Uniform mixing equipment and method for preparing high-viscosity injection

Abstract

The invention belongs to the technical field of medicine preparation, and particularly relates to uniform mixing equipment and a uniform mixing method for preparing a high-viscosity injection. The high-viscosity injection preparation and uniform mixing equipment comprises a stud, a tank body, a set of mixed magnetic rings a and a set of mixed magnetic rings b, the set of mixed magnetic rings a are correspondingly arranged inside and outside the tank body, the set of mixed magnetic rings b are correspondingly arranged inside and outside the tank body, the stud is connected with the head of the stud, the head of the stud is installed on the tank body, and a cavity is formed by the head of the stud and the interior of the tank body. The parts, in the tank body, of the mixed magnetic rings a and b are electromagnetic circular rings with holes, and the diameter of the holes and the diameter of the studs are completely closed to form a plane. And threads are arranged on the stud. Products with different batches and different viscosities can be produced, and two sets of mixed magnetic rings a and b with different apertures and stud bottom assemblies can be replaced. The high-viscosity injection preparation uniform mixing equipment provided by the invention has the advantages of simple installation, high cleanliness and no residue. According to the uniform mixing method carried out by using the equipment, the high-viscosity injection is uniformly mixed without residues.

Description

Technical Field

[0001] The present invention belongs to the technical field of pharmaceutical preparation, and particularly relates to a mixing device and a mixing method for preparing high-viscosity injections. Background Art

[0002] As a special type of preparation in the medical industry, high-viscosity injections are mainly used to deliver highly viscous drug active ingredients, such as polysaccharide drugs (e.g., hyaluronic acid derivatives), liposome drug delivery systems, and high-concentration biopolymer preparations. Due to their complex molecular structures and significant hydrodynamic characteristics, the viscosities of such drugs are usually dozens or even hundreds of times that of ordinary injections, posing strict requirements on the preparation process.

[0003] Traditional preparation processes mostly rely on mechanical stirring or magnetic stirring techniques to achieve the mixing of drugs and solvents through shear force. However, in high-viscosity systems, the non-Newtonian characteristics of fluids lead to significant laminar flow effects, and conventional stirring is difficult to overcome the intermolecular forces, easily resulting in the following problems: Insufficient mixing uniformity: The poor fluidity of high-viscosity media and uneven shear force distribution lead to incomplete drug dispersion and significant local concentration gradient differences, directly affecting the quality uniformity and clinical efficacy of the preparation; High liquid residue rate: Viscous drugs are easily adhered to the inner surfaces of containers, stirring paddles, and pipelines, causing loss of active ingredients (the residue rate can reach 10%-20%). This not only reduces the yield but also may pose a risk of cross-contamination; Limited process stability: Traditional equipment is sensitive to viscosity changes, and process parameters (such as stirring speed and time) need to be repeatedly optimized, and it is difficult to achieve batch consistency in large-scale production.

[0004] In addition, some high-viscosity drugs (such as liposomes) have low shear force tolerance, and excessive mechanical action causes the carrier structure to rupture or drug activity to degrade. With the rapid development of biological preparations and complex drug delivery systems, developing an efficient, low-residue, and precisely controllable high-viscosity injection preparation technology has become a key bottleneck that the industry urgently needs to break through. Summary of the Invention

[0005] The technical problem to be solved by the present invention is to overcome the problems of uneven preparation and serious residue in the preparation of high-viscosity injections in the prior art, and provide a mixing device for preparing high-viscosity injections. The device is simply installed, easy to disassemble and assemble, has high cleanliness, and no drug residue. Using the mixing method of the device of the present invention, the high-viscosity injection is evenly mixed and has no residue.

[0006] The high-viscosity injection preparation and mixing equipment described in the present invention includes a stud, a tank body, a set of mixing magnetic rings A, and a set of mixing magnetic rings B. The set of mixing magnetic rings A is correspondingly arranged inside and outside the tank body, and the set of mixing magnetic rings B is correspondingly arranged inside and outside the tank body. The stud is connected to the stud head, and the stud head is installed on the tank body and forms a cavity with the inside of the tank body. The parts of the two sets of mixing magnetic rings A and B inside the tank body are perforated electromagnetic circular rings, and the diameter of the holes is completely closed with the diameter of the stud, forming a plane. There are threads on the stud, and different sets of mixing magnetic rings A and B with different hole diameters and the bottom assembly of the stud can be replaced to produce products with different batches and viscosities.

[0007] The described tank body is a cylinder, and the material is non-magnetic and corrosion-resistant. An electric heating plate is provided at the bottom of the tank body.

[0008] A Luer lock is provided on the bottom body of the described tank body, and a material transfer device is correspondingly placed on the Luer lock.

[0009] The set of mixing magnetic rings A includes a mixing orifice plate A arranged inside the tank body and an electromagnetic coupling magnetic ring A arranged inside the tank body. The electromagnetic coupling magnetic ring A is connected to a worm gear C, the worm gear C is arranged on a worm C, and a servo motor C is arranged on the worm C. The movement of the set of mixing magnetic rings A is realized by these driving components such as the worm gear C, the worm C, and the servo motor C.

[0010] The set of mixing magnetic rings B includes a mixing orifice plate B arranged inside the tank body and an electromagnetic coupling magnetic ring B arranged inside the tank body. The electromagnetic coupling magnetic ring B is connected to a worm gear B, the worm gear B is arranged on a worm B, and a servo motor B is arranged on the worm B. The movement of the set of mixing magnetic rings B is realized by these driving components such as the worm gear B, the worm B, and the servo motor B.

[0011] The described stud head is installed on the tank body, and a piston is installed inside the tank body and sleeved on the stud head.

[0012] The described stud and the stud head are connected together by a worm A. A worm gear A is arranged on the worm A, and a servo motor A is arranged on the worm gear A.

[0013] Two apertures are provided inside the stud head, namely aperture A and aperture B. One end of aperture A is closed to the piston, and one end of aperture B is communicated with the inside of the tank body. Aperture A and the piston partially seal the tank body, and aperture B evacuates the inside of the tank body.

[0014] The method for mixing the high-viscosity injection includes the following steps: (1) Feeding: In sequence, add solvent to the tank body, install the set of mixing magnetic rings B, control heating, add the raw drug, install the set of mixing magnetic rings A, continue to add solvent to the tank body, install the piston, the stud head, and seal the stud. (2)Initial mixing: Vacuum is pumped inside the tank. By controlling the a set of mixing magnetic rings, the a mixing orifice plate is controlled to move up and down until no grains are visible to the naked eye. By controlling the b set of mixing magnetic rings, the liquid under the b mixing orifice plate is mixed evenly. (3)Program-controlled mixing: Control the a mixing orifice plate and the b mixing orifice plate to move downward simultaneously, and keep the downward running speed of the a mixing orifice plate less than that of the b mixing orifice plate. After the a mixing orifice plate reaches the bottom of the tank, the a mixing orifice plate and the b mixing orifice plate stay at intervals simultaneously. Control the a mixing orifice plate and the b mixing orifice plate to move upward simultaneously, and keep the upward running speed of the a mixing orifice plate greater than that of the b mixing orifice plate. After the b mixing orifice plate reaches the bottom of the tank, the a mixing orifice plate and the b mixing orifice plate stay at intervals simultaneously. Repeat the above process multiple times in a cycle. (4)Discharging: The mixed material is pushed out through the stud to obtain a highly viscous injection with uniform mixing.

[0015] In step (3), control the a mixing orifice plate and the b mixing orifice plate to move downward simultaneously, and keep the downward running speed of the a mixing orifice plate less than that of the b mixing orifice plate, and the speed difference is 0.04 - 0.08 m / s. After the a mixing orifice plate reaches the bottom of the tank, the a mixing orifice plate and the b mixing orifice plate stay at intervals of 1.4 - 1.7 s simultaneously. Control the a mixing orifice plate and the b mixing orifice plate to move upward simultaneously, and keep the upward running speed of the a mixing orifice plate greater than that of the b mixing orifice plate, and the speed difference is 0.04 - 0.08 m / s. After the b mixing orifice plate reaches the bottom of the tank, the a mixing orifice plate and the b mixing orifice plate stay at intervals of 1.4 - 1.7 s simultaneously.

[0016] Detailed steps of feeding in step (1): 1) Lock the Luer lock, add water into the tank. Install the b mixing orifice plate inside the tank and the b electromagnetic coupling magnetic ring outside. Through the control of the b mixing orifice plate magnetic coupling position controller, the b mixing orifice plate is flush with the internal liquid level. 2) Control the electric heating plate through the thermostat to heat the liquid in the tank, and add the active pharmaceutical ingredient. 3) Install the a mixing orifice plate inside the tank and the a electromagnetic coupling magnetic ring outside. Through the control of the a mixing orifice plate magnetic coupling position controller, the a mixing orifice plate is flush with the internal liquid level. 4) Continue to add water into the tank. Install the piston, the stud head, the worm gear A, and the worm A at the top of the tank. Inflate and seal the piston through aperture A. The servo motor A drives the worm gear A and the worm A, and the piston is pushed downward by the stud to the position flush with the liquid level. The piston inflates the piston sealing ring to achieve a better effect.

[0017] The steps for using the high-viscosity injection preparation and mixing equipment described in the present invention are as follows: (1)When producing products with different batches and viscosities, replace the corresponding stud heads, studs, worm gear A, worm A, servo motor A components, as well as set a of mixed magnetic rings and set b of mixed magnetic rings. (2)Install the b mixing orifice plate. After manually controlling the b electromagnetic coupling magnetic ring to be slowly powered on by 20% - 30%, manually control the position controller of the b electromagnetic coupling magnetic ring to lower the b mixing orifice plate until it is flush with the liquid level. (3)Install the a mixing orifice plate. After manually controlling the a electromagnetic coupling magnetic ring to be slowly powered on by 20% - 30%, manually control the position controller of the a electromagnetic coupling magnetic ring to lower the a mixing orifice plate until it just touches the raw material.

[0018] (4)Primary mixing: Slowly evacuate the inside of the tank. Control the position controller of the a electromagnetic coupling magnetic ring to slowly power on set a of mixed magnetic rings to 100%, and control the up and down movement of the a mixing orifice plate. Control the position controller of the b electromagnetic coupling magnetic ring to slowly power on set b of mixed magnetic rings to 100%, and control the up and down movement of the b mixing orifice plate.

[0019] (5)Program - controlled mixing (schematic diagram of program control is as Figure 3 shown): The a mixing orifice plate and the b mixing orifice plate move downward simultaneously. The downward running speed of the a mixing orifice plate is slower than that of the b mixing orifice plate. After the a mixing orifice plate reaches the bottom, the a mixing orifice plate and the b mixing orifice plate both pause for 1.5 s.

[0020] The a mixing orifice plate and the b mixing orifice plate move upward simultaneously: The upward running speed of the a mixing orifice plate is faster than that of the b mixing orifice plate. After the b mixing orifice plate reaches the top, the a mixing orifice plate and the b mixing orifice plate both pause for 1.5 s.

[0021] Then repeat the above cyclic movement.

[0022] The speed difference in the operation of the a mixing orifice plate and the b mixing orifice plate forms a cavity with variable volume between the a and b orifice plates, which is beneficial to the mixing of materials.

[0023] (6)Discharging: Connect the material transfer device to the discharge port at the Luer lock part. The servo motor A drives the worm gear A and the worm A to push the piston downward through the stud until the material transfer device reaches the rated capacity. Replace the material transfer device and continue filling until the materials in the tank are emptied.

[0024] Compared with the prior art, the beneficial effects of the present invention are: (1)The equipment of the present invention forms a dynamically changing cavity shear force through the synergistic effect of set a and set b of mixed magnetic rings and program - controlled speed difference control, significantly improving the mixing uniformity of high - viscosity materials. The differential - speed movement of the a and b orifice plates can directionally guide the flow of materials, eliminating the traditional mixing dead corners, and is especially suitable for the uniform dispersion of easily crystallized or highly viscous injections.

[0025] (2) The present invention adopts a modular design driven by magnetic coupling, combined with magnetic rings and stud components with replaceable apertures, to achieve zero-contact mixing. The seamless sealing structure between the tank body and the piston, and the precise docking of the Luer lock and the material transfer device ensure no residue during the material transfer process, meeting the stringent requirements of the pharmaceutical industry for cleanliness and sterility.

[0026] (3) The mixing method of the present invention optimizes the dissolution and dispersion process of high-viscosity preparations through staged vacuum treatment, temperature-controlled heating, and programmed cyclic mixing strategies. Equipment parameters (such as speed difference, residence interval) can be precisely regulated to adapt to the production requirements of different viscosities and batches, greatly improving process flexibility and production efficiency, and reducing the cost of product changeover. Description of the Drawings

[0027] Figure 1 is an assembly drawing of the high-viscosity injection preparation and mixing equipment of the present invention.

[0028] Figure 2 is a schematic diagram of the disassembled structure of the high-viscosity injection preparation and mixing equipment of the present invention.

[0029] Figure 3 is a schematic diagram of the control system of the high-viscosity injection preparation and mixing method of the present invention.

[0030] In the figure: 1, stud; 2, stud head; 3, worm gear A; 4, worm A; 5, servo motor A; 6, piston; 7, a mixing orifice plate; 8, b mixing orifice plate; 9, tank body; 10, Luer lock; 11, electric heating plate; 12, material transfer device; 13, servo motor B; 14, worm B; 15, worm gear B; 16, a electromagnetic coupling magnetic ring; 17, b electromagnetic coupling magnetic ring; 18, servo motor C; 19, worm gear C; 20, worm C; 21, aperture A; 22, aperture B. Detailed Embodiments

[0031] The present invention will be further described below in conjunction with specific embodiments.

[0032] As Figures 1-2 shown, the high-viscosity injection preparation and mixing equipment described includes a stud 1, a tank body 9, and a set of a mixing magnetic rings and a set of b mixing magnetic rings. The set of a mixing magnetic rings is correspondingly arranged inside and outside the tank body 9, and the set of b mixing magnetic rings is correspondingly arranged inside and outside the tank body 9. The stud 1 is connected to the stud head 2, and the stud head 2 is installed on the tank body 9 and forms a cavity with the inside of the tank body 9. The parts of the two sets of a and b mixing magnetic rings inside the tank body 9 are perforated electromagnetic rings, and the diameter of the holes is completely closed with the diameter of the stud to form a plane. There is a thread on the stud 1. The two sets of a and b mixing magnetic rings with different apertures and the bottom components of the stud 1 can be replaced for producing products with different batches and different viscosities.

[0033] The described tank body 9 is a cylinder, made of non-magnetic and corrosion-resistant material. An electric heating plate 11 is provided at the bottom of the tank body 9. A Luer lock 10 is provided on the bottom body of the tank body 9, and a material transfer device 12 is correspondingly placed at the Luer lock 10. The a set of mixing magnetic rings includes an a mixing orifice plate 7 provided inside the tank body 9 and an a electromagnetic coupling magnetic ring 16 provided inside the tank body 9. The a electromagnetic coupling magnetic ring 16 is connected to a worm gear C19, the worm gear C19 is arranged on a worm shaft C20, and a servo motor C18 is arranged on the worm shaft C20. The movement of the a set of mixing magnetic rings is realized by these driving components such as the worm gear C19, the worm shaft C20, and the servo motor C18. The b set of mixing magnetic rings includes a b mixing orifice plate 8 provided inside the tank body 9 and a b electromagnetic coupling magnetic ring 17 provided inside the tank body 9. The b electromagnetic coupling magnetic ring 17 is connected to a worm gear B15, the worm gear B15 is arranged on a worm shaft B14, and a servo motor B13 is arranged on the worm shaft B14. The movement of the b set of mixing magnetic rings is realized by these driving components such as the worm gear B15, the worm shaft B14, and the servo motor B13. The stud head 2 is installed on the tank body 9, and a piston 6 is installed inside the tank body 9, and the piston 6 is sleeved on the stud head 2. The stud 1 and the stud head 2 are connected together by a worm shaft A4, a worm gear A3 is arranged on the worm shaft A4, and a servo motor A5 is arranged on the worm gear A3. Two apertures are provided inside the stud head 2, namely aperture A21 and aperture B22 respectively. One end of the aperture A21 is closed at the piston 6, and one end of the aperture B22 communicates with the inside of the tank body 9. The aperture A21 and the piston 6 partially seal the tank body 9, and the aperture B22 evacuates the inside of the tank body 9.

[0034] The usage steps of the above-mentioned high-viscosity injection preparation and mixing equipment are as follows: (1) When producing products with different batches and different viscosities, replace the corresponding components of the stud head 2, stud 1, worm gear A3, worm shaft A4, and servo motor A5, as well as the a set of mixing magnetic rings and the b set of mixing magnetic rings; (2) Install the b mixing orifice plate 8. After manually controlling the b electromagnetic coupling magnetic ring 17 to be slowly powered on by 20% - 30%, manually control the position controller of the b electromagnetic coupling magnetic ring to move the b mixing orifice plate 8 down to be flush with the liquid level; (3) Install the a mixing orifice plate 7. After manually controlling the a electromagnetic coupling magnetic ring 16 to be slowly powered on by 20% - 30%, manually control the position controller of the a electromagnetic coupling magnetic ring to move the a mixing orifice plate 7 down until it just touches the raw materials.

[0035] (4) Primary mixing: Slowly evacuate the inside of the tank body 9, control the position controller of the a electromagnetic coupling magnetic ring to slowly power on the a set of mixing magnetic rings to 100%, and control the up and down movement of the a mixing orifice plate 7. Control the position controller of the b electromagnetic coupling magnetic ring to slowly power on the b set of mixing magnetic rings to 100%, and control the up and down movement of the b mixing orifice plate 8.

[0036] (5)Program-controlled mixing (schematic diagram of program control as shown in Figure 3 ): The a mixing orifice plate 7 and the b mixing orifice plate 8 move downward simultaneously. The downward running speed of the a mixing orifice plate 7 is slower than that of the b mixing orifice plate 8. After the a mixing orifice plate 7 reaches the bottom, the a mixing orifice plate 7 and the b mixing orifice plate 8 pause simultaneously for 1.5 s.

[0037] The a mixing orifice plate 7 and the b mixing orifice plate 8 move upward simultaneously: the upward running speed of the a mixing orifice plate 7 is faster than that of the b mixing orifice plate 8. After the b mixing orifice plate 8 reaches the top, the a mixing orifice plate 7 and the b mixing orifice plate 8 pause simultaneously for 1.5 s.

[0038] Then repeat the above cyclic motion.

[0039] The running speed difference between the a mixing orifice plate 7 and the b mixing orifice plate 8 forms a volume change cavity between the a and b orifice plates, which is beneficial to material mixing.

[0040] (6)Discharging: Connect the material transfer device 12 to the discharging port at the part of the Luer lock 10. The servo motor A5 drives the worm gear A3 and the worm A4 to push the piston 6 downward through the stud 1 until the material transfer device reaches the rated capacity. Replace the material transfer device and continue filling until the materials in the tank are emptied.

[0041] The following examples are all carried out using the above equipment.

[0042] Example 1 In this example, 4500 mL of lanreotide is produced, with a specification of 90 mg / 0.3 mL (1500 injection agents), and the target viscosity of the prepared raw material drug is 20000 - 50000 centipoises.

[0043] The mixing method of the high-viscosity injection agent includes the following steps: I. Feeding: 1. Precisely weigh 500 g of water at 50 °C and slowly feed it into the bottom of the cylindrical tank.

[0044] 2. Install the b mixing orifice plate. After manually controlling the b electromagnetic coupling magnetic ring to be slowly powered on by 20%, manually control the position controller of the b electromagnetic coupling magnetic ring to move the b mixing orifice plate down until it is flush with the liquid level.

[0045] 3. Control the temperature of the heating plate to 85 °C. After waiting for 5 min and the water temperature is not lower than 80 °C, add the raw material drug lanreotide. Precisely weigh 1350 g of the raw material and slowly add it along the edge of the tank.

[0046] 4. Install the a mixing orifice plate. After manually controlling the a electromagnetic coupling magnetic ring to be slowly powered on by 20%, manually control the position controller of the a electromagnetic coupling magnetic ring to move the a mixing orifice plate down until it just touches the raw material.

[0047] 5. Weigh 2650 g of water at 50 °C precisely and add it to the tank.

[0048] 6. Install the piston, stud and drive assembly, inflate and seal the piston, and the drive assembly pushes the piston down to the position flush with the liquid level through the stud.

[0049] II. Primary mixing: 1. Slowly evacuate the tank to above -95 kPa.

[0050] 2. Control the a electromagnetic coupling magnetic ring position controller to slowly power on the a set of mixing magnetic rings to 100%, and control the up and down movement of the a mixing orifice until the grains are no longer visible to the naked eye.

[0051] 3. Control the b electromagnetic coupling magnetic ring position controller to slowly power on the b set of mixing magnetic rings to 100%, and control the up and down movement of the b mixing orifice until the liquid under the b orifice is evenly mixed as visible to the naked eye.

[0052] III. Program-controlled mixing: 1. Control the a mixing orifice and the b mixing orifice to move downward simultaneously: Keep the downward movement speed of the a mixing orifice at 0.2 m / s and the downward movement speed of the b mixing orifice at 0.25 m / s. After the a mixing orifice reaches the bottom, both the a mixing orifice and the b mixing orifice pause for 1.5 s.

[0053] 2. Control the a mixing orifice and the b mixing orifice to move upward simultaneously: The upward movement speed of the a mixing orifice is 0.25 m / s, and the upward movement speed of the b mixing orifice is 0.2 m / s. After the b orifice reaches the top, both the a and b orifices pause for 1.5 s.

[0054] 3. Then repeat the above steps 1 - 2 for cyclic movement. The cyclic movement is not less than 70 times, and the mixing time is 450 s.

[0055] IV. Discharging: Connect the material transfer device to the discharge port at the Luer lock part. The servo motor A, drive worm gear A, and worm A push the piston down through the stud until the material transfer device reaches the rated capacity. Replace the material transfer device and continue filling until the materials in the tank are emptied.

[0056] V. Tank cleaning: 1. Add 5000 mL of 1% sodium hydroxide solution to the tank.

[0057] 2. Repeat the "program-controlled mixing" operation for 5 min and drain the sodium hydroxide solution.

[0058] 3. Add 5000 mL of 1% sodium chloride to the preparation tank.

[0059] 4. Repeat the "program-controlled mixing" operation for 5 min and drain the sodium chloride solution.

[0060] 5. Add 5000 mL of pure water into the preparation tank.

[0061] 6. Repeat the "program-controlled mixing" operation for 5 minutes to drain all the pure water.

[0062] 7. Repeat steps 5-6 multiple times until the discharged water meets the standards.

[0063] Example 2 In this example, 4500 mL of lanreotide is produced, with a specification of 90 mg / 0.3 mL (1500 injection vials), and the target viscosity of the prepared active pharmaceutical ingredient is 20,000 - 50,000 centipoises.

[0064] The method for mixing the high-viscosity injection solution includes the following steps: I. Feeding: 1. Precisely weigh 500 g of water at 60°C and slowly feed it into the bottom of the cylindrical tank.

[0065] 2. Install the b mixing orifice plate. After manually controlling the b electromagnetic coupling magnetic ring to slowly power on by 30%, manually control the b electromagnetic coupling magnetic ring position controller to lower the b mixing orifice plate until it is level with the liquid surface.

[0066] 3. Control the temperature of the heating plate to 85°C. After waiting for 5 minutes until the water temperature is not lower than 80°C, add the active pharmaceutical ingredient lanreotide. Precisely weigh 1350 g of the raw material and slowly add it along the edge of the tank.

[0067] 4. Install the a mixing orifice plate. After manually controlling the a electromagnetic coupling magnetic ring to slowly power on by 30%, manually control the a electromagnetic coupling magnetic ring position controller to lower the a mixing orifice plate until it just touches the raw material.

[0068] 5. Precisely weigh 2650 g of water at 60°C and add it into the tank.

[0069] 6. Install the piston, stud, and drive assembly. Inflate the piston for sealing, and the drive assembly pushes the piston down to the position level with the liquid surface through the stud.

[0070] II. Initial mixing: 1. Slowly evacuate the inside of the tank to above -95 kPa.

[0071] 2. Control the a electromagnetic coupling magnetic ring position controller to slowly power on the a set of mixing magnetic rings to 100%, and control the up and down movement of the a mixing orifice plate until no visible grains can be seen with the naked eye.

[0072] 3. Control the b electromagnetic coupling magnetic ring position controller to slowly power on the b set of mixing magnetic rings to 100%, and control the up and down movement of the b mixing orifice plate until the liquid under the b orifice plate is visually mixed.

[0073] III. Program-controlled mixing: 1. Control the a mixing orifice plate and the b mixing orifice plate to move downward simultaneously: Keep the downward running speed of the a mixing orifice plate at 0.2 m / s, and the downward running speed of the b mixing orifice plate at 0.25 m / s. After the a mixing orifice plate reaches the bottom, the a mixing orifice plate and the b mixing orifice plate pause simultaneously for 1.5 s.

[0074] 2. Control the a mixing orifice plate and the b mixing orifice plate to move upward simultaneously: The upward running speed of the a mixing orifice plate is 0.25 m / s, and the upward running speed of the b mixing orifice plate is 0.2 m / s. After the b orifice plate reaches the top, the a and b orifice plates pause simultaneously for 1.5 s.

[0075] 3. Then repeat the above steps 1-2 for cyclic motion, with the cyclic motion no less than 70 times and the mixing time of 550 s.

[0076] IV. Discharging: Dock the material transfer device with the discharge port at the Luer lock part. The servo motor A, drive worm gear A, and worm A push the piston downward through the stud until the material transfer device reaches the rated capacity. Replace the material transfer device and continue filling until the materials in the tank are emptied.

[0077] V. Tank cleaning: 1. Add 5000 mL of 1% sodium hydroxide solution into the tank.

[0078] 2. Repeat the "program-controlled mixing" operation for 10 min and drain the sodium hydroxide solution.

[0079] 3. Add 5000 mL of 1% sodium chloride into the preparation tank.

[0080] 4. Repeat the "program-controlled mixing" operation for 10 min and drain the sodium chloride solution.

[0081] 5. Add 5000 mL of pure water into the preparation tank.

[0082] 6. Repeat the "program-controlled mixing" operation for 10 min and drain the pure water.

[0083] 7. Repeat steps 5-6 multiple times until the discharged water meets the standards.

[0084] The present invention utilizes the proposed high-viscosity injection preparation and mixing equipment. For the injection with a viscosity as high as 20,000 - 50,000 centipoises during the mixing process, through the verification of the above embodiments, the mixture is uniform, with high viscosity and no residual liquid medicine.

Claims

1. A high viscosity injection preparation and mixing equipment, characterized in that: The invention comprises a stud (1), a tank body (9), and a set of mixed magnetic rings, and a set of mixed magnetic rings. The set of mixed magnetic rings is arranged inside and outside the tank body (9) respectively, and the set of mixed magnetic rings is arranged inside and outside the tank body (9) respectively. The stud (1) is connected to a stud head (2), and the stud head (2) is mounted on the tank body (9) and forms a cavity with the inside of the tank body (9). The parts of the two sets of mixed magnetic rings, a set of mixed magnetic rings and b set of mixed magnetic rings, inside the tank body (9) are electromagnetic circular rings with holes, and the diameter of the holes is completely closed to the diameter of the stud to form a plane.

2. The high viscosity injection preparation and mixing equipment according to claim 1, characterized in that: The tank body (9) is a cylinder made of a non-magnetic and corrosion-resistant material, and an electric heating plate (11) is provided at the bottom of the tank body (9).

3. The high viscosity injection preparation and mixing equipment according to claim 2, characterized in that: A Luer lock (10) is provided on the bottom body of the tank body (9), and a material transfer device (12) is placed corresponding to the Luer lock (10).

4. The high viscosity injection preparation and mixing equipment according to claim 1, characterized in that: The a set of hybrid magnetic rings comprises a hybrid orifice plate (7) arranged inside the tank body (9) and an electromagnetic coupling magnetic ring (16) arranged inside the tank body (9); the electromagnetic coupling magnetic ring (16) is connected to a worm gear C (19); the worm gear C (19) is arranged on a worm gear C (20); and a servo motor C (18) is arranged on the worm gear C (20).

5. The high viscosity injection preparation and mixing equipment according to claim 4, characterized in that: The b set of hybrid magnetic rings comprises a b hybrid orifice plate (8) arranged inside the tank body (9) and a b electromagnetic coupling magnetic ring (17) arranged inside the tank body (9); the b electromagnetic coupling magnetic ring (17) is connected to a worm gear B (15); the worm gear B (15) is arranged on a worm gear B (14); and a servo motor B (13) is arranged on the worm gear B (14).

6. The high viscosity injection preparation and mixing equipment according to claim 1, characterized in that: The stud head (2) is mounted on the tank body (9), a piston (6) is mounted inside the tank body (9), and the piston (6) is sleeved on the stud head (2).

7. The high viscosity injection preparation and mixing equipment according to claim 1, characterized in that: The stud (1) and the stud head (2) are connected together via a worm A (4), a worm wheel A (3) is arranged on the worm A (4), and a servo motor A (5) is arranged on the worm wheel A (3).

8. The high viscosity injection preparation and mixing equipment according to claim 1, characterized in that: Two apertures are arranged inside the stud head (2), namely aperture A (21) and aperture B (22). One end of aperture A (21) is sealed to the piston (6), and one end of aperture B (22) is communicated with the interior of the tank body (9).

9. A mixing method using the high viscosity injection preparation mixing device according to any one of claims 1 to 8, characterized in that: The steps include: (1) Adding materials: Add solvent to the tank, install set b of mixing magnetic rings, control heating, add API, install set a of mixing magnetic rings, continue adding solvent to the tank, install piston, stud head, and stud seal; (2) Initial mixing: The tank is vacuumed, and the mixing orifice plate a is moved up and down by controlling the mixing magnetic ring a until the grains are invisible to the naked eye; the liquid under the mixing orifice plate b is mixed by controlling the mixing magnetic ring b; (3) Program-controlled mixing: Control the a mixing orifice plate and the b mixing orifice plate to move downward at the same time, keep the downward running speed of the a mixing orifice plate lower than the speed of the b mixing orifice plate, and after the a mixing orifice plate reaches the bottom of the tank, the a mixing orifice plate and the b mixing orifice plate stay at the same interval; control the a mixing orifice plate and the b mixing orifice plate to move upward at the same time, keep the upward running speed of the a mixing orifice plate higher than the speed of the b mixing orifice plate, and after the b mixing orifice plate reaches the bottom of the tank, the a mixing orifice plate and the b mixing orifice plate stay at the same interval; repeat the above cycle multiple times; (4) Discharging: The mixed material is pushed out through the stud to obtain a uniformly mixed high-viscosity injection.

10. The mixing method according to claim 9, characterized in that: In step (3), the a mixing orifice plate and the b mixing orifice plate are controlled to move downward at the same time, and the downward running speed of the a mixing orifice plate is kept lower than the speed of the b mixing orifice plate, and the speed difference is 0.04-0.08 m / s. After the a mixing orifice plate reaches the bottom of the tank body, the a mixing orifice plate and the b mixing orifice plate stay at the same time for 1.4-1.7 s; the a mixing orifice plate and the b mixing orifice plate are controlled to move upward at the same time, and the upward running speed of the a mixing orifice plate is kept higher than the speed of the b mixing orifice plate, and the speed difference is 0.04-0.08 m / s. After the b mixing orifice plate reaches the bottom of the tank body, the a mixing orifice plate and the b mixing orifice plate stay at the same time for 1.4-1.7 s.

Images