CN104666335A - Preparation method of peritoneal dialysis solution (lactate) (low-calcium) composition - Google Patents
Preparation method of peritoneal dialysis solution (lactate) (low-calcium) composition Download PDFInfo
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Abstract
The invention provides a peritoneal dialysis solution (lactate) (low-calcium) composition. The peritoneal dialysis solution (lactate) (low-calcium) composition contains vitamin C or vitamin C derivates which can drop the adverse influence of a peritoneal dialysis solution on peritoneum. The preparation method comprises the following steps: preparing a thick solution; diluting a medicine liquid; and sterilizing. The process using the vitamin C is different from the process using the vitamin C derivate; when the vitamin C is used, the pH needs to be regulated, otherwise, the content is reduced.
Description
Technical field
The present invention relates to the preparation method of a kind of peritoneal dialysis solution (lactate) (low calcium) compositions.
Background technology
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.Desirable peritoneal dialysis liquid not only fully can remove toxin, ultrafiltration moisture, can also protect peritoneal membrane function, reduces the generation of ultrafiltration exhaustion (UFF).The lactate dialysate that traditional peritoneal dialysis liquid is is penetrating agent with the glucose of variable concentrations; clinical practice for many years shows; although PD has played very important effect in the treatment of chronic kidney hypofunction; but from human physiology's angle; the dialysis solution that current routine uses is still outstanding exists following problem: (1) dialysis solution is main penetrating agent with glucose; because it can be absorbed by peritoneum, therefore its osmosis is held time very short, is difficult to reach desirable liquid and Solute removal; (2) in dialysis solution, some composition (glucose and base etc.) can activate inflammatory cytokine (somatomedin, nitric oxide synthetase); life-time service can cause peritoneum chronic inflammatory to change, and promotes peritoneal fibrosis and thickens; (3) after the glucose in dialysis solution is decomposed in vivo; the non-product of a large amount of advanced glycosylation endproducts (AGEs) can be produced; the latter can extensively deposit in vivo, especially interstitial can be caused to thicken after blood vessel wall and peritoneum interstitial deposition, cause ultrafiltration function to decline; (4) glucose degradable in high-temperature sterilization forms a series of glucose degradation products (GDPs), and GDPs can coup injury peritoneal cell, and promotes that AGE is formed; (5) in dialysis solution, buffer base adopts lactate mostly, and they must first after the metabolic conversion of liver be bicarbonate, can play and correct acidosic effect, therefore often has certain limitation to the patient that a part is associated with hepatic disease.
Summary of the invention
In the present invention, " peritoneal dialysis solution (lactate) (low calcium) " name is called that State Food and Drug Administration is the title of such dialysis solution Uniform provisions, specifically see State Food and Drug Administration standard YBH00232007, below can by peritoneal dialysis solution (lactate) (low calcium) referred to as peritoneal dialysis solution.
By our experimentation, be surprised to find, in peritoneal dialysis solution, add vitamin C or derivatives thereof, peritoneal dialysis solution can be made to decline to the harmful effect of peritoneum, reduce peritoneal fibrosis and thickened degree, reduce the situation that peritoneum ultrafiltration function is declined.
The generation of above-mentioned situation, we think it may is that can to improve ascorbic content in peritoneal tissues, blood relevant with increasing vitamin C in peritoneal dialysis solution, because vitamin C runs off in a large number in peritoneal dialysis process in peritoneal tissues, blood, cause peritoneum malnutrition, and add the possibility of angiogenesis, also may exist in peritoneal dialysis solution with vitamin C, the degraded that can reduce glucose is relevant.
In the above-mentioned peritoneal dialysis solution of preparation, we are surprised to find, and using vitamin C to there is certain difference with using the technique of vitamin C derivatives, needing to regulate pH value, otherwise can cause the decline of content when using vitamin C.
A kind of prescription is by vitamin C or vitamin C derivatives, the glucose of 1.5-4.0%, the sodium chloride of 0.5-0.6%, the calcium chloride of 0.01-0.02%, the magnesium chloride of 0.004-0.006%, the preparation method of peritoneal dialysis solution (lactate) (low calcium) compositions of the sodium lactate of 0.4-0.5% and water composition, is characterized in that preparation method is:
Dope is prepared: the water for injection getting recipe quantity part, and other compositions adding recipe quantity are stirred to whole dissolving, filters and obtain dope after placing.
Medicinal liquid dilute: by dope pressure filtration in dilute preparing tank, after adding water for injection to full dose through 0.22 μm of ultimate filter be filtered to visible foreign matters qualified after embedding.
Upper described peritoneal dialysis liquid and preparation method thereof, is characterized in that the amount of recipe quantity partial syringe water in dope preparation is less than or equal to 20% of recipe quantity water for injection.
Above-mentioned peritoneal dialysis liquid and preparation method thereof, after it is characterized in that other compositions of recipe quantity in dope preparation are stirred to all dissolvings, the medicinal charcoal adding 0.1-1% before placement stirs.
Above-mentioned peritoneal dialysis liquid and preparation method thereof, is characterized in that medicinal liquid after diluting 115 DEG C of constant temperature sterilizings 20 minutes.
Above-mentioned peritoneal dialysis liquid and preparation method thereof, is characterized in that adopting nitrogen protection in preparation process.
Above-mentioned peritoneal dialysis solution, it is characterized in that vitamin C derivatives is preferably the one in VCE, sodium ascorbyl phosphate, Magnesium L-Asacorbic Acid 2-O-Phosphate, vitamin C phosphoric ester, Catergen-poly phosphate, Catergen-tripolyphosphate, benzoic acid vitamin C magnesium, be more preferably the one in VCE, Magnesium L-Asacorbic Acid 2-O-Phosphate, vitamin C tripolyphosphate.
Above-mentioned peritoneal dialysis solution, it is characterized in that the content of vitamin C or vitamin C derivatives is 0.05-1%, preferred content is 0.2-0.5%.
Above-mentioned peritoneal dialysis liquid and preparation method thereof, it is characterized in that also containing 0.1% ~ 0.2% sodium pyrosulfite, sodium sulfite or sodium sulfite.
Above-mentioned peritoneal dialysis liquid and preparation method thereof, it is characterized in that the content of vitamin C or vitamin C derivatives is 0.05-1%, the content of sodium chloride is 0.5377%, the content of calcium chloride is 0.0147%, the content of magnesium chloride is 0.00508%, the content of sodium lactate is 0.4483%, and the content of sodium pyrosulfite is 0.1% ~ 0.2%, and the content of glucose is 1.5%, 2.5% or 4.0%.
Above-mentioned peritoneal dialysis liquid and preparation method thereof, when it is characterized in that not containing vitamin C derivatives containing vitamin C, adds and uses the aqueous solution of inorganic base to regulate the PH of peritoneal dialysis solution between 6.0-7.0 in water for injection to full dose in medicinal liquid dilution step.Above-mentioned peritoneal dialysis liquid and preparation method thereof, it is characterized in that the inorganic base in medicinal liquid dilution is sodium salt, be preferably one or more in sodium hydroxide, sodium bicarbonate, sodium carbonate, sodium acetate, preferred inorganic base is one or more in sodium hydroxide, sodium bicarbonate, sodium carbonate, preferred inorganic base is one or more in sodium hydroxide, sodium bicarbonate, and preferred inorganic base is sodium hydroxide.
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 0.4-0.7g in 100ml water.
The content of the glucose in the present invention, calcium chloride, magnesium chloride calculates with Dextrose monohydrate, calcium chloride dihydrate, magnesium chloride hexahydrate respectively, the glucose of such as 1.5-4% is actually 1.5-4% Dextrose monohydrate, the glucose of such as 1.5-4% is the Dextrose monohydrate having 1.5-4g during 100ml water contains, instead of 100ml water contain in have the glucose of 1.5-4g.
Embodiment
In case of no particular description, the glucose in embodiment, calcium chloride, magnesium chloride refer to Dextrose monohydrate, calcium chloride dihydrate, magnesium chloride hexahydrate respectively.
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
| Embodiment is numbered | 1-1 | 1-2 | 1-3 | 1-4 |
| Glucose (g) | 15 | 15 | 15 | 15 |
| Sodium chloride (g) | 5 | 5.377 | 5.377 | 6 |
| Calcium chloride (g) | 0.1 | 0.147 | 0.147 | 0.2 |
| Magnesium chloride (g) | 0.05 | 0.0508 | 0.0508 | 0.06 |
| Sodium lactate (g) | 4 | 4.483 | 4.483 | 5 |
| Vitamin C (g) | 0.5 | 2 | 5 | 10 |
| PH | 6.0 | 6.5 | 6.5 | 7.0 |
1. dope preparation: the water for injection getting recipe quantity 10%, other compositions adding recipe quantity are stirred to whole dissolving.Then add after medicinal charcoal 0.1 ~ 1% stirs, place to filter after 10 ~ 20 minutes and obtain dope.
2. medicinal liquid dilution: by dope pressure filtration in dilute preparing tank, regulates pH value to designated value and to full dose with 0.01%NaOH aqueous solution, water for injection.Through 0.22 μm of ultimate filter be filtered to visible foreign matters qualified after embedding.
Nitrogen protection is adopted when preparation and embedding
3, sterilizing: 115 DEG C of constant temperature 20 minutes
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
| Embodiment is numbered | 2-1 | 2-2 | 2-3 | 2-4 |
| Glucose (g) | 15 | 15 | 15 | 15 |
| Sodium chloride (g) | 5 | 5.377 | 5.377 | 6 |
| Calcium chloride (g) | 0.1 | 0.147 | 0.147 | 0.2 |
| Magnesium chloride (g) | 0.05 | 0.0508 | 0.0508 | 0.06 |
| Sodium lactate (g) | 4 | 4.483 | 4.483 | 5 |
| Vitamin C (g) | 0.5 | 2 | 5 | 10 |
| PH | 6.5 | 6.5 | 6.5 | 6.5 |
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
| Embodiment is numbered | 3-1 | 3-2 | 3-3 | 3-4 |
| Glucose (g) | 25 | 25 | 25 | 25 |
| Sodium chloride (g) | 5 | 5.377 | 5.377 | 6 |
| Calcium chloride (g) | 0.1 | 0.147 | 0.147 | 0.2 |
| Magnesium chloride (g) | 0.05 | 0.0508 | 0.0508 | 0.06 |
| Sodium lactate (g) | 4 | 4.483 | 4.483 | 5 |
| VCE (g) | 0.5 | 2 | 5 | 10 |
Preparation method, with embodiment 1, does not use 0.01%NaOH aqueous solution to regulate pH value.
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
| Embodiment is numbered | 4-1 | 4-2 | 4-3 |
| Glucose (g) | 25 | 25 | 25 |
| Sodium chloride (g) | 5 | 5.377 | 6 |
| Calcium chloride (g) | 0.1 | 0.147 | 0.2 |
| Magnesium chloride (g) | 0.05 | 0.0508 | 0.06 |
| Sodium lactate (g) | 4 | 4.483 | 5 |
| Magnesium L-Asacorbic Acid 2-O-Phosphate (g) | 0.5 | 2 | 10 |
Preparation method, with embodiment 1, does not use 0.01%NaOH aqueous solution to regulate pH value.
Example of formulations 5
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
| Embodiment is numbered | 5-1 | 5-2 | 5-3 |
| Glucose (g) | 40 | 40 | 40 |
| Sodium chloride (g) | 5 | 5.377 | 6 |
| Calcium chloride (g) | 0.1 | 0.147 | 0.2 |
| Magnesium chloride (g) | 0.05 | 0.0508 | 0.06 |
| Sodium lactate (g) | 4 | 4.483 | 5 |
| Vitamin C tripolyphosphate (g) | 0.5 | 5 | 10 |
Preparation method, with embodiment 1, does not use 0.01%NaOH aqueous solution to regulate pH value.
Example of formulations 6
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
| Embodiment is numbered | 6-1 | 6-2 | 6-3 | 6-4 |
| Glucose (g) | 40 | 40 | 40 | 40 |
| Sodium chloride (g) | 5.377 | 5.377 | 5.377 | 5.377 |
| Calcium chloride (g) | 0.147 | 0.147 | 0.147 | 0.147 |
| Magnesium chloride (g) | 0.0508 | 0.0508 | 0.0508 | 0.0508 |
| Sodium lactate (g) | 4.483 | 4.483 | 4.483 | 4.483 |
| Vitamin C (g) | 5 | 5 | 5 | 5 |
| Pyrosulfurous acid (g) | 1 | 2 | ||
| Sodium sulfite (g) | 1 | |||
| Sodium sulfite (g) | 2 | |||
| PH | 6.5 | 6.5 | 6.5 | 6.5 |
Preparation method is with embodiment 1.
Example of formulations 7
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
| Embodiment is numbered | 7-1 | 7-2 | 7-3 |
| Glucose (g) | 15 | 15 | 15 |
| Sodium chloride (g) | 5 | 5.377 | 5.377 |
| Calcium chloride (g) | 0.1 | 0.147 | 0.147 |
| Magnesium chloride (g) | 0.05 | 0.0508 | 0.0508 |
| Sodium lactate (g) | 4 | 4.483 | 4.483 |
| Vitamin C (g) | 0.5 | 2 | 5 |
| PH | 4.0 | 5.5 | 7.0 |
Preparation method, with embodiment 1, is in step 2 in order to regulate pH value to designated value, with 0.01%NaOH aqueous solution or 1%HCl aqueous solution.
Comparative examples 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
| Embodiment is numbered | 1-1 | 1-2 | 1-3 |
| Glucose (g) | 15 | 15 | 15 |
| Sodium chloride (g) | 5 | 5.377 | 6 |
| Calcium chloride (g) | 0.1 | 0.147 | 0.2 |
| Magnesium chloride (g) | 0.05 | 0.0508 | 0.06 |
| Sodium lactate (g) | 4 | 4.483 | 5 |
| PH | 6.0 | 6.5 | 7.0 |
1. dope preparation: the water for injection getting recipe quantity 10%, other compositions adding recipe quantity are stirred to whole dissolving.Then add after medicinal charcoal 0.1 ~ 1% stirs, place to filter after 10 ~ 20 minutes and obtain dope.
2. medicinal liquid dilution: by dope pressure filtration in dilute preparing tank, regulates pH value to designated value and to full dose with 0.01%NaOH aqueous solution, water for injection.Through 0.22 μm of ultimate filter be filtered to visible foreign matters qualified after embedding.
3, sterilizing: 115 DEG C of constant temperature 20 minutes
Nitrogen protection is adopted when preparation and embedding.
Comparative examples 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
| Embodiment is numbered | 2-1 | 2-2 | 2-3 |
| Glucose (g) | 25 | 25 | 25 |
| Sodium chloride (g) | 5 | 5.377 | 6 |
| Calcium chloride (g) | 0.1 | 0.147 | 0.2 |
| Magnesium chloride (g) | 0.05 | 0.0508 | 0.06 |
| Sodium lactate (g) | 4 | 4.483 | 5 |
| PH | 6.0 | 6.5 | 7.0 |
Preparation method is with comparative examples 1.
Comparative examples 3
| Embodiment is numbered | 3-1 | 3-2 | 3-3 |
| Glucose (g) | 15 | 15 | 15 |
| Sodium chloride (g) | 5 | 5.377 | 5.377 |
| Calcium chloride (g) | 0.1 | 0.147 | 0.147 |
| Magnesium chloride (g) | 0.05 | 0.0508 | 0.0508 |
| Sodium lactate (g) | 4 | 4.483 | 4.483 |
| Vitamin C (g) | 0.5 | 2 | 5 |
| PH | 4.0 | 5.5 | 7.0 |
Preparation method:
1. get the water for injection of 90% recipe quantity, after other compositions adding recipe quantity are stirred to and all dissolve, regulate pH value to designated value and to full dose with the water for injection of 0.01%NaOH aqueous solution, surplus.Then add after medicinal charcoal 0.1 ~ 1% stirs, after filtration again through 0.22 μm of ultimate filter be filtered to visible foreign matters qualified after embedding.
2, sterilizing: 115 DEG C of constant temperature 20 minutes
Comparative examples 4
| Embodiment is numbered | 4-1 | 4-2 | 4-3 |
| Glucose (g) | 40 | 40 | 40 |
| Sodium chloride (g) | 5 | 5.377 | 5.377 |
| Calcium chloride (g) | 0.1 | 0.147 | 0.147 |
| Magnesium chloride (g) | 0.05 | 0.0508 | 0.0508 |
| Sodium lactate (g) | 4 | 4.483 | 4.483 |
| Vitamin C tripolyphosphate (g) | 0.5 | 5 | 10 |
| PH | 4.0 | 5.5 | 7.0 |
Preparation method is with comparative examples 3.
Stability test 1
Add prescription labelled amount medicine and adjuvant (error is lower than one thousandth gram), according to embodiment 1,2,6,7, measure 0 day content before the peritoneal dialysis solution subpackage that obtains of the method for comparative examples 3,4, (using the crude drug of same batch, adjuvant, water for injection) divides into groups according to group number, often organize 10 bags, every bag of 100ml, store respectively under thermostatic accelerated experiment, room temperature long term test condition, detect in the stipulated time.
1, ascorbic content is measured
Thermostatic accelerated experiment (abbreviation accelerated test) condition: by commercially available back, in temperature 50 C ± 2 DEG C, place under the condition of relative humidity 75% ± 5%.
Room temperature long term test (abbreviation long term test) condition: commercially available back, temperature 25 DEG C ± 2 DEG C, places under the condition of relative humidity 60% ± 10%.
Vitamin C content assay method measures according to the method for Vitamin C content in Chinese Pharmacopoeia (2010 editions) 903-904 vitamin C injection, result/labelled amount X100% after measuring.
Vitamin C content (n=10, meansigma methods)
Known by above-mentioned inspection, the ordinary temperature stability verification experimental verification of alkalescence peritoneal dialysis solution (lactate) and 12 months in the accelerated test of 4 months, comparatively stable between PH6.0-7.0 containing ascorbic peritoneal dialysis solution, after adding the sodium pyrosulfite of 0.1% ~ 0.2%, sodium sulfite or sodium sulfite simultaneously, ascorbic stability obtains reinforcement, and it is more outstanding wherein to add sodium pyrosulfite rear stability effect.Measure 0 day content before can finding the method for embodiment simultaneously and using the method for comparative examples to cause subpackage and there is certain difference, stable advantageously in vitamin C or its ester of the method for visible embodiment, especially in use vitamin C instead of ascorbic derivant.
The embodiment used in effect example, the peritoneal dialysis solution of comparative examples, be all temperature 25 DEG C ± 2 DEG C, place the product of 12 months under the condition of relative humidity 60% ± 10%.
Effect example 1 peritoneum impact test
Laboratory animal: SD rat, male, body weight 200 ± 10g
Test method: by rat random packet, often organize 10, blank group accepts normal saline 2Oml lumbar injection every day, embodiment 1-1 to 5-3 group gives the peritoneal dialysis solution lumbar injection of the corresponding group number of embodiment group to rat, every day 100ml/Kg, matched group 1-1 to 2-3 group gives the peritoneal dialysis solution lumbar injection in the corresponding group number of comparative examples group to rat, and every day, 100ml/Kg, injected 28 days continuously.29th, within 30 days, injection is stopped, within 31st day, measure animal peritoneal function, every rat 10% chloral hydrate anesthesia pneumoretroperitoneum injects 4.25% glucose peritoneal dialysis solution 25ml, and 4h tailing edge hunter's line cuts off stomach wall, accurately measure intraperitoneal liquid, leave and take 0 and 4h peritoneal dialysis liquid and blood preparation simultaneously.Blood preparation is centrifugal 10 minutes with 5000 revs/min, and peritoneal dialysis liquid specimen is centrifugal 5 minutes with 1500 revs/min, measures concentration of glucose with automatic clinical chemistry analyzer.
Ultrafiltration volume (ultrafiltration, UF)=(last water yield-25);
Glucose transport amount (mass transfer of glucose, MTG)=(dialysis solution initial glucose concentration × injection dialysis liquid measure)-(last dialysis solution output at last concentration of glucose × end of dialysing).
Put to death animal afterwards, HE(hematoxylin-eosin staining method carried out to parietal peritoneum tissue), Masson dyeing, measure 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.
Result:
Each group of rat 4 weeks posterior peritoneum thickness, glucose transport amount, ultrafiltration volumes compare (n=10, mean ± SD)
| Group number | Peritoneum thickness (μm) | Ultrafiltration volume (ml) | Glucose transport amount (mmol/kg) |
| Blank group | 13.71±1.45 | 7.97±0.89 | 12.98±0.42 |
| Embodiment 1-1 | 23.77±1.48 | 3.92±0.33 | 15.01±0.43 |
| Embodiment 1-2 | 22.65±1.47 | 4.17±0.41 | 14.65±0.47 |
| Embodiment 1-3 | 22.20±1.42 | 4.26±0.40 | 14.47±0.42 |
| Embodiment 1-4 | 22.17±1.50 | 4.19±0.42 | 14.44±0.40 |
| Embodiment 2-1 | 27.20±1.45 | 3.18±0.35 | 16.40±0.44 |
| Embodiment 2-2 | 26.46±1.40 | 3.49±0.36 | 16.15±0.41 |
| Embodiment 2-3 | 26.11±1.39 | 3.56±0.38 | 16.03±0.43 |
| Embodiment 2-4 | 25.93±1.51 | 3.60±0.42 | 15.92±0.47 |
| Embodiment 3-1 | 26.85±1.45 | 3.31±0.43 | 16.23±0.40 |
| Embodiment 3-2 | 26.13±1.50 | 3.54±0.39 | 15.99±0.43 |
| Embodiment 3-3 | 25.90±1.48 | 3.60±0.41 | 15.86±0.38 |
| Embodiment 3-4 | 25.76±1.52 | 3.72±0.38 | 15.80±0.40 |
| Embodiment 4-1 | 25.63±1.43 | 3.79±0.39 | 15.76±0.41 |
| Embodiment 4-2 | 24.68±1.49 | 3.90±0.42 | 15.46±0.51 |
| Embodiment 4-3 | 24.56±1.44 | 3.95±0.39 | 15.45±0.47 |
| Embodiment 5-1 | 26.69±1.38 | 3.38±0.35 | 16.05±0.47 |
| Embodiment 5-2 | 25.58±1.46 | 3.80±0.39 | 15.64±0.46 |
| Embodiment 5-3 | 25.60±1.47 | 3.77±0.40 | 15.66±0.52 |
| Comparative examples 1-1 | 25.60±1.48 | 3.64±0.35 | 15.72±0.56 |
| Comparative examples 1-2 | 25.35±1.53 | 3.57±0.37 | 15.67±0.51 |
| Comparative examples 1-3 | 25.83±1.62 | 3.85±0.32 | 15.90±0.58 |
| Comparative examples 2-1 | 30.92±1.42 | 2.80±0.39 | 17.18±0.52 |
| Comparative examples 2-1 | 30.52±1.43 | 2.83±0.34 | 17.03±0.53 |
| Comparative examples 2-3 | 31.30±1.43 | 2.73±0.42 | 17.54±0.59 |
Proved by above-mentioned experiment, the peritoneal dialysis solution containing vitamin C or derivatives thereof with do not contain to compare the impact that peritoneum thickens less, ultrafiltration volume, glucose transport amount are closer to normal physiological condition simultaneously.
Claims (10)
1. a prescription is by vitamin C or vitamin C derivatives, the glucose of 1.5-4.0%, the sodium chloride of 0.5-0.6%, the calcium chloride of 0.01-0.02%, the magnesium chloride of 0.004-0.006%, the preparation method of peritoneal dialysis solution (lactate) (low calcium) compositions of the sodium lactate of 0.4-0.5% and water composition, is characterized in that preparation method is:
Dope is prepared: the water for injection getting recipe quantity part, and other compositions adding recipe quantity are stirred to whole dissolving, filters and obtain dope after placing.
Medicinal liquid dilute: by dope pressure filtration in dilute preparing tank, after adding water for injection to full dose through 0.22 μm of ultimate filter be filtered to visible foreign matters qualified after embedding.
2. peritoneal dialysis liquid and preparation method thereof as claimed in claim 1, is characterized in that the amount of recipe quantity partial syringe water in dope preparation is less than or equal to 20% of recipe quantity water for injection.
3. peritoneal dialysis liquid and preparation method thereof as claimed in claim 1, is characterized in that medicinal liquid after diluting 115 DEG C of constant temperature sterilizings 20 minutes.
4. peritoneal dialysis solution as claimed in claim 1, is characterized in that vitamin C derivatives is the one in VCE, Magnesium L-Asacorbic Acid 2-O-Phosphate, vitamin C tripolyphosphate.
5. peritoneal dialysis solution as claimed in claim 1, is characterized in that the content of vitamin C or vitamin C derivatives is 0.05-1%.
6. peritoneal dialysis liquid and preparation method thereof as claimed in claim 1, it is characterized in that also containing 0.1% ~ 0.2% sodium pyrosulfite, sodium sulfite or sodium sulfite.
7. peritoneal dialysis liquid and preparation method thereof as claimed in claim 1, it is characterized in that the content of vitamin C or vitamin C derivatives is 0.05-1%, the content of sodium chloride is 0.5377%, the content of calcium chloride is 0.0147%, the content of magnesium chloride is 0.00508%, the content of sodium lactate is 0.4483%, and the content of sodium pyrosulfite is 0.1% ~ 0.2%, and the content of glucose is 1.5%, 2.5% or 4.0%.
8. peritoneal dialysis liquid and preparation method thereof as claimed in claim 1, when it is characterized in that not containing vitamin C derivatives containing vitamin C, add in medicinal liquid dilution step and in water for injection to full dose, use the aqueous solution of inorganic base to regulate the PH of peritoneal dialysis solution between 6.0-7.0.
9. peritoneal dialysis liquid and preparation method thereof as claimed in claim 8, is characterized in that the inorganic base in medicinal liquid dilution is sodium salt.
10. peritoneal dialysis liquid and preparation method thereof as claimed in claim 8, is characterized in that the inorganic base in medicinal liquid dilution is sodium hydroxide.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN107281219A (en) * | 2017-06-30 | 2017-10-24 | 华仁药业股份有限公司 | A kind of anti-peritoneal fibrosiss and the peritoneal dialysis solution of infection and preparation method thereof |
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