A method and system for producing a liquid formulation

Abstract

This application discloses a method and system for producing liquid formulations. In the liquid formulation production system, the formulation production unit has a liquid channel for conveying the drug solution. The formulation production unit includes a preparation unit and a filling unit. The preparation unit has a dispensing channel section, and the filling unit has a filling channel section. The dispensing channel section is connected to the filling channel section to form a liquid channel. The preparation unit is used to prepare the target drug solution using raw materials and excipients through the dispensing channel section. The filling unit is used to fill the target drug solution into a bottle through the filling channel section to form a liquid formulation. A pneumatic power unit is used to provide inert gas. A gas distribution unit has an inlet and several outlets. The inlet is connected to the pneumatic power unit, and the outlets are respectively connected to the preparation unit and the filling unit of the formulation production unit, for conveying inert gas into the liquid channel. This can reduce the introduction of oxygen during the preparation process, reduce the exposure time of the target drug solution, and improve the quality of the liquid formulation.

Description

Technical Field

[0001] This application relates to the field of pharmaceutical preparation manufacturing technology, and more specifically, to a method and system for producing liquid preparations. Background Technology

[0002] To ensure product quality, liquid formulations that are particularly sensitive to oxygen often require extremely low residual oxygen levels. To achieve this oxygen reduction target, inert gases are commonly used to isolate the liquid formulation from air during production. Currently, the following two methods are commonly employed: One method involves continuously introducing an inert gas (such as nitrogen) into the bottle during the drug filling stage to replace the air before sealing. The residual oxygen level is generally controlled between 3% and 7%. One method is liquid nitrogen dripping, which involves dripping liquid nitrogen into the bottle and using the instantaneous vaporization and expansion properties of liquid nitrogen to replace the air in the bottle and create a positive pressure environment inside the bottle. The residual oxygen control level is generally between 1% and 2%. However, neither of the above two methods can prevent the target drug solution from coming into contact with air throughout the entire preparation process, and therefore cannot guarantee the quality of liquid formulations that are particularly sensitive to oxygen.

[0003] In summary, how to control and reduce oxygen introduction and exposure time during the preparation of liquid formulations is a problem that urgently needs to be solved by those skilled in the art. Summary of the Invention

[0004] In view of this, the purpose of this application is to provide a liquid formulation production method and system that can reduce the introduction of oxygen during the preparation process, reduce the exposure time of the target drug solution, and improve the quality of the liquid formulation.

[0005] To achieve the above objectives, this application provides the following technical solution: A liquid formulation production system, comprising: A formulation production unit has a liquid channel for conveying a drug solution, and the formulation production unit includes a preparation unit and a filling unit. The preparation unit has a dispensing channel section, and the filling unit has a filling channel section. The dispensing channel section is connected to the filling channel section to form the liquid channel. The preparation unit is used to prepare the target drug solution using raw materials and excipients through the dispensing channel section, and the filling unit is used to fill the target drug solution into a bottle through the filling channel section to form a liquid formulation. A pneumatic power unit, which is used to supply inert gas; The gas distribution unit has a gas inlet and several gas outlets. The gas inlet is connected to the pneumatic power unit, and the several gas outlets are respectively connected to the preparation unit of the formulation production unit and the filling unit, for conveying inert gas into the liquid channel.

[0006] Preferably, the preparation unit includes a plurality of connector assemblies; The connector assembly is optionally and sealed at the opening of the corresponding material container. The material container is used to hold raw and auxiliary materials. The connector assembly has a feeding port, an inflation port, and an overflow pressure relief port that are connected to the inner cavity of the material container. The feeding port is used to supply raw and auxiliary materials. The inflation port is connected to one of the gas supply ports of the gas distribution unit. The overflow pressure relief port is equipped with a pressure relief valve.

[0007] Preferably, the preparation unit further includes a liquid preparation tank, several peristaltic pumps for pumping liquids, a vacuum pump, and a first pressure detector for detecting pressure. The liquid preparation tank has a feed inlet, a drain outlet, a vacuum interface, a replacement port, and a pressure measuring port; The peristaltic pump has a liquid delivery port and a liquid extraction port. The liquid extraction ports of the peristaltic pumps are connected to the feed port of the connector assembly corresponding to the material tank. The liquid delivery ports of the peristaltic pumps are all connected to the feed port. The drain port is connected to the filling unit; The vacuum pump is connected to the vacuum interface; The displacement port is connected to one of the gas supply ports of the gas distribution unit; The first pressure detector is located at the pressure measuring port.

[0008] Preferably, the preparation unit further includes a weighing mechanism, and the liquid preparation tank is disposed on the weighing mechanism for weighing the liquid preparation tank.

[0009] Preferably, the filling unit includes a conveying subunit, a pre-filling subunit, a filling subunit, an inflation subunit, and a sealing subunit; The pre-filling subunit, the filling subunit, the inflation subunit, and the sealing subunit are arranged sequentially along the material flow direction of the conveying subunit; The pre-filling subunit is connected to one of the gas outlets of the gas distribution unit and is used to spray inert gas into the bottle. The filling subunit is connected to the drain port of the liquid preparation tank and one of the gas supply ports of the gas distribution unit, and is used to inject the medicine into the bottle under the protection of inert gas; The inflation subunit is connected to one of the gas outlets of the gas distribution unit and is used to inject inert gas into the bottle. The sealing subunit is used to assemble the bottle cap into the bottle opening of the bottle body in a sealing fit.

[0010] Preferably, the filling unit further includes a buffer tank and an exhaust regulating valve; The buffer tank has a liquid inlet, a liquid outlet, an air inlet, and an air outlet; The inlet is connected to the liquid preparation tank, and the infusion needle of the filling subunit is connected to the outlet. The filling subunit is used to drive the target drug solution from the liquid preparation tank to the buffer tank and pump the target drug solution in the buffer tank to the infusion needle. The air inlet is connected to one of the air outlets of the gas distribution unit, and the exhaust regulating valve is located at the air outlet to discharge the gas in the buffer tank in order to stabilize the pressure inside the buffer tank.

[0011] Preferably, the gas distribution unit includes a main channel, a primary gas distribution manifold, several primary distribution channels, and several pressure regulating valves; The first end of the main channel has the air inlet, and the second end is connected to the first end of several primary sub-channels through the primary air distribution manifold. The second end of several primary sub-channels has the air outlet. Each of the aforementioned primary sub-channels is equipped with a corresponding pressure regulating valve for adjusting the pressure of the corresponding primary sub-channel.

[0012] Preferably, one of the primary distribution channels connected to the filling unit is connected to the pre-filling sub-unit, the filling sub-unit, and the inflation sub-unit respectively via a secondary gas distribution assembly; The secondary gas distribution assembly includes a secondary gas distribution manifold, several secondary gas distribution channels, and several flow regulating valves; The secondary gas distribution manifold is connected to the corresponding primary distribution channel. The secondary gas distribution manifold is also connected to the first end of several secondary distribution channels. The second end of several secondary distribution channels has the gas inlet, which is connected to the pre-filling subunit, the filling subunit, and the inflation subunit, respectively. Each of the aforementioned secondary sub-channels is equipped with a corresponding flow regulating valve for regulating the flow rate of the corresponding secondary sub-channel.

[0013] Preferably, the pneumatic power unit includes a storage tank, a vaporizer, and a pressure reducing and stabilizing valve group connected in sequence, used to vaporize the liquid inert gas in the storage tank and output it at the target pressure.

[0014] A method for producing a liquid dosage form, applied to any of the liquid dosage form production systems described above, the method comprising: The pneumatic power unit and gas distribution unit are activated to deliver inert gas into the liquid channel; The preparation unit is activated to prepare the target drug solution using raw and auxiliary materials; The filling unit is activated to fill the target drug solution into the bottle to form a liquid formulation.

[0015] Preferably, before activating the pneumatic power unit and the gas distribution unit, the method further includes: starting the vacuum pump and obtaining the detection result of the first pressure detector; Once the pressure reading from the first pressure detector reaches the preset pressure value, the pneumatic power unit and gas distribution unit are activated.

[0016] In this application, the formulation production unit, which consists of a preparation unit and a filling unit, has a liquid channel. The liquid channel is composed of a liquid dispensing channel section in the preparation unit and a liquid filling channel section in the filling unit. When the preparation unit is activated, the raw materials and excipients can be pumped through the liquid dispensing channel section to complete the preparation of the target drug solution. When the filling unit is activated, the target drug solution can be pumped through the liquid filling channel section to complete the filling of the target drug solution.

[0017] Correspondingly, the pneumatic power unit is connected to the air inlet of the gas distribution unit, which can deliver pressure-stabilized inert gas into the gas distribution unit. The gas distribution unit has several air outlets to deliver inert gas into each section of the liquid channel, so that nitrogen covers the entire length of the liquid channel. This allows for systematic and continuous oxygen control during the preparation of liquid formulations, reduces oxygen introduction points, shortens the exposure time of the target drug solution, and improves the quality of the liquid formulation. Attached Figure Description

[0018] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only embodiments of this application. For those skilled in the art, other drawings can be obtained based on the provided drawings without creative effort.

[0019] Figure 1 Hydraulic schematic diagram of the preparation unit, filling unit and gas distribution unit for the specific embodiments provided in this application; Figure 2 A hydraulic schematic diagram of the formulation production unit in a vacuum state in a specific embodiment provided in this application; Figure 3 Hydraulic schematic diagram of the pneumatic power unit for a specific embodiment provided in this application; Figure 4 Hydraulic schematic diagram of the gas distribution unit provided in the specific embodiments of this application; Figure 5 A schematic diagram showing the connection between the connector assembly and the pressure relief valve in a specific embodiment provided in this application; Figure 6 An axial front view of the connector assembly of a specific embodiment provided in this application; Figure 7 For this Figure 6 AA section view; Figure 8 A schematic diagram of the connector assembly for a specific embodiment provided in this application; Figure 9 A front view of the buffer container for a specific embodiment provided in this application; Figure 10 A side view of the buffer container provided in the specific embodiments of this application; Figure 11 This is a partial hydraulic schematic diagram of the buffer tank in the specific embodiment provided in this application; Figure 12 This is a partial hydraulic schematic diagram of the liquid preparation tank in a specific embodiment provided in this application.

[0020] Figure label: 1-Preparation unit; 101-Connector assembly; 1011-Feeding port; 1012-Air inlet; 1013-Overflow and pressure relief port; 102-Pressure relief valve; 103-Peristaltic pump; 104-Liquid preparation tank; 1041-Feed inlet; 1042-Vacuum interface; 1043-Replacement port; 1044-Pressure measuring port; 1045-Residual oxygen detection port; 105-Weighing mechanism; 106-Bottom valve; 2-Filling unit; 201-Pre-filling subunit; 202-Filling subunit; 203-Inflating subunit; 204-Buffer tank; 2041-Liquid inlet; 2042-Liquid outlet; 2043-Air inlet; 2044-Air outlet; 2045-Pressure port; 2046-Oxygen detection port; 2047-Safety relief port; 205-Exhaust regulating valve; 206-Safety valve; 207-Pump; 3-Pneumatic power unit; 301-Storage tank; 302-Vaporizer; 303-Pressure reducing and stabilizing valve assembly; 304-Buffer tank; 4-Gas distribution unit; 401-Main channel; 402-Primary gas distributor; 403-Primary gas distribution channel; 404-Secondary gas distribution assembly; 4041-Secondary gas distributor; 4042-Secondary gas distribution channel; 5-Vacuum pump; 6-First pressure measuring instrument; 7-First oxygen content detector; 8-Second pressure detector; 9-Second oxygen content detector; 10-Material bucket. Detailed Implementation

[0021] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0022] The core of this application is to provide a method and system for producing liquid formulations that can reduce the introduction of oxygen during the preparation process, reduce the exposure time of the target drug solution, and improve the quality of the liquid formulation.

[0023] This application provides a liquid formulation production system, including a formulation production unit, a pneumatic power unit 3, and a gas distribution unit 4. The formulation production unit has a liquid channel for conveying the drug solution and includes a preparation unit 1 and a filling unit 2. The preparation unit 1 has a dispensing channel section, and the filling unit 2 has a filling channel section. The dispensing channel section is connected to the filling channel section to form a liquid channel. The preparation unit 1 is used to prepare the target drug solution using raw materials and excipients through the dispensing channel section, and the filling unit 2 is used to fill the target drug solution into a bottle through the filling channel section to form a liquid formulation. The pneumatic power unit 3 provides inert gas. The gas distribution unit 4 has a gas inlet and several gas outlets. The gas inlet is connected to the pneumatic power unit 3, and the several gas outlets are respectively connected to the preparation unit 1 and the filling unit 2 of the formulation production unit for conveying inert gas into the liquid channel.

[0024] Please refer to Figure 1 and Figure 3 The formulation production unit, consisting of a preparation unit 1 and a filling unit 2, has a liquid channel. The liquid channel consists of a liquid dispensing channel section of the preparation unit 1 that is interconnected with each other, and a liquid filling channel section of the filling unit 2. When the preparation unit 1 is activated, the raw materials and excipients can be pumped through the liquid dispensing channel section to complete the preparation of the target drug solution. When the filling unit 2 is activated, the target drug solution can be pumped through the liquid filling channel section to complete the filling of the target drug solution.

[0025] Correspondingly, the pneumatic power unit 3 is connected to the gas supply port of the gas distribution unit 4, which can deliver a pressure-stabilized inert gas into the gas distribution unit 4. The gas distribution unit 4 has several gas outlets to deliver inert gas into each section of the liquid channel, so that nitrogen covers the entire length of the liquid channel. This allows for systematic and continuous oxygen control during the preparation of liquid formulations, reduces oxygen introduction points, and shortens the exposure time of the target drug solution, thereby improving the quality of the liquid formulation.

[0026] Based on the above embodiments, the preparation unit 1 includes a plurality of connector assemblies 101; the connector assembly 101 is selectively and sealingly disposed at the opening of the corresponding material barrel 10, the material barrel 10 is used to hold raw and auxiliary materials, and the connector assembly 101 has a feeding port 1011, an air inlet 1012, and an overflow pressure relief port 1013 connected to the inner cavity of the material barrel 10. The feeding port 1011 is used to supply raw and auxiliary materials for output, the air inlet 1012 is connected to an air outlet of the gas distribution unit 4, and the overflow pressure relief port 1013 is provided with a pressure relief valve 102.

[0027] Please refer to Figure 1 , Figure 5 , Figure 6 , Figure 7 , Figure 8 The raw and auxiliary materials stored in the material tank 10 are used to supply the liquid preparation tank 104. After the raw and auxiliary materials in several material tanks 10 are transported into the liquid preparation tank 104 according to the target ratio, the preparation of the medicine solution can be completed.

[0028] To meet the liquid supply requirements and to ensure inert gas protection during the drug preparation process, a connector assembly 101 is installed at the opening of the material tank 10. The connector assembly 101 is sealed to the material tank 10 and has three openings, which serve as a feeding port 1011, an inflation port 1012, and an overflow pressure relief port 1013. Correspondingly, the feeding port 1011 is connected to the liquid preparation tank 104, which enables the material to be transported; the inflation port 1012 is connected to the gas outlet of the gas distribution unit 4, which connects to the inert gas source; and the overflow pressure relief port 1013 is equipped with a pressure relief valve 102, which allows the material tank 10 to automatically depressurize.

[0029] In use, inert gas can be introduced into the material tank 10 first, so that the material tank 10 is in a slightly positive pressure inert gas atmosphere, so as to replace the air in the raw materials with inert gas.

[0030] Preferably, the automatic pressure relief of the pressure relief valve 102 is less than or equal to 0.05 MPa.

[0031] Based on the above embodiments, the preparation unit 1 further includes a liquid preparation tank 104, a plurality of peristaltic pumps 103 for pumping liquids, a vacuum pump 5, and a first pressure detector 6 for detecting pressure. The liquid preparation tank 104 has an inlet 1041, a outlet, a vacuum interface 1042, a displacement port 1043, and a pressure measuring port 1044. The peristaltic pumps 103 have a delivery port and a suction port. The suction ports of the plurality of peristaltic pumps 103 are connected to the loading port 1011 of the connector assembly 101 provided with the corresponding material tank 10. The delivery ports of the plurality of peristaltic pumps 103 are all connected to the inlet 1041. The outlet is connected to the filling unit 2. The vacuum pump 5 is connected to the vacuum interface 1042. The displacement port 1043 is connected to a gas outlet of the gas distribution unit 4. The first pressure detector 6 is located at the pressure measuring port 1044.

[0032] Please refer to Figure 1 , Figure 2 , Figure 12 The mixing tank 104 has at least five openings, which serve as a feed inlet 1041, a drain outlet, a vacuum interface 1042, a replacement port 1043, and a pressure measuring port 1044, respectively. The inlet 1041 at the top of the mixing tank 104 is connected to the feed port 1011 of the connector assembly 101 via a pipe. A peristaltic pump 103 is installed in the passage connecting the inlet 1041 of the mixing tank 104 and the feed port 1011 of the connector assembly 101. The peristaltic pump 103 is used to pump the raw and auxiliary materials in the material tank 10 into the mixing tank 104 to prepare the target drug solution. The drain port at the bottom of the liquid preparation tank 104 is connected to the filling needle of the filling unit 2 through a pipe so as to deliver the liquid medicine to the filling unit 2. The vacuum interface 1042 at the top of the liquid preparation tank 104 is connected to the inlet of the vacuum pump 5. Starting the vacuum pump 5 can extract the air from the liquid channel of the formulation production unit to the outside. The replacement port 1043 at the top of the liquid preparation tank 104 is connected to a gas supply port of the gas distribution unit 4, which can deliver inert gas into the liquid preparation tank 104, that is, connect to an inert gas source. A first pressure detector 6 is installed at the pressure measuring port 1044 at the top of the liquid preparation tank 104 to detect the real-time gas pressure in the liquid preparation tank 104.

[0033] Please refer to the following when using it. Figure 2Before preparation begins, vacuum pump 5 is turned on to evacuate the liquid channel of the formulation production unit to complete the venting operation. Preferably, 2-3 vacuuming operations can be performed during production to complete the replacement, ensuring the vacuum level of the liquid channel of the formulation production unit is equal to -80 kPa, or within the pressure range of -80 ± N kPa, where N is the allowable pressure adjustment deviation. Simultaneously, the working vacuum level in the liquid channel of the formulation production unit is monitored in real time using the first pressure detector 6 to control the vacuum level at the target pressure. Then, please refer to... Figure 1 Then, inert gas is continuously introduced into the liquid channel of the formulation production unit to complete the inert gas purging operation; preferably, two purging-nitrogen purging operations are performed to remove all air from the liquid channel of the formulation production unit. After the purging is completed, the production of liquid formulations begins, and the system is maintained in a slightly positive pressure inert gas atmosphere, preferably controlled below 0.05 MPa. This ensures that the preparation unit 1 completes the material conveying, picking up, and preparation process under completely sealed conditions. On this basis, the corresponding branches of the pneumatic power unit 3 and the gas distribution unit 4 are coordinated to complete the process under nitrogen protection, preventing air from entering the system with the materials.

[0034] Alternatively, please refer to Figure 1 , Figure 12 The mixing tank 104 also has a residual oxygen detection port 1045. The residual oxygen detection port 1045 at the top of the mixing tank 104 is equipped with a first oxygen content detector 7, which can detect the real-time oxygen content in the mixing tank 104.

[0035] Alternatively, please refer to Figure 1 , Figure 12 The liquid preparation tank 104 is provided with a bottom valve 106 at the drain port. The inlet of the bottom valve 106 is preferably sealed to the liquid outlet of the liquid preparation tank 104 by welding. The outlet of the bottom valve 106 is connected to the inlet 2041 of the buffer tank 204 through a pipeline.

[0036] Based on the above embodiments, the preparation unit 1 further includes a weighing mechanism 105, and a liquid preparation tank 104 is disposed on the weighing mechanism 105 for weighing the weight of the liquid preparation in the liquid preparation tank 104.

[0037] Please refer to Figure 1 It is also equipped with a weighing mechanism 105 to detect the weight of the prepared liquid in the liquid preparation tank 104 in real time. Based on the detection result of the weighing mechanism 105, the weight of the corresponding raw and auxiliary materials input into the liquid preparation tank 104 can be determined, so as to control the raw and auxiliary materials to be input into the liquid preparation tank 104 according to the target ratio to prepare the target drug solution.

[0038] Based on the above embodiments, the filling unit 2 includes a conveying subunit, a pre-filling subunit 201, a filling subunit 202, an inflation subunit 203, and a sealing subunit; the pre-filling subunit 201, the filling subunit 202, the inflation subunit 203, and the sealing subunit are arranged sequentially along the material flow direction of the conveying subunit; the pre-filling subunit 201 is connected to a gas outlet of the gas distribution unit 4 for blowing inert gas into the bottle; the filling subunit 202 is connected to the drain outlet of the liquid preparation tank 104 and a gas outlet of the gas distribution unit 4 for injecting liquid medicine into the bottle under the protection of inert gas; the inflation subunit 203 is connected to a gas outlet of the gas distribution unit 4 for blowing inert gas into the bottle; the sealing subunit is used to seal the bottle cap to the bottle mouth.

[0039] In filling unit 2, pre-filling subunit 201 is used to drive the pre-filling needle into the bottle body, filling subunit 202 is used to drive the filling needle into the bottle body, inflation subunit 203 is used to drive the air nozzle to align with the bottle body, and sealing subunit is used to drive the bottle cap into the bottle mouth. It should be noted that the structure of the conveying subunit, pre-filling subunit 201, filling subunit 202, inflation subunit 203, and sealing subunit is not limited, and existing mechanisms can be selected, as long as they can achieve the above-mentioned corresponding functions.

[0040] Correspondingly, the pre-filling needle tail end of the pre-filling subunit 201 and the air nozzle tail end of the air filling subunit 203 are both connected to the air inlet of the gas distribution unit 4, so that they can receive and spray the inert gas provided by the gas distribution unit 4; the filling needle tail end of the filling subunit 202 is connected to the air inlet of the gas distribution unit 4 and the drain outlet of the liquid preparation tank 104 through a three-way pipe, so that the filling subunit 202 can inject the liquid medicine under the condition of continuous inert gas protection to prevent the liquid medicine from contacting the air; the sealing subunit is used to seal the bottle to complete the preparation of the liquid preparation; in addition, the air filling subunit 203 is located between the filling subunit 202 and the sealing subunit and is equipped with an electric slide rail and other devices to drive the air filling main mechanism to move along the moving direction of the conveying subunit, so that the air filling main mechanism can move synchronously with the bottle to continuously deliver inert gas into the bottle during the bottle transportation process to prevent the liquid medicine in the bottle from contacting the air.

[0041] Furthermore, the pre-filling subunit 201, filling subunit 202, aeration subunit 203, and sealing subunit are arranged sequentially along the material flow direction of the conveying subunit. Therefore, the filling process of liquid formulations using the filling unit 2 involves the conveying subunit carrying the bottle, causing it to sequentially pass through the stations of the pre-filling subunit 201, the filling subunit 202, the aeration subunit 203, and the sealing subunit. First, the conveying subunit transports the bottle to the pre-filling subunit 201. The pre-filling subunit 201 then inserts its pre-filling needle into the bottle to pre-fill it with inert gas, replacing the air inside. Preferably, the pressure range of the inert gas injected into the bottle at the pre-filling station is 0.3-0.4 MPa, and the flow rate range is 15-20 m³ / h. 3 / h; Then, the conveying subunit transports the bottle to the filling subunit 202. The filling subunit 202 inserts its filling needle into the bottle to fill it with the medicine, completing the filling process. During the filling process, inert gas is continuously introduced into the bottle. Preferably, the pressure range of the inert gas introduced into the bottle at the filling station is 0.2-0.3 MPa, and the flow rate range of the inert gas introduced into the bottle at the filling station is 15-20 m³ / h. 3 / h; After filling is completed, as the filling subunit 202 pulls its filling needle out of the bottle, the inflation subunit 203 is positioned in the top cavity of the bottle and aligns its air nozzle with the bottle opening to inject a stable stream of inert gas into the bottle. Preferably, the pressure range of the inert gas injected into the bottle at the inflation position is 0.3-0.4 MPa, and the flow rate range of the inert gas injected into the bottle at the inflation position is 15-20 m³ / h. 3 / h, to expel any air that may have been mixed in or remained in the bottle during the filling process; During the process of the conveying subunit carrying the bottle from the station where the filling subunit 202 is located to the station where the sealing subunit is located, the inflation main body mechanism of the inflation subunit 203 moves with the bottle, so that the air nozzle is always in the top empty position of the bottle, so as to continuously deliver inert airflow into the bottle, so as to solve the problem of nitrogen escape and residual oxygen rise, and achieve immediate protection. Finally, after the conveying subunit moves the bottle to the station of the sealing subunit, the sealing subunit pushes or screws the bottle cap it has grabbed into the bottle opening to complete the sealing of the bottle.

[0042] Based on the above embodiments, the filling unit 2 further includes a buffer tank 204 and an exhaust regulating valve 205; the buffer tank 204 has a liquid inlet 2041, a liquid outlet 2042, an air inlet 2043, and an air outlet 2044; the liquid inlet 2041 is connected to the liquid preparation tank 104, and the filling needle of the filling subunit 202 is connected to the liquid outlet 2042. The filling subunit 202 is used to drive the target drug solution from the liquid preparation tank 104 to the buffer tank 204, and to pump the target drug solution in the buffer tank 204 to the filling needle; the air inlet 2043 is connected to an air outlet of the gas distribution unit 4, and the exhaust regulating valve 205 is located at the air outlet 2044 to discharge the gas in the buffer tank 204 in order to stabilize the pressure in the inner cavity of the buffer tank 204.

[0043] Please refer to Figure 1 , Figure 3 , Figure 9 , Figure 10 The filling subunit 202 is equipped with a buffer tank 204. The inlet 2041 of the buffer tank 204 is connected to the outlet of the dispensing tank 104, and at least one outlet 2042 of the buffer tank 204 is connected to the tail inlet of the infusion needle. That is, the dispensing tank 104, the buffer tank 204, and the infusion needle are connected in sequence. After the filling subunit 202 is started, the medicine liquid in the dispensing tank 104 can be pumped into the buffer tank 204 for storage. Then, according to the needs, the medicine liquid in the buffer tank 204 can be injected into the bottle through the infusion needle to complete the medicine liquid filling operation, thereby improving the flow stability of the medicine liquid injected by the infusion needle.

[0044] Optionally, one of the several outlets 2042 of the buffer tank 204 is used for drainage, and the remaining outlets 2042 are connected to the tail end inlet of the infusion needle.

[0045] Meanwhile, the air inlet 2043 of the buffer tank 204 is connected to the air outlet of the gas distribution unit 4, so that it can receive the inert airflow provided by the gas distribution unit 4 to prevent the liquid medicine in the buffer tank 204 from contacting the air; and the air outlet 2044 of the buffer tank 204 is connected to an exhaust regulating valve 205, which is opened to discharge the gas in the buffer tank 204 to the outside when the air pressure in the buffer tank 204 exceeds the target range, thereby realizing the air pressure regulation in the buffer tank 204 and avoiding affecting the filling accuracy control.

[0046] In summary, filling unit 2 achieves nitrogen protection throughout the entire filling process while ensuring the stability of the liquid filling.

[0047] In some embodiments, the filling subunit 202 includes a plunger pump, and a one-way valve is provided between the inlet of the plunger pump and the outlet 2042 of the buffer tank 204. When in use, the plunger pump is started so that the medicine liquid in the buffer tank can be pumped into the bottle after flowing through the filling needle.

[0048] Alternatively, please refer to Figure 9 , Figure 11 The buffer tank 204 also has a pressure port 2045, which is equipped with a second pressure detector 8 to detect the real-time air pressure in the buffer tank 204.

[0049] Alternatively, please refer to Figure 9 , Figure 11 The buffer tank 204 also has an oxygen detection port 2046, which is equipped with a second oxygen content detector 9 to detect the real-time oxygen content in the buffer tank 204.

[0050] Alternatively, please refer to Figure 9 , Figure 11 The buffer tank 204 also has a safety relief port 2047, which is equipped with a safety valve 206, so that the buffer tank 204 can automatically depressurize. Preferably, the automatic relief pressure of the safety valve 206 is 0.1 MPa.

[0051] Based on the above embodiment, the gas distribution unit 4 includes a main channel 401, a primary gas distribution manifold 402, several primary distribution channels 403, and several pressure regulating valves; the first end of the main channel 401 has a gas inlet, and the second end is connected to the first end of several primary distribution channels 403 through the primary gas distribution manifold 402, and the second end of several primary distribution channels 403 has a gas outlet; each of the several primary distribution channels 403 is provided with a corresponding pressure regulating valve for adjusting the pressure of the corresponding primary distribution channel 403. A primary distribution channel 403 connected to the filling unit 2 is connected to the pre-filling sub-unit 201, the filling sub-unit 202, and the inflation sub-unit 203 respectively via a secondary gas distribution assembly 404. The secondary gas distribution assembly 404 includes a secondary gas distribution manifold 4041, several secondary distribution channels 4042, and several flow regulating valves. The secondary gas distribution manifold 4041 is connected to the corresponding primary distribution channel 403 and is also connected to the first end of several secondary distribution channels 4042. The second end of each of the several secondary distribution channels 4042 has a gas outlet, which is connected to the pre-filling sub-unit 201, the filling sub-unit 202, and the inflation sub-unit 203 respectively. Each of the several secondary distribution channels 4042 is equipped with a corresponding flow regulating valve to regulate the flow rate of the corresponding secondary distribution channel 4042.

[0052] Please refer to Figure 1 , Figure 4To achieve nitrogen distribution and supply to several branches, the gas distribution unit 4 is equipped with a main channel 401, a primary gas distribution manifold 402, and several primary distribution channels 403. Given that the primary distribution channels 403 are defined as primary distribution channel A, primary distribution channel B, primary distribution channel C, primary distribution channel D… and the primary gas distribution manifold 402 has several outlets defined as outlet A, outlet B, outlet C, outlet D…, the connection path for the primary gas distribution manifold 402, which has one inlet and several outlets, is as follows: The inlet of the primary air distribution manifold 402 is connected to the pneumatic power unit 3 through the main channel 401; The outlet A of the primary gas distributor 402 is connected to the liquid mixing tank through the primary gas distribution channel A; preferably, it is connected to the replacement port 1043 of the liquid mixing tank; specifically, the inlet end of the primary gas distribution channel A is connected to the outlet A of the primary gas distributor 402, and the gas delivery port end of the primary gas distribution channel A is connected to the liquid mixing tank. The outlet B of the primary air distribution manifold 402 is connected to the buffer tank 204 via the primary air distribution channel B; preferably, it is connected to the air inlet 2043 of the buffer tank 204; specifically, the inlet end of the primary air distribution channel B is connected to the outlet B of the primary air distribution manifold 402, and the outlet end of the primary air distribution channel B is connected to the buffer tank 204. The outlet C of the primary air distribution manifold 402 is connected to the material tank 10 through the primary distribution channel C; preferably, it is connected to the air inlet 1012 of the connector assembly 101; specifically, the inlet end of the primary distribution channel C is connected to the outlet C of the primary air distribution manifold 402, and the air outlet end of the primary distribution channel C is connected to the material tank 10. The outlet D of the primary air distribution unit 402 is connected to the pre-filling sub-unit 201, the filling sub-unit 202, and the air-filling sub-unit 203 through the primary distribution channel D.

[0053] The outlet D of the primary gas distributor 402 is connected to the pre-filling subunit 201, the filling subunit 202, and the inflation subunit 203 via the primary gas distribution channel D. Optionally, there are three primary gas distribution channels D, and the three primary gas distribution channels D are connected to the pre-filling subunit 201, the filling subunit 202, and the inflation subunit 203 in a one-to-one correspondence.

[0054] Preferably, the gas distribution unit 4 is further configured with a secondary gas distribution assembly 404. The primary distribution channel D is connected to the pre-filling subunit 201, the filling subunit 202, and the inflation subunit 203 through the secondary gas distribution assembly 404. Specifically, the secondary gas distribution assembly 404 is configured with a secondary gas distribution manifold 4041 and several secondary distribution channels 4042. Under the premise that the several secondary distribution channels 4042 are defined as secondary distribution channel A, secondary distribution channel B, secondary distribution channel C, secondary distribution channel D..., and the several outlets of the secondary gas distribution manifold 4041 are defined as outlet A', outlet B', outlet C', outlet D'..., the connection path of the secondary gas distribution manifold 4041 with one inlet and several outlets is as follows: The inlet of the secondary gas distributor 4041 is connected to the primary gas distributor 402 through the primary gas distributor channel D; The outlet A' of the secondary gas distributor 4041 is connected to the pre-charge sub-unit 201 through the secondary sub-channel A. In some embodiments, the inlet end of the secondary sub-channel A is connected to the outlet A' of the secondary gas distributor 4041, and the gas delivery port end of the secondary sub-channel A is connected to the tail end inlet of the pre-charge needle of the pre-charge sub-unit 201. The outlet B' of the secondary gas distribution manifold 4041 is connected to the pre-filling subunit 201 through the secondary sub-channel B. In some embodiments, the inlet end of the secondary sub-channel B is connected to the outlet B' of the secondary gas distribution manifold 4041, and the gas delivery port end of the secondary sub-channel B is connected to the inlet end of the filling needle of the filling subunit 202. The outlet C' of the secondary gas distributor 4041 is connected to the inflation subunit 203 through the secondary distribution channel C. In some embodiments, the inlet end of the secondary distribution channel C is connected to the outlet C' of the secondary gas distributor 4041, and the gas delivery port end of the secondary distribution channel C is connected to the inlet end of the gas nozzle of the inflation subunit 203.

[0055] The outlet of the pneumatic power unit 3 branches directly into four branches, which flow to the material tank 10, the liquid preparation tank 104, the buffer tank 204 and the filling unit 2 respectively; and the branch flowing to the filling unit 2 branches into three branches, which flow to the pre-filling sub-unit 201, the filling sub-unit 202 and the air filling sub-unit 203 respectively.

[0056] Furthermore, each of the primary sub-channels 403 is equipped with a pressure regulating valve to adjust the air pressure of the corresponding branch; and each of the secondary sub-channels 4042 is equipped with a flow regulating valve to adjust the flow rate of the corresponding branch.

[0057] In summary, the air source for the pre-filling subunit 201, the filling subunit 202, and the inflation subunit 203 is the same branch path of the primary air distribution manifold 402, and the flow rate can be independently adjusted through the flow regulating valve to ensure the stability of the airflow.

[0058] The pneumatic power unit 3 serves as an inert gas supply station, which is the gas source foundation of the entire system, and is designed to provide a stable flow of inert gas.

[0059] In some embodiments, please refer to Figure 3 The pneumatic power unit 3 consists of a storage tank 301, a vaporizer 302, and a pressure-reducing and stabilizing valve assembly 303 connected in sequence. It is designed to process cryogenic liquid inert gas. Specifically, the inlet of the storage tank 301 is connected to the inlet of the vaporizer 302 via a pipe, the outlet of the vaporizer 302 is connected to the inlet of the pressure-reducing and stabilizing valve assembly 303 via a pipe, and the outlet of the pressure-reducing and stabilizing valve assembly 303 is connected to the gas distribution unit 4 via a pipe. In use, the vaporizer 302 converts the cryogenic liquid inert gas into room-temperature gaseous inert gas; subsequently, the gas flows through the pressure-reducing and stabilizing valve assembly 303, outputting a stable pressure and constant purity inert gas flow. Preferably, the pressure-reducing and stabilizing valve assembly 303 has a pressure stabilization range of 0.3-0.5 MPa.

[0060] It should be noted that the type of pressure reducing and stabilizing valve assembly 303 is not limited. It can be a unit that includes multiple valves such as pressure reducing valves and proportional regulating valves, or a single valve such as a gas pressure stabilizing valve; as long as the intended pressure stabilizing function can be achieved.

[0061] Based on the above embodiments, please refer to Figure 3 The pneumatic power unit 3 also includes a buffer tank 304. In the pneumatic power unit 3, the storage tank 301, the vaporizer 302, the pressure reducing and stabilizing valve group 303, and the buffer tank 304 are connected in sequence. In this embodiment, the outlet of the pressure reducing and stabilizing valve group 303 is connected to the gas distribution unit 4 through the buffer tank 304. Specifically, the outlet of the pressure reducing and stabilizing valve group 303 is connected to the inlet at the bottom of the buffer tank 304, and the outlet at the top of the buffer tank 304 is connected to the gas distribution unit 4, so as to improve the stability of the inert gas flow output by the pneumatic power unit 3.

[0062] It should be noted that the type of inert gas output by the pneumatic power unit 3 is not limited; it can be nitrogen, carbon dioxide, argon, etc., as long as it is suitable for the production protection of the target liquid formulation.

[0063] Optionally, the filling unit 2 includes a pump 207, preferably a twin rotor pump. The pump 207 is provided between the drain port of the liquid preparation tank 104 and the inlet 2041 of the buffer tank 204, so as to pump the liquid medicine in the liquid preparation tank 104 to the buffer tank 204.

[0064] In an embodiment where the preparation unit 1 includes a material tank 10, a connector assembly 101, a peristaltic pump 103, and a liquid preparation tank 104, and the filling unit 2 includes a buffer tank 204, the liquid channel of the formulation production unit includes a channel formed by the sequential connection of the feed port 1011 of the connector assembly 101, the internal cavity of the peristaltic pump 103, the internal cavity of the liquid preparation tank 104, and the internal cavity of the buffer tank 204 through a pipe; correspondingly, the liquid preparation channel section includes a channel formed by the sequential connection of the feed port 1011 of the connector assembly 101, the internal cavity of the peristaltic pump 103, and the internal cavity of the liquid preparation tank 104 through a pipe; the liquid filling channel section is the internal cavity of the buffer tank 204 and the pipe connected to the internal cavity of the liquid preparation tank 104.

[0065] Additionally, optionally, please refer to Figure 2 The feed inlet 1041 of the mixing tank 104 is connected to the liquid inlet 2041 of the buffer tank 204. The vacuum pump 5 is used to evacuate the liquid channel, that is, before mixing, the inner cavity of the mixing tank 104, the inner cavity of the buffer tank 204, and the pipelines in the formulation production unit (the pipeline connected to the feed inlet 1041 of the mixing tank 104 to connect to the material tank 10, the pipeline connecting the feed inlet 1041 of the mixing tank 104 to the liquid inlet 2041 of the buffer tank 204, and the pipeline connecting the drain outlet of the mixing tank 104 to the liquid inlet 2041 of the buffer tank 204) can be evacuated. Optionally, a switch valve can be installed on the pipelines connected to the material tank 10, the mixing tank 104, and the buffer tank 204 to facilitate evacuation of the inner cavity of the mixing tank 104 and / or the inner cavity of the buffer tank 204 and / or the target pipeline, that is, evacuation can be selectively performed on the target channel section of the liquid channel.

[0066] In addition to the liquid dosage form production system described above, this application also provides a production method for the liquid dosage form production system disclosed in the above embodiments, the liquid dosage form production method comprising the following steps: Step S1: Activate the pneumatic power unit 3 and the gas distribution unit 4 to deliver inert gas into the liquid channel; Step S2: Activate preparation unit 1 to prepare the target drug solution using raw materials and excipients; Step S3: Activate filling unit 2 to fill the target drug solution into the bottle to form a liquid formulation.

[0067] Understandably, in step S1, the pneumatic power unit 3 and the pneumatic distribution unit are first activated to inject an inert gas flow into the liquid channel of the formulation production unit to achieve protection; in step S2, the preparation unit 1 is activated to prepare the target drug solution in the preparation tank 104; and after the preparation is completed, in step S3, the filling unit 2 is activated to complete the filling of the drug solution, thereby producing a liquid formulation.

[0068] Based on the above embodiment, before step S1, the method further includes: starting the vacuum pump 5 and obtaining the detection result of the first pressure detector 6; After the first pressure detector 6 detects that the pressure value reaches the preset value, it activates the pneumatic power unit 3 and the gas distribution unit 4.

[0069] In this embodiment, before performing nitrogen protection step S1, the air in the liquid channel is emptied to ensure that the vacuum degree in the liquid channel of the system meets the standard. Preferably, the vacuum degree of the liquid channel of the formulation production unit is equal to -80 kPa, or within the pressure range of -80 ± N kPa, before performing step S1. Furthermore, during the process from step S1 to step S3, the gas pressure in the liquid preparation tank 104 can be continuously monitored by the first pressure detector 6, which can be used in conjunction with the pressure regulating valve set in the branch of the gas distribution unit 4 connected to the liquid preparation tank 104.

[0070] Optionally, it also includes acquiring the detection results of the second pressure detector 8, which can be used in conjunction with the pressure regulating valve set in the branch of the gas distribution unit 4 connected to the buffer tank 204.

[0071] Optionally, it also includes acquiring the detection results of the first oxygen content detector 7; optionally, it also includes acquiring the detection results of the second oxygen content detector 9; it can be used in conjunction with adjusting the actions of the pneumatic power unit 3 and the gas distribution unit 4, such as enabling or disabling them.

[0072] Preferably, the above-mentioned liquid preparation production system and method are pharmaceutical production systems and methods for low residual oxygen liquid preparations; correspondingly, the inert gas output by the pneumatic power unit 3 is nitrogen.

[0073] In some embodiments, a controller is also included. The preparation unit 1, filling unit 2, pneumatic power unit 3, and gas distribution unit 4 are all signal-connected to the controller. Furthermore, the vacuum pump 5, the first pressure detector 6, the first oxygen content detector 7, the second pressure detector 8, and the second oxygen content detector 9 are signal-connected to the controller. The controller is capable of executing the above-described production method to improve the automation level and efficiency of liquid preparation production.

[0074] The liquid formulation production system of this application can significantly reduce the accidental introduction of oxygen due to human operation or environmental factors, greatly improving the stability of the process. Verification shows that the liquid formulation production system of this application can control residual oxygen in the formulation to below 1%, with small batch-to-batch data dispersion, and residual oxygen levels at most detection points are 0.00%-0.03%. Compared with related technologies, the extremely low and stably controlled residual oxygen level results in a lower degradation rate of easily oxidized components in the formulation, which is beneficial for extending the product's shelf life and provides a key process guarantee for ensuring clinical efficacy, thus having significant quality control implications. Furthermore, the liquid formulation production system of this application can be obtained by modifying and integrating general formulation production equipment and can be applied to most liquid formulation delivery subunits with low residual oxygen control.

[0075] It should be noted that the relational terms such as "first" and "second" mentioned above are only used to distinguish one entity from several other entities, and do not necessarily require or imply any such actual relationship or order between these entities; the terms "upper surface," "lower surface," "top," and "bottom" and the directional terms "upper," "lower," "left," and "right" mentioned above are defined based on the accompanying drawings in the specification.

[0076] The various embodiments in this specification are described in a progressive manner, with each embodiment focusing on the differences from other embodiments. The same or similar parts between the various embodiments can be referred to each other.

[0077] The liquid formulation production method and system provided in this application have been described in detail above. Specific examples have been used to illustrate the principles and implementation methods of this application. The descriptions of the above embodiments are only for the purpose of helping to understand the method and its core ideas. It should be noted that those skilled in the art can make several improvements and modifications to this application without departing from the principles of this application, and these improvements and modifications also fall within the protection scope of this application.

Claims

1. A liquid preparation production system characterized by comprising: include: A formulation production unit having a liquid channel for conveying a drug solution, and the formulation production unit includes a preparation unit (1) and a filling unit (2). The preparation unit (1) has a liquid dispensing channel section, and the filling unit (2) has a liquid filling channel section. The liquid dispensing channel section is connected to the liquid filling channel section to form the liquid channel. The preparation unit (1) is used to prepare the target drug solution using raw materials and excipients through the liquid dispensing channel section, and the filling unit (2) is used to fill the target drug solution into a bottle through the liquid filling channel section to form a liquid formulation. A pneumatic power unit (3) is used to provide inert gas; The gas distribution unit (4) has a gas inlet and several gas outlets. The gas inlet is connected to the pneumatic power unit (3), and the several gas outlets are respectively connected to the preparation unit (1) of the formulation production unit and the filling unit (2) for conveying inert gas into the liquid channel.

2. The liquid preparation production system according to claim 1, characterized by The preparation unit (1) includes a plurality of connector assemblies (101). The connector assembly (101) is optionally and sealed at the opening of the corresponding material container (10). The material container (10) is used to hold raw and auxiliary materials. The connector assembly (101) has a feeding port (1011), an air inlet (1012), and an overflow pressure relief port (1013) connected to the inner cavity of the material container (10). The feeding port (1011) is used to supply raw and auxiliary materials. The air inlet (1012) is connected to one of the air outlets of the gas distribution unit (4). The overflow pressure relief port (1013) is equipped with a pressure relief valve (102).

3. The liquid formulation production system according to claim 2, characterized in that, The preparation unit (1) also includes a liquid preparation tank (104), several peristaltic pumps (103) for pumping liquid; it also includes a vacuum pump (5) and a first pressure detector (6) for detecting pressure. The liquid preparation tank (104) has a feed inlet (1041), a drain outlet, a vacuum interface (1042), a replacement port (1043), and a pressure measuring port (1044). The peristaltic pump (103) has a liquid delivery port and a liquid extraction port. The liquid extraction ports of a plurality of peristaltic pumps (103) are connected to the feed port (1011) of the connector assembly (101) corresponding to the material tank (10). The liquid delivery ports of a plurality of peristaltic pumps (103) are all connected to the feed port (1041). The drain port is connected to the filling unit (2). The vacuum pump (5) is connected to the vacuum interface (1042). The replacement port (1043) is connected to one of the gas supply ports of the gas distribution unit (4); The first pressure detector (6) is located at the pressure measuring port (1044).

4. The liquid formulation production system according to claim 3, characterized in that, The preparation unit (1) further includes a weighing mechanism (105), and the liquid preparation tank (104) is located on the weighing mechanism (105) for weighing the weight of the prepared liquid in the liquid preparation tank (104).

5. The liquid formulation production system according to claim 3, characterized in that, The filling unit (2) includes a conveying subunit, a pre-filling subunit (201), a filling subunit (202), an inflation subunit (203), and a sealing subunit; The pre-filling subunit (201), the filling subunit (202), the inflation subunit (203), and the sealing subunit are arranged sequentially along the material flow direction of the conveying subunit; The pre-filling subunit (201) is connected to one of the gas outlets of the gas distribution unit (4) for injecting inert gas into the bottle; The filling subunit (202) is connected to the drain port of the liquid preparation tank (104) and one of the gas supply ports of the gas distribution unit (4) for injecting liquid medicine into the bottle under the protection of inert gas. The inflation subunit (203) is connected to one of the gas outlets of the gas distribution unit (4) for injecting inert gas into the bottle; The sealing subunit is used to assemble the bottle cap into the bottle opening of the bottle body in a sealing fit.

6. The liquid formulation production system according to claim 5, characterized in that, The filling unit (2) also includes a buffer tank (204) and an exhaust regulating valve (205); The buffer tank (204) has a liquid inlet (2041), a liquid outlet (2042), an air inlet (2043), and an air outlet (2044). The inlet (2041) is connected to the liquid preparation tank (104), and the infusion needle of the filling subunit (202) is connected to the outlet (2042). The filling subunit (202) is used to drive the target drug solution from the liquid preparation tank (104) to the buffer tank (204) and pump the target drug solution in the buffer tank (204) to the infusion needle. The air inlet (2043) is connected to one of the air outlets of the gas distribution unit (4), and the exhaust regulating valve (205) is located at the air outlet (2044) to discharge the gas in the buffer tank (204) in order to stabilize the pressure in the inner cavity of the buffer tank (204).

7. The liquid formulation production system according to claim 6, characterized in that, The gas distribution unit (4) includes a main channel (401), a primary gas distribution manifold (402), several primary distribution channels (403), and several pressure regulating valves; The first end of the main channel (401) has the air inlet, and the second end is connected to the first end of several primary sub-channels (403) through the primary air distribution manifold (402). The second end of several primary sub-channels (403) all have the air outlet. Each of the aforementioned primary sub-channels (403) is equipped with a corresponding pressure regulating valve for adjusting the pressure of the corresponding primary sub-channel (403).

8. The liquid formulation production system according to claim 7, characterized in that, One of the primary channels (403) connected to the filling unit (2) is connected to the pre-filling sub-unit (201), the filling sub-unit (202), and the inflation sub-unit (203) respectively through the secondary gas distribution component (404); The secondary gas distribution assembly (404) includes a secondary gas distribution manifold (4041), several secondary gas distribution channels (4042), and several flow regulating valves; The secondary gas distribution manifold (4041) is connected to the corresponding primary distribution channel (403). The secondary gas distribution manifold (4041) is also connected to the first end of several secondary distribution channels (4042). The second end of several secondary distribution channels (4042) has the gas inlet, which is connected to the pre-filling subunit (201), the filling subunit (202), and the inflation subunit (203), respectively. Each of the aforementioned secondary sub-channels (4042) is equipped with a corresponding flow regulating valve for regulating the flow rate of the corresponding secondary sub-channel (4042).

9. The liquid formulation production system according to any one of claims 1-8, characterized in that, The pneumatic power unit (3) includes a storage tank (301), a vaporizer (302), and a pressure reducing and stabilizing valve group (303) connected in sequence, which are used to vaporize the liquid inert gas in the storage tank (301) and output it at the target pressure.

10. A method for producing a liquid formulation, characterized in that, The liquid formulation production system according to any one of claims 1-9, the liquid formulation production method comprising: The pneumatic power unit (3) and the gas distribution unit (4) are activated to deliver inert gas into the liquid channel; Activate the preparation unit (1) to prepare the target drug solution using raw materials and excipients; The filling unit (2) is activated to fill the target drug solution into the bottle to form a liquid formulation.

11. The method for producing liquid formulations according to claim 10, characterized in that, Before activating the pneumatic power unit (3) and the gas distribution unit (4), the process also includes: starting the vacuum pump (5) and obtaining the detection result of the first pressure detector (6); After the first pressure detector (6) detects the pressure value, the pneumatic power unit (3) and the gas distribution unit (4) are activated.

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