Emulsion ophthalmic preparation continuous preparation system and preparation process based on circulating homogenization

By using a circulating homogenization system and process, the problems of homogenization dead zones and uneven particle size in emulsion ophthalmic preparations have been solved, achieving uniformity in particle size distribution and improved homogenization efficiency, thus ensuring the stability and uniformity of the emulsion.

CN121198129APending Publication Date: 2025-12-26GUANGDONG LUSTRE PHARM LAB CO LTD
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Patent Information

Application Number
CN202511739067.1
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-11-25
Publication Date
2025-12-26

AI Technical Summary

Technical Problem

In the homogenization process of emulsion ophthalmic preparations, there are problems of homogenization dead zones and uneven droplet size. In particular, the effective area of ​​the rotor-stator structure is small, which makes it impossible for some solutions to be fully homogenized. Furthermore, the stable flow field mode of the shear structure is difficult to prevent droplet re-aggregation.

Method used

The system and process based on circulation homogenization are adopted. Through the combination of a stirring tank, a homogenizing tank, a pumping cylinder and a swash plate reflux mechanism, the solution is circulated and dynamically disturbed. This ensures that the solution at the edge of the homogenizing tank re-enters the high-shear zone for secondary treatment. Combined with the reciprocating swash plate motion of the swash plate and the flow guidance of the arc-shaped guide plate, droplet aggregation is prevented.

Benefits of technology

This method achieves uniformity in emulsion particle size distribution and improves homogenization efficiency, avoiding local inhomogeneity and dead zones in traditional methods, shortening processing time, and ensuring the stability and uniformity of the emulsion.

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Abstract

The invention relates to the technical field of ophthalmic preparation preparation, in particular to an emulsion ophthalmic preparation continuous preparation system and process based on circulation homogenization, the system comprises a homogenization tank and a stirring tank fixed at the top of the homogenization tank, the bottom of the stirring tank is communicated with a conveying pipe communicated with the homogenization tank, and a stirring assembly is arranged in the stirring tank; the pumping cylinder is fixed in the homogenizing tank, and a homogenizing mechanism for homogenizing the solution is arranged on the pumping cylinder; the circulating assembly is arranged on the pumping cylinder and is used for circularly pumping the solution at the edge of the homogenizing tank to the action area of the homogenizing mechanism; the deflection backflow mechanism is arranged on the pumping cylinder, a deflection blade is connected to the deflection backflow mechanism, an arc-shaped guide plate is fixed to the deflection blade, and when the solution is separated from the homogenizing area and acts on the deflection blade, the deflection backflow mechanism can control the deflection blade to execute reciprocating deflection action so as to disturb flow of the solution, and it is ensured that the solution is fully homogenized.
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Description

TECHNICAL FIELD

[0001] The present application relates to the field of ophthalmic preparation technology, in particular to a continuous preparation system and process for emulsion ophthalmic preparation based on circulating homogenization. BACKGROUND

[0002] Emulsion ophthalmic preparation is an important ocular drug delivery system, which is usually a uniform dispersion system formed by water phase and oil phase under the action of emulsifier. This kind of preparation can accommodate both hydrophilic and hydrophobic drugs, improve drug bioavailability, and has a wide application in ophthalmic treatment.

[0003] In the preparation process of emulsion ophthalmic preparation, the oil phase and the water phase need to be heated to a suitable temperature first, then the oil phase is slowly added to the water phase under stirring to form a coarse emulsion, and finally refined by homogenization equipment.

[0004] In the homogenization process, high-speed shearing emulsifier is usually used to process the mixed solution, which utilizes the rotor-stator structure to generate strong mechanical shearing effect to realize the homogenization of the solution. However, in the homogenization process, the effective area of the rotor-stator structure is small, and under the action of high-speed centrifugation, part of the solution in the edge area of the tank cannot flow back. The solution in this area can only be subjected to single homogenization treatment, which can easily produce treatment dead angles, resulting in poor emulsion uniformity and large particle size of some emulsion droplets. In addition, the continuous rotation of the shearing structure can easily form a stable flow field pattern, which is difficult to produce effective disturbance to prevent the re-aggregation of emulsion droplets. SUMMARY

[0005] The present application aims to provide a continuous preparation system and process for emulsion ophthalmic preparation based on circulating homogenization to solve the problems raised in the background.

[0006] To achieve the above-mentioned purpose, the present application provides the following technical solution: a continuous preparation system for emulsion ophthalmic preparation based on circulating homogenization, comprising: a homogenization tank and a stirring tank fixed on the top of the homogenization tank, the bottom of the stirring tank is connected with a conveying pipe connected with the homogenization tank, and a stirring assembly is arranged in the stirring tank; further comprising: a pumping cylinder fixed in the homogenization tank, a homogenization mechanism for homogenizing the solution is arranged on the pumping cylinder; a circulating assembly is arranged on the pumping cylinder for circulating and pumping the solution at the edge of the homogenization tank to the action area of the homogenization mechanism.

[0007] As a further solution of the present application: the homogenization mechanism comprises a second motor fixed at the bottom of the homogenization tank, a rotating rod penetrating through the pumping cylinder and connected with the output shaft of the second motor is rotatably installed in the homogenization tank, and a crushing blade is fixed at the end of the rotating rod.

[0008] As a further further scheme of the present application: the top of the pumping cylinder is fixed with a stator pipe, the outer wall of the stator pipe is formed with a plurality of through grooves distributed at equal intervals in the circumference, and the end of the stator pipe is fixed with a tapered pipe.

[0009] As a further further scheme of the present application: the circulating assembly comprises a piston disc slidingly and sealingly connected in the pumping cylinder, and the bottom of the homogenizing tank is fixed with a cylinder penetrating through the pumping cylinder and fixedly connected with the piston disc.

[0010] As a further further scheme of the present application: the outer wall of the pumping cylinder is connected with an absorption pipe, and the top of the pumping cylinder is connected with a plurality of backflow nozzles distributed at equal intervals in the circumference.

[0011] As a further further scheme of the present application: further comprising a yawing backflow mechanism arranged on the pumping cylinder, a yawing blade is connected to the yawing backflow mechanism, an arc-shaped guide plate is fixed to the yawing blade, the yawing backflow mechanism can act when the yawing blade is impacted, and controls the yawing blade to perform reciprocating yawing action; as a further further scheme of the present application: the yawing backflow mechanism comprises a support frame fixed to the pumping cylinder, a support rod is fixed to the support frame, a sealing pipe is rotatably installed on the support rod and arranged symmetrically, and the sealing pipe is fixedly connected with the yawing blade.

[0012] As a further further scheme of the present application: further comprising a guide assembly and an elastic assembly arranged on the support rod and connected with the sealing pipe; the guide assembly comprises helical grooves formed in the outer wall of the support rod and arranged symmetrically, and movable sleeves are arranged symmetrically on the support rod in the axial direction, and a limiting block is fixed to the inner wall of the movable sleeve and slidingly fitted in the helical groove; the elastic assembly comprises a clamping groove formed in the inner wall of the sealing pipe, a limiting ring is fixed to the movable sleeve and slidingly fitted in the clamping groove, and a spring is sleeved on the support rod, and the two ends of the spring abut against the limiting ring and the inner wall of the sealing pipe, respectively.

[0013] As a further further scheme of the present application: the stirring assembly comprises a first motor fixed to the top of the stirring tank, a transmission rod connected with the output shaft of the first motor is rotatably installed in the stirring tank, and stirring blades are fixed to the transmission rod.

[0014] The continuous preparation process of the emulsion eye preparation based on circulating homogenization comprises the following steps: Step one: add the required raw materials for preparation into the stirring tank according to the proportion, respectively; Step two: under the action of the stirring assembly, the raw materials are preliminarily mixed; Step three: the mixed raw materials are transported into the homogenizing tank through the conveying pipe, and the raw materials are subjected to homogenizing treatment under the action of the homogenizing mechanism, at the same time, the circulating assembly works and guides the solution at the edge of the homogenizing tank to flow back to the action area of the homogenizing mechanism; Step four: the homogenizing mechanism guides the solution to impact on the eccentric swing blade, and drives the eccentric swing flow back mechanism to move, so that the eccentric swing blade performs reciprocating eccentric swing action to disturb the solution and guide the solution to flow back to the action area of the homogenizing mechanism again.

[0015] Compared with the prior art, the beneficial effects of the present application are that: after the preliminary emulsification is completed in the stirring tank, the coarse emulsion after the preliminary emulsification can be quickly transferred to the next process, effectively avoiding the phase separation phenomenon that may occur in the traditional transfer process, and in combination with the circulating flow back and dynamic disturbance, the uniformity of the drop particle size distribution after homogenization is ensured.

[0016] Through the cooperation of the circulating assembly and the eccentric swing flow back mechanism, the solution is subjected to circulating flow back, ensuring the uniformity of the solution homogenization. Under the forced flow back action of the circulating assembly, the solution in the edge area of the homogenizing tank can be continuously pumped back to the high shear action area, and through the forced circulating flow back mode, the homogenizing emulsification efficiency can be improved, thereby shortening the homogenizing treatment time, and the uniformity of the solution treatment in the tank can be ensured, effectively avoiding the local unevenness or dead angle problem, so that the final obtained emulsion particle size distribution reaches the required value.

[0017] When the solution is homogenized and forms a high-speed fluid impact on the eccentric swing blade, the eccentric swing flow back mechanism can guide the eccentric swing blade to perform reciprocating eccentric swing action, and under the action of the eccentric swing blade, the stable laminar boundary layer is effectively broken, the re-aggregation of the emulsion drops is prevented, and at the same time, through the flow guiding of the arc-shaped guide plate to the solution, a stable internal flow back channel is established, so that part of the emulsion can automatically return to the homogenizing area for secondary treatment. BRIEF DESCRIPTION OF DRAWINGS

[0018] Figure 1 Structure schematic view of the embodiment of the continuous preparation system of the emulsion ophthalmic preparation based on circulating homogenization; Figure 2 Structure schematic view of the embodiment of the continuous preparation system of the emulsion ophthalmic preparation based on circulating homogenization from another angle; Figure 3 Structure schematic view of the embodiment of the continuous preparation system of the emulsion ophthalmic preparation based on circulating homogenization; Figure 4 Structure schematic view of the embodiment of the continuous preparation system of the emulsion ophthalmic preparation based on circulating homogenization, showing the cross-sectional structure of the stirring tank, the homogenizing tank and the pumping cylinder; Figure 5 Structure schematic view of the embodiment of the continuous preparation system of the emulsion ophthalmic preparation based on circulating homogenization, showing the cross-sectional structure of the stirring tank, the homogenizing tank and the pumping cylinder; Figure 4 Structure schematic view of the embodiment of the continuous preparation system of the emulsion ophthalmic preparation based on circulating homogenization, showing the cross-sectional structure of the stirring tank, the homogenizing tank and the pumping cylinder; Figure 6 Structure diagram of the inside of the homogenizing tank in the embodiment of the continuous preparation system of the emulsion type ophthalmic preparation based on circulating homogenization; Figure 7 Structure diagram of the inside of the homogenizing tank in the embodiment of the continuous preparation system of the emulsion type ophthalmic preparation based on circulating homogenization; Figure 8 Structure diagram of the inside of the homogenizing tank in the embodiment of the continuous preparation system of the emulsion type ophthalmic preparation based on circulating homogenization; Figure 9 Structure diagram of the inside of the homogenizing tank in the embodiment of the continuous preparation system of the emulsion type ophthalmic preparation based on circulating homogenization; Figure 10 Structure diagram of the inside of the homogenizing tank in the embodiment of the continuous preparation system of the emulsion type ophthalmic preparation based on circulating homogenization; Figure 11 Structure diagram of the inside of the homogenizing tank in the embodiment of the continuous preparation system of the emulsion type ophthalmic preparation based on circulating homogenization.

[0019] In the figure: 1, homogenizing tank; 2, stirring tank; 3, first motor; 4, transmission rod; 5, stirring blade; 6, conveying pipe; 7, pumping cylinder; 8, piston disc; 9, air cylinder; 10, absorption pipe; 11, second motor; 12, rotating rod; 13, crushing blade; 14, stator pipe; 1401, through groove; 1402, conical pipe; 15, support frame; 16, support rod; 1601, helical groove; 17, sealing pipe; 1701, clamping groove; 18, deflection blade; 1801, arc-shaped guide plate; 19, movable sleeve; 1901, limiting block; 20, limiting ring; 21, spring; 22, backflow nozzle. DETAILED DESCRIPTION

[0020] The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative work fall within the scope of protection of the present application.

[0021] In addition, the elements in the present application are referred to as "fixed to" or "provided on" another element, which can be directly on another element or can have a middle element. When an element is considered to be "connected" to another element, it can be directly connected to another element or can have a middle element. The terms "vertical", "horizontal", "left", "right" and similar expressions used herein are only for illustrative purposes and do not represent the only implementation.

[0022] Please refer to Figures 1-11 In the embodiment of the present application, the continuous preparation system of the emulsion eye preparation based on circulating homogenization comprises: a homogenization tank 1 and a stirring tank 2 fixed on the top of the homogenization tank 1, the bottom of the stirring tank 2 is connected with a conveying pipe 6 connected with the homogenization tank 1, and a stirring assembly is arranged in the stirring tank 2; further comprising: a pumping cylinder 7 fixed in the homogenization tank 1, a homogenization mechanism for homogenizing the solution is arranged on the pumping cylinder 7; a circulating assembly arranged on the pumping cylinder 7 for circulating and pumping the solution at the edge of the homogenization tank 1 to the action area of the homogenization mechanism; a deflection backflow mechanism arranged on the pumping cylinder 7, the deflection backflow mechanism is connected with a deflection leaf 18, the deflection leaf 18 is fixed with an arc guide plate 1801, and the deflection backflow mechanism can act when the deflection leaf 18 is impacted and control the deflection leaf 18 to perform reciprocating deflection action.

[0023] Specifically, when the emulsion eye preparation is prepared, the oil phase and the water phase need to be mixed uniformly and homogenized to the required particle size, and finally sterilized and filled. For this, in the production process, the corresponding raw material solution is added to the stirring tank 2, and the raw material solution is preliminarily mixed under the action of the stirring assembly. After mixing, the solution is conveyed to the action area of the homogenization mechanism through the conveying pipe 6. At this time, the homogenization mechanism works and breaks the mixture of the water phase and the oil phase into the required size under the action of the homogenization mechanism. In order to ensure more comprehensive homogenization, the solution at the edge of the homogenization tank 1 is sucked into the pumping cylinder 7 under the action of the circulating assembly and pumped again to the effective action area of the homogenization mechanism, so as to realize comprehensive homogenization of the solution. When the solution is thrown out of the action area of the homogenization mechanism, it will impact on the deflection leaf 18 and drive the deflection backflow mechanism to move. The deflection backflow mechanism will control the deflection leaf 18 to reciprocate to disturb the solution in the homogenization tank 1. At the same time, the arc guide plate 1801 guides the solution to flow back to the effective action area of the homogenization mechanism again. In this way, the uniformity and comprehensiveness of the solution homogenization can be realized.

[0024] Please refer to Figures 1-4 The stirring assembly comprises a first motor 3 fixed on the top of the stirring tank 2, a transmission rod 4 connected with the output shaft of the first motor 3 is rotatably installed in the stirring tank 2, and a stirring blade 5 is fixed on the transmission rod 4.

[0025] Please refer to Figures 4-8The homogenizing mechanism comprises a second motor 11 fixed at the bottom of the homogenizing tank 1, a rotating rod 12 penetrating through the pumping cylinder 7 and connected with the output shaft of the second motor 11 is rotatably installed in the homogenizing tank 1, a crushing blade 13 is fixed at the end of the rotating rod 12, a stator tube 14 is fixed at the top of the pumping cylinder 7, a plurality of through grooves 1401 are formed on the circumferential outer wall of the stator tube 14 in a circumferentially equidistant manner, and a tapered tube 1402 is fixed at the end of the stator tube 14.

[0026] Please refer to Figure 4 、 Figure 7 The circulating assembly comprises a piston disc 8 slidingly and sealingly connected in the pumping cylinder 7, a cylinder 9 penetrating through the pumping cylinder 7 and fixedly connected with the piston disc 8 is fixed at the bottom of the homogenizing tank 1, an absorption tube 10 is connected to the circumferential outer wall of the pumping cylinder 7, and a plurality of backflow nozzles 22 are connected to the top of the pumping cylinder 7 in a circumferentially equidistant manner.

[0027] In detail, the through groove 1401 is the outlet diameter of the homogenized solution, the tapered tube 1402 is provided in a tapered opening shape, so that the solution can be collected and enter the effective action area of the crushing blade 13, the absorption tube 10 is provided on the circumferential side wall of the pumping cylinder 7 and is circumferentially equidistantly distributed, the absorption tube 10 extends to the edge area inside the homogenizing tank 1, the spraying direction of the backflow nozzle 22 is towards the through groove 1401, so as to pump the solution in the edge area which is not completely homogenized again to the effective action area of the crushing blade 13 for homogenization treatment by means of suction pumping, two groups of one-way valves are provided on the pumping cylinder 7, one group of one-way valves is connected with the absorption tube 10, and the other group of one-way valves is connected with the backflow nozzle 22, under the action of the one-way valves, the solution can only be sucked into the pumping cylinder 7 through the absorption tube 10 and discharged through the backflow nozzle 22.

[0028] Specifically, the feeding port for injecting the water phase and the oil phase is arranged at the top of the stirring tank 2, when the solution in the corresponding proportion is added into the stirring tank 2, the first motor 3 drives the transmission rod 4 to rotate the stirring blade 5, the water phase and the oil phase are preliminarily mixed to form a coarse emulsion, the bottom of the stirring tank 2 is connected with the conveying pipe 6, the valve is arranged in the conveying pipe 6, during the stirring, the valve in the conveying pipe 6 is in the closed state, when the stirring is completed, the valve in the conveying pipe 6 is opened, and the preliminarily mixed coarse emulsion is directly pumped into the stator pipe 14 through the conveying pipe 6; wherein, since the conveying direction of the conveying pipe 6 is directly towards the stator pipe 14, the preliminarily emulsified coarse emulsion can be quickly transferred to the next process, and the phase separation phenomenon that may occur in the traditional transfer process is effectively avoided; at the same time, the second motor 11 drives the rotating rod 12 to rotate the crushing blade 13 at high speed, under the converging and guiding action of the conical pipe 1402, the coarse emulsion is forced to be conveyed to the position matched with the crushing blade 13, under the action of the crushing blade 13, the emulsion will bear severe mechanical shearing and turbulent flow, the oil phase is rapidly broken into liquid droplets of corresponding particle size, and is thrown out through the through slot 1401, and the fine emulsification and homogenization are completed; in this process, since the solution after single homogenization may not reach the required particle size, it is necessary to homogenize the solution for multiple times, and the solution after throwing will be uniformly dispersed in the homogenizing tank 1, which will cause that part of the solution located at the edge of the homogenizing tank 1 cannot be fully homogenized, for this reason, the air cylinder 9 works and drives the piston disc 8 to reciprocate in the pumping cylinder 7, when the piston disc 8 returns, the pressure in the pumping cylinder 7 decreases, under the action of negative pressure, the solution in the edge area in the homogenizing tank 1 is sucked into the pumping cylinder 7, when the piston disc 8 advances, the pressure in the pumping cylinder 7 increases, the sucked solution is pressed into the backflow jet head 22 and is sprayed in the form of jet, the spraying direction of the backflow jet head 22 is towards the through slot 1401 area, in this way, under the action of the circulating backflow, the solution that may exist in the edge of the homogenizing tank 1 and is not fully homogenized or occurs creaming can be effectively recaptured and directly sent back to the high shear area for secondary or multiple homogenization treatment.

[0029] Preferably, by means of forced circulating backflow, the homogenization and emulsification efficiency can be improved, so as to shorten the homogenization treatment time, and the uniformity of the solution treatment in the tank can be ensured, the local non-uniformity or dead angle problem is effectively avoided, so that the particle size distribution of the finally obtained emulsion reaches the required.

[0030] Please refer to Figures 4-11The eccentric backflow mechanism comprises a support frame 15 fixed on the pumping cylinder 7, a support rod 16 fixed on the support frame 15, symmetrically arranged sealing pipes 17 rotatably installed on the support rod 16, and eccentric leaves 18 fixedly connected with the sealing pipes 17; further comprising a guide assembly and an elastic assembly arranged on the support rod 16 and connected with the sealing pipes 17, the guide assembly comprises symmetrically arranged spiral grooves 1601 formed on the circumferential outer wall of the support rod 16, the support rod 16 axially slides symmetrically arranged movable sleeves 19, the inner wall of the movable sleeve 19 is fixedly connected with a limiting block 1901 which is slidably embedded in the spiral groove 1601, the elastic assembly comprises a clamping groove 1701 formed on the inner wall of the sealing pipe 17, the movable sleeve 19 is fixedly connected with a limiting ring 20 which is slidably embedded in the clamping groove 1701, a spring 21 is sleeved on the support rod 16, and the two ends of the spring 21 respectively abut against the limiting ring 20 and the inner wall of the sealing pipe 17.

[0031] Please refer to Figure 9 , Figure 10Further, in the initial state, the distance between the two limiting rings 20 is the smallest, that is, the distance between the limiting ring 20 and the end of the corresponding sealing tube 17 is the largest. In this state, the limiting ring 20 controls the limiting block 1901 of the movable sleeve 19 to be located at one end of the spiral groove 1601 close to the support frame 15. Under the action of the limiting block 1901 and the spiral groove 1601, the included angle between the deflection vane 18 and the stator tube 14 is the largest. The elongation of the spring 21 in the natural state is greater than the maximum distance between the limiting ring 20 and the end of the sealing tube 17. Therefore, the spring 21 is in a pre-compressed state and always provides a pushing force to the two limiting rings 20 in the direction of approaching each other. Under the action of the pushing force, the deflection vane 18 and the arc-shaped guide plate 1801 always have a tendency to deflect away from the stator tube 14, that is, have a tendency to increase the included angle with the stator tube 14. When the crushing blade 13 rotates at high speed, the solution will be quickly thrown out through the through groove 1401, and the liquid stream shot at high speed directly impacts on the surface of the deflection vane 18, and the fluid impact force drives the deflection vane 18 to deflect against the pre-tightening force of the spring 21. In the deflection process, the sealing tube 17 fixedly connected with the deflection vane 18 rotates synchronously, and under the action of the clamping groove 1701, the limiting ring 20 rotates synchronously. The limiting ring 20 will drive the movable sleeve 19 to rotate around the support rod 16, so that the limiting block 1901 slides along the track of the spiral groove 1601. Under the action of the limiting block 1901 and the spiral groove 1601, the movable sleeve 19 and the limiting ring 20 are guided to slide radially along the clamping groove 1701, so as to compress the spring 21. Under the action of inertia, the rotational resistance of the deflection vane 18 caused by the compression of the spring 21 will exceed the force of the fluid impact on the deflection vane 18. Therefore, after the compression amount of the spring 21 reaches the maximum, the spring 21 will release the elastic potential energy and push the limiting ring 20 to move towards the initial position. Under the action of the spiral groove 1601 and the limiting block 1901, the deflection vane 18 is guided to reset. Therefore, the deflection vane 18 realizes continuous reciprocating deflection under the action of the fluid impact force and the elastic potential energy of the spring 21, and the included angle between the deflection vane 18 and the stator tube 14 is dynamically adjusted. The deflection vane 18 will disturb the solution, so that a non-steady turbulent flow field is generated in the solution, the stable laminar boundary layer is effectively broken, and the mixing of the solutions in different regions is promoted. At the same time, since the deflection vane 18 itself is in an inclined state, when the solution impacts on the deflection vane 18, it will flow on the deflection vane 18 and change the flow direction under the guidance of the curved surface of the arc-shaped guide plate 1801. When the included angle between the arc-shaped guide plate 1801 and the stator tube 14 decreases, the flow direction of the arc-shaped guide plate 1801 is towards the position of the conical tube 1402. At this time, the arc-shaped guide plate 1801 can control the solution to flow back into the stator tube 14 again, so as to realize the effect of guiding the solution to be homogenized again.

[0032] Preferably, by reciprocating swing of the swing leaf 18 and guidance of the backflow by the arc-shaped guide plate 1801, effective disturbance of the outflowing solution is realized, re-aggregation of the emulsion droplets is prevented, emulsion stability is ensured, a stable internal backflow channel is established, homogenization efficiency is improved, and uniformity of the emulsion droplet size distribution is ensured.

[0033] The continuous preparation process of the emulsion eye preparation based on the circulation homogenization comprises the following steps: Step one: the raw materials required for preparation are added into the stirring tank 2 according to the proportion; Step two: the raw materials are preliminarily mixed under the action of the stirring assembly; Step three: the mixed raw materials are transported into the homogenization tank 1 through the conveying pipe 6, and the raw materials are subjected to homogenization treatment under the action of the homogenization mechanism, and at the same time, the circulation assembly works and guides the solution at the edge of the homogenization tank 1 to flow back to the action area of the homogenization mechanism; Step four: the solution is guided by the homogenization mechanism to impact on the swing leaf 18, and the swing backflow mechanism is driven to move, so that the swing leaf 18 performs reciprocating swing action to disturb the solution and guide the solution to flow back to the action area of the homogenization mechanism again.

[0034] It is apparent to those skilled in the art that the present application is not limited to the details of the foregoing exemplary embodiments, and that the present application can be implemented in other specific forms without departing from the spirit or essential characteristics of the present application. Therefore, the embodiments should be considered in all respects as illustrative and not restrictive, and the scope of the present application should be defined by the appended claims rather than the above description, and it is intended to encompass all changes falling within the meaning and scope of equivalents of the claims. Any reference signs in the claims should not be considered as limiting the claims involved.

[0035] In addition, it should be understood that although the present specification is described in terms of embodiments, not every embodiment contains only one independent technical solution, and the description of the specification is only for the sake of clarity, and those skilled in the art should consider the specification as a whole, and the technical solutions in each embodiment can be combined appropriately to form other embodiments that those skilled in the art can understand.

Claims

1. A continuous formulation system for emulsion ophthalmic preparations based on cyclic homogenization, comprising: A homogenizing tank, and a stirring tank fixed to the top of the homogenizing tank, wherein a conveying pipe connected to the bottom of the stirring tank is provided, and a stirring assembly is provided inside the stirring tank; characterized in that it further includes: a pumping cylinder fixed inside the homogenizing tank, wherein a homogenizing mechanism for homogenizing the solution is provided on the pumping cylinder; and a circulation assembly provided on the pumping cylinder for circulating and pumping the solution from the edge of the homogenizing tank to the working area of ​​the homogenizing mechanism.

2. The continuous formulation system for emulsion ophthalmic preparations based on cyclic homogenization according to claim 1, characterized in that, The homogenizing mechanism includes a second motor fixed to the bottom of the homogenizing tank. A rotating rod is rotatably installed inside the homogenizing tank, passing through the pumping cylinder and connected to the output shaft of the second motor. A crushing blade is fixed to the end of the rotating rod.

3. The continuous formulation system for emulsion ophthalmic preparations based on cyclic homogenization according to claim 1, characterized in that, A stator tube is fixed to the top of the pumping cylinder. Multiple through grooves are formed on the outer circumference of the stator tube at equal intervals. A tapered tube is fixed to the end of the stator tube.

4. The continuous formulation system for emulsion ophthalmic preparations based on cyclic homogenization according to claim 1, characterized in that, The circulation assembly includes a piston disc that is slidably and sealed within the pumping cylinder, and a cylinder that passes through the pumping cylinder and is fixedly connected to the piston disc is fixedly located at the bottom of the homogenizing tank.

5. The continuous formulation system for emulsion ophthalmic preparations based on cyclic homogenization according to claim 1, characterized in that, The outer circumference of the pumping cylinder is connected to an absorption pipe, and the top of the pumping cylinder is connected to multiple return nozzles that are equidistantly distributed in a circle.

6. The continuous formulation system for emulsion ophthalmic preparations based on cyclic homogenization according to claim 1, characterized in that, It also includes a swaying return mechanism, which is installed on the pumping cylinder. A swaying vane is connected to the swaying return mechanism, and an arc-shaped guide plate is fixed on the swaying vane. The swaying return mechanism can operate when the swaying vane is impacted and control the swaying vane to perform a reciprocating swaying motion.

7. The continuous formulation system for emulsion ophthalmic preparations based on cyclic homogenization according to claim 6, characterized in that, The oscillating return mechanism includes a support frame fixed on the pumping cylinder, a support rod fixed on the support frame, and symmetrically arranged sealing tubes rotatably mounted on the support rod. The sealing tubes are fixedly connected to the oscillating blade.

8. The continuous formulation system for emulsion ophthalmic preparations based on cyclic homogenization according to claim 7, characterized in that, It also includes a guide assembly and an elastic assembly disposed on the support rod and connected to the sealing tube; the guide assembly includes a spiral groove formed on the outer circumference of the support rod and arranged symmetrically, and a movable sleeve arranged symmetrically slidably on the axial side of the support rod, and a limiting block fixed on the inner wall of the movable sleeve that slides and engages with the spiral groove; the elastic assembly includes a groove formed on the inner wall of the sealing tube, a limiting ring fixed on the movable sleeve that slides and engages with the groove, and a spring sleeved on the support rod, with both ends of the spring abutting against the limiting ring and the inner wall of the sealing tube, respectively.

9. The continuous formulation system for emulsion ophthalmic preparations based on cyclic homogenization according to claim 1, characterized in that, The stirring assembly includes a first motor fixed to the top of the stirring tank, a transmission rod rotatably mounted inside the stirring tank and connected to the output shaft of the first motor, and stirring blades fixed on the transmission rod.

10. A continuous formulation process for emulsion-type ophthalmic preparations based on cyclic homogenization, employing the continuous formulation system for emulsion-type ophthalmic preparations based on cyclic homogenization as described in claim 6, characterized in that... Includes the following steps: Step 1: Add the required raw materials to the mixing tank according to the specified proportions; Step 2: The raw materials are initially mixed under the action of the stirring component; Step 3: The mixed raw materials are transported to the homogenizing tank through the conveying pipe, and the raw materials are homogenized under the action of the homogenizing mechanism. At the same time, the circulation component works and guides the solution located at the edge of the homogenizing tank back to the action area of ​​the homogenizing mechanism. Step 4: The homogenizing mechanism guides the solution to impact the oscillating blades, which in turn drive the oscillating return mechanism to move, causing the oscillating blades to perform reciprocating oscillating motions to disturb the solution and guide it back to the working area of ​​the homogenizing mechanism.