Sterilization equipment and sterilization method for production of landiolol hydrochloride injection

Abstract

The invention relates to the technical field of sterilization, in particular to sterilization equipment for landiolol hydrochloride injection production and a sterilization method.The sterilization equipment comprises a box body, a bearing mechanism is arranged at the lower end of an inner cavity of the box body, a rotating mechanism is arranged at the top of the bearing mechanism, and the bearing mechanism comprises a rotating table of a hollow structure; a plurality of air supply pipes are arranged above the rotating table in a communicating mode, the outer sides of the air supply pipes are sleeved with injection medicine bottles with downward bottle openings, neutral gas is filled into the inverted injection medicine bottles through a connecting structure between the rotating mechanism and the bearing mechanism, and plasma airflow is generated through plasma excitation electrodes in the injection medicine bottles; the plasma flows along the inner wall of the injection medicine bottle from top to bottom in the injection medicine bottle, the flowing path of the plasma directly acts on the injection medicine bottle area, direct sinking caused by density is avoided, sterilization dead angles are reduced, meanwhile, sterilization gas flows from a bottle opening of the injection medicine bottle, and efficient sterilization operation is emphasized on the complex structure of the bottle opening.

Description

A sterilization device and sterilization method for the production of landiolol hydrochloride injection. Technical Field

[0001] This invention relates to the field of sterilization technology, and more specifically, to a sterilization equipment and method for the production of landiolol hydrochloride injection. Background Technology

[0002] Landilol hydrochloride injection is a short-acting, highly selective β1-receptor blocker, mainly used for the treatment of clinical cardiovascular diseases. The dosage form is a sterile aqueous solution for injection, which needs to be administered intravenously. It is especially suitable for scenarios that require rapid control of heart rate. During the production of landilol hydrochloride injection, appropriate sterilization technology is required to kill or remove microorganisms in the packaging container of the injection solution, and to ensure that the process of drug packaging meets the sterile preparation standards.

[0003] Existing technologies can employ low-temperature plasma sterilization gas in conjunction with ultraviolet sterilization. However, when the plasma sterilization gas is filled or disturbed in contact with the injection vial, the flow of the sterilization gas is disordered, resulting in sterilization dead zones inside and outside the vial. Furthermore, the density of the plasma sterilization gas is higher than that of air, so it tends to sink directly during filling, making it difficult to achieve full coverage inside and outside the injection vial, thus affecting the sterilization quality. Summary of the Invention

[0004] The purpose of this invention is to provide a sterilization device and method for the production of landiolol hydrochloride injection, in order to solve the problem in the above-mentioned background technology that the sterilization gas of plasma tends to sink due to density issues, making it difficult to achieve full coverage inside and outside the injection vial, thus affecting the sterilization quality.

[0005] To achieve the above objectives, the present invention first provides a sterilization device for the production of landiolol hydrochloride injection, comprising a housing, a supporting mechanism at the lower end of the inner cavity of the housing, and a rotating mechanism at the top of the supporting mechanism. The supporting mechanism includes a hollow rotating platform, with several air supply pipes connected above the rotating platform. An injection vial with its opening facing downwards is fitted onto the outer side of each air supply pipe, and there is a space between the outer wall of the air supply pipe and the inner wall of the injection vial. An upper gap is formed between the end of the air supply pipe and the end of the inner cavity of the injection vial, and a lower gap is formed between the injection vial and the rotating platform by a clamping assembly. The lower gap is used to connect the internal environment of the injection vial to the external environment. The rotating mechanism includes an air inlet pipe that forms a gas delivery channel with the inner cavity of the rotating platform. A connecting plate is fixedly installed on the outer wall of the air inlet pipe near the top of the inner cavity of the housing, and a spiral plate for delivering plasma from bottom to top is provided at the bottom of the connecting plate.

[0006] The beneficial effects of this invention are: by connecting the supporting mechanism and the rotating mechanism, neutral gas is injected into the injection vial to generate a plasma flow, which sterilizes the inside of the injection vial; and by driving the supporting mechanism and the rotating mechanism with a motor to disturb the plasma flow from the injection vial, the contact range between the injection vial and the airflow is increased, sterilization dead zones are reduced, and the sterilization effect of the equipment is guaranteed.

[0007] Based on the above technical solution, the present invention can be further improved as follows.

[0008] Preferably, the box body is provided with a box cover, and the box cover is frame-shaped, with its outer side slidingly contacting the inner side of the box body; the bottom of the two side ears of the box cover is fixedly connected to the output end of the pushing mechanism, and the top of the outer shell of the pushing mechanism is fixedly connected to the bottom of the two side ears of the box body; the air inlet pipe is rotatably connected to the inside of the box cover and is the same as the central axis of the box cover.

[0009] The beneficial effects of adopting the above-mentioned further solution are that it avoids the obstruction of the injection vial loading position by the rotating mechanism structure, prevents external air, dust and microorganisms from entering the inside of the chamber during the loading and unloading process, and prevents the sterile environment from being contaminated.

[0010] Preferably, the lower end of the rotating platform is rotatably connected to the lower end of the inner cavity of the box, and the bottom side of the air inlet pipe is symmetrically fixed with a locking block. When the position of the air inlet pipe in the box is determined, the locking block is engaged in the locking groove at the center of the top surface of the rotating platform; the top end of the air inlet pipe is rotatably connected to the external gas filling device.

[0011] The beneficial effect of adopting the above-mentioned further solution is that it achieves a stable connection between the rotating mechanism and the bearing mechanism, which facilitates the subsequent rotation of the bearing mechanism and the rotating mechanism.

[0012] Preferably, the clamping assembly includes clamps, and multiple clamps are arranged in a ring around the air delivery tube at the mouth of the injection bottle; the clamps are L-shaped, with the bottom end of the injection bottle mouth placed on the lower horizontal surface of the clamps, and its outer side contacting one side of the clamps; the side of the clamps near the air delivery tube is elastically connected to the air delivery tube by multiple damping springs.

[0013] The beneficial effects of adopting the above-mentioned further solutions are that the elastic clamping avoids scratching and squeezing damage to the glass surface of the injection vial caused by rigid contact, reduces the risk of leakage of medicine due to vial breakage, and the damping structure can absorb the vibration generated during the sterilization of the injection vial and reduce shaking.

[0014] Preferably, an ultraviolet irradiator is fixedly connected to the outside of the air inlet pipe. The ultraviolet irradiator is positioned at the central axis formed by multiple injection vials, and is equidistant from each injection vial.

[0015] The beneficial effects of adopting the above-mentioned further solution are that the injection vials are sterilized by radiation using an ultraviolet irradiator, leaving no chemical reagent residue, avoiding contamination of the drug solution by sterilizing agents, improving the safety of drug use, and the ultraviolet light can penetrate the vial, enabling sterilization of both the inside and outside of the injection vial.

[0016] Preferably, the bottom end of the air supply pipe is rotatably connected to the top end of the rotating platform, and the internal channel of the air supply pipe is connected to the inner cavity of the rotating platform. A turbine is fixedly connected to the lower end of the inner side of the air supply pipe. A booster valve is fixedly connected to each position in the inner cavity of the rotating platform that is aligned with the central axis of the air supply pipe.

[0017] The beneficial effect of adopting the above-mentioned further solution is that the airflow drives the air delivery pipe and the injection bottle to rotate through the turbine and the booster valve, so that the entire circumference of the injection bottle can be irradiated by the ultraviolet irradiator.

[0018] Preferably, a plasma excitation electrode for generating plasma gas flow is fixedly connected to the top of the gas delivery pipe; the plasma excitation electrode includes an outer electrode and an inner electrode, the inner electrode is placed inside the outer electrode and fixedly connected to the inner side of the outer electrode by a support rod, and the outer electrode and the inner electrode belong to the same axis; a baffle is fixedly connected to the lower end of the outer side of the outer electrode, the diameter of the baffle is adapted to the inner diameter of the injection bottle, and a vent hole is provided inside the baffle, the inner diameter of the vent hole gradually decreases from top to bottom, forming an inverted cone shape.

[0019] The beneficial effect of adopting the above-mentioned further scheme is to achieve the effective generation of plasma gas flow.

[0020] Preferably, the spiral plate is placed outside the multiple injection vials and does not contact the injection vials; a second gear is fixedly connected to the upper end of the outer side of the air inlet pipe, a first gear is meshed with the outer side of the second gear, the bottom end of the first gear is fixedly connected to the output end of the motor, and the bottom of the outer side of the motor is fixedly connected to the top of the box cover.

[0021] The beneficial effects of adopting the above-mentioned further solutions are that they achieve uniform airflow distribution inside the chamber, while increasing the contact frequency between plasma and the outer surface of the injection vial and the sealing surface of the vial opening, thereby improving the sterilization efficiency of the vial opening, especially for dead corner areas such as the threaded area of ​​the vial opening.

[0022] Preferably, a limiting cylinder is fixedly connected to the bottom surface of the connecting plate and the vertically aligned position of the injection bottle, and the top of the injection bottle is placed inside the limiting cylinder; a ball bearing is rolled on the bottom surface of the connecting plate placed inside the limiting cylinder, and the bottom end of the ball bearing contacts the top of the injection bottle; an anti-wear strip is fixedly connected to the lower end of the inner side of the limiting cylinder, and the inner side of the anti-wear strip adopts an arc-shaped structure and contacts the outer surface of the injection bottle.

[0023] The beneficial effects of adopting the above-mentioned further solution are that it limits the position of the injection vial, reduces frictional resistance, and avoids displacement and collision during the rotation and revolution of the injection vial.

[0024] Furthermore, a sterilization method is provided, including the following steps: S1, Bottle loading: The pushing mechanism is activated, causing the box lid and rotating mechanism to move upward, opening the box door, and placing multiple injection bottles with their mouths facing downward on the outside of the air delivery pipe. These bottles are held in place by clamps and damping springs. The box door is closed, and the pushing mechanism drives the box lid to move downward, causing the locking block to engage with the slot on the rotating table, completing the connection between the rotating mechanism and the supporting mechanism; S2, Gas filling and pressurization: Neutral gas (such as argon) is supplied to the air inlet pipe through an external gas filling device. The gas enters the inner cavity of the rotating table through the air inlet pipe and is distributed to each pressurization valve. The pressurization valves pressurize the gas and fill the air delivery pipe; S3, Bottle rotation: The pressurized airflow impacts the turbine, causing the air delivery pipe and injection bottles to rotate. Simultaneously, the motor is started, and the first gear meshes with the second gear. The rotating mechanism, the carrying mechanism, and the injection vials revolve around the central axis; S4, Co-sterilization: The ultraviolet irradiator is activated to radiate ultraviolet light onto the injection vials, and the plasma excitation electrode is activated to ionize the airflow in the gas supply pipe into low-temperature plasma. The plasma flows down the bottle wall through the inverted conical vent in the baffle, killing microorganisms inside the bottle. At the same time, it flows out from the bottle opening to fill the chamber, killing microorganisms outside the bottle and inside the chamber. During the sterilization process, the spiral plate disturbs the airflow to ensure uniform plasma distribution; S5, Post-sterilization treatment: After the preset sterilization time (e.g., 15-20 minutes) is reached, the ultraviolet irradiator, plasma excitation electrode, and motor are turned off in sequence, the gas filling is stopped, the exhaust valve is opened to release the pressure inside the chamber, the mechanism drives the chamber lid to move upward, the chamber door is opened, and the sterilized injection vials are removed, completing the sterilization process.

[0025] Compared with the prior art, the beneficial effects of the present invention are as follows: Neutral gas is introduced into the inverted injection vial through the connection structure between the rotating mechanism and the carrying mechanism. A plasma gas flow is generated by the plasma excitation electrode inside the injection vial, flowing downwards along the inner wall of the vial. The plasma flow path directly acts on the entire area inside the injection vial, preventing active particles in the plasma from sinking directly due to density before sterilization, thus reducing sterilization dead zones. Simultaneously, the sterilizing gas flows from the vial opening, focusing on efficiently sterilizing the complex structure of the opening. The rotating mechanism and carrying mechanism, driven by a motor, cause the injection vial to revolve within the chamber. This allows the rotating mechanism to transport the plasma gas flow from the bottom of the injection vial upwards, increasing the contact area between the outside of the injection vial and the plasma gas flow, reducing sterilization dead zones, and sterilizing the outside of the injection vial.

[0026] By using a neutral gas impact turbine to drive the air delivery pipe and injection vial to rotate, combined with ultraviolet radiation from an ultraviolet irradiator for synergistic sterilization, all-round sterilization without dead angles is achieved inside and outside the vial, improving the sterilization effect of the equipment. Attached Figure Description

[0027] Figure 1 is an isometric structural diagram of one side of the present invention; Figure 2 is a front sectional structural diagram of the present invention; Figure 3 is a front sectional structural diagram of the medicine bottle loading and unloading of the present invention; Figure 4 is an isometric structural diagram of one side of the bearing mechanism and rotating mechanism of the present invention; Figure 5 is an isometric structural diagram of the other side of the bearing mechanism and rotating mechanism of the present invention; Figure 6 is a schematic diagram of the plasma airflow generation and flow structure of the present invention; Figure 7 is a three-dimensional structural diagram of point A in Figure 6 of the present invention; Figure 8 is a structural schematic diagram of point B in Figure 6 of the present invention.

[0028] The labels in the diagram represent the following: 1. Box body; 11. Box cover; 12. Pushing mechanism; 2. Bearing mechanism; 21. Rotating table; 22. Air supply pipe; 23. Clamping plate; 24. Damping spring; 25. Turbine; 26. Pressure boosting valve; 27. Plasma excitation electrode; 271. External electrode; 272. Internal electrode; 273. Baffle; 3. Injection vial; 4. Rotating mechanism; 41. Air inlet pipe; 42. Clamping block; 43. Ultraviolet irradiator; 44. Connecting plate; 45. Limiting cylinder; 451. Ball bearing; 452. Anti-wear strip; 46. Spiral plate; 5. Motor; 51. First gear; 52. Second gear. Detailed Implementation

[0029] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0030] Please refer to Figures 1-8. For the pre-sterilization treatment of vials storing landiolol hydrochloride injection during production, to avoid contamination of the solution by residual bacteria, fungi, spores, and other microorganisms inside and outside the vials, this embodiment provides a sterilization device for the production of landiolol hydrochloride injection, as shown in Figure 2. It includes a box body 1, with a supporting mechanism 2 at the lower end of the inner cavity of the box body 1. Multiple injection vials 3 are evenly distributed in a ring shape at the upper end of the supporting mechanism 2. A rotating mechanism 4 is provided on the top of each injection vial 3. Before sterilizing the injection vials 3, they need to be stably placed in the box body 1. To avoid the rotating mechanism 4 obstructing the feeding position of the injection vials 3, as shown in Figure 3, a box cover 11 is provided inside the box body 1. The box cover 11 is frame-shaped, with its outer side slidingly contacting the inner side of the box body 1. The rotating mechanism 4 is rotatably disposed inside the box cover 11. The rotating mechanism 4 can rotate relative to the lid 11. It is aligned with the central axis of the lid 11. The bottom of the ear plates on both sides of the lid 11 is fixedly connected to the output end of the pushing mechanism 12. The top of the outer shell of the pushing mechanism 12 is fixedly connected to the bottom of the ear plates on both sides of the box body 1. When loading and unloading, the pushing mechanism 12 is activated to push the lid 11 upward, which simultaneously drives the rotating mechanism 4 upward, moving the rotating mechanism 4 away from the injection vial 3. This facilitates opening the box door of the box body 1 before and after sterilization to load and unload the injection vial 3, avoiding the obstruction of the injection vial 3 by the rotating mechanism 4. The working principle of the pushing mechanism 12 is as follows: The pushing mechanism 12 is an electric push rod. The motor drives the lead screw to extend and retract, causing the lid 11 connected to the output end to slide up and down along the inner side of the box body 1, realizing the synchronous lifting and lowering of the lid 11 and the rotating mechanism 4. This is well known to those skilled in the art and will not be described in detail here.

[0031] Considering the limitations of traditional sterilization techniques in simultaneously sterilizing the inner and outer surfaces of the injection vials 3, and the difficulty in ensuring high-efficiency sterilization, this example employs the synergistic effect of plasma sterilization gas and ultraviolet lamp radiation, along with the linkage between various mechanisms, to simultaneously sterilize the inner and outer surfaces of the injection vials 3. However, because the density of plasma sterilization gas is higher than that of air, it tends to sink directly during filling, making it difficult to achieve full coverage of the injection vials, thus affecting sterilization quality. Therefore, it is necessary to disclose the specific structures of the supporting mechanism 2 and the rotating mechanism 4. As shown in Figures 4 and 5, the supporting mechanism 2 includes a rotating platform 21, the lower end of which is rotatably connected to the lower end of the inner cavity of the housing 1. Several air supply pipes 22 are evenly arranged in a ring shape on the top of the rotating platform 21. Multiple injection vials 3 are placed with their mouths facing downwards on the outside of the multiple air supply pipes 22. There is an upper gap between the top of the inner cavity of the injection vials 3 and the top of the air supply pipes 22, and a lower gap between the injection vials 3 and the rotating platform 21. The injection vials 3 are fitted onto the outer wall of the air supply pipes 22. For initial positioning, to ensure the stability of the injection vial 3 during sterilization, as shown in Figure 7, a clamping assembly is also provided on the outer wall near the bottom of the air supply tube 22. The clamping assembly includes multiple clamping plates 23 evenly distributed in a ring around the air supply tube 22 at the mouth of the injection vial 3. The clamping plates 23 are L-shaped, and the bottom end of the injection vial 3 mouth is placed on the low horizontal surface of the L-shaped clamping plate 23. The low horizontal surface of the L-shaped clamping plate 23 has a distance between one end and the upper surface of the rotating table 21, which satisfies the requirement that there is a lower distance between the bottom end of the injection vial 3 mouth and the upper surface of the rotating table 21. The gap (this gap facilitates communication between the inside and outside of the injection vial 3); and the outer side of the injection vial 3 contacts one side of the clamp 23. The side of the clamp 23 near the air supply tube 22 is elastically connected to the air supply tube 22 through multiple damping springs 24, thereby achieving stable clamping of the mouth of the injection vial 3. The elastic clamping avoids scratching and squeezing damage to the glass surface of the injection vial 3 caused by rigid contact, reducing the risk of leakage of medicine due to bottle breakage. At the same time, the damping structure can absorb the vibration generated during the sterilization of the injection vial 3 and reduce shaking.

[0032] After the material is loaded, close the box door and push the output end of the mechanism 12 to pull the box cover 11 and the rotating mechanism 4 down, so that the rotating mechanism 4 is connected to the bearing mechanism 2, which facilitates the subsequent sterilization work.

[0033] As shown in Figures 4 to 6, the rotating mechanism 4 includes an air inlet pipe 41, a connecting plate 44 fixedly connected to the outside of the air inlet pipe 41, and a spiral plate 46 fixedly connected to the bottom surface of the connecting plate 44. The spiral plate 46 is placed outside the multiple injection vials 3 and does not contact the injection vials 3. The internal channel of the air inlet pipe 41 is connected to the inner cavity of the rotating platform 21. The top end of the air inlet pipe 41 is rotatably connected to an external gas filling device, so that gas can be transported downward through the internal channel of the air inlet pipe 41 to the inner cavity of the rotating platform 21, which is convenient for subsequent filling into multiple air delivery pipes 22, and then dispersed into the injection vials 3 through the upper gap at the top end of the air delivery pipes 22. Furthermore, a locking block 42 is symmetrically fixedly connected to the side of the bottom end of the air inlet pipe 41. When the position of the air inlet pipe 41 in the housing 1 is determined, the locking block 42 is engaged in the slot at the center of the top surface of the rotating platform 21 (so that when the air inlet pipe 41 rotates, it can synchronously drive the rotating platform 21 to rotate).

[0034] The air inlet pipe 41 is fixedly connected to an ultraviolet irradiator 43. The ultraviolet irradiator 43 is placed at the central axis formed by multiple injection vials 3, and is equidistant from each injection vial 3 to ensure that the ultraviolet radiation intensity received by each injection vial 3 is consistent, thus ensuring the quality uniformity of mass production. The injection vials 3 are sterilized by radiation through the ultraviolet irradiator 43, leaving no chemical reagent residue, avoiding contamination of the medicine liquid by sterilizing agent, improving the safety of medication use, and the ultraviolet light can penetrate the vial, so that the inside and outside of the injection vial 3 can be sterilized.

[0035] Considering that the ultraviolet irradiator 43 cannot irradiate all parts of the outer surface of the injection vial 3 in a fixed position, as shown in Figure 7, the bottom end of the air delivery pipe 22 is rotatably connected to the top end of the rotating platform 21, and the internal channel of the air delivery pipe 22 is connected to the inner cavity of the rotating platform 21. The lower end of the inner side of the air delivery pipe 22 is fixedly connected to the turbine 25. The gas enters the inner cavity of the rotating platform 21 through the air inlet pipe 41, and then flows to each air delivery pipe 22. The airflow impacts the blades of the turbine 25 upward through the air delivery pipe 22. The blades generate torque due to the thrust of the airflow, driving the turbine 25 to rotate. The turbine 25 is fixedly connected to the air delivery pipe 22, causing the air delivery pipe 22 to rotate synchronously. The air delivery pipe 22 generates frictional force by clamping the mouth of the injection vial 3 through the clamping plate 23. The frictional force is transmitted to the injection vial 3, and finally causes the injection vial 3 to rotate around its own axis.

[0036] Considering the low initial gas pressure (typically 0.005-0.01 MPa) and insufficient airflow thrust, it is difficult to overcome the rotational resistance of the turbine 25, the bearing friction of the air delivery pipe 22, and the inertial resistance of the injection bottle 3, resulting in excessively low rotational speed or failure to rotate. Therefore, it is necessary to increase the impact force of the airflow to effectively drive the turbine 25 to rotate the air delivery pipe 22 and the injection bottle 3. Thus, as shown in Figure 6, a booster valve 26 is fixedly connected in the inner cavity of the rotating platform 21 at a position aligned with the central axis of the air delivery pipe 22. The booster valve 26 adopts a miniature Venturi structure, and the flow velocity increases sharply when the airflow passes through the throat, forming a negative pressure in the expansion section to draw in the surrounding auxiliary gas. To achieve a doubling of airflow pressure (the outlet pressure is 2-3 times higher than the inlet pressure); it should be noted that the airflow impact force must be balanced with the total resistance (rotational resistance of turbine 25 + bearing friction resistance of air delivery pipe 22 + inertial resistance of injection bottle 3 + air damping), that is, the thrust torque generated by the airflow is greater than or equal to the total resistance torque. For example, for a 5-20ml medicine bottle 3 (total weight 20-35g), after being pressurized by the pressure booster valve 26, the airflow pressure needs to reach 0.015-0.025MPa, the flow velocity needs to be 12-18m / s, and a thrust torque of ≥0.005N・m needs to be generated to overcome the total resistance and drive the medicine bottle to rotate stably at 100-150rpm.

[0037] Furthermore, considering that directly pressurizing the plasma gas flow would lead to excessively high collision frequencies of active particles (such as free radicals and electrons) in the plasma, accelerating particle decay and reducing sterilization efficiency, as shown in Figure 8, a plasma excitation electrode 27 is fixedly connected to the top of the air supply pipe 22. The plasma excitation electrode 27 includes an outer electrode 271 and an inner electrode 272. The inner electrode 272 is placed inside the outer electrode 271 and is fixedly connected to the inner side of the outer electrode 271 by a support rod. The outer electrode 271 and the inner electrode 272 belong to the same axis. During sterilization (as indicated by the dashed arrow in Figure 6), a low-temperature environment is maintained inside the chamber 1. At temperatures between 40℃ and 60℃, neutral gas (such as argon or nitrogen) is introduced into the inlet pipe 41 via an external gas filling device. The gas is then conveyed downwards through the inlet pipe 41 into the rotating platform 21, and then distributed to the bottom inlets of multiple pressure boosting valves 26. After being pressurized by the pressure boosting valves 26, the gas is injected into the delivery pipe 22, causing the turbine 25 to drive the delivery pipe 22 and the injection vial 3 to rotate. This ensures that the entire circumference of the injection vial 3 is irradiated by the ultraviolet irradiator 43. Simultaneously, the airflow continuously flows upwards within the delivery pipe 22 to between the outer electrode 271 and the inner electrode 272. The pressure is gradually reduced through the delivery pipe 22, minimizing the impact of the airflow on the plasma excitation electrode 27, preventing instability in the discharge arc, and ensuring the uniformity of plasma generation. The outer electrode 271 is a ring-shaped copper mesh (coated with an insulating ceramic layer), and the inner electrode 272 is a tungsten needle electrode. Both possess excellent conductivity and corrosion resistance, and are suitable for use in low-temperature plasmas. No chemical decomposition occurs in the environment, avoiding contamination of the drug solution; a high-voltage power supply supplies power to the inner and outer electrodes 271, forming a strong electric field between the electrodes. When the depressurized neutral gas (such as argon or nitrogen) flows through the electric field region, it is ionized into low-temperature plasma containing high-energy particles, free radicals, and electrons, realizing the conversion of gas flow into plasma; during the process, it is also considered that the residual oxygen in the injection vial 3 may react with the active particles in the plasma, consuming sterilization active ingredients such as free radicals, reducing the plasma concentration, and thus affecting the sterilization effect. Therefore, a baffle 273 is fixedly connected to the lower end of the outer side of the outer electrode 271. The diameter of the baffle 273 is adapted to the inner diameter of the injection vial 3, and a vent is provided inside the baffle 273. The inner diameter of the vent gradually decreases from top to bottom, forming an inverted cone shape. While not affecting the diffusion of plasma to the bottom of the injection vial 3, it reduces the backflow of air below the injection vial 3 to the top, reducing the impact of oxygen in the air on plasma generation;The generated plasma gas flow originates from the top of the plasma excitation electrode 27 and flows out to fill the upper end of the inner cavity of the injection vial 3. With continuous filling, the plasma gas flows through the vent in the baffle 273 and downwards along the inner wall of the injection vial 3 (as indicated by the dashed arrow in Figure 8). The plasma gas flows close to the vial wall, ensuring full contact with the inner wall of the injection vial 3. Utilizing the high-energy particles (electrons, ions) and active free radicals (such as OH, O3) in the low-temperature plasma, it destroys the microbial structure through a dual action of physical impact and chemical oxidation, killing microorganisms attached to the inner wall and compensating for the blind spots caused by insufficient ultraviolet penetration. During the process, the flow path of the active particles directly acts on the entire area inside the injection vial, reducing the loss of sterilization activity and ensuring efficient plasma sterilization. The downward-discharged plasma gas flows outward from the mouth of the injection vial 3. Due to its density, it settles and concentrates at the mouth of the injection vial 3 inside the chamber 1. The mouth and sealing surface, due to their complex structure, are key risk points for vial sterilization (microorganisms are easily left behind during subsequent filling and sealing). The high-density plasma settles and accumulates here, forming a high-concentration plasma environment, prolonging the contact time with the threaded mouth and sealing surface, killing microorganisms hidden in the gaps, and solving the problem of incomplete sterilization of dead corners at the mouth in traditional sterilization methods.

[0038] During the process, considering that irradiation of the outside of the injection vial 3 by the ultraviolet irradiator 43 alone may not meet the required sterilization requirements, in order to further improve the sterilization effect of the equipment, as shown in Figure 6, a second gear 52 is fixedly connected to the upper end of the outside of the air inlet pipe 41, and a first gear 51 is meshed with the outside of the second gear 52. The bottom end of the first gear 51 is fixedly connected to the output end of the motor 5, and the bottom of the outside of the motor 5 is fixedly connected to the top of the box cover 11. By starting the motor 5, the first gear 51 is driven to rotate, and through the meshing connection between the first gear 51 and the second gear 52, the second gear 52 and the air inlet pipe 41 are driven to rotate. The rotation, and the engagement connection between the air inlet pipe 41 and the rotating platform 21 via the locking block 42, enables the bearing mechanism 2, the injection bottle 3, and the rotating mechanism 4 to rotate simultaneously around the central axis of the rotating mechanism 4 inside the box 1. This causes the injection bottle 3 to disturb the airflow inside the box 1, and the spiral plate 46 to spirally transport the plasma gathered at the lower end upward, breaking the airflow state and preventing the plasma from accumulating in a local area. This achieves a uniform distribution of airflow inside the box 1, while also increasing the contact frequency between the plasma and the outer surface of the injection bottle 3 and the bottle mouth sealing surface, thus improving the external sterilization efficiency, especially for dead corner areas such as the bottle mouth threads.

[0039] The sterilizing gas that generates plasma first contacts the top of the inner cavity of the injection vial 3, and then sinks along the space between the injection vial 3 and the gas delivery pipe 22. On the one hand, this facilitates the sterilizing gas filling the inner wall of the injection vial 3 for sterilization, reducing the generation of sterilization dead zones. On the other hand, as the gas continues to be filled, the gas is discharged from the lower gap between the chamber 1 and the injection vial 3. The sterilizing gas flows from the mouth of the injection vial 3, focusing on sterilizing the complex structure of the mouth. Then, the gas is simultaneously rotated through the air inlet pipe 41, the connecting plate 44, and the spiral plate 46. Due to the spiral angle design of the spiral plate 46, the gas is forced to flow axially (upward) while rotating, reducing the problem that the sterilizing gas cannot contact the vial body as much as possible due to sinking. This helps to strengthen the upward movement of the gas to sterilize the outer wall of the injection vial 3. Furthermore, if the spiral plate 46 stops rotating, the sinking sterilizing gas can contact the vial body of the injection vial 3 again for sterilization.

[0040] It should be noted that the density of air at room temperature and pressure is about 1.29 kg / m³, while the density of neutral gases used for sterilization plasma (such as argon) at room pressure is 1.78 kg / m³. After pressurization (such as 0.015-0.025 MPa), the density increases further. Even after ionization, it is still higher than that of air, so it is easy to sink in space.

[0041] Based on the above, other structures also need to be disclosed in detail. For example, during the rotation of the injection vial 3, in order to further ensure the stability of the rotation, as shown in Figure 8, the bottom surface of the connecting plate 44 and the vertically aligned position of the injection vial 3 are fixedly connected to the limiting cylinder 45. The top of the injection vial 3 is placed inside the limiting cylinder 45. The limiting cylinder 45 limits the position of the injection vial 3, preventing tilting or deviation during the rotation and revolution of the injection vial 3, and ensuring the consistency of the distance with the ultraviolet irradiator 43. At the same time, in order to further reduce the resistance of the limiting cylinder 45 to the rotation of the injection vial 3, the connecting plate 44 is placed inside the limiting cylinder. A ball bearing 451 is rolled on the bottom surface inside the limit cylinder 45. The bottom of the ball bearing 451 contacts the top of the injection bottle 3, converting the sliding friction between the top of the injection bottle 3 and the limit cylinder 45 into rolling friction, which greatly reduces the rotational resistance, ensures the stable rotational speed of the injection bottle 3, and prevents the top glass of the bottle from being scratched. An anti-wear strip 452 is fixedly connected to the lower end of the inner side of the limit cylinder 45. The inner side of the anti-wear strip 452 adopts an arc-shaped structure and contacts the outer surface of the injection bottle 3, further constraining radial displacement. The anti-wear strip 452 is made of food-grade silicone material, which has good lubricity and elasticity, reducing frictional resistance and preventing rigid contact from damaging the bottle body.

[0042] Based on the above embodiments, a sterilization method for sterilization equipment used in the production of landiolol hydrochloride injection is also provided. The specific steps are as follows: S1, Bottle loading: Start the pushing mechanism 12 to move the box cover 11 and the rotating mechanism 4 upward, open the box door, and place multiple injection bottles 3 with their mouths facing down on the outside of the air supply pipe 22. They are elastically clamped and fixed by the clamping plate 23 and the damping spring 24. Close the box door, and the pushing mechanism 12 drives the box cover 11 to move the rotating mechanism 4 downward, so that the locking block 42 is engaged. The slots on the rotating platform 21 complete the docking of the rotating mechanism 4 and the supporting mechanism 2; S2, Gas filling and pressurization: Neutral gas (such as argon) is supplied to the inlet pipe 41 through an external gas filling device. The gas enters the inner cavity of the rotating platform 21 through the inlet pipe 41 and is distributed to each pressurization valve 26. The pressurization valve 26 pressurizes the gas and fills the gas delivery pipe 22; S3, Medicine bottle rotation: The pressurized airflow impacts the turbine 25, causing the gas delivery pipe 22 and the injection bottle 3 to rotate, and the motor is started at the same time. 5. Through the meshing of the first gear 51 and the second gear 52, the rotating mechanism 4, the carrying mechanism 2, and the injection bottle 3 are driven to revolve around the central axis; S4. Cooperative sterilization: The ultraviolet irradiator 43 is activated to radiate ultraviolet light onto the injection bottle 3, and the plasma excitation electrode 27 is activated to ionize the airflow in the gas delivery pipe 22 into low-temperature plasma. The plasma flows down the bottle wall through the inverted conical vent in the baffle 273 to kill microorganisms inside the bottle. At the same time, it flows out from the bottle mouth to fill the box 1, killing microorganisms outside the bottle and inside the box 1. During the sterilization process, the spiral plate 46 disturbs the airflow to ensure uniform distribution of plasma; S5. Post-sterilization treatment: After the preset sterilization time (e.g., 15-20 minutes) is reached, the ultraviolet irradiator 43, the plasma excitation electrode 27, and the motor 5 are turned off in sequence to stop the gas filling. The exhaust valve is opened to release the pressure inside the box 1, and the push mechanism 12 drives the box cover 11 to move upward, opening the box door and removing the sterilized injection bottle 3 to complete the sterilization process.

[0043] The foregoing has shown and described the basic principles, main features, and advantages of the present invention. Those skilled in the art should understand that the present invention is not limited to the above embodiments. The embodiments and descriptions in the specification are merely preferred examples and are not intended to limit the invention. Various changes and modifications can be made to the invention without departing from its spirit and scope, and all such changes and modifications fall within the scope of the present invention as claimed. The scope of protection of the present invention is defined by the appended claims and their equivalents.

Claims

1. A sterilization device for the production of landiolol hydrochloride injection, comprising a housing (1), characterized in that: A supporting mechanism (2) is provided at the lower end of the inner cavity of the box (1), and a rotating mechanism (4) is provided at the top of the supporting mechanism (2). The supporting mechanism (2) includes a hollow rotating platform (21), and several air supply pipes (22) are connected above the rotating platform (21). An injection bottle (3) with its mouth facing downward is sleeved on the outside of the air supply pipe (22), and there is a space between the outer wall of the air supply pipe (22) and the inner wall of the injection bottle (3); the end of the air supply pipe (22) and the end of the inner cavity of the injection bottle (3) are connected. An upper gap is formed between the injection vial (3) and the rotating platform (21), and a lower gap is formed between them by a clamping assembly. The lower gap is used to connect the internal environment of the injection vial (3) and the external environment. The rotating mechanism (4) includes an air inlet pipe (41) that forms a gas delivery channel with the inner cavity of the rotating platform (21). A connecting plate (44) is fixedly installed on the outer wall of the air inlet pipe (41) near the top of the inner cavity of the box (1). A spiral plate (46) for delivering plasma from bottom to top is provided at the bottom of the connecting plate (44).

2. The sterilization equipment for producing landiolol hydrochloride injection according to claim 1, characterized in that: The box body (1) is provided with a box cover (11), and the box cover (11) is frame-shaped, with its outer side slidingly contacting the inner side of the box body (1); the bottom of the ear plates on both sides of the box cover (11) is fixedly connected to the output end of the push mechanism (12), and the top of the outer shell of the push mechanism (12) is fixedly connected to the bottom of the ear plates on both sides of the box body (1); the air inlet pipe (41) is rotatably connected to the inside of the box cover (11) and is the same as the central axis of the box cover (11).

3. The sterilization equipment for producing landiolol hydrochloride injection according to claim 1, characterized in that: The lower end of the rotating platform (21) is rotatably connected to the lower end of the inner cavity of the box (1). The bottom side of the air inlet pipe (41) is symmetrically fixed with a locking block (42). When the position of the air inlet pipe (41) in the box (1) is determined, the locking block (42) is engaged in the slot at the center of the top surface of the rotating platform (21). The top end of the air inlet pipe (41) is rotatably connected to the external gas filling device.

4. The sterilization equipment for producing landiolol hydrochloride injection according to claim 1, characterized in that: The clamping assembly includes clamps (23), and multiple clamps (23) are arranged in a ring around the air delivery tube (22) at the mouth of the injection vial (3); the clamps (23) are L-shaped, and the bottom end of the mouth of the injection vial (3) is placed on the lower horizontal surface of the clamps (23), with its outer side in contact with one side of the clamps (23); the side of the clamps (23) near the air delivery tube (22) is elastically connected to the air delivery tube (22) through multiple damping springs (24).

5. The sterilization equipment for producing landiolol hydrochloride injection according to claim 1, characterized in that: An ultraviolet irradiator (43) is fixedly connected to the outside of the air inlet pipe (41). The ultraviolet irradiator (43) is placed at the central axis formed by multiple injection bottles (3) and is equidistant from each injection bottle (3).

6. The sterilization equipment for producing landiolol hydrochloride injection according to claim 1, characterized in that: The bottom end of the air supply pipe (22) is rotatably connected to the top end of the rotating platform (21), and the internal channel of the air supply pipe (22) is connected to the inner cavity of the rotating platform (21). A turbine (25) is fixedly connected to the lower end of the inner side of the air supply pipe (22). A booster valve (26) is fixedly connected to the position in the inner cavity of the rotating platform (21) that is aligned with the central axis of the air supply pipe (22).

7. The sterilization equipment for producing landiolol hydrochloride injection according to claim 1, characterized in that: The top of the gas delivery pipe (22) is fixedly connected to a plasma excitation electrode (27) for generating plasma gas flow; the plasma excitation electrode (27) includes an outer electrode (271) and an inner electrode (272). The inner electrode (272) is placed inside the outer electrode (271) and is fixedly connected to the inner side of the outer electrode (271) by a support rod. The outer electrode (271) and the inner electrode (272) belong to the same axis. A baffle (273) is fixedly connected to the lower end of the outer side of the outer electrode (271). The diameter of the baffle (273) is adapted to the inner diameter of the injection bottle (3). A vent hole is provided inside the baffle (273). The inner diameter of the vent hole gradually decreases from top to bottom and forms an inverted cone shape.

8. The sterilization equipment for producing landiolol hydrochloride injection according to claim 1, characterized in that: The spiral plate (46) is placed outside the multiple injection bottles (3) and does not contact the injection bottles (3); the upper end of the outer side of the air inlet pipe (41) is fixedly connected to the second gear (52), the outer side of the second gear (52) is meshed with the first gear (51), the bottom end of the first gear (51) is fixedly connected to the output end of the motor (5), and the bottom of the outer side of the motor (5) is fixedly connected to the top of the box cover (11).

9. The sterilization equipment for producing landiolol hydrochloride injection according to claim 1, characterized in that: The bottom surface of the connecting plate (44) and the vertically aligned position of the injection bottle (3) are both fixedly connected to the limiting cylinder (45), and the top of the injection bottle (3) is placed inside the limiting cylinder (45); the bottom surface of the connecting plate (44) placed inside the limiting cylinder (45) is connected to a ball bearing (451) that rolls, and the bottom of the ball bearing (451) is in contact with the top of the injection bottle (3); the lower end of the inner side of the limiting cylinder (45) is fixedly connected to an anti-wear strip (452), and the inner side of the anti-wear strip (452) adopts an arc-shaped structure and is in contact with the outer surface of the injection bottle (3).

10. A sterilization method for a sterilization device used in the production of landiolol hydrochloride injection, applied to the sterilization device for the production of landiolol hydrochloride injection as described in any one of claims 1-9, characterized in that: The steps include: S1, Bottle loading: Start the push mechanism (12) to move the box cover (11) and the rotating mechanism (4) upward, open the box door, and place multiple injection bottles (3) with their mouths facing down on the outside of the gas delivery pipe (22). They are held and fixed by the clamp (23) and the damping spring (24) elastically. Close the box door, and the push mechanism (12) drives the box cover (11) to move the rotating mechanism (4) downward, so that the locking block (42) is locked into the slot of the rotating table (21), completing the docking of the rotating mechanism (4) and the bearing mechanism (2); S2, Gas filling and pressurization: Neutral gas (such as argon) is delivered to the gas inlet pipe (41) through the external gas filling device. The gas enters the inner cavity of the rotating table (21) through the gas inlet pipe (41) and is diverted to each pressurization valve (26). The pressurization valve (26) fills the gas delivery pipe (22) with the increased pressure; S3, Bottle rotation: After pressurization The airflow impacts the turbine (25), causing the air supply pipe (22) and the injection bottle (3) to rotate. At the same time, the motor (5) is started, and the first gear (51) and the second gear (52) mesh to drive the rotating mechanism (4), the bearing mechanism (2) and the injection bottle (3) to revolve around the central axis. S4, Co-sterilization: The ultraviolet irradiator (43) is started to radiate ultraviolet light onto the injection bottle (3). The plasma excitation electrode (27) is started to ionize the airflow in the air supply pipe (22) into low-temperature plasma. The plasma flows down the bottle wall through the inverted conical vent in the baffle (273) to kill the microorganisms in the bottle. At the same time, it flows out from the bottle mouth to fill the box (1) to kill the microorganisms outside the bottle and inside the box (1). During the sterilization process, the spiral plate (46) disturbs the airflow to ensure that the plasma is evenly distributed. S5, Post-sterilization treatment: The preset sterilization time (e.g., 15-20 minutes) is reached. After 1 minute, turn off the ultraviolet irradiator (43), plasma excitation electrode (27) and motor (5) in sequence, stop the gas filling, open the exhaust valve to release the pressure inside the box (1), push the mechanism (12) to drive the box cover (11) to move up, open the box door, remove the sterilized injection bottle (3), and complete the sterilization process.

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