CN109464458A - A kind of peritoneal dialysis solution (lactate) composition and preparation method thereof - Google Patents
A kind of peritoneal dialysis solution (lactate) composition and preparation method thereof Download PDFInfo
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- CN109464458A CN109464458A CN201811549848.4A CN201811549848A CN109464458A CN 109464458 A CN109464458 A CN 109464458A CN 201811549848 A CN201811549848 A CN 201811549848A CN 109464458 A CN109464458 A CN 109464458A
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K31/19—Carboxylic acids, e.g. valproic acid
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
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- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/08—Plasma substitutes; Perfusion solutions; Dialytics or haemodialytics; Drugs for electrolytic or acid-base disorders, e.g. hypovolemic shock
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Abstract
The invention discloses a kind of peritoneal dialysis solution (lactate) compositions and preparation method thereof, glucose containing 1.8-4.2%, the sodium chloride of 0.5-0.6%, the calcium chloride of 0.02-0.03%, the magnesium chloride of 0.01-0.02%, the sodium lactate and water for injection of 0.35-0.56%；Wherein, peritoneal dialysis solution (lactate) composition is sterilized by the way of high pressure cold sterilization.The mode of present invention application high pressure cold sterilization sterilizes during preparation and packing to peritoneal dialysis solution (lactate) composition, relative to high-temperature sterilization, reduce the harmful substances such as 5 hydroxymethyl furfural (5-HMF), the formaldehyde that the peritoneal dialysis solution of glucose is generated in high-temperature sterilization, the stability for improving peritoneal dialysis solution (lactate) composition reduces the risk of the ultrafiltration performance lesion of peritonaeum in therapeutic process.
Description
Technical field
The present invention relates to peritoneal dialysis solutions, and in particular, to a kind of peritoneal dialysis solution (lactate) composition.
Background technique
Peritoneal dialysis, due to having compared with haemodialysis, applied widely, dialytic efficiency is high, residual renal function saves
Well, the advantages that patients ' life quality is high, occupies more and more consequence in the alternative medicine of chronic renal failure.Success
The key of peritoneal dialysis be the good peritonaeum of ultrafiltration function.However, being treated due to the chronicity of peritoneal dialysis treatment
The ultrafiltration performance of peritonaeum is often affected by various factors in journey changes, and it is this change be it is irreversible, eventually
It causes patient's peritonaeum ultrafiltration function to lose, abdomen can not be carried out again and treated thoroughly.Traditional peritoneal dialysis solution is mainly various concentration
Glucose electrolyte solution generates 5- methylol since the peritoneal dialysis solution containing glucose can be decomposed in high-temperature sterilization and storage
The impurity such as furfural (5-HMF), and existing research shows that in peritoneal dialysis solution using 5-HMF as the glucose degradation products of representative
One of an important factor for (glucose degradation produ cts, GDP) is to peritonaeum generation adverse effect, in view of saturating
The chronicity of Case treatment is analysed, is become using 5-HMF as the GDP content of representative in reduction peritoneal dialysis lead in the prior art as far as possible
Want problem to be solved.
Summary of the invention
It is cold using high pressure the object of the present invention is to provide a kind of peritoneal dialysis solution (lactate) composition and preparation method thereof
The mode of sterilizing sterilizes during preparation and packing to peritoneal dialysis solution (lactate) composition, goes out relative to high temperature
Bacterium reduces the nuisances such as 5 hydroxymethyl furfural (5-HMF), the formaldehyde that the peritoneal dialysis solution of glucose is generated in high-temperature sterilization
Matter improves the stability of peritoneal dialysis solution (lactate) composition, reduces the ultrafiltration performance lesion of peritonaeum in therapeutic process
Risk.
To achieve the goals above, the present invention provides a kind of peritoneal dialysis solution (lactate) composition, contain 1.8-
4.2% glucose, the sodium chloride of 0.5-0.6%, the calcium chloride of 0.02-0.03%, the magnesium chloride of 0.01-0.02%, 0.35-
0.56% sodium lactate and water for injection；Wherein, peritoneal dialysis solution (lactate) composition uses the side of high pressure cold sterilization
Formula sterilizes.In the above-mentioned technical solutions, the mode of peritoneal dialysis solution application high pressure cold sterilization provided by the invention is gone out
Bacterium effectively reduces glucose degradation in conventional high temperature sterilizing and generates the noxious materials such as 5 hydroxymethyl furfural (5-HMF), formaldehyde
The phenomenon that, improve the stability of peritoneal dialysis solution.
The present invention also provides a kind of preparation methods of previously described peritoneal dialysis solution (lactate) composition, including first press
Glucose, sodium chloride, calcium chloride, magnesium chloride and sodium lactate are dissolved in first water for injection according to formula, obtain being concentrated standby
With liquid, medical charcoal filtering is added, filtrate is through high pressure cold sterilization；With the filtrate after trishydroxymethylaminomethane adjustment sterilizing
PH is settled to 100% with second batch water for injection, adds medical charcoal filtering, packing, then high pressure cold sterilization again.
Through the above technical solutions, the mode of peritoneal dialysis solution application high pressure cold sterilization provided by the invention sterilizes,
It effectively reduces glucose degradation in conventional high temperature sterilizing and generates the noxious materials such as 5 hydroxymethyl furfural (5-HMF), formaldehyde
Phenomenon improves the stability of peritoneal dialysis solution.
Other features and advantages of the present invention will the following detailed description will be given in the detailed implementation section.
Specific embodiment
Detailed description of the preferred embodiments below.It should be understood that described herein specific
Embodiment is merely to illustrate and explain the present invention, and is not intended to restrict the invention.
The endpoint of disclosed range and any value are not limited to the accurate range or value herein, these ranges or
Value should be understood as comprising the value close to these ranges or value.For numberical range, between the endpoint value of each range, respectively
It can be combined with each other between the endpoint value of a range and individual point value, and individually between point value and obtain one or more
New numberical range, these numberical ranges should be considered as specific open herein.
" peritoneal dialysis solution (lactate) " entitled State Food and Drug Administration is such dialyzate in the present invention
The title of Uniform provisions is specifically shown in State Food and Drug Administration standard YBH12272006, below can be by peritoneal dialysis
Liquid (lactate) composition is referred to as peritoneal dialysis solution.
Percentage as described below refers both to percent weight in volume unless otherwise instructed in the present invention.Wherein glucose with
C6H12O6·H2O meter, calcium chloride is with CaCl2·2H2O meter, magnesium chloride is with MgCl2·6H2O meter.
The present invention provides a kind of peritoneal dialysis solution (lactate) composition, the glucose containing 1.8-4.2%, 0.5-
0.6% sodium chloride, the calcium chloride of 0.02-0.03%, the magnesium chloride of 0.01-0.02%, the sodium lactate and note of 0.35-0.56%
It penetrates and uses water；Wherein, peritoneal dialysis solution (lactate) composition is sterilized by the way of high pressure cold sterilization.In above-mentioned skill
In art scheme, the mode of peritoneal dialysis solution application high pressure cold sterilization provided by the invention sterilizes, and effectively reduces glucose
The phenomenon that degradation generates the noxious materials such as 5 hydroxymethyl furfural (5-HMF), formaldehyde in conventional high temperature sterilizing, it is saturating to improve peritonaeum
Analyse the stability of liquid.
In a kind of preferred embodiment of the present invention, the temperature of the high pressure cold sterilization is 20-40 DEG C, pressure 350-
550MPa, time are 15-30 minutes.Such mode sterilizes, and can effectively kill the bacteriums such as bacillus stearothermophilus, moreover, energy
The case where glucose degradation generates the noxious materials such as 5 hydroxymethyl furfural (5-HMF), formaldehyde is enough substantially reduced, this method is simple,
Controllably, application value with higher.
In a kind of preferred embodiment of the present invention, pH 6.2-6.5.At this ph, human body peritonaeum will not both be produced
Raw stimulation, and the degradation risk of glucose in acid condition can be effectively reduced, it is possible to reduce breakdown of glucose generates life
5 hydroxymethyl furfural (5-HMF), formaldehyde, improve the stability of peritoneal dialysis solution.
In a kind of preferred embodiment of the present invention, pH adjusting agent is trishydroxymethylaminomethane.So that pH is adjusted more
Quick and safety.
The present invention also provides a kind of preparation methods of previously described peritoneal dialysis solution (lactate) composition, including first press
Glucose, sodium chloride, calcium chloride, magnesium chloride and sodium lactate are dissolved in first water for injection according to formula, obtain being concentrated standby
With liquid, medical charcoal filtering is added, filtrate is through high pressure cold sterilization；With the filtrate after trishydroxymethylaminomethane adjustment sterilizing
PH is settled to 100% with second batch water for injection, adds medical charcoal filtering, packing, then high pressure cold sterilization again.
In the above-mentioned technical solutions, present invention application high pressure cold sterilization technique reduces glucose and generates 5- at high temperature
The risk of the harmful substances such as hydroxymethylfurfural (5-HMF), formaldehyde, improves the stability of peritoneal dialysis solution.
In a kind of preferred embodiment of the present invention, after packing the content of trishydroxymethylaminomethane less than 4%, more into
The stability of one step raising peritoneal dialysis solution.
In a kind of preferred embodiment of the present invention, when filtering and concentrating reserve liquid the additive amount of medical charcoal be 0.1~
1%.Not only it can be reduced impurity in peritoneal dialysis solution, but also can effectively remove.
In a kind of preferred embodiment of the present invention, when filtering the composition of constant volume the additive amount of medical charcoal be 0.1~
1%.Not only it can be reduced impurity in peritoneal dialysis solution, but also can effectively remove.
In a kind of preferred embodiment of the present invention, the aperture of terminal is filtered no more than 0.25 μm.Both it can be reduced peritonaeum
Impurity in dialyzate, and can effectively remove.
In a kind of preferred embodiment of the present invention, pH 6.2-6.5.At this ph, human body peritonaeum will not both be produced
Raw stimulation, and the degradation risk of glucose in acid condition can be effectively reduced, it is possible to reduce breakdown of glucose generates life
5 hydroxymethyl furfural (5-HMF), formaldehyde, improve the stability of peritoneal dialysis solution.
The present invention will be described in detail by way of examples below.
Formula described in the present embodiment is the inventory in terms of 1000 bottles of injections.Compare (several pressure such as Chen Jinqiu
The comparison of steam sterilizing indicator, Chinese Disinfection magazine, the 3rd phase of volume 9 in 1992,186-187) disclosure of that, choosing
Select damp and hot pimelobacter sp Bacillus piece (culture presevation number ATCC7953, Hangzhou Fu Jie Bioisystech Co., Ltd production, every
Bacterial content is 5 × 105~5 × 106Cfu sterilizes under testing conditions in 121 DEG C of saturated vapors, and D value is 1.3~1.9min) conduct
Biological indicator verifies the reliability of high pressure cold sterilization sterilizing methods.
Embodiment 1
The preparation method of peritoneal dialysis solution (lactate) composition, including elder generation according to formula: containing in the total amount after constant volume
1.8% glucose, 0.5% sodium chloride, 0.02% calcium chloride, 0.01% magnesium chloride, 0.35% sodium lactate；By Portugal
Grape sugar, sodium chloride, calcium chloride, magnesium chloride and sodium lactate dissolve in first water for injection, obtain concentration reserve liquid；
Medical charcoal filtering is added, the additive amount of medical charcoal is 0.1% when filtering and concentrating reserve liquid, and filtrate is gone out through high pressure is cold
Bacterium；The temperature of high pressure cold sterilization is 20 DEG C, pressure 550MPa, and the time is 15 minutes；
Formula according to the content of trishydroxymethylaminomethane after packing less than 4%, is adjusted with trishydroxymethylaminomethane
The pH to 6.2 of filtrate after sterilizing is settled to 100% with second batch water for injection, adds medical charcoal filtering again, filters constant volume
Composition when medical charcoal additive amount be 0.1%, filter the aperture of terminal no more than 0.25 μm, packing, then high pressure is cold goes out
Bacterium, the temperature of the high pressure cold sterilization are 20 DEG C, pressure 550MPa, and the time is 15 minutes.
Embodiment 2
The preparation method of peritoneal dialysis solution (lactate) composition, including elder generation according to formula: containing in the total amount after constant volume
4.2% glucose, 0.6% sodium chloride, 0.03% calcium chloride, 0.02% magnesium chloride, 0.56% sodium lactate；By Portugal
Grape sugar, sodium chloride, calcium chloride, magnesium chloride and sodium lactate dissolve in first water for injection, obtain concentration reserve liquid；
Medical charcoal filtering is added, the additive amount of medical charcoal is 1% when filtering and concentrating reserve liquid, and filtrate is gone out through high pressure is cold
Bacterium；The temperature of high pressure cold sterilization is 40 DEG C, pressure 350MPa, and the time is 30 minutes；
Formula according to the content of trishydroxymethylaminomethane after packing less than 4%, is adjusted with trishydroxymethylaminomethane
The pH to 6.5 of filtrate after sterilizing is settled to 100% with second batch water for injection, adds medical charcoal filtering again, filters constant volume
Composition when medical charcoal additive amount be 1%, filter the aperture of terminal no more than 0.25 μm, packing, then high pressure cold sterilization,
The temperature of the high pressure cold sterilization is 40 DEG C, pressure 350MPa, and the time is 30 minutes.
Embodiment 3
The preparation method of peritoneal dialysis solution (lactate) composition, including elder generation according to formula: containing in the total amount after constant volume
3% glucose, 0.5% sodium chloride, 0.025% calcium chloride, 0.015% magnesium chloride, 0.45% sodium lactate；By Portugal
Grape sugar, sodium chloride, calcium chloride, magnesium chloride and sodium lactate dissolve in first water for injection, obtain concentration reserve liquid；
Medical charcoal filtering is added, the additive amount of medical charcoal is 0.5% when filtering and concentrating reserve liquid, and filtrate is gone out through high pressure is cold
Bacterium；The temperature of high pressure cold sterilization is 30 DEG C, pressure 450MPa, and the time is 20 minutes；
Formula according to the content of trishydroxymethylaminomethane after packing less than 4%, is adjusted with trishydroxymethylaminomethane
The pH to 6.4 of filtrate after sterilizing is settled to 100% with second batch water for injection, adds medical charcoal filtering again, filters constant volume
Composition when medical charcoal additive amount be 0.5%, filter the aperture of terminal no more than 0.25 μm, packing, then high pressure is cold goes out
Bacterium, the temperature of the high pressure cold sterilization are 30 DEG C, pressure 450MPa, and the time is 20 minutes.
Detect example 1
It takes and before packing, thermophilic rouge is added after filtration sterilization by each group peritoneal dialysis solution of example of formulations method preparation
Fat bacillus Bacillus piece biological indicator, is added after bacterium piece is broken up in sterile water for injection, and additional amount is every 2000ml/
Piece, each experimental group takes 15 bags of injection, respectively according to example of formulations 1-3 formula preparation, each example of formulations 5
Bag, aseptically base samples, and is to be positive with culture medium flavescence with culture culture 7 days containing coeruleum bromocresolis, detection sterilizing
Effect, discovery positive rate are 0.
By sterilizing experiment as can be seen that explanation sterilizing methods provided by the invention can be on the basis of high pressure cold sterilization
On, the collaboration killing effect for the hot bacterium that creates antagonism realizes the effect well to sterilize.
Detect example 2
The sample detection 5HMF content of experimental group 1-3 is taken respectively.Detection method is according to Chinese Pharmacopoeia 2010 editions second 94
Detection method in page under Mannitol sodium chloride injection item carries out absorbance detection.It was found that absorbance is below 0.07.
Testing result show using high pressure cold sterilization sterilization process prepare peritoneal dialysis solution, can be significantly reduced in product with
5HMF is the glucose degradation products of representative, to reduce the saturating dialyzate of abdomen to the toxicity of human body peritonaeum, it is super to avoid peritonaeum
The forfeiture for filtering function improves the safety of its long-time service.
The preferred embodiment of the present invention has been described above in detail, still, during present invention is not limited to the embodiments described above
Detail within the scope of the technical concept of the present invention can be with various simple variants of the technical solution of the present invention are made, this
A little simple variants all belong to the scope of protection of the present invention.
It is further to note that specific technical features described in the above specific embodiments, in not lance
In the case where shield, can be combined in any appropriate way, in order to avoid unnecessary repetition, the present invention to it is various can
No further explanation will be given for the combination of energy.
In addition, various embodiments of the present invention can be combined randomly, as long as it is without prejudice to originally
The thought of invention, it should also be regarded as the disclosure of the present invention.
Claims (10)
1. a kind of peritoneal dialysis solution (lactate) composition, which is characterized in that the glucose containing 1.8-4.2%, 0.5-0.6%
Sodium chloride, the calcium chloride of 0.02-0.03%, the magnesium chloride of 0.01-0.02%, the sodium lactate and injection of 0.35-0.56%
Water；
Wherein, peritoneal dialysis solution (lactate) composition is sterilized by the way of high pressure cold sterilization.
2. peritoneal dialysis solution (lactate) composition according to claim 1, wherein the temperature of the high pressure cold sterilization is
20-40 DEG C, pressure 350-550MPa, the time is 15-30 minutes.
3. peritoneal dialysis solution (lactate) composition according to claim 1 or 2, wherein pH 6.2-6.5.
4. peritoneal dialysis solution (lactate) composition according to claim 3, wherein pH adjusting agent is trihydroxy methyl amino
Methane.
5. a kind of preparation method of the described in any item peritoneal dialysis solutions of claim 1-4 (lactate) composition, feature exist
In, including elder generation dissolves glucose, sodium chloride, calcium chloride, magnesium chloride and sodium lactate according to formula in first water for injection,
Concentration reserve liquid is obtained, adds medical charcoal filtering, filtrate is through high pressure cold sterilization；
With the pH of the filtrate after trishydroxymethylaminomethane adjustment sterilizing, it is settled to 100% with second batch water for injection, is added again
Add medical charcoal to filter, dispenses, then high pressure cold sterilization.
6. preparation method according to claim 5, wherein the content of trishydroxymethylaminomethane is less than 4% after packing.
7. preparation method according to claim 5, wherein when filtering and concentrating reserve liquid the additive amount of medical charcoal be 0.1~
1%.
8. preparation method according to claim 5, wherein the additive amount of medical charcoal is 0.1 when filtering the composition of constant volume
~1%.
9. preparation method according to claim 5, wherein filter the aperture of terminal no more than 0.25 μm.
10. according to the described in any item preparation methods of claim 5-9, wherein pH 6.2-6.5.
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Cited By (1)
| 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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| WO2008157748A2 (en) * | 2007-06-21 | 2008-12-24 | Baxter International Inc. | High-pressure sterilization to terminally sterilize pharmaceutical preparations and medical products |
| CN105640982A (en) * | 2014-11-10 | 2016-06-08 | 天津金耀集团有限公司 | Peritoneal dialysis fluid (lactate) medical composition |
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2018
- 2018-12-18 CN CN201811549848.4A patent/CN109464458A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2008157748A2 (en) * | 2007-06-21 | 2008-12-24 | Baxter International Inc. | High-pressure sterilization to terminally sterilize pharmaceutical preparations and medical products |
| CN105640982A (en) * | 2014-11-10 | 2016-06-08 | 天津金耀集团有限公司 | Peritoneal dialysis fluid (lactate) medical composition |
Non-Patent Citations (2)
| Title |
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| 崔山风: "《保健食品制剂技术》", 30 July 2010, 中国医药科技出版社 * |
| 张广斌等: ""葡萄糖注射液不同灭菌条件下5-羟甲基糠醛的含量"，张广斌等，实用医药杂志，第1076页", 《实用医药杂志》 * |
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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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