Pilot-scale test type oral dissolving film agent film making machine

Abstract

The utility model relates to a pilot plant test type oral dissolving film agent film making machine which is characterized in that one port of a medicine slurry conveying hose is inserted into a medicine slurry container, the middle section of the hose penetrates through a peristaltic pump, the other port of the hose extends into an upper cavity of a slitting device, and a liquid level sensor is located above the upper cavity of the slitting device. The liquid level of traditional Chinese medicine slurry input into the upper cavity of the slitting device is monitored in real time, a liquid level signal is transmitted to the control device, and then starting, stopping and the speed of the peristaltic pump are controlled. The other characteristic is that the scraper is fixed at the lower end of the knife rest, the two sides of the knife rest are limited in the sliding grooves of the fixed seat, the micrometer head fixed on the top plate is connected with the knife rest, the micrometer head is manually adjusted to enable the scraper to move up and down, and the digital micrometer displays the thickness of the coated medicine slurry in real time and transmits a signal to the control device. According to the utility model, the high-standard requirements of film medicine research and development and manufacturing can be met, and the research and screening of prescriptions and pilot-scale, small-batch or personalized production are realized. The modular assembly design facilitates quick disassembly, maintenance and cleaning.

Description

Technical Field

[0001] This utility model relates to the field of film-based drug research and development and manufacturing technology, specifically to a pilot-scale oral dissolving films (ODF) film-making machine. Background Technology

[0002] Film-forming agents refer to drug formulations made by processing drugs with suitable film-forming materials into a film-like form for oral or mucosal use. In the field of film-forming drug research and manufacturing technology, as a novel solid dosage form, they have been widely used in the pharmaceutical industry due to their accurate dosage, convenient administration, and good stability. Currently, the research and development of film-forming agents mainly relies on desktop coating devices for sample preparation, and mass production mainly depends on imported equipment. However, existing film-forming agent preparation equipment often has the following drawbacks: 1. Desktop coating devices have small coating amounts, insufficient thickness control, lack hot air drying capabilities, and cannot operate continuously. 2. Production-grade equipment is costly, bulky, occupies a large space, has high energy consumption, and is complex to clean and maintain, resulting in high maintenance costs and affecting production efficiency and product quality; it is not suitable for small-batch or customized production. 3. Existing film-forming agent preparation equipment typically includes one or more manual operation steps, such as mixing, coating, drying, and cutting of drugs and film materials. These devices often rely on human experience, making automation and precise control difficult, leading to poor batch-to-batch quality stability. 4. Currently, there is no film-forming machine that can be specifically used for formulation research and screening, precise control, and highly automated pilot-scale and small-batch or personalized trial production of film-forming agents. Summary of the Invention

[0003] The purpose of this invention is to provide a novel pilot-scale orally disintegrating film (ODF) film-forming machine to meet the needs of drug trial production in the formulation research and screening stage.

[0004] To achieve the aforementioned objectives, the technical solution of this utility model is a pilot-scale oral disintegrating film-forming machine, comprising a feeding mechanism, a coating mechanism, a drying device, and a control device. The feeding mechanism consists of a slurry platform, a slurry container, a delivery hose, a peristaltic pump, a level sensor, and a rotatable support. The slurry container is placed on the slurry platform. One end of the delivery hose is inserted into the slurry container, the middle section of the delivery hose passes through the peristaltic pump, and the other end of the delivery hose extends into the upper cavity of the slitting device. The level sensor is located above the upper cavity of the slitting device and fixed to the rotatable support. The peristaltic pump delivers the slurry into the upper cavity of the slitting device through the delivery hose. The level sensor monitors the upper cavity of the slitting device in real time. The liquid level of the Chinese herbal medicine slurry is monitored, and the liquid level signal is transmitted to the control device to control the start, stop, and speed of the peristaltic pump. The coating mechanism consists of a slitting device, a doctor blade adjustment mechanism, a traction power mechanism, an unwinding damping mechanism, and a winding power mechanism. The doctor blade adjustment mechanism consists of a bracket, a fixed base, a blade holder and a doctor blade, a top plate, a micrometer head, and a digital micrometer. The lower part of the fixed base is fixed to the coating platform, and the upper part is fixed to the top plate. The doctor blade is fixed to the lower end of the blade holder, and the two sides of the blade holder are limited in the sliding groove of the fixed base. The micrometer head fixed to the top plate is connected to the blade holder. Adjusting the micrometer head can move the blade holder and doctor blade up and down. The digital micrometer displays the thickness of the coated medicine slurry in real time and transmits the signal to the control device. The micrometer head can be manually adjusted to move the doctor blade up and down appropriately.

[0005] In the above technical solution, the drying device includes an upper drying chamber, a lower drying chamber, a fan, an electric air heater, a drying temperature controller, and a hot air circulation pipeline. The upper and lower drying chambers are each composed of a housing, a hot air circulation inlet, a hot air circulation outlet, and a temperature sensor. The drying temperature controller uses a fan to send air into the electric heater for heating before sending it into the upper and lower drying chambers, and mixes in fresh air to regulate the hot air temperature. The temperature sensor in the drying chamber transmits the temperature signal to the drying temperature controller in real time, thereby ensuring that the hot air input into the drying chamber is at a fixed temperature.

[0006] In the above technical solution, the control device consists of a programmable logic controller (PCL) and a human-machine interface. The programmable logic controller (PCL) is connected to the feeding mechanism, coating mechanism and drying device for signal control, so as to realize automated and intelligent control.

[0007] In the above technical solution, the width of the slitting device of the doctor blade adjustment mechanism is customized according to the needs of pilot production. By changing different slitting devices, coatings with different widths and numbers of strips can be achieved.

[0008] In the above technical solution, the coating speed controller adjusts the speed of the servo motor of the traction power mechanism according to the coating uniformity and production requirements, thereby adjusting the coating speed.

[0009] The advantages of this invention are that the equipment enables prescription research and screening, as well as pilot-scale, small-batch, or customized production; it achieves automation and precise control, improving the drug loading accuracy and preparation efficiency of membrane formulations, reducing R&D and production costs, and simultaneously enhancing product quality stability and batch-to-batch consistency to meet the high standards required for membrane drug R&D and manufacturing. The equipment adopts a modular component design, facilitating rapid disassembly, replacement, maintenance, and cleaning.

[0010] This invention achieves the following technical effects: 1. Improves the accuracy of drug loading and preparation efficiency of film-forming agents, enhancing the market competitiveness of enterprises; 2. Reduces production costs and maintenance difficulty, improving product competitiveness; 3. Improves product quality stability and batch-to-batch consistency; 4. Reduces human error and improves production safety; 5. Reduces the space occupied; 6. Improves coating uniformity, ensuring the quality of the film-forming agent. This invention provides a highly efficient, stable, and easy-to-maintain film-forming equipment for the field of film-forming drug research and manufacturing, with broad application prospects. Attached Figure Description

[0011] Figure 1 This is a schematic diagram of the overall system structure of the pilot-scale ODF film-making machine of this utility model.

[0012] Figure 2 This is a schematic diagram of the overall structure layout of this utility model.

[0013] Figure 3 This is a schematic diagram of the feeding mechanism of this utility model.

[0014] Figure 4 This is a schematic diagram of the scraper adjustment mechanism of this utility model.

[0015] Figure 5 This is a schematic diagram of the slitting device structure of this utility model.

[0016] Figure 6 This is a schematic diagram of the slitting device and scraper structure of this utility model.

[0017] In the attached diagrams, 101 is a touchscreen, 102 is a feeding mechanism, 103 is a coating mechanism, 104 is a temperature sensor for the upper drying chamber, 105 is the upper drying chamber, 106 is the circulating air inlet for the upper drying chamber, 107 is the circulating air outlet for the upper drying chamber, 108 is the circulating air inlet for the lower drying chamber, 109 is the circulating air outlet for the lower drying chamber, 110 is the lower drying chamber, 111 is the temperature sensor for the lower drying chamber, and 112 is a winding mechanism. The power mechanism includes: 113 traction power mechanism, 114 unwinding damping mechanism, 201 back plate, 202 peristaltic pump, 203 delivery hose, 204 slurry container, 205 slurry platform, 206 blank baseband, 207 delivery hose, 208 level sensor, 209 rotating support, 210 slurry outlet, 211 support, 212 slitting device, 213 coating platform, and 214 drug-loaded baseband. 301 is the top plate, 302 is the right micrometer head, 303 is the right digital micrometer, 304 is the right support, 305 is the right measuring rod, 306 is the right extension arm of the blade holder, 307 is the fixed base, 308 is the scraper, 309 is the coating platform, 310 is the blade holder, 311 is the fixed base connecting plate, 312 is the left fixed base, 313 is the left extension arm of the blade holder, 314 is the left measuring rod, 315 is the left support, 316 is the left digital micrometer, and 317 is the left micrometer head. 401 is the upper cavity of the slitting machine, 402 is the slurry outlet, and 403 is the scraper. Detailed implementation method.

[0018] The complete system structure of the prototype ODF film-forming machine in this embodiment is as follows: Figure 1 As shown.

[0019] The human-machine interface 1 and the programmable logic controller (PLC) 2 constitute the control device; the peristaltic pump 3, the ultrasonic level gauge 4, and the slurry slitting device constitute the feeding mechanism; the digital micrometer 6 and the scraper adjustment mechanism 7 constitute the coating mechanism; the constant temperature heating mechanism 8 and the fan air supply mechanism 9 constitute the drying device; and the traction power mechanism 10, the unwinding damping mechanism 11, and the winding power mechanism 12 constitute the baseband conveying mechanism.

[0020] This embodiment achieves automated and intelligent control, adopts a modular design to facilitate equipment maintenance and cleaning, and is equipped with a quick disassembly device for easy and rapid equipment replacement.

[0021] The overall structural layout of the prototype ODF film-forming machine in this embodiment is shown in the attached figure. Figure 2 As shown.

[0022] The feeding mechanism in this embodiment is as follows: Figure 3As shown, the peristaltic pump 202 in the feeding mechanism delivers the slurry from the slurry container 204 into the slitting machine 212 through the hose 203. The ultrasonic level gauge 208 monitors the slurry level in the slitting machine 204 in real time and transmits the signal to the PLC to control the start, stop, and speed of the peristaltic pump. Under the coordinated action of the traction power mechanism 10, the unwinding damping mechanism 11, and the winding power mechanism 12, the blank baseband 206 adjusts the servo motor speed of the traction roller according to the coating uniformity and production requirements, thereby adjusting the baseband movement speed and thus the coating speed.

[0023] The coating mechanism in this embodiment consists of a doctor blade mechanism and a slitting device. The doctor blade mechanism is shown in the attached diagram. Figure 4 As shown, the upper end of the scraper 308 is fixed to the tool holder 310. The tool holder 310 and the scraper 308 are limited to the left and right by the fixing seats 307 and 312. The precise vertical displacement of the tool holder 310 and the scraper 308 is achieved by manually operating the micrometer heads 302 and 317. The digital micrometers 303 and 317 are fixed to the brackets 304 and 315. The right measuring rod 305 and the left measuring rod 314 of the digital micrometers abut against the right extension arm 306 and the left extension arm 313 of the tool holder, respectively. First, adjust the tool holder 310 to the lowest position and clear the values ​​of the digital micrometers 303 and 317 to zero. Then, adjust the tool holder 310 to rise. At this time, the displayed value of the digital micrometer is the height between the lower edge of the scraper 308 and the baseband. Based on the required thickness of the coating slurry on the baseband, the vertical displacement of the doctor blade 308 is determined by adjusting the micrometer heads 302 and 317 according to the real-time height values ​​displayed by the digital micrometers 303 and 317. This precise control of the doctor blade 308 ensures accurate and uniform coating thickness on the baseband during the coating process. This embodiment employs a high-precision adjustment mechanism and real-time height data feedback from the digital micrometer to guarantee precise doctor blade height adjustment.

[0024] The slitting device in this embodiment is as shown in the attached diagram. Figure 5 As shown, the slitting width can be customized according to production needs; different slitting machines can be used to achieve different widths and numbers of slits. The slitting machine and scraper structure in this embodiment is shown in the attached figure. Figure 6 As shown. This embodiment uses a drying apparatus (see attached diagram). Figure 2The drying chamber is divided into an upper drying chamber 105 and a lower drying chamber 110. A fan delivers air into an electric heater container controlled by a PID controller. The electric heater continuously outputs constant-temperature hot air. This constant-temperature hot air enters the upper drying chamber 105 through the upper drying chamber's circulating air inlet 106, exits through the upper drying chamber's circulating air outlet 107, then enters the lower drying chamber 110 through the lower drying chamber's circulating air inlet 108, and exits through the lower drying chamber's circulating air outlet 109. After being mixed with fresh air, it re-enters the electric heater and is heated to a constant temperature. The mixed fresh air also regulates the humidity of the hot air. Temperature sensors 104 and 111 are installed in both the upper and lower drying chambers to monitor the temperature and humidity in real time. This reciprocating multi-layer drying chamber in this embodiment reduces space occupation, and the multi-stage hot air circulation heating and mixing method improves drying efficiency, enabling the recycling of hot air and improving thermal energy utilization efficiency.

Claims

1. A pilot-scale film casting machine for a mouth-dissolving film, comprising a feeding mechanism, a coating mechanism, a drying device, and a control device, characterized in that: The feeding mechanism is composed of a medicine paste platform, a medicine paste container, a conveying hose, a peristaltic pump, a liquid level sensor and a rotatable support, the medicine paste container is placed on the medicine paste platform, one end of the conveying hose is inserted into the medicine paste container, the middle section of the conveying hose passes through the peristaltic pump, the other end of the conveying hose extends into the upper cavity of the slitting device, the liquid level sensor is located above the upper cavity of the slitting device and is fixed to the rotatable support, the peristaltic pump sends the medicine paste into the upper cavity of the slitting device through the conveying hose, the liquid level sensor monitors the liquid level of the medicine paste in the upper cavity of the slitting device in real time and transmits the liquid level signal to the control device, thereby controlling the start-stop and speed of the peristaltic pump; the coating mechanism is composed of a slitting device, a scraper adjusting mechanism, a traction power mechanism, a unwinding damping mechanism and a winding power mechanism, the scraper adjusting mechanism is composed of a support, a fixed seat, a knife holder and a scraper, a top plate, a differential head and a digital micrometer, the lower part of the fixed seat is fixed to the coating platform, the upper part is fixed to the top plate, the scraper is fixed to the lower end of the knife holder, the knife holder is limited in the sliding groove of the fixed seat on both sides, the differential head fixed to the top plate is connected to the knife holder, adjusting the differential head can move the knife holder and the scraper up and down, the digital micrometer displays the thickness of the coated medicine paste in real time and transmits the signal to the control device, and the differential head is manually adjusted to move the scraper up and down.

2. A pilot scale film coating machine for film coating of orally dissolving film dosage forms as claimed in claim 1, wherein: The drying device includes an upper drying chamber, a lower drying chamber, a fan, an air electric heater, a drying temperature controller and a hot circulating air conveying pipeline, the upper and lower drying chambers are both composed of a box, a hot circulating air inlet, a hot circulating air outlet and a temperature sensor, the drying temperature controller uses the fan to send air into the electric heater for heating, then sends it into the upper and lower drying chambers, and mixes with fresh air to adjust the hot air temperature, the temperature sensor in the drying chamber transmits the temperature signal to the drying temperature controller in real time, thereby making the hot air input into the drying chamber have a fixed temperature.

3. The pilot scale film casting machine for film casting of orally dissolving film dosage form as claimed in claim 1 wherein: The control device is composed of a programmable controller (PCL) and a human-machine interface, the programmable controller (PCL) is connected with the feeding mechanism, the coating mechanism and the drying device for signal control, realizing automatic and intelligent control.

4. The pilot scale film casting machine for film casting of orally dissolving film dosage form as claimed in claim 1 wherein: The width of the slitting device of the scraper adjusting mechanism is customized according to the needs of pilot test, and different slitting devices can realize coating with different widths and numbers of strips.

5. The pilot scale film casting machine for film casting of orally dissolving film dosage form as claimed in claim 1 wherein: The coating speed controller adjusts the speed of the servo motor of the traction power mechanism according to the coating uniformity and yield requirements, realizing the adjustment of the coating speed.

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