A production system and production process of peritoneal dialysis solution

Abstract

This application discloses a peritoneal dialysis fluid production system and its production process. The system includes a concentration tank for dissolving raw materials and a dilution tank for mixing and volume adjustment. The volume ratio of the concentration tank to the dilution tank is 1:12 to 1:8. The concentration tank includes a shear mixer and a tank body. The shear mixer includes a drive mechanism, a rotating shaft, and a stirring mechanism. One end of the rotating shaft extends obliquely upwards into the tank body from the bottom. The stirring mechanism is fixed to the end of the rotating shaft that extends into the tank body. The stirring mechanism includes a turntable that rotates with the rotating shaft. An inclined blade and a slurry column are installed on the side of the turntable facing the center of the tank body. The inclined blade and the slurry column are circumferentially distributed around the rotation center of the turntable. The inclined blade is inclined to the rotating shaft, and the inclined blade is parallel to one radial direction of the rotating shaft. The height of the slurry column is such that the extension surface of the inclined blade intersects the side of the slurry column, ensuring that the slurry and injection water are mixed evenly, effectively reducing the amount of gas dissolved in the liquid, reducing the need for replenishment during volume adjustment, and improving the product filling quality.

Description

Technical Field

[0001] This application relates to peritoneal dialysis fluid, and more particularly to a peritoneal dialysis fluid production system and its production process. Background Technology

[0002] Peritoneal dialysis fluid is a liquid used for peritoneal dialysis. It is introduced into the patient's peritoneal cavity using a special peritoneal dialysis catheter. Then, through the exchange of water and solutes between the peritoneal capillaries and the dialysis fluid, the excess water and toxins in the body are removed.

[0003] The applicant sells lactate peritoneal dialysis solution, which is prepared from water for injection, glucose, sodium chloride, calcium chloride, magnesium chloride, and sodium lactate. For example, peritoneal dialysis solution (lactate-G 2.5%) contains 2.5g glucose, 5.67g sodium chloride, 0.257g calcium chloride, 0.152g magnesium chloride, and 5g sodium lactate per 1000ml. The preparation method involves first preparing a concentrated solution, mixing the concentrated solution, and then adding water for injection to make up the volume. During the preparation process, because sodium lactate tends to agglomerate and crystallize when mixed with water for injection, it puts a heavy burden on the reflux filtration system. Therefore, a sodium lactate slurry with a concentration of 60-80% (by weight) is used for preparation.

[0004] However, sodium lactate slurry is a syrupy liquid with high viscosity. Existing anchor and paddle mixers have poor mixing effect on high-viscosity syrups at low speeds, while high-speed mixing easily introduces and dissolves gas, leading to gas release during volume setting and frequent material replenishment, or gas release after filling, affecting product filling quality. Summary of the Invention

[0005] To ensure uniform dispersion and mixing of sodium lactate slurry in the preparation of lactate peritoneal dialysis fluid, reduce product bubbles, and guarantee product quality, a peritoneal dialysis fluid production system and its production process are provided.

[0006] The first objective of this invention is achieved through the following technical solution:

[0007] A peritoneal dialysis fluid production system includes a concentration tank for dissolving raw materials, a dilution tank for mixing and volume adjustment, and a feed pipeline connecting the concentration tank and the dilution tank.

[0008] When preparing sodium lactate solution in the concentration tank, the volume of sodium lactate solution prepared is 0.036 to 0.0484 of the fixed volume of the dilution tank;

[0009] The concentration tank includes a shear mixer and a tank body;

[0010] The shear mixer includes a drive mechanism, a rotating shaft, and a stirring mechanism;

[0011] One end of the rotating shaft extends into the tank body from the bottom of the tank at an angle, while the other end is connected to the drive mechanism for transmission.

[0012] The stirring mechanism is fixed to one end of the rotating shaft that extends into the tank.

[0013] The stirring mechanism includes a turntable that rotates with the rotating shaft, and inclined blades and a slurry column are installed on the side of the turntable facing the center of the tank.

[0014] The inclined blades and slurry columns are distributed circumferentially around the rotation center of the turntable. The inclined blades are inclined to the rotation axis and are parallel to one radial direction of the rotation axis.

[0015] The height of the grout column is such that the extension surface of the inclined blade intersects the side of the grout column.

[0016] By adopting the above technical solution, the existing stirring paddle is inserted into the liquid from top to bottom. During the stirring process, the angular velocity of the stirring paddle remains unchanged, and the linear velocity of the central rotation is much lower than that of the outer rotation. After the flow velocity difference is formed, the central liquid flow diffuses outward and sinks downward, which is reflected in the concave and sinking of the center of the liquid surface. As a result, the gas is easily mixed in and carried into the liquid below the liquid surface and dissolved / mixed into the liquid.

[0017] In this application, the inclined blades and the slurry column rotate around the axis of rotation. For the tank, the axis of rotation is oriented towards the center of the tank and is inclined upward. The liquid flows upward and spreads outward as it flows upward. The flow rate slows down as it goes up, and the flow rate also decreases from the center outward. Thus, when the liquid reaches the liquid surface, the liquid spreads evenly and the flow rate is relatively uniform. The outer layer has a slow flow rate. When the liquid hits the inner wall of the tank and sinks, it is not easy to carry gas. The liquid has a low gas content. Furthermore, due to the inclination of the rotating shaft, the stirring mechanism has a height difference during stirring, which can fully mix liquids with different heights and concentration gradients.

[0018] On the other hand, the specific tilting setting of the inclined blades during rotation causes them to scoop up some of the slurry when they cut into the bottom. This scooped-up slurry is then accelerated on the blade surface by the push of the blades until it is thrown out of the blade edge. Subsequently, it is impacted and dispersed by the rotating slurry column. This allows for better mixing with water, resulting in a highly efficient mixing effect.

[0019] In summary, the improved concentration tank of this application ensures uniform mixing of slurry and injection water, effectively reduces gas dissolution into the liquid, reduces material replenishment during volume adjustment, and improves product filling quality.

[0020] Optionally: There are multiple inclined blades and slurry columns, which are evenly distributed, and the inclination angle of each of the multiple inclined blades is different.

[0021] By adopting the above technical solution, the slurry concentration changes with the mixing process. The density of the slurry is different at different concentrations, and the settling speed and trend are different. The blades with different tilt angles have a better mixing effect.

[0022] Optional: The inclined blade has a through-hole for diverting flow.

[0023] By adopting the above technical solution, when the slurry is initially added for mixing, the amount of slurry is large and the viscosity is high, making it difficult for the mixing mechanism to mix. When the slurry is scooped up by the inclined blade, the amount of slurry on the inclined blade can be appropriately controlled. Excess slurry is squeezed out from the diversion hole by hydraulic pressure, maintaining good dispersion action of the inclined blade and the slurry column. At the same time, the slurry separated from the diversion hole can also play a certain role in mixing the slurry.

[0024] Optionally: the slurry column is provided with a vortex slurry distribution surface facing the side of the inclined blade, and the vortex slurry distribution surface is a saddle-shaped curved surface.

[0025] By adopting the above technical solution, compared with a planar or cylindrical surface, the slurry forms vortices on both sides of the vortex dispersing surface after impacting the vortex dispersing surface, resulting in a better mixing effect.

[0026] Optionally, the stirring mechanism further includes a fixed sheath, within which the turntable, inclined blades, and slurry column are all located. The sheath has a slurry return port on one side of the tank along the rotation axis towards the center.

[0027] The sheath has a feed port on its side for material to enter.

[0028] By adopting the above technical solution, the pressure of liquid delivery (slurry, mixture of slurry and water) towards the center of the tank is increased, the height of the shear mixer is enhanced, and the material mixing effect is improved.

[0029] Optionally: The return slurry inlet is provided with a first diameter changing section and a second diameter changing section in sequence along the axial direction of the rotation axis toward the center of the tank.

[0030] The diameter of the first variable diameter section decreases, while the diameter of the second variable diameter section increases.

[0031] By adopting the above technical solution, the mixing range can be expanded by utilizing the pressure difference principle, which allows for a smaller stirring mechanism while reducing bubbles and increasing the mixing effect.

[0032] Optionally: The side of the inclined blade facing away from the turntable is a liquid-pushing surface, and the liquid-pushing surface is provided with a raised grid edge, the height of the raised grid edge gradually decreasing from the end of the inclined blade near the turntable to the end away from the turntable.

[0033] By adopting the above technical solution, the scooping effect of the inclined blade on the slurry is increased. In particular, the viscosity of the slurry decreases when it is initially thin or during the middle stage of mixing. The gradual decrease in the height of the grid along the ridge is a support for ensuring the original mixing effect, which ensures that the slurry can be thrown out and dispersed by the slurry column.

[0034] The second objective of this invention is achieved through the following technical solution:

[0035] A process for producing peritoneal dialysis fluid, the aforementioned peritoneal dialysis fluid production system comprising the following steps:

[0036] S1: Weigh the sodium lactate slurry and put it into the concentration tank, then inject water for injection, mix it with a shear mixer, and reflux it with an ultrafiltration pump. The reflux mixing time shall not be less than 30 minutes to obtain a sodium lactate solution.

[0037] S2: Discharge the sodium lactate solution into the dilution tank;

[0038] S3: After the sodium lactate solution is drained, inject water for injection again, slowly add glucose, stir until completely dissolved, then slowly add sodium chloride, magnesium chloride, and calcium chloride, then add pH adjuster, stir and dissolve for 40-50 minutes to obtain drug solution A;

[0039] S4: Drug solution A is filtered through coarse filtration and ultrafiltration to remove endotoxins and undissolved crystals before being discharged into the dilution tank;

[0040] S5: Add water for injection to the dilution tank to the prepared volume, stir and reflux for more than 30 minutes, take a sample for testing, adjust the pH, add water and add materials, and obtain drug solution B after passing the test;

[0041] S6: After coarse filtration and fine filtration of drug solution B, and reflux and mix evenly, the peritoneal dialysis solution to be filled is obtained.

[0042] In summary, this application has at least the following beneficial effects:

[0043] In this application, the inclined blades and the slurry column rotate around the axis of rotation. For the tank body, the axis of rotation is oriented towards the center of the tank body and inclined upwards. The liquid flow rises from bottom to top, and when it reaches the liquid surface, the liquid flow spreads evenly and the flow velocity is relatively uniform. The outer layer has a slower flow velocity. When the liquid flow hits the inner wall of the tank and sinks, it is not easy to carry gas. The liquid material has a low gas content. Furthermore, due to the inclination of the rotating shaft and the specific inclination setting of the inclined blades, liquid slurries of different heights and concentration gradients are scooped up and accelerated and thrown out on the surface of the inclined blades. They are then impacted and dispersed by the rotating slurry column, which then mixes better with water, achieving a highly efficient mixing effect. Thus, the improved concentration tank of this application ensures that the slurry and injection water are mixed evenly, effectively reduces the dissolution of gas into the liquid material, reduces the need for replenishment during volume adjustment, and improves the product filling quality. Attached image description:

[0044] Appendix Figure 1 A simplified system module diagram of a peritoneal dialysis fluid production system;

[0045] Appendix Figure 2 This is a cross-sectional view of the concentrate preparation tank;

[0046] Appendix Figure 3 A cross-sectional view of the shear mixer in its exploded state;

[0047] Appendix Figure 4 This is a schematic diagram of the stirring mechanism;

[0048] Appendix Figure 5 This is a partial schematic diagram of the stirring mechanism;

[0049] Appendix Figure 6 This is a cross-sectional view of the stirring mechanism.

[0050] Attached reference numerals: 1. Concentrated preparation tank; 11. Tank body; 111. Piping; 112. Flange; 2. Ultrafiltration pump; 3. Coarse filter for drug solution A; 4. Ultrafiltration filter for drug solution A; 5. Dilute preparation tank; 6. Reflux pump; 7. Coarse filter for drug solution; 8. Fine filter for drug solution; 9. Shear mixer; 91. Drive mechanism; 92. Rotating shaft; 93. Stirring mechanism; 931. Sheath; 9311. Inlet; 39 12. Return slurry inlet; 9313. First diameter changing section; 9314. Second diameter changing section; 9315. Shaft through hole; 932. Turntable; 9321. Bearing surface; 9322. Mounting surface; 9323. Mounting part; 933. Slurry column; 9331. Vortex slurry distribution surface; 934. Mounting column; 935. Inclined blade; 9351. Liquid pushing surface; 9352. Grid edge; 9353. Diversion hole. Detailed Implementation

[0051] Example 1

[0052] As attached Figure 1 As shown, a peritoneal dialysis fluid production system includes a concentration tank 1 and a dilution tank 5.

[0053] The concentration tank 1 includes a tank body 11, and the production system is equipped with an ultrafiltration pump 2 for reflux of materials in the tank and a shear mixer 9 for accelerating material mixing.

[0054] The inlet and outlet of the ultrafiltration pump 2 are both connected to the side of the tank 11, with the outlet being higher than the inlet. When the ultrafiltration pump 2 is started, it can draw out the liquid in the tank 11 and pump it back into the tank 11, forming a material reflux cycle.

[0055] As attached Figure 2 As shown, the shear mixer 9 is installed at the bottom of the tank 11, and includes a drive mechanism 91 located outside the tank 11 and a stirring mechanism 93 located inside the tank 11.

[0056] As attached Figure 3 As shown, the bottom of the tank 11 is provided with a through pipe 111 connecting the inside and outside. The through pipe 111 is inclined upward, and flanges 112 are fixed at both ends. The drive mechanism 91 and the stirring mechanism 93 are respectively fixed on the flanges 112 at both ends of the through pipe 111. The drive mechanism 91 and the stirring mechanism 93 are connected by a rotating shaft 92 passing through the through pipe 111. The axial angle between the rotating shaft 92 and the vertical central axis of the tank 11 is 30° to 45°.

[0057] The stirring mechanism 93 includes an external sheath 931. The sheath 931 is barrel-shaped, with one end of the bottom of the barrel coaxially fixed to the flange 112 inside the tank body 11, and the other end open as the return port 3912.

[0058] As attached Figure 4 As shown, the return slurry inlet 3912 has two variable diameter sections, which are divided into a first variable diameter section 9313 and a second variable diameter section 9314 from the inside of the sheath 931 to the outside of the sheath 931. From the inside of the sheath 931 to the outside, the inner diameter of the first variable diameter section 9313 gradually decreases, while the inner diameter of the second variable diameter section 9314 gradually increases.

[0059] The sheath 931 has multiple feed ports 9311 on its side circumferentially, connecting the inside and outside of the sheath 931. The feed ports 9311 are evenly distributed. The number of feed ports 9311 depends on the size of the sheath 931; in this case, there are eight feed ports 9311.

[0060] As attached Figure 3 As shown, a shaft through hole 9315 is opened at the center of the bottom of the sheath 931. The shaft through hole 9315 is aligned with the inner hole of the through tube 111 so that the rotating shaft 92 can be inserted into the sheath 931.

[0061] As attached Figure 5 and attached Figure 6 As shown, the stirring mechanism 93 also includes a turntable 932, a slurry column 933, a mounting column 934, and an inclined blade 935 installed in the sheath 931.

[0062] The turntable 932 is fixed at the center and the end of the rotating shaft 92. It is a plate perpendicular to the rotating shaft 92. The side facing away from the rotating shaft is the bearing surface 9321, and the side facing the rotating shaft 92 is the mounting surface 9322.

[0063] The turntable 932 extends outward from the center with mounting parts 9323 for mounting grout columns 933. The mounting parts 9323 are distributed circumferentially around the center of the turntable 932, and their number is relative to the number of grout columns 933. Here, the number of mounting parts 9323 and grout columns 933 is two.

[0064] The slurry column 933 is vertically installed on the bearing surface 9321 of the mounting part 9323. It is provided with a vortex slurry distribution surface 9331, which is a saddle-shaped curved surface. The positive z-axis of the curved surface coincides with the rotation tangential direction of the turntable 932. The two peaks of the saddle-shaped curved surface are located at the upper and lower ends of the slurry column 933, respectively, with the lower wavelength being greater than the upper wavelength.

[0065] The number of mounting posts 934 is the same as the number of mounting parts 9323, which is two in this case. The mounting posts 934 and mounting parts 9323 are offset by 90°. The two mounting posts 934 are coaxial, and the axis of the mounting posts 934 is perpendicular to the axis of the rotation shaft 92. One end of the mounting post 934 is attached to and fixed to the mounting surface 9322 of the turntable 93, while the other end extends outside the turntable 93.

[0066] The oblique blade 935 is a fan-shaped ring, which is inclined and overlaps the mounting column 934 in an attitude parallel to the axis of the mounting column 934. The angle of inclination of the oblique blade 935 relative to the bearing surface 9322 is 27° to 49°.

[0067] The number of oblique blades 935 depends on the size of the space inside the sheath 931 and the viscosity of the sodium lactate slurry. The larger the space inside the sheath 931 and the higher the viscosity of the sodium lactate slurry, the more oblique blades 935 there are. The number of slurry columns 933 is equal to the number of oblique blades 935, and here there are two oblique blades.

[0068] The angle between each inclined blade 935 and the inclination angle of the bearing surface 9322 is different. In this embodiment, there are two inclined blades 935, with inclination angles of 34° and 47° respectively. If there are three inclined blades 935, the inclination angles are 27°, 32° and 49° respectively.

[0069] The outer side of the oblique blade 935 is adjacent to but not in contact with the inner side of the sheath 931, with a spacing of 1±0.5mm. The side of the oblique blade 935 facing away from the turntable 932 is the liquid pushing surface 9351. The extended surface of the raised side of the liquid pushing surface 9351 along the arc trajectory of the oblique blade 935 intersects with the vortex dispersing surface 9331 of the slurry column 933.

[0070] Meanwhile, the liquid-pushing surface 9351 has a grid edge 9352. The grid edge 9352 is a raised grid stripe, and the shape of the individual grid members can be triangular, square, pentagonal, hexagonal, etc. In this embodiment, it is hexagonal. The thickness of the raised grid edge 9352 decreases from bottom to top, with the bottom end being the maximum thickness and the top end being the minimum thickness.

[0071] The maximum thickness of the mesh along 9352 is 0.8–1 mm, depending on the arc length of the 935 blade; the larger the arc length, the greater the maximum thickness. The minimum thickness of the mesh along 9352 is 0–0.1 mm, also depending on the arc length of the 935 blade; the larger the arc length, the greater the minimum thickness.

[0072] The liquid-pushing surface 9351 also has two diversion holes 9353 that penetrate the inclined blade 935. These are elongated holes that extend along the annular arc length of the inclined blade 935. Bolts pass through the diversion holes 9353 and are threadedly connected to the mounting post 934 to fix the inclined blade 935.

[0073] As attached Figure 1 As shown, a sodium lactate pipeline and a drug solution A pipeline are connected between the concentrated preparation tank 1 and the diluted preparation tank 5.

[0074] The sodium lactate pipeline is connected upstream to the bottom of the concentration tank 1 and downstream directly to the dilution tank 5.

[0075] The upstream of the drug solution A pipeline is connected to the bottom of the concentration tank 1, and the downstream is connected to the side of the dilution tank 5. The sodium lactate pipeline is equipped with a drug solution A coarse filter 3 and a drug solution A ultrafilter 4 in sequence.

[0076] The dilution tank 5 is also equipped with a mixing reflux pump 6 and a liquid preparation and filtration pipeline.

[0077] The mixing reflux pump 6 is used to assist in mixing the liquid solution in the dilution tank 5, and its outlet and inlet are both connected to the dilution tank 5.

[0078] The liquid preparation and filtration pipeline uses the liquid in the dilution tank 5 to prepare a refined liquid. The inlet of the liquid preparation and filtration pipeline is connected to the bottom of the dilution tank 5, and its outlet is connected to the side of the dilution tank 5. A coarse filter 7 and a fine filter 8 are installed sequentially on the liquid preparation and filtration pipeline.

[0079] Advantages of this embodiment:

[0080] In this application, the inclined blade 935 and the slurry column 933 rotate around the axis of the rotating shaft 92. For the tank 11, the axis of rotation is axially oriented towards the center of the tank 11 and inclined upward. The liquid flow rises from bottom to top and spreads outward as it flows upward. The flow rate decreases as it goes up, and the flow rate also decreases from the center outward. Thus, when the liquid reaches the liquid surface, the liquid flow spreads evenly and the flow rate is relatively uniform. The outer layer has a slow flow rate. When the liquid flows down after hitting the inner wall of the tank 11, it is not easy to carry gas. The liquid has a low gas content. Furthermore, due to the inclination of the rotating shaft 92, the stirring mechanism 93 has a height difference when stirring, which can fully mix liquids with different heights and concentration gradients. On the other hand, the specific inclination setting of the inclined blade 935 during the rotation process means that when the inclined blade 935 cuts into the slurry at the bottom, it will scoop up part of the slurry. After being scooped up, this part of the slurry is accelerated on the surface of the inclined blade 935 by the push of the inclined blade 935 until it is thrown out of the edge of the inclined blade 935. Then it is impacted and dispersed by the rotating slurry column 933. This allows it to mix better with water, resulting in a more efficient mixing effect;

[0081] In summary, the improved concentration tank 1 of this application ensures uniform mixing of slurry and injection water, effectively reduces gas dissolution into the liquid, reduces material replenishment during volume adjustment, and improves product filling quality.

[0082] For the purpose of facilitating the verification of the process embodiments described below, some parameters of the concentration tank 1 and the shear mixer 9 are disclosed herein.

[0083] The internal space parameters of the tank body 11 of the concentration tank 1 are as follows: the inner diameter of the upper straight cylinder is 0.5m and the height is 0.96m, the height of the lower spherical cavity is 0.3m, and the maximum capacity is 885L.

[0084] Shear mixer 9 parameters:

[0085] Rotating shaft 92 rotates at 100 r / min;

[0086] The inner diameter of the sheath 931 is 18cm and the inner height is 9.5cm. The first diameter-changing section 9313 is 1.25cm high and 1.5cm narrower, and the second diameter-changing section 9314 is 1.25cm high and 1.5cm wide.

[0087] The oblique blade 935 has a width of 4.3cm and an arc length of 6.24cm; the slurry column has a width of 2.16cm and a height of 3.5cm.

[0088] Example 2

[0089] A process for producing peritoneal dialysis fluid, based on the system of Example 1, includes the following steps:

[0090] S1: Weigh 72.3wt% sodium lactate slurry into the concentration tank, then inject water for mixing, mix by shear mixer, and reflux by ultrafiltration pump for 30 minutes to obtain sodium lactate solution.

[0091] S2: Discharge the sodium lactate solution into the dilution tank;

[0092] S3: After the sodium lactate solution is drained, inject water for injection again, slowly add glucose powder, stir until completely dissolved, then slowly add sodium chloride powder, magnesium chloride hexahydrate powder, and calcium chloride powder, add pH adjuster, stir and dissolve for 45 minutes to obtain drug solution A;

[0093] S4: Drug solution A is filtered through coarse filtration and ultrafiltration to remove endotoxins and undissolved crystals before being discharged into the dilution tank;

[0094] S5: Add water for injection to the dilution tank to the prepared volume, stir and reflux for 30 minutes, take a sample for testing, adjust the pH, add feed and water, and obtain drug solution B after passing the test;

[0095] S6: After coarse filtration, fine filtration, and reflux, the drug solution B is mixed evenly to obtain the peritoneal dialysis solution to be filled.

[0096] The material input quantities and the volume parameters of the dilution tank are shown in Table 1 below. Except for water for injection, the material quantities in the table include the amount of replenishment. The material quantities are recorded based on the actual mass of the material. For example, sodium lactate = sodium lactate slurry * 0.723, and magnesium chloride hexahydrate is recorded in the table based on the actual amount of magnesium chloride after conversion.

[0097] Table 1. Material input and diluent tank volume in Example 2

[0098]

[0099]

[0100] Examples 3-6

[0101] A peritoneal dialysis fluid production process is based on the system of Example 1 and is similar to that of Example 2, except that the material input amounts are shown in Table 2 below. Table 2. Material input amounts and dilution tank volume table for Example 3

[0102]

[0103] This application samples and measures the sodium lactate solution and peritoneal dialysis fluid to be filled in the preparation process of Examples 2-5 to determine their gas content;

[0104] Take another 10 sodium lactate solution samples to measure the concentration and calculate the relative deviation rate of the concentration.

[0105] Relative deviation rate = (sum of concentrations from 10 measurements - 10 * theoretical concentration) / (10 * theoretical concentration) * 100%.

[0106] The test results are shown in Table 3 below.

[0107] Table 3. Gas content, relative deviation rate, and gas content of peritoneal dialysis fluid to be filled in sodium lactate solutions from Examples 2 to 6.

[0108]

[0109]

[0110] As can be seen from Examples 2 to 6, when controlling the volume of sodium lactate solution in the concentration tank in this application, it is preferable to select a volume of sodium lactate solution of 0.036 to 0.0484 times the fixed volume of the dilution tank.

[0111] Comparative Example 1

[0112] A peritoneal dialysis fluid production system, different from Example 1, has the following internal spatial parameters for the concentrated mixing tank: the upper straight cylinder has an inner diameter of 0.5m and a height of 0.96m, the lower spherical cavity has a height of 0.3m, and the maximum capacity is 885L; while the rotating shaft and stirring mechanism in the shear mixer are both vertically arranged, and the horizontal distance between the rotating shaft and the tank axis is 0.25m.

[0113] Comparative Example 2

[0114] A process for producing peritoneal dialysis fluid is similar to that of Example 2, except that the system of Comparative Example 1 is used for preparation.

[0115] Comparative Example 3

[0116] A peritoneal dialysis fluid production system, differing from Example 1, uses a flat paddle agitator instead of a shear mixer in its concentrate mixing tank. The flat paddle agitator uses a double-blade design, with each blade being 0.2m long. The blades descend 0.94m within the tank and rotate at a speed of 100 r / min.

[0117] Comparative Example 4

[0118] A peritoneal dialysis fluid production system, differing from Example 1, uses a flat paddle agitator instead of a shear mixer in its concentration mixing tank. The flat paddle agitator employs a double-bladed design, with each blade 0.2m long. The rotating shaft is vertically inserted into the tank from top to bottom, with the blades positioned 0.94m below the tank at a rotational speed of 300 rpm.

[0119] Comparative Example 5

[0120] A process for producing peritoneal dialysis fluid is similar to that of Example 2, except that the system of Comparative Example 3 is used for preparation.

[0121] Comparative Example 6

[0122] A process for producing peritoneal dialysis fluid is similar to that of Example 2, except that the system of Comparative Example 4 is used for preparation.

[0123] The sodium lactate solution and peritoneal dialysis fluid to be filled in the preparation process of Comparative Examples 2, 5, and 6 were sampled and tested to determine their gas content; in addition, 10 sodium lactate solution samples were taken to measure their concentration, and the relative deviation rate of the concentration was calculated. The test results are shown in Table 4 below.

[0124] Table 4. Gas content, relative deviation rate, and gas content of sodium lactate solution and peritoneal dialysis fluid to be filled in Comparative Examples 2, 5, and 6

[0125]

[0126] By comparing Example 2 and Comparative Example 2 with Tables 3 and 4, it can be seen that in Comparative Example 2, the shear mixer is set vertically, the liquid flow direction is vertically upward, and the liquid entering it from the side of the sheath all come from the same height, which reduces the mixing effect and significantly increases the amount of gas entrained in the liquid.

[0127] This achieves the intended effect of this application and solves the technical problem by setting the shear mixer at an angle to tilt and stir the material.

[0128] Comparing Example 2 with Comparative Examples 5 and 6, it can be seen that in Comparative Examples 5 and 6, the rotating shaft is vertically inserted into the tank from top to bottom to drive the paddle to stir.

[0129] The rotation speed of Comparative Example 5 was 100 r / min. Its liquid concentration was lower than that of Comparative Example 2, but still higher than that of Example 2. Moreover, the relative deviation of its sodium lactate solution concentration was much larger than that of Comparative Example 2 and Example 2, indicating a significant difference in mixing effect.

[0130] Comparative Example 5, with a stirring speed of 300 r / min, showed a lower relative deviation in sodium lactate solution concentration compared to Comparative Example 2. Although higher than Example 2, its mixing effect was close to that of Example 2. However, while increasing the stirring speed in Comparative Example 6 improved the mixing effect, it also accelerated the sinking of the liquid in the center of the tank, increased the central vortex, and significantly increased the gas content in the liquid, which was detrimental to product production and quality control.

[0131] Existing mixing paddles are inserted into the liquid from top to bottom, which cannot simultaneously achieve mixing efficiency and reduce the gas content in the liquid. However, the specific inclined setting of the inclined blades in this application, combined with the inclined blades and the slurry column rotating around the inclined rotation axis, ensures that the slurry and the injected water are mixed evenly, effectively reduces the amount of gas dissolved in the liquid, reduces the need for replenishment during volume setting, and improves the product filling quality.

[0132] Example 7

[0133] A peritoneal dialysis fluid production system, which differs from Example 1, has a cylindrical concentrated slurry column.

[0134] Example 8

[0135] A process for producing peritoneal dialysis fluid is similar to that of Example 2, except that the system of Comparative Example 3 is used for preparation.

[0136] The sodium lactate solution and peritoneal dialysis fluid to be filled in the preparation process of Example 8 were sampled and tested to determine their gas content; in addition, 10 sodium lactate solution samples were taken to measure their concentration, and the relative deviation rate of the concentration was calculated. The test results are as follows:

[0137]

[0138]

[0139] Comparing Examples 2 and 8, it is evident that the slurry column in this application, with its saddle-shaped vortex separating surface, enhances the liquid mixing effect. When the slurry and liquid material impact the vortex separating surface and separate from both sides, the curved surface of the surface causes vortices to form, promoting mixing. Therefore, the relative deviation rate of the sodium lactate solution in Example 2 is lower than that in Example 8, and the gas content of both the sodium lactate solution and the peritoneal dialysis fluid to be filled is also reduced.

[0140] This specific embodiment is merely an explanation of the present invention and is not intended to limit the invention. After reading this specification, those skilled in the art can make modifications to this embodiment without contributing any inventive step, but such modifications are protected by patent law as long as they are within the scope of the claims of the present invention.

Claims

1. A peritoneal dialysis fluid production system, characterized in that: It includes a concentration tank (1) for dissolving raw materials, a dilution tank (5) for mixing and volume adjustment, and a feeding pipeline connecting the concentration tank (1) and the dilution tank (5); When preparing sodium lactate solution in the concentration tank (1), the volume of sodium lactate solution prepared is 0.036~0.0484 of the fixed volume of the dilution tank (5); The concentration tank (1) includes a shear mixer (9) and a tank body (11). The shear mixer (9) includes a drive mechanism (91), a rotating shaft (92), and a stirring mechanism (93). One end of the rotating shaft (92) extends obliquely upward from the bottom of the tank (11) into the tank (11), and the other end is connected to the drive mechanism (91) for transmission. The stirring mechanism (93) and the rotating shaft (92) are fixed at one end of the shaft that extends into the tank (11); The angle between the axis of the rotating shaft (92) and the vertical center axis of the tank (11) is 30~45°; The stirring mechanism (93) includes an external sheath (931), which is barrel-shaped. One end of the bottom of the barrel is coaxially fixed with the flange (112) inside the tank (11), and the other end is open and called the return port (3912). The return slurry inlet (3912) is provided with two variable diameter sections, which are divided into a first variable diameter section (9313) and a second variable diameter section (9314) from the inside of the sheath (931) to the outside of the sheath (931). From the inside of the sheath (931) to the outside, the inner diameter of the first variable diameter section (9313) gradually decreases, and the inner diameter of the second variable diameter section (9314) gradually increases. The side of the sheath (931) has multiple feed ports (9311) that connect the inside and outside of the sheath (931). The mixing mechanism (93) also includes a turntable (932), a slurry column (933), a mounting column (934), and an inclined blade (935) installed in the sheath (931); The stirring mechanism (93) includes a turntable (932) that rotates with the rotating shaft (92), and the turntable (932) is equipped with an inclined blade (935) and a slurry column (933) on the side facing the center of the tank (11). The oblique blades (935) and the slurry column (933) are circumferentially distributed around the rotation center of the turntable (932). The center of the turntable (932) is fixed to the end of the rotating shaft (92), and it is a plate perpendicular to the rotating shaft (92). The side facing away from the rotating shaft (92) is the bearing surface (9322), and the side facing the rotating shaft (92) is the mounting surface (9321). The turntable (932) extends outward from its center with mounting sections (9323) for installing grout columns (933). The mounting sections (9323) are distributed circumferentially around the center of the turntable (932), and their number corresponds to the number of grout columns (933). The slurry column (933) is vertically installed on the bearing surface (9322) of the mounting part (9323), and a vortex slurry distribution surface (9331) is provided on it. The vortex slurry distribution surface (9331) is a saddle-shaped curved surface, and the z-axis direction of the curved surface coincides with the rotation tangential direction of the turntable (932). The two peaks of the saddle-shaped curved surface are located at the upper and lower ends of the slurry column (933), respectively, and the lower wavelength is greater than the upper wavelength. The number of mounting columns (934) is the same as the number of mounting parts (9323). The axis of the mounting column (934) is perpendicular to the axis of the rotating shaft (92). One end of the mounting column (934) is attached to and fixed to the mounting surface (9321) of the turntable (932), and the other end extends outside the turntable (932). The oblique blade (935) is a fan-shaped ring, which is inclined and pressed against the mounting column (934) in a posture parallel to the axis of the mounting column (934). The angle of inclination of the oblique blade (935) relative to the bearing surface (9322) is 27~49°. The side of the oblique blade (935) facing away from the turntable (932) is the liquid pushing surface (9351). The extended surface of the side of the liquid pushing surface (9351) along the arc trajectory of the oblique blade (935) intersects with the vortex dispersing surface (9331) of the slurry column (933).

2. The peritoneal dialysis fluid production system according to claim 1, characterized in that: The oblique blades (935) and the slurry columns (933) are multiple and evenly distributed, and the oblique blades (935) have different tilt angles.

3. The peritoneal dialysis fluid production system according to claim 1, characterized in that: The oblique blade (935) has a through-hole (9353).

4. The peritoneal dialysis fluid production system according to claim 1, characterized in that: The liquid-pushing surface (9351) is provided with a raised grid edge (9352), and the height of the raised grid edge (9352) gradually decreases from the end of the inclined blade (935) near the turntable (932) to the end away from the turntable (932).

5. A process for producing peritoneal dialysis fluid, characterized in that, Using the peritoneal dialysis fluid production system according to any one of claims 1 to 4 Includes the following steps, S1: Weigh the sodium lactate slurry and put it into the concentration tank (1), then inject water, mix it by the shear mixer (9), and reflux it by the ultrafiltration pump (2). The reflux mixing time is not less than 30 minutes to obtain sodium lactate solution. S2: Discharge the sodium lactate solution into the dilution tank (5); S3: After draining the sodium lactate solution, inject water for injection again, slowly add glucose, stir until completely dissolved, then slowly add sodium chloride, magnesium chloride, and calcium chloride, then add pH adjuster, stir and dissolve for 40-50 minutes to obtain drug solution A; S4: Drug solution A is filtered through coarse filtration and ultrafiltration to remove endotoxins and undissolved crystals, and then discharged into the dilution tank (5); S5: Add water for injection to the dilution tank (5) to the prepared volume, stir and reflux for more than 30 minutes, take a sample for testing to adjust the pH, add water and add materials, and obtain drug solution B after passing the test; S6: After coarse filtration and fine filtration of drug solution B, and reflux and mix evenly, the peritoneal dialysis solution to be filled is obtained.

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