CN107550928A - A kind of glucose polymer peritoneal dialysis solution and its preparation technology - Google Patents
A kind of glucose polymer peritoneal dialysis solution and its preparation technology Download PDFInfo
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- CN107550928A CN107550928A CN201610502432.1A CN201610502432A CN107550928A CN 107550928 A CN107550928 A CN 107550928A CN 201610502432 A CN201610502432 A CN 201610502432A CN 107550928 A CN107550928 A CN 107550928A
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Abstract
The invention discloses a kind of glucose polymer peritoneal dialysis solution and its preparation technology, belong to the technical field of peritoneal dialysis.The present invention includes the component of following parts by weight：The 150g/L of glucose polymer 50, the 150mEq/L of sodium ion 80, the 110mEq/L of chlorion 80, the 4.0mEq/L of calcium ion 0, the 4.0mEq/L of magnesium ion 0, the 45mEq/L of lactate ion 10, appropriate water for injection；By said components mixed dissolution, activated carbon is added, insulation absorption, decarbonization filtering, adjusts pH value, it is filling, seal, sterilizing, and obtain the product of the present invention.Compared with traditional peritoneal dialysis solution, product of the invention generates less glucose degradation products, particularly 5 hydroxymethylfurfurals, reduces damage of the product in Clinical practice to peritonaeum；Meanwhile the stability of glucose polymer molecular weight is ensure that, realize the long efficient ultrafiltration for staying the abdomen phase.
Description
Technical field
The invention belongs to the technical field of peritoneal dialysis, particularly relates to a kind of glucose polymer peritoneal dialysis solution and its system
Standby technique.
Background technology
Peritoneal dialysis（PD）Be by the use of the peritonaeum of patient as pellicle, to intraperitoneal injection peritoneal dialysis liquid, by blood plasma with
Solute concentration gradient between peritoneal dialysis liquid is removed under normal circumstances as caused by nitrogen metabolism and kidney excretion with osmotic gradient
Noxious material, and help to adjust body fluid, electrolyte and the acid-base balance in body；It treats whole end stage renal as one kind
Disease（End stage renal disease, ESRD）The method of patient, it is easy to operate due to being treated with house, reduce blood source
The special benefits such as sexual disease transmission, protection residual renal function, have been widely used in recent years.
Existing peritoneal dialysis liquid is lactic acid salt form peritoneal dialysis solution, and it is used as using glucose and oozed using glucose as bleeding agent
Saturating agent, have the advantages that easily acquirement is cheap to pass；But also there is high sugared, high grape in this traditional peritoneal dialysis solution
Sugared catabolite（GDPs）, high-glycosylation dead end product（AGEs）And the problems such as low ph value, this can be produced not to patient
The influence of profit, peritoneal fibrosiss and ultrafiltration volume can be caused to reduce after long-time use, this is the master that the saturating patient of abdomen exits PD treatments
Want reason.In addition, glucose molecule size is small, glucose is transported by rapidly peritonaeum, so as in the note of about 2 to 4 hours
In entering, cause the loss of loss and the ultrafiltration of osmotic gradient.
The content of the invention
The present invention provides a kind of glucose polymer peritoneal dialysis solution and its preparation technology, solves peritonaeum in the prior art
Dialyzate have that glucose molecule size is small and its degradation speed it is fast and the problem of influence peritoneal dialysis curative effect.
A kind of glucose polymer peritoneal dialysis solution of the present invention, it is mainly realized by the following technical programs
's：The dialyzate includes the component of following parts by weight：Glucose polymer 50-150g/L, sodium ion 80-150mEq/L, chlorine
Ion 80-110mEq/L, calcium ion 0-4.0mEq/L, magnesium ion 0-4.0mEq/L, lactate ion 10-45mEq/L, injection
Appropriate amount of water.
The present invention uses glucose polymer as bleeding agent, and glucose polymer is macromolecular polymeric body, and molecular volume is big,
It directly can not be absorbed by peritoneal wall via diffusion into intraperitoneal capilary by body, be had stable well
Property.Therefore, high colloid osmotic pressure is produced in cavum peritoneale, to maintain the dehydration of indwelling phase and clean up efficiency；Meanwhile also provide more
Item clinical benefit, such as：Lifting patients undergoing peritoneal dialysis length stays the ultrafiltration effect of abdomen phase, effectively manages patients undergoing peritoneal dialysis body fluid and puts down
Weighing apparatus；Patient's carbohydrate amount through peritoneal dialysis solution absorption daily is reduced, reduces patients with lipid's disease risks；Delay high peritonaeum or Gao Ping
The forfeiture of equal peritonaeum characteristic patient's ultrafiltration efficiency, extend the saturating age of patients undergoing peritoneal dialysis；Reduce product Portugal in Clinical practice
Damage of the grape sugar catabolite to peritonaeum, improve the Clinical practice curative effect of peritoneal dialysis solution.
As a kind of preferred embodiment, the dialyzate includes the component of following parts by weight：Glucose polymer 50-
150g/L, sodium chloride 60-100mEq/L, calcium chloride 2.0-4.0mEq/L, magnesium chloride 2.0-4.0mEq/L, sodium lactate 15-
45mEq/L, appropriate water for injection.Sodium lactate is used as buffer, under the mating reaction of sodium chloride, calcium chloride and magnesium chloride,
Improve the composition of peritoneal dialysis solution, to reach more preferable dialysis-effect.
As a kind of preferred embodiment, the glucose polymer be Icodextrin, maltodextrin, cyclodextrin,
Any one or a few in glucan, chitosan, the pH value of the dialyzate is 4.0-6.5.Reasonable adjustment of the present invention is thoroughly
The pH value of liquid is analysed, the pH value of dialyzate is met the physiological ph of human body, realizes the less generation of glucose degradation products, keep away
Exempt from for a long time using the reduction that can cause peritoneal fibrosiss and ultrafiltration volume after peritoneal dialysis solution；The present invention is with glucose polymer
For bleeding agent, glucose polymer can be any one in Icodextrin, maltodextrin, cyclodextrin, glucan, chitosan
Kind is several, and certainly, glucose polymer of the invention is not limited to these, can also be other any glucose polymerisations
Thing.
As a kind of preferred embodiment, the pH value of the dialyzate is 5.0-5.5.Pass through the further tune of pH value
It is whole, dialyzate is better met the needs of patient, further reduce the unfavorable shadow for a long time using peritoneal dialysis solution to patient
Ring.
A kind of preparation technology of glucose polymer peritoneal dialysis solution of the present invention, it is mainly by the following technical programs
Realized：Comprise the following steps：（1）Into dense dispensing containers, the fresh water for injection of the full batch volumes of 40-80% is added,
The temperature of water for injection be 50-80 DEG C, then, add the glucose polymer of recipe quantity 100% and containing sodium ion, chlorion,
The raw material of calcium ion, magnesium ion and lactate ion, stirring, makes its dissolving；（2）Treat step（1）Component all dissolving after, add
Enter activated carbon, be sufficiently stirred, at 50-60 DEG C, insulated and stirred absorption, decarbonization filtering；（3）By step（2）Gained decoction shifts
To dilute dispensing container, after cooling, remaining water for injection is added, decoction initial pH value is determined, regulation pH value to 4.0-6.5, obtains half
Finished product；（4）By step（3）Gained semi-finished product filter by micropore filter element, are fitted into the outer bag of high temperature resistant, sealing；（5）By step
（4）Product after sealing, moist heat sterilization, sterilising temp are 115-121 DEG C, sterilization time 8-30min.
The present invention carries out insulation absorption to dialyzate using activated carbon, decarbonization filtering, dialyzate is carried out using activated carbon
Integrated treatment；Then, adjust the pH value of dialyzate, filtered by micropore filter element, it is filling, sealing and moist heat sterilization and obtain this hair
Bright product.This preparation technology can preferably improve the product quality of peritoneal dialysis solution, greatly reduce peritoneal dialysis solution
To the adverse effect of patient；The preparation technology is simple, easy to operate, it is easy to accomplish industrialization.With traditional peritoneal dialysis liquid phase
Than product of the invention generates less glucose degradation products, is especially reduction of the content of 5 hydroxymethyl furfural, reduces
The product damage of glucose degradation products to peritonaeum in Clinical practice, meanwhile, it ensure that glucose polymer molecular weight
Stability, it is achieved thereby that the long efficient ultrafiltration for staying the abdomen phase.
As a kind of preferred embodiment, the step（5）In, outer bag is non-PVC packaging bags, the non-PVC bags
Pack is formed using the compacting of three-layer co-extruded film for transfusion, and the volume of the non-PVC packaging bags is 1-3L.Traditional PVC material is being made
Substantial amounts of plasticizer is with the addition of when being produced for film bag, such as widely used DEHP [phthalic acid two (2- ethyl hexyls) ester]；By
Directly contacted in peritonaeum packaging bag with decoction, film bag made of traditional use PVC material, its when containing decoction plasticizer compared with
Easy dissolution, these plasticizer are potentially carcinogenic, moreover, having genetoxic and teratogenesis；Meanwhile patients undergoing peritoneal dialysis daily will
Using dialyzate, dosage is very big, and long-term use is possible to amplify the harmfulness of plasticizer.
As a kind of preferred embodiment, the non-PVC packaging bags include internal layer, middle level and outer layer, and the internal layer is
The mixed layer of polypropylene and SEB polymer composition, the middle level are the mixed layer of polypropylene, polyethylene and SEB polymer composition,
The outer layer is the mixed layer that polypropylene and SEB polymer form.Non- PVC co-extrusions film membrane material is free of adhesive and plasticizer
（DEHP）, have the characteristics that nontoxic, environmentally friendly, drug compatibility is good, avoid toxic action caused by PVC material.
As a kind of preferred embodiment, the step（1）In, the temperature of water for injection is 50-60 DEG C, the sodium from
The raw material of son is sodium chloride, sodium lactate, sodium acid carbonate, any one or a few in sodium citrate, the raw material of the chlorion
For any one or a few in sodium chloride, calcium chloride, magnesium chloride, potassium chloride, the raw material of the calcium ion is calcium chloride, described
The raw material of magnesium ion is magnesium chloride, and the raw material of the lactate ion is sodium lactate.These medical raw material sources enrich, and price is low
It is honest and clean, conveniently it is easy to get, reduce further the cost of peritoneal dialysis solution.
As a kind of preferred embodiment, the step（2）In, the addition of activated carbon is 0.01-0.5%, and insulation is inhaled
The attached time is 5-40min；The step（4）In, any one being filtered into 1 grade, 2 grades or 3 grades filtering is described micro-
Hole filter core is 0.2 μm or 0.2 μm and any one in 0.45 μm, 5 μm or two kinds of combination.The addition 0.01- of activated carbon
0.5% refers to quality and volume ratio, i.e. W/V, and its unit is g/100mL, is represented with %, using the work put into every 100mL decoctions
The quality g of property charcoal is calculated；By controlling the addition of activated carbon, the insulation absorption of activated carbon can be preferably completed, is improved
The treatment effect of peritoneal dialysis solution；Meanwhile facilitate filtering decarbonization, improve production efficiency.0.2 μm of filter core is selected in micro porous filtration,
Meanwhile 0.2 μm of filter core can also coordinate 0.45 μm of filter core and/or 5 μm of filter core to be used together, so as to carry out 2 grades or 3 grades
Filtering；Certainly, filter core size of the invention is also not limited to these three, can also select the filter core of other sizes or carry out it
The filtering of its rank.
As a kind of preferred embodiment, the step（3）In, dilute dispensing container inner liquid medicine is cooled to 20-50 DEG C, uses
Acidity regulator carry out pH value regulation, the acidity regulator be watery hydrochloric acid, citric acid, lactic acid, phosphoric acid, citric acid, tartaric acid,
Any one or a few in malic acid, metatartaric acid, acetic acid, adipic acid, fumaric acid.Using acidity regulator to dialyzate
PH value is adjusted, and the species of acidity regulator is a lot, can be selected according to being actually needed, its source is wide, cheap and easy to get.
The beneficial effects of the invention are as follows：It is bleeding agent present invention employs glucose polymer, glucose polymer is big
Molecular aggregate, molecular volume is big, can not directly via diffusion by peritoneal wall into intraperitoneal capilary be body institute
Absorb, there is good stability, realize the long efficient ultrafiltration for staying the abdomen phase；The pH of the invention for rationally controlling peritoneal dialysis solution
Value, makes it better meet the demand of Human Physiology pH value, meanwhile, present invention reduces glucose polymer in high-temperature sterilization mistake
Palliating degradation degree in journey, reduce damage of the product in Clinical practice to peritonaeum；The present invention is also used using three-layer co-extruded transfusion
The non-PVC packaging bags that mould system forms are packed, and avoid the harm of PVC packaging bags plasticizer-containing and plasticizer to human body
Phenomenon, improve the Clinical practice curative effect of peritoneal dialysis solution.
Embodiment
Technical scheme is clearly and completely described below in conjunction with the specific embodiment of the present invention, shown
So, described embodiment is only the part of the embodiment of the present invention, rather than whole embodiments.Based in the present invention
Embodiment, the every other embodiment that those of ordinary skill in the art are obtained under the premise of creative work is not made, all
Belong to the scope of protection of the invention.
A kind of glucose polymer peritoneal dialysis solution of the present invention, the dialyzate include the component of following parts by weight：Portugal
Grape glycopolymers 50-150g/L, sodium ion 80-150mEq/L, chlorion 80-110mEq/L, calcium ion 0-4.0mEq/L, magnesium from
Sub- 0-4.0mEq/L, lactate ion 10-45mEq/L, appropriate water for injection.
Preferably, the dialyzate includes the component of following parts by weight：Glucose polymer 50-150g/L, sodium chloride 60-
100mEq/L, calcium chloride 2.0-4.0mEq/L, magnesium chloride 2.0-4.0mEq/L, sodium lactate 15-45mEq/L, appropriate water for injection.
Further, the glucose polymer is in Icodextrin, maltodextrin, cyclodextrin, glucan, chitosan
Any one or a few, the pH value of the dialyzate is 4.0-6.5.
Further, the pH value of the dialyzate is 5.0-5.5.
A kind of preparation technology of glucose polymer peritoneal dialysis solution of the present invention, comprises the following steps：（1）Put to concentrated compounding
In container, the fresh water for injection of the full batch volumes of 40-80% is added, the temperature of water for injection is 50-80 DEG C, then, at addition
Side's 100% glucose polymer of amount and the raw material containing sodium ion, chlorion, calcium ion, magnesium ion and lactate ion, are stirred
Mix, make its dissolving；（2）Treat step（1）Component all dissolving after, add activated carbon, be sufficiently stirred, at 50-60 DEG C, insulation
Stirring and adsorbing, decarbonization filtering；（3）By step（2）Gained decoction is transferred to dilute dispensing container, after cooling, adds remaining injection
Water, determines decoction initial pH value, and regulation pH value obtains semi-finished product to 4.0-6.5；（4）By step（3）Gained semi-finished product pass through micropore
Filter element filtering, it is fitted into the outer bag of high temperature resistant, sealing；（5）By step（4）Product after sealing, moist heat sterilization, sterilising temp are
115-121 DEG C, sterilization time 8-30min.
Specifically, the step（5）In, outer bag is non-PVC packaging bags, and the non-PVC packaging bags are using three-layer co-extruded
Film for transfusion compacting forms, and the volume of the non-PVC packaging bags is 1-3L.
Further, the non-PVC packaging bags include internal layer, middle level and outer layer, and the internal layer is that polypropylene and SEB polymerize
The mixed layer of thing composition, the middle level are the mixed layer of polypropylene, polyethylene and SEB polymer composition, and the outer layer is poly- third
The mixed layer of alkene and SEB polymer composition.
Preferably, the step（1）In, the temperature of water for injection is 50-60 DEG C, and the raw material of the sodium ion is chlorination
Any one or a few in sodium, sodium lactate, sodium acid carbonate, sodium citrate, the raw material of the chlorion is sodium chloride, chlorination
Any one or a few in calcium, magnesium chloride, potassium chloride, the raw material of the calcium ion are calcium chloride, the raw material of the magnesium ion
For magnesium chloride, the raw material of the lactate ion is sodium lactate.
Further, the step（2）In, the addition of activated carbon is 0.01-0.5%, and the time for being incubated absorption is 5-
40min；The step（4）In, any one being filtered into 1 grade, 2 grades or 3 grades filtering, the micropore filter element is 0.2 μ
M or 0.2 μm with any one in 0.45 μm, 5 μm or two kinds of combination.
Specifically, the step（3）In, dilute dispensing container inner liquid medicine is cooled to 25-40 DEG C, and pH is carried out using acidity regulator
Value regulation, the acidity regulator be watery hydrochloric acid, citric acid, lactic acid, phosphoric acid, citric acid, tartaric acid, malic acid, metatartaric acid,
Any one or a few in acetic acid, adipic acid, fumaric acid.
Embodiment one
The present embodiment is exemplified by producing 300 bags of 2.0L specifications product scales, amount of preparation 600L.
（1）Weighing：Glucose polymer 45kg, magnesium chloride 0.030kg, calcium chloride 0.154kg, sodium chloride 3.21kg, breast
Sour sodium 2.688kg, glucose polymer is Icodextrin here.
（2）Into concentrated compounding container, the fresh water for injection of 80% full batch volumes is added, the temperature of water for injection is 50 DEG C；
Then, the glucose polymer of recipe quantity 100%, calcium chloride, sodium chloride, magnesium chloride, sodium lactate are added, stirring, makes its dissolving.
（3）After said components all dissolving, 0.01% is added（W/V）Activated carbon, it is sufficiently stirred, at 50-60 DEG C, protects
Warm stirring and adsorbing, decarbonization filtering.
（4）Above-mentioned decoction is transferred to dilute preparing tank, after cooling, remaining water for injection is added, determines decoction initial pH value,
PH value is adjusted to 4.0 with watery hydrochloric acid, obtains semi-finished product.
（5）Spray pump is opened, above-mentioned semi-finished product are filtered by 0.2 μm of micropore filter element, and is fitted into the outer bag of high temperature resistant,
Sealing.
（6）By after above-mentioned sealing product carry out moist heat sterilization, 115 DEG C, 30min.
Embodiment two
The present embodiment is exemplified by producing 600 bags of 1.0L specifications product scales, amount of preparation 600L.
（1）Weighing：Glucose polymer 60kg, magnesium chloride 0.030kg, calcium chloride 0.154kg, sodium chloride 3.21kg, breast
Sour sodium 2.688kg, glucose polymer is maltodextrin here.
（2）Into concentrated compounding container, the fresh water for injection of 70% full batch volumes is added, water for injection temperature is 60 DEG C；So
Afterwards, the glucose polymer of recipe quantity 100%, calcium chloride, sodium chloride, magnesium chloride, sodium lactate are added, stirring, makes its dissolving.
（3）After said components all dissolving, 0.1% is added（W/V）Activated carbon, be sufficiently stirred, at 50 DEG C, insulation
Stirring and adsorbing, decarbonization filtering.
（4）Above-mentioned decoction is transferred to dilute preparing tank, after cooling, remaining water for injection is added, determines decoction initial pH value,
With citron acid for adjusting pH value to 5.0, semi-finished product are obtained.
（5）Spray pump is opened, by above-mentioned semi-finished product successively by 0.45 μm and 0.2 μm of micropore filter element filtering, and load resistance to
In the outer bag of high temperature, sealing.
（6）By the product moist heat sterilization after above-mentioned sealing, 121 DEG C, 15min.
Embodiment three
The present embodiment is exemplified by producing 200 bags of 3.0L specifications product scales, amount of preparation 600L.
（1）Weighing：Glucose polymer 90kg, magnesium chloride 0.030kg, calcium chloride 0.154kg, sodium chloride 3.21kg, breast
Sour sodium 2.688kg, glucose polymer is Icodextrin and maltodextrin according to 1 here:The mixing of 1 mass ratio composition
Thing.
（2）Into concentrated compounding container, the fresh water for injection of 60% full batch volumes is added, the temperature of water for injection is 80 DEG C；
Then, the glucose polymer of recipe quantity 100%, calcium chloride, sodium chloride, magnesium chloride, sodium lactate are added, stirring, makes its dissolving.
（3）0.5% is added after all dissolving（W/V）Activated carbon, it is sufficiently stirred, at 60 DEG C, insulated and stirred absorption,
Decarbonization filtering.
（4）Above-mentioned decoction is transferred to dilute preparing tank, after cooling, remaining water for injection is added, determines decoction initial pH value,
With newborn acid for adjusting pH value to 5.5, semi-finished product are obtained.
（5）Spray pump is opened, above-mentioned semi-finished product are filtered by 5 μm, 0.45 μm and 0.2 μm micropore filter elements successively, and fills
Enter in the outer bag of high temperature resistant, sealing.
（6）By the product moist heat sterilization after above-mentioned sealing：121 DEG C, 15min.
Example IV
The present embodiment is exemplified by producing 300 bags of 2.0L specifications product scales, amount of preparation 600L.
（1）Weighing：Glucose polymer 30kg, magnesium chloride 0.2436kg, sodium chloride 3.21kg, sodium lactate 3.024kg, this
In glucose polymer be glucan.
（2）Into concentrated compounding container, the fresh water for injection of 50% full batch volumes is added, the temperature of water for injection is 60 DEG C；
Then, the glucose polymer of recipe quantity 100%, sodium chloride, magnesium chloride, sodium lactate are added, stirring, makes its dissolving.
（3）0.05% is added after all dissolving（W/V）Activated carbon, it is sufficiently stirred, at 60 DEG C, insulated and stirred absorption,
Adsorb 40min, decarbonization filtering.
（4）Above-mentioned decoction is transferred to dilute preparing tank, after cooling, remaining water for injection is added, determines decoction initial pH value,
With second acid for adjusting pH value to 5.7, semi-finished product are obtained.
（5）Spray pump is opened, above-mentioned semi-finished product are filtered by 0.2 μm of micropore filter element, and is fitted into the outer bag of high temperature resistant,
Sealing.
（6）By the product moist heat sterilization after above-mentioned sealing：121 DEG C, 8min.
Embodiment five
The present embodiment is exemplified by producing 200 bags of 3.0L specifications product scales, amount of preparation 600L.
（1）Weighing：Glucose polymer 90kg, calcium chloride 0.1764kg, sodium chloride 3.21kg, sodium lactate 0.672kg, this
In glucose polymer be Icodextrin, maltodextrin, cyclodextrin, glucan and chitosan mixture.
（2）Into concentrated compounding container, the fresh water for injection of 40% full batch volumes is added, the temperature of water for injection is 55 DEG C；
Then, the glucose polymer of recipe quantity 100%, calcium chloride, sodium chloride, sodium lactate are added, stirring, makes its dissolving.
（3）0.15% is added after all dissolving（W/V）Activated carbon, it is sufficiently stirred, at 55 DEG C, insulated and stirred absorption,
Adsorb 5min, decarbonization filtering.
（4）Above-mentioned decoction is transferred to dilute preparing tank, after cooling, remaining water for injection is added, determines decoction initial pH value,
With apple acid for adjusting pH value to 6.0, semi-finished product are obtained.
（5）Spray pump is opened, above-mentioned semi-finished product are filtered by 5 μm, 0.45 μm and 0.2 μm micropore filter elements successively, and fills
Enter in the outer bag of high temperature resistant, sealing.
（6）By the product moist heat sterilization after above-mentioned sealing：121 DEG C, 20min.
Experiment 1
Finished product obtained by the control sample of charcoal absorption and semi-finished product difference are not added the embodiment of the present invention one to embodiment five and
Lactic acid sodium content, glucose polymer assay are carried out, lactic acid sodium content uses high effective liquid chromatography for measuring, and glucose gathers
Compound content is determined using polarimetry, and determines the embodiment of the present invention one to the bacterial endotoxin of the gained finished product of embodiment five, real
It is as shown in table 1 to test result.
As can be seen from Table 1, when carrying out adsorption treatment without using activated carbon, gained finished product only has<0.25EU/mL's is thin
Bacterium endotoxin meets regulation, and<0.1EU/mL bacterial endotoxin is then against regulation.The present invention is adsorbed by activated carbon
After processing, gained finished product<0.25EU/mL bacterial endotoxin and<0.1EU/mL bacterial endotoxin meets regulation；Also,
The present invention is can be seen that by the sodium lactate to semi-finished product and finished product and glucose polymer assay to carry out by activated carbon
The main component of gained finished product and semi-finished product is not affected after adsorption treatment.Therefore, the present invention do not influence mainly into
On the premise of part content, the removing to bacterium is realized, particularly<The removing of 0.1EU/mL bacterium.
The semi-finished product and end properties test result of the present invention of table 1
Experiment 2
The embodiment of the present invention one is distinguished to embodiment five and by finished product obtained by the control sample of bleeding agent and semi-finished product of glucose
PH value measure is carried out, and determines the embodiment of the present invention one to the 5 hydroxymethyl furfural of the gained finished product of embodiment five（5-HMF）And Portugal
Grape glycopolymers content, 5 hydroxymethyl furfural（5-HMF）With being carried out using Optical Rotation for glucose polymer Content
Measure, as a result as shown in table 2.
As can be seen from Table 2, with using glucose, compared with the control sample dialyzate of bleeding agent, the present invention is gathered using glucose
When compound is as bleeding agent, under identical glucose or glucose polymer content, glucose degradation products 5- of the invention
Hydroxymethylfurfural（5-HMF）Content significantly reduces；Therefore, present invention reduces glucose polymer in autoclaving process
Palliating degradation degree.
The semi-finished product and end properties test result of the present invention of table 2
The beneficial effects of the invention are as follows：It is bleeding agent present invention employs glucose polymer, glucose polymer is macromolecular
Condensate, molecular volume is big, directly can not be absorbed via diffusion by peritoneal wall into intraperitoneal capilary by body,
With good stability, the long efficient ultrafiltration for staying the abdomen phase is realized；The pH value of the invention for rationally controlling peritoneal dialysis solution, makes
It better meets the demand of Human Physiology pH value, meanwhile, present invention reduces glucose polymer in autoclaving process
Palliating degradation degree, reduce damage of the product in Clinical practice to peritonaeum；The present invention also uses three-layer co-extruded film for transfusion pressure
Make the non-PVC packaging bags formed to be packed, avoid showing for the harm of PVC packaging bags plasticizer-containing and plasticizer to human body
As improving the Clinical practice curative effect of peritoneal dialysis solution.
The foregoing is merely illustrative of the preferred embodiments of the present invention, is not intended to limit the invention, all essences in the present invention
God any modification, equivalent substitution and improvements made etc., should be included in the scope of the protection with principle.
Claims (10)
- A kind of 1. glucose polymer peritoneal dialysis solution, it is characterised in that：The dialyzate includes the component of following parts by weight：Glucose polymer 50-150g/L, sodium ion 80-150mEq/L, chlorion 80-110mEq/L, calcium ion 0-4.0mEq/ L, magnesium ion 0-4.0mEq/L, lactate ion 10-45mEq/L, appropriate water for injection.
- 2. glucose polymer peritoneal dialysis solution according to claim 1, it is characterised in that：The dialyzate includes following The component of parts by weight：Glucose polymer 50-150g/L, sodium chloride 60-100mEq/L, calcium chloride 2.0-4.0mEq/L, magnesium chloride 2.0- 4.0mEq/L, sodium lactate 15-45mEq/L, appropriate water for injection.
- 3. glucose polymer peritoneal dialysis solution according to claim 1 or 2, it is characterised in that：The glucose polymer be Icodextrin, maltodextrin, cyclodextrin, glucan, in chitosan any one or Several, the pH value of the dialyzate is 4.0-6.5.
- 4. glucose polymer peritoneal dialysis solution according to claim 3, it is characterised in that：The pH value of the dialyzate is 5.0-5.5.
- 5. the preparation technology of glucose polymer peritoneal dialysis solution according to claim 1, it is characterised in that including following Step：（1）Into dense dispensing containers, the fresh water for injection of the full batch volumes of 40-80% is added, the temperature of water for injection is 50- 80 DEG C, then, add the glucose polymer of recipe quantity 100% and contain sodium ion, chlorion, calcium ion, magnesium ion and lactic acid The raw material of radical ion, stirring, makes its dissolving；（2）Treat step（1）Component all dissolving after, add activated carbon, be sufficiently stirred, at 50-60 DEG C, insulated and stirred inhale It is attached, decarbonization filtering；（3）By step（2）Gained decoction is transferred to dilute dispensing container, after cooling, adds remaining water for injection, measure decoction is initial PH value, regulation pH value obtain semi-finished product to 4.0-6.5；（4）By step（3）Gained semi-finished product filter by micropore filter element, are fitted into the outer bag of high temperature resistant, sealing；（5）By step（4）Product after sealing, moist heat sterilization, sterilising temp are 115-121 DEG C, sterilization time 8-30min.
- 6. the preparation technology of glucose polymer peritoneal dialysis solution according to claim 5, it is characterised in that：The step（4）In, outer bag is non-PVC packaging bags, and the non-PVC packaging bags are suppressed using three-layer co-extruded film for transfusion Form, the volume of the non-PVC packaging bags is 1-3L.
- 7. the preparation technology of glucose polymer peritoneal dialysis solution according to claim 6, it is characterised in that：The non-PVC packaging bags include internal layer, middle level and outer layer, and the internal layer is the mixing that polypropylene and SEB polymer form Layer, the middle level are the mixed layer of polypropylene, polyethylene and SEB polymer composition, and the outer layer is polypropylene and SEB polymer The mixed layer of composition.
- 8. the preparation technology of glucose polymer peritoneal dialysis solution according to claim 5, it is characterised in that：The step（1）In, the temperature of water for injection is 50-60 DEG C, and the raw material of the sodium ion is sodium chloride, sodium lactate, carbon Any one or a few in sour hydrogen sodium, sodium citrate, the raw material of the chlorion is sodium chloride, calcium chloride, magnesium chloride, chlorination Any one or a few in potassium, the raw material of the calcium ion are calcium chloride, and the raw material of the magnesium ion is magnesium chloride, the breast The raw material of acid ion is sodium lactate.
- 9. the preparation technology of glucose polymer peritoneal dialysis solution according to claim 5, it is characterised in that：The step（2）In, the addition of activated carbon is 0.01-0.5%, and the time for being incubated absorption is 5-40min；The step （4）In, any one in 1 grade, 2 grades or 3 grades filtering is filtered into, micropore filter element is in 0.2 μm or 0.2 μm and 0.45 μm, 5 μm Any one or two kinds combination.
- 10. the preparation technology of glucose polymer peritoneal dialysis solution according to claim 5, it is characterised in that：The step（3）In, dilute dispensing container inner liquid medicine is cooled to 20-50 DEG C, and pH value regulation is carried out using acidity regulator, described Acidity regulator be watery hydrochloric acid, citric acid, lactic acid, phosphoric acid, citric acid, tartaric acid, malic acid, metatartaric acid, acetic acid, oneself two Acid, any one or a few in fumaric acid.
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