CN105560275A - Alkaline low-calcium necessary amino acid peritoneal dialyzate medicament composition - Google Patents
Alkaline low-calcium necessary amino acid peritoneal dialyzate medicament composition Download PDFInfo
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Abstract
The invention relates to a low-alkali low-calcium peritoneal dialyzate composition which contains 9 amino acids serving as main components and does not contain glucose. The pH value is adjusted by THAM, so that the contact time between peritoneum and the glucose can be shortened; furthermore, the low-alkali low-calcium peritoneal dialyzate composition is more physiologic, so as to reduce irritation to the peritoneum. Meanwhile, the amino acid dialyzate does not contain the glucose, so that generation of GDP can be avoided.
Description
Technical field
The present invention relates to a kind of based on 9 kinds of essential amino acids, the low calcium peritoneal dialysat composition of alkalescence not containing glucose.
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 (peritonealdialysis, 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.
Abdomen abdomen dialysis solution (peritonealdialysisfluid, 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.Peritoneal fibrosis and ultrafiltration caused by the poor biocompatibility of peritoneal dialysis solution (peritonealdialysisfluid, PDF) unsuccessfully become the major issue that current peritoneal dialysis is badly in need of and must be solved.
Traditional glucose peritoneal dialysis liquid can form glucose degradation products, has obvious cytotoxicity to Peritoneal Mesothelial Cells, is the main cause causing peritoneal fibrosis and ultrafiltration failure.
The peritoneal dialysis solution generally used clinically is at present using glucose as main penetrating agent, due to its high sugar, height ooze, low ph value (pH=5.2) and have glucose degradation products (GDP) to produce, poor biocompatibility, the change of peritoneum 26S Proteasome Structure and Function can be caused, and finally cause peritoneal fibrosis and make peritoneum generation ultrafiltration failure.In addition, long-term glucose dialysis is also cause patient that hyperlipemia, hyperinsulinemia, fat major reason occur.
Glucose 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, and (4) intraor extracellular amino acids distribution can change.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.Based on above reason, lot of documents is reported, the bad incidence rate of continuous ambulatory peritoneal dialysis (CAPD) patient Middle nutrition is up to 18% ~ 56%.Along with the prolongation of PD time, incidence rate can be higher.
For the untoward reaction of the malnutrition occurred after peritoneal dialysis and glucose peritoneal dialysis solution, there is aminoacid peritoneal dialysis solution clinically.In amino acid dialysis, aminoacid substitutes glucose as penetrating agent, can reduce the time of contact of peritoneum and glucose, and aminoacid peritoneal dialysis solution acid-base value higher (6≤PH < 7), closer to physiological, can reduce and peritoneum is stimulated.In addition, not containing glucose in amino acid dialysis, the generation of GDP can be avoided.External and zoopery is verified, the common glucose dialysis of amino acid dialysis liquor ratio has better biocompatibility.
Generally believe that glucose solution is stablized in acid condition at present, and bibliographical information (pH value is on the impact of five kinds of infusion solutions stability, practical medical technologies magazine, 2007, 8, 3236) glucose solution semi-finished product pH value is higher, finished product pH value fall is larger, it is larger that content declines, it is more that 5 hydroxymethyl furfural (5-HMF) produces, medicinal liquid variable color is darker, simultaneously other documents also have similar report (pH value are on the impact of glucose injection stability, modern combination of Chinese and Western medicine magazine, 1999, 8, 1221), be 3.2-6.5 for glucose injection PH claimed range in Chinese Pharmacopoeia (2010 editions), be 3.5-5.5 for Dextrose and Sodium Chloride Inj. PH claimed range, also illustrate that above-mentioned viewpoint.Just because of peritoneal dialysis solution pH value all≤7, in use there are some problems in peritoneal dialysis solution, first the body fluid of normal person is in alkalescence substantially, such as pH value of blood 7.35 ~ 7.45, the pH value 7.0 ~ 7.5 of tissue fluid, the pH value 7.20 ~ 7.45 of Cell sap, equal≤7 peritoneal dialysis solution of pH value and body fluid gap cause larger zest compared with conference, damage is caused to peritoneum, secondly end stage renal failure patient often all has acidosic problem, and the conventional peritoneal dialysis liquid of life-time service acidity can increase the weight of this point undoubtedly.
In addition in peritoneal dialysis solution also containing a large amount of divalent calcium, magnesium ion as buffer salt, it is generally acknowledged the calcium salt in dialysis solution in the basic conditions, magnesium salt meeting and base, as hydroxyl, carbonate react and cause precipitation.
Just because of the requirement of the buffer salt stability of glucose, divalent calcium, magnesium ion, research worker can not get both between the puzzled effect in medicine, stability, zest, untoward reaction always, cannot accept or reject, so in order to ensure that current peritoneal dialysis solution is still penetrating agent with glucose, with divalent calcium, magnesium ion for buffer salt, so peritoneal dialysis solution pH value still≤7.
So the pH value of current peritoneal dialysis solution all≤7, even adding base is also solved by the method for two rooms bag system, deposit in the bag of two rooms respectively by base and other divalent calcium, magnesium ion, in use base is mixed mutually with divalent ion, but this kind of method cost is higher, easily there is partial over saturation phenomenon in bicarbonate and divalent calcium, magnesium ion simultaneously in mixing, increases the possibility that insoluble microparticle produces, but also cannot detect, add the risk of patient.
Peritoneal dialysis patient wishes that blood calcium is in level normally on the low side usually, except blood calcium, also relevant to serium inorganic phosphorus and blood parathyroid hormone etc., if there is hypercalcemia, usually needs to use Low-calcium dialysate.
Summary of the invention
Through Literature Consult and research, we find in dialysis solution, use aminoacid to substitute glucose as penetrating agent, can reduce the time of contact of peritoneum and glucose, and aminoacid peritoneal dialysis solution acid-base value are higher closer to physiological, can reduce and stimulate peritoneum.In addition, not containing glucose in amino acid dialysis, the generation of GDP can be avoided.Aqueous solution containing 9 kinds of essential amino acids in peritoneal dialysis solution of the present invention, the various functions of Peritoneal Mesothelial Cells can be maintained, less on the transport features impact of peritoneum, simultaneously can the loss of amino acid and protein in added body, correct the aminogram disorder because renal failure causes, maintain nitrogen balance, the synthetic ratio of protein is increased, after especially PH is adjusted to alkalescence, can effectively avoid aminoacid peritoneal dialysis solution in use to cause the untoward reaction-acidosis the most easily occurred.The calcium ion concentration controlled in peritoneal dialysis solution will contribute to blood calcium in control volume simultaneously, avoid the too high or too low impact on health caused of blood calcium concentration.
Aminoacid in peritoneal dialysis solution of the present invention for generation of hyperosmotic solution, thus forms osmotic gradient, to promote that liquid transfers to abdominal cavity by blood plasma.Noxious substance and the metabolite of blood middle high concentration enter dialysis solution by peritoneum.Except the lactate as bicarbonate precursor, other electrolyte in solution can correct the electrolyte concentration in blood plasma.
Aminoacid in peritoneal dialysis solution of the present invention is essential amino acids, on the basis ensureing certain osmotic pressure, both can supplement the essential amino acids loss that chronic renal insufficiency causes in time, and histidine is considered to essential amino acids under renal failure state.Aminoacid in this prescription both can improve the aminogram in blood, can improve nitrogen balance again.
The alkaline essential amino acids such as histidine, lysine is employed in aminoacid in peritoneal dialysis solution of the present invention.
A kind of peritoneal dialysis solution pharmaceutical composition, is characterized in that 7≤PH < 7.45 and contains following compositions in every 1000ml:
| Composition | Recipe quantity |
| Histidine (C 6H 9N 3O 2) | 0.65-0.75g |
| Threonine (C 4H 9NO 3) | 0.6-0.7g |
| Valine (C 5H 11NO 2) | 1.3-1.5g |
| Methionine (C 15H 11NO 2S) | 0.8-0.9g |
| Isoleucine (C 6H 13NO 2) | 0.8-0.9g |
| Leucine (C 6H 13NO 2) | 1.0-1.1g |
| Phenylalanine (C 9H 11NO 2) | 0.50-0.60g |
| Tryptophan (C 11H 12N 2O 2) | 0.25-0.35g |
| Lysine hydrochloride (C 6H 14N 2O 2·HCl) | 0.9-1.0g |
| Water for injection | Surplus |
。
Above-mentioned a kind of peritoneal dialysis solution pharmaceutical composition, is characterized in that often liter of peritoneal dialysis solution contains following composition:
| Composition | Recipe quantity |
| Histidine (C 6H 9N 3O 2) | 0.714g |
| Threonine (C 4H 9NO 3) | 0.646g |
| Valine (C 5H 11NO 2) | 1.393g |
| Methionine (C 15H 11NO 2S) | 0.850g |
| Isoleucine (C 6H 13NO 2) | 0.850g |
| Leucine (C 6H 13NO 2) | 1.020g |
| Phenylalanine (C 9H 11NO 2) | 0.570g |
| Tryptophan (C 11H 12N 2O 2) | 0.270g |
| Lysine hydrochloride (C 6H 14N 2O 2·HCl) | 0.955g |
| Water for injection | Surplus |
。
Above-mentioned peritoneal dialysis solution pharmaceutical composition, is characterized in that often liter of peritoneal dialysis solution consists of the following composition:
| Composition | Recipe quantity |
| Histidine (C 6H 9N 3O 2) | 0.65-0.75g |
| Threonine (C 4H 9NO 3) | 0.6-0.7g |
| Valine (C 5H 11NO 2) | 1.3-1.5g |
| Methionine (C 15H 11NO 2S) | 0.8-0.9g |
| Isoleucine (C 6H 13NO 2) | 0.8-0.9g |
| Leucine (C 6H 13NO 2) | 1.0-1.1g |
| Phenylalanine (C 9H 11NO 2) | 0.50-0.60g |
| Tryptophan (C 11H 12N 2O 2) | 0.25-0.35g |
| Lysine hydrochloride (C 6H 14N 2O 2·HCl) | 0.9-1.0g |
| Sodium chloride (NaCl) | 5.3-5.4g |
| Calcium chloride (CaCl 2·2H 2O) | 0.15-0.20g |
| Magnesium chloride (M gCl 2·6H 2O) | 0.04-0.06g |
| Sodium lactate (C 3H 5NaO 3) | 4.4-4.5g |
| Water for injection | Surplus |
。
Above-mentioned peritoneal dialysis solution pharmaceutical composition, is characterized in that often liter of peritoneal dialysis solution consists of the following composition:
| Composition | Recipe quantity |
| Histidine (C 6H 9N 3O 2) | 0.714g |
| Threonine (C 4H 9NO 3) | 0.646g |
| Valine (C 5H 11NO 2) | 1.393g |
| Methionine (C 15H 11NO 2S) | 0.850g |
| Isoleucine (C 6H 13NO 2) | 0.850g |
| Leucine (C 6H 13NO 2) | 1.020g |
| Phenylalanine (C 9H 11NO 2) | 0.570g |
| Tryptophan (C 11H 12N 2O 2) | 0.270g |
| Lysine hydrochloride (C 6H 14N 2O 2·HCl) | 0.955g |
| Sodium chloride (NaCl) | 5.380g |
| Calcium chloride (CaCl 2·2H 2O) | 0.184g |
| Magnesium chloride (M gCl 2·6H 2O) | 0.051g |
| Sodium lactate (C 3H 5NaO 3) | 4.480g |
| Water for injection | Surplus |
。
Above-mentioned peritoneal dialysis solution, is characterized in that 7≤PH < 7.30.
Above-mentioned peritoneal dialysis solution, is characterized in that using Tris to regulate pH value.
Above-mentioned peritoneal dialysis solution, is characterized in that osmotic pressure is 330 ~ 400mOsm/kg.
The application of above-mentioned peritoneal dialysis solution in peritoneal dialysis.
The application of above-mentioned peritoneal dialysis solution in 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.
The application of above-mentioned peritoneal dialysis solution in the low albumin medicine that causes of preparation treatment chronic renal failure.
Calcium chloride dihydrate in the present invention, magnesium chloride hexahydrate can replace with calcium chloride, the magnesium chloride of respective amount, also in protection domain.
Embodiment
Example of formulations 1-3
Often liter of peritoneal dialysis solution consists of the following composition
Preparation method:
Dope is prepared: the water for injection getting recipe quantity 20%, after other compositions adding recipe quantity are stirred to and all dissolve, then add after medicinal charcoal 0.1 ~ 1% stirs, to place after 10 ~ 20 minutes after 0.22 μm of end-filtration 115 DEG C of steam sterilizations 10 minutes, obtain dope for subsequent use.
2. Alkali liquid compounding: the tris solution of configuration content 0.1mol/L, then adds after medicinal charcoal 0.1 ~ 1% stirs, places after 10 ~ 20 minutes after 0.22 μm of end-filtration, and 115 DEG C of steam sterilizations 10 minutes, obtain alkali liquor for subsequent use.
3, dope, alkali liquor are at the uniform velocity mixed, by alkali liquor, water for injection, regulate solution to 1000ml, pH value is the numerical value in upper table, by embedding after 0.22 μm of end-filtration (every bag of 1000ml or 2000ml).
In preparation process step 3, note mixing velocity, precipitation must not be occurred.
Nitrogen protection is adopted when preparation and embedding.
4, sterilizing: 115 DEG C of constant temperature 10 minutes
Nitrogen protection is adopted when preparation and embedding.
5, Quan Jian, packaging.
Example of formulations 4-6
Often liter of peritoneal dialysis solution consists of the following composition
Make 1000ml
Preparation method:
Preparation method is with embodiment 1-3.
Control formulation embodiment 1-3
Often liter of peritoneal dialysis solution consists of the following composition
Preparation method:
1, in Agitation Tank, add the fresh water for injection (70 ~ 80 DEG C) of recipe quantity 80%, under nitrogen flowing, feed intake according to prescription order, stirring and dissolving.
2, treat that fluid temperature is down to room temperature, be adjusted to 6≤PH < 7 with hydrochloric acid, moisturizing is to full dose.
3, active carbon 0.1% (w/v) is added, stir about 30 minutes, de-charcoal.
4, clear and bright to medicinal liquid with φ 0.45 μm of+φ 0.22 μm of double-deck filtering with microporous membrane, fill under the condition of inflated with nitrogen, jumps a queue.
5, sterilizing 15 minutes under 118 DEG C of conditions.
6, Quan Jian, packaging.
Control formulation embodiment 4-6
Often liter of peritoneal dialysis solution consists of the following composition
Make 1000ml
Preparation method:
Preparation method is with control formulation embodiment 1-3.
Control formulation embodiment 7
According to " aminoacid peritoneal dialysis is on the impact of the saturating Nutritional Status of Patients of abdomen " (nephropathy and dialysis renal transplantation magazine, 13rd volume, 4th phase, in August, 2004,330-332) peritoneal dialysis solution prepared by the partial amino-acid prescription (seeing the following form) of table 2 in 331 pages, preparation method is with control formulation embodiment 1, and pH value regulates between 6-7.
| Essential amino acids | (g/dl) |
| Valine | 0.625 |
| L-Leu | 1.250 |
| ILE | 0.625 |
| L-Methionine | 0.300 |
| 1B | 1.000 |
| L-Histidine | 0.281 |
| L-threonine | 0.300 |
| L-Phe | 0.260 |
| L-Trp | 0.120 |
Control formulation embodiment 8
According to " aminoacid peritoneal dialysis solution and conventional peritoneal dialysis liquid are on the impact of Peritoneal Mesothelial Cells function " (Chinese Journal of Nephrology, in February, 2004,20th volume the 1st phase, 37-41) peritoneal dialysis solution prepared by the aminoacid prescription (seeing the following form) of table 2 in 38 pages, preparation method is with control formulation embodiment 1, and pH value regulates between 6-7.
| Essential amino acids | (g/l) |
| Valine | 1.39 |
| L-Leu | 1.02 |
| ILE | 0.85 |
| L-Methionine | 0.85 |
| 1B | 0.76 |
| L-Histidine | 0.71 |
| L-threonine | 0.65 |
| L-Phe | 0.57 |
Clarity is tested
According to (temperature 25 ± 2 DEG C under Chinese Pharmacopoeia 2010 editions stability long term test conditions, humidity 60% ± 10%) according to example of formulations 1-6, control formulation embodiment 1-8 prescription is tested, example of formulations 1-6 did not pinpoint the problems in 24 months, the pharmaceutical composition of control formulation embodiment 1-3 prescription does not find clarity problem when pH value < 7.30 in 18 months, and there is the defective phenomenon of clarity when pH value >=7.30 respectively 13-14 month period in the pharmaceutical composition of control formulation embodiment 1-3 prescription, the pharmaceutical composition of control formulation embodiment 4-6 prescription does not find clarity problem when pH value < 7.45 in 18 months, and there is the defective phenomenon of clarity when pH value >=7.45 respectively 15-18 month period in the pharmaceutical composition of control formulation embodiment 4-6 prescription.
Effect example 1 pair of amino acid supplementation effect experiment
With peritoneal dialysis inpatient for object of study, carry out the research of 3 days by a definite date, investigate the compensating action that embodiment runs off to amino acid and protein.
Research adopts EXPERIMENTAL DESIGN that is simple and easy, open, that intersect, successive administration, and often group 20 peritoneal dialysis are in hospital male patient, and body weight is between 60-70Kg.The all patients of first day all carry out peritoneal equilibrium test (peritonealequilibrationtest, PET).Within second day, first all patients accept the glucose peritoneal dialysis solution (lactate) (Tianjin TianAn Medicine Industry Co., Ltd's production) of 1.5%, then carry out conventional therapy.Within 3rd day, respectively organize the dialysis solution that patient uses embodiment 1-6 and comparative examples 1-8 respectively, then carry out conventional therapy.The dialysis solution consumption used for two days, number of times, method are all identical, and the dialysis waste liquid collecting second day and the 3rd day carries out amino acid and protein analysis, meansigma methods in mensuration group.
Result shows, and uses aminoacid peritoneal dialysis solution comparatively to use glucose peritoneal dialysis solution can increase amino acid whose intake better, is conducive to patient body health.
Effect example 2 change of serum C O2 total amount (TCO2) tests
Because the final acid product of aminoacid metabolism is in vivo CO
2, for investigating the safety of aminoacid peritoneal dialysis solution dialysis long-term treatment, carry out change of serum C O by DimensionAR automatic clinical chemistry analyzer
2total amount (TCO
2) experiment.
With peritoneal dialysis inpatient for object of study, carry out the research of 30 days by a definite date, investigate embodiment, comparative examples to change of serum C O in body
2total amount (TCO
2) impact.
Research adopts EXPERIMENTAL DESIGN that is simple and easy, open, that intersect, successive administration, and often group 20 peritoneal dialysis are in hospital male patient, and body weight is between 60-70Kg.Embodiment respectively organizes the dialysis solution that patient uses embodiment 1-6 and comparative examples 1-8 respectively, then carries out conventional therapy.Glucose group, the dialysis solution consumption that embodiment group uses, method are all identical, are and once dialyse every day, carry out the peritoneal dialysis of 90 days, measure proprietary change of serum C O respectively at 0 day
2total amount (TCO
2) and calculating mean value, the 90th day grouping mensuration change of serum C O
2total amount (TCO
2) and calculating mean value.
Result shows, and uses the aminoacid peritoneal dialysis solution of embodiment prescription comparatively to use the peritoneal dialysis solution of comparative examples prescription better can control ground change of serum C O
2total amount, especially life-time service will more be conducive to patient body health, reduce the acidosis because using aminoacid peritoneal dialysis solution to cause.
Effect example 3 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 conventional feed.
Healthy group: by the rat random packet of health model, often organizes 10, accepts 20ml normal saline gavage every day, totally 90 days.
Blank group: successful for modeling chronic renal failure rat model is got at random 10 groupings, blank group is accepted normal saline 20ml lumbar injection every day, totally 90 days.
Administration group: by successful for modeling Chronic Renal Failure Rats random packet, often organizes 10.The peritoneal dialysis solution that the rat of embodiment 1 to 6 group gives the corresponding group number of embodiment group carries out peritoneal dialysis, each 30ml/Kg, twice daily, and totally 90 days.The peritoneal dialysis solution that the rat of matched group 1 to 8 group gives in the corresponding group number of comparative examples group carries out peritoneal dialysis, each 30ml/Kg, twice daily, and totally 90 days.Each group of the 1st day administration phase administration measures rat weight in first 0 hour and the 91st day, by taking a blood sample to each group of rat tail vein, measure albumin level in blood, and measure twenty-four-hour urine albumen, calculate the difference of body weight, albumin, twenty-four-hour urine albumen forward backward averaging value, i.e. statistical average before the 91st day data meansigma methods-administration in 1 day.
Put to death animal afterwards, HE (hematoxylin-eosin staining method), Masson dyeing is carried out to parietal peritoneum tissue, measures peritoneum thickness.Masson staining procedure: paraffin-embedded tissue is cut into 3m section, dewaxes to water, the blue dye liquor dye of celestite 6 ~ 10min, running water, WeigerShi Garapa element liquid dye 5 ~ 10min, running water, Ponceaux acid fuchsin liquid (2:1) contaminates l5 ~ 20min, 1% phosphomolybdic acid aqueous solution and 1% glacial acetic acid break up fast, viride nitens solution-dyed 2 ~ 10min, again break up fast with phosphomolybdic acid aqueous solution and glacial acetic acid, 95% dehydration of alcohol, dry, dimethylbenzene is transparent, neutral gum mounting.Get 12 high power fields and measure peritoneum thickness, average as the standard judging peritoneum thickness.
Each group of rat serum albumin (Alb), (n=10)
Proved by above-mentioned experiment, aminoacid peritoneal dialysis solution in the present invention absorbs better compared with the aminoacid peritoneal dialysis solution of other prescriptions, Alb in body is increased, and the surprisingly trend that also takes an evident turn for the better of twenty-four-hour urine albumen, thus the body weight of the rat made increases obviously, health degree improves.
Above-mentioned experiment also proves, it is less that basic amino acid peritoneal dialysis solution and acidic amino acid peritoneal dialysis solution compare the impact that peritoneum thickens.
Claims (10)
1. a peritoneal dialysis solution pharmaceutical composition, is characterized in that 7≤PH < 7.45 and contains following compositions in every 1000ml:
。
2. a kind of peritoneal dialysis solution pharmaceutical composition as claimed in claim 1, is characterized in that often liter of peritoneal dialysis solution contains following composition:
。
3. peritoneal dialysis solution pharmaceutical composition as claimed in claim 1, is characterized in that often liter of peritoneal dialysis solution consists of the following composition:
。
4. peritoneal dialysis solution pharmaceutical composition as claimed in claim 1, is characterized in that often liter of peritoneal dialysis solution consists of the following composition:
。
5. peritoneal dialysis solution as claimed in claim 1, is characterized in that 7≤PH < 7.30.
6. peritoneal dialysis solution as claimed in claim 1, is characterized in that using Tris to regulate pH value.
7. the application of peritoneal dialysis solution as claimed in claim 1 in peritoneal dialysis.
8. the application of peritoneal dialysis solution as claimed in claim 1 in preparation treatment chronic renal failure.
9. 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.
10. the application in the low albumin medicine that causes in preparation treatment chronic renal failure of a peritoneal dialysis solution as claimed in claim 1.
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| CN107854426A (en) * | 2017-10-31 | 2018-03-30 | 华仁药业股份有限公司 | A kind of novel amino peritoneal dialysis solution |
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