Preparation device and preparation method of multivitamins for injection

Abstract

The invention discloses a preparation device and a preparation method of multivitamins for injection, and relates to the technical field of vitamin preparation, and the technical key points are as follows: the preparation device comprises a nitrogen charging device for supplying nitrogen; the first liquid preparation tank is communicated with the nitrogen charging device, is internally provided with a heating assembly and is used for preparing oxygen-free injection water; the second liquid preparation tank is communicated with the nitrogen charging device, a second stirring assembly is arranged in the second liquid preparation tank, and fat-soluble vitamins and the like are mixed to prepare a micelle solution; a third stirring assembly is arranged in the third liquid preparation tank, and a fat-soluble vitamin solution is independently prepared; a fourth stirring assembly is arranged in the fourth liquid preparation tank, and the fourth liquid preparation tank is used for preparing a water-soluble vitamin solution and is connected with the second liquid preparation tank; the PH adjusting device is connected with the fourth liquid preparation tank; the injection water supply device is arranged between the first liquid preparation tank and the fourth liquid preparation tank and is used for supplementing water and fixing the volume; the degerming and filtering device is connected with a liquid outlet of the fourth liquid preparation tank and filling equipment; according to the invention, convenience can be ensured, and efficiency and automation degree are improved.

Description

Technical Field

[0001] This invention relates to the field of vitamin preparation technology, and in particular to an apparatus and method for preparing injectable multivitamins. Background Technology

[0002] Multivitamins for injection (12) play an irreplaceable and important role in clinical nutritional support as an intravenous parenteral nutrition solution. Their scientifically formulated formula covers nine water-soluble vitamins (including vitamins B1, B2, B6, B12, vitamin C, nicotinamide, dextropanthenol, biotin, and folic acid) and three fat-soluble vitamins (vitamins A, D, and E) essential for metabolism in adults and children over 11 years of age, excluding vitamin K. This provides comprehensive and balanced vitamin support to meet the vitamin needs of patients under different physiological and pathological conditions. In my country, malnutrition is a prominent problem among hospitalized patients, with an incidence rate ranging from 30% to 55%. This rate is even higher in critically ill patients, reaching as high as 80%. For example, the incidence of severe malnutrition among cancer patients hospitalized in tertiary hospitals is 58%, and the total incidence, including mild malnutrition, is as high as 80%. However, only 31% of malnourished patients receive nutritional therapy, and over 50% of severely malnourished patients do not receive nutritional therapy. This indicates that the market demand for parenteral nutrition drugs in my country has huge potential, and injectable multivitamins (12) have broad market application prospects as an important parenteral nutrition supplement.

[0003] Injectable multivitamins (12) have many significant advantages that make them stand out in the market competition. First, they are highly stable. As a powder injection preparation, they have a long shelf life and can maintain excellent stability when added to binary or ternary mixtures of parenteral nutrition solutions, ensuring the quality and longevity of the product's efficacy. Second, they are highly safe. They do not contain VK1, which avoids interference with anticoagulation therapy during clinical use. At the same time, they contain fewer excipients, reducing some safety hazards caused by excipients and providing strong protection for patients' medication safety. 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 their injectability in the final preparation while being preserved, better meeting different clinical needs. At present, the main products that directly compete with this product are water-soluble vitamins for injection, fat-soluble vitamins for injection, and multivitamins for injection (13), but the market share of this 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.

[0004] From the market sales data, injectable multivitamins (12) have performed strongly. According to statistics from Yaozhi.com, its domestic sales in 2023 were RMB 1.848 billion; according to data from Menet.com, its market sales in public medical institutions in the three major terminals of cities, counties, communities and townships in my country in 2023 were approximately RMB 2.05 billion. Moreover, the product was included in the National Medical Insurance Catalog on December 28, 2020, which will further benefit its market expansion and consolidate its market position in the field of intravenous vitamin supplements. Internationally, this product was first launched in Germany in 1992, and the original research was imported into China on October 29, 1999. The licensee is Baxter S.A., the specification is 5ml / vial, and the trade name is Cernevit®. As of January 13, 2025, however, the existing technical solutions for the preparation of injectable multivitamins are not convenient enough, and the degree of automation and efficiency need to be improved. Summary of the Invention

[0005] In order to at least solve one of the above-mentioned technical problems, the present invention aims to provide an apparatus and method for preparing injectable multivitamins, which ensures convenience and improves efficiency and automation.

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

[0007] An apparatus for preparing injectable multivitamins, comprising:

[0008] A nitrogen purging device is used to supply nitrogen gas.

[0009] The first liquid preparation tank is connected to the nitrogen filling device and is equipped with a heating component. The first liquid preparation tank is used to prepare oxygen-free water for injection.

[0010] The second mixing tank is connected to the nitrogen filling device. The second mixing tank is equipped with a second stirring assembly. The second mixing tank is used to mix fat-soluble vitamins, micelle carriers and sodium hydroxide to prepare a micelle solution.

[0011] The third mixing tank is equipped with a third stirring assembly and is used to prepare fat-soluble vitamin solutions separately.

[0012] A fourth mixing tank is provided with a fourth stirring assembly. The fourth mixing tank is used to prepare water-soluble vitamin solutions. The fourth mixing tank is connected to the second mixing tank through a pipeline.

[0013] The pH adjustment device is connected to the fourth liquid preparation tank via a pipeline;

[0014] A water-for-injection supply device is installed between the first and fourth mixing tanks and is used to replenish and adjust the volume of water-soluble vitamin solutions.

[0015] The sterilization filtration device is used to connect the outlet of the fourth liquid preparation tank to a filling device.

[0016] Preferably, the heating assembly includes an electric heating tube disposed in a first liquid mixing tank, a temperature sensor disposed in the first liquid mixing tank, and a first control unit disposed on the outer wall of the first liquid mixing tank. The temperature sensor controls the output power of the electric heating tube through the first control unit and according to a preset boiling temperature.

[0017] Preferably, a first electromagnetic control valve is provided on the top of the first liquid preparation tank, and a pressure sensor is provided inside the first liquid preparation tank. The pressure sensor controls the opening and closing of the first electromagnetic control valve through a first control unit and according to a preset exhaust pressure.

[0018] Preferably, the fat-soluble vitamins include vitamin A palmitate, vitamin D3, and racemic α-tocopherol; the micelle carriers include soybean lecithin and glycocholic acid; and the water-soluble vitamin solution includes vitamin C, B vitamins, and folic acid.

[0019] Preferably, the pH adjustment device includes an acidic buffer solution tank and an alkaline buffer solution tank connected to the fourth mixing tank. The acidic buffer solution tank and the alkaline buffer solution tank are respectively connected to the top of the fourth mixing tank through independent buffer tubes. A fourth electromagnetic control valve is installed on the buffer tube. A pH meter is installed inside the fourth mixing tank. A fourth control unit is installed outside the fourth mixing tank. The pH meter controls the two fourth electromagnetic control valves to close or open according to a preset pH value through the fourth control unit.

[0020] Preferably, the water for injection supply device includes a water supply pipe, the two ends of which are respectively connected to a first liquid preparation tank and a fourth liquid preparation tank, and the water supply pipe is equipped with a water supply control valve and a water supply pump.

[0021] Preferably, the sterilization and filtration device includes a filter box, and the filter box is provided with a sterilization layer and a filtration layer.

[0022] Preferably, the sterilization layer is a silver ion nonwoven fabric layer, and the filter layer is an activated carbon layer.

[0023] Preferably, the second, third, and fourth stirring components have the same structure, each including a stirring motor, and the output shaft of the stirring motor is fixedly connected to stirring blades.

[0024] A method for preparing injectable multivitamins includes the following steps:

[0025] Step 1: Preparation of oxygen-free water for injection: Turn on the nitrogen filling device to fill the first solution tank with nitrogen gas. At the same time, start the heating component in the first solution tank. The heating component controls the output power according to the preset boiling temperature to heat the water in the first solution tank to boiling. The pressure sensor in the first solution tank monitors the pressure in real time. When the pressure reaches the preset exhaust pressure, the first control unit controls the first electromagnetic control valve to open to exhaust gas, so as to maintain a stable pressure environment in the tank, thereby preparing oxygen-free water for injection.

[0026] Step 2: Preparation of micelle solution: Turn on the nitrogen filling device to fill the second liquid preparation tank with nitrogen gas, add the fat-soluble vitamins and micelle carrier to the second liquid preparation tank, start the second stirring component to stir and mix, and prepare a micelle solution;

[0027] Step 3: Preparation of fat-soluble vitamin solution: Add fat-soluble vitamins to the third mixing tank, start the third stirring component to stir, and prepare fat-soluble vitamin solution separately;

[0028] Step 4: Prepare water-soluble vitamin solution: Add water-soluble vitamins to the fourth mixing tank, start the fourth stirring component to stir, and at the same time add the micelle solution from the second mixing tank to the fourth mixing tank through the pipeline to mix with the water-soluble vitamin solution;

[0029] Step 5: Adjust pH value: The pH meter detects the pH value of the solution in the fourth mixing tank in real time and transmits the detection data to the fourth control unit. When the pH value deviates from the preset value, the fourth control unit controls the fourth electromagnetic control valve corresponding to the acid buffer solution tank or alkaline buffer solution tank to open according to the preset pH value, and adds the corresponding buffer solution to the fourth mixing tank until the solution pH value reaches the preset value.

[0030] Step 6, replenish water and adjust volume: turn on the water supply control valve and water supply pump, and transport the oxygen-free water for injection in the first solution tank to the fourth solution tank through the water supply pipe, and replenish water and adjust volume in the fourth solution tank.

[0031] Step 7, Sterilization Filtration and Filling: The solution in the fourth preparation tank passes through the filter box of the sterilization filtration device, and is sterilized by passing through the silver ion non-woven fabric layer and filtered by the activated carbon layer in sequence. Then it enters the filling equipment for filling. Subsequently, it undergoes freeze drying, nitrogen refilling and capping, packaging and other operations to finally obtain the injectable multivitamin product.

[0032] The present invention has the following beneficial effects:

[0033] I. Rational Apparatus Design: The preparation apparatus of this invention includes multiple specially designed dispensing tanks. For example, the first dispensing tank is used to prepare anaerobic water for injection, the second dispensing tank is used to prepare micellar solutions, the third dispensing tank is used to prepare fat-soluble vitamin solutions separately, and the fourth dispensing tank is used to prepare water-soluble vitamin solutions. Each dispensing tank has a clear function and a clear operating procedure, making the entire preparation process orderly and convenient for operators to follow the steps, thus improving the ease of preparation.

[0034] II. Precise Automated Control: Multiple stages of the preparation process are automated. For example, a temperature sensor and a first control unit are installed in the first mixing tank. The temperature sensor, through the first control unit and based on a preset boiling temperature, controls the output power of the heating element, precisely controlling the water heating temperature. A pressure sensor, through the first control unit and based on a preset exhaust pressure, controls the opening and closing of the first electromagnetic control valve, maintaining a stable pressure environment within the tank. In the pH adjustment device, the pH meter, through the fourth control unit and based on a preset pH value, controls the opening and closing of the fourth electromagnetic control valve corresponding to the acidic or alkaline buffer solution tank, precisely adjusting the solution's pH value. These automated controls reduce errors and complexity associated with manual operation, further ensuring the convenience of the preparation process.

[0035] III. Parallel Operation of Multiple Steps: Multiple steps can be performed simultaneously during the preparation process. For example, while preparing oxygen-free water for injection, nitrogen can be introduced into the second mixing tank via a nitrogen purging device to prepare the micelle solution. Simultaneously, fat-soluble vitamins can be added to the third mixing tank, and the third stirring assembly can be activated to prepare the fat-soluble vitamin solution separately. This parallel operation of multiple steps significantly shortens the overall preparation time and improves preparation efficiency.

[0036] IV. Rapid Water Replenishment and Volume Adjustment: The water-for-injection supply device includes a water supply pipe, with its two ends connected to the first and fourth mixing tanks, respectively. The water supply pipe is equipped with a water supply control valve and a water supply pump. By activating the water supply control valve and the water supply pump, the oxygen-free water for injection in the first mixing tank can be quickly delivered to the fourth mixing tank, replenishing and adjusting the volume of the solution in the fourth mixing tank. This saves replenishment time and improves overall preparation efficiency.

[0037] V. Fully Automated Process: From the preparation of oxygen-free water for injection to subsequent steps such as micellar solution preparation, fat-soluble vitamin solution preparation, water-soluble vitamin solution preparation, pH adjustment, water replenishment and volume adjustment, as well as sterilization filtration and filling, all processes are automated through corresponding devices and control systems. The entire preparation process requires minimal manual intervention; simply setting the relevant parameters allows the device to operate automatically according to a preset program, significantly improving the level of automation.

[0038] VI. Intelligent Monitoring and Control: The device is equipped with various sensors, such as temperature sensors, pressure sensors, and pH meters. These sensors can monitor various parameters during the preparation process in real time and transmit the data to the corresponding control unit. The control unit intelligently controls and adjusts the preparation process according to preset values, ensuring that each step is carried out under optimal conditions, further improving the degree of automation and preparation quality.

[0039] VII. Stable Fusion of Multiple Vitamins: The preparation method of this invention, through specific steps and apparatus design, can stably fuse fat-soluble and water-soluble vitamins together. In the preparation process, fat-soluble vitamins are first prepared into micellar solutions or individual fat-soluble vitamin solutions, then mixed with water-soluble vitamin solutions, and finally subjected to a series of treatments to obtain an injectable multivitamin product. This unique combination method ensures the stability of the multiple vitamins in the product, maintaining their injectability in the final formulation while preserving them, thus better meeting diverse clinical needs.

[0040] 8. High-efficiency sterilization filtration ensures quality: The sterilization filtration device includes a filter box containing a layer of silver ion non-woven fabric and an activated carbon layer. When the solution passes through the silver ion non-woven fabric layer, the silver ions exert their antibacterial effect, effectively killing bacteria in the solution. Further filtration through the activated carbon layer removes impurities and odors, ensuring product quality and safety. This unique sterilization filtration combination provides strong assurance for the quality of injectable multivitamin products. Attached Figure Description

[0041] 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.

[0042] Fig. 1 This is a front view of an embodiment of the present invention.

[0043] Fig. 2 This is a cross-sectional view of the fourth liquid preparation tank according to an embodiment of the present invention.

[0044] Fig. 3 This is a cross-sectional view of the first liquid preparation tank according to an embodiment of the present invention.

[0045] Fig. 4 This is a cross-sectional view of the sterilization and filtration device according to an embodiment of the present invention.

[0046] In the diagram: 1. Nitrogen purging device; 2. First mixing tank; 201. Heating element; 202. Temperature sensor; 203. First control unit; 204. First electromagnetic control valve; 205. Pressure sensor; 3. Second mixing tank; 4. Third mixing tank; 5. Fourth mixing tank; 501. Acidic buffer solution tank; 502. Alkaline buffer solution tank; 503. Buffer tubing; 504. Fourth electromagnetic control valve; 505. pH meter; 506. Fourth control unit; 601. Stirring motor; 602. Stirring blades; 701. Water supply pipe and water supply control valve; 702. Water supply pump; 801. Filter box; 802. Silver ion non-woven fabric layer; 803. Activated carbon layer; 9. Filling equipment. Detailed Implementation

[0047] 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.

[0048] like Figs. 1 to 4 As shown, an apparatus for preparing injectable multivitamins includes:

[0049] Nitrogen purging device 1 is used to supply nitrogen gas;

[0050] First liquid preparation tank 2 is connected to nitrogen filling device 1. Heating component is installed in first liquid preparation tank 2. First liquid preparation tank 2 is used to prepare oxygen-free water for injection.

[0051] The second mixing tank 3 is connected to the nitrogen filling device 1. The second mixing tank 3 is equipped with a second stirring component. The second mixing tank 3 is used to mix fat-soluble vitamins, micelle carriers and sodium hydroxide to prepare a micelle solution.

[0052] The third mixing tank 4 is equipped with a third stirring component and is used to prepare fat-soluble vitamin solutions separately.

[0053] The fourth mixing tank 5 is equipped with a fourth stirring component. The fourth mixing tank 5 is used to prepare water-soluble vitamin solutions. The fourth mixing tank 5 is connected to the second mixing tank 3 through a pipe.

[0054] The pH adjustment device is connected to the fourth mixing tank 5 via a pipeline;

[0055] A water-for-injection supply device is installed between the first mixing tank 2 and the fourth mixing tank 5, and is used to replenish water and adjust the volume of the water-soluble vitamin solution.

[0056] The sterilization filtration device connects the outlet of the fourth liquid preparation tank 5 to the filling equipment 9.

[0057] like Figs. 1 to 4 As shown, nitrogen filling device 1 provides a nitrogen environment for the entire preparation process, preventing vitamins from being oxidized during preparation and ensuring product stability. For example, in the preparation of oxygen-free water for injection and micellar solutions, nitrogen filling can remove air from the tank and reduce the potential impact of oxygen on vitamins. The first mixing tank 2 heats water through a heating element (heating tube 201). Temperature sensor 202 monitors the water temperature in real time and feeds it back to the first control unit 203. The first control unit 203 controls the output power of the heating tube 201 according to the preset boiling temperature to heat the water to boiling. At the same time, pressure sensor 205 monitors the pressure inside the tank. When the pressure reaches the preset exhaust pressure, the first control unit 203 controls the first electromagnetic control valve 204 to open and exhaust, maintaining a stable pressure environment inside the tank, thereby preparing oxygen-free water for injection.

[0058] The second mixing tank 3 is filled with nitrogen by the nitrogen filling device 1. Then, fat-soluble vitamins, micelle carriers, and sodium hydroxide are added to the tank. The second stirring assembly (stirring motor 601 driving stirring blades 602) stirs and mixes the components, ensuring a thorough reaction between the fat-soluble vitamins and the micelle carrier to prepare a micelle solution. The third mixing tank 4 contains fat-soluble vitamins, which are stirred by the third stirring assembly to prepare a separate fat-soluble vitamin solution. The fourth mixing tank 5 contains water-soluble vitamins, which are stirred by the fourth stirring assembly to prepare a water-soluble vitamin solution. Simultaneously, the micelle solution from the second mixing tank 3 is received through a pipeline, allowing the two solutions to mix. A pH meter 505 monitors the solution's pH value in real time and feeds it back to the fourth control unit 506. When the pH value deviates from the preset value, the fourth control unit 506 controls the opening of the fourth electromagnetic control valve 504 corresponding to the acid buffer solution tank 501 or the alkaline buffer solution tank 502, adding the appropriate buffer solution to adjust the pH value to the preset value. The water-for-injection supply device delivers oxygen-free water for injection from the first mixing tank 2 to the fourth mixing tank 5 for replenishment and volume adjustment via a water supply pipe. The pH adjustment device connects the acidic buffer solution tank 501 and the alkaline buffer solution tank 502 to the top of the fourth mixing tank 5 via independent buffer solution pipes 503. The fourth electromagnetic control valve 504 on the buffer solution pipe 503 is controlled by the fourth control unit 506 based on data from the pH detector 505, allowing for precise adjustment of the pH value of the solution in the fourth mixing tank 5. The water-for-injection supply device connects the first mixing tank 2 and the fourth mixing tank 5 at both ends of the water supply pipe. The water supply control valve and the water supply pump 702 work together; when opened, they quickly deliver oxygen-free water for injection from the first mixing tank 2 to the fourth mixing tank 5 for replenishment and volume adjustment. The sterilization filtration device uses a silver ion non-woven fabric layer 802 in the filter box 801 to kill bacteria in the solution using the antibacterial properties of silver ions, while the activated carbon layer 803 further removes impurities and odors from the solution, ensuring product quality and safety. The solution is sterilized and filtered before entering the filling equipment 9 for filling.

[0059] like Figs. 1 to 4As shown, the heating assembly includes an electric heating element 201 disposed within a first liquid mixing tank 2. A temperature sensor 202 is disposed within the first liquid mixing tank 2, and a first control unit 203 is disposed on the outer wall of the first liquid mixing tank 2. The temperature sensor 202 controls the output power of the electric heating element 201 according to a preset boiling temperature via the first control unit 203. The electric heating element 201 serves as the heating source within the first liquid mixing tank 2, and the temperature sensor 202 is used to monitor the liquid temperature inside the tank in real time. The first control unit 203 on the outer wall of the first liquid mixing tank 2 has a preset boiling temperature. The temperature sensor 202 transmits the detected temperature signal inside the tank to the first control unit 203, which controls the heating intensity by adjusting the output power of the electric heating element 201 based on the difference between the preset boiling temperature and the actual detected temperature. When the actual temperature is lower than the preset boiling temperature, the first control unit 203 increases the output power of the heating element 201 to accelerate the heating speed; when the actual temperature approaches or reaches the preset boiling temperature, the first control unit 203 reduces the output power of the heating element 201 to avoid the temperature from getting too high, thereby achieving precise temperature control.

[0060] like Figs. 1 to 4 As shown, a first electromagnetic control valve 204 is installed on the top of the first liquid preparation tank 2, and a pressure sensor 205 is installed inside the first liquid preparation tank 2. The pressure sensor 205 controls the opening and closing of the first electromagnetic control valve 204 according to a preset exhaust pressure via a first control unit 203. The first control unit 203 presets the exhaust pressure. The pressure sensor 205 monitors the pressure inside the tank in real time and transmits the pressure signal to the first control unit 203. When the pressure inside the tank reaches the preset exhaust pressure, the first control unit 203 issues a command to open the first electromagnetic control valve 204, releasing the gas inside the tank and reducing the pressure. When the pressure inside the tank is lower than the preset exhaust pressure, the first control unit 203 controls the first electromagnetic control valve 204 to close, maintaining a stable pressure inside the tank, thereby achieving automatic control of the pressure inside the first liquid preparation tank 2.

[0061] Fat-soluble vitamins include vitamin A palmitate, vitamin D3, and racemic α-tocopherol; micelle carriers include soybean lecithin and glycocholic acid; water-soluble vitamin solutions include vitamin C, B vitamins, and folic acid. Fat-soluble vitamins (vitamin A palmitate, vitamin D3, and racemic α-tocopherol) are insoluble in water due to their chemical properties, but they can interact with micelle carriers (soybean lecithin and glycocholic acid) under specific conditions. Micellar carriers are amphiphilic, with one end hydrophilic and the other hydrophobic. The hydrophobic end can encapsulate the fat-soluble vitamins, while the hydrophilic end faces outwards, allowing the fat-soluble vitamins to form stable micelle structures in aqueous solutions, thereby increasing their solubility and stability in water. Water-soluble vitamin solutions (vitamin C, B vitamins, and folic acid) can dissolve directly in water and, when mixed with the aforementioned micelle solutions containing fat-soluble vitamins, together form a stable vitamin mixture solution, meeting specific nutritional needs or pharmaceutical preparation requirements.

[0062] like Figs. 1 to 4 As shown, the pH adjustment device includes an acidic buffer solution tank 501 and an alkaline buffer solution tank 502 connected to the fourth mixing tank 5. The acidic buffer solution tank 501 and the alkaline buffer solution tank 502 are respectively connected to the top of the fourth mixing tank 5 through independent buffer tubes 503. A fourth electromagnetic control valve 504 is installed on the buffer tube 503. A pH detector 505 is installed inside the fourth mixing tank 5. A fourth control unit 506 is installed outside the fourth mixing tank 5. The pH detector 505 controls the two fourth electromagnetic control valves 504 to close or open according to the preset pH value through the fourth control unit 506.

[0063] Acidic buffer solution tank 501 and alkaline buffer solution tank 502 store acidic and alkaline buffer solutions respectively, and are connected to the top of the fourth mixing tank 5 via independent buffer tubing 503. A pH meter 505 inside the fourth mixing tank 5 monitors the pH value of the solution in real time and transmits the detected pH signal to the fourth control unit 506. The fourth control unit 506 has a preset target pH value (preset pH value). When the pH value of the solution in the tank detected by the pH meter 505 is lower than the preset pH value, the fourth control unit 506 issues a command to open the fourth electromagnetic control valve 504 on the buffer tube 503 connected to the alkaline buffer solution tank 502, allowing the alkaline buffer solution to flow into the fourth mixing tank 5, where it neutralizes the solution and increases the pH value. When the pH value of the solution in the tank detected by the pH meter 505 is higher than the preset pH value, the fourth control unit 506 issues a command to open the fourth electromagnetic control valve 504 on the buffer tube 503 connected to the acidic buffer solution tank 501, allowing the acidic buffer solution to flow into the fourth mixing tank 5, where it neutralizes the solution and decreases the pH value. When the solution pH value reaches the preset pH value, the fourth control unit 506 controls both fourth electromagnetic control valves 504 to close, stopping the flow of buffer solution, thereby achieving precise adjustment of the pH value of the solution in the fourth mixing tank 5.

[0064] like Figs. 1 to 4 As shown, the water-to-injection supply device includes a water supply pipe, with its two ends connected to the first mixing tank 2 and the fourth mixing tank 5, respectively. The water supply pipe is equipped with a water supply control valve and a water supply pump 702. The water supply pipe serves as a connecting channel, introducing water for injection from a water source (the specific source is not specified, but it can be understood as a storage location that meets the standards for water for injection). The water supply pump 702 provides power, enabling the water for injection to flow within the water supply pipe, overcoming pipe resistance, and delivering water to the first mixing tank 2 and the fourth mixing tank 5. The water supply control valve controls the on / off state and flow rate of the water supply. When water for injection needs to be supplied to the mixing tanks, the water supply control valve is opened, and the water supply pump 702 is started, allowing water for injection to enter the corresponding mixing tank through the water supply pipe. When the required water volume is reached or water supply is no longer needed, the water supply control valve is closed, stopping the water supply.

[0065] like Figs. 1 to 4 As shown, the sterilization filtration device includes a filter box 801, which contains a sterilization layer and a filtration layer. The sterilization layer is a silver ion nonwoven fabric layer 802, and the filtration layer is an activated carbon layer 803. After water for injection enters the filter box 801, it first passes through the sterilization layer. The silver ions in the silver ion nonwoven fabric layer 802 have broad-spectrum antibacterial properties. When water flows through, the silver ions can interact with the cell membranes and proteins of bacteria, viruses, and other microorganisms in the water, destroying their structure and function, thereby achieving sterilization and reducing microbial contamination in the water.

[0066] After sterilization, the water flows through a filter layer. The activated carbon layer 803 has a large number of micropores and a strong adsorption capacity. It can adsorb organic impurities, odors, pigments, and other substances in the water, further purifying the water quality and making the water for injection after treatment by the sterilization filtration device even purer and meeting higher usage standards.

[0067] like Figs. 1 to 4 As shown, the second, third, and fourth stirring components have the same structure, all including a stirring motor 601, the output shaft of which is fixedly connected to a stirring blade 602. After the water for injection enters the filter box 801, it first passes through a sterilization layer. The silver ions in the silver ion nonwoven fabric layer 802 have broad-spectrum antibacterial properties. When water flows through, the silver ions can interact with the cell membranes and proteins of bacteria, viruses, and other microorganisms in the water, destroying their structure and function, thereby achieving sterilization and reducing microbial contamination in the water.

[0068] After sterilization, the water flows through a filter layer. The activated carbon layer 803 has a large number of micropores and a strong adsorption capacity. It can adsorb organic impurities, odors, pigments, and other substances in the water, further purifying the water quality and making the water for injection after treatment by the sterilization filtration device even purer and meeting higher usage standards.

[0069] Necessary control valves and pumps are installed on the pipes connecting the above components.

[0070] A method for preparing injectable multivitamins includes the following steps:

[0071] Step 1: Preparation of oxygen-free water for injection: Nitrogen gas is introduced into the first mixing tank 2 by activating the nitrogen filling device 1. Simultaneously, the heating element in the first mixing tank 2 is activated. The heating element controls its output power according to the preset boiling temperature (e.g., 100℃) to heat the water in the first mixing tank 2 to boiling. The pressure sensor 205 in the first mixing tank 2 monitors the pressure in real time. When the pressure reaches the preset exhaust pressure (e.g., 0.1 - 0.2 MPa), the first control unit 203 controls the first electromagnetic control valve 204 to open and exhaust gas, maintaining a stable pressure environment inside the tank, thereby preparing oxygen-free water for injection. Throughout the heating process, nitrogen gas is continuously introduced to prevent outside air from entering and ensure an oxygen-free environment.

[0072] Step 2: Preparation of micelle solution: Nitrogen gas is introduced into the second mixing tank 3 by activating nitrogen purging device 1. The fat-soluble vitamins (vitamin A palmitate, vitamin D3, racemic-α-tocopherol) and micelle carriers (glycocholic acid, soybean lecithin) are added to the second mixing tank 3. The second stirring assembly is then started for mixing. The stirring speed is set to a suitable rotation speed, such as 100-200 rpm. The stirring time is determined according to the actual situation, generally 10-30 minutes, to prepare the micelle solution. During the stirring process, nitrogen gas is continuously introduced to prevent oxidation of the fat-soluble vitamins.

[0073] Step 3: Prepare a fat-soluble vitamin solution (this step can be optimized and adjusted according to actual process requirements. If the micelle solution prepared in Step 2 already meets the requirements of subsequent processes, this step can be omitted; if further processing of the fat-soluble vitamins is required, proceed as follows): Add the fat-soluble vitamins (if the portion not fully used in Step 2 or fat-soluble vitamins that need to be processed separately) to the third mixing tank 4, start the third stirring assembly to stir, set the stirring speed to 100-150 rpm, and the stirring time to 10-20 minutes to prepare the fat-soluble vitamin solution separately. Similarly, maintain nitrogen protection during the stirring process.

[0074] Step 4: Preparation of water-soluble vitamin solution: Add the water-soluble vitamins (vitamin C, decarboxylase tetrahydrate, riboflavin sodium phosphate, vitamin B6, vitamin B12, folic acid, dextropanthenol, biotin, and nicotinamide) to the fourth mixing tank 5. Start the fourth stirring assembly and set the stirring speed to 120-180 rpm for 15-25 minutes. Simultaneously, slowly add the micelle solution from the second mixing tank 3 to the fourth mixing tank 5 through a pipe to mix with the water-soluble vitamin solution. Continue stirring during the mixing process to ensure the solution is thoroughly and evenly mixed.

[0075] Step 5: Adjusting the pH value: The pH meter 505 monitors the pH value of the solution in the fourth mixing tank 5 in real time and transmits the data to the fourth control unit 506. The preset pH value is set according to product requirements, such as 5.5-7.0. When the pH value deviates from the preset value, the fourth control unit 506 controls the corresponding fourth electromagnetic control valve 504 of the acidic buffer solution tank 501 (e.g., containing hydrochloric acid solution) or the alkaline buffer solution tank 502 (e.g., containing sodium hydroxide solution) to open, adding the corresponding buffer solution to the fourth mixing tank 5. During the addition process, the solution is continuously stirred until the pH value reaches the preset value. After each addition of buffer solution, the pH value is checked again at a certain interval (e.g., 1-2 minutes) to ensure that the pH value is stable within the preset range.

[0076] Step Six: Water Replenishment and Volume Adjustment: Turn on the water supply control valve and water supply pump 702 to transfer the oxygen-free water for injection from the first mixing tank 2 to the fourth mixing tank 5 via the water supply pipe. Replenish the solution in the fourth mixing tank 5 to achieve the specified volume. During the water replenishment process, precisely control the amount of oxygen-free water for injection added using a flow meter to ensure the final solution reaches the specified volume. Simultaneously, continuously stir the solution to ensure uniform composition.

[0077] Step 7: Sterilization, Filtration, and Filling: The solution in the fourth mixing tank 5 passes through the filter box 801 of the sterilization filtration device, and then through the silver ion nonwoven fabric layer 802 for sterilization. The silver ion nonwoven fabric layer 802 can effectively kill bacteria and microorganisms in the solution. Next, it enters the activated carbon layer 803 for filtration, which can adsorb impurities and odors in the solution. Then, it enters the filling equipment 9 for filling. Following this, freeze-drying is performed. The filled solution is placed in the freeze-drying equipment and operated according to the preset freeze-drying process parameters to remove water by sublimation. Nitrogen refilling and sealing: After freeze-drying, nitrogen is refilled into the container, and then sealing is performed to ensure the product's airtightness. Capping: The sealed containers are capped to further ensure the product's airtightness and stability. Packaging: The capped product is packaged to finally obtain the injectable multivitamin product.

[0078] 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 preparation device for a multivitamin for injection, characterized by comprising: The utility model relates to a preparation device for fat-soluble vitamin injection, which comprises: a nitrogen filling device (1) for supplying nitrogen; a first liquid preparation tank (2) connected with the nitrogen filling device (1), wherein a heating assembly is arranged in the first liquid preparation tank (2), and the first liquid preparation tank (2) is used for preparing oxygen-free water for injection; a second liquid preparation tank (3) connected with the nitrogen filling device (1), wherein a second stirring assembly is arranged in the second liquid preparation tank (3), and the second liquid preparation tank (3) is used for mixing fat-soluble vitamins, micellar carriers and sodium hydroxide to prepare a micellar solution; a third liquid preparation tank (4) provided with a third stirring assembly, and used for preparing a fat-soluble vitamin solution; a fourth liquid preparation tank (5) provided with a fourth stirring assembly, and used for preparing a water-soluble vitamin solution, wherein the fourth liquid preparation tank (5) is connected with the second liquid preparation tank (3) through a pipeline; a PH adjusting device connected with the fourth liquid preparation tank (5) through a pipeline; an injection water supply device arranged between the first liquid preparation tank (2) and the fourth liquid preparation tank (5), and used for supplementing water and constant volume for the water-soluble vitamin solution; and a sterilization filtration device, wherein a filling device (9) is connected with the liquid outlet of the fourth liquid preparation tank (5) through the sterilization filtration device.

2. The preparation device for a multivitamin for injection according to claim 1, characterized by The heating assembly comprises an electric heating tube (201) arranged in the first liquid preparation tank (2), wherein a temperature sensor (202) is arranged in the first liquid preparation tank (2), a first control unit (203) is arranged on the outer wall of the first liquid preparation tank (2), the temperature sensor (202) controls the output power of the electric heating tube (201) through the first control unit (203) and according to a preset boiling temperature.

3. The preparation device for a plurality of vitamins for injection according to claim 2, characterized by The first liquid preparation tank (2) is provided with a first electromagnetic control valve (204) at the top, and a pressure sensor (205) is arranged in the first liquid preparation tank (2), wherein the pressure sensor (205) controls the opening and closing of the first electromagnetic control valve (204) through the first control unit (203) and according to a preset exhaust pressure.

4. The preparation device for a plurality of vitamins for injection according to claim 3, characterized by The fat-soluble vitamins include vitamin A palmitate, vitamin D3 and racemic alpha-tocopherol; the micellar carriers include soybean phospholipid and glycocholic acid; and the water-soluble vitamin solution includes vitamin C, B vitamins and folic acid.

5. The preparation device for a plurality of vitamins for injection according to claim 4, characterized by The PH adjusting device comprises an acidic buffer solution tank (501) and an alkaline buffer solution tank (502) connected with the fourth liquid preparation tank (5), wherein the acidic buffer solution tank (501) and the alkaline buffer solution tank (502) are respectively connected with the top of the fourth liquid preparation tank (5) through independent buffer solution pipes (503), the buffer solution pipes (503) are provided with fourth electromagnetic control valves (504), a PH detector (505) is arranged in the fourth liquid preparation tank (5), and a fourth control unit (506) is arranged outside the fourth liquid preparation tank (5), wherein the PH detector (505) controls the closing or opening of the two fourth electromagnetic control valves (504) through the fourth control unit (506) and according to a preset PH value.

6. The preparation device for a plurality of vitamins for injection according to claim 5, characterized by The water supply device for injection comprises a water supply pipe, the two ends of the water supply pipe are respectively connected with a first liquid preparation tank (2) and a fourth liquid preparation tank (5), and a water supply control valve and a water supply pump (702) are arranged on the water supply pipe.

7. The preparation device for a multivitamin for injection according to claim 6, characterized by The sterilization filter device comprises a filter box (801), and a sterilization layer and a filter layer are arranged in the filter box (801).

8. The preparation device for a plurality of vitamins for injection according to claim 7, characterized by The sterilization layer is a silver ion non-woven fabric layer (802), and the filter layer is an activated carbon layer (803).

9. The preparation device for a plurality of vitamins for injection according to claim 8, characterized by The second stirring assembly, the third stirring assembly and the fourth stirring assembly are the same in structure and each comprises a stirring motor (601), and a stirring fan blade (602) is fixedly connected to an output shaft of the stirring motor (601).

10. A method for preparing a multivitamin injection using the multivitamin injection preparation device according to any one of claims 1 to 9, characterized by, The method comprises the following steps: Step one, preparation of oxygen-free water for injection: open the nitrogen charging device (1) to charge nitrogen into the first liquid preparation tank (2), and simultaneously start the heating assembly in the first liquid preparation tank (2); the heating assembly controls the output power according to the preset boiling temperature, heats the water in the first liquid preparation tank (2) to boiling, and a pressure sensor (205) in the first liquid preparation tank (2) monitors the pressure in real time; when the pressure reaches the preset exhaust pressure, the first control unit (203) controls the first electromagnetic control valve (204) to open and exhaust, so as to maintain a stable pressure environment in the tank, thereby obtaining oxygen-free water for injection; Step two, preparation of micelle solution: open the nitrogen charging device (1) to charge nitrogen into the second liquid preparation tank (3), add fat-soluble vitamins and micelle carriers into the second liquid preparation tank (3), and start the second stirring assembly to stir and mix, thereby preparing the micelle solution; Step three, preparation of fat-soluble vitamin solution: add fat-soluble vitamins into the third liquid preparation tank (4), and start the third stirring assembly to stir, thereby preparing the fat-soluble vitamin solution; Step four, preparation of water-soluble vitamin solution: add water-soluble vitamins into the fourth liquid preparation tank (5), start the fourth stirring assembly to stir, and simultaneously add the micelle solution in the second liquid preparation tank (3) into the fourth liquid preparation tank (5) through a pipeline to mix with the water-soluble vitamin solution; Step five, PH value adjustment: a PH detector (505) detects the PH value of the solution in the fourth liquid preparation tank (5) in real time, and transmits the detection data to the fourth control unit (506); when the PH value deviates from the preset value, the fourth control unit (506) controls the fourth electromagnetic control valve (504) corresponding to the acid buffer solution tank (501) or the alkaline buffer solution tank (502) to open according to the preset PH value, so that the corresponding buffer solution is added into the fourth liquid preparation tank (5), and the PH value of the solution reaches the preset value; Step six, water supplementing and constant volume: open the water supply control valve and the water supply pump (702), and transport the oxygen-free water for injection in the first liquid preparation tank (2) to the fourth liquid preparation tank (5) through the water supply pipe, so as to supplement and constant volume the solution in the fourth liquid preparation tank (5). Step seven, sterile filtration and filling: the solution in the fourth solution preparation tank (5) is filtered through the filter box (801) of the sterile filtration device, sterilized through the silver ion non-woven fabric layer (802), filtered through the activated carbon layer (803), and then enters the filling equipment (9) for filling. Subsequent operations such as freeze-drying, back-filling nitrogen pressure plug, cap rolling, packaging, etc. are performed, and finally the multi-vitamin product for injection is obtained.

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