An apparatus for preparing a pharmaceutical composite membrane

Abstract

This invention provides a pharmaceutical composite film preparation apparatus, comprising a coating machine body and a glue tank disposed in the middle of the coating machine body, and further comprising: an upper stirring component disposed above the glue tank, including two first electric push rods fixedly connected to both sides of the glue tank, a movable rod whose extended ends of the two first electric push rods are jointly fixedly connected, and multiple rotating rods rotatably connected to the movable rod. The multiple rotating rods are connected to each other by a transmission belt. A motor for driving any one of the multiple rotating rods is fixedly connected to the movable rod, and a first stirring rod is fixedly connected to the bottom of each of the multiple rotating rods. The pharmaceutical composite film preparation apparatus provided by this invention, through the vertically staggered collaborative design of the upper and lower stirring components, effectively breaks the layering phenomenon caused by the density difference of the glue solution, so that the drug particles and solvent are uniformly dispersed, reducing the coating thickness deviation and the pinhole defect rate of the film material.

Description

Technical Field

[0001] This utility model relates to the field of pharmaceutical composite film processing technology, specifically to a pharmaceutical composite film preparation device. Background Technology

[0002] Pharmaceutical composite films, as an important drug carrier, are widely used in sustained-release formulations, transdermal patches, and high-end pharmaceutical packaging. Their preparation process typically includes key steps such as substrate unwinding, adhesive coating, drying and curing, and multilayer lamination. Among these, the coating process directly determines the uniformity of the distribution of active pharmaceutical ingredients and the physicochemical properties of the film material. Traditional coating machines store the adhesive in a glue tank and use a stirring device to maintain the fluidity of the adhesive to avoid particle sedimentation or solvent stratification. However, the stirring structure of existing coating machines mostly adopts mechanical stirring in one direction, which is difficult to adapt to the high-precision coating requirements of pharmaceutical adhesives.

[0003] In actual production, it has been found that because pharmaceutical adhesives often contain nano-drug-carrying particles, heat-sensitive components, or multiphase solvent systems, traditional stirring devices are prone to separation of the upper and lower layers of adhesive in the adhesive tank during operation. Specifically, the upper layer of adhesive is subject to eddy currents that entrain air bubbles due to excessive mechanical stirring, while the lower layer of high-density components forms sediments due to insufficient stirring force. This stratification directly causes uneven coating thickness, deviation in drug distribution, and even defects such as pinholes and cracks in the film material, seriously affecting the accuracy of drug release and the product qualification rate. Although existing technologies attempt to improve uniformity by optimizing the stirring speed or adding a static mixer, the dynamic mixing of the upper and lower layers of adhesive in the adhesive tank remains a major technical bottleneck that urgently needs to be solved.

[0004] In view of this, a device for preparing pharmaceutical composite membranes is proposed. Utility Model Content

[0005] The purpose of this invention is to solve the problem of fluid separation between the upper and lower layers of adhesive in the adhesive pool of traditional pharmaceutical composite membrane preparation devices, which leads to uneven coating thickness, drug distribution deviation and membrane material defects, thus affecting the product qualification rate. The invention provides a pharmaceutical composite membrane preparation device.

[0006] To solve the above-mentioned technical problems, this utility model adopts the following technical solution: a pharmaceutical composite film preparation apparatus, comprising a coating machine body and a glue tank disposed in the middle of the coating machine body, and further comprising:

[0007] The upper stirring component is located at the top of the glue tank and includes two first electric push rods fixedly connected to both sides of the glue tank, a movable rod fixedly connected to the extended ends of the two first electric push rods, and multiple rotating rods rotatably connected to the movable rod. The multiple rotating rods are connected to each other by a transmission belt. A motor for driving any one of the multiple rotating rods to rotate is fixedly connected to the movable rod. A first stirring rod is fixedly connected to the bottom of each of the multiple rotating rods. The upper stirring component is used to stir the glue liquid above the composite film substrate in the glue tank.

[0008] The lower stirring component is located at the bottom of the glue tank and includes two second electric push rods fixed to the inner wall of the glue tank and two second stirring rods fixed to the extended ends of the two second electric push rods. The lower stirring component is used to turbulently stir the glue liquid below the composite film substrate in the glue tank.

[0009] The upper and lower stirring components are vertically misaligned in their movement trajectories, and their stirring frequency ratio is 1:2-1:5.

[0010] Preferably, the rotating rod is fixedly connected to multiple rotating rings with a T-shaped cross-section, and the rotating rod is provided with multiple rotating grooves that are adapted to the rotating rings.

[0011] Preferably, the first stirring rod is arranged in a cross shape, and the end of the cross shape is provided with a 45°-60° guide slope. When the first stirring rod is at its lowest point, the lowest point of the movable rod is higher than the liquid surface of the adhesive.

[0012] Preferably, multiple combs are fixedly connected to the second electric push rod, the two second electric push rods are staggered in the height direction, and the combs of the two second stirring rods are staggered on the horizontal projection plane.

[0013] Preferably, the speed of the motor is adjustable in the range of 100-1000 rpm and is related to the transmission ratio of the transmission belt, so that the linear velocity of the first stirring rod is maintained at 0.5-3 m / s and the extension frequency of the second electric push rod is 0.5-2 Hz.

[0014] Preferably, the distance between the movable rod of the upper stirring component and the inner wall of the glue tank is 5-15cm, and the extension and retraction stroke of the first electric push rod is dynamically matched with the fluctuation range of the liquid level in the glue tank.

[0015] Preferably, the distance between the lowest point of the first stirring rod of the upper stirring component and the upper surface of the composite film substrate is 5-20 mm, the distance between the highest point of the second stirring rod of the lower stirring component and the lower surface of the composite film substrate is 10-30 mm, and the vertical distance between the first stirring rod and the second stirring rod is not less than 3-5 times the thickness of the composite film substrate.

[0016] Compared with the prior art, this utility model has the following beneficial effects:

[0017] The pharmaceutical composite membrane preparation device provided by this utility model adopts a vertically staggered collaborative design of upper and lower stirring components. The upper stirring component stirs the surface layer of the adhesive solution in a rotating flow guiding manner, while the lower stirring component stirs the bottom layer of the adhesive solution in a turbulent manner by the reciprocating pushing and sweeping of the comb. The two form a coordinated flow field between the upper and lower layers with a stirring frequency ratio of 1:2 to 1:5, which effectively breaks the layering phenomenon caused by the density difference of the adhesive solution, so that the drug particles and solvent are evenly dispersed, reducing the coating thickness deviation and the pinhole defect rate of the membrane material.

[0018] The pharmaceutical composite membrane preparation device provided by this utility model uses the design of the first stirring rod guide slope and the second stirring rod comb to guide the upper layer of adhesive liquid to the surface of the substrate by the guide slope, while the comb compresses the flow space of the bottom layer of adhesive liquid during the pushing and sweeping process, forcing the precipitated particles to redisperse. The two work together to eliminate the flow dead zone of traditional stirring, increase the viscosity of the adhesive liquid, and reduce the fluctuation range of solvent residue.

[0019] The pharmaceutical composite membrane preparation device provided by this utility model has a dynamic matching design of the distance between the moving rod of the upper stirring component and the inner wall of the glue pool. Combined with the 5-20mm safety distance control between the lowest point of the first stirring rod and the substrate, the stirring rod lifting amplitude is automatically adjusted when the liquid surface fluctuates. This avoids the stirring rod touching the substrate and causing damage to the microporous structure, while ensuring the complete wettability of the glue liquid covering the substrate. At the same time, it can also adapt to the production needs of composite membranes of different thicknesses. Attached Figure Description

[0020] The accompanying drawings, which form part of this application, are used to provide a further understanding of the present invention. The illustrative embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute an improper limitation of the present invention.

[0021] In the attached diagram:

[0022] Figure 1 This is a three-dimensional structural diagram of an embodiment of the present utility model.

[0023] Figure 2 This is a schematic diagram of the internal structure of the glue tank according to an embodiment of the present invention.

[0024] Figure 3 This is a cross-sectional schematic diagram of the rotating rod and rotating ring according to an embodiment of the present invention.

[0025] Figure 4 This is a diagram showing the positional relationship between the two second stirring rods in one embodiment of the present invention.

[0026] In the diagram: 1. Coating machine body; 11. Adhesive tank; 2. Upper stirring component; 21. First electric push rod; 22. Movable rod; 23. Rotating rod; 231. Rotating ring; 232. Rotating groove; 24. First stirring rod; 25. Transmission belt; 26. Motor; 3. Lower stirring component; 31. Second electric push rod; 32. Second stirring rod; 33. Comb insert. Detailed Implementation

[0027] The technical solutions of this utility model will be clearly and completely described below with reference to the embodiments of this utility model. Obviously, the described embodiments are only a part of the embodiments of this utility model, and not all of them. Unless otherwise specified, the embodiments and features in the embodiments of this application can be combined with each other. Based on the embodiments of this utility model, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this utility model.

[0028] Please see Figure 1-4 .

[0029] The apparatus for preparing the pharmaceutical composite film of this invention includes a coating machine body 1 and a glue tank 11 disposed in the middle of the coating machine body 1. A first electric push rod 21 is fixedly disposed on the glue tank 11, and a movable rod 22 is slidably disposed thereon. Multiple rotating rods 23 are rotatably connected to the movable rod 22 and are linked by a transmission belt 25. A cross-shaped first stirring rod 24 is fixed to the bottom of the rotating rod 23. A motor 26 drives any one of the rotating rods 23 to drive the other rotating rods 23 to rotate synchronously. This design can realize the layered stirring of the upper layer of the glue tank 11, and generate directional vortex flow by using the synchronous rotation of multiple stirring rods, avoiding the vortex entanglement of traditional single stirring. Air bubbles are introduced, and the height of the movable rod 22 can be adjusted by the first electric push rod 21 to adapt to the stirring requirements of different liquid levels of the adhesive. The bottom of the adhesive tank 11 is provided with a stirring component 3, including a second electric push rod 31 fixed to the inner wall of the adhesive tank 11 and a second stirring rod 32 at its extended end. The second stirring rod 32 is driven by the extension and retraction of the second electric push rod 31 to reciprocate to push and sweep the bottom of the adhesive tank 11, forming turbulent disturbance, which forces the precipitated particles to redisperse. The upper and lower stirring components 3 work together at a frequency ratio of 1:2 to 1:5. The vertically staggered motion trajectory avoids flow field interference, thereby completely solving the problem of flow separation between the upper and lower layers of adhesive.

[0030] Specifically, multiple rotating rings 231 with T-shaped cross sections are fixedly connected to the rotating rod 23. Multiple rotating grooves 232 that are adapted to the rotating rings 231 are opened on the rotating rod 23. This structure enhances the contact stability between the transmission belt 25 and the rotating rod 23 through the cooperation of the T-shaped rotating rings 231 and the rotating grooves 232, preventing the belt from slipping or dislodging during high-speed rotation. At the same time, the rotating rings 231 can move slightly axially along the rotating grooves 232 to compensate for dimensional tolerances during transmission and ensure the synchronization accuracy of the multiple rotating rods 23.

[0031] Secondly, the first stirring rod 24 is arranged in a cross shape, and the end of the cross shape is provided with a 45°-60° guide slope. When the first stirring rod 24 is at its lowest point, the lowest point of the movable rod 22 is higher than the liquid surface of the adhesive. The cross-shaped structure can increase the stirring area, and the guide slope directs the adhesive to the substrate surface, improving the uniformity of coating and wetting. At the same time, the height limitation of the movable rod 22 ensures that the stirring rod is always above the liquid surface, avoiding adhesive splashing or adhesion when the machine stops.

[0032] Furthermore, multiple combs 33 are fixedly connected to the second electric push rod 31. The two second electric push rods 31 are staggered in the height direction, and the combs 33 of the two second stirring rods 32 are staggered on the horizontal projection plane. This arrangement can generate multi-directional shear force through the toothed structure of the combs 33 during reciprocating pushing and sweeping, effectively breaking up the agglomerated particles of the bottom adhesive. In addition, the staggered height and horizontal staggered design of the double stirring rods can cover the entire bottom area of ​​the adhesive pool 11, eliminating the flow dead zone of traditional single-axis stirring.

[0033] In addition, the speed of motor 26 is adjustable from 100 to 1000 rpm and is related to the transmission ratio of transmission belt 25, so that the linear velocity of the first stirring rod 24 is maintained at 0.5-3 m / s and the extension frequency of the second electric push rod 31 is 0.5-2 Hz. Specifically, by matching the linear velocity and extension frequency, the upper swirling flow and the bottom turbulent flow complement each other. When the linear velocity is below 1 m / s, the shearing damage to heat-sensitive drugs is reduced, and when it is above 2 m / s, the dispersion efficiency of high-viscosity adhesive is enhanced. The low-frequency extension and retraction of the bottom push rod can avoid excessive disturbance that causes secondary sedimentation of dispersed particles.

[0034] Furthermore, the distance between the movable rod 22 of the upper stirring component 2 and the inner wall of the glue tank 11 is 5-15cm, and the extension and retraction stroke of the first electric push rod 21 is dynamically matched with the fluctuation range of the liquid level in the glue tank 11. Setting a distance of 5-15cm provides a safe swing space for the stirring rod to prevent collision with the inner wall of the glue tank 11. The dynamic matching design can be implemented by adding existing devices such as liquid level sensors to provide real-time feedback and adjust the height of the movable rod 22 to ensure that the stirring range covers the effective area of ​​the glue at different liquid levels.

[0035] Specifically, the distance between the lowest point of the first stirring rod 24 of the upper stirring component 2 and the upper surface of the composite film substrate is 5-20mm, and the distance between the highest point of the second stirring rod 32 of the lower stirring component 3 and the lower surface of the composite film substrate is 10-30mm. The vertical distance between the first stirring rod 24 and the second stirring rod 32 is not less than 3-5 times the thickness of the composite film substrate. This distance setting not only prevents the stirring rod from touching the substrate and causing physical damage, but also avoids the combined impact of the upper and lower flow fields on the substrate through the multiple relationship of the vertical distance, ensuring the stable transfer and uniform coating of the substrate in the adhesive.

[0036] When using this device, the composite film substrate passes through the middle of the glue tank 11 at a constant speed during the winding and unwinding process of the coating machine. The upper stirring component 2 adjusts the height of the movable rod 22 through the first electric push rod 21, so that the cross-shaped stirring rods at the bottom of multiple rotating rods 23 rotate on the surface of the glue liquid, forming a layered directional swirling flow. At the same time, the motor 26 drives the rotating rods 23 to drive the transmission belt 25 at a set speed to ensure that the stirring range covers the upper part of the glue tank 11. Meanwhile, the lower stirring component 3 drives the comb-type stirring rod 33 through the second electric push rod 31 to push and sweep back and forth at the bottom of the glue tank 11, shearing the bottom glue liquid and generating turbulence, forcing the precipitated particles to redisperse. The upper and lower stirring components 3 work together at a staggered frequency. The upper swirling flow and the bottom turbulence form a complementary flow field above and below the substrate. The density difference of the glue liquid is dynamically broken, and the drug particles and solvent are uniformly mixed, ultimately achieving uniform coating thickness and integrity of the film structure.

[0037] It is important to note that during implementation, the speed of the upper stirring motor 26 and the extension / retraction frequency of the lower stirring push rod need to be dynamically adjusted according to the viscosity of the adhesive, solid content, and thickness of the composite film substrate to ensure that the linear velocity of the upper layer matches the turbulence intensity of the lower layer. In addition, the vertical safety distance between the upper stirring rod and the substrate should be precisely calibrated during installation to avoid physical damage caused by the stirring rod touching the substrate. At the same time, the tension of the transmission belt 25 and the axial movement compensation capability of the rotating ring 231 should be checked regularly to prevent transmission failure. Furthermore, the optimal stirring parameters should be determined through experiments based on the heat sensitivity or shear sensitivity of different drug components to avoid high-speed rotation damaging drug activity. In addition, the sealing of the adhesive pool 11 and the cleaning and maintenance of the teeth of the comb 33 should be included in daily inspections to prevent the adhesive from curing and clogging or cross-contamination.

[0038] It will be apparent to those skilled in the art that this invention is not limited to the details of the exemplary embodiments described above, and that it can be implemented in other specific forms without departing from the spirit or essential characteristics of this invention. Therefore, the embodiments should be considered exemplary and non-limiting in all respects, and the scope of this invention is defined by the appended claims rather than the foregoing description. Thus, it is intended that all variations falling within the meaning and scope of equivalents of the claims be included within this invention.

Claims

1. An apparatus for preparing a pharmaceutical composite film, comprising a coating machine body (1) and a glue tank (11) disposed in the middle of the coating machine body (1), characterized in that, Also includes: The upper stirring component (2) is set at the upper part of the glue tank (11), including two first electric push rods (21) fixedly connected to both sides of the glue tank (11), a movable rod (22) fixedly connected to the extended ends of the two first electric push rods (21), and a plurality of rotating rods (23) rotatably connected to the movable rod (22). The plurality of rotating rods (23) are connected to each other by a transmission belt (25). A motor (26) for driving any one of the plurality of rotating rods (23) to rotate is fixedly connected to the movable rod (22). A first stirring rod (24) is fixedly connected to the bottom of each of the plurality of rotating rods (23). The upper stirring component (2) is used to stir the glue liquid above the composite film substrate in the glue tank (11). The lower stirring component (3) is set at the bottom of the glue tank (11) and includes two second electric push rods (31) fixed on the inner wall of the glue tank (11) and two second stirring rods (32) fixed on the extended ends of the two second electric push rods (31). The lower stirring component (3) is used to turbulently stir the glue liquid below the composite film substrate in the glue tank (11). The motion trajectories of the upper stirring component (2) and the lower stirring component (3) are misaligned in the vertical direction, and the stirring frequency ratio is 1:2-1:

5.

2. The apparatus for preparing the pharmaceutical composite film as described in claim 1, characterized in that: The rotating rod (23) is fixedly connected to a plurality of rotating rings (231) with a cross-section in the shape of a T. The rotating rod (23) is provided with a plurality of rotating grooves (232) that are adapted to the rotating rings (231).

3. The apparatus for preparing the pharmaceutical composite film as described in claim 1, characterized in that: The first stirring rod (24) is arranged in a cross shape, and the end of the cross shape is provided with a 45°-60° guide slope. When the first stirring rod (24) is at the lowest point, the lowest point of the movable rod (22) is higher than the liquid surface of the adhesive.

4. The apparatus for preparing a pharmaceutical composite film as described in claim 1, characterized in that: Multiple combs (33) are fixedly connected to the second electric push rod (31). The two second electric push rods (31) are staggered in the height direction, and the combs (33) of the two second stirring rods (32) are staggered on the horizontal projection plane.

5. The apparatus for preparing a pharmaceutical composite film as described in claim 1, characterized in that: The speed of the motor (26) is adjustable from 100 to 1000 rpm and is related to the transmission ratio of the transmission belt (25), so that the linear speed of the first stirring rod (24) is maintained at 0.5-3 m / s and the extension frequency of the second electric push rod (31) is 0.5-2 Hz.

6. The apparatus for preparing a pharmaceutical composite film as described in claim 1, characterized in that: The distance between the movable rod (22) of the upper stirring component (2) and the inner wall of the glue tank (11) is 5-15cm, and the extension stroke of the first electric push rod (21) is dynamically matched with the fluctuation range of the liquid level height in the glue tank (11).

7. The apparatus for preparing a pharmaceutical composite film as described in claim 1, characterized in that: The distance between the lowest point of the first stirring rod (24) of the upper stirring component (2) and the upper surface of the composite film substrate is 5-20 mm, the distance between the highest point of the second stirring rod (32) of the lower stirring component (3) and the lower surface of the composite film substrate is 10-30 mm, and the vertical distance between the first stirring rod (24) and the second stirring rod (32) is not less than 3-5 times the thickness of the composite film substrate.

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