Preparation system and process of calcium dobesilate bulk drug

Abstract

The invention relates to the technical field of preparation and production of calcium dobesilate, and particularly discloses a preparation system and process of a calcium dobesilate bulk drug, the preparation system comprises a powder mixing barrel and a solid-liquid stirring barrel, the powder mixing barrel is provided with a raw powder adding hole and a mixed powder discharging hole, the solid-liquid stirring barrel is provided with a powder inlet hole, and the powder inlet hole is communicated with the solid-liquid stirring barrel. A dual-purpose stirring shaft is coaxially and rotatably connected to the solid-liquid stirring barrel; the powder mixing barrel is movably connected with the solid-liquid stirring barrel, a control valve is connected to a mixed powder discharge hole of the powder mixing barrel, the mixed powder discharge hole of the powder mixing barrel is located at a powder inlet hole of the solid-liquid stirring barrel, and a transmission structure is arranged at the end, close to the driving motor, of the dual-purpose stirring shaft. And the transmission structure is used for transmitting kinetic energy generated when the dual-purpose stirring shaft rotates to the powder mixing barrel so as to enable the powder mixing barrel to move. The powder mixing barrel and the solid-liquid stirring barrel are jointed, powder leaves the powder mixing barrel after being mixed and directly enters the solid-liquid stirring barrel to be in contact with water, and the production efficiency is improved.

Description

Technical Field

[0001] The present invention relates to the technical field of the preparation and production of calcium dobesilate, and particularly relates to a preparation system and process for calcium dobesilate raw materials. Background Art

[0002] Calcium dobesilate is a drug that acts on the endothelial cell layer and the basal layer of capillary vessels, can regulate and improve the permeability and flexibility of capillaries, increase the resistance of capillary walls, activate the lymphatic circulation system, and can also be used to treat diabetes and the like.

[0003] Currently, the main production process of calcium dobesilate is to first synthesize the crude product and then generate high-purity calcium dobesilate through recrystallization. The first step of synthesizing the crude product is to first mix, dissolve, and filter various raw materials to remove insoluble impurities in the raw materials. The raw materials for mixing are powders, and a mixer is used for mixing treatment so that the various powders are doped with each other to form a crude product mixture; the white solid crude product is mixed with water, stirred, heated and dissolved, and then insolubles are removed by hot filtration. The filtrate is pumped into a crystallization tank, crystallized, and centrifuged to obtain a wet product, and then dried to obtain high-purity calcium dobesilate.

[0004] As disclosed in a Chinese patent document with the publication number CN210752424U, a calcium dobesilate dispersible tablet mixer includes a mixing container and a discharge cover; there is a mixing chamber inside the mixing container, the mixing container is provided with a discharge port, a discharge pipe extends outside the discharge port of the mixing container, a discharge channel is arranged inside the discharge pipe, and an external thread is arranged on the outer side of the end of the discharge pipe away from the discharge port; the discharge cover includes a cover body and a plug body. A screwing portion is convexly arranged on the outer edge of the cover body towards the discharge pipe, an internal thread is arranged on the screwing portion, the screwing portion is threadedly connected with the outer side of the discharge pipe, the plug body passes through the discharge channel and is inserted into the discharge port, and a rubber ring is arranged on the outer side of the plug body.

[0005] As can be seen from the above content, in order to improve the sealing performance of the discharge port during the mixing process, a rubber ring is arranged on the plug body. When the discharge cover closes the discharge channel, the rubber ring is in close contact with the inner wall of the discharge channel. The presence of the rubber ring also increases the friction between the discharge cover and the discharge pipe, and the discharge pipe and the discharge cover are threadedly connected. After the raw material mixing is completed, the operator manually opens the discharge cover, then makes the discharge port be below the mixing container to make the mixture fall out, and then the operator uses a utensil or a special transfer device to collect, transport and then add the mixture into the solid-liquid mixing equipment. The whole process is time-consuming and laborious, which affects the production efficiency. Summary of the Invention

[0006] The present invention provides a preparation system and process for calcium dobesilate raw materials, aiming to solve the problem that the operation after raw material mixing is complicated and affects the production efficiency in the related technology.

[0007] In a first aspect, a preparation system for calcium dobesilate bulk drugs according to the present invention includes a powder mixing cylinder and a solid-liquid stirring cylinder. The powder mixing cylinder is provided with a raw powder adding hole and a mixed powder discharging hole. A liquid supply pipe is connected to the solid-liquid stirring cylinder. The solid-liquid stirring cylinder is provided with a powder inlet hole. A dual-purpose stirring shaft is coaxially and rotatably connected to the solid-liquid stirring cylinder. A driving motor for driving the dual-purpose stirring shaft to rotate is arranged on the solid-liquid stirring cylinder. The powder mixing cylinder and the solid-liquid stirring cylinder are movably connected. A control valve is connected to the mixed powder discharging hole of the powder mixing cylinder. The control valve is used to control the opening and closing of the mixed powder discharging hole. The mixed powder discharging hole of the powder mixing cylinder is located at the powder inlet hole of the solid-liquid stirring cylinder and the two are communicated. One end of the dual-purpose stirring shaft close to the driving motor extends out from the end of the solid-liquid stirring cylinder. A transmission structure is arranged at the end of the dual-purpose stirring shaft. The transmission structure is used to transmit the kinetic energy generated when the dual-purpose stirring shaft rotates to the powder mixing cylinder to make it move.

[0008] The effect is as follows: The powder mixing cylinder is responsible for the preliminary mixing of various powder raw materials. The solid-liquid stirring cylinder is used to dissolve the mixed powder in water. The opening and closing of the mixed powder discharging hole of the powder mixing cylinder are controlled by the control valve. When the mixing is completed, the control valve is opened, and the powder in the powder mixing cylinder naturally falls and thus leaves the powder mixing cylinder. At the same time, since the mixed powder discharging hole is located at the powder inlet hole, the powder falling from the powder mixing cylinder smoothly enters the solid-liquid stirring cylinder and contacts with water for dissolution, without manual transfer, thereby improving the operation efficiency. At the same time, during the rotation of the dual-purpose stirring shaft working on the solid-liquid stirring cylinder, kinetic energy is transmitted to the powder mixing cylinder through the transmission structure, which is one of the working powers for making the powder mixing cylinder move. Thus, the powder mixing and the powder dissolution can be carried out synchronously, further improving the working efficiency from the powder mixing to the dissolution process.

[0009] Preferably, an adapter bottom hopper is rotatably connected and communicated at the mixed powder discharging hole of the powder mixing cylinder. The control valve is located in the adapter bottom hopper. The adapter bottom hopper is connected to the solid-liquid stirring cylinder. The transmission structure is a transmission gear. The transmission gear is relatively fixed to the dual-purpose stirring shaft. The axis of the transmission gear is parallel to the axis of the dual-purpose stirring shaft. A friction drive ring is coaxially and fixedly connected to the powder mixing cylinder. The outer edge of the friction drive ring abuts against the teeth of the transmission gear.

[0010] The effect is as follows: During the rotation of the transmission gear together with the dual-purpose stirring shaft, a torque is applied to the friction drive ring through friction, thereby driving the powder mixing cylinder to rotate, and the powder inside the powder mixing cylinder also moves accordingly for mixing.

[0011] Preferably, the connecting bottom hopper is located at the bottom of the powder mixing cylinder and they are coaxial. The raw powder adding hole is located at the top of the powder mixing cylinder. A connecting cover is coaxially rotatably connected to the powder mixing cylinder at the raw powder adding hole. A powder pipe joint is fixedly connected to the connecting cover. A movable support frame is fixedly connected to the solid-liquid stirring cylinder. The connecting cover and the movable support frame are movably connected. The connecting bottom hopper is movably connected to the hole wall of the powder inlet hole. The magnitude of the abutting force of the transmission gear pair on the friction driving ring changes periodically.

[0012] The effect is that: since the abutting force of the transmission gear pair on the friction driving ring is sometimes large and sometimes small, the powder mixing cylinder, the connecting cover and the connecting bottom hopper will perform moving actions due to the dynamic force conditions, improving the mixing efficiency of the powder in the powder mixing cylinder.

[0013] Preferably, the contour of the transmission gear is non-circular, or the contour of the transmission gear is circular and the transmission gear and the dual-purpose stirring shaft are relatively eccentrically arranged.

[0014] The effect is that: when the contour of the transmission gear is circular and it is eccentrically arranged relative to the dual-purpose stirring shaft, during the process of the dual-purpose stirring shaft driving the transmission gear to rotate, the position of the transmission gear towards the edge of each powder mixing cylinder changes periodically, generating a periodically changing pushing effect on each powder mixing cylinder, so that each powder mixing cylinder can swing periodically; when the contour of the transmission gear is non-circular, similar to the transmission gear with a circular contour, the transmission gear also generates a periodically changing pushing effect on the powder mixing cylinder, except that the swing amplitude and period are changed.

[0015] Preferably, the connecting bottom hopper and the solid-liquid stirring cylinder are hinged, and the hinge axis is perpendicular to the radial direction of the solid-liquid stirring cylinder. The connecting cover is slidably connected to the movable support frame, and the sliding direction is an arc centered on the hinge axis of the connecting bottom hopper. A top support spring is connected between the movable support frame and the connecting cover, and the elastic force exerted by the top support spring on the connecting cover is towards the dual-purpose stirring shaft.

[0016] The effect is that: since the axis of the hinge shaft is perpendicular to the radial direction of the solid-liquid stirring cylinder, when the powder mixing cylinder is subjected to a periodically changing thrust, the powder mixing cylinder will perform a reciprocating swinging action of approaching or moving away from the dual-purpose stirring shaft, further improving the mixing efficiency of the powder in the powder mixing cylinder. During the swinging process of the powder mixing cylinder, the height of the side of the friction driving ring on it facing the transmission gear changes. And since the torque is transmitted between the friction driving ring and the transmission gear through contact friction, the matching precision requirement is very low, so it is only necessary to ensure that the friction driving ring can always be in an effective contact state with the teeth of the transmission gear during the height change process.

[0017] Preferably, an elastic isolation cloth is fixedly connected to the solid-liquid mixing cylinder at the powder inlet hole, and the elastic isolation cloth is fixedly connected to the connecting bottom hopper.

[0018] The effect is as follows: The opening size of the powder inlet hole needs to ensure that it does not block the swinging action of the connecting bottom hopper, that is, there are relatively large pores within the contour of the powder inlet hole in the normal state. The elastic isolation cloth can seal the pores of the powder inlet hole, and at the same time, it does not affect the swinging of the connecting bottom hopper, reducing the negative impact of external factors on the inner cavity space of the solid-liquid mixing cylinder.

[0019] Preferably, there are multiple powder mixing cylinders, and the multiple powder mixing cylinders are arranged in a circumferential array around the dual-purpose stirring shaft. The deflection angle range of the axis of the connecting bottom hopper relative to the axis of the solid-liquid mixing cylinder is 0° - 33°.

[0020] Preferably, an auxiliary feeding rod is slidably arranged on the connecting cover, and the sliding direction is parallel to the axis of the powder mixing cylinder. One end of the auxiliary feeding rod extends into the powder mixing cylinder, and a feeding paddle is fixedly connected to the side wall of the part of the auxiliary feeding rod located in the powder mixing cylinder. A control component for driving the auxiliary feeding rod to slide is arranged between the connecting cover and the movable support frame.

[0021] The effect is as follows: Under the action of the control component, the auxiliary feeding rod reciprocates axially relative to the powder mixing cylinder, and each feeding paddle continuously stirs the powder in the powder mixing cylinder, improving the powder mixing efficiency inside it.

[0022] Preferably, the control component includes a reciprocating spring, a feedback roller, and a guiding wavy strip. The reciprocating spring is connected between the auxiliary feeding rod and the connecting cover, and the telescopic direction of the reciprocating spring is parallel to the sliding direction of the auxiliary feeding rod. The guiding wavy strip is fixedly connected to the movable support frame, and the length direction of the guiding wavy strip is parallel to the sliding direction of the connecting cover relative to the movable support frame. The feedback roller is rotatably arranged on the auxiliary feeding rod and is located outside the powder mixing cylinder, and the wheel surface of the feedback roller rolls against the curved surface of the guiding wavy strip.

[0023] The effect is as follows: Under the elastic force of the reciprocating spring, the auxiliary feeding rod always has a tendency to move closer to the connecting bottom hopper, and the wheel surface of the feedback roller always clings to the curved surface of the guiding wavy strip. During the swinging process of the powder mixing cylinder, the wheel surface of the feedback roller rolls up and down along the curved surface of the guiding wavy strip, and the auxiliary feeding rod then reciprocates axially relative to the powder mixing cylinder, enabling the feeding paddle to perform the feeding action.

[0024] On the other hand, a calcium dobesilate raw material drug production process using the above-mentioned calcium dobesilate raw material drug preparation system of the present invention sequentially includes the following steps: S1: Powder mixing. Add powder raw materials into each powder mixing cylinder in sequence, start the driving motor, and the powder mixing cylinder rotates on its own axis and reciprocates relative to the solid-liquid stirring cylinder; S2: Powder dissolution. Add water with a temperature in the range of 50°C - 60°C into the solid-liquid stirring cylinder through the liquid supply pipe, open the control valve, and the powder in the powder mixing cylinder falls into the solid-liquid stirring cylinder for dissolution; S3: Filtration. Physically filter the mixture in the solid-liquid stirring cylinder to separate the insoluble substances from the liquid; S4: Crystallization. Pump the liquid in the solid-liquid stirring cylinder into the crystallization tank for crystallization treatment; In step S2, when the control valve keeps the powder discharge hole open, the dual-purpose stirring shaft continues to rotate, and the rotation speed is lower than that when the control valve closes the powder discharge hole.

[0025] The effect is as follows: After the dual-purpose stirring shaft starts to rotate, all the powder mixing cylinders move relative to the solid-liquid stirring cylinder at the same time. When the mixing degree of the materials in a certain powder mixing cylinder meets the requirements, the powder discharge hole can be opened to allow the powder to fall into the solid-liquid stirring cylinder smoothly, directly contacting and dissolving with the water in the solid-liquid stirring cylinder. Each powder mixing cylinder releases the powder one by one. When the powder particles contact the water, the specific surface area is relatively large, which is beneficial to improving the dissolution rate. At the same time, when the powder discharge hole is open, the dual-purpose stirring shaft keeps rotating, and the powder falling angle of the connecting bottom hopper keeps changing, thereby improving the uniformity of the powder landing point distribution.

[0026] Adopting the above technical solution, the beneficial effects of the present invention are: The present invention directly connects the powder mixing cylinder and the solid-liquid stirring cylinder. After the powder mixing is completed, the powder discharge hole is opened, and the powder leaving the powder mixing cylinder directly falls into the solid-liquid stirring cylinder to contact the water, without manual operation or handling. At the same time, the rotation of the dual-purpose stirring shaft not only improves the dissolution efficiency in the solid-liquid stirring cylinder but also generates the driving force for the movement of the powder mixing cylinder. The powder mixing and powder dissolution are carried out synchronously, so the preparation process has the characteristics of high efficiency and high continuity. At the same time, the powder in the powder mixing cylinder enters the solid-liquid stirring cylinder in batches, and the instantaneous rate of solid-liquid mixing is also relatively fast. Description of the Drawings

[0027] Figure 1 It is a schematic cross-sectional view of the overall structure of the preparation system for calcium dobesilate raw material drug in the embodiment of the present invention.

[0028] Figure 2 It is a schematic top view of the preparation system for calcium dobesilate raw material drug in the embodiment of the present invention.

[0029] Figure 3 It is Figure 1 The partial enlarged view of part A in

[0030] Figure 4 It is a schematic structural diagram showing the swing angle range of the powder mixing cylinder in the embodiment of the present invention.

[0031] Figure 5 It is a schematic structural diagram showing the working principle of the control component in the embodiment of the present invention.

[0032] Figure 6 It is a schematic structural diagram showing the connection between the connecting cover and the auxiliary feeding rod in the embodiment of the present invention.

[0033] Figure 7 It is a process flow diagram showing the preparation process of calcium dobesilate bulk drug in the embodiment of the present invention.

[0034] Reference numerals: 1, solid-liquid mixing cylinder; 11, dual-purpose mixing shaft; 12, drive motor; 13, liquid supply pipe; 14, powder inlet hole; 15, elastic isolation cloth; 2, movable support frame; 21, top support spring; 22, guiding arc groove; 3, powder mixing cylinder; 31, raw powder addition hole; 32, mixed powder discharge hole; 33, connecting bottom hopper; 331, reciprocating hinge shaft; 34, connecting cover; 341, powder pipe joint; 342, guiding sliding pin; 35, auxiliary feeding rod; 351, feeding paddle; 36, friction drive ring; 4, control component; 41, reciprocating spring; 42, feedback roller; 43, guiding wavy strip; 5, transmission gear. Detailed implementation manners

[0035] The following combines Figures 1 to 7 to describe a preparation system and process of calcium dobesilate bulk drug of the present invention.

[0036] This embodiment discloses a preparation system of calcium dobesilate bulk drug. As shown in Figure 1 and Figure 2 It includes a powder mixing cylinder 3 and a solid-liquid mixing cylinder 1. The powder mixing cylinder 3 is used to mix various powder raw materials to form a crude product, and then the crude product mixture enters the solid-liquid mixing cylinder 1 to contact with water at a specific temperature for dissolution. Both of them are cylindrical; the axis of the solid-liquid mixing cylinder 1 is a vertical straight line. A dual-purpose mixing shaft 11 is coaxially rotatably connected to the solid-liquid mixing cylinder 1. A drive motor 12 for driving the dual-purpose mixing shaft 11 to rotate is installed on the solid-liquid mixing cylinder 1, and the output shaft of the drive motor 12 is coaxially connected to the dual-purpose mixing shaft 11.

[0037] As shown in Figure 1 , Figure 2 and Figure 3As shown, the powder mixing barrel 3 is movably arranged above the solid-liquid mixing barrel 1. In this embodiment, there are four powder mixing barrels 3, and the four powder mixing barrels 3 are arranged in a circumferential array around the dual-purpose stirring shaft 11. One end of the powder mixing barrel 3 is a raw powder adding hole 31, and the other end is a mixed powder discharge hole 32. The raw powder adding hole 31 is coaxially connected to a connecting cover 34, and the mixed powder discharge hole 32 is coaxially connected to a connecting bottom bucket 33. A powder pipe joint 341 is fixedly connected to the connecting cover 34, and the internal passage of the powder pipe joint 341 extends to the inner cavity of the powder mixing barrel 3 and communicates with it. The powder pipe joint 341 can be detachably connected to the supply pipeline of the powder raw material, that is, the operator adds the powder raw material to the powder mixing barrel 3 through the powder pipe joint 341. A control valve (not shown in the figure) is arranged in the connecting bottom bucket 33. In this embodiment, the control valve adopts an electromagnetic butterfly valve, which is used to control whether the connecting bottom bucket 33 is conductive or not, thereby controlling the opening or closing of the mixed powder discharge hole 32. A powder inlet hole 14 is provided on the top of the solid-liquid mixing drum 1 , and the number of the powder inlet holes 14 is consistent with the number of the powder mixing drum 3 and the two correspond one to one.

[0038] like Figure 3 , Figure 4 and Figure 5 As shown, a reciprocating hinge shaft 331 is fixedly connected to the connecting bottom hopper 33, and the reciprocating hinge shaft 331 is horizontally inserted into the hole wall of the powder inlet hole 14. The connecting bottom hopper 33 is hinged to the solid-liquid mixing drum 1 through the reciprocating hinge shaft 331, and the axis of the reciprocating hinge shaft 331 is perpendicular to the radial direction of the solid-liquid mixing drum 1, that is, the powder mixing drum 3 and the connecting cover 34 on the connecting bottom hopper 33 can swing close to or away from the axis of the solid-liquid mixing drum 1. A movable support frame 2 is fixedly connected to the solid-liquid mixing drum 1, and a guide arc groove 22 is provided on the movable support frame 2. The trajectory of the guide arc groove 22 is an arc with the hinge axis of the connecting bottom bucket 33 as the center. A guide slide pin 342 is fixedly connected to the connecting cover 34, and the guide slide pin 342 is inserted into the guide arc groove 22. During the swinging of the connecting bottom bucket 33 relative to the solid-liquid mixing drum 1, the guide slide pin 342 slides in the guide arc groove 22, that is, the connecting cover 34 is slidably arranged along the movable support frame 2 through the guide slide pin 342, thereby improving the overall stability of the powder mixing drum 3 and the connecting cover 34 when they swing with the connecting bottom bucket 33. A support spring 21 is connected between the movable support frame 2 and the connecting cover 34. One end of the support spring 21 is fixedly connected to the movable support frame 2, and the other end is fixedly connected to the connecting cover 34. The support spring 21 is located on the side of the connecting cover 34 away from the dual-purpose stirring shaft 11. The support spring 21 always applies thrust to the connecting cover 34. When the connecting cover 34 is at the position closest to the dual-purpose stirring shaft 11, the axis of the powder mixing drum 3 is parallel to the axis of the solid-liquid mixing drum 1.

[0039] like Figure 1 , Figure 3 and Figure 4As shown, one end of the dual-purpose stirring shaft 11 close to the driving motor 12 extends a certain distance from the end of the solid-liquid stirring cylinder 1, and a transmission structure is provided on this part of the dual-purpose stirring shaft 11. The transmission structure is used to transmit the kinetic energy generated when the dual-purpose stirring shaft 11 rotates to the powder mixing cylinder 3 to make it swing. The transmission structure is a transmission gear 5. The transmission gear 5 is relatively fixed to the dual-purpose stirring shaft 11, and the axis of the transmission gear 5 is parallel to the axis of the dual-purpose stirring shaft 11. A friction driving ring 36 made of rubber is coaxially and fixedly connected to the powder mixing cylinder 3, and the outer edge of the friction driving ring 36 abuts against the teeth of the transmission gear 5. During the rotation of the transmission gear 5 together with the dual-purpose stirring shaft 11, a torque is applied to the friction driving ring 36 through friction, thereby driving the powder mixing cylinder 3 to rotate.

[0040] As Figure 2 , Figure 3 and Figure 4 shown, the axial length of the friction driving ring 36 is greater than the axial thickness of the transmission gear 5. In this embodiment, the contour of the transmission gear 5 is circular and the transmission gear 5 and the dual-purpose stirring shaft 11 are relatively eccentrically arranged, so that the edge of the transmission gear 5 has a near-center point and a far-center point. For a certain position of the powder mixing cylinder 3, during the rotation of the transmission gear 5, the distance between the teeth of the transmission gear 5 and the dual-purpose stirring shaft 11 changes periodically in terms of distance, that is, the magnitude of the abutting force of the transmission gear 5 on the friction driving ring 36 changes periodically. Under the influence of this change, the transmission gear 5 pushes the powder mixing cylinder 3 to swing reciprocally. When the friction driving ring 36 contacts the teeth at the near-center point of the transmission gear 5, the axis of the powder mixing cylinder 3 is in the vertical direction. When the friction driving ring 36 contacts the teeth at the far-center point of the transmission gear 5, the deflection angle of the axis of the powder mixing cylinder 3 relative to the axis of the solid-liquid stirring cylinder 1 is 33°. Within the swing stroke range of the powder mixing cylinder 3, the surface of the friction driving ring 36 always contacts and abuts against the edge of the transmission gear 5. In this embodiment, the outer diameter of the powder mixing cylinder 3 is 200 mm. In the two stroke end states of the powder mixing cylinder 3, the maximum vertical lifting distance of the side of the friction driving ring 36 facing the transmission gear 5 is 47 mm. Whenever the transmission gear 5 rotates one week, each powder mixing cylinder 3 swings reciprocally for one cycle. Correspondingly, when the transmission gear 5 and the dual-purpose stirring shaft 11 are coaxially connected and the contour of the transmission gear 5 is non-circular, the transmission structure can also achieve the above functions, that is, when the transmission gear 5 is coaxially and fixedly connected to the dual-purpose stirring shaft 11, it can be an elliptical gear, a square gear, a Reuleaux triangle gear, etc., which are not shown in the figure here for details.

[0041] As Figure 3As shown in the figure, the opening size of the powder inlet hole 14 should ensure that it does not block the swinging movement of the connecting bottom hopper 33. In order to improve the sealing of the internal space of the solid-liquid mixing cylinder 1, an elastic isolation cloth 15 is fixedly connected to the solid-liquid mixing cylinder 1 at the powder inlet hole 14. The elastic isolation cloth 15 is fixedly connected to the connecting bottom hopper 33, and its connection point with the connecting bottom hopper 33 is located below the reciprocating hinge shaft 331; during the swinging process of the connecting bottom hopper 33, the elastic isolation cloth 15 always keeps the powder inlet hole 14 closed. In this embodiment, the elastic isolation cloth 15 is made of a rubber film with a thickness of 2 mm.

[0042] As Figure 5 and Figure 6 shown in the figure, an auxiliary material stirring rod 35 is slidably arranged on the connecting cover 34, and the sliding direction is parallel to the axis of the powder mixing cylinder 3. One end of the auxiliary material stirring rod 35 extends into the powder mixing cylinder 3, and the other end is located outside the powder mixing cylinder 3. A plurality of material stirring paddle plates 351 are fixedly connected to the side wall of the part of the auxiliary material stirring rod 35 located in the powder mixing cylinder 3. A control component 4 for driving the auxiliary material stirring rod 35 to slide is arranged between the connecting cover 34 and the movable support frame 2. The control component 4 includes a reciprocating spring 41, a feedback roller 42 and a guiding wavy strip 43. One end of the reciprocating spring 41 is fixedly connected to the connecting cover 34, and the other end is fixedly connected to the auxiliary material stirring rod 35. The telescopic direction of the reciprocating spring 41 is parallel to the sliding direction of the auxiliary material stirring rod 35. The guiding wavy strip 43 is fixedly connected to the upper side of the movable support frame 2. The length direction of the guiding wavy strip 43 is also an arc with the hinge axis of the connecting bottom hopper 33 as the center, and is parallel to the length direction of the guiding arc groove 22. The upper surface of the guiding wavy strip 43 is a continuously undulating curved surface similar to a wavy line; the feedback roller 42 is rotatably arranged on the auxiliary material stirring rod 35 and is located outside the powder mixing cylinder 3, and its rotation axis is parallel to the hinge axis of the connecting bottom hopper 33; under the elastic force of the reciprocating spring 41, the auxiliary material stirring rod 35 always has a tendency to move closer to the connecting bottom hopper 33, and the wheel surface of the feedback roller 42 always clings to the curved surface of the guiding wavy strip 43. During the swinging process of the powder mixing cylinder 3, the wheel surface of the feedback roller 42 rolls up and down along the curved surface of the guiding wavy strip 43, and the auxiliary material stirring rod 35 reciprocates axially relative to the powder mixing cylinder 3, and each material stirring paddle plate 351 continuously stirs the powder in the powder mixing cylinder 3 to improve the powder mixing efficiency inside it.

[0043] As Figure 7 shown in the figure, this embodiment also discloses a calcium dobesilate raw material drug production process using the above-mentioned calcium dobesilate raw material drug preparation system, which successively includes the following steps: S1: Powder mixing, successively adding various required powder raw materials into each powder mixing cylinder 3, starting the driving motor 12, the powder mixing cylinder 3 rotates self, and at the same time, under the thrust of the transmission gear 5, each powder mixing cylinder 3 swings reciprocally relative to the solid-liquid mixing cylinder 1; S2: Powder dissolution. Water with a temperature in the range of 50°C - 60°C is added into the solid-liquid stirring cylinder 1 through the liquid supply pipe 13. The control valve is opened, and the powder in each powder mixing cylinder 3 falls into the solid-liquid stirring cylinder 1 in sequence, mixes with the water after contact, and the powder dissolves. The discharging sequence of each powder mixing cylinder 3 is the same as the powder adding sequence in S1, thereby ensuring that the mixing degree of the powder in each powder mixing cylinder 3 is relatively uniform and sufficient. S3: Filtration; The mixture in the solid-liquid stirring cylinder 1 is filtered by physical methods (such as centrifugation, filter mesh method, etc.) to separate the insoluble substances from the liquid. S4: Crystallization: The liquid in the solid-liquid stirring cylinder 1 is pumped out and into the crystallization tank for crystallization treatment.

[0044] It should be noted that when the control valve keeps the powder discharge hole 32 open in S2, the dual-purpose stirring shaft 11 rotates continuously, and at this time, the rotation speed of the dual-purpose stirring shaft 11 is lower than the rotation speed of the dual-purpose stirring shaft 11 when the control valve closes the powder discharge hole 32; In this embodiment, when the powder discharge hole 32 of any one powder mixing cylinder 3 is in the open state, the rotation speed of the dual-purpose stirring shaft 11 is adjusted to 38 r / min, that is, the swing frequency of the powder mixing cylinder 3 is 38 times per minute at this time. When the powder discharge holes 32 of all powder mixing cylinders 3 are in the closed state, the rotation speed of the dual-purpose stirring shaft 11 is adjusted to 75 r / min, that is, the swing frequency of the powder mixing cylinder 3 is 75 times per minute at this time. When the powder discharge hole 32 is in the closed state, it is necessary to ensure that the continuous reciprocating swing duration of each powder mixing cylinder 3 is at least 100 s.

[0045] Although the embodiments of the present invention have been shown and described above, it can be understood that the above textual descriptions and the content of the drawings of the embodiments are all exemplary, aiming to explain the inventive concept of the present invention and cannot be understood as a limitation to the present invention. Those of ordinary skill in the art can make changes, modifications, substitutions, and variations to the above embodiments within the scope of the present invention; Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts belong to the scope of protection of the present invention.

Claims

1. A preparation system for calcium dobesilate API, comprising a powder mixing cylinder (3) and a solid-liquid stirring cylinder (1). The powder mixing cylinder (3) is provided with a raw powder adding hole (31) and a mixed powder discharging hole (32). The solid-liquid stirring cylinder (1) is connected with a liquid supply pipe (13). The solid-liquid stirring cylinder (1) is provided with a powder inlet hole (14). A dual-purpose stirring shaft (11) is coaxially and rotatably connected to the solid-liquid stirring cylinder (1), and a driving motor (12) for driving the dual-purpose stirring shaft (11) to rotate is arranged on the solid-liquid stirring cylinder (1). It is characterized in that The powder mixing cylinder (3) and the solid-liquid stirring cylinder (1) are movably connected. A control valve is connected at the mixed powder discharging hole (32) of the powder mixing cylinder (3) for controlling the opening and closing of the mixed powder discharging hole (32). The mixed powder discharging hole (32) of the powder mixing cylinder (3) is located at the powder inlet hole (14) of the solid-liquid stirring cylinder (1) and the two are communicated. One end of the dual-purpose stirring shaft (11) close to the driving motor (12) extends out from the end of the solid-liquid stirring cylinder (1), and a transmission structure is arranged at the end of the dual-purpose stirring shaft (11) for transmitting the kinetic energy generated when the dual-purpose stirring shaft (11) rotates to the powder mixing cylinder (3) to make it move.

2. The preparation system of calcium dobesilate bulk drug according to claim 1, characterized in that, A connecting bottom hopper (33) is rotatably connected and communicated at the mixed powder discharging hole (32) of the powder mixing cylinder (3). The control valve is located in the connecting bottom hopper (33), and the connecting bottom hopper (33) is connected with the solid-liquid stirring cylinder (1). The transmission structure is a transmission gear (5). The transmission gear (5) is relatively fixed to the dual-purpose stirring shaft (11). The axis of the transmission gear (5) is parallel to the axis of the dual-purpose stirring shaft (11). A friction driving ring (36) is coaxially and fixedly connected to the powder mixing cylinder (3), and the outer edge of the friction driving ring (36) abuts against the teeth of the transmission gear (5).

3. The preparation system of calcium dobesilate raw material drug according to claim 2, characterized in that, The connecting bottom hopper (33) is located at the bottom of the powder mixing cylinder (3) and the two are coaxial. The raw powder adding hole (31) is located at the top of the powder mixing cylinder (3). A connecting cover (34) is coaxially and rotatably connected to the powder mixing cylinder (3) at the raw powder adding hole (31). A powder pipe joint (341) is fixedly connected to the connecting cover (34). An activity support frame (2) is fixedly connected to the solid-liquid stirring cylinder (1). The connecting cover (34) is movably connected with the activity support frame (2). The connecting bottom hopper (33) is movably connected with the hole wall of the powder inlet hole (14). The abutting force of the transmission gear (5) on the friction driving ring (36) changes periodically.

4. The preparation system of calcium dobesilate bulk drug according to claim 3, characterized in that, The contour of the transmission gear (5) is non-circular, or the contour of the transmission gear (5) is circular and the transmission gear (5) is relatively eccentrically arranged with the dual-purpose stirring shaft (11).

5. The preparation system of calcium dobesilate bulk drug according to claim 4, characterized in that, The connecting bottom hopper (33) is hinged to the solid-liquid mixing drum (1), and the hinge axis is perpendicular to the radial direction of the solid-liquid mixing drum (1). The connecting cover (34) is slidably connected to the movable support frame (2), and the sliding direction is an arc with the hinge axis of the connecting bottom hopper (33) as the center of the circle. A top support spring (21) is connected between the movable support frame (2) and the connecting cover (34), and the elastic force exerted by the top support spring (21) on the connecting cover (34) is directed towards the dual-purpose mixing shaft (11).

6. The preparation system of calcium dobesilate bulk drug according to claim 5, characterized in that, An elastic isolation cloth (15) is fixedly connected to the solid-liquid mixing drum (1) at the powder inlet hole (14), and the elastic isolation cloth (15) is fixedly connected to the connecting bottom hopper (33).

7. The preparation system of calcium dobesilate bulk drug according to claim 6, characterized in that, There are multiple powder mixing drums (3), and the multiple powder mixing drums (3) are arranged in a circumferential array around the dual-purpose mixing shaft (11). The deflection angle range of the axis of the connecting bottom hopper (33) relative to the axis of the solid-liquid mixing drum (1) is 0° - 33°.

8. A preparation system for calcium dobesilate bulk drug according to any one of claims 5-7, characterized in that, An auxiliary material stirring rod (35) is slidably arranged on the connecting cover (34), and the sliding direction is parallel to the axis of the powder mixing drum (3). One end of the auxiliary material stirring rod (35) extends into the powder mixing drum (3), and a stirring paddle (351) is fixedly connected to the side wall of the part of the auxiliary material stirring rod (35) located in the powder mixing drum (3). A control component (4) for driving the auxiliary material stirring rod (35) to slide is arranged between the connecting cover (34) and the movable support frame (2).

9. The preparation system of calcium dobesilate bulk drug according to claim 8, characterized in that, The control component (4) includes a reciprocating spring (41), a feedback roller (42) and a guiding wavy strip (43). The reciprocating spring (41) is connected between the auxiliary material stirring rod (35) and the connecting cover (34), and the telescopic direction of the reciprocating spring (41) is parallel to the sliding direction of the auxiliary material stirring rod (35). The guiding wavy strip (43) is fixedly connected to the movable support frame (2), and the length direction of the guiding wavy strip (43) is parallel to the sliding direction of the connecting cover (34) relative to the movable support frame (2). The feedback roller (42) is rotatably arranged on the auxiliary material stirring rod (35) and is located outside the powder mixing drum (3), and the wheel surface of the feedback roller (42) is in rolling contact with the curved surface of the guiding wavy strip (43).

10. A production process of calcium dobesilate bulk drug using the preparation system of calcium dobesilate bulk drug described in claim 7, characterized in that, It successively includes the following steps: S1: Powder mixing. Powder raw materials are successively added into each powder mixing drum (3), and the driving motor (12) is started. The powder mixing drum (3) rotates and reciprocates relative to the solid-liquid mixing drum (1). S2: Powder dissolution. Water with a temperature in the range of 50°C - 60°C is added into the solid-liquid mixing drum (1) through the liquid supply pipe (13), and the control valve is opened. The powder in the powder mixing drum (3) falls into the solid-liquid mixing drum (1) for dissolution. S3: Filtration. The mixture in the solid-liquid mixing drum (1) is filtered by a physical method to separate the insoluble substances from the liquid. S4: Crystallization. The liquid in the solid-liquid mixing drum (1) is pumped into the crystallization tank for crystallization treatment. In S2, when the control valve keeps the powder mixing discharge hole (32) open, the dual-purpose stirring shaft (11) rotates continuously, and the rotation speed is lower than that when the control valve closes the powder mixing discharge hole (32).

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