CN108144042A - A kind of peritoneal dialysis solution containing glucose polymer and preparation method thereof - Google Patents
A kind of peritoneal dialysis solution containing glucose polymer and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a kind of peritoneal dialysis solutions containing glucose polymer and preparation method thereof, belong to the technical field of peritoneal dialysis solution.The present invention includes the first liquid of acidity and the second liquid separately packed, and the first liquid includes glucose polymer, and the second liquid includes glutamine dipeptide and buffer base (BB), includes following components after the first liquid and the mixing of the second liquid：60 150g/L of glucose polymer, 1 5g/L of glutamine dipeptide, 2 42mmol/L of buffer base (BB), 0 2.5mmol/L of calcium ion, 0 1.0mmol/L of magnesium ion, 80 110mmol/L of chlorion.The present invention realizes glucose polymer and is in relatively low pH environment, reduces the generation of glucose degradation products, significantly improves bio-incompatibility of the glucose polymer to peritonaeum；Reach the pH value of physiological range after the mixing of two liquid, avoid local irritation of the acid peritoneal dialysis solution to peritonaeum.
Description
Technical field
The invention belongs to the technical fields of peritoneal dialysis solution, particularly relate to a kind of peritoneal dialysis containing glucose polymer
Liquid.
Background technology
Peritoneal dialysis is a kind of common whole end stage renal Replacement Therapy.Compared with haemodialysis, peritoneal dialysis is excellent
Gesture show as medical expense relative moderate, it is easy to operate, independent of large-scale dialysis machine, can realize and treat at home, to suffering from
The free less-restrictive of life of person.Therefore, the patient numbers for receiving peritoneal dialysis increase year by year.Peritoneal dialysis solution is usually with highly concentrated
The glucose of degree is main bleeding agent, although glucose bleeding agent has many advantages, such as cheap, easy acquisition, glucose
The high glucose catabolite generated when the high sugared, hypertonicity and high-temperature sterilization of peritoneal dialysis solution can generate damage to peritonaeum and make
With peritoneal fibrosiss, even ultrafiltration failure can be caused after prolonged application, and becoming leads to CAPD（Continuous Ambulatory
Peritoneal Dialysis, continuous ambulatory peritoneal dialysis）Patient exits the main reason for peritoneal dialysis treatment.
With the raising of dialysis, novel dialytic liquid clinically continuously emerges, using polyglucose as the saturating of bleeding agent
It is exactly one kind therein to analyse liquid, and polyglucose is starch derivatives by α (1-4) and less than 10% α (1-6) glucosides key connection
Water-Soluble Glucose polymer.Glucose polymer dialyzate makes moisture pass through on peritonaeum by generating colloid osmotic pressure
Aperture is purged, so as to play ultrafiltration.
At present, the Icodextrin peritoneal dialysis solution that the whole world mainly provides is the Extraneal of Baxter companies, is remained as
Traditional peritoneal dialysis solution is the same, and using single pouch package, solution is acidity, and 5.2 or so, this peritoneal dialysis solution has pH
Following shortcoming：1. low ph value may cause pain, and to peritoneal cell when being injected to certain patients（Including mesothelial cell,
Macrophage and fibroblast）With cytotoxicity, intraperitoneal neutrocyte and macrophage function can be inhibited, influence abdomen
Film mesothelial cell etc. influences the dimension to the lasting intraperitoneal immunocompetence that plays an important role of progress peritoneal dialysis and peritonaeum function
It holds；Icodextrin under low ph condition generates many different catabolites so as to cause to glycosylate it can also happen that degradation
End products（AGE）Formation, and AGE can cause the damage of peritoneal tissues, lead to ultrafiltration function obstacle.2. In vitro cell experiment
Prompting Icodextrin may result in the acute injury of Peritoneal Mesothelial Cells, such as Icodextrin peritoneal dialysis solution is incubated people's peritonaeum
1-4 hours proliferation, the vigor that can significantly inhibit cell of mesothelial cell（It is similar with the result of 1.5 % glucose peritoneal dialysis solutions）,
It is additionally made, which to discharge the IL-6 factors, increases；In addition, Kuo HT et al. researchs find that human mesothelial cells are exposed to 7.5% Chinese mugwort
It examines dextrin peritoneal dialysis solution after sixty minutes, the ROS generated into the cell can be caused horizontal significantly raised, mitochondrial membrane potential declines,
And the cell for having necrosis occurs.It, can apparent inducing lipids 3. in vivo studies is also confirmed that when Icodextrin is administered through rat abdominal cavity
Peroxidating even results in peritoneal fibrosiss adhesion.Oxidativestress damage may be the main reason for it causes peritonaeum to be damaged, because
This, it is current urgent problem to be solved to improve polyglucose peritoneal dialysis solution bio-incompatibility.
Invention content
The present invention provides a kind of peritoneal dialysis solution containing glucose polymer and preparation method thereof, solves in the prior art
There is high sugar, hypertonicity and damaging action and polyglucose peritoneal dialysis solution can be generated to peritonaeum in glucose peritoneal dialysis solution
There are problems that bio-incompatibility.
A kind of peritoneal dialysis solution containing glucose polymer of the present invention, is mainly subject to reality by the following technical programs
Existing：The dialyzate includes the first liquid and the second liquid temporarily separately packed；First liquid be acid solution, institute
The pH value for stating the first liquid is 2.5-5.0, and first liquid includes glucose polymer, calcium ion, magnesium ion and chlorion,
The volume of first liquid is the 30-65% of the total dialysate volume, and the pH value of second liquid is 6.5-8.5, described
Second liquid includes glutamine dipeptide and buffer base (BB)；The dialysis is obtained after first liquid and second liquid mixing
Liquid, the dialyzate include following components：Glucose polymer 60-150g/L, glutamine dipeptide 1-5g/L, buffer base (BB) 2-
42mmol/L, calcium ion 0-2.5mmol/L, magnesium ion 0-1.0mmol/L, chlorion 80-110mmol/L.
The present invention provides a kind of glucose polymer peritoneal dialysis solution containing glutamine dipeptide, by the way that glucose is gathered
It closes object and buffer base (BB) is separately packed, glucose polymer is made to be in acid environment, to enhance the stabilization of glucose polymer
Property and reduce glucose degradation products generation；Glutamine dipeptide is added in buffer base (BB), glutamine dipeptide is quick
Propagated cell（Such as mucomembranous cell and lymphocyte）The breathing fuel preferentially selected, can adjust internal acid-base balance, be tissue
Between nitrogen carrier；Glutamine dipeptide is added in the second liquid, the stability of buffer base (BB), two kinds of medicines can be further increased
After liquid mixing, whole pH value tends to be neutral, is more nearly the physiologic pH values with human body, effectively improves the biology of peritonaeum
Compatibility.
As a kind of preferred embodiment, the dialyzate further include vasodilator, diuretics, hormone, vitamin,
Any one or a few in antioxidant.The present invention can also further add vasodilator, diuretics, hormone, dimension life
Element, antioxidant etc., further to improve the performance of peritoneal dialysis liquid product；Added respectively according to the acid-base property of above-mentioned substance
Add in the first liquid or the second liquid, certainly, these substances can also separately made third liquid, be packed into the third of medicinal fluid bag
Chamber is mixed again when in use；The specific dosage of above-mentioned substance is depending on the clinical treatment demand of patient.
As a kind of preferred embodiment, the buffer base (BB) is lactate, bicarbonate, citrate, isocitric acid
Salt, acetonate, succinate, fumarate, malate, any one or a few in oxaloacetate, it is preferable that
The buffer base (BB) is lactate and the mixture of bicarbonate, it is highly preferred that the buffer base (BB) is sodium lactate and sodium bicarbonate
Mixture.There are many kinds of selections, the preferably mixture of lactate and bicarbonate, particularly sodium lactate for the buffer base (BB) of the present invention
With the mixture of sodium bicarbonate.
As a kind of preferred embodiment, the dialyzate includes following components：Glucose polymer 60-90g/L, paddy
Glutamine dipeptides 1-5g/L, sodium ion 80-150mmol/L, bicarbonate ion 2-40mmol/L, lactate ion 0-
40mmol/L, chlorion 80-110mmol/L, calcium ion 0-2.5mmol/L, magnesium ion 0-1.0mmol/L.The present invention realizes
The peritoneal dialysis solution of physiological ph can realize good ultrafiltration using glucose polymer as main bleeding agent, be conducive to
The removing of metabolic waste；Glutamine dipeptide is added in, can effectively protect peritoneal tissues reduce damage of the glucose polymer to peritonaeum
Wound, avoids relevant adverse reaction；The present invention can realize efficient ultrafiltration and small molecule toxins scavenging effect, while have good
Good peritonaeum biocompatibility.
As a kind of preferred embodiment, in the dialyzate, a concentration of 22-28mmol/L of bicarbonate ion,
A concentration of 12-18mmol/L of lactate ion.When the present invention selects the mixture of sodium lactate and sodium bicarbonate as buffer base (BB),
The concentration of bicarbonate ion and the concentration of lactate ion can advanced optimize in dialyzate, to improve the property of dialyzate
Energy.
As a kind of preferred embodiment, the glucose polymer for Icodextrin, maltodextrin, cyclodextrin,
Any one or a few in glucan, chitosan.There are many kinds of the types of glucose polymer, can be with unrestricted choice, valency
It is honest and clean to be easy to get, the performance of dialyzate can be effectively improved for peritoneal dialysis solution.
As a kind of preferred embodiment, the glutamine dipeptide is Ala-Gln dipeptides or sweet
Any one in aminoacyl glutamine dipeptide or two kinds, it is preferable that a concentration of 1-3g/L of glutamine dipeptide.The third ammonia of L-
The aqueous stability of acyl-L-Glutamine dipeptides or glycylglutamine dipeptides is good, if glycylglutamine dipeptides is put
Enter in the second liquid containing bicarbonate, can also increase the stability of bicarbonate；Further, by optimizing glutamine
The concentration of dipeptides can advanced optimize the composition of dialyzate.
As a kind of preferred embodiment, the weight average molecular weight of the glucose polymer is 13-45 kDa, preferably
23-40 kDa.The glucose polymer molecular dimension of this weight average molecular weight is suitable, has good stability, and not The book of Changes
Peritonaeum is absorbed, it can be achieved that good ultrafiltration, is conducive to the removing of metabolic waste.
A kind of preparation method of the peritoneal dialysis solution containing glucose polymer of the present invention, mainly by following technical side
What case was realized：Include the following steps：1）Glucose polymer is weighed, is weighed containing calcium ion, magnesium ion and chlorion
Medicinal crude drug is mixed, and adds injection water, adjusts pH value, the first liquid is made；2）Weigh respectively glutamine dipeptide and
Buffer base (BB) is mixed, and adds injection water, adjusts pH value, the second liquid is made；3）Respectively to step 1）The first liquid of gained and
Step 2）The second liquid of gained be filtered with it is filling, then, carry out moist heat sterilization, 115-121 DEG C of sterilising temp, sterilization time
8-32min obtains product.
The preparation method of the present invention is simple for process, easy to operate, and biological safety is high, it is easy to accomplish industrialization；By adding
Acid adding adjusts the pH value of the first liquid, makes in the environment that glucose polymer is 2.5-5.0 in pH value, and stability is more preferable,
In autoclaving process, glucose degradation products can be less generated；The raw material of second liquid can reach after mixing
Required pH value if the pH value of the second liquid is undesirable, is adjusted it using pH adjusting agent.With traditional abdomen
Film dialyzate is compared, and product of the invention produces less glucose degradation products, is especially reduction of 5 hydroxymethyl furfural
With the content of 3,4- dideoxy arabino-hexosone -3- alkene, reduce product in Clinical practice glucose degradation products to peritonaeum
Damage, the stability of glucose polymer molecular weight is ensure that, it is achieved thereby that the long efficient ultrafiltration for staying the abdomen phase；Meanwhile have
Effect improves the biocompatibility of peritonaeum, has good dialysis-effect.
As a kind of preferred embodiment, the step 3）In, when filling, the first liquid and the second liquid are sequentially loaded into
Containing at least two for contain liquid the plastic containers of chamber in two chambers, the plastic containers are by polypropylene, poly-
In ethylene, polyvinyl chloride, polyester, ethylene/vinyl acetate copolymer, styrene-ethylene-butadiene, nylon any one or
It is several to be prepared.First liquid and the second liquid can be packed into dual-chamber bag, it is of course also possible to be packed into three-chamber bag, three Room
Bag another chamber patient's Treatment need can be packed into the unstable adjunctive therapeutic ingredient of compatibility according to demand, as antibiotic,
Vitamin etc..
The beneficial effects of the invention are as follows：The present invention makes glucose by the way that glucose polymer and buffer base (BB) are separately packed
Polymer is in acid environment, to enhance the generation of the stability of glucose polymer and reduction glucose degradation products,
The stability of glucose polymer molecular weight is ensure that, it is achieved thereby that the long efficient ultrafiltration for staying the abdomen phase；The present invention is in buffer base (BB)
In be added to glutamine dipeptide, make its aqueous stability more preferable, internal acid-base balance can be adjusted, be the load of nitrogen between tissue
Body effectively improves the biocompatibility of peritonaeum；After the mixing of two kinds of liquids, whole pH value tends to be neutral, is more nearly and people
The physiologic pH values of body avoid local irritation of the acid peritoneal dialysis solution to peritonaeum.The preparation method technique of the present invention
Simply, it is easy to operate, it is easy to accomplish industrialization, products obtained therefrom are saturating for a kind of glucose polymer peritonaeum containing glutamine dipeptide
Liquid is analysed, is used suitable for Renal Failure Patients, including continuous bedside peritoneal dialysis（CAPD）And automated peritoneal dialysis（APD）, have
Good drug effect and peritonaeum biocompatibility.
Description of the drawings
In order to illustrate more clearly about the embodiment of the present invention or technical scheme of the prior art, to embodiment or will show below
There is attached drawing needed in technology description to be briefly described, it should be apparent that, the accompanying drawings in the following description is only this
Some embodiments of invention, for those of ordinary skill in the art, without creative efforts, can be with
Other attached drawings are obtained according to these attached drawings.
Fig. 1 is that TGF β 1 contain spirogram in different groups of saturating effluxes of rat abdomen；
Fig. 2 is that VEGF contains spirogram in different groups of saturating effluxes of rat abdomen；
In figure：A-G1.5 glucose peritoneal dialysis solution control groups；B- Icodextrin peritoneal dialysis solution control groups；1- embodiments 1 are real
Test group；2 experimental group of 2- embodiments；3 experimental group of 3- embodiments；4 experimental group of 4- embodiments；5 experimental group of 5- embodiments；6- embodiments
6 experimental groups；*-and compared with G1.5 glucose peritoneal dialysis solutions, P<0.05；Compared with Icodextrin peritoneal dialysis solution, P<
0.05。
Specific embodiment
Technical scheme of the present invention is clearly and completely described below in conjunction with specific embodiments of the present invention, is shown
So, described embodiment is only the part of the embodiment of the present invention, instead of all the embodiments.Based in the present invention
Embodiment, those of ordinary skill in the art's all other embodiments obtained without creative efforts, all
Belong to the scope of protection of the invention.
A kind of peritoneal dialysis solution containing glucose polymer, the dialyzate include temporarily the first liquid for separately packing and
Second liquid；First liquid is acid solution, and the pH value of first liquid is 2.5-5.0, and first liquid includes
Glucose polymer, calcium ion, magnesium ion and chlorion, the volume of first liquid are the 30- of the total dialysate volume
65%, the pH value of second liquid is 6.5-8.5, and second liquid includes glutamine dipeptide and buffer base (BB)；Described first
The dialyzate is obtained after liquid and second liquid mixing, the dialyzate includes following components：Glucose polymer 60-
150g/L, glutamine dipeptide 1-5g/L, buffer base (BB) 2-42mmol/L, calcium ion 0-2.5mmol/L, magnesium ion 0-1.0mmol/
L, chlorion 80-110mmol/L.
Specifically, the dialyzate further includes arbitrary in vasodilator, diuretics, hormone, vitamin, antioxidant
It is one or more of.
Specifically, the buffer base (BB) is lactate, bicarbonate, citrate, isocitrate, acetonate, amber
Hydrochlorate, fumarate, malate, any one or a few in oxaloacetate, it is preferable that the buffer base (BB) is lactic acid
The mixture of salt and bicarbonate, it is highly preferred that the buffer base (BB) is sodium lactate and the mixture of sodium bicarbonate.
More specifically, the dialyzate includes following components：Glucose polymer 60-90g/L, glutamine dipeptide 1-
5g/L, sodium ion 80-150mmol/L, bicarbonate ion 2-40mmol/L, lactate ion 0-40mmol/L, chlorion 80-
110mmol/L, calcium ion 0-2.5mmol/L, magnesium ion 0-1.0mmol/L.
Specifically, in the dialyzate, a concentration of 22-28mmol/L of bicarbonate ion, the concentration of lactate ion
For 12-18mmol/L.
Specifically, the glucose polymer is Icodextrin, in maltodextrin, cyclodextrin, glucan, chitosan
Any one or a few.
Specifically, the glutamine dipeptide is Ala-Gln dipeptides or glycylglutamine dipeptides
In any one or two kinds, it is preferable that a concentration of 1-3g/L of glutamine dipeptide.
Specifically, the weight average molecular weight of the glucose polymer is 13-45 kDa, preferably 23-40 kDa.
A kind of preparation method of the peritoneal dialysis solution containing glucose polymer, includes the following steps：1）Glucose is weighed to gather
Object is closed, the Medicinal crude drug containing calcium ion, magnesium ion and chlorion is weighed, is mixed, adds injection water, adjusts pH value,
The first liquid is made；2）Glutamine dipeptide and buffer base (BB) are weighed respectively, is mixed, adds injection water, are adjusted pH value, are made
Second liquid；3）Respectively to step 1）The first liquid of gained and step 2）The second liquid of gained be filtered with it is filling, then, into
Row moist heat sterilization, 115-121 DEG C of sterilising temp, sterilization time 8-32min obtain product.
Specifically, the step 3）In, when filling, the first liquid and the second liquid are sequentially loaded into and are used for containing at least two
Contain the two chambers in the plastic containers of the chamber of liquid, the plastic containers are by polypropylene, polyethylene, polyvinyl chloride, poly-
Any one or a few in ester, ethylene/vinyl acetate copolymer, styrene-ethylene-butadiene, nylon is prepared.
Embodiment 1
The dual-chamber bag containing A and B two chambers is made with co-extrusion film bag using three layers of infusion, sterilizing is spare；Glucose is weighed to gather
Close object and MgCl2·6H2O raw materials add injection water, adjust pH value, and it is 4.5 to make its pH value, are made into acid first liquid, filter,
And it is loaded into A chambers；Ala-Gln dipeptides, sodium chloride and sodium bicarbonate raw material are weighed, adds injection water,
PH value is adjusted, it is 7.0 to make its pH value, is made into the second liquid, is filtered, and be loaded into B chambers；Then, the first liquid will be contained
Moist heat sterilization, 115 DEG C of sterilising temp are carried out with the dual-chamber bag of the second liquid, 32 min of sterilization time obtains finished product, institute after sterilizing
The liquid mixing, it can be achieved that A and B two chambers is obtained after product is opened by rosin joint band, matching for peritoneal dialysis solution is obtained after mixing
Side is as shown in table 1.
Wherein, the volume of the first liquid is 360mL in A chambers, and the volume of the second liquid is 640mL in B chambers, glucose
Polymer is cyclodextrin, and the weight average molecular weight of cyclodextrin is 13kDa, and buffer base (BB) is sodium bicarbonate, belongs to bicarbonate, certainly,
Buffer base (BB) may be lactate, citrate, isocitrate, acetonate, succinate, fumarate, malic acid
Salt, any one in oxaloacetate.
The composition of 1 peritoneal dialysis solution of table
Embodiment 2
The dual-chamber bag containing A and B two chambers is made with co-extrusion film bag using three layers of infusion, sterilizing is spare；Glucose is weighed to gather
Close object and CaCl2·2H2O raw materials add injection water, adjust pH value, and it is 3.5 to make its pH value, are made into acid first liquid, filter,
And it is loaded into A chambers；Weigh glycylglutamine dipeptides, sodium chloride, sodium bicarbonate and lactic acid sodium raw materials, addition injection
Water adjusts pH value, and it is 7.5 to make its pH value, is made into the second liquid, filters, and be loaded into B chambers；Then, the first medicine will be contained
The dual-chamber bag of liquid and the second liquid carries out moist heat sterilization, and 121 DEG C, sterilization time 8min of sterilising temp obtains finished product, institute after sterilizing
The liquid mixing, it can be achieved that A and B two chambers is obtained after product is opened by rosin joint band, matching for peritoneal dialysis solution is obtained after mixing
Side is as shown in table 1.
Wherein, the volume of the first liquid is 650mL in A chambers, and the volume of the second liquid is 350mL in B chambers, glucose
Polymer is maltodextrin, and the weight average molecular weight of maltodextrin is 13kDa, the mixing of buffer base (BB) sodium lactate and sodium bicarbonate
Object belongs to the mixture of lactate and bicarbonate, and certainly, buffer base (BB) here can also be lactate, bicarbonate, lemon
Hydrochlorate, isocitrate, acetonate, succinate, fumarate, malate, it is other arbitrary in oxaloacetate
Combination.
Embodiment 3
The three-chamber bag containing tri- chambers of A, B and C is made with co-extrusion film bag using three layers of infusion, sterilizing is spare；Weigh glucose
Polymer, CaCl2·2H2O and MgCl2·6H2O raw materials add injection water, adjust pH value, and it is 3.0 to make its pH value, is made into acidity
First liquid, filtering, and it is loaded into A chambers；Weigh Ala-Gln dipeptides, sodium chloride, sodium bicarbonate and breast
Sour sodium raw materials add injection water, adjust pH value, and it is 8.0 to make its pH value, is made into the second liquid, filter, and be loaded into B chambers；
Suitable vitamin is weighed, is packed into C chambers；Then, it will be carried out containing the three-chamber bag of the first liquid, the second liquid and vitamin wet
Heat sterilization, 121 DEG C, sterilization time 15min of sterilising temp obtain finished product after sterilizing, can after products obtained therefrom is opened by rosin joint band
Realize the liquid mixing of tri- chambers of A, B and C, the formula that peritoneal dialysis solution is obtained after mixing is as shown in table 1.
Wherein, the volume of the first liquid is 360mL in A chambers, and the volume of the second liquid is 620mL in B chambers, C chambers
The volume of middle vitamin is 20mL, and glucose polymer is Icodextrin, and the weight average molecular weight of Icodextrin is 13kDa, certainly,
It can be with any one in filling vasodilator, diuretics, hormone, vitamin, antioxidant in C chambers.
Embodiment 4
The dual-chamber bag containing bis- chambers of A and B is made with co-extrusion film bag using three layers of infusion, sterilizing is spare；Glucose is weighed to gather
Close object, CaCl2·2H2O and MgCl2·6H2O raw materials add injection water, and adjusting pH value makes its pH value for 2.5, are made into acid the
One liquid, filtering, and it is loaded into A chambers；Weigh Ala-Gln dipeptides, sodium chloride, sodium bicarbonate, lactic acid
Sodium and suitable antioxidant raw material add injection water, adjust pH value, and it is 8.5 to make its pH value, is made into the second liquid, filter, and
It is loaded into B chambers；Then, moist heat sterilization, sterilising temp 115 will be carried out containing the dual-chamber bag of the first liquid and the second liquid
DEG C, sterilization time 30min obtains finished product after sterilizing, it can be achieved that A and B two chambers after products obtained therefrom is opened by rosin joint band
Liquid mixes, and the formula that peritoneal dialysis solution is obtained after mixing is as shown in table 1.
Wherein, the volume of the first liquid is 500mL in A chambers, and the volume of the second liquid is 500mL in B chambers, glucose
Polymer is Icodextrin, and the weight average molecular weight of Icodextrin is 45kDa, certainly, including vasodilator, diuretics, hormone,
Any one or a few acidic materials including vitamin and antioxidant can be filling in A chambers.
Embodiment 5
The dual-chamber bag containing bis- chambers of A and B is made with co-extrusion film bag using three layers of infusion, sterilizing is spare；Glucose is weighed to gather
Close object and MgCl2·6H2O raw materials add injection water, adjust pH value, and it is 5.0 to make its pH value, are made into acid first liquid, filter,
And it is loaded into A chambers；Weigh Ala-Gln dipeptides, sodium chloride, sodium bicarbonate and suitable vasodilator
Raw material adds injection water, adjusts pH value, and it is 7.0 to make its pH value, is made into the second liquid, the pH value of the second liquid is relative to first
Liquid is meta-alkalescence, filtering, and is loaded into B chambers；Then, it will be carried out containing the dual-chamber bag of the first liquid and the second liquid
Moist heat sterilization, 121 DEG C, sterilization time 12min of sterilising temp obtain finished product after sterilizing, after products obtained therefrom is opened by rosin joint band,
The liquid mixing of A and B two chambers can be achieved, the formula that peritoneal dialysis solution is obtained after mixing is as shown in table 1.
Wherein, the volume of the first liquid is 400mL in A chambers, and the volume of the second liquid is 600mL in B chambers, glucose
Polymer is glucan, and the weight average molecular weight of glucan is 45kDa, certainly, including vasodilator, diuretics, hormone, dimension life
Any one or a few alkaline matter including element and antioxidant can be filling in B chambers.
Embodiment 6
Prepare the dual-chamber bag with A and B two chambers, it is spare；Weigh glucose polymer and CaCl2·2H2O raw materials, addition
Injection water adjusts pH value, and it is 5.0 to make its pH value, is made into acid first liquid, filtering, and be loaded into A chambers；Weigh sweet ammonia
Acyl glutamine dipeptide, sodium chloride, sodium bicarbonate and lactic acid sodium raw materials add injection water, adjust pH value, and it is 6.5 to make its pH value,
The second liquid is made into, is filtered, and be loaded into B chambers；Then, it will be carried out containing the dual-chamber bag of the first liquid and the second liquid wet
Heat sterilization, 121 DEG C, sterilization time 15min of sterilising temp obtain finished product after sterilizing, can after products obtained therefrom is opened by rosin joint band
Realize the liquid mixing of A and B two chambers, the formula that peritoneal dialysis solution is obtained after mixing is as shown in table 1.
Wherein, the volume of the first liquid is 400mL in A chambers, and the volume of the second liquid is 600mL in B chambers, glucose
Polymer is chitosan, and the weight average molecular weight of chitosan is 45kDa.
Experiment 1
Glucose degradation products detect：
5 hydroxymethyl furfural（5-HMF）Precision measurement above example 1 is appropriate to 6 gained peritoneal dialysis solution of embodiment, is placed in 50
In mL volumetric flasks, scale is diluted with water to, is shaken up, according to UV-VIS spectrophotometry, extinction is measured at 284 nm wavelength
Degree calculates the concentration of 5-HMF in embodiment 1 to embodiment 6 according to 5-HMF standard curves.Wherein, it is saturating with G1.5 glucose peritonaeums
Liquid and Icodextrin peritoneal dialysis solution are analysed as control sample, result of the test is as shown in table 2.
3,4- dideoxy arabino-hexosone -3- alkene（3,4-DGE）Precision measures above example 1 to 6 gained abdomen of embodiment
Film dialyzate is appropriate, is placed in 50 mL volumetric flasks, is diluted with water to scale, shakes up, according to UV-VIS spectrophotometry,
Absorbance is measured at 228nm wavelength, the concentration of 3,4-DGE in embodiment 1 to embodiment 6 is calculated according to 3,4-DGE standard curves.
Wherein, using G1.5 glucose peritoneal dialysis solution and Icodextrin peritoneal dialysis solution as control sample, result of the test is as shown in table 2.
Icodextrin peritoneal dialysis solution and G1.5 glucose peritoneal dialysis solution are marketed drug, and composition is as follows：Every 100
The composition of mL Icodextrin peritoneal dialysis solutions is：7.5 g of Icodextrin, 535 mg of sodium chloride, 448 mg of sodium lactate, calcium chloride
25.7 mg, 5.08 mg of magnesium chloride；The composition of every 100 mL G1.5 glucose peritoneal dialysis solutions is：538 mg of sodium chloride, breast
Sour 448 mg of sodium, 26 mg of calcium chloride, 5.1 mg of magnesium chloride.
Glucose degradation products concentration mensuration result in the different peritoneal dialysis solutions of table 2
As can be seen from Table 2,5-HMF and 3,4-DGE in the peritoneal dialysis solution containing glucose polymer that prepared by the present invention contain
Amount is less than significantly lower than G1.5 glucose peritoneal dialysis solutions in acid Icodextrin peritoneal dialysis solution；This explanation contains
The glucose degradation products level that the glucose polymer peritoneal dialysis solution of glutamine dipeptide generates is relatively low.
Experiment 2
Glucose polymer dialyzate pharmacodynamic experiment
Choose the New Zealand White Rabbit 64 of health, half male and half female, weight about 1.5-2.0 Kg.Normal diet, drinking-water are given, is fitted
Answering property is raised one week.It is anaesthetized, abdomen is placed in abdominal cavity and is managed thoroughly, rest 7-10 days is complete to wound healing after operation.At random
It is divided into 8 groups, i.e. G1.5 glucose peritoneal dialysis solution control group, Icodextrin peritoneal dialysis solution control group and embodiment 1 to reality
Apply six experimental groups of 6 gained peritoneal dialysis solution of example composition, every group of 8 animals.Carry out single peritoneal dialysis treatment, injection 30
The different peritoneal dialysis solutions of mL/Kg at the end of 240 min that dialyse, collect blood plasma and dialysis efflux sample.It detects respectively
During 240 min blood plasma and dialysis efflux in the concentration of creatinine and the concentration of urea nitrogen, and measure dialysis efflux total volume.Meter
Calculate in the concentration of creatinine and the concentration proportion of creatinine in blood plasma in dialysis efflux and dialysis efflux the concentration of urea nitrogen with
The concentration proportion of urea nitrogen, is represented with D/P in blood plasma, and experimental result is as shown in table 3.
3 each example ultrafiltration of table and small molecule clearance test result
The dialysis treatment effect of glucose polymer dialyzate is reacted using creatinine clearance rate and urea nitrogen clearance, wherein,
The calculation formula of creatinine clearance rate and urea nitrogen clearance difference is as follows：
Creatinine clearance rate=（It dialyses in efflux total volume mL × dialysis efflux the concentration of creatinine in the concentration of creatinine and blood plasma
Ratio D/P）÷240 min；
Urea nitrogen clearance=（It dialyses in efflux total volume mL × dialysis efflux urea nitrogen in the concentration of urea nitrogen and blood plasma
Concentration proportion D/P）÷240 min.
As can be seen from Table 3, embodiment 1 is equal to the net ultrafiltration of 6 six experimental groups of embodiment and the scavenging effect of small molecule
More than G1.5 glucose peritoneal dialysis solution control groups, and better than acid Icodextrin peritoneal dialysis solution control group.
Experiment 3
Peritonaeum biocompatibility test
SD rats 64, weight 200-220 g are chosen, are randomly divided into 8 groups, respectively G1.5 glucose peritoneal dialysis solution compares
Six experimental groups that group, Icodextrin peritoneal dialysis solution control group, embodiment 1 to embodiment 6 form.Every group of rat distinguishes abdominal cavity
Inject each peritoneal dialysis solution of 20 mL, continuous 4 weeks, once a day.After last dose 2 hours, dialysis efflux is collected,
Bradford methods measure the total protein concentration in dialysis efflux, and using Elisa（Enzyme-linked
Immunosorbent assay, enzyme linked immunosorbent assay (ELISA)）Method detects its VEGF（Vascular endothelial growth
Factor, vascular endothelial growth factor）、TGFβ1（Transforming growth factor- β, transforminggrowthfactor-β1）'s
Concentration.After each group rat is put to death, peritoneal tissues are taken, carry out HE（Hematoxylin-eosin staining, hematoxylin-eosin
Decoration method）Dyeing.It takes pictures under light microscopic, measures peritonaeum thickness, experimental result is as shown in table 4, TGF β 1 and VEGF in the saturating efflux of abdomen
Concentration mensuration result respectively as depicted in figs. 1 and 2.
4 each group rat peritoneum thickness of table（X ± s, μm）
Remarks：a——P<0.05, compared with G1.5 glucose peritoneal dialysis solutions；b——P<0.05, it is saturating with Icodextrin peritonaeum
Analyse liquor ratio compared with.
Since vascular endothelial growth factor can effectively facilitate the generation of new vessels, and then influence the permeability of peritonaeum.Turn
Change grouth factor beta 1 has important adjustment effect to the growth, differentiation and immune function of cell, in peritoneal fibrosiss process
Play apparent inducing action.Six experimental groups that Icodextrin, embodiment 1 to embodiment 6 form it can be seen from Fig. 1 and Fig. 2
The content of TGF β 1 and VEGF in peritonaeum efflux are below G1.5 glucose peritoneal dialysis solutions, moreover, embodiment 1 is to implementation
Six experimental groups that example 6 forms are less than acid Icodextrin peritoneal dialysis solution control group again.This explanation is containing glutamine two
The glucose polymer peritoneal dialysis solution of peptide has the function of to inhibit peritonaeum angiogenesis and peritoneal fibrosiss, and its inhibiting effect
It is better than acid Icodextrin peritoneal dialysis solution.
As can be seen from Table 4, the peritoneal dialysis solution for six experimental groups that embodiment 1 is formed to embodiment 6 leads to rat
Peritonaeum thickness is significantly lower than conventional listing medicine G1.5 glucose peritoneal dialysis solution and Icodextrin peritoneal dialysis solution, therefore, containing paddy
The glucose polymer peritoneal dialysis solution of glutamine dipeptides is smaller to the damage of rat peritoneum tissue；So containing glutamine two
The specific good peritonaeum biocompatibility of the glucose polymer peritoneal dialysis solution of peptide.
Therefore, the beneficial effects of the invention are as follows：The present invention makes Portugal by the way that glucose polymer and buffer base (BB) are separately packed
Grape glycopolymers are in acid environment, with the life for enhancing the stability of glucose polymer and reducing glucose degradation products
Into the stability of glucose polymer molecular weight being ensure that, it is achieved thereby that the long efficient ultrafiltration for staying the abdomen phase；The present invention is buffering
Glutamine dipeptide is added in alkali, makes its aqueous stability more preferable, internal acid-base balance can be adjusted, is nitrogen between tissue
Carrier effectively improves the biocompatibility of peritonaeum；After the mixing of two kinds of liquids, whole pH value tends to be neutral, be more nearly with
The physiologic pH values of human body avoid local irritation of the acid peritoneal dialysis solution to peritonaeum.The preparation method work of the present invention
Skill is simple, easy to operate, it is easy to accomplish industrialization, products obtained therefrom are a kind of glucose polymer peritonaeum containing glutamine dipeptide
Dialyzate is used suitable for Renal Failure Patients, including continuous bedside peritoneal dialysis（CAPD）And automated peritoneal dialysis（APD）, tool
There are good drug effect and peritonaeum biocompatibility.
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
With within principle, any modification, equivalent replacement, improvement and so on should all be included in the protection scope of the present invention god.
Claims (10)
1. a kind of peritoneal dialysis solution containing glucose polymer, it is characterised in that：The dialyzate includes what is temporarily separately packed
First liquid and the second liquid；
First liquid is acid solution, and the pH value of first liquid is 2.5-5.0, and first liquid includes glucose
Polymer, calcium ion, magnesium ion and chlorion, the volume of first liquid are the 30-65% of the total dialysate volume, institute
The pH value for stating the second liquid is 6.5-8.5, and second liquid includes glutamine dipeptide and buffer base (BB)；
The dialyzate is obtained after first liquid and second liquid mixing, the dialyzate includes following components：Portugal
Grape glycopolymers 60-150g/L, glutamine dipeptide 1-5g/L, buffer base (BB) 2-42mmol/L, calcium ion 0-2.5mmol/L, magnesium
Ion 0-1.0mmol/L, chlorion 80-110mmol/L.
2. the peritoneal dialysis solution according to claim 1 containing glucose polymer, it is characterised in that：
The dialyzate further includes any one or a few in vasodilator, diuretics, hormone, vitamin, antioxidant.
3. the peritoneal dialysis solution according to claim 1 or 2 containing glucose polymer, it is characterised in that：
The buffer base (BB) is lactate, bicarbonate, citrate, isocitrate, acetonate, succinate, corydalis tuber
Hydrochlorate, malate, any one or a few in oxaloacetate, it is preferable that the buffer base (BB) is lactate and bicarbonate
The mixture of salt, it is highly preferred that the buffer base (BB) is sodium lactate and the mixture of sodium bicarbonate.
4. the peritoneal dialysis solution according to claim 3 containing glucose polymer, it is characterised in that：
The dialyzate includes following components：Glucose polymer 60-150g/L, glutamine dipeptide 1-5g/L, sodium ion 80-
150mmol/L, bicarbonate ion 2-40mmol/L, lactate ion 0-40mmol/L, chlorion 80-110mmol/L, calcium from
Sub- 0-2.5mmol/L, magnesium ion 0-1.0mmol/L.
5. the peritoneal dialysis solution according to claim 4 containing glucose polymer, it is characterised in that：
In the dialyzate, a concentration of 22-28mmol/L of bicarbonate ion, a concentration of 12-18mmol/ of lactate ion
L。
6. the peritoneal dialysis solution according to claim 1 or 2 containing glucose polymer, it is characterised in that：
The glucose polymer is Icodextrin, maltodextrin, cyclodextrin, glucan, in chitosan any one or
It is several.
7. the peritoneal dialysis solution according to claim 1 or 2 containing glucose polymer, it is characterised in that：
The glutamine dipeptide is any one in Ala-Gln dipeptides or glycylglutamine dipeptides
Or two kinds, it is preferable that a concentration of 1-3g/L of glutamine dipeptide.
8. the peritoneal dialysis solution according to claim 1 containing glucose polymer, it is characterised in that：
The weight average molecular weight of the glucose polymer is 13-45 kDa, preferably 23-40 kDa.
9. a kind of preparation method of the peritoneal dialysis solution according to claim 1 containing glucose polymer, which is characterized in that
Include the following steps：
1）Glucose polymer is weighed, the Medicinal crude drug containing calcium ion, magnesium ion and chlorion is weighed, is mixed, add
Jetting is filled, pH value is adjusted, the first liquid is made；
2）Glutamine dipeptide and buffer base (BB) are weighed respectively, is mixed, adds injection water, adjust pH value, the second liquid is made；
3）Respectively to step 1）The first liquid of gained and step 2）The second liquid of gained be filtered with it is filling, then, carry out it is wet
Heat sterilization, 115-121 DEG C of sterilising temp, sterilization time 8-32min obtain product.
10. the preparation method of the peritoneal dialysis solution according to claim 9 containing glucose polymer, it is characterised in that：
The step 3）In, when filling, the first liquid and the second liquid are sequentially loaded into and are used to contain liquid containing at least two
Two chambers in the plastic containers of chamber, the plastic containers are by polypropylene, polyethylene, polyvinyl chloride, polyester, ethylene/vinegar
Any one or a few in vinyl acetate copolymer, styrene-ethylene-butadiene, nylon is prepared.
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| CN109200215A (en) * | 2018-10-25 | 2019-01-15 | 湖南博隽生物医药有限公司 | A kind of peritoneal dialysis solution and preparation method thereof |
| CN109394781A (en) * | 2018-11-13 | 2019-03-01 | 华仁药业股份有限公司 | A kind of preparation method and its peritoneal dialysis solution of glucose polymer peritoneal dialysis solution |
| CN109528760A (en) * | 2018-11-13 | 2019-03-29 | 华仁药业股份有限公司 | A kind of Icodextrin peritoneal dialysis solution and preparation method thereof |
| CN113683661A (en) * | 2021-09-01 | 2021-11-23 | 济宁医学院 | Dual-response dipeptide supramolecular polymer and preparation method and application thereof |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN109200215A (en) * | 2018-10-25 | 2019-01-15 | 湖南博隽生物医药有限公司 | A kind of peritoneal dialysis solution and preparation method thereof |
| CN109394781A (en) * | 2018-11-13 | 2019-03-01 | 华仁药业股份有限公司 | A kind of preparation method and its peritoneal dialysis solution of glucose polymer peritoneal dialysis solution |
| CN109528760A (en) * | 2018-11-13 | 2019-03-29 | 华仁药业股份有限公司 | A kind of Icodextrin peritoneal dialysis solution and preparation method thereof |
| CN113683661A (en) * | 2021-09-01 | 2021-11-23 | 济宁医学院 | Dual-response dipeptide supramolecular polymer and preparation method and application thereof |
| CN113683661B (en) * | 2021-09-01 | 2022-03-11 | 济宁医学院 | Dual-response dipeptide supramolecular polymer and preparation method and application thereof |
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