CN107281196A - A kind of low calcium lactate peritoneal dialysat pharmaceutical composition containing Azulene sulfonic acid and its salt - Google Patents
A kind of low calcium lactate peritoneal dialysat pharmaceutical composition containing Azulene sulfonic acid and its salt Download PDFInfo
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- CN107281196A CN107281196A CN201610204466.2A CN201610204466A CN107281196A CN 107281196 A CN107281196 A CN 107281196A CN 201610204466 A CN201610204466 A CN 201610204466A CN 107281196 A CN107281196 A CN 107281196A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/14—Alkali metal chlorides; Alkaline earth metal chlorides
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7004—Monosaccharides having only carbon, hydrogen and oxygen atoms
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
Abstract
A kind of low calcium lactate peritoneal dialysat composition, containing glucose, sodium chloride, calcium chloride, magnesium chloride, alkali, Azulene sulfonic acid and salt or ester can decline harmful effect of the peritoneal dialysis solution to peritonaeum in terms of Azulene sulfonic acid and water.
Description
Technical field
The present invention relates to a kind of low calcium lactate peritoneal dialysat pharmaceutical composition containing Azulene sulfonic acid and its salt.
Background technology
Peritoneal dialysis (peritoneal dialysis, PD) is that the important kidney of end stage renal failure patient is replaced
For therapy (CRRT), due to compared with haemodialysis, with applied widely, dialytic efficiency is high, remaining kidney work(
It can keep, the advantages of patients ' life quality is high, occupy more and more in the alternative medicine of chronic renal failure
Consequence.The key of successful peritoneal dialysis is the good peritonaeum and peritoneal dialysis solution of ultrafiltration function.By
In the chronicity of peritoneal dialysis treatment, the ultrafiltration performance of peritonaeum is often affected by various factors over the course for the treatment of
Change, and this change is irreversible, will ultimately result in the forfeiture of patient's peritonaeum ultrafiltration function, it is impossible to
Abdomen is carried out again to treat thoroughly.The wherein biofacies of peritoneal dialysis solution (peritoneal dialysis fluid, PDF)
Peritoneal fibrosiss and ultrafiltration caused by capacitive difference unsuccessfully turn into current peritoneal dialysis and are badly in need of important asking with what must be solved
Topic.Abdomen abdomen dialyzate (peritoneal dialysis fluid, PDF) is the core link in PD, peritonaeum
The general principle of dialysis, is exactly the different institutes of concentration using each composition between patients serum and peritoneal dialysis liquid in cavum peritoneale
The electrochemistry potential energy difference of formation, it is different to correct the physiology in uremic patient blood with ultrafiltration by disperse
Often.The setting of each composition of peritoneal dialysis liquid is based primarily upon this principle with compatibility.Preferable peritoneal dialysis liquid not only can be fully clear
Except toxin, ultrafiltration moisture, moreover it is possible to protect peritoneal membrane function, the generation of ultrafiltration exhaustion (UFF) is reduced.Traditional abdomen
Transparent liquid is the lactate dialysate using the glucose of various concentrations as bleeding agent, and clinical practice for many years shows,
Although PD has played highly important effect in the treatment of chronic kidney hypofunction, in terms of Human physiology angle, mesh
There is problems with preceding conventional use of dialyzate still protrusion:(1) dialyzate is using glucose as main bleeding agent, because
It can be absorbed by peritonaeum, thus its osmosis hold time it is very short, it is difficult to reach that preferable liquid and solute are clear
Remove；(2) in dialyzate some compositions (glucose and base etc.) can activate inflammatory cytokine (growth factor,
Nitric oxide synthetase), long-term use can cause peritonaeum chronic inflammatory to change, and promote peritoneal fibrosiss and increasing
It is thick；(3) after the glucose in dialyzate is decomposed in vivo, the non-product of substantial amounts of advanced glycosylation endproduct can be produced
(AGEs), the latter can deposit in vivo extensively, especially interstitial can be caused to increase after vascular wall and peritonaeum interstitial deposition
Thickness, causes ultrafiltration function to decline；(4) glucose is degradable in high-temperature sterilization forms a series of glucose degradation productions
Thing (GDPs), GDPs can coup injury peritoneal cell, and promote AGE to be formed；(5) buffer base (BB) is big in dialyzate
Use lactate, they must first pass through the metabolic conversion of liver after bicarbonate, can play correction acid more
The effect of poisoning, therefore the patient for being associated with liver diseases to a part often has certain limitation.
Also document thinks that high concentration glucose and glucose degradation products (GDPs) have to the cell of peritoneal tissues
There is direct toxic action, it is connected and Adherents junction by destroying the close connection of Peritoneal Mesothelial Cells, gap,
And oxidative stress and mitochondria pathway make Peritoneal Mesothelial Cells occur apoptosis, so that Peritoneal Mesothelial Cells are lost
Lose, finally destroy the integrality of peritonaeum structure.
The mechanism of the peritoneal fibrosiss occurrence and development related to peritoneal dialysis is extremely complex in a word.
Azulene sulfonic acid (Isosorbide-5-Nitrae-dimethyl -7- isopropyl azulenes -3- sulfonic acid) is the active ingredient of anthemidis flos, again
Name azulene, with strong suppression inflammatory effect.Its mechanism is the conjunction of prostaglandin E2 in increase mucous membrane
Into promoting, granulation formation and epithelial cell are newborn, reduce pepsin activity, are suppressed by local directly effect
Inflammatory cell discharges histamine.
The content of the invention
, can be with it has surprisingly been found that add Azulene sulfonic acid and salt in peritoneal dialysis solution by our experimental study
Decline harmful effect of the peritoneal dialysis solution to peritonaeum, reduction peritoneal fibrosiss and thickened degree are reduced to peritonaeum
The situation that ultrafiltration function declines.
One kind contains the peritoneal dialysis solution pharmaceutical composition of Azulene sulfonic acid and salt, glucose and water.
Above-mentioned peritoneal dialysis solution pharmaceutical composition, it is characterised in that said composition also contains inorganic salts.Above-mentioned
Peritoneal dialysis solution pharmaceutical composition, it is characterised in that inorganic salts are sodium chloride, calcium chloride, magnesium chloride, hydroxide
One or more in sodium, sodium carbonate, sodium acid carbonate.
Above-mentioned peritoneal dialysis solution pharmaceutical composition, it is characterised in that the salt of Azulene sulfonic acid is the alkali metal of Azulene sulfonic acid
Salt.
Above-mentioned peritoneal dialysis solution pharmaceutical composition, it is characterised in that the salt of Azulene sulfonic acid is the sodium salt or potassium of Azulene sulfonic acid
Salt.
Above-mentioned peritoneal dialysis solution pharmaceutical composition, it is characterised in that the salt of Azulene sulfonic acid is sodium azulenesulfonate.
Above-mentioned peritoneal dialysis solution pharmaceutical composition, it is characterised in that the w/v content of glucose is
1-5%.
Above-mentioned peritoneal dialysis solution pharmaceutical composition, it is characterised in that the w/v content of glucose is
1-4.25%.
Above-mentioned peritoneal dialysis solution pharmaceutical composition, it is characterised in that the weight of Azulene sulfonic acid and salt or ester in terms of Azulene sulfonic acid
It is 0.01-0.4% to measure volume ratio content.
Peritoneal dialysis solution pharmaceutical composition as claimed in claim 1, it is characterised in that Azulene sulfonic acid and salt or ester with
The w/v content of Azulene sulfonic acid meter is 0.05-0.2%.
Above-mentioned peritoneal dialysis solution pharmaceutical composition, it is characterised in that the weight of Azulene sulfonic acid and salt or ester in terms of Azulene sulfonic acid
It is 0.1-0.2% to measure volume ratio content.
Above-mentioned peritoneal dialysis solution pharmaceutical composition, it is characterised in that composition osmotic pressure molar density scope is
330~400mOsm/kg.
Above-mentioned peritoneal dialysis solution pharmaceutical composition, it is characterised in that composition osmotic pressure molar density scope is
340~390mOsm/kg.
Above-mentioned peritoneal dialysis solution pharmaceutical composition, it is characterised in that composition osmotic pressure molar density scope is
350~390mOsm/kg.
Above-mentioned peritoneal dialysis solution pharmaceutical composition, it is characterized in that also containing 0.001%~0.01% burnt sulfurous
Sour sodium, sodium sulfite or sodium hydrogensulfite.
Above-mentioned peritoneal dialysis solution pharmaceutical composition, it is characterised in that sodium lactate can also be contained.
Above-mentioned peritoneal dialysis solution pharmaceutical composition, it is characterised in that inorganic salts are sodium chloride, calcium chloride, chlorination
One or more in magnesium, sodium hydroxide, sodium carbonate, sodium acid carbonate.The peritoneal dialysis solution pharmaceutical composition stated,
It is characterized in that containing glucose, sodium chloride, calcium chloride, magnesium chloride, alkali, Azulene sulfonic acid and salt or ester are with Azulene sulphur
Acid meter and water, wherein alkali are the one or more in sodium lactate, sodium hydroxide, sodium carbonate, sodium acid carbonate, are adjusted
Whole group compound osmotic pressure molar density scope is 330~400mOsm/kg.Above-mentioned peritoneal dialysis solution drug regimen
Thing, it is characterized in that also containing one kind in sodium lactate, sodium hydroxide, sodium carbonate, sodium acid carbonate, its weighing body
Product is than for 0.3-0.6%'s.Above-mentioned peritoneal dialysis solution pharmaceutical composition, it is characterized in that also containing sodium lactate, hydrogen
One kind in sodium oxide molybdena, sodium carbonate, sodium acid carbonate, the content of its w/v is 0.4-0.6%'s.It is above-mentioned
Peritoneal dialysis solution pharmaceutical composition, it is characterized in that also contain sodium pyrosulfite, sodium sulfite or sodium hydrogensulfite
In one kind, the content that its w/v is is 0.003-0.01%.
Above-mentioned peritoneal dialysis solution pharmaceutical composition, containing with the 1.5-4.0% of weight by volume basis glucose,
0.5-0.6% sodium chloride, 0.01-0.02% calcium chloride, 0.004-0.006% magnesium chloride, 0.4-0.5%'s
Sodium lactate and water, 0.01-0.4% Azulene sulfonic acid and salt or ester are in terms of Azulene sulfonic acid and water.
Above-mentioned peritoneal dialysis solution pharmaceutical composition, it is characterised in that inorganic acid or inorganic base regulation PH can be used
For 4.5-6.5.
Above-mentioned peritoneal dialysis solution pharmaceutical composition, it is characterised in that inorganic acid or inorganic base regulation PH can be used
For 5.5-6.5.
The preparation method of above-mentioned peritoneal dialysis solution pharmaceutical composition, it is characterized in that will be various in pharmaceutical composition
Sterilized after composition is well mixed, obtain above-mentioned peritoneal dialysis solution pharmaceutical composition.
In case of no particular description, the content of composition is w/v in the present invention, for example
0.4-0.7% sodium chloride is the sodium chloride for having 0.4-0.7g in 100ml water.
The content of glucose, calcium chloride, magnesium chloride in the present invention is respectively with Dextrose monohydrate, calcium chloride
Dihydrate, magnesium chloride hexahydrate are calculated, and such as 1.5-4% glucose is actually 1.5-4% grapes
The glucose of sugared monohydrate, such as 1.5-4% is the hydration of glucose one for having 1.5-4g during 100ml water contains
Thing, rather than 100ml water contain in have 1.5-4g glucose.
The ester of Azulene sulfonic acid in the present invention or the content of salt are in terms of the wherein weight of Azulene sulfonic acid, for example
0.01-0.4% sodium azulenesulfonate actually refers to that 100ml water has 0.01-0.4% Azulene sulfonic acid in containing.
Embodiment
In case of no particular description, in embodiment glucose, calcium chloride, magnesium chloride refers respectively to Portugal
Grape sugar monohydrate, calcium chloride dihydrate, magnesium chloride hexahydrate.
Example of formulations 1
Formula such as following table, packing specification is 1000ml/ bags, and data are the formula for converting into every bag of dialyzate in table
| 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 |
| Sodium azulenesulfonate (g) | 0.1 | 1 | 2 | 4 |
| PH | 6.0 | 6.5 | 6.5 | 7.0 |
1. dope is prepared：The water for injection of recipe quantity 10% is taken, the other compositions for adding recipe quantity are stirred to all molten
Solution.Then after addition medical charcoal 0.1~1% stirs, dope is filtrated to get after placing 10~20 minutes.
2. decoction dilutes：By dope pressure filtration into dilute preparing tank, adjusted with the 0.01%NaOH aqueous solution, water for injection
PH value is saved to designated value and to full dose.Through 0.22 μm of ultimate filter filter to visible foreign matters it is qualified after embedding.
Protected in preparation and embedding using nitrogen
3rd, sterilize：115 DEG C of constant temperature 20 minutes
Example of formulations 2
Formula such as following table, packing specification is 1000ml/ bags, and data are the formula for converting into every bag of dialyzate in table
| Embodiment is numbered | 2-1 | 2-2 | 2-3 | 2-4 |
| 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 |
| Sodium azulenesulfonate (g) | 0.1 | 0.5 | 1 | 2 |
| PH | 6.5 | 6.5 | 6.5 | 6.5 |
Preparation method be the same as Example 1.
Example of formulations 3
Formula such as following table, packing specification is 1000ml/ bags, and data are the formula for converting into every bag of dialyzate in table
Preparation method be the same as Example 1.
Comparative examples
Comparative examples 1
Formula such as following table, packing specification is 1000ml/ bags, and data are the formula for converting into every bag of dialyzate in table
| 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 is prepared：The water for injection of recipe quantity 10% is taken, the other compositions for adding recipe quantity are stirred to all molten
Solution.Then after addition medical charcoal 0.1~1% stirs, dope is filtrated to get after placing 10~20 minutes.
2. decoction dilutes：By dope pressure filtration into dilute preparing tank, adjusted with the 0.01%NaOH aqueous solution, water for injection
PH value is saved to designated value and to full dose.Through 0.22 μm of ultimate filter filter to visible foreign matters it is qualified after embedding.
3rd, sterilize：115 DEG C of constant temperature 20 minutes
Protected in preparation and embedding using nitrogen.
Comparative examples 2
Formula such as following table, packing specification is 1000ml/ bags, and data are the formula for converting into every bag of dialyzate in table
Preparation method is with comparative examples 1.
Example of formulations 3
Formula such as following table, packing specification is 1000ml/ bags, and data are the formula for converting into every bag of dialyzate in table
| Embodiment is numbered | 3-1 | 3-2 | 3-3 | 3-4 |
| 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 |
| Pyrosulfurous acid (g) | 1 | 2 | ||
| Sodium sulfite (g) | 1 | |||
| Sodium hydrogensulfite (g) | 2 | |||
| PH | 6.5 | 6.5 | 6.5 | 6.5 |
The influence experiment of the peritonaeum of effect example 1
Experimental animal：SD rats, male, 200 ± 10g of body weight
Test method：Rat is grouped at random, every group 8, blank group receives physiological saline 2O ml intraperitoneal injections daily,
Embodiment 1-1 gives the peritoneal dialysis solution intraperitoneal injection of the corresponding group number of embodiment group to 5-3 groups to rat, daily
100ml/Kg, control group 1-1 give the peritoneal dialysis in the corresponding group number of comparative examples group to 2-3 groups to rat
Liquid is injected intraperitoneally, daily 100ml/Kg, continuous injection 35 days.36th, 37 days stop injection, survey within the 38th day
Determine animal peritoneal function, it is saturating that every rat injects 4.25% glucose peritonaeum with 10% chloral hydrate anesthesia pneumoretroperitoneum
Stomach wall is cut off along hunter's line after analysis liquid 25ml, 4h, intraperitoneal liquid is accurately measured, while leaving and taking 0 and 4h abdomens
Transparent liquid and blood preparation.Blood preparation with 5000 revs/min centrifuge 10 minutes, peritoneal dialysis liquid sample with 1500 turns/
Separate the heart 5 minutes, concentration of glucose is determined with automatic clinical chemistry analyzer.
Ultrafiltration volume (ultrafiltration, UF)=(last water yield -25)；
Glucose transport amount (mass transfer of glucose, MTG)=(dialyzate initial glucose concentration × note
Enter liquid measure of dialysing)-(dialysis last dialyzate output of last concentration of glucose × end).
Animal is put to death afterwards, and carrying out HE (hematoxylin eosin staining method), Masson to parietal peritoneum tissue dyes,
Determine peritonaeum thickness.Masson staining procedures：Paraffin-embedded tissue is cut into 3m sections, dewaxes to water, reddish black
Stone orchid dye liquor contaminates 6~10min, and flowing water is rinsed, and WeigerShi Garapas element liquid contaminates 5~10min, and flowing water is rinsed,
Ponceaux acid fuchsin liquid (2：1) l5~20min is contaminated, the 1% phosphomolybdic acid aqueous solution and 1% glacial acetic acid quickly break up,
BG solution dyes 2~10min, is quickly broken up with the phosphomolybdic acid aqueous solution and glacial acetic acid again, 95% alcohol
Dehydration, is dried, dimethylbenzene is transparent, neutral gum mounting.Take 12 high power fields to determine peritonaeum thickness, make even
Average is used as the standard for judging peritonaeum thickness.
As a result：
Each group rat 4 weeks posterior peritoneum thickness, glucose transport amount, ultrafiltration volumes compare (n=10, mean ± SD)
| Group number | Peritonaeum thickness (μm) | Ultrafiltration volume (ml) | Glucose transport amount (mmol/kg) |
| Blank group | 14.21±1.34 | 7.52±0.79 | 12.98±0.42 |
| Embodiment 1-1 | 23.37±1.41 | 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 | 4.25±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 | 3.67±0.42 | 15.87±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 |
| Comparative examples 1-1 | 26.51±1.25 | 3.58±0.43 | 16.34±0.42 |
| Comparative examples 1-2 | 26.04±1.31 | 3.70±0.39 | 16.03±0.47 |
| Comparative examples 1-3 | 25.93±1.37 | 3.73±0.41 | 15.91±0.41 |
| Comparative examples 2-1 | 32.51±1.40 | 2.90±0.42 | 17.48±0.54 |
| Comparative examples 2-1 | 32.15±1.31 | 3.01±0.44 | 17.14±0.48 |
| Comparative examples 2-3 | 31.91±1.29 | 3.08±0.37 | 17.02±0.51 |
| Comparative examples 3-1 | 27.58±1.22 | 3.21±0.40 | 17.61±0.58 |
| Comparative examples 3-2 | 27.51±1.31 | 3.23±0.36 | 17.64±0.43 |
| Comparative examples 3-3 | 27.65±1.32 | 3.30±0.43 | 17.56±0.51 |
| Comparative examples 3-4 | 25.56±1.27 | 3.27±0.36 | 17.53±0.42 |
By above-mentioned it is demonstrated experimentally that the peritoneal dialysis solution containing Azulene sulfonic acid and salt is thickened with without compared with to peritonaeum
Influence it is smaller, while ultrafiltration volume, glucose transport amount are closer to normal physiological condition.
Claims (10)
1. one kind contains the peritoneal dialysis solution pharmaceutical composition of Azulene sulfonic acid and salt, glucose and water.
2. peritoneal dialysis solution pharmaceutical composition as claimed in claim 1, it is characterised in that said composition, which also contains, to be whether there is
Machine salt.
3. peritoneal dialysis solution pharmaceutical composition as claimed in claim 1, it is characterised in that the salt of Azulene sulfonic acid is Azulene sulphur
Sour sodium.
4. peritoneal dialysis solution pharmaceutical composition as claimed in claim 1, it is characterised in that the bulking value of glucose
It is 1-4.25% than content.
5. peritoneal dialysis solution pharmaceutical composition as claimed in claim 1, it is characterised in that Azulene sulfonic acid and salt or ester with
The w/v content of Azulene sulfonic acid meter is 0.01-0.4%.
6. peritoneal dialysis solution pharmaceutical composition as claimed in claim 2, it is characterised in that inorganic salts be sodium chloride,
One or more in calcium chloride, magnesium chloride, sodium hydroxide, sodium carbonate, sodium acid carbonate.
7. peritoneal dialysis solution pharmaceutical composition as claimed in claim 1, it is characterized in that also containing 0.001%~
0.01% sodium pyrosulfite, sodium sulfite or sodium hydrogensulfite.
8. peritoneal dialysis solution pharmaceutical composition as claimed in claim 1, it is characterised in that sodium lactate can also be contained.
9. peritoneal dialysis solution pharmaceutical composition as claimed in claim 1, it is characterised in that contain glucose, chlorination
Sodium, calcium chloride, magnesium chloride, alkali, Azulene sulfonic acid and salt or ester are in terms of Azulene sulfonic acid and water, and wherein alkali is lactic acid
One or more in sodium, sodium hydroxide, sodium carbonate, sodium acid carbonate, adjust composition osmol(e)
Concentration range is 330~400mOsm/kg.
10. peritoneal dialysis solution pharmaceutical composition as claimed in claim 1, containing with weight by volume basis
1.5-4.0% glucose, 0.5-0.6% sodium chloride, 0.01-0.02% calcium chloride, 0.004-0.006%
Magnesium chloride, 0.4-0.5% sodium lactate and water, 0.01-0.4% Azulene sulfonic acid and salt or ester are in terms of Azulene sulfonic acid
And water.
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| CN115624557A (en) * | 2022-12-22 | 2023-01-20 | 广东省人民医院 | Peritoneal dialysis solution for preventing peritoneal infection and preparation method and application thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115624557A (en) * | 2022-12-22 | 2023-01-20 | 广东省人民医院 | Peritoneal dialysis solution for preventing peritoneal infection and preparation method and application thereof |
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Application publication date: 20171024 |