Sterilizing and filtering equipment and method for multivitamins for injection

Abstract

The invention discloses degerming and filtering equipment and method for multivitamins for injection, and relates to the technical field of vitamin preparation.The degerming and filtering equipment is technically characterized in that the degerming and filtering equipment comprises a filtering box, the two sides of the filtering box are connected with a liquid inlet pipe and a liquid outlet pipe respectively, the liquid inlet pipe is connected with mixing equipment of multivitamin solutions, and the liquid outlet pipe is connected with filling equipment; a plurality of filling frames are arranged in the filter box, the filling frames are filled with filter units, the two faces of each filling frame are attached to each other, each filter unit is one of an activated carbon layer or a filter membrane, and the surface of each filter unit is coated with a silver ion antibacterial coating; according to the invention, the filtering efficiency and effect can be improved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of vitamin preparation, and particularly relates to a sterilization filtering device and method for multiple vitamins for injection. BACKGROUND

[0002] The multiple vitamins for injection (12) as parenteral nutrition intravenous injection solution occupies an important position in the field of clinical nutrition support. The formula is scientific and reasonable, and covers 9 kinds of water-soluble vitamins necessary for metabolism of adults and children over 11 years old except vitamin K, including vitamin B1, B2, B6, B12, vitamin C, nicotinamide, dexpanthenol, biotin and folic acid, and also contains 3 kinds of fat-soluble vitamins, namely vitamin A, D and E, which can provide comprehensive and balanced vitamin support for patients and meet the needs of vitamins in different physiological and pathological states. The parenteral nutrition drug market has great potential demand, and the multiple vitamins for injection (12) as an important parenteral nutrition supplement has a very broad market application prospect.

[0003] The multiple vitamins for injection (12) has many outstanding advantages, which makes it stand out in the market competition. First, it has strong stability, as a powder injection, it has a long shelf life, and when it is added to the parenteral nutrition liquid binary and ternary mixture, it can still maintain excellent stability, ensuring the quality and persistence of the product. Second, it has high safety, does not contain VK1, avoids interference with anticoagulant therapy during clinical use, and has few auxiliary materials, reducing some safety hazards caused by auxiliary materials, providing strong protection for the safety of patient medication. Compared with ordinary fat-soluble and water-soluble vitamins, its biggest feature is that fat-soluble vitamins and water-soluble vitamins can be dissolved in the same container, which can maintain its injectable properties in the final preparation while being preserved, better meeting different clinical needs. At present, the products directly competing with the product are water-soluble vitamins for injection, fat-soluble vitamins for injection and multiple vitamins for injection (13), but the market share of the product has been increasing year by year, and it has gradually replaced the former two, occupying an important position in the field of intravenous vitamin supplements. Internationally, the product was first marketed in Germany in 1992, and was imported into China on October 29, 1999. The holder of the certificate is Baxter S.A., the specification is 5ml / branch, and the trade name is Schinivit® / Cernevit®.

[0004] In existing technologies for the preparation of injectable multivitamins, sterilization filtration is a crucial and indispensable step. Its main purpose is to thoroughly remove various microorganisms, such as bacteria and fungi, from the formulation, thereby ensuring the sterility of the final product, protecting patient safety, and preventing serious adverse reactions such as infections caused by microbial contamination. Currently, commonly used sterilization filtration methods in the industry mainly rely on specific filter membrane materials. These membranes have specific pore sizes that can intercept microorganisms larger than the pore size while allowing small molecules such as vitamin solutions to pass through. However, existing sterilization filtration methods have revealed many problems in practical applications, and there is significant room for improvement in both efficiency and effectiveness. Summary of the Invention

[0005] In order to at least solve one of the above-mentioned technical problems, the present invention aims to provide a sterilization filtration device and method for injectable multivitamins, thereby improving the efficiency and effectiveness of filtration.

[0006] To achieve the above objectives, the present invention provides the following technical solution:

[0007] A sterilization filtration device for injectable multivitamins includes a filter box with an inlet pipe and an outlet pipe connected to both sides of the filter box. The inlet pipe is connected to a mixing device for the multivitamin solution, and the outlet pipe is connected to a filling device. The filter box contains multiple filling frames, each filled with a filter unit. The multiple filling frames are bonded together on both sides. The filter unit is either an activated carbon layer or a filter membrane, and the surface of the filter unit is coated with a silver ion antibacterial coating.

[0008] Preferably, the filling frame includes a fixed mesh frame and a movable mesh plate, the movable mesh plate is hinged to the fixed mesh frame, the other end of the movable mesh plate is provided with a locking plate, and the fixed mesh frame is provided with a locking groove adapted to the locking plate.

[0009] Preferably, the filter box is cylindrical, and the end of the filter box near the liquid inlet pipe is provided with an internally threaded end cap. The outer wall of one end of the filter box is provided with an external thread, which is threadedly matched with the internally threaded end cap. The internally threaded end cap is fixedly connected to the liquid inlet pipe.

[0010] Preferably, both the inlet pipe and the outlet pipe are equipped with flow valves, and the inlet pipe is equipped with a booster pump.

[0011] Preferably, a pressure sensor is installed inside the filter box, and a control unit is fixedly connected to the outer wall of the filter box. The pressure sensor controls the output power of the booster pump through the control unit and according to a preset pressure threshold.

[0012] Preferably, the material of the filter membrane is at least one of polyvinylidene fluoride, polyether sulfone and polypropylene.

[0013] A sterilization filtering method for multi-vitamin injection, comprising the following steps:

[0014] Start the mixing device to mix the multi-vitamin raw materials sufficiently to prepare a multi-vitamin solution;

[0015] Start the booster pump to pump the multi-vitamin solution into the filter box through the liquid inlet pipe;

[0016] The multi-vitamin solution flows through the filter units in the filling frames in sequence, the silver ion antibacterial coating on the surface of the filter units preliminarily inhibits and kills the bacteria in the solution, and the activated carbon layer or filter membrane adsorbs or intercepts the impurities and microorganisms in the solution to achieve sterilization filtering;

[0017] The filtered multi-vitamin solution is transported to the filling device through the liquid outlet pipe for filling.

[0018] The present application has the following advantages:

[0019] I. Improve the filtering efficiency and effect: In the sterilization filtering device of the present application, a plurality of filling frames are arranged in the filter box, the filling frames are filled with filter units such as activated carbon layers or filter membranes, and the two surfaces of the plurality of filling frames are in close contact with each other. This structure increases the filtering area, and the multi-vitamin solution flows through the plurality of filter units in sequence in the filter box, so that the impurities and microorganisms in the solution can be more fully adsorbed or intercepted, thereby improving the filtering effect. At the same time, the booster pump on the liquid inlet pipe increases the pressure of the solution entering the filter box, promotes the rapid passage of the solution through the filter units, and accelerates the filtering speed, thereby improving the filtering efficiency. The silver ion antibacterial coating on the surface of the filter unit can preliminarily inhibit and kill the bacteria in the solution during the filtering process, further improving the effect of sterilization filtering.

[0020] II. Facilitate the replacement and maintenance of the filter units: The filling frame adopts a design in which a fixed mesh frame is hinged to a movable mesh plate, and a clamping plate is arranged at the other end of the movable mesh plate, and a clamping groove matching the clamping plate is formed on the fixed mesh frame. This structure allows the movable mesh plate to be easily opened and closed, and when the filter units (activated carbon layers or filter membranes) need to be replaced or maintained, the movable mesh plate can be opened to easily remove and replace the filter units, which is simple to operate, saves time and labor cost, and improves the maintainability of the device.

[0021] III. Convenient Cleaning and Maintenance of the Filter Box: The filter box is cylindrical, with an internally threaded end cap near the inlet pipe. An external thread is located on the outer wall of one end of the filter box, matching the thread of the internally threaded end cap, which is then fixedly connected to the inlet pipe. This threaded connection allows for easy disassembly and assembly of the filter box. When cleaning or maintenance is required, simply unscrew the internally threaded end cap to open the filter box and perform a thorough cleaning and inspection, ensuring the cleanliness and normal operation of the equipment.

[0022] IV. Precise Control of the Filtration Process: Flow valves are installed on both the inlet and outlet pipes to precisely control the flow rate of various vitamin solutions, ensuring the stability and consistency of the filtration process. A pressure sensor is installed inside the filter chamber, and a control unit is fixedly connected to the outer wall of the filter chamber. The pressure sensor, through the control unit and based on a preset pressure threshold, controls the output power of the booster pump. This intelligent control system can automatically adjust the power of the booster pump according to the actual pressure inside the filter chamber, keeping the filtration process under optimal pressure conditions, thus improving the quality and reliability of filtration.

[0023] V. Synergistic Effect of Multiple Filtration Methods: In the sterilization filtration method of this invention, the silver ion antibacterial coating on the surface of the filter unit initially inhibits and kills bacteria in the solution, while the activated carbon layer or filter membrane adsorbs or intercepts impurities and microorganisms in the solution. The silver ion antibacterial coating and the activated carbon layer or filter membrane work together to form a multi-layered sterilization filtration system. The silver ion antibacterial coating first pre-treats the bacteria, reducing their number and lowering the burden on subsequent filtration units; the activated carbon layer or filter membrane further adsorbs or intercepts the remaining impurities and microorganisms, ensuring that the final filtered multivitamin solution meets sterility requirements. This synergistic effect of multiple filtration methods greatly improves the efficiency and reliability of sterilization filtration. Attached Figure Description

[0024] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of the present invention and should not be regarded as a limitation on the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0025] Fig. 1 This is a cross-sectional view of an embodiment of the present invention.

[0026] Fig. 2 This is a disassembly and assembly diagram of an embodiment of the present invention.

[0027] Fig. 3 This is an unfolded view of the filling frame according to an embodiment of the present invention.

[0028] In the diagram: 1. Filter box; 101. Internal threaded end cap; 201. Inlet pipe; 202. Outlet pipe; 203. Booster pump; 204. Flow valve; 3. Filler frame; 301. Fixed mesh frame; 302. Movable mesh plate; 303. Clamping plate; 401. Activated carbon layer; 402. Filter membrane; 501. Pressure sensor; 502. Control unit. 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] like Figs. 1 to 3 As shown, a sterilization filtration device for injectable multivitamins includes a filter box 1. An inlet pipe 201 and an outlet pipe 202 are respectively connected to both sides of the filter box 1. The inlet pipe 201 is connected to a mixing device for multivitamin solutions, and the outlet pipe 202 is connected to a filling device. Multiple filling frames 3 are provided inside the filter box 1, and filter units are filled inside the filling frames 3. The multiple filling frames 3 are attached to each other on both sides. The filter unit is one of an activated carbon layer 401 or a filter membrane 402, and the surface of the filter unit is coated with a silver ion antibacterial coating.

[0031] like Figs. 1 to 3 As shown, after the various vitamin raw materials are thoroughly mixed in the mixing equipment to prepare a multivitamin solution, the multivitamin solution enters the filter box 1 through the inlet pipe 201, which is connected to the mixing equipment, under the action of gravity or the output pressure of the mixing equipment (if there is a related power device to push the solution out). After entering the filter box 1, the solution first comes into contact with the silver ion antibacterial coating on the surface of the filter unit. Silver ions have broad-spectrum antibacterial properties. The mechanism of action is mainly that silver ions bind to proteins on the surface of bacterial cell membranes, destroying the structure and function of bacterial cell membranes and causing substances inside the bacterial cells to flow out. At the same time, silver ions can also enter the bacterial cells and bind to enzyme proteins inside the bacteria, inhibiting key physiological processes such as bacterial respiration and metabolism, thereby achieving a preliminary inhibitory and killing effect on bacteria in the solution.

[0032] After initial sterilization, the solution continues to flow within the filter chamber 1, sequentially passing through multiple filter units within the packed frames 3. If the filter unit is an activated carbon layer 401, the activated carbon, with its numerous microporous structures and large specific surface area, can adsorb impurities, microorganisms, and some organic matter in the solution through physical adsorption. If the filter unit is a filter membrane 402, depending on the pore size of the membrane 402, microorganisms and impurities larger than the pore size will be intercepted on the surface of the membrane 402, while small molecules such as vitamin solutions smaller than the pore size can pass through the membrane 402, achieving deep filtration for sterilization and impurity removal. The multiple packed frames 3 are bonded together on both sides, increasing the contact area between the filter unit and the solution and the filtration path, thus improving the filtration effect. After deep filtration and impurity adsorption by the filter units, the multivitamin solution is transported to the filling equipment through the outlet pipe 202 for filling, ultimately yielding a sterile injectable multivitamin product.

[0033] like Figs. 1 to 3 As shown, the filling frame 3 includes a fixed mesh frame 301 and a movable mesh plate 302. The movable mesh plate 302 is hinged to the fixed mesh frame 301, and a locking plate 303 is provided at the other end of the movable mesh plate 302. The fixed mesh frame 301 has a locking groove that matches the locking plate 303. This design allows the movable mesh plate 302 to rotate around the hinge point. When it is necessary to install or replace the filter unit (activated carbon layer 401 or filter membrane 402), the movable mesh plate 302 is opened around the hinge point, the filter unit is placed in the fixed mesh frame 301, and then the movable mesh plate 302 is rotated back to its original position, so that the locking plate 303 on the movable mesh plate 302 is engaged in the locking groove on the fixed mesh frame 301, thereby achieving a fixed connection between the movable mesh plate 302 and the fixed mesh frame 301, and thus firmly fixing the filter unit in the filling frame 3. Multiple such filling frames 3 are placed inside the filter box 1 with their two sides attached to each other, which can increase the contact area between the filter unit and the multivitamin solution and improve the filtration efficiency.

[0034] like Figs. 1 to 3As shown, the filter box 1 is cylindrical. One end of the filter box 1 near the inlet pipe 201 is fitted with an internally threaded end cap 101. The outer wall of one end of the filter box 1 has external threads that mate with the threads of the internally threaded end cap 101. The internally threaded end cap 101 is fixedly connected to the inlet pipe 201. The cylindrical design of the filter box 1 facilitates uniform solution flow within the box, reducing dead zones. The internally threaded end cap 101, fixedly connected to the inlet pipe 201, and the external threads on the outer wall of one end of the filter box 1 mate with the threads of the internally threaded end cap 101, allow for cleaning, maintenance, or replacement of the filter unit inside the filter box 1. The internally threaded end cap 101 is rotated to separate from the external threads on the outer wall of the filter box 1, thus opening the filter box 1. After the operation is complete, the internally threaded end cap 101 is tightened to seal the filter box 1, preventing solution leakage and the entry of external microorganisms. The booster pump 203 installed on the inlet pipe 201 can provide additional pressure for the multivitamin solution, enabling the solution to enter the filter box 1 at a certain flow rate and pressure, accelerating the flow speed of the solution in the filter unit and improving filtration efficiency. Flow valves 204 installed on both the inlet pipe 201 and the outlet pipe 202 can precisely control the inflow and outflow of the solution. By adjusting the opening of the flow valves 204, the flow rate of the solution entering and exiting the filter box 1 can be kept stable, ensuring the stability and consistency of the filtration process and preventing excessive flow fluctuations from affecting the filtration effect.

[0035] like Figs. 1 to 3 As shown, both the inlet pipe 201 and the outlet pipe 202 are equipped with flow valves 204, and the inlet pipe 201 is equipped with a booster pump 203. The booster pump 203 on the inlet pipe 201 can provide additional pressure for the multivitamin solution, allowing the solution to enter the filter box 1 at a certain flow rate and pressure, accelerating the flow speed of the solution in the filtration unit and improving filtration efficiency. The flow valves 204 on both the inlet pipe 201 and the outlet pipe 202 can precisely control the inflow and outflow of the solution. By adjusting the opening of the flow valves 204, the flow rate of the solution entering and leaving the filter box 1 can be kept stable, ensuring the stability and consistency of the filtration process and avoiding the impact of excessive flow fluctuations on the filtration effect.

[0036] like Figs. 1 to 3As shown, a pressure sensor 501 is installed inside the filter box 1, and a control unit 502 is fixedly connected to the outer wall of the filter box 1. The pressure sensor 501 controls the output power of the booster pump 203 through the control unit 502 and according to a preset pressure threshold. The pressure sensor 501, located inside the filter box 1, can sense the pressure of the multivitamin solution inside the filter box 1 in real time. It converts the detected pressure signal into an electrical signal and transmits it to the control unit 502 fixedly connected to the outer wall of the filter box 1. The control unit 502 has a preset pressure threshold. When the actual pressure value corresponding to the pressure signal from the pressure sensor 501 is lower than the preset pressure threshold, the control unit 502 sends a command to the booster pump 203 to increase its output power. Upon receiving the command, the booster pump 203 accelerates its motor speed, thereby increasing the pressurization effect on the solution and raising the pressure inside the filter box 1. Conversely, when the actual pressure value is higher than the preset pressure threshold, the control unit 502 sends a command to the booster pump 203 to decrease its output power. The booster pump 203 slows down its motor speed, reducing the pressurization effect on the solution and lowering the pressure inside the filter box 1. In this way, the pressure inside the filter box 1 can be maintained within a suitable range, which is beneficial to the stable operation of the filtration process and improves the filtration effect.

[0037] The filter membrane 402 is made of at least one of polyvinylidene fluoride, polyethersulfone, and polypropylene.

[0038] When the filter membrane 402 is made of polyvinylidene fluoride (PVDF), PVDF possesses excellent chemical stability, heat resistance, and mechanical strength. Its compact molecular structure and uniform pore size distribution effectively intercept microorganisms, impurities, and other particulate matter in multivitamin solutions, while allowing small molecules such as vitamins to pass through, achieving the purpose of filtration, sterilization, and impurity separation. If the filter membrane 402 is made of polyethersulfone (PES), PES exhibits excellent chemical corrosion resistance, thermal stability, and good film-forming properties. Its pore size can be precisely controlled according to the manufacturing process, selectively filtering substances of different sizes in the solution, effectively retaining microorganisms and impurities, and ensuring the purity of the filtered multivitamin solution. When the filter membrane 402 is made of polypropylene (PP), polypropylene is relatively inexpensive and possesses certain chemical stability and mechanical properties. Its 402 filter membrane can be formed into membrane layers with different pore sizes and structures through different processing methods, providing some filtration for larger particulate impurities and some microorganisms in the solution, meeting general filtration needs. When the filter membrane 402 is made of at least one of these three materials, the appropriate material or combination of materials can be selected to make the filter membrane 402 according to the actual filtration requirements and considerations such as cost.

[0039] The above are merely specific embodiments of the present invention, but the technical features of the present invention are not limited thereto. Any simple changes, equivalent substitutions, or modifications made based on the present invention to solve essentially the same technical problems and achieve essentially the same technical effects are all covered within the protection scope of the present invention.

Claims

1. A bacteria-removing filter apparatus for a multi-vitamin injection, characterized by, The application relates to a filter box (1) which is connected with an inlet pipe (201) and an outlet pipe (202) on two sides, the inlet pipe (201) is connected with a mixing device of multiple vitamin solutions, the outlet pipe (202) is connected with a filling device, multiple filling frames (3) are arranged in the filter box (1), the filling frames (3) are filled with filter units, the filter units are one of activated carbon layers (401) or filter membranes (402), and the surfaces of the filter units are coated with silver ion antibacterial coating.

2. The apparatus for bacteria removal filtration of multivitamin for injection according to claim 1, characterized in that, The filling frame (3) comprises a fixed net frame (301) and a movable net plate (302), the movable net plate (302) is hinged to the fixed net frame (301), a clamping plate (303) is arranged at the other end of the movable net plate (302), and a clamping groove matched with the clamping plate (303) is formed in the fixed net frame (301).

3. The apparatus for bacteria removal filtration of multivitamin for injection according to claim 2, characterized in that, The filter box (1) is in a cylindrical shape, one end of the filter box (1) close to the inlet pipe (201) is provided with an internally-threaded end cover (101), an external thread is arranged on the outer wall of one end of the filter box (1), the external thread is threadedly matched with the internally-threaded end cover (101), and the internally-threaded end cover (101) is fixedly connected with the inlet pipe (201).

4. The apparatus for bacteria removal filtration of multivitamin for injection according to claim 4, characterized in that, Flow valves (204) are arranged on the inlet pipe (201) and the outlet pipe (202), and a booster pump (203) is arranged on the inlet pipe (201).

5. The apparatus for bacteria removal filtration of multivitamin for injection according to claim 4, characterized in that, A pressure sensor (501) is arranged in the filter box (1), a control unit (502) is fixedly connected to the outer wall of the filter box (1), the pressure sensor (501) controls the output power of the booster pump (203) through the control unit (502) and according to a preset pressure threshold.

6. The apparatus for bacteria removal filtration of multivitamin for injection according to claim 5, characterized by, The filter membrane (402) is made of at least one of polyvinylidene fluoride, polyether sulfone and polypropylene.

7. A method for sterilizing filtration of a multivitamin for injection using the multivitamin for injection sterilizing filtration apparatus according to any one of claims 1 to 9, characterized by, The application further discloses a preparation method of the multiple vitamin solution. The multiple vitamin raw materials are mixed by starting the mixing device to prepare the multiple vitamin solution. The multiple vitamin solution is pumped into the filter box (1) through the inlet pipe (201) by starting the booster pump (203). The multiple vitamin solution flows through the filter units in the filling frames (3) in sequence, the silver ion antibacterial coating on the surfaces of the filter units preliminarily inhibits and kills bacteria in the solution, and the activated carbon layers (401) or the filter membranes (402) adsorb or intercept impurities and microorganisms in the solution to realize bacterium-removing filtration. The filtered multiple vitamin solution is delivered to the filling device through the outlet pipe (202) for filling.

Images