CN113648328A - Peritoneal dialysis solution containing hydroxyethyl starch, novel peritoneal dialysis tube and manufacturing method - Google Patents

Abstract

The invention discloses peritoneal dialysis solution containing hydroxyethyl starch, a novel peritoneal dialysis tube and a manufacturing method. According to the mass percentage concentration, the sodium lactate comprises 0.5-15 percent of hydroxyethyl starch, 0.3-0.6 percent of sodium chloride, 0.01-0.03 percent of calcium chloride, 0.002-0.006 percent of magnesium chloride and 0.2-0.5 percent of sodium lactate. The preparation method of the peritoneal dialysis solution comprises the steps of putting hydroxyethyl starch, sodium chloride, calcium chloride, magnesium chloride and sodium lactate into 1000 ml of water according to the proportion of the preparation concentration, stirring and dissolving, filtering and sterilizing in sequence, and filling the solution into a single-cavity bag; or the hydroxyethyl starch is separately filled into a single-cavity bag by adopting a double-cavity bag process; according to the invention, the structural member is formed by adopting the cross-linked polyolefin material added with barium sulfate, then the structural member is coated by using the cross-linked polyolefin material not added with barium sulfate, and the dialysis holes are drilled to avoid the structural member, so that the technical problems of exposure of barium sulfate solid particles on the surface, precipitation and the like are greatly reduced, and the safety of the peritoneal dialysis process is improved.

Description

Peritoneal dialysis solution containing hydroxyethyl starch, novel peritoneal dialysis tube and manufacturing method

Technical Field

The invention relates to the technical field of medical instruments, in particular to peritoneal dialysis solution containing hydroxyethyl starch, a novel peritoneal dialysis tube and a manufacturing method thereof.

Background

According to the statistics of 'lancet' in 2020, 1.3 billion nephropathy patients exist in China, which is the first major country of nephropathy, and the number of nephropathy patients increases at a rate of 10% per year. Among the nephropathy, diabetes is the first cause, and the number of people suffering from diabetes is the front in China. In addition, kidney disease is currently not treated radically, but is only maintenance therapy. Therefore, kidney disease is a serious medical burden in China. Uremia is the later stage of development of chronic kidney disease, and three treatment modes are provided, wherein the first mode is kidney transplantation, but a kidney source is unavailable, the treatment range of the method is limited, the second mode is hemodialysis, but the dialysis is required for 2-3 times in a week and is carried out in a central urban hospital, the running is carried out in the coming and going, the cost is high, the third mode is peritoneal dialysis, the technology can be used for household treatment, and the technology is relatively economical and convenient.

The peritoneal dialysis technology is a treatment method for end stage uremia of kidney, which is worth popularizing greatly, and is suitable for life of general nephrotic patients who live normal people due to the characteristics of the residual kidney protection function and home dialysis, so that day work and night dialysis can be realized, and the life quality can be greatly improved. The dialysis effect is the same as hemodialysis, and even the long-term effect is better than hemodialysis.

Peritoneal dialysis techniques rely primarily on osmotic agents to create osmotic pressure. The penetrating agent for the peritoneal dialysis solution product on the market at present is mainly glucose, is an endogenous substance, is an energy substance for life metabolism, and has slight toxic and side effects.

Peritoneal dialysis is a new technology which is being popularized by our country and is suitable for the national conditions of China. The technology is in the development stage in China, but compared with hemodialysis, the technology has the characteristic of home treatment, so that the life quality of patients can be greatly improved, and the patients can go to work, work and study as normal people. Because the patient does not need to frequently go to and fro to the hospital, the patient is also suitable for the nephropathy patients in vast rural remote areas.

Peritoneal dialysis as a treatment for end-stage renal disease (ESRD) has the advantages that patients can complete the treatment independently and the protection of the function of the residual kidney is facilitated. The peritoneal dialysis tube is used as a necessary passage for the peritoneal dialysis solution to enter a human body, and consists of a silicone tube, a polyester lantern ring and a barium sulfate developing line in the conventional production, and the peritoneal dialysis tube prepared from a silica gel material is easy to adsorb protein and bacteria in peritoneal fluid in the peritoneal dialysis process, so that a dialysis hole is blocked, even a pipeline passage is blocked, and the blockage is caused by the property of the silicone rubber material. In addition, the production process of the peritoneal dialysis catheter made of the silicone rubber material is an extrusion process, the silicone rubber material of the AB component is subjected to crosslinking and solidification under the action of a crosslinking agent while being extruded, the added crosslinking agent cannot be completely consumed, and a free crosslinking agent remains in the material of the peritoneal dialysis catheter, so that the possibility of peritonitis of a dialysis patient is increased due to precipitation of the free crosslinking agent, and the peritoneal dialysis failure can be caused and even the life safety of the patient is threatened. The peritoneal dialysis catheter made of the silicone rubber material is only provided with a barium sulfate developing line with the width of 0.7mm-1.2mm, and when the body fat of a patient is thick, the specific position of the patient cannot be observed conveniently under the irradiation of X-rays.

The peritoneal dialysis solution on the market in China is a dialysis solution imitating foreign countries and taking glucose as an osmotic agent, and the glucose as the osmotic agent has the advantages of light toxic and side effects, easily available raw materials, economy and convenience, but has the defect that the glucose can be absorbed into blood through the peritoneum, so that the concentration difference is avoided, and the osmotic effect is lost. So 4 bags a day are used for the dialysis solution with glucose as osmotic agent.

The peritoneal dialysis catheter prepared by the cross-linked polyolefin material added with barium sulfate in the prior art is developed, the cross-linked polyolefin material has weak adsorption capacity on protein and bacteria, the problem that peritonitis is caused by tube blockage and precipitation of small molecular substances due to adhesion of protein and bacteria in an abdominal cavity is solved, and the problem that the specific position of a patient cannot be observed conveniently under X-ray irradiation when the body fat of the patient is thick due to a barium sulfate developing line of the existing peritoneal dialysis catheter is also solved. Still have the risk that barium sulfate is precipitated, because barium sulfate powder is dispersed in cross-linked polyolefin material evenly, most of part barium sulfate powder particle may expose on the inner and outer surface of peritoneal dialysis catheter wall, in the application and use, because of slight change or the process of buckling such as temperature, solution environment, etc., make cross-linked polyolefin material stretch, this part of exposed barium sulfate powder has the possibility of coming off; in addition, the surface properties of the peritoneal dialysis tube wall are also changed by the barium sulfate powder which is possibly exposed, so that the possibility of protein adsorption is increased, and the occurrence of blockage of the dialysis holes is caused.

Therefore, it is required to develop a novel peritoneal dialysis solution and a preparation method thereof, a novel peritoneal dialysis tube suitable for the solution and capable of preventing calcium sulfate powder from being exposed on the surface, and a manufacturing method thereof.

Disclosure of Invention

In view of the disadvantages of the prior art, an object of the present invention is to provide a peritoneal dialysis solution containing hydroxyethyl starch, a novel peritoneal dialysis tube and a method for manufacturing the same, in which a member is formed using a cross-linked polyolefin material to which barium sulfate is added, and then the member is coated using a cross-linked polyolefin material to which barium sulfate is not added, and a dialysis hole is formed to avoid the member, thereby greatly reducing the technical problems of exposure of barium sulfate solid particles to the surface, precipitation, etc., and improving the safety of the peritoneal dialysis process.

In order to achieve the purpose, the invention adopts the following technical scheme:

according to the first aspect, the invention provides a novel peritoneal dialysis solution formula which mainly comprises, by mass, 0.5% -15% of hydroxyethyl starch, 0.3% -0.6% of sodium chloride, 0.01% -0.03% of calcium chloride, 0.002% -0.006% of magnesium chloride and 0.2% -0.5% of sodium lactate.

In a second aspect, the present invention provides a method for preparing a peritoneal dialysis solution, comprising the steps of:

according to the concentration ratio, hydroxyethyl starch, sodium chloride, calcium chloride, magnesium chloride and sodium lactate are put into 1000 ml of water, stirred and dissolved, and then filtered by a 0.45 mu m filter membrane, a 0.22 mu m filter membrane and a 0.22 mu m filter membrane in sequence; sterilizing the filtered solution at 121 ℃ for 12 minutes; filling the filtered solution into a single-cavity bag;

or: putting hydroxyethyl starch into 500 ml of water, stirring and dissolving, and then sequentially filtering by adopting a 0.45 mu m filter membrane, a 0.22 mu m filter membrane and a 0.22 mu m filter membrane; sterilizing the filtered solution at 121 ℃ for 12 minutes; filling the filtered solution into a single-cavity bag; then putting sodium chloride, calcium chloride, magnesium chloride and sodium lactate into 500 ml of water, stirring and dissolving, and then sequentially filtering by adopting a 0.45 mu m filter membrane, a 0.22 mu m filter membrane and a 0.22 mu m filter membrane; sterilizing the filtered solution at 121 ℃ for 12 minutes; the filtered solution was filled into another single-chamber bag.

Adding 500 ml of water into a first preparation tank, adding 5g of hydroxyethyl starch, adding 500 ml of water into a second preparation tank, adding 5.38g of sodium chloride, 0.26g of calcium chloride, 0.051g of magnesium chloride and 4.48g of sodium lactate, stirring to dissolve, filtering through 0.45 mu m, 0.22 mu m and 0.22 mu m filter membranes respectively, and filling into double-cavity bags respectively. And sterilized at 121 ℃ for 12 minutes.

The preparation method adopts a single-cavity bag or double-cavity bag packaging sterilization process, wherein the single-cavity bag process is that all materials are placed in one cavity, and the double-cavity bag process is that the hydroxyethyl starch solution and other material solutions are not in the same cavity and are packaged separately. The sterilization process adopts a residual probability method or an overkill method.

In a third aspect, the invention provides a novel peritoneal dialysis tube which can use hydroxyethyl starch peritoneal dialysis solution, and the peritoneal dialysis tube comprises a tube body, a terylene lantern ring and a dialysis hole;

the pipe body is made of cross-linked polyolefin material;

a cross-linked polyolefin material component added with barium sulfate is arranged in the pipe wall of one end of the pipe body extending into the abdominal cavity;

the shape of the member comprises interconnected rings;

the dialysis holes do not overlap with the ring shape of the member and its connecting section.

Preferably, the mass ratio of barium sulfate in the cross-linked polyolefin material added with barium sulfate is 15-25%.

Preferably, the distance between the adjacent rings of the member (4) close to the end of the tube body (1) extending into the abdominal cavity becomes smaller, the distance between the adjacent rings of the end far away from the end extending into the abdominal cavity becomes larger, and the width between the two adjacent rings is larger than 2.0 mm.

Preferably, the width of the terylene lantern ring (2) is 0.9-1.1 cm, and the terylene lantern ring (2) is arranged at the position 15cm away from the two ends of the dialysis tube.

Preferably, the crosslinked polyolefin material includes at least one of an isobutylene and styrene copolymer, an isobutylene and isoprene copolymer, an isobutylene and vinylbenzocyclobutene copolymer, an isobutylene and butadiene copolymer, a styrene and isoprene copolymer.

In a fourth aspect, the present invention provides a method for manufacturing the above novel peritoneal dialysis catheter using hydroxyethyl starch peritoneal dialysis solution, the method comprising the steps of:

1) preparing raw materials of a component: mixing barium sulfate and a cross-linked polyolefin material to obtain a component raw material;

2) preparing a component: preheating a component raw material and a component mold, and then injecting the preheated component raw material into the component mold to obtain a component;

3) preparing a pipe body: placing the component prepared in the step 2) into a corresponding position of a pipe body forming die to enable the component to be positioned in the middle of the wall of the pipe body, and then injecting a preheated cross-linked polyolefin material;

4) thermal crosslinking: placing the molding die injected with the crosslinked polyolefin material obtained in the step 3) in a hot press for thermal crosslinking reaction;

5) post-processing of the pipe body: after the thermal crosslinking reaction is finished, cooling, taking out the formed peritoneal dialysis tube blank, perforating, and then performing static electricity removal and particle removal;

6) bonding a polyester lantern ring: respectively bonding the terylene lantern rings at the two ends of the tube body obtained in the step 5) to obtain the novel peritoneal dialysis tube.

Preferably, the raw materials of the components in the step 1) are prepared, the used barium sulfate is powder, the rotating speed in the mixing process is 110-200 r/min, the mixing time is 4-6 hours, and the injection speed in thestep 3 is 10-15 mL/min; the temperature of the thermal crosslinking reaction in the step (4) is 220-230 ℃, and the reaction time is 80-120 min.

Preferably, the cooling mode of the step 5) is natural cooling or water cooling; the punching position is between two adjacent rings and is not at the position of the ring-shaped connecting section; the number of the holes is 40-50; the aperture is 0.9-1.1 mm; and clean ion wind with the pressure of 0.1-0.6 Mpa is used in the processes of static electricity removal and particle removal.

Preferably, the manufacturing method further comprises the steps of packaging, sterilizing and analyzing, wherein the novel peritoneal dialysis tube is packaged by a V-shaped bottom sealing bag, and then the packaged novel peritoneal dialysis tube is sterilized and analyzed by ethylene oxide.

Preferably, in the packaging process, the packaging temperature is 110-120 ℃, the packaging pressure is 300-400 kpa, and the packaging time is 2.0-2.5 s; the ethylene oxide sterilization time is 640-800 min, and the resolution time is 8-10 days.

Compared with the prior art, the invention has the following beneficial effects: hydroxyethyl starch cannot enter blood through the peritoneum, so that the osmotic pressure of the dialysate can be maintained for a long time, a long-term ultrafiltration effect is kept, the use amount of the dialysate for single peritoneal dialysis is greatly reduced, and the use of the dialysate once a day is convenient for patients; secondly, the novel peritoneal dialysis tube capable of using the hydroxyethyl starch peritoneal dialysis solution and the manufacturing method thereof adopt a mode that a cross-linked polyolefin material added with barium sulfate is firstly used for forming a component, then the cross-linked polyolefin material not added with barium sulfate is used for coating the component, and a dialysis hole is drilled to avoid the component part, thereby greatly reducing the technical problems of exposure of barium sulfate solid particles on the surface, precipitation and the like and improving the safety of the peritoneal dialysis process; and thirdly, the annular structure added with barium sulfate is gradually densified in the direction close to one end extending into the abdominal cavity, the density of the annular structure is gradually increased, the port of the peritoneal dialysis catheter for entering and exiting liquid can be prevented from floating on the liquid level, and the problem of low liquid discharge efficiency is solved.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and other drawings can be obtained by those skilled in the art without creative efforts.

FIG. 1 is a structural diagram of a structural member of a crosslinked polyolefin material with barium sulfate added according to the present invention;

FIG. 2 is a schematic view of the structure of a novel peritoneal dialysis solution of the present invention that can use hydroxyethyl starch;

FIG. 3 is a schematic view showing a method for manufacturing a novel peritoneal dialysis catheter using hydroxyethyl starch peritoneal dialysis solution according to the present invention.

Wherein:

1. a tube body, 2, a terylene lantern ring, 3, a dialysis hole, 4 and a cross-linked polyolefin material component added with barium sulfate.

Detailed Description

The invention provides peritoneal dialysis solution containing hydroxyethyl starch, a novel peritoneal dialysis tube and a manufacturing method thereof, wherein a member is formed by adding a cross-linked polyolefin material containing barium sulfate, then the member is coated by using the cross-linked polyolefin material without adding barium sulfate, and a dialysis hole is formed to avoid the position of the member, so that the technical problems of exposure, precipitation and the like of barium sulfate solid particles to the surface are greatly reduced, and the safety of the peritoneal dialysis process is improved.

The invention provides a novel peritoneal dialysis solution formula which mainly comprises, by mass, 0.5% -15% of hydroxyethyl starch, 0.3% -0.6% of sodium chloride, 0.01% -0.03% of calcium chloride, 0.002% -0.006% of magnesium chloride and 0.2% -0.5% of sodium lactate.

The invention also provides a preparation method of the peritoneal dialysis solution, which comprises the following steps:

according to the concentration ratio, hydroxyethyl starch, sodium chloride, calcium chloride, magnesium chloride and sodium lactate are put into 1000 ml of water, stirred and dissolved, and then filtered by a 0.45 mu m filter membrane, a 0.22 mu m filter membrane and a 0.22 mu m filter membrane in sequence; sterilizing the filtered solution at 121 ℃ for 12 minutes; filling the filtered solution into a single-cavity bag;

or: putting hydroxyethyl starch into 500 ml of water, stirring and dissolving, and then sequentially filtering by adopting a 0.45 mu m filter membrane, a 0.22 mu m filter membrane and a 0.22 mu m filter membrane; sterilizing the filtered solution at 121 ℃ for 12 minutes; filling the filtered solution into a single-cavity bag; then putting sodium chloride, calcium chloride, magnesium chloride and sodium lactate into 500 ml of water, stirring and dissolving, and then sequentially filtering by adopting a 0.45 mu m filter membrane, a 0.22 mu m filter membrane and a 0.22 mu m filter membrane; sterilizing the filtered solution at 121 ℃ for 12 minutes; the filtered solution was filled into another single-chamber bag.

Adding 500 ml of water into a first preparation tank, adding 5g of hydroxyethyl starch, adding 500 ml of water into a second preparation tank, adding 5.38g of sodium chloride, 0.26g of calcium chloride, 0.051g of magnesium chloride and 4.48g of sodium lactate, stirring to dissolve, filtering through 0.45 mu m, 0.22 mu m and 0.22 mu m filter membranes respectively, and filling into double-cavity bags respectively. And sterilized at 121 ℃ for 12 minutes.

The preparation method adopts a single-cavity bag or double-cavity bag packaging sterilization process, wherein the single-cavity bag process is that all materials are placed in one cavity, and the double-cavity bag process is that the hydroxyethyl starch solution and other material solutions are not in the same cavity and are packaged separately. The sterilization process adopts a residual probability method or an overkill method.

Besides the dialysate, the invention also provides a peritoneal dialysis tube which can use the hydroxyethyl starch peritoneal dialysate, and the peritoneal dialysis tube comprises atube body 1, aterylene lantern ring 2 anddialysis holes 3;

thepipe body 1 is made of cross-linked polyolefin material;

a cross-linkedpolyolefin material component 4 added with barium sulfate is arranged in the tube wall of one end of thetube body 1 extending into the abdominal cavity, as shown in figure 2;

the shape of themember 4 comprises interconnected rings, as shown in fig. 1;

thedialysis port 3 does not overlap with the ring shape of themember 4 and its connecting section.

Preferably, the mass ratio of barium sulfate in the cross-linked polyolefin material added with barium sulfate is 15-25%.

Preferably, the distance between the adjacent rings of themember 4 close to the end of thetube body 1 extending into the abdominal cavity becomes smaller, the distance between the adjacent rings far from the end extending into the abdominal cavity becomes larger, and the width between the two adjacent rings is larger than 2.0 mm.

Further preferably, the width of the ring-shaped structure of themember 4, i.e. the width in the length direction of the peritoneal dialysis catheter, can be adjusted as desired; further preferably, the width of the annular structure of themember 4 is 1-3 mm;

further preferably, the number of the ring-shaped structures of themember 4 can be adjusted as required, the length of themember 4 is determined by the number of the ring-shaped structures, and the length of themember 4 should be not less than the length of the peritoneal dialysis catheter extending into the abdominal cavity, so as to facilitate observation under an X-ray machine.

Further preferably, the distance between the annular structures added with barium sulfate can be evenly distributed or can be unevenly distributed according to needs, for example, the annular structures added with barium sulfate can be gradually densified and gradually increased in density in the direction close to one end extending into the abdominal cavity, so that the ports of the peritoneal dialysis catheter for entering and exiting liquid can be prevented from floating on the liquid level, and the problem of low liquid discharge efficiency is solved.

Preferably, the width of theterylene lantern ring 2 is 0.9-1.1 cm, and theterylene lantern ring 2 is arranged at the position 15cm away from the two ends of the dialysis tube.

Preferably, the crosslinked polyolefin material includes at least one of isobutylene and styrene copolymer, isobutylene and isoprene copolymer, isobutylene and vinylbenzocyclobutene copolymer, isobutylene and butadiene copolymer, styrene and isoprene copolymer.

Further preferably, the peritoneal dialysis catheter of the present invention can use hydroxyethyl starch peritoneal dialysis solution for peritoneal dialysis. The hydroxyethyl starch peritoneal dialysis solution is a novel peritoneal dialysis solution, and has the advantages of prolonging the dialysis time, solving the problems that the dialysis needs to be changed 4 times a day by adopting the conventional dialysis solution, the operation is troublesome and the infection chance is increased. The novel hydroxyethyl starch peritoneal dialysis solution is only required to be changed once a day.

The present invention also provides a method for manufacturing the novel peritoneal dialysis catheter using hydroxyethyl starch peritoneal dialysis solution, as shown in fig. 3, comprising the following steps:

1) preparing raw materials of a component: mixing barium sulfate and a cross-linked polyolefin material to obtain a component raw material;

2) preparing a component: preheating a component raw material and a component mold, and then injecting the preheated component raw material into the component mold to obtain a component;

3) preparing a pipe body: placing the component prepared in the step 2) into a corresponding position of a pipe body forming die to enable the component to be positioned in the middle of the wall of the pipe body, and then injecting a preheated cross-linked polyolefin material;

4) thermal crosslinking: placing the molding die injected with the crosslinked polyolefin material obtained in the step 3) in a hot press for thermal crosslinking reaction;

5) post-processing of the pipe body: after the thermal crosslinking reaction is finished, cooling, taking out the formed peritoneal dialysis tube blank, perforating, and then performing static electricity removal and particle removal;

6) bonding a polyester lantern ring: respectively bonding the terylene lantern rings at the two ends of the tube body obtained in the step 5) to obtain the novel peritoneal dialysis tube.

Preferably, the raw materials of the components in the step 1) are prepared, the used barium sulfate is powder, the rotating speed in the mixing process is 110-200 r/min, the mixing time is 4-6 hours, and the injection speed in thestep 3 is 10-15 mL/min; the temperature of the thermal crosslinking reaction in the step (4) is 220-230 ℃, and the reaction time is 80-120 min.

Preferably, the cooling mode of the step 5) is natural cooling or water cooling; the punching position is between two adjacent rings and is not at the position of the ring-shaped connecting section; the number of the holes is 40-50; the aperture is 0.9-1.1 mm; and clean ion wind with the pressure of 0.1-0.6 Mpa is used in the processes of static electricity removal and particle removal.

Further preferably, the polyester collar of step (6) is bonded by a silicone adhesive.

Preferably, the manufacturing method further comprises the steps of packaging, sterilizing and analyzing, wherein the novel peritoneal dialysis catheter is packaged by a V-shaped bottom sealing bag, and then the packaged novel peritoneal dialysis catheter is sterilized and analyzed by ethylene oxide.

Preferably, in the packaging process, the packaging temperature is 110-120 ℃, the packaging pressure is 300-400 kpa, and the packaging time is 2.0-2.5 s; the ethylene oxide sterilization time is 640-800 min, and the resolution time is 8-10 days.

The technical solutions of the present invention will be described clearly and completely with reference to the accompanying drawings, and it should be understood that the described embodiments are some, but not all embodiments of the present invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

Example 1

Adding 500 ml of water into a first preparation tank, adding 5g of hydroxyethyl starch, adding 500 ml of water into a second preparation tank, adding 5.38g of sodium chloride, 0.26g of calcium chloride, 0.051g of magnesium chloride and 4.48g of sodium lactate, stirring to dissolve, filtering through 0.45 mu m, 0.22 mu m and 0.22 mu m filter membranes respectively, and filling into double-cavity bags respectively. Sterilizing at 121 deg.C for 12 min. And (5) obtaining the product.

Example 2

1000 ml of water is added into a preparation tank, 8g of hydroxyethyl starch, 5.38g of sodium chloride, 0.26g of calcium chloride, 0.051g of magnesium chloride and 4.48g of sodium lactate are added, stirred and dissolved, filtered by 0.45 mu m, 0.22 mu m and 0.22 mu m filter membranes respectively and filled into single-cavity bags respectively. Sterilizing at 121 deg.C for 12 min. And (5) obtaining the product.

Example 3

Adding 500 ml of water into a first preparation tank, adding 1g of hydroxyethyl starch, adding 500 ml of water into a second preparation tank, adding 5.38g of sodium chloride, 0.26g of calcium chloride, 0.051g of magnesium chloride and 4.48g of sodium lactate, stirring to dissolve, filtering through 0.45 mu m, 0.22 mu m and 0.22 mu m filter membranes respectively, and filling into double-cavity bags respectively. Sterilizing at 115 deg.C for 30 min. And (5) obtaining the product.

Example 4

Adding 500 ml of water into a first preparation tank, adding 0.5g of hydroxyethyl starch, adding 500 ml of water into a second preparation tank, adding 5.38g of sodium chloride, 0.26g of calcium chloride, 0.051g of magnesium chloride and 4.48g of sodium lactate, stirring for dissolving, filtering through 0.45 mu m, 0.22 mu m and 0.22 mu m filter membranes respectively, and filling into double-cavity bags respectively. Sterilizing at 121 deg.C for 12 min. And (5) obtaining the product.

Example 5

1000 ml of water is added into a preparation tank, 15g of hydroxyethyl starch, 5.38g of sodium chloride, 0.26g of calcium chloride, 0.051g of magnesium chloride and 4.48g of sodium lactate are added, stirred and dissolved, filtered by 0.45 mu m, 0.22 mu m and 0.22 mu m filter membranes respectively and filled into single-cavity bags respectively. Sterilizing at 115 deg.C for 32 min. And (5) obtaining the product.

Example 6

1000 ml of water is added into a preparation tank, 10g of hydroxyethyl starch, 5.38g of sodium chloride, 0.26g of calcium chloride, 0.051g of magnesium chloride and 4.48g of sodium lactate are added, stirred and dissolved, filtered by 0.45 mu m, 0.22 mu m and 0.22 mu m filter membranes respectively and filled into single-cavity bags respectively. Sterilizing at 121 deg.C for 12 min. And (5) obtaining the product.

Example 7

Adding 500 ml of water into a first preparation tank, adding 3g of hydroxyethyl starch, adding 500 ml of water into a second preparation tank, adding 5.38g of sodium chloride, 0.26g of calcium chloride, 0.051g of magnesium chloride and 4.48g of sodium lactate, stirring to dissolve, filtering through 0.45 mu m, 0.22 mu m and 0.22 mu m filter membranes respectively, and filling into double-cavity bags respectively. Sterilizing at 121 deg.C for 8 min. And (5) obtaining the product.

Example 8

The peritoneal dialysis tube of the embodiment comprises atube body 1, aterylene lantern ring 2 and adialysis hole 3; thepipe body 1 is made of copolymer of isobutene and styrene; the tube wall of thetube body 1 extending into the abdominal cavity is internally provided with an isobutene andstyrene copolymer component 4 added with barium sulfate, as shown in figure 2; the shape of themember 4 comprises interconnected rings, as shown in fig. 1; thedialysis port 3 does not overlap with the ring shape of themember 4 and its connecting section. The mass ratio of barium sulfate in the isobutylene and styrene copolymer added with barium sulfate is 15%. The adjacent annular space of the end, which is close to thetube body 1 and extends into the abdominal cavity, of themember 4 is reduced, the adjacent annular space of the end, which is far away from the end extending into the abdominal cavity, of the member is increased, and the width between the two adjacent annular spaces is larger than 2.0 mm. The annular structure added with barium sulfate is gradually densified in the direction close to one end extending into the abdominal cavity, the density of the annular structure is gradually increased, the port of the peritoneal dialysis catheter for entering and exiting liquid can be prevented from floating on the liquid level, and the problem of low liquid discharge efficiency is solved. The width of theterylene lantern ring 2 is 0.9cm, and theterylene lantern ring 2 is arranged at the position 15cm away from the two ends of the dialysis tube.

The preparation method of the peritoneal dialysis catheter of the embodiment, as shown in fig. 3, comprises the following steps:

1) preparing raw materials of a component: mixing barium sulfate with isobutylene and styrene copolymer to obtain a component raw material;

2) preparing a component: preheating a component raw material and a component mold, and then injecting the preheated component raw material into the component mold to obtain a component;

3) preparing a pipe body: placing the component prepared in the step 2) into a corresponding position of a pipe body forming die to enable the component to be positioned in the middle of the wall of the pipe body, and then injecting a preheated cross-linked polyolefin material;

4) thermal crosslinking: placing the molding die injected with the copolymer of isobutylene and styrene obtained in the step 3) in a hot press for thermal crosslinking reaction;

5) post-processing of the pipe body: after the thermal crosslinking reaction is finished, cooling, taking out the formed peritoneal dialysis tube blank, perforating, and then performing static electricity removal and particle removal;

6) bonding a polyester lantern ring: respectively bonding the terylene lantern rings at the two ends of the tube body obtained in the step 5) to obtain the novel peritoneal dialysis tube.

Step 1) preparing raw materials of a component, wherein the used barium sulfate is powder, the rotating speed in the mixing process is 110 revolutions per minute, the mixing time is 6 hours, and the injection speed in thestep 3 is 10mL per minute; the temperature of the thermal crosslinking reaction in the step (4) is 230 ℃, and the reaction time is 80 min.

The cooling mode of the step 5) is natural cooling or water cooling; the punching position is between two adjacent rings and is not at the position of the ring-shaped connecting section; the number of the punched holes is 40; the aperture is 1.1 mm; the static electricity removing and particle removing process uses clean ion wind with pressure of 0.1 Mpa.

And (5) bonding the polyester lantern ring in the step (6) through a silica gel adhesive.

The manufacturing method also comprises the steps of packaging, sterilizing and analyzing, wherein the novel peritoneal dialysis tube is packaged by a V-shaped bottom sealing bag, and then the packaged novel peritoneal dialysis tube is sterilized and analyzed by ethylene oxide.

In the packaging process, the packaging temperature is 110 ℃, the packaging pressure is 300kpa, and the packaging time is 2.0 s; the ethylene oxide sterilization time is 640min, and the resolution time is 8 days.

Example 9

The peritoneal dialysis tube of the embodiment comprises atube body 1, aterylene lantern ring 2 and adialysis hole 3; thetube body 1 is made of isobutylene and vinylbenzocyclobutene copolymer; the tube wall of thetube body 1 extending into the abdominal cavity is internally provided with an isobutene andvinylbenzocyclobutene copolymer member 4 added with barium sulfate, as shown in figure 2; the shape of themember 4 comprises interconnected rings, as shown in fig. 1; thedialysis port 3 does not overlap with the ring shape of themember 4 and its connecting section. The mass ratio of barium sulfate in the isobutylene and vinylbenzocyclobutene copolymer added with barium sulfate is 25%. The adjacent annular space of the end, which is close to thetube body 1 and extends into the abdominal cavity, of themember 4 is reduced, the adjacent annular space of the end, which is far away from the end extending into the abdominal cavity, of the member is increased, and the width between the two adjacent annular spaces is larger than 2.2 mm. The annular structure added with barium sulfate is gradually densified in the direction close to one end extending into the abdominal cavity, the density of the annular structure is gradually increased, the port of the peritoneal dialysis catheter for entering and exiting liquid can be prevented from floating on the liquid level, and the problem of low liquid discharge efficiency is solved. The width of theterylene lantern ring 2 is 1.1cm, and theterylene lantern ring 2 is arranged at the position 15cm away from the two ends of the dialysis tube.

The preparation method of the peritoneal dialysis catheter of the embodiment, as shown in fig. 3, comprises the following steps:

1) preparing raw materials of a component: mixing barium sulfate with isobutylene and vinylbenzocyclobutene copolymer to obtain a component raw material;

2) preparing a component: preheating a component raw material and a component mold, and then injecting the preheated component raw material into the component mold to obtain a component;

3) preparing a pipe body: placing the component prepared in the step 2) into a corresponding position of a pipe body forming die to enable the component to be positioned in the middle of the wall of the pipe body, and then injecting a preheated cross-linked polyolefin material;

4) thermal crosslinking: placing the molding die injected with the copolymer of isobutylene and styrene obtained in the step 3) in a hot press for thermal crosslinking reaction;

5) post-processing of the pipe body: after the thermal crosslinking reaction is finished, cooling, taking out the formed peritoneal dialysis tube blank, perforating, and then performing static electricity removal and particle removal;

6) bonding a polyester lantern ring: respectively bonding the terylene lantern rings at the two ends of the tube body obtained in the step 5) to obtain the novel peritoneal dialysis tube.

Step 1) preparing raw materials of a component, wherein the used barium sulfate is powder, the rotating speed in the mixing process is 200 revolutions per minute, the mixing time is 4 hours, and the injection speed in thestep 3 is 15mL per minute; the temperature of the thermal crosslinking reaction in the step (4) is 230 ℃, and the reaction time is 80 min.

The cooling mode of the step 5) is natural cooling or water cooling; the punching position is between two adjacent rings and is not at the position of the ring-shaped connecting section; the number of the punched holes is 50; the aperture is 0.9 mm; the static electricity removing and particle removing process uses clean ion wind with pressure of 0.6 Mpa.

And (5) bonding the polyester lantern ring in the step (6) through a silica gel adhesive.

Example 10

The peritoneal dialysis tube of the embodiment comprises atube body 1, aterylene lantern ring 2 and adialysis hole 3; thetube body 1 is made of a copolymer of styrene and isoprene; a styrene andisoprene copolymer member 4 added with barium sulfate is arranged in the tube wall of one end of thetube body 1 extending into the abdominal cavity, as shown in figure 2; the shape of themember 4 comprises interconnected rings, as shown in fig. 1; thedialysis port 3 does not overlap with the ring shape of themember 4 and its connecting section. The mass ratio of barium sulfate in the styrene and isoprene copolymer added with barium sulfate is 20%. The adjacent annular space of the end, which is close to thetube body 1 and extends into the abdominal cavity, of themember 4 is reduced, the adjacent annular space of the end, which is far away from the end extending into the abdominal cavity, of the member is increased, and the width between the two adjacent annular spaces is larger than 2.6 mm. The annular structure added with barium sulfate is gradually densified in the direction close to one end extending into the abdominal cavity, the density of the annular structure is gradually increased, the port of the peritoneal dialysis catheter for entering and exiting liquid can be prevented from floating on the liquid level, and the problem of low liquid discharge efficiency is solved. The width of theterylene lantern ring 2 is 1.0cm, and theterylene lantern ring 2 is arranged at the position 15cm away from the two ends of the dialysis tube.

The preparation method of the peritoneal dialysis catheter of the embodiment, as shown in fig. 3, comprises the following steps:

1) preparing raw materials of a component: mixing barium sulfate with a styrene and isoprene copolymer to obtain a component raw material;

2) preparing a component: preheating a component raw material and a component mold, and then injecting the preheated component raw material into the component mold to obtain a component;

3) preparing a pipe body: placing the component prepared in the step 2) into a corresponding position of a pipe body forming die to enable the component to be positioned in the middle of the wall of the pipe body, and then injecting a preheated cross-linked polyolefin material;

4) thermal crosslinking: placing the molding die injected with the copolymer of isobutylene and styrene obtained in the step 3) in a hot press for thermal crosslinking reaction;

5) post-processing of the pipe body: after the thermal crosslinking reaction is finished, cooling, taking out the formed peritoneal dialysis tube blank, perforating, and then performing static electricity removal and particle removal;

6) bonding a polyester lantern ring: respectively bonding the terylene lantern rings at the two ends of the tube body obtained in the step 5) to obtain the novel peritoneal dialysis tube.

Step 1) preparing raw materials of a component, wherein the used barium sulfate is powder, the rotating speed in the mixing process is 160 revolutions per minute, the mixing time is 5 hours, and the injection speed in thestep 3 is 13mL per minute; the temperature of the thermal crosslinking reaction in the step (4) is 225 ℃, and the reaction time is 100 min.

The cooling mode of the step 5) is natural cooling or water cooling; the punching position is between two adjacent rings and is not at the position of the ring-shaped connecting section; the number of the holes is 45; the aperture is 1.0 mm; the static electricity removing and particle removing process uses clean ion wind with pressure of 0.3 Mpa.

The manufacturing method also comprises the steps of packaging, sterilizing and analyzing, wherein the novel peritoneal dialysis tube is packaged by a V-shaped bottom sealing bag, and then the packaged novel peritoneal dialysis tube is sterilized and analyzed by ethylene oxide.

In the packaging process, the packaging temperature is 115 ℃, the packaging pressure is 350kpa, and the packaging time is 2.2 s; the ethylene oxide sterilization time was 720min, and the resolution time was 9 days.

Finally, it should be noted that: the above-mentioned embodiments are only specific embodiments of the present invention, which are used for illustrating the technical solutions of the present invention and not for limiting the same, and the protection scope of the present invention is not limited thereto, although the present invention is described in detail with reference to the foregoing embodiments, those skilled in the art should understand that: any person skilled in the art can modify or easily conceive the technical solutions described in the foregoing embodiments or equivalent substitutes for some technical features within the technical scope of the present disclosure; such modifications, changes or substitutions do not depart from the spirit and scope of the present invention in its spirit and scope. Are intended to be covered by the scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the appended claims.

The applicant declares that the technical solution of the present invention is illustrated by the above embodiments, but the present invention is not limited to the above embodiments, that is, the present invention is not meant to be implemented only by relying on the above embodiments. It should be understood by those skilled in the art that any modification of the present invention, equivalent substitutions of the raw materials of the product of the present invention, addition of auxiliary components, selection of specific modes, etc., are within the scope and disclosure of the present invention.

The preferred embodiments of the present invention have been described in detail, however, the present invention is not limited to the specific details of the above embodiments, and various simple modifications may be made to the technical solution of the present invention within the technical idea of the present invention, and these simple modifications are within the protective scope of the present invention.

It should be noted that the various technical features described in the above embodiments can be combined in any suitable manner without contradiction, and the invention is not described in any way for the possible combinations in order to avoid unnecessary repetition.

Claims (10)

1. The peritoneal dialysis solution containing hydroxyethyl starch is characterized by comprising, by mass, 0.5% -15% of hydroxyethyl starch, 0.3% -0.6% of sodium chloride, 0.01% -0.03% of calcium chloride, 0.002% -0.006% of magnesium chloride and 0.2% -0.5% of sodium lactate.

2. The method for preparing a peritoneal dialysis solution according to claim 1, characterized in that:

according to the concentration ratio, hydroxyethyl starch, sodium chloride, calcium chloride, magnesium chloride and sodium lactate are put into 1000 ml of water, stirred and dissolved, and then filtered by a 0.45 mu m filter membrane, a 0.22 mu m filter membrane and a 0.22 mu m filter membrane in sequence; sterilizing the filtered solution at 121 ℃ for 12 minutes; filling the filtered solution into a single-cavity bag;

or: putting hydroxyethyl starch into 500 ml of water, stirring and dissolving, and then sequentially filtering by adopting a 0.45 mu m filter membrane, a 0.22 mu m filter membrane and a 0.22 mu m filter membrane; sterilizing the filtered solution at 121 ℃ for 12 minutes; filling the filtered solution into a single-cavity bag; then putting sodium chloride, calcium chloride, magnesium chloride and sodium lactate into 500 ml of water, stirring and dissolving, and then sequentially filtering by adopting a 0.45 mu m filter membrane, a 0.22 mu m filter membrane and a 0.22 mu m filter membrane; sterilizing the filtered solution at 121 ℃ for 12 minutes; the filtered solution was filled into another single-chamber bag.

3. A novel peritoneal dialysis catheter using peritoneal dialysis solution containing hydroxyethyl starch, which can use peritoneal dialysis solution containing hydroxyethyl starch as claimed in claim 1, characterized in that the peritoneal dialysis catheter comprises a tube body (1), a dacron collar (2), dialysis holes (3);

the pipe body (1) is made of a cross-linked polyolefin material;

a cross-linked polyolefin material component (4) added with barium sulfate is arranged in the pipe wall of one end of the pipe body (1) extending into the abdominal cavity;

the shape of the member (4) comprises interconnected rings;

the dialysis holes (3) are not overlapped with the ring shape of the component (4) and the connecting section thereof.

4. The novel peritoneal dialysis tube of claim 3, wherein the mass ratio of barium sulfate in the cross-linked polyolefin material added with barium sulfate is 15% -25%.

5. A novel peritoneal dialysis tube according to claim 3, characterized in that the spacing between adjacent rings of the member (4) near the end of the tube body (1) extending into the abdominal cavity becomes smaller, the spacing between adjacent rings far from the end extending into the abdominal cavity becomes larger, and the width between two adjacent rings is larger than 2.0 mm; the width of the terylene lantern ring (2) is 0.9-1.1 cm, and the terylene lantern ring (2) is arranged at a position 15cm away from the two ends of the dialysis tube.

6. The novel peritoneal dialysis tube of claim 3, wherein the cross-linked polyolefin material comprises at least one of isobutylene and styrene copolymer, isobutylene and isoprene copolymer, isobutylene and vinylbenzocyclobutene copolymer, isobutylene and butadiene copolymer, styrene and isoprene copolymer.

7. A method for manufacturing a novel peritoneal dialysis tube according to any of claims 3 to 5, comprising the steps of:

1) preparing raw materials of a component: mixing barium sulfate and a cross-linked polyolefin material to obtain a component raw material;

2) preparing a component: preheating a component raw material and a component mold, and then injecting the preheated component raw material into the component mold to obtain a component;

3) preparing a pipe body: placing the component prepared in the step 2) into a corresponding position of a pipe body forming die to enable the component to be positioned in the middle of the wall of the pipe body, and then injecting a preheated cross-linked polyolefin material;

4) thermal crosslinking: placing the molding die injected with the crosslinked polyolefin material obtained in the step 3) in a hot press for thermal crosslinking reaction;

5) post-processing of the pipe body: after the thermal crosslinking reaction is finished, cooling, taking out the formed peritoneal dialysis tube blank, perforating, and then performing static electricity removal and particle removal;

6) bonding a polyester lantern ring: respectively bonding the terylene lantern rings at the two ends of the tube body obtained in the step 5) to obtain the novel peritoneal dialysis tube.

8. The method for manufacturing a novel peritoneal dialysis tube according to claim 7, wherein the raw material of the member in step 1) is prepared by using powdered barium sulfate, the rotation speed in the mixing process is 110-200 rpm, the mixing time is 4-6 hours, and the injection speed in step (3) is 10-15 mL/min; the temperature of the thermal crosslinking reaction in the step (4) is 220-230 ℃, and the reaction time is 80-120 min.

9. The method for manufacturing a novel peritoneal dialysis tube according to claim 7, wherein the cooling in step 5) is natural cooling or water cooling; the punching position is between two adjacent rings and is not at the position of the ring-shaped connecting section; the number of the holes is 40-50; the aperture is 0.9-1.1 mm; and clean ion wind with the pressure of 0.1-0.6 Mpa is used in the processes of static electricity removal and particle removal.

10. The method for manufacturing a novel peritoneal dialysis tube according to claim 7, further comprising the steps of packaging, sterilizing, and analyzing, wherein the novel peritoneal dialysis tube is packaged by a V-shaped bottom sealing bag, and then sterilized and analyzed by ethylene oxide; wherein in the packaging process, the packaging temperature is 110-120 ℃, the packaging pressure is 300-400 kpa, and the packaging time is 2.0-2.5 s; the ethylene oxide sterilization time is 640-800 min, and the resolution time is 8-10 days.

Images