Mitomycin freeze-dried powder for use after pterygium surgery, low-temperature drying device and method

Abstract

The present invention relates to the field of pharmaceutical technology, and particularly to a mitomycin lyophilized powder, a low-temperature drying device and method for use after pterygium surgery. The lyophilized powder is prepared from a pre-freeze-drying solution through a freeze-drying process; in the pre-freeze-drying solution by mass, it includes mitomycin C: 0.75 mg / ml - 0.95 mg / ml, mannitol: 1.6 mg / ml - 2 mg / ml, and water for injection: make up to the volume. The mitomycin pre-freeze-drying solution provided by the present invention strictly controls the proportion of the solvent system, improves the solution stability, reduces the reconstitution time, reduces the probability of product solvent residue, has better stability of the finished product, and reduces the safety risk of the product.

Description

Technical Field

[0001] The present invention relates to the field of pharmaceutical technology, and particularly relates to a mitomycin freeze-dried powder for use after pterygium surgery, a low-temperature drying device and method. Background Art

[0002] Mitomycin freeze-dried powder is a drug used to treat various cancers and solid tumors. Its main active ingredient is mitomycin C, which mainly inhibits DNA synthesis and repair, thereby preventing cell proliferation. In order to improve the stability of mitomycin C and facilitate its storage and transportation, mitomycin is currently prepared in the form of freeze-dried powder by a freeze dryer.

[0003] When preparing mitomycin C using the existing technology, mannitol and water are preferably used as the main mixture as the solvent. Although such methods can improve the stability of the solution and can quickly redissolve to form a solution, due to the low volatility of mannitol, it is not easily completely removed during the freeze-drying process, resulting in the retention of mannitol solvent, which in turn affects the properties of the mitomycin freeze-dried powder itself. Summary of the Invention

[0004] In order to overcome the drawback that due to the low volatility of mannitol, it is not easily completely removed during the freeze-drying process, resulting in the retention of mannitol solvent, the present invention provides a mitomycin freeze-dried powder for use after pterygium surgery, a low-temperature drying device and method.

[0005] The technical solution is: A mitomycin freeze-dried powder for use after pterygium surgery, the freeze-dried powder is prepared from a pre-freeze-drying solution by a freeze-drying process; in the pre-freeze-drying solution by mass, it includes mitomycin C: 0.75 mg / ml - 0.95 mg / ml, mannitol: 1.6 mg / ml - 2 mg / ml, and water for injection: make up to the volume;

[0006] The preparation method of the pre-freeze-drying solution is as follows:

[0007] S1: Pass the raw material drug through a 200-mesh sieve and set aside;

[0008] S2: Weigh about 60% of the prescription amount of water for injection into the liquid preparation tank, cool the water for injection and control it at 1°C to 5°C;

[0009] S3: Add the prescription amount of mannitol to the liquid preparation tank;

[0010] S4: Disperse the prescription amount of mitomycin C in an isolator with an appropriate amount of water for injection (1°C to 5°C) and then add it to the liquid preparation tank;

[0011] S5: Add water for injection (1°C to 5°C) to make up the full volume, and keep the liquid medicine at a controlled temperature of 1°C to 5°C;

[0012] S6: Start the stirring of the liquid preparation tank until it is completely dissolved;

[0013] S7: Control the temperature of the liquid preparation tank to -2°C to 5°C, and perform online filtration and filling.

[0014] Furthermore, mitomycin C: 0.85 mg / ml, mannitol: 1.8 mg / ml, and water for injection: make up to the volume.

[0015] A low-temperature drying device for mitomycin freeze-dried powder after pterygium surgery, comprising a housing. The top of the housing is fixedly connected and communicated with an air extraction device. The outside of the housing is fixedly connected and communicated with a vacuum device and a low-temperature device. A first servo motor is fixedly connected to the outside of the housing. Inside the housing, there are trays arranged in a linear array. Inside the housing, there are fixed sliding shafts arranged in a linear array. All the fixed sliding shafts in the linear array are located on one side of the trays in the linear array. Inside the housing, there are reciprocating lead screws arranged in a linear array. One of the reciprocating lead screws in the linear array is fixedly connected to the output shaft of the first servo motor. All the reciprocating lead screws in the linear array are located on the other side of the trays in the linear array. All the reciprocating lead screws in the linear array are fixedly connected with gears, and the gears on adjacent reciprocating lead screws mesh with each other. All the reciprocating lead screws in the linear array are threadedly connected with push plates. The push plates are slidably connected to the adjacent fixed sliding shafts. The push plates on the reciprocating lead screws in the linear array are divided into two groups. Each group includes the push plates in the linear array. The two groups of push plates in the linear array are respectively located on both sides of the trays in the linear array. A retention component for retaining cold air between adjacent trays is arranged on the push plates.

[0016] Furthermore, the push plate is composed of mirror-distributed first sliding seats, mirror-distributed adjusting slide rods, mirror-distributed elastic elements, and elastic cloth. One of the mirror-distributed first sliding seats is threadedly connected to the adjacent reciprocating lead screw, and the other of the mirror-distributed first sliding seats is slidably connected to the adjacent fixed sliding shaft. The mirror-distributed first sliding seats are jointly slidably connected to the mirror-distributed adjusting slide rods. An elastic cloth is fixedly connected between the mirror-distributed adjusting slide rods. The mirror-distributed adjusting slide rods are respectively provided with the elastic elements between them and the mirror-distributed first sliding seats.

[0017] Furthermore, the retention component includes a sliding frame. The sliding frame is slidably connected to the adjacent first sliding seats. Pulling ropes are fixedly connected between the mirror-distributed adjusting slide rods and the adjacent sliding frames. A driving component for pushing the sliding frames in the linear array is arranged inside the housing.

[0018] Further, the driving assembly includes second servo motors distributed in a mirror image. The second servo motors distributed in a mirror image are fixedly connected to the inner side of the housing. Output shafts of the second servo motors distributed in a mirror image are respectively fixedly connected to a first transmission shaft and a second transmission shaft. The first transmission shaft is rotationally connected to the second transmission shaft. The first transmission shaft and the second transmission shaft are both fixedly connected with fixing blocks arranged in a linear array. The fixing blocks arranged in a linear array on the first transmission shaft and the second transmission shaft are staggeredly distributed. The fixing block is provided with an adjusting sliding shaft. The adjusting sliding shaft is slidably connected with a second sliding seat. The second sliding seat is hinged to an adjacent sliding frame.

[0019] Further, it further includes an adjusting assembly for switching the positions of all the adjusting sliding shafts. The adjusting assembly is arranged inside the housing. The adjusting assembly includes arc-shaped sliding shafts arranged in a linear array. The arc-shaped sliding shafts arranged in a linear array are respectively fixedly connected to adjacent adjusting sliding shafts. An electric push rod is fixedly connected to the inside of the housing. A telescopic end of the electric push rod is fixedly connected to an adjusting sliding rod. The arc-shaped sliding shafts arranged in a linear array are all slidably connected with the adjusting sliding rod. A locking assembly for locking adjacent adjusting sliding rods distributed in a mirror image is arranged on the sliding frame.

[0020] Further, the locking assembly includes first extrusion blocks distributed in a mirror image. The first extrusion blocks distributed in a mirror image are all fixedly connected to adjacent sliding frames. Second extrusion blocks are fixedly connected to one side of the adjusting sliding rods distributed in a mirror image close to the adjacent sliding frames. The first extrusion blocks distributed in a mirror image are respectively in extrusion fit with the adjacent second extrusion blocks.

[0021] Further, both the first extrusion block and the second extrusion block are provided with inclined surfaces. The inclined surface of the first extrusion block faces the reverse direction of the adjacent sliding frame. The inclined surface of the second extrusion block faces the adjacent sliding frame.

[0022] Further, a method for low-temperature drying of mitomycin freeze-dried powder after pterygium surgery, which applies a device for low-temperature drying of mitomycin freeze-dried powder after pterygium surgery, includes the following steps:

[0023] S1: Place the prepared solution before freeze-drying in a tray, and then cool it down. At the same time, the first servo motor controls the reciprocating lead screw and the gear to drive the push plate into the space between adjacent trays, so that the push plate drives the cold air in the housing into the space between the trays. At the same time, control the adjusting sliding shaft to drive the adjacent sliding frames to move. The sliding frames pull the ropes distributed in a mirror image. The ropes distributed in a mirror image respectively drive the adjacent adjusting sliding rods to move towards each other, reducing the pushing area of the push plate, so that the cold air stays between the trays;

[0024] S2: After the temperature reduction ends, start to evacuate the inside of the outer shell to a vacuum state, control the second servo motor for mirror distribution. The second servo motor for mirror distribution drives the first transmission shaft and the second transmission shaft to rotate respectively, making the adjustment sliding shaft parallel to the reciprocating lead screw. The electric push rod controls the adjustment sliding rod and the arc-shaped sliding shaft to drive the adjustment sliding shaft to slide along the adjacent fixed block, and switches the working mode of the push plate.

[0025] S3: After the outer shell is in a low-temperature vacuum state, the ice in the solution begins to sublime. The first servo motor controls the reciprocating lead screw and the gear to drive the push plate into the space between adjacent trays. The push plate pushes the sublimated water vapor out of the trays. In this way, until the ice in the solution is completely sublimated, at this time, the mitomycin lyophilized powder is prepared. Then reset this device and turn it off.

[0026] The present invention has the following beneficial effects: 1. The solvent system ratio of the mitomycin solution before lyophilization provided by the present invention is strictly controlled, which improves the solution stability, reduces the reconstitution time, reduces the probability of product solvent residue, the stability of the finished product is better, and the safety risk of the product is reduced.

[0027] 2. The present invention pushes the cold air between two adjacent trays through the push plate, so that the cold air can quickly enter between the two trays to cool the solution inside, and improves the preparation rate of mitomycin lyophilized powder.

[0028] 3. By pulling two adjacent adjustment sliding rods respectively with two pull ropes, the two adjustment sliding rods slide towards each other to reduce the pushing area of the elastic cloth on the cold air, so that the cold air gradually stays between the two trays, avoiding the elastic cloth from pushing the cold air out of the two trays again, resulting in a reduction in the cooling rate of the cold air on the solution inside the trays.

[0029] 4. By changing the relative position of the adjustment sliding shaft to make the adjustment sliding shaft parallel to the reciprocating lead screw, the push plate is stabilized to the maximum area, ensuring that the push plate can push the water vapor between the trays out, and discharging it to the outside by the air extraction device.

[0030] 5. By the first extrusion block extruding the adjacent second extrusion block, the adjustment sliding rod is pressed tightly against the adjacent first sliding seat by the extrusion force and cannot move towards each other. The adjustment sliding rod presses the adjacent elastic element by the extrusion force, and the elastic element is in a state where it cannot be stretched under the extrusion force, avoiding the vibration force generated by this device from causing the movement of two adjacent adjustment sliding rods with mirror distribution. Description of the Drawings

[0031] Figure 1 is a three-dimensional structure schematic diagram of the present invention;

[0032] Figure 2 is a three-dimensional structure sectional view schematic diagram of the outer shell of the present invention;

[0033] Figure 3Schematic three-dimensional structure diagram of the fixed sliding shaft and the reciprocating lead screw of the present invention;

[0034] Figure 4 Schematic three-dimensional structure diagram of the push plate of the present invention;

[0035] Figure 5 Schematic three-dimensional structure diagram of the adjusting slide bar and the elastic element of the present invention;

[0036] Figure 6 Schematic three-dimensional structure diagram of the sliding frame and the pulling rope of the present invention;

[0037] Figure 7 Schematic three-dimensional structure diagram of the adjusting sliding shaft of the present invention;

[0038] Figure 8 Schematic three-dimensional structure diagram of the arc-shaped sliding shaft and the adjusting sliding rod of the present invention.

[0039] Reference numerals in the attached drawings: 1 - outer shell, 2 - air extraction device, 3 - vacuum device, 4 - low-temperature device, 5 - first servo motor, 6 - tray, 7 - fixed sliding shaft, 8 - reciprocating lead screw, 9 - gear, 10 - push plate, 201 - first sliding seat, 202 - adjusting slide bar, 203 - elastic element, 204 - sliding frame, 205 - pulling rope, 206 - second servo motor, 2071 - first transmission shaft, 2072 - second transmission shaft, 208 - fixed block, 209 - adjusting sliding shaft, 210 - second sliding seat, 301 - arc-shaped sliding shaft, 302 - electric push rod, 303 - adjusting sliding rod, 304 - first extrusion block, 305 - second extrusion block. Detailed implementation manners

[0040] In order to make the objectives, technical solutions and advantages of the present invention clearer and more understandable, the present invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention.

[0041] Embodiment 1: A mitomycin freeze-dried powder for use after pterygium surgery. The freeze-dried powder is prepared from a pre-freezing solution through a freeze-drying process; in the pre-freezing solution by mass, it includes mitomycin C: 0.85 mg / ml, mannitol: 1.8 mg / ml, and injection water: make up to the volume.

[0042] The preparation method of the pre-freezing solution is as follows:

[0043] S1: Pass the raw material medicine through a 200-mesh sieve and set aside;

[0044] S2: Weigh about 60% of the prescription amount of injection water into the liquid preparation tank, cool the injection water and control it at 1°C to 5°C;

[0045] S3: Add the prescribed amount of mannitol into the liquid preparation tank;

[0046] S4: Disperse the prescribed amount of mitomycin C in an isolator with an appropriate amount of injection water (1°C to 5°C), and then add it to the liquid preparation tank;

[0047] S5: Make up the injection water (1°C to 5°C) to the full volume, and keep the temperature of the liquid medicine at 1°C to 5°C continuously;

[0048] S6: Start the stirrer of the liquid preparation tank until it is completely dissolved;

[0049] S7: Control the temperature of the liquid preparation tank to -2°C to 2°C (acceptable range -2°C to 5°C), and filter and fill it online.

[0050] The time taken from the start of mitomycin feeding to the end of loading into the box should be ≤10 h, and the exposure limit of the prepared product solution at room temperature should be ≤2 h. The prepared solution is filtered online from the liquid preparation tank to the buffer tank of the filling machine through two 0.22 µm sterilizing filters. The filtration should be completed within 10 hours from the start to the end of filtration, and the filtration pressure should be controlled at ≤2.0 bar.

[0051] The existing device for low-temperature drying of mitomycin is a freeze dryer. The working process of the freeze dryer is that the freeze dryer converts the water in the drug solution into ice through a low-temperature environment, and then directly sublimes the ice inside it into gas under a low-temperature and vacuum environment, aiming to maintain the activity of the drug and extend its shelf life. However, the existing freeze dryer supports the drug through trays. Due to the dense arrangement of the trays, when the temperature starts to drop initially, the cold air in the freeze dryer cannot enter between the two trays in time to cool the solution in the trays, resulting in a low preparation rate of mitomycin freeze-dried powder.

[0052] Example 2: On the basis of Example 1, a low-temperature drying device for mitomycin freeze-dried powder after pterygium surgery, as Figures 1 - 4As shown in the figure, it includes a housing 1. A gas extraction device 2 is fixedly connected and communicated with the top of the housing 1. The gas extraction device 2 is used to extract the sublimated water vapor inside the housing 1. A vacuum device 3 and a low-temperature device 4 are fixedly connected and communicated with the left side outside the housing 1. The vacuum device 3 is used to make the housing 1 in a vacuum state, and the low-temperature device 4 is used to reduce the internal temperature of the housing 1. A first servo motor 5 is fixedly connected to the right side outside the housing 1. Seven trays 6 (seven are shown in the figure as an example) are arranged in a linear array inside the housing 1. The trays 6 are used to place the solution before freeze-drying of mitomycin. Six fixed sliding shafts 7 are fixedly connected in a linear array to the front side inside the housing 1. The six fixed sliding shafts 7 in the linear array are all located in front of the seven trays 6 in the linear array. Six reciprocating lead screws 8 are rotatably connected to the rear side inside the housing 1. The reciprocating lead screw 8 at the top is fixedly connected to the output shaft of the first servo motor 5. The six reciprocating lead screws 8 in the linear array are all located behind the trays 6 in the linear array. A gear 9 is fixedly connected to the left side of each of the six reciprocating lead screws 8 in the linear array, and the gears 9 on two adjacent reciprocating lead screws 8 are meshed with each other, so that the first servo motor 5 drives all the reciprocating lead screws 8 to rotate synchronously through the reciprocating lead screw 8 at the top and the gears 9 in the linear array. Six push plates 10 are threadedly connected to the six reciprocating lead screws 8. The push plates 10 are slidably connected to the adjacent fixed sliding shafts 7. The six push plates 10 on the six reciprocating lead screws 8 are divided into two groups. Each group includes three push plates 10 arranged in a linear array. The two groups of push plates 10 are respectively located on the left and right sides of the trays 6 in the linear array. And the distance between the push plates 10 in the vertical direction is smaller than the distance between two adjacent trays 6, which is convenient for the push plates 10 to enter between the two trays 6. And the push plates 10 in the linear array are staggered on both sides of the trays 6 in the linear array. A retention component for retaining cold air between adjacent trays 6 is arranged on the push plates 10. The cold air is pushed by the push plates 10 between two adjacent trays 6, so that the cold air can quickly enter between the two trays 6 to cool the solution inside, and improve the preparation rate of mitomycin freeze-dried powder.

[0053] As Figure 5 and Figure 6As shown, the push plate 10 is composed of two first sliding seats 201 that are mirror - distributed front - to - back, two adjusting slide rods 202 that are mirror - distributed front - to - back, two groups of elastic elements 203 that are mirror - distributed front - to - back, and an elastic cloth. Each group of elastic elements 203 consists of two elastic elements 203 that are mirror - distributed up - and - down. The first sliding seat 201 located at the rear is thread - connected to the adjacent reciprocating lead screw 8, and the first sliding seat 201 located at the front is slidably connected to the adjacent fixed slide shaft 7. The two mirror - distributed first sliding seats 201 are jointly slidably connected to the two mirror - distributed adjusting slide rods 202. An elastic cloth is fixedly connected between the two mirror - distributed adjusting slide rods 202. The elastic cloth is in a stretched state in its initial state and is used to adapt to the change in the distance between two adjacent adjusting slide rods 202. Elastic elements 203 are arranged between the two mirror - distributed adjusting slide rods 202 and the mirror - distributed first sliding seats 201. The elastic elements 203 are tension springs and are used to drive the adjacent adjusting slide rods 202 to reset. The sum of the elastic forces of the four mirror - distributed elastic elements 203 is greater than the elastic force of the adjacent elastic cloth.

[0054] As Figure 5 and Figure 6 shown, the retention component includes a sliding frame 204. The sliding frame 204 is slidably connected to the adjacent first sliding seat 201. Pull ropes 205 are fixedly connected between the two mirror - distributed adjusting slide rods 202 and the adjacent sliding frame 204. A drive component for pushing the linear - array sliding frame 204 is arranged in the housing 1.

[0055] As Figure 2 、 Figure 3 and Figure 7As shown in the figure, the driving assembly includes two second servo motors 206 that are vertically mirror-distributed. The second servo motors 206 are low-temperature motors, which are used to adapt to the temperature changes inside the housing 1. The mirror-distributed second servo motors 206 are respectively fixedly connected to the top and bottom inside the housing 1. The output shaft of the upper second servo motor 206 is fixedly connected to a first transmission shaft 2071, and the output shaft of the lower second servo motor 206 is fixedly connected to a second transmission shaft 2072. The first transmission shaft 2071 is rotationally connected to the second transmission shaft 2072. Three fixing blocks 208 in a linear array are fixedly connected to both the first transmission shaft 2071 and the second transmission shaft 2072. The three fixing blocks 208 in the linear array on the first transmission shaft 2071 and the second transmission shaft 2072 are staggeredly distributed. An adjusting sliding shaft 209 is provided on the fixing block 208. The distances from the three adjusting sliding shafts 209 adjacent to each other on the first transmission shaft 2071 to the adjacent reciprocating lead screw 8 gradually increase from left to right in the initial state. The distances from the three adjusting sliding shafts 209 adjacent to each other on the second transmission shaft 2072 to the adjacent reciprocating lead screw 8 gradually decrease from left to right in the initial state. The second servo motor 206 drives the adjusting sliding shaft 209 to deflect through the first transmission shaft 2071 and the second transmission shaft 2072, thereby changing the distance between the second sliding seat 210 thereon and the adjacent first sliding seat 201. The sliding frame 204 relies on two adjacent pull ropes 205 to control the distance between two adjacent adjusting sliding rods 202. The adjusting sliding shaft 209 is slidably connected to a second sliding seat 210. The second sliding seat 210 is hinged to the adjacent sliding frame 204. By pulling the adjacent adjusting sliding rods 202 respectively with two pull ropes 205, the two adjusting sliding rods 202 slide towards each other to reduce the pushing area of the elastic cloth on the cold air, so that the cold air stays between the two trays 6 step by step, preventing the elastic cloth from pushing the cold air out of the two trays 6 again, resulting in a low cooling rate of the cold air on the solution inside the trays.

[0056] When preparing mitomycin freeze-dried powder, the staff opens the outer shell 1, and then pours the prepared solution into the seven trays 6 in a linear array. After the required solution is poured into all seven trays 6, the outer shell 1 is closed, and the low-temperature device 4 is turned on to start injecting cold air into the outer shell 1. Since the cold air initially enters the outer shell 1, due to the stacked state of the trays 6, the cold air will accumulate on both sides of the trays 6 and cannot quickly enter between the trays 6, resulting in the solution in the trays 6 not being cooled in time. In response to this situation, the first servo motor 5 is turned on. The output shaft of the first servo motor 5 drives the adjacent reciprocating screw rod 8 to rotate. The rotation of the reciprocating screw rod 8 drives the adjacent reciprocating screw rod 8 to rotate through the gear 9, so that the six reciprocating screw rods 8 in the linear array rotate synchronously. At this time, the six reciprocating screw rods 8 drive the push plates 10 on them to move synchronously. At this time, the three push plates 10 on the left and right sides of the tray 6 start to move towards each other. In this way, until the push plate 10 moves from one side of the tray 6 to the other side, and then the push plate 10 moves in the reverse direction, pushing the cold air into the space between the two trays 6 again. In this cycle, the push plate 10 pushes the cold air into the space between the adjacent two trays 6, enabling the cold air to quickly enter the space between the two trays 6 to cool the solution inside, thereby improving the preparation rate of mitomycin freeze-dried powder.

[0057] When the push plate 10 drives the cold air to move between the two trays 6, the reciprocating screw rod 8 drives the first sliding seat 201 on it to move, so that the first sliding seat 201 drives the two adjusting slide rods 202 mirror-distributed on it to move synchronously. The first sliding seat 201 drives the sliding frame 204 on it to move synchronously. The sliding frame 204 drives the adjacent second sliding seat 210 to slide along the adjacent adjusting slide shaft 209. At this time, since the adjusting slide shaft 209 is in a deflected state, when the second sliding seat 210 slides along the adjacent adjusting slide shaft 209, the second sliding seat 210 pulls the adjacent sliding frame 204 to slide along the adjacent first sliding seat 201. At this time, the sliding frame 204 pulls the two pull ropes 205 mirror-distributed on it. The two pull ropes 205 pull the adjacent adjusting slide rods 202 to move towards each other. At this time, the two elastic elements 203 mirror-distributed on it are stretched. The two adjusting slide rods 202 slide towards each other to reduce the pushing area of the elastic cloth on the cold air, so that the cold air gradually stays between the two trays 6, reducing the amount of cold air pushed out of the two trays 6 again by the elastic cloth, leaving some cold air between the two trays 6, and improving the cooling rate of the cold air on the solution inside the tray 6. In this way, until the two adjusting slide rods 202 move to the other side of the tray 6.

[0058] After the two adjusting slide bars 202 move to the other side of the tray 6, the first servo motor 5 is turned off, and at the same time, two second servo motors 206 with mirror-image distribution are turned on. The output shafts of the two second servo motors 206 drive the first transmission shaft 2071 and the second transmission shaft 2072 to rotate respectively, so that the first transmission shaft 2071 and the second transmission shaft 2072 drive three adjusting slide shafts 209 of the adjacent linear array to rotate synchronously, and the inclination states of the adjusting slide shafts 209 on the first transmission shaft 2071 and the adjusting slide shafts 209 on the second transmission shaft 2072 are swapped. During this process, since the adjusting slide shafts 209 rotate, the adjusting slide shafts 209 drive the adjacent second sliding seats 210 to push the adjacent sliding frames 204, so that the sliding frames 204 slide along the adjacent first sliding seats 201, and the sliding frames 204 relieve the tension on the two pull ropes 205. At this time, the elastic element 203 resets and drives the adjacent adjusting slide bars 202 to reset, so that until the area of the elastic cloth resets to the initial state, then the first servo motor 5 is turned on again, and the output shaft of the first servo motor 5 drives the reciprocating lead screw 8 to rotate, and the above steps are repeated again, so that until after the cold air injection ends, the six push plates 10 are run to the initial position, and then the first servo motor 5 and the low-temperature device 4 are turned off.

[0059] After the cold air injection ends, it is static for a certain period of time to freeze the water in the solution in the tray 6 and reduce it to the required temperature, then the vacuum device 3 is turned on to reduce the pressure in the outer shell 1 to the required value, and then it is placed for a certain period of time again. At this time, the frozen water in the solution begins to sublime in the low-temperature and low-pressure environment, transforming from a solid to a gas. At the same time, the air extraction device 2 is turned on, and the air extraction device 2 extracts the sublimated gas to the outside of the outer shell 1, so that until the frozen water in the solution is completely discharged to the outside, then the air extraction device 2 and the vacuum device 3 are turned off, and the outer shell 1 is opened to take out the lyophilized mitomycin dry powder after low-temperature drying in the tray 6 for the next preparation step. When preparation is required again, the above steps are repeated.

[0060] Since the trays are vertically stacked in the freeze dryer, when the ice in the solution in the trays begins to sublime in the low-temperature and low-pressure environment, the water vapor will be blocked by the upper trays and cannot move upward, resulting in that the external air extraction device cannot extract the water vapor to the outside of the freeze dryer, and then remains between the trays. When the freeze-drying ends, it is very easy to liquefy again and enter the lyophilized mitomycin dry powder, reducing its own properties.

[0061] Example 3: On the basis of Example 2, as Figure 2 、 Figure 7 and Figure 8As shown in the figure, it further includes an adjusting component for switching the positions of all the adjusting sliding shafts 209. The adjusting component is arranged inside the housing 1. The adjusting component includes six arc-shaped sliding shafts 301 arranged in a linear array. The centers of the arc-shaped sliding shafts 301 pass through the rotation axis lines of the first transmission shaft 2071 and the second transmission shaft 2072. The six arc-shaped sliding shafts 301 arranged in a linear array are respectively fixedly connected to the adjacent adjusting sliding shafts 209. The arc-shaped sliding shafts 301 are used to adapt to the position deflection of the adjacent adjusting sliding shafts 209. A electric push rod 302 is fixedly connected to the bottom inside the housing 1. The electric push rod 302 is a low-temperature electric push rod, which is used to adapt to the temperature change inside the housing 1. The upper side of the telescopic end of the electric push rod 302 is fixedly connected with an adjusting sliding rod 303. The six arc-shaped sliding shafts 301 arranged in a linear array are all slidably connected to the adjusting sliding rod 303. The electric push rod 302 drives the adjusting sliding shafts 209 to slide along the fixed block 208 through the adjusting sliding rod 303 and the arc-shaped sliding shafts 301, reducing the distance between the second sliding seat 210 and the adjacent first sliding seat 201, so that when the push plate 10 moves along the adjusting sliding shafts 209, the pushing area of the elastic cloth is in the maximum state. A locking component for locking the adjacent mirror-distributed adjusting sliding rods 202 is arranged on the sliding frame 204. By changing the deflection angles of the adjacent adjusting sliding shafts 209 through the second servo motor 206, the first transmission shaft 2071 and the second transmission shaft 2072, the adjusting sliding shafts 209 are made parallel to the reciprocating lead screw 8. Then, the telescopic end of the electric push rod 302 changes the positions of the adjacent adjusting sliding shafts 209 through the adjusting sliding rod 303 and the arc-shaped sliding shafts 301, making the elastic cloth stable to the maximum area, increasing the water vapor content between the elastic cloth and the tray 6, and discharging it to the outside by the air extraction device.

[0062] As Figure 6 shown, the locking component includes two first extrusion blocks 304 distributed in a mirror image. The first extrusion blocks 304 are provided with inclined surfaces. The inclined surfaces of the first extrusion blocks 304 face upward and forward. The two first extrusion blocks 304 distributed in a mirror image are both fixedly connected to the adjacent sliding frame 204. Second extrusion blocks 305 are fixedly connected to the rear sides of the two mirror-distributed adjusting sliding rods 202. The second extrusion blocks 305 are provided with inclined surfaces. The inclined surfaces of the second extrusion blocks 305 face downward and backward. The two first extrusion blocks 304 distributed in a mirror image are respectively in extrusion cooperation with the adjacent second extrusion blocks 305. The sliding frame 204 drives the two first extrusion blocks 304 distributed in a mirror image on it to extrude the adjacent second extrusion blocks 305, so that the adjusting sliding rods 202 are extruded by the extrusion force to squeeze the adjacent elastic elements 203. The elastic elements 203 are in a state where they cannot be stretched under the extrusion force, avoiding the movement of the two adjacent mirror-distributed adjusting sliding rods 202 caused by the vibration force generated by the device, resulting in a change in the area of the elastic cloth, and thus leaving some water vapor.

[0063] After a low-temperature and low-pressure environment is formed inside the outer shell 1, the ice in the solution on the tray 6 begins to sublime into gas at this time. After the gas sublimes, it moves upward and is extremely easy to be blocked by the upper tray 6, and then accumulates between the two trays 6 and cannot be discharged, inhibiting the sublimation of the ice in the solution on the tray 6. At this time, two second servo motors 206 distributed in mirror image are started. The output shafts of the second servo motors 206 drive three fixed blocks 208 arranged in a straight line array thereon to deflect to be parallel to the reciprocating lead screw 8. During this process, the adjusting slide shaft 209 drives the second sliding seat 210 thereon to move synchronously, so that the distance between the second sliding seat 210 and the adjacent first sliding seat 201 increases. At this time, the second sliding seat 210 pulls two pull ropes 205 distributed in mirror image through the adjacent sliding frame 204. At this time, the pull ropes 205 respectively pull the adjacent adjusting slide rods 202 to slide, and the elastic element 203 is stretched, reducing the area of the elastic cloth. At this time, the second servo motor 206 is turned off, and then the electric push rod 302 is started. The telescopic end of the electric push rod 302 drives the adjusting slide rod 303 to move forward. The adjusting slide rod 303 pushes six arc-shaped slide shafts 301 arranged in a straight line array. The six arc-shaped slide shafts 301 arranged in a straight line array respectively drive the adjacent adjusting slide shafts 209 to slide along the adjacent fixed blocks 208. At this time, the adjusting slide shaft 209 drives the second sliding seat 210 thereon to move synchronously, reducing the distance between the second sliding seat 210 and the adjacent first sliding seat 201. At this time, the pulling force of the sliding frame 204 on the two pull ropes 205 distributed in mirror image adjacent thereto is released, and then the two elastic elements 203 distributed in mirror image reset and drive the adjacent adjusting slide rods 202 to reset, so that the area of the elastic cloth is in the maximum state.

[0064] When the adjusting slide shaft 209 drives the adjacent second sliding seat 210 to push the adjacent sliding frame 204 to move, the sliding frame 204 drives two first extrusion blocks 304 distributed in mirror image thereon to move synchronously. The first extrusion block 304 extrudes the adjacent second extrusion block 305. The two second extrusion blocks 305 are respectively driven by the extrusion force to drive the adjacent adjusting slide rods 202 to slide away from each other, so that the elastic element 203 is in a state where it cannot be stretched under the extrusion force, avoiding that when the reciprocating lead screw 8 drives the push plate 10 to push the water vapor between the adjacent two trays 6, the vibration force generated by this device causes the two adjusting slide rods 202 distributed in mirror image adjacent thereto to move, resulting in a change in the area of the elastic cloth and a deterioration in the pushing effect of the elastic cloth on the water vapor.

[0065] After the adjustment slide bar 202 is locked, turn on the first servo motor 5. The output shaft of the first servo motor 5 drives the adjacent reciprocating lead screw 8, so that the reciprocating lead screw 8 drives the other reciprocating lead screws 8 to rotate synchronously through the gear 9. The rotation of the reciprocating lead screw 8 drives the push plate 10 thereon to perform a linear reciprocating motion. The push plate 10 pushes out the water vapor accumulated between two adjacent trays 6. This cycle continues until the preparation of mitomycin lyophilized powder is completed. Then, the reciprocating lead screw 8 drives the push plate 10 thereon to reset to the initial state. Then, turn on the electric push rod 302. The telescopic end of the electric push rod 302 drives the adjustment sliding rod 303 to reset. The adjustment sliding rod 303 drives the six in the linear array to reset synchronously. Then, turn on the two second servo motors 206 distributed mirror-image. The output shafts of the two second servo motors 206 drive the first transmission shaft 2071 and the second transmission shaft 2072 to rotate to the initial state respectively. When it is necessary to prepare mitomycin lyophilized powder again, repeat the above steps.

[0066] Example 4: On the basis of Example 3, as Figures 1 - 8 shown, a method for low-temperature drying of mitomycin lyophilized powder for use after pterygium surgery, applying a device for low-temperature drying of mitomycin lyophilized powder for use after pterygium surgery, includes the following steps:

[0067] S1: Place the prepared solution before freeze-drying in the tray 6, and then cool it down. At the same time, the first servo motor 5 controls the reciprocating lead screw 8 and the gear 9 to drive the push plate 10 into the space between adjacent trays 6, so that the push plate 10 drives the cold air in the housing 1 into the space between the trays 6. At the same time, control the adjustment sliding shaft 209 to drive the adjacent sliding frames 204 to move. The sliding frame 204 pulls the mirror-image distributed pull ropes 205. The mirror-image distributed pull ropes 205 drive the adjacent adjustment slide bars 202 to move towards each other respectively, reducing the pushing area of the push plate 10, so that the cold air stays between the trays 6.

[0068] S2: When the cooling is completed, start to evacuate the inside of the housing 1 to a vacuum state. Control the mirror-image distributed second servo motors 206. The mirror-image distributed second servo motors 206 drive the first transmission shaft 2071 and the second transmission shaft 2072 to rotate respectively, so that the adjustment sliding shaft 209 and the reciprocating lead screw 8 are parallel to each other. The electric push rod 302 controls the adjustment sliding rod 303 and the arc-shaped sliding shaft 301 to drive the adjustment sliding shaft 209 to slide along the adjacent fixed block 208, switching the working mode of the push plate 10.

[0069] S3: When the inside of the housing 1 is in a low-temperature vacuum state, the ice in the solution begins to sublimate. The first servo motor 5 controls the reciprocating lead screw 8 and the gear 9 to drive the push plate 10 into the space between adjacent trays 6. The push plate 10 pushes the sublimated water vapor out of the tray 6. In this way, until the ice in the solution is completely sublimated, at this time the preparation of mitomycin lyophilized powder is completed. Then, reset the device and turn it off.

[0070] The above are only the preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principles of the present invention shall be included within the protection scope of the present invention.

Claims

1. A low-temperature drying device for mitomycin freeze-dried powder after pterygium surgery, characterized in that: It includes a housing (1), a gas extraction device (2) is fixedly connected and communicated at the top of the housing (1), a vacuum device (3) and a low-temperature device (4) are fixedly connected and communicated outside the housing (1), a first servo motor (5) is fixedly connected outside the housing (1), a linear array of trays (6) is arranged inside the housing (1), a linear array of fixed sliding shafts (7) is fixedly connected inside the housing (1), and the linear array of fixed sliding shafts (7) are all located on one side of the linear array of trays (6). A linear array of reciprocating lead screws (8) is rotatably connected inside the housing (1), and one of the linear array of reciprocating lead screws (8) is fixedly connected to the output shaft of the first servo motor (5). The linear array of reciprocating lead screws (8) are all located on the other side of the linear array of trays (6). The linear array of reciprocating lead screws (8) are all fixedly connected with gears (9), and the gears (9) on adjacent reciprocating lead screws (8) are meshed with each other. The linear array of reciprocating lead screws (8) are all threadedly connected with push plates (10), and the push plates (10) are slidably connected to the adjacent fixed sliding shafts (7). The push plates (10) on the linear array of reciprocating lead screws (8) are divided into two groups, each group includes the linear array of push plates (10), and the two groups of linear array of push plates (10) are respectively located on both sides of the linear array of trays (6). A retention component for retaining cold air between adjacent trays (6) is arranged on the push plates (10). It further includes an adjustment component for switching the positions of all the adjustment sliding shafts (209). The adjustment component is arranged inside the housing (1). The adjustment component includes a linear array of arc-shaped sliding shafts (301), and the linear array of arc-shaped sliding shafts (301) are respectively fixedly connected to the adjacent adjustment sliding shafts (209). An electric push rod (302) is fixedly connected inside the housing (1), and an adjustment sliding rod (303) is fixedly connected to the telescopic end of the electric push rod (302). The linear array of arc-shaped sliding shafts (301) are all slidably connected to the adjustment sliding rod (303). A locking component for locking adjacent mirror-distributed adjustment sliding rods (202) is arranged on the sliding frame (204). The push plate (10) is composed of first sliding seats (201) distributed mirror-symmetrically, adjusting slide rods (202) distributed mirror-symmetrically, elastic elements (203) distributed mirror-symmetrically, and elastic cloth. One of the first sliding seats (201) distributed mirror-symmetrically is threadedly connected to the adjacent reciprocating lead screw (8), and the other of the first sliding seats (201) distributed mirror-symmetrically is slidably connected to the adjacent fixed slide shaft (7). The first sliding seats (201) distributed mirror-symmetrically are jointly slidably connected to the adjusting slide rods (202) distributed mirror-symmetrically. An elastic cloth is fixedly connected between the adjusting slide rods (202) distributed mirror-symmetrically. Elastic elements (203) are arranged between the adjusting slide rods (202) distributed mirror-symmetrically and the first sliding seats (201) distributed mirror-symmetrically respectively; The retention assembly includes a sliding frame (204). The sliding frame (204) is slidably connected to the adjacent first sliding seat (201). Pulling ropes (205) are fixedly connected between the adjusting slide rods (202) distributed mirror-symmetrically and the adjacent sliding frame (204). A driving assembly for pushing the sliding frames (204) arranged in a linear array is arranged in the housing (1); The driving assembly includes second servo motors (206) distributed mirror-symmetrically. The second servo motors (206) distributed mirror-symmetrically are fixedly connected to the inner side of the housing (1) respectively. Output shafts of the second servo motors (206) distributed mirror-symmetrically are fixedly connected with a first transmission shaft (2071) and a second transmission shaft (2072) respectively. The first transmission shaft (2071) is rotationally connected to the second transmission shaft (2072). Linear arrays of fixed blocks (208) are fixedly connected to both the first transmission shaft (2071) and the second transmission shaft (2072). The fixed blocks (208) arranged in a linear array on the first transmission shaft (2071) and the second transmission shaft (2072) are distributed staggeredly. An adjusting slide shaft (209) is arranged on the fixed block (208). The adjusting slide shaft (209) is slidably connected with a second sliding seat (210). The second sliding seat (210) is hinged to the adjacent sliding frame (204).

2. The cryogenic drying device for mitomycin freeze-dried powder after pterygium surgery according to claim 1, wherein: The locking assembly includes first extrusion blocks (304) distributed mirror-symmetrically. The first extrusion blocks (304) distributed mirror-symmetrically are fixedly connected to the adjacent sliding frames (204) respectively. Second extrusion blocks (305) are fixedly connected to one sides of the adjusting slide rods (202) close to the adjacent sliding frames (204). The first extrusion blocks (304) distributed mirror-symmetrically are respectively in extrusion fit with the adjacent second extrusion blocks (305).

3. A mitomycin freeze-dried powder low-temperature drying device for use after pterygium surgery according to claim 2, characterized in that: Both the first extrusion block (304) and the second extrusion block (305) are provided with inclined surfaces. The inclined surface of the first extrusion block (304) faces the reverse direction of the adjacent sliding frame (204), and the inclined surface of the second extrusion block (305) faces the adjacent sliding frame (204).

4. A mitomycin freeze-dried powder low-temperature drying device for use after pterygium surgery according to claim 3, characterized in that: A method for low-temperature drying of mitomycin freeze-dried powder after pterygium surgery, using a low-temperature drying device for mitomycin freeze-dried powder after pterygium surgery, includes the following steps: S1: Place the prepared solution before freeze-drying in the tray (6), then cool down. At the same time, the first servo motor (5) controls the reciprocating lead screw (8) and the gear (9) to drive the push plate (10) into the space between adjacent trays (6), so that the push plate (10) drives the cold air in the housing (1) into the space between the trays (6). At the same time, control the adjusting slide shaft (209) to drive the adjacent sliding frames (204) to move. The sliding frames (204) pull the mirror-distributed pull ropes (205), and the mirror-distributed pull ropes (205) drive the adjacent adjusting slide rods (202) to move towards each other respectively, reducing the pushing area of the push plate (10), so that the cold air stays between the trays (6); S2: After the cooling is completed, start to evacuate the inside of the housing (1) to a vacuum state. Control the mirror-distributed second servo motors (206). The mirror-distributed second servo motors (206) drive the first transmission shaft (2071) and the second transmission shaft (2072) to rotate respectively, so that the adjusting slide shaft (209) is parallel to the reciprocating lead screw (8). The electric push rod (302) controls the adjusting slide rod (303) and the arc slide shaft (301) to drive the adjusting slide shaft (209) to slide along the adjacent fixed blocks (208), switching the working mode of the push plate (10); S3: When the housing (1) is in a low-temperature vacuum state, the ice in the solution begins to sublime. The first servo motor (5) controls the reciprocating lead screw (8) and the gear (9) to drive the push plate (10) into the space between adjacent trays (6). The push plate (10) pushes the sublimated water vapor out of the tray (6). In this way, until the ice in the solution is completely sublimated, at this time the mitomycin freeze-dried powder is prepared. Then reset the device and turn it off.

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