to correct acidosis and maintain the body's acid-base balance; electrolytes such as sodium, potassium, magnesium, calcium, etc., their function is to maintain normal electrolyte levels in the human body.

[0004] The commonly used peritoneal dialysis fluids are:

[0005] ① Glucose peritoneal dialysis fluid

[0006] Glucose peritoneal dialysis fluid has three concentrations: 1.5%, 2.5%, and 4.25%. In clinical practice, 1.5% glucose peritoneal dialysis fluid is the most commonly used. It uses 1.5% glucose as an osmotic agent with a molecular weight of 180Da, lactate as a buffer, and an overall osmotic pressure of about 350 mOsm / L. The pH value of the dialysate is 5.2, and it can be used in various peritoneal dialysis treatment modes. Glucose peritoneal dialysis fluid has the characteristics of high sugar, high osmotic pressure, and low pH. In addition, glucose metabolites (GDPs) and advanced glycation end products (AGEs) are produced during the production and storage process, which may lead to peritoneal neovascularization, peritoneal epithelial-mesenchymal transition, and peritoneal fibrosis, thereby affecting peritoneal function. In addition, as a small molecule, glucose is easily absorbed in peritoneal dialysis fluid, which reduces osmotic pressure. Long-term peritoneal treatment affects ultrafiltration volume. At the same time, the patient's sugar exposure is aggravated. A bag of 1.5% glucose peritoneal dialysis fluid contains 30g of glucose, and an average of 4 bags are used per day. Such a high sugar intake will affect the patient's glucose and lipid metabolism and may increase the risk of adverse events such as obesity, hyperglycemia, insulin resistance, and lipid metabolism disorders.

[0007] ② Icodextrin peritoneal dialysis fluid

[0008] An isotonic peritoneal dialysis fluid with 7.5% icodextrin (a glucose polymer) as an osmotic agent, with a molecular weight of 13000-19000Da, lactate as a buffer, and an overall osmotic pressure of about 282-286 mOsm / L. The pH value of the dialysate is 5.2, which is suitable for long-term use in patients with ultrafiltration failure. Although icodextrin is a large molecular weight glucose polymer, a small part of it may still enter the human body through the peritoneum, causing a false increase in blood sugar test results by the test strip method, misleading excessive use of insulin, and even life-threatening in severe cases; secondly, as a branched water-soluble glucose polymer, icodextrin may produce toxic glucose degradation products during high-temperature sterilization, affecting the structure and function of the peritoneum.

[0009] ③Amino acid peritoneal dialysis fluid

[0010] With 1.1% amino acids as osmotic agents and lactate as buffers, the overall osmotic pressure of peritoneal dialysis fluid is about 365mOsm / L, and the pH value of the dialysate is 6.6, which is suitable for maintenance peritoneal dialysis in malnourished patients. Amino acid peritoneal dialysis fluid may cause metabolic acidosis. Large doses of amino acid peritoneal dialysis fluid can cause significant gastrointestinal reactions and suppress appetite. In the event of peritonitis, amino acid peritoneal dialysis fluid may become a culture medium for bacterial growth.

[0011] ④ Bicarbonate peritoneal dialysis fluid

[0012] With 1.5% glucose as the osmotic agent and lactate + bicarbonate as the buffer, the overall osmotic pressure of the peritoneal dialysis fluid is about 350 mOsm / L, and the pH value of the dialysate is 7.4, which is suitable for patients who are uncomfortable with acidic peritoneal dialysis fluid. The osmotic agent still contains glucose, which has similar disadvantages to traditional glucose peritoneal dialysis fluid.

[0013] Succinylated Gelatin is a colloidal plasma substitute, mainly used to treat hypovolemic shock caused by various reasons, such as blood loss, acute trauma or surgery, burns, sepsis, etc. It can maintain the colloidal osmotic pressure of plasma, increase plasma volume, improve venous return and cardiac output, and increase urine output. The half-life of succinylated gelatin is about 4 hours, most of it is excreted through the kidneys within 24 hours, and it can be completely cleared from the blood within 3 days. The main ingredients of succinylated gelatin injection include succinylated gelatin (modified liquid gelatin), sodium chloride, sodium hydroxide and water for injection. When used, the dosage and speed should be determined according to the actual situation of the patient (such as pulse, blood pressure, peripheral tissue perfusion, urine volume, etc.). The liquid should be warmed during rapid infusion, but not more than 37°C. However, succinylated gelatin is not suitable for all situations. It is contraindicated for patients who are allergic to gelatin drugs, patients with renal failure, patients with bleeding constitution, patients with pulmonary edema, and patients with circulatory overload and water retention. In addition, pregnant and lactating women should use it with caution. Although no effects on the fetus have been observed to date, there is a lack of evidence from controlled clinical studies.

[0014] Plasma substitutes are mainly used to supplement blood volume and are widely used in clinical situations such as massive blood loss, plasma loss, and large-area burns. They reduce the need for blood transfusions by expanding blood volume and improving microcirculation. However, plasma substitutes are not suitable for all situations, especially in certain specific clinical settings, such as peritoneal dialysis. Peritoneal dialysis is a renal replacement therapy that uses the peritoneum as a dialysis membrane to remove metabolic waste and excess water from the body by infusing dialysate into the peritoneal cavity. The main components of peritoneal dialysis fluid include glucose, sodium chloride, sodium lactate, etc. Its formulation principle is that the electrolyte concentration is similar to that of normal plasma and can be adjusted according to clinical conditions. In peritoneal dialysis, the osmotic pressure of the dialysate is usually slightly higher than the plasma osmotic concentration to promote the removal of water from the body. The glucose concentration in the dialysate is the main factor affecting the osmotic pressure, and plasma substitutes such as hydroxyethyl starch and gelatin, although they can increase plasma volume, are not suitable for peritoneal dialysis fluid because they may interfere with the dialysis process, affect the ultrafiltration function of the peritoneum, and may cause damage to the peritoneum. Therefore, plasma substitutes are generally not used in peritoneal dialysis. Summary of the invention

[0015] In view of the defects of current peritoneal dialysis fluid, the inventors of the present application unexpectedly discovered that using succinylated gelatin as an osmotic agent for peritoneal dialysis is not easily absorbed through the peritoneum, which can avoid metabolic disorders caused by glucose exposure and acidosis caused by amino acid peritoneal dialysis fluid. At the same time, the stable colloidal osmotic pressure can continuously produce ultrafiltration effect.

[0016] The invention provides use of succinylated gelatin in preparing peritoneal dialysis fluid.

[0017] The invention provides a peritoneal dialysis solution, which contains 20-80g of succinylated gelatin per 1000ml.

[0018] Furthermore, the peritoneal dialysis fluid also contains sodium citrate, with each 1000 ml containing 3.0-4.0 g of sodium citrate.

[0019] Further preferably, the peritoneal dialysis fluid also contains calcium chloride, magnesium chloride, sodium chloride and glucose, with each 1000 ml containing 0.15-0.25 g of calcium chloride, 0.05-0.1 g of magnesium chloride, 5.0-6.0 g of sodium chloride and 1-1.5 g of glucose.

[0020] More preferably, each 1000 ml contains 40 g succinylated gelatin, 3.5 g sodium citrate, 0.18 g calcium chloride, 0.05 g magnesium chloride, 5.4 g sodium chloride and 1 g glucose.

[0021] Wherein, the relative molecular weight of the succinylated gelatin is 18000-26600 Daltons.

[0022] The beneficial effects of the present invention are:

[0023] The peritoneal dialysis fluid of the present invention is an isotonic and neutral peritoneal dialysis fluid with better biocompatibility, and can delay changes in peritoneal structure and function; succinylated gelatin is used as an osmotic agent, which is not easily absorbed through the peritoneum, and can avoid metabolic disorders caused by glucose exposure and acidosis caused by amino acid peritoneal dialysis fluid, while the stable colloid osmotic pressure can continuously produce ultrafiltration; the peritoneal dialysis fluid of the present invention uses citrate as a buffer, and the increase in calcium ion levels is closely related to the occurrence of inflammatory reactions. Citric acid can chelate calcium ions, which can reduce the risk of peritonitis to a certain extent and protect the peritoneal function.

[0024] The peritoneal dialysis solution of the present invention uses succinylated gelatin as an osmotic agent. As a colloidal macromolecule, it can continuously provide a stable osmotic pressure and has good biocompatibility, and can protect the peritoneal structure and function and delay the occurrence of peritoneal fibrosis. At the same time, the present invention uses sodium citrate as a buffer. The increase in calcium ion levels is closely related to the occurrence of inflammatory reactions, and citric acid can chelate some calcium ions, which can reduce the risk of peritonitis to a certain extent, protect the peritoneal function, and provide a new choice for clinical peritoneal dialysis solution. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 Peritoneal dialysis fluid drainage diagram

[0026] Figure 2 Creatinine clearance time relationship diagram DETAILED DESCRIPTION

[0027] Example 1 Preparation of the peritoneal dialysis solution of the present invention

[0028] prescription:

[0029] Succinylated gelatin 20g

[0030] Sodium citrate 3.0g

[0031] Calcium chloride 0.15g

[0032] Magnesium chloride 0.05g

[0033] Sodium chloride 5.0g

[0034] Glucose 1g

[0035] Add water for injection to 1000ml

[0036] Sodium citrate is used as a buffer in the prescription, magnesium chloride, calcium chloride, and sodium chloride are used as electrolyte components in simulated body fluids, and glucose simulates the blood sugar content in body fluids. All raw materials in the prescription are for injection, and the osmotic pressure is about 280mOsm / L.

[0037] 20 g of succinylated gelatin was stirred and dissolved in 500 mL of sterile water to obtain a succinylated gelatin aqueous solution, wherein the temperature of the sterile water was 60-90° C.; 5.0 g of sodium chloride, 0.15 g of calcium chloride, 0.05 g of magnesium chloride, 1.0 g of glucose and 3.0 g of sodium citrate were added to the succinylated gelatin aqueous solution and stirred to dissolve, and then transferred to a 1000 mL volumetric flask and sterile water was added to make up to 1000 mL to obtain a succinylated gelatin peritoneal dialysis solution.

[0038] The succinylated gelatin peritoneal dialysis fluid is sterilized by high-pressure steam sterilization at 121° C. for 30 minutes and then divided into three-layer co-extruded peritoneal dialysis fluid bags.

[0039] Example 2 Preparation of peritoneal dialysis fluid of the present invention

[0040] prescription:

[0041] Succinylated gelatin 40g

[0042] Sodium citrate 3.5g

[0043] Calcium chloride 0.18g

[0044] Magnesium chloride 0.05g

[0045] Sodium chloride 5.4g

[0046] Glucose 1g

[0047] Add water for injection to 1000ml

[0048] Prepared according to the method of Example 1.

[0049] Example 3 Preparation of peritoneal dialysis fluid of the present invention

[0050] prescription:

[0051] Succinylated gelatin 60g

[0052] Sodium citrate 4.0g

[0053] Calcium chloride 0.25g

[0054] Magnesium chloride 0.1g

[0055] Sodium chloride 6.0g

[0056] Glucose 1.5g

[0057] Add water for injection to 1000ml

[0058] Prepared according to the method of Example 1.

[0059] Example 4 Preparation of peritoneal dialysis fluid of the present invention

[0060] prescription:

[0061] Succinylated gelatin 80g

[0062] Sodium citrate 4.0g

[0063] Calcium chloride 0.25g

[0064] Magnesium chloride 0.1g

[0065] Sodium chloride 6.0g

[0066] Glucose 1.5g

[0067] Add water for injection to 1000ml

[0068] Prepared according to the method of Example 1.

[0069] The beneficial effects of the present invention are demonstrated below through the physicochemical properties and efficacy tests of the peritoneal dialysis fluid of the present invention.

[0070] Test Example 1 Evaluation of the basic pH value and osmotic pressure of the peritoneal dialysis fluid of the present invention

[0071] 1. Basic pH evaluation

[0072] The pH value of the succinylated gelatin peritoneal dialysis fluid prepared in Examples 1 to 4 was measured using a pH meter. The results showed that the pH value of each peritoneal dialysis fluid was 7.30±0.5, indicating that the pH value of the succinylated gelatin peritoneal dialysis fluid was very stable and neutral, consistent with the physiological pH value of the human body, and was beneficial to reducing perfusion pain and protecting the structure and function of the peritoneum.

[0073] 2. Evaluation of basal osmotic pressure

[0074] 1. Experimental materials:

[0075] Twelve SPF male SD rats, weighing 250-300 g, were provided by Vital River Animal Company.

[0076] Succinylated gelatin peritoneal dialysis solution prepared in Example 1-4

[0077] 2. Methods:

[0078] The succinylated gelatin peritoneal dialysis fluid prepared in Example 1-4 was subjected to an osmotic pressure test; 0.5 ml of blood was drawn from the jugular vein of 12 SPF-grade male SD rats for the rat plasma basal osmotic pressure test. The measurement results are shown in Table 1.

[0079] Table 1 Osmotic pressure test results of succinylated gelatin peritoneal dialysis fluid with different concentrations

[0080] Sample name Osmol / L Example 1 2% Succinylated Gelatin Peritoneal Dialysis Solution 280 Example 2 4% Succinylated Gelatin Peritoneal Dialysis Solution 320 Example 3 6% Succinylated Gelatin Peritoneal Dialysis Solution 352 Example 4 8% Succinylated Gelatin Peritoneal Dialysis Solution 409 Rat plasma osmotic pressure Rat plasma osmotic pressure 303

[0081] Succinylated gelatin acts as a colloidal osmotic agent, exerting osmotic pressure on the pores between each small cell, and exerting a transcapillary ultrafiltration effect during the abdominal dwell period. As shown in Table 1, the osmotic pressure of 4% succinylated gelatin peritoneal dialysis fluid is 320mOsmol / L, which is slightly higher than the plasma osmotic pressure of 303mOsmol / L. The appropriate osmotic pressure gradient can provide sufficient ultrafiltration power during the abdominal dwell period, while also avoiding the poor biocompatibility of hypertonic fluids and reducing damage to the peritoneal structure and function.

[0082] Test Example 2 Test for evaluating pH and osmotic pressure of the peritoneal dialysis solution of the present invention during the retention period

[0083] 1. Experimental materials:

[0084] SPF male SD rats, weighing 250-300 g, were provided by Victoria River Animal Company.

[0085] 2. Methods:

[0086] 1. Twelve SPF male SD rats were randomly divided into three groups: normal saline group (n=4), 2.5% glucose dialysate group (n=4), and 4% succinylated gelatin dialysate group (n=4).

[0087] 2. In the normal saline group, 25 ml of normal saline was injected into the peritoneal cavity, and 2 ml of drainage fluid was collected for inspection after 4 hours of abdominal retention; in the 4% succinylated gelatin dialysate group, the peritoneal dialysis fluid of Example 2 was used, 25 ml of succinylated gelatin peritoneal dialysis fluid was injected into the peritoneal cavity, and 2 ml of drainage fluid was collected for inspection after 4 hours of abdominal retention; in the 2.5% glucose dialysate group, 25 ml of 2.5% glucose dialysate was injected into the peritoneal cavity, and 2 ml of drainage fluid was collected for inspection after 4 hours of abdominal retention.

[0088] 3. The results of the osmotic pressure and pH value test during the abdominal retention period of the present invention are shown in Table 2

[0089] Table 2 Evaluation test results of pH and osmotic pressure of peritoneal dialysis solution during the peritoneal retention period of the present invention

[0090] Dialysate basal osmotic pressure mOsmol / L Osmol / L after 4h dialysis Dialysate basal pH pH value after 4h dialysis Normal saline 263 313 7.0 8.4 2.5% glucose dialysate 385 309 5.4 7.8 4% succinylated gelatin dialysis solution 320 330 7.3 7.8

[0091] As can be seen from Table 2, the basic pH value and osmotic pressure of 4% succinylated gelatin peritoneal dialysis fluid are more in line with the physiological state of the human body and have better biocompatibility. The osmotic pressure of glucose peritoneal dialysis fluid drops rapidly during dialysis, while 4% succinylated gelatin peritoneal dialysis fluid can maintain a stable osmotic pressure during the 4-hour abdominal residence process, producing a continuous ultrafiltration effect.

[0092] Test Example 3 Test for evaluating the ultrafiltration effect of peritoneal dialysis fluid of the present invention

[0093] 1. Experimental materials:

[0094] SPF male SD rats, weighing 250-300 g, provided by Weitonglihua Animal Company

[0095] 2. Methods:

[0096] 1. Twelve SPF male SD rats were randomly divided into three groups: normal saline group (n=4), 2.5% glucose dialysate group (n=4), and 4% succinylated gelatin dialysate group (n=4).

[0097] 2. Rats were fed with feed containing 0.5% adenine for 4 weeks to establish a rat chronic kidney disease model. The feed was purchased from Kuibu Qianli Biotechnology (Xuancheng) Co., Ltd.

[0098] 3. Construction of rat peritoneal dialysis model: Use disposable pressure extension tube (standard number 2011 No. 3660207, product number 20100031) produced by Shandong Weigao Group as peritoneal dialysis tube. Before surgery, the rats' neck and entire abdomen were prepared and disinfected. In prone position, select the skin behind the neck 1 cm below the midpoint of the line connecting the two ears of the rat and cut 0.5 cm horizontally. Turn the rat to supine position, select the abdominal incision position for incision, punch a subcutaneous tunnel, pull the peritoneal dialysis tube from the neck incision to the abdominal incision, and fix the dialysis tube mouth to the abdominal wall of the rat.

[0099] 4. In the normal saline group, 25 ml of normal saline was injected into the peritoneal cavity, and the peritoneal dialysis fluid was fully extracted with a syringe after 4 hours of abdominal retention; in the 4% succinylated gelatin peritoneal dialysis fluid group, the peritoneal dialysis fluid of Example 2 was used, 25 ml of 4% succinylated gelatin peritoneal dialysis fluid was injected into the peritoneal cavity, and the peritoneal dialysis fluid was fully extracted with a syringe after 4 hours of abdominal retention; in the 2.5% glucose dialysate group, 25 ml of 2.5% glucose dialysate was injected into the peritoneal cavity, and the peritoneal dialysis fluid was fully extracted with a syringe after 4 hours of abdominal retention.

[0100] 5. Peritoneal dialysis fluid drainage volume is shown in Table 3

[0101] Table 3 Peritoneal dialysis fluid drainage volume

[0102] A. Normal saline B 2.5% glucose dialysate C 4% succinylated gelatin dialysis solution Peritoneal dialysis fluid drainage volume (ml) 3.5±0.4 14.9±4.1* 20.5±3.5*#

[0103] *P<0.05 compared with group A; #P<0.05 compared with group B

[0104] Peritoneal dialysis fluid drainage Figure 1 (A: normal saline group, B: 2.5% glucose dialysate group, C: 4% succinylated gelatin dialysate group)

[0105] As shown in Table 3, the drainage volume of 4% succinylated gelatin peritoneal dialysis solution after 4 hours of abdominal retention was better than that of normal saline and 2.5% glucose dialysate groups, indicating that succinylated gelatin peritoneal dialysis solution has better ultrafiltration capacity during the abdominal retention process.

[0106] Test Example 4 Evaluation test of the toxin removal effect of the peritoneal dialysis solution of the present invention

[0107] 1. Experimental materials:

[0108] SPF male SD rats, weighing 250-300 g, were provided by Victoria River Animal Company.

[0109] 2. Methods:

[0110] 1. Four SPF male SD rats were fed with a diet containing 0.5% adenine for 4 weeks to establish a rat chronic kidney disease model. The diet was purchased from Kuibu Qianli Biotechnology (Xuancheng) Co., Ltd.

[0111] 2. Construction of rat peritoneal dialysis model: Use disposable pressure extension tube (standard number 2011 No. 3660207, product number 20100031) produced by Shandong Weigao Group as peritoneal dialysis tube. Before surgery, the rat's neck and entire abdomen were prepared and disinfected. In prone position, select the skin behind the neck 1 cm below the midpoint of the line connecting the two ears of the rat and cut 0.5 cm horizontally. Turn the rat to supine position, select the abdominal incision position for incision, punch a subcutaneous tunnel, pull the peritoneal dialysis tube from the neck incision to the abdominal incision, and fix the dialysis tube mouth to the rat's abdominal wall.

[0112] 3. Before starting dialysis, 0.5 ml of blood was drawn from the jugular vein of the four rats to test the blood creatinine level.

[0113] 4. All 4 rats were treated with the peritoneal dialysis fluid of Example 2, and 25 ml of 4% succinylated gelatin peritoneal dialysis fluid was injected into the peritoneal cavity. 0.5 ml of peritoneal dialysis fluid was extracted after 2, 4, 6, and 8 hours of abdominal retention for creatinine testing.

[0114] 5. Creatinine clearance time relationship diagram is shown in Figure 2 .

[0115] Table 4 Phase changes of creatinine concentration in peritoneal dialysis fluid

[0116] Serum creatinine umol / L 2h peritoneal dialysis fluid creatinine umol / L 4h peritoneal dialysis fluid creatinine umol / L 6h peritoneal dialysis fluid creatinine umol / L 8h peritoneal dialysis fluid creatinine umol / L ① 63.8 58.9 65.6 62.4 62.4 ② 268.8 347.7 405 414.1 424.4 ③ 156.4 128.5 170.2 151.6 155.4 ④ 155.3 112.2 142 152.7 157.3

[0117] from Figure 2 As shown in Table 4, succinylated gelatin peritoneal dialysis fluid has the ability to clear creatinine, and the creatinine concentration on both sides of the peritoneum basically reaches exchange equilibrium at 4 hours. Combined with the results of previous studies (Wang Yu, Kang Han, Zhong Xiaohong, et al. Establishment and application of peritoneal dialysis model of chronic renal failure SD rats [J]. Advances in Veterinary Medicine, 2020, 41(09): 55-60.), succinylated gelatin peritoneal dialysis fluid has a similar creatinine clearance effect as glucose dialysis fluid, proving the effectiveness of this product.

[0118] In summary, the succinylated gelatin peritoneal dialysis solution of the present invention has the following advantages:

[0119] 1. Succinylated gelatin peritoneal dialysis fluid has the characteristics of isotonicity, neutral pH, and no glucose degradation products. It has good biocompatibility and can delay the changes in peritoneal structure and function during long-term peritoneal dialysis in patients.

[0120] 2. Avoid obesity, hyperglycemia, insulin resistance, dyslipidemia and other problems caused by glucose exposure;

[0121] 3. As a colloidal macromolecule, succinylated gelatin is not easily absorbed through the peritoneum. It can maintain a stable colloidal osmotic pressure during the peritoneal retention process and produce a continuous ultrafiltration effect;

[0122] 4. Avoid acidosis and loss of appetite caused by amino acid peritoneal dialysis fluid;

[0123] 5. Reduce the risk of peritonitis to a certain extent and protect the peritoneal function.

Claims

1. A peritoneal dialysis fluid, characterized in that: Each 1000 ml contains 40 g of succinylated gelatin, 3.5 g of sodium citrate, 0.18 g of calcium chloride, 0.05 g of magnesium chloride, 5.4 g of sodium chloride and 1 g of glucose; the relative molecular weight of the succinylated gelatin is 18000-26600 Daltons.

Citation Information

Patent Citations

  • Additives for peritoneal dialysis solutions

    US4339433A