CN104688770A - Peritoneal dialysis solution composition containing multiple alpha-ketone acid calcium - Google Patents
Peritoneal dialysis solution composition containing multiple alpha-ketone acid calcium Download PDFInfo
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- CN104688770A CN104688770A CN201310665288.XA CN201310665288A CN104688770A CN 104688770 A CN104688770 A CN 104688770A CN 201310665288 A CN201310665288 A CN 201310665288A CN 104688770 A CN104688770 A CN 104688770A
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Abstract
The invention discloses a peritoneal dialysis solution composition, which contains 1.5%-4.25% of glucose, sodium chloride, multiple alpha-ketone acid calcium and water, wherein the multiple alpha-ketone acid calcium are calcium 3-methyl-2-oxovalerate, ketoleucine calcium, ketophenylalanine calcium and ketovaline calcium.
Description
Technical field
The present invention relates to the peritoneal dialysat composition of one kind of multiple α-one base acid calcium.
Background technology
Chronic renal insufficiency (CRF) refers to that a variety of causes causes chronic progressive external Renal lesion, cause the obvious atrophy of kidney, basic function can not be maintained, clinical appearance is with metabolite retention, water, electrolyte, acid base imbalance, each system involvement of whole body is the clinical syndrome of main manifestations.Wherein protein metabolism produces that toxin accumulates in vivo is one of the important pathogeny of chronic renal insufficiency.The degree of symptoms of uremia is directly relevant with the accumulation of protein metabolism product.Low protein diet can alleviate symptoms of uremia, and the further deterioration of the chronic renal insufficiency that can slow down.But can the shortage of essential amino acids in primosome while limit protein matter.Clinical practice nearly ten years along with peritoneal dialysis technology is increasingly extensive, then corresponding prolongation life cycle of uremic patient, but its long-term complications is also more aobvious outstanding, and especially protein malnutrition has become the main factor affecting patient survival.
Peritoneal dialysis (peritoneal dialysis, PD) be the important renal replacement therapy (CRRT) of end stage renal failure patient, due to compared with hemodialysis, have applied widely, dialytic efficiency is high, residual renal function is kept, patients ' life quality advantages of higher, occupies more and more consequence in the alternative medicine of chronic renal failure.The key of successful peritoneal dialysis is the peritoneum that ultrafiltration function is good and peritoneal dialysis solution.Due to the chronicity of peritoneal dialysis treatment, the ultrafiltration performance of peritoneum often affects by various factors and changes over the course for the treatment of, and this change is irreversible, and patient's peritoneum ultrafiltration function finally can be caused to lose, and cannot carry out abdomen again and thoroughly treat.Peritoneal fibrosis and ultrafiltration caused by the poor biocompatibility of wherein peritoneal dialysis solution (peritoneal dialysis fluid, PDF) unsuccessfully become the major issue that current peritoneal dialysis is badly in need of and must be solved.Abdomen abdomen dialysis solution (peritoneal dialysis fluid, PDF) be core link in PD, the ultimate principle of peritoneal dialysis, utilize different the formed electrochemistry potential energy difference of the concentration of each composition between patients serum from peritoneal dialysis liquid in peritoneal cavity exactly, correct in uremic patient blood by disperse and Ultrafiltration physically different.The setting of each composition of peritoneal dialysis liquid and compatibility are mainly based on this principle.Traditional peritoneal dialysis liquid Main Function is for removing toxin, ultrafiltration moisture, but the amino acid moiety in body also can be made to run off simultaneously, amino acid balance for the fragility in chronic renal insufficiency patient body causes larger pressure, thus amino acid whose shortage in aggravation patient body, thus cause the decline of patient's body constitution.There are some researches prove, albumen synthesis reduces, and decompose the main mechanism accelerated as CRF malnutrition occurs, and uremic toxins's accumulation Profilin synthesis is the important mechanisms that CRF malnutrition occurs.As everyone knows, there is obvious protein metabolism disorder and the accumulation of Proteometabolism product in Chronic Renal Failure Patients body.Be characterized in, in blood plasma, most essential amino acids, TEAA level reduce, and some non essential amino acid level is higher, and, its exact mechanism still imperfectly understands after protein-bearing more so.Think at present its mechanism may with following factor about: (1) albumen takes the photograph the minimizing of people, (2) branched-chain amino acid decomposes and may play a role in skeletal muscle, (3) viscera tissue excessively absorbs to it reason can not explaining its low SI, (4) intraor extracellular amino acids distribution can change, show only to pick propylhomoserin low SI in the branched-chain amino acid of Renal Failure Patients to the research of amino acid levels in histiocyte, be obviously different from blood plasma.Chronic renal insufficiency patient ubiquity protein/Aminoacidopathy also reported by document. its mechanism and influence factor mainly comprise the exception and branched-chain amino acid Developmental and Metabolic Disorder etc. of anorexia, low protein diet and abnormal, the cytokine to the adaptive damage of low protein diet, acidosis, hormonal resistance, energy metabolism.
How to supplement the aminoacid of chronic renal insufficiency (CRF) patient, improve health degree and just become a kind of urgent requirement.
Summary of the invention
Through Literature Consult and research, we find that in peritoneal dialysis solution, add α-one base acid calcium can make vivo acid horizontal stable go up, more surprisingly compared with oral administration of alpha-one base acid calcium medicine, vivo acid level is gone up stable, blood calcium is stablized, and not easily hypercalcemia occurs, compared with amino acids peritoneal dialysis solution, not easily there is body fluid pH value decline phenomenon, thus reduce the acidosic possibility of generation.
A kind of peritoneal dialysat composition, the glucose containing 1.5-4.25%, sodium chloride, multiple α-one base acid calcium and water.
Above-mentioned peritoneal dialysis solution, is characterized in that regulating compositions isotonic with sodium chloride.
Above-mentioned peritoneal dialysis solution, is characterized in that multiple α-one base acid calcium is racemic ketoprofen isoleucine calcium, keto-leucine calcium, tung-oil coated urea and keto-valine calcium.Wherein the content of racemic ketoprofen isoleucine calcium is 0.02-0.04%; The content of keto-leucine calcium is 0.04-0.06%; The content of tung-oil coated urea is 0.03-0.04%; The content of keto-valine calcium is 0.04-0.05%.The content of preferred racemic ketoprofen isoleucine calcium is 0.02-0.04%, and the content of keto-leucine calcium is 0.04-0.06%, and the content of tung-oil coated urea is 0.03-0.04%, and the content of keto-valine calcium is 0.04-0.05%.
Above-mentioned peritoneal dialysis solution, is characterized in that multiple α-one base acid calcium is racemic ketoprofen isoleucine calcium 0.033%, keto-leucine calcium 0.051%, tung-oil coated urea 0.034%, keto-valine calcium 0.043%.
Above-mentioned peritoneal dialysis solution, it is characterized in that also containing 0.001% ~ 0.01% sodium pyrosulfite, sodium sulfite or sodium sulfite.
Above-mentioned peritoneal dialysis solution, is characterized in that PH to be regulated to be 3.5-6.5 with mineral acid or inorganic base.Above-mentioned peritoneal dialysis solution, is characterized in that inorganic base is one or more in sodium hydroxide, sodium bicarbonate, sodium carbonate.Above-mentioned peritoneal dialysis solution, is characterized in that mineral acid is one or more in hydrochloric acid, phosphoric acid, carbonic acid.
The application of above-mentioned peritoneal dialysis solution in preparation treatment chronic renal failure.
The application of above-mentioned peritoneal dialysis solution in the electrolyte disturbance medicine that causes of preparation treatment chronic renal failure.
Above-mentioned peritoneal dialysis solution causes in preparation treatment or preventing chronic renal insufficiency the application that protein metabolism is lacked of proper care in medicine.
Above-mentioned peritoneal dialysis solution, is characterized in that by glucose, sodium chloride, multiple α-one base acid calcium and water composition.
In case of no particular description, in the present invention, the content of compositions is w/v, and the sodium chloride of such as 0.4-0.7% is the sodium chloride having 0.4-.07g in 100ml water.
The content of the glucose in the present invention calculates with Dextrose monohydrate, the glucose of such as 1.5-4.25% is actually 1.5-4.25% Dextrose monohydrate, the glucose of such as 1.5-4.25% is the Dextrose monohydrate having 1.5-4.25g during 100ml water contains, instead of 100ml water contain in have the glucose of 1.5-4.25g.
Embodiment
In case of no particular description, the glucose in embodiment refers to Dextrose monohydrate.
Example of formulations 1
Formula is as following table, and subpackage specification is 1000ml/ bag, and in table, data are amount to the formula of every bag of dialysis solution
1. get 20% water for injection, put into the glucose, racemic ketoprofen isoleucine calcium, keto-leucine calcium, tung-oil coated urea, the keto-valine calcium that weigh up to be stirred to dissolve, after whole dissolving, pH value is regulated as above to show with sodium chloride, 5%HCl aqueous solution or 5%NaOH aqueous solution, water for injection, isotonic and be settled to full dose.Then add medicinal charcoal 0.1 ~ 1%(g/ml) stir after, medicinal liquid through 0.22 μm of ultimate filter be filtered to visible foreign matters qualified after embedding (every bag of 1000ml or 2000ml)
2. sterilizing: 115 DEG C of constant temperature 20 minutes
Nitrogen protection is adopted when preparation and embedding.
Example of formulations 2
Formula is as following table, and subpackage specification is 1000ml/ bag, and in table, data are amount to the formula of every bag of dialysis solution
Preparation method is with embodiment 1.
Example of formulations 3
Formula is as following table, and subpackage specification is 1000ml/ bag, and in table, data are amount to the formula of every bag of dialysis solution
Preparation method is with embodiment 1.
Example of formulations 4
Formula is as following table, and subpackage specification is 1000ml/ bag, and in table, data are amount to the formula of every bag of dialysis solution
Control formulation embodiment 1
Formula is as following table, and subpackage specification is 1000ml/ bag, and in table, data are amount to the formula of every bag of dialysis solution
Preparation method is with embodiment 1.
Control formulation embodiment 2
Substantially identical with the prescription of embodiment 2, but racemic ketoprofen isoleucine calcium, keto-leucine calcium, tung-oil coated urea and the keto-valine calcium in the prescription of embodiment 2 is replaced with isoleucine, leucine, phenylalanine, the valine of corresponding mole, and increase the calcium lactate (namely the amount of calcium ion is equal) with the prescription racemic ketoprofen isoleucine calcium of embodiment 2, keto-leucine calcium, tung-oil coated urea and keto-valine calcium TC equivalent.
Effect example 1 peritoneum impact test
Laboratory animal: SD male rat, 6-8 week age, body weight 200 ± 10g
Chronic renal failure animal model: by laboratory animal SD rat, feeds with containing 0.5% adenine feedstuff, detects serum creatinine, urea nitrogen levels, reach the standard of chronic renal failure after 10 weeks.
Health model: give same recipe with above-mentioned healthy rat but forage feed 10 weeks not containing 0.5% adenine.
Blank model group and the post processing of chronic renal failure animal model: 2% pentobarbital sodium anesthetized rat.Under rat xiphoid-process, 1.scm place work one stringer otch is inserted abdomen and is thoroughly managed, and pipe end is placed in left back wall.Purse string suture is made with fixing Dialysis tubing along stomach wall around Dialysis tubing.Preparation gives peritoneal dialysis.
Low protein diet: heat is the feedstuff of 3600Kcal, wherein tyrosine content is 6%, and calcium content is 1.5%.
Test method: by successful for modeling chronic renal failure rat model, healthy rat random packet, often organizes 10, and every day is given and Low protein diet.
Healthy group: by the rat random packet of health model, often organizes 10, accepts 20ml normal saline gavage every day.
Blank group: divide 2 groups at random by successful for modeling chronic renal failure rat model, often organize 10, blank 1 group of every day is accepted normal saline 20ml lumbar injection, and blank two groups of every days accept 20ml normal saline gavage.
Administration group: by successful for modeling Chronic Renal Failure Rats random packet, often organizes 10.The peritoneal dialysis solution that the rat that embodiment 1-1 to 3-3 organizes gives the corresponding group number of embodiment group carries out peritoneal dialysis, every day 100ml/Kg, the peritoneal dialysis solution that the rat that matched group 1-1 to 2-3 organizes gives in the corresponding group number of comparative examples group carries out peritoneal dialysis, every day 100ml/Kg, contrast 3-1 to 3-3 group gives corresponding α-one base acid calcium salt (calculating with the α-one base acid calcium salt in embodiment 2-1 to the 2-3 group peritoneal dialysis solution of 100ml/Kg every day) gavage according to the proportioning of the α-one base acid calcium salt given in embodiment 2-1 to 2-3 group to rat, and use the peritoneal dialysis solution of corresponding comparative examples 2-2 group to carry out peritoneal dialysis dialysis, every day 100ml/Kg, all continuous 14 days.Each group of the 1st day administration phase administration is taken a blood sample to each group of rat tail vein for first 0 hour, administration starts latter 0.5 hour, 1.25 hour, 3 hours, (blood serum sample 100 μ L and acetonitrile by volume 1:2 fully mix within 6 hours, to measure serum by amino-acid analyzer (Beckman company of the U.S.), in 4 DEG C after 4 DEG C of standing 30min, the centrifugal 30min Deproteinization of 12000r/min, get supernatant for subsequent use) middle isoleucine, leucine, phenylalanine, the total content of valine, on 15th, each group of rat tail vein is taken a blood sample again, each group of serum albumin (Alb) is measured by automatic clinical chemistry analyzer (Japanese Hitachi company), serum urea nitrogen (BUN), blood calcium concentration (Ca), the content of pH value.
Result:
Isoleucine in each group of rat blood serum, leucine, phenylalanine, valine total content meansigma methods compares (n=10)
| Group number | When 0 | When 0.5 | 1.25 time | When 3 | When 6 |
| Blank 1 group | 13.35 | 12.48 | 12.88 | 13.09 | 13.40 |
| Blank 2 groups | 13.39 | 12.71 | 12.95 | 13.17 | 13.36 |
| Healthy group | 18.67 | 18.19 | 18.46 | 18.69 | 18.60 |
| Embodiment 1-1 | 13.22 | 13.29 | 13.92 | 13.78 | 13.19 |
| Embodiment 1-2 | 13.10 | 13.67 | 14.86 | 13.98 | 14.39 |
| Embodiment 1-3 | 13.37 | 14.17 | 14.91 | 14.06 | 13.25 |
| Embodiment 2-1 | 13.15 | 12.84 | 14.23 | 13.45 | 13.31 |
| Embodiment 2-2 | 13.32 | 13.23 | 15.37 | 13.64 | 13.15 |
| Embodiment 2-3 | 13.27 | 13.42 | 15.43 | 14.31 | 13.38 |
| Embodiment 3-1 | 13.15 | 12.41 | 14.79 | 13.20 | 13.21 |
| Embodiment 3-2 | 13.26 | 13.01 | 15.31 | 13.57 | 13.37 |
| Embodiment 3-3 | 13.13 | 13.09 | 15.89 | 14.28 | 13.24 |
| Comparative examples 1-1 | 13.19 | 12.89 | 13.37 | 13.78 | 13.27 |
| Comparative examples 1-2 | 13.29 | 12.34 | 12.93 | 13.52 | 13.10 |
| Comparative examples 1-3 | 13.12 | 12.01 | 12.70 | 13.39 | 13.48 |
| Comparative examples 2-1 | 13.20 | 12.75 | 13.20 | 13.84 | 13.01 |
| Comparative examples 2-2 | 13.24 | 13.04 | 13.87 | 14.04 | 14.13 |
| Comparative examples 2-3 | 13.21 | 13.37 | 13.94 | 14.19 | 13.17 |
| Comparative examples 3-1 | 13.33 | 12.13 | 13.02 | 12.91 | 13.20 |
| Comparative examples 3-2 | 13.29 | 12.77 | 13.47 | 13.14 | 13.15 |
| Comparative examples 3-3 | 13.27 | 13.01 | 13.59 | 13.27 | 13.39 |
Each group of rat serum albumin (Alb), serum urea nitrogen (BUN), blood calcium concentration (Ca), pH value meansigma methods compare (n=10)
Proved by above-mentioned experiment, peritoneal dialysis solution containing multiple α-one base acid calcium and conventional peritoneal dialysis solution and the sour calcium of oral multiple α-one base the vivo acid that compares absorb better, Alb is also better simultaneously, it also avoid the hypercalcemia that oral administration of alpha-one base acid calcium causes simultaneously, to decline the acidotic state caused as pH value in the body of peritoneal dialysis solution with directly using aminoacid, thus the body weight of the rat made increases obviously, health degree improves.
Claims (10)
1. a peritoneal dialysat composition, the glucose containing 1.5-4.25%, sodium chloride, multiple α-one base acid calcium and water.
2. peritoneal dialysis solution as claimed in claim 1, is characterized in that regulating compositions isotonic with sodium chloride.
3. peritoneal dialysis solution as claimed in claim 1, is characterized in that multiple α-one base acid calcium is racemic ketoprofen isoleucine calcium, keto-leucine calcium, tung-oil coated urea and keto-valine calcium.
4. peritoneal dialysis solution as claimed in claim 3, the content of its feature racemic ketoprofen isoleucine calcium is 0.02-0.04%, the content of keto-leucine calcium is 0.04-0.06%, and the content of tung-oil coated urea is 0.03-0.04%, and the content of keto-valine calcium is 0.04-0.05%.
5. peritoneal dialysis solution as claimed in claim 3, is characterized in that multiple α-one base acid calcium is racemic ketoprofen isoleucine calcium 0.033%, keto-leucine calcium 0.051%, tung-oil coated urea 0.034%, keto-valine calcium 0.043%.
6. peritoneal dialysis solution as claimed in claim 1, it is characterized in that also containing 0.001% ~ 0.01% sodium pyrosulfite, sodium sulfite or sodium sulfite.
7. peritoneal dialysis solution as claimed in claim 1, is characterized in that PH to be regulated to be 3.5-6.5 with mineral acid or inorganic base.
8. the application of peritoneal dialysis solution as claimed in claim 1 in preparation treatment chronic renal failure.
9. the application in the electrolyte disturbance medicine that causes in preparation treatment chronic renal failure of a peritoneal dialysis solution as claimed in claim 1.
10. a peritoneal dialysis solution as claimed in claim 1 causes in preparation treatment or preventing chronic renal insufficiency the application that protein metabolism is lacked of proper care in medicine.
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101340904A (en) * | 2005-11-18 | 2009-01-07 | RenoBiz株式会社 | Compositions for peritoneal dialysis |
| CN101416947A (en) * | 2007-10-23 | 2009-04-29 | 江苏信孚药业有限公司 | Compound alpha-ketoacid chewing tablet and preparation method |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101340904A (en) * | 2005-11-18 | 2009-01-07 | RenoBiz株式会社 | Compositions for peritoneal dialysis |
| CN101416947A (en) * | 2007-10-23 | 2009-04-29 | 江苏信孚药业有限公司 | Compound alpha-ketoacid chewing tablet and preparation method |
Non-Patent Citations (1)
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| 《药物分析杂志》 * |
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