CN106821748A - A kind of peritoneal dialysis dual-chamber bag - Google Patents
A kind of peritoneal dialysis dual-chamber bag Download PDFInfo
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- CN106821748A CN106821748A CN201510887296.8A CN201510887296A CN106821748A CN 106821748 A CN106821748 A CN 106821748A CN 201510887296 A CN201510887296 A CN 201510887296A CN 106821748 A CN106821748 A CN 106821748A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
- A61J1/10—Bag-type containers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/28—Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
- A61M1/287—Dialysates therefor
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- Health & Medical Sciences (AREA)
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- General Health & Medical Sciences (AREA)
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- Pharmacology & Pharmacy (AREA)
- External Artificial Organs (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention discloses a kind of peritoneal dialysis dual-chamber bag, belong to the technical field of peritoneal dialysis.The present invention includes bag, and the first liquid room and the second liquid room of temporary transient segmentation are provided with bag, and bleeding agent is provided with the first liquid room, and the volume of the first liquid room accounts for the 15-40% of bag cumulative volume；Buffer is provided with second liquid room, the volume of the second liquid room accounts for the 60-85% of bag cumulative volume.The present invention scientifically devises the volume and proportioning of the first liquid room and the second liquid room, liquid containing bleeding agent is in the liquid room of small volume, pH value is 2.5-4.0, the less generation under low ph environment of glucose degradation products is realized, two mixed physiological pHs in liquid room are also achieved；The big cell is reasonable in design, and easily firmly, rosin joint is easily opened, easy to use；Facilitate the folding of bag, protect rosin joint, it is to avoid the product rejection phenomenon that product is produced in transport and placement process because rosin joint snaps.
Description
Technical field
The invention belongs to the technical field of peritoneal dialysis, a kind of peritoneal dialysis dual-chamber bag is particularly related to.
Background technology
Peritoneal dialysis（PD）It is, with peritonaeum as pellicle, to enter exchanging for water-filling and solute between peritonaeum capillary and dialyzate, electrolyte and small-molecule substance are from a concentration lateral low side shifting high（Dispersion）, hydrone is then from the side shifting that the low lateral osmotic concentration of osmotic concentration is high（Osmosis）, improve dialysate concentration and can reach the purpose for removing internal water；Uremic material is removed from dialyzate in can making blood by solute concentration gradient difference, and maintains electrolyte and acid-base balance, instead of the partial function of kidney.It is easy to operate because it is treated at home, reduce blood borne disease and propagate, the special benefits such as protection residual renal function have been widely used in recent years.
At present, existing peritoneal dialysis solution is with glucose as bleeding agent and with lactate as buffer（Also referred to as buffer base (BB)）, glucose has easily acquirement as bleeding agent, the advantages of cheap.But, this traditional peritoneal dialysis solution is in high concentration glucose, high glucose catabolite（GDP）, high-glycosylation dead end product（AGEs）Have a negative impact to patient etc. all many-sided meetings, peritoneal fibrosiss and ultrafiltration volume can be caused to reduce after long-time use, be the main cause that the saturating patient of abdomen exits PD treatments.In addition, in order to avoid glucose excessive degradation at a high ph, the pH value of peritoneal dialysis solution are selected in the range of 5.0-5.5, this pH value range is not the pH value of physiological, the characteristic symptoms such as stomachache clinically easily occurs.
The content of the invention
The present invention provides a kind of peritoneal dialysis dual-chamber bag, and solve the problems, such as that the transport of the bag of peritoneal dialysis in the prior art and placement are inconvenient, easily cause product rejection and glucose degradation speed influences peritoneal dialysis curative effect soon.
A kind of peritoneal dialysis dual-chamber bag of the invention, what it was mainly realized by the following technical programs：Including bag, the first liquid room and the second liquid room are provided with the bag, the first liquid room and the second liquid room are connected by openable partition member；The first liquid is provided with the first liquid room, first liquid is contained within bleeding agent, calcium ion, magnesium ion and chlorion, and the pH value of first liquid is 2.5-4.0, and the volume of the first liquid room accounts for the 15-40% of the bag cumulative volume；The second liquid is provided with the second liquid room, second liquid is contained within buffer and sodium ion, and the pH value of second liquid is 7.0-9.0, and the volume of the second liquid room accounts for the 60-85% of the bag cumulative volume；The first liquid room connects with the second liquid room after opening partition member, and first liquid and second liquid are mixed to form dialyzate, and in the dialyzate, the content of each composition is：Sodium ion 80-150mmol/L, chlorion 80-110mmol/L, calcium ion 0-4.0mmol/L, magnesium ion 0-4.0mmol/L, buffer 15-45mmol/L, bleeding agent 1-10w/v%.
Used as a kind of preferred embodiment, the bleeding agent is glucose or glucose polymer, and the concentration of bleeding agent is 25.00-670.00g/L in first liquid；The buffer is sodium lactate and/or sodium acid carbonate, and the concentration of buffer is 1.48-8.40g/L in second liquid.
Used as a kind of preferred embodiment, the volume of the first liquid room accounts for the 15-36% of the bag cumulative volume, and the volume of the second liquid room accounts for the 64-85% of the bag cumulative volume.
Used as a kind of preferred embodiment, the volume of the first liquid room accounts for the 36.5-40% of the bag cumulative volume, and the volume of the second liquid room accounts for the 60-63.5% of the bag cumulative volume.
Used as a kind of preferred embodiment, the pH value of first liquid is 3.6-4.0, and the pH value of second liquid is 7.6-9.0.
Used as a kind of preferred embodiment, the partition member is rosin joint bar.
Used as a kind of preferred embodiment, the pH value of the dialyzate is 6.5-7.5.
Used as a kind of preferred embodiment, the pH value of the dialyzate is 7.35.
Used as a kind of preferred embodiment, the bag is one or more in polypropylene bag, polyethylene bag, polybutene bag or SEBS bags.
Compared with prior art, the beneficial effects of the invention are as follows：
（1）The present invention scientifically devises the volume of the first liquid room and the second liquid room, the first liquid of the injection of aqueous solution composition containing bleeding agent is provided with first liquid room, the second liquid of the injection of aqueous solution composition containing buffer is provided with second liquid room, the first liquid containing bleeding agent is in the liquid room of small volume, through the peritoneal dialysis solution after high-temperature sterilization, its glucose degradation products 5 hydroxymethyl furfural and 3, the content of 4- dideoxy glucose furfural -3- alkene is kept at extremely low level, realize the less generation under low ph environment of glucose degradation products, also achieve the physiological ph of gained dialyzate after two liquid rooms mix.
（2）First liquid room and the second liquid room are separated by an openable rosin joint bar, and rosin joint is easily opened, easily firmly, meanwhile, bag folding convenient protects rosin joint；Both ensure that patient and nurse can easily press off rosin joint when in use, in turn ensure that product rosin joint bar in transport and placement process was not prematurely to snap and influence product quality；Overcome existing peritoneal dialysis bag in order to avoid in transportation rosin joint impacted and strengthened the heat sealing strength of rosin joint, squeeze rosin joint so as to cause patient and nurse to be difficult when in use, in turn result in the very inconvenient problem of use.
Specific embodiment
Technical scheme is clearly and completely described below in conjunction with specific embodiment of the invention, it is clear that described embodiment is only a part of embodiment of the invention, rather than whole embodiments.Based on the embodiment in the present invention, the every other embodiment that those of ordinary skill in the art are obtained under the premise of creative work is not made belongs to the scope of protection of the invention.
A kind of peritoneal dialysis dual-chamber bag of the invention, including bag, are provided with the first liquid room and the second liquid room in the bag, the first liquid room and the second liquid room are connected by openable partition member；The first liquid is provided with the first liquid room, first liquid is contained within bleeding agent, calcium ion, magnesium ion and chlorion, and the pH value of first liquid is 2.5-4.0, and the volume of the first liquid room accounts for the 15-40% of the bag cumulative volume；The second liquid is provided with the second liquid room, second liquid is contained within buffer and sodium ion, and the pH value of second liquid is 7.0-9.0, and the volume of the second liquid room accounts for the 60-85% of the bag cumulative volume；The first liquid room connects with the second liquid room after opening partition member, and first liquid and second liquid are mixed to form dialyzate, and in the dialyzate, the content of each composition is：Sodium ion 80-150mmol/L, chlorion 80-110mmol/L, calcium ion 0-4.0mmol/L, magnesium ion 0-4.0mmol/L, buffer 15-45mmol/L, bleeding agent 1-10w/v%.
Specifically, the bleeding agent is glucose or glucose polymer, and the concentration of bleeding agent is 25.00-670.00g/L in first liquid；The buffer is sodium lactate and/or sodium acid carbonate, and the concentration of buffer is 1.48-8.40g/L in second liquid.
Preferably, the volume of the first liquid room accounts for the 15-36% of the bag cumulative volume, and the volume of the second liquid room accounts for the 64-85% of the bag cumulative volume.
Preferably, the volume of the first liquid room accounts for the 36.5-40% of the bag cumulative volume, and the volume of the second liquid room accounts for the 60-63.5% of the bag cumulative volume.
It is further preferred that the pH value of first liquid is 3.6-4.0, the pH value of second liquid is 7.6-9.0.
Specifically, the partition member is rosin joint bar.
Further, the pH value of the dialyzate is 6.5-7.5.
Specifically, the pH value of the dialyzate is 7.35.
Further, the bag is one or more in polypropylene bag, polyethylene bag, polybutene bag or SEBS bags.
Embodiment
1
With in the second liquid in the first liquid in the first liquid room and the second liquid room upon mixing dialyzate, concentration of glucose is 1.5w/v%, calcium ion concentration is 1.75mmol/L, magnesium ion concentration is 0.25mmol/L, lactate ion is 40 mmol/L, the preparation of liquid is carried out according to the ratio and concentration shown in table 1, continuous 3 batches of samples are prepared under each experiment condition, it is filled in dual-chamber bag, experiment is prepared using water for injection；Wherein, glucose is contained in the first liquid room（C6H12O6•H2O）, calcium chloride (CaCl2•2H2O), magnesium chloride (MgCl2•6H2O), sodium chloride is contained in the second liquid room（NaCl）, sodium lactate（C3H5NaO3）.
Above-mentioned peritoneal dialysis solution is by high-temperature sterilization（121 DEG C, 15min）Afterwards, two kinds of main glucose degradation products are determined（GDP）Content, wherein, 5 hydroxymethyl furfural（5-HMF）With 3,4- dideoxy arabino-hexosone -3- alkene（3,4-DGE）The assay method of content is analyzed using high performance liquid chromatography, and experimental result is as shown in table 2.And mixed the first liquid with the second liquid, the pH value of dialyzate after mixing is determined, experimental results show that in design proportion A- ratios D, the pH value of gained dialyzate is distributed near 7.35 between 6.5-7.5, has reached physiological pH value.
As can be seen from Table 2, when the volume that room containing glucose is the first liquid room accounts for bag cumulative volume ratio in 15-40%, its two kinds main glucose degradation products are all maintained than relatively low level, wherein, the content of 5 hydroxymethyl furfural is less than 3.5mg/L, the content of 3,4- dideoxy arabino-hexosone -3- alkene is less than 0.8mg/L.The continuous rising of bag cumulative volume ratio is accounted for the volume that room containing glucose is the first liquid room, GDP growing amounts are constantly raised, the content of larger 3,4-DGE, 3,4-DGE especially is influenceed more than 1.5mg/L, even up to 6mg/L on peritonaeum；Meanwhile, experiment is it has also been found that smaller as the concentration of the glucose of bleeding agent, and glucose is more unstable in autoclaving process, and GDP generations are more, and damage of the peritoneal dialysis solution to peritonaeum is more serious.Therefore, the volume of the first liquid room accounts for bag cumulative volume ratio for 15-40% can significantly reduce two kinds of generations of main glucose degradation products, simultaneously, as the concentration of the glucose of bleeding agent for 37.5-100.00g/L can also substantially reduce two kinds of generations of main glucose degradation products in autoclaving process, damage of the peritoneal dialysis solution to peritonaeum is substantially reduced.
The empirical factor of table 1 designs table
The experimental result statistical form of table 2
Embodiment
2
According to the design proportion of embodiment 1（Ratio A- ratios D）Dual-chamber bag is designed, dual-chamber bag is using with identical heat sealing strength（6~9N）First liquid room and the second liquid room are connected by rosin joint bar；Investigate security of the dual-chamber bag under the conditions of different distances, different time etc., reliability and the vibration resistance of different designs ratio（Rosin joint part）, study its rosin joint stability in whether meeting transport and placement process；Dual-chamber bag under each design proportion（Dress water）There are five casees, totally two ten case, there are four bags per case, four handling are experienced in each distance, experimental result is as shown in table 3.
The dual-chamber bag rosin joint stability test result of table 3
As can be seen from Table 3, when the volume of the first liquid room accounts for bag cumulative volume proportion in 15-40%, 15 casees dual-chamber bags of these three ratios, in the transportation of different distances and different time, substantially there is not the phenomenon that rosin joint snaps, almost all of sample is remained intact.This is that rosin joint is protected well as a result of along rosin joint foldover design, and the impulsive force of transportation is difficult to have influence on rosin joint, so, rosin joint stability is showed preferably, is not likely to produce because snapping produced scrap products in advance using preceding rosin joint.And the volume of the first liquid room accounts for the ratio of bag cumulative volume when being 50%, the phenomenon that rosin joint snaps in advance is occurred in that in three different distances and three transportations of different time, rosin joint snaps rate up to more than 40%；This be due to this design proportion under, ability to bear is poor in transportation, and rosin joint stability is equally also difficult to ensure that in transport and placement process, is also easy to produce scrap products.
The beneficial effects of the invention are as follows：（1）The present invention scientifically devises the volume of the first liquid room and the second liquid room, the first liquid of the injection of aqueous solution composition containing bleeding agent is provided with first liquid room, the second liquid of the injection of aqueous solution composition containing buffer is provided with second liquid room, the first liquid containing bleeding agent is in the liquid room of small volume, through the peritoneal dialysis solution after high-temperature sterilization, its glucose degradation products 5 hydroxymethyl furfural and 3, the content of 4- dideoxy glucose furfural -3- alkene is kept at extremely low level, realize the less generation under low ph environment of glucose degradation products, also achieve the physiological ph of gained dialyzate after two liquid rooms mix.
（2）First liquid room and the second liquid room are separated by an openable rosin joint bar, and rosin joint is easily opened, easily firmly, meanwhile, bag folding convenient protects rosin joint；Both ensure that patient and nurse can easily press off rosin joint when in use, in turn ensure that product rosin joint bar in transport and placement process was not prematurely to snap and influence product quality；Overcome existing peritoneal dialysis bag in order to avoid in transportation rosin joint impacted and strengthened the heat sealing strength of rosin joint, squeeze rosin joint so as to cause patient and nurse to be difficult when in use, in turn result in the very inconvenient problem of use.
Presently preferred embodiments of the present invention is the foregoing is only, is not intended to limit the invention, all any modification, equivalent substitution and improvements within the spirit and principles in the present invention, made etc. should be included within the scope of the present invention.
Claims (9)
1. a kind of peritoneal dialysis dual-chamber bag, it is characterised in that：Including bag, the first liquid room and the second liquid room are provided with the bag, the first liquid room and the second liquid room are connected by openable partition member；
The first liquid is provided with the first liquid room, first liquid is contained within bleeding agent, calcium ion, magnesium ion and chlorion, and the pH value of first liquid is 2.5-4.0, and the volume of the first liquid room accounts for the 15-40% of the bag cumulative volume；
The second liquid is provided with the second liquid room, second liquid is contained within buffer and sodium ion, and the pH value of second liquid is 7.0-9.0, and the volume of the second liquid room accounts for the 60-85% of the bag cumulative volume；
The first liquid room connects with the second liquid room after opening partition member, and first liquid and second liquid are mixed to form dialyzate, and in the dialyzate, the content of each composition is：Sodium ion 80-150mmol/L, chlorion 80-110mmol/L, calcium ion 0-4.0mmol/L, magnesium ion 0-4.0mmol/L, buffer 15-45mmol/L, bleeding agent 1-10w/v%.
2. peritoneal dialysis dual-chamber bag according to claim 1, it is characterised in that：
The bleeding agent is glucose or glucose polymer, and the concentration of bleeding agent is 25.00-670.00g/L in first liquid；
The buffer is sodium lactate and/or sodium acid carbonate, and the concentration of buffer is 1.48-8.10g/L in second liquid.
3. peritoneal dialysis dual-chamber bag according to claim 1 and 2, it is characterised in that：
The volume of the first liquid room accounts for the 15-36% of the bag cumulative volume, and the volume of the second liquid room accounts for the 64-85% of the bag cumulative volume.
4. peritoneal dialysis dual-chamber bag according to claim 1 and 2, it is characterised in that：
The volume of the first liquid room accounts for the 36.5-40% of the bag cumulative volume, and the volume of the second liquid room accounts for the 60-63.5% of the bag cumulative volume.
5. peritoneal dialysis dual-chamber bag according to claim 1 and 2, it is characterised in that：
The pH value of first liquid is 3.6-4.0, and the pH value of second liquid is 7.6-9.0.
6. peritoneal dialysis dual-chamber bag according to claim 1, it is characterised in that：
The partition member is rosin joint bar.
7. peritoneal dialysis dual-chamber bag according to claim 6, it is characterised in that：
The pH value of the dialyzate is 6.5-7.5.
8. peritoneal dialysis dual-chamber bag according to claim 7, it is characterised in that：
The pH value of the dialyzate is 7.35.
9. peritoneal dialysis dual-chamber bag according to claim 1, it is characterised in that：
The bag is one or more in polypropylene bag, polyethylene bag, polybutene bag or SEBS bags.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN201510887296.8A CN106821748A (en) | 2015-12-07 | 2015-12-07 | A kind of peritoneal dialysis dual-chamber bag |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201510887296.8A CN106821748A (en) | 2015-12-07 | 2015-12-07 | A kind of peritoneal dialysis dual-chamber bag |
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| CN106821748A true CN106821748A (en) | 2017-06-13 |
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| CN201510887296.8A Pending CN106821748A (en) | 2015-12-07 | 2015-12-07 | A kind of peritoneal dialysis dual-chamber bag |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109078019A (en) * | 2018-07-16 | 2018-12-25 | 石家庄四药有限公司 | A kind of bicarbonate dialysis liquid system and preparation method thereof of dual-chamber bag packaging |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102824660A (en) * | 2004-05-13 | 2012-12-19 | 弗雷森纽斯医疗护理德国有限责任公司 | Peritoneal dialysis solution |
| CN103432164A (en) * | 2013-09-11 | 2013-12-11 | 华仁药业股份有限公司 | Peritoneal dialysis solution and preparation method thereof |
| CN103446181A (en) * | 2013-09-22 | 2013-12-18 | 华仁药业股份有限公司 | Preparation process of peritoneal dialysate with physiologic pH value |
| CN103445961A (en) * | 2013-08-16 | 2013-12-18 | 华仁药业股份有限公司 | Liquid medicine bag for PD (Peritoneal Dialysis) |
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2015
- 2015-12-07 CN CN201510887296.8A patent/CN106821748A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102824660A (en) * | 2004-05-13 | 2012-12-19 | 弗雷森纽斯医疗护理德国有限责任公司 | Peritoneal dialysis solution |
| CN103445961A (en) * | 2013-08-16 | 2013-12-18 | 华仁药业股份有限公司 | Liquid medicine bag for PD (Peritoneal Dialysis) |
| CN103432164A (en) * | 2013-09-11 | 2013-12-11 | 华仁药业股份有限公司 | Peritoneal dialysis solution and preparation method thereof |
| CN103446181A (en) * | 2013-09-22 | 2013-12-18 | 华仁药业股份有限公司 | Preparation process of peritoneal dialysate with physiologic pH value |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109078019A (en) * | 2018-07-16 | 2018-12-25 | 石家庄四药有限公司 | A kind of bicarbonate dialysis liquid system and preparation method thereof of dual-chamber bag packaging |
| CN109078019B (en) * | 2018-07-16 | 2020-12-11 | 石家庄四药有限公司 | Bicarbonate dialysate packaged by double-chamber bag and preparation method thereof |
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