Compound amlodipine atorvastatin calcium tablet and production mixing device

Abstract

The invention relates to the technical field of medicines, in particular to a compound amlodipine atorvastatin calcium tablet and a production mixing device. The compound amlodipine atorvastatin calcium tablet is a core-coated tablet and comprises an inner-layer tablet core containing atorvastatin calcium and an outer-layer tablet layer containing amlodipine besylate, the inner-layer tablet core further comprises meglumine and sodium lauryl sulfate, the mass ratio of meglumine to sodium lauryl sulfate is (0.5-5): 1, the mass ratio of meglumine to sodium lauryl sulfate is (0.5-5): 1, and the mass ratio of meglumine to sodium lauryl sulfate is (0.5-5): 1. And the mass of the meglumine accounts for 1-3% of the total mass of the inner-layer tablet core. The amlodipine and atorvastatin calcium are prepared into the coated tablet, so that two active ingredients in the same tablet are effectively isolated, and the compatibility of the atorvastatin calcium and the amlodipine besylate is remarkably improved; meanwhile, the inner layer and the outer layer of the core-coated sheet are separately granulated before tabletting, so that the problem that the mixing uniformity of total mixed particles is relatively poor when conventional tablets are prepared is effectively solved.

Description

Technical Field

[0001] The invention relates to the technical field of medicines, and in particular to a compound amlodipine and atorvastatin calcium tablet and a production mixing device. Background Art

[0002] Statins are drugs widely used worldwide to treat cardiovascular and cerebrovascular diseases. Atorvastatin calcium is a statin lipid-regulating drug that mainly acts on the liver. It can reduce the synthesis of cholesterol, increase the synthesis of low-density lipoprotein receptors, lower blood cholesterol and low-density lipoprotein cholesterol levels, moderately reduce serum triglyceride levels and increase blood high-density lipoprotein levels. Research results show that atorvastatin can not only comprehensively regulate blood lipids, but also stabilize atherosclerotic plaques, improve vascular endothelial function, inhibit inflammation and reduce thrombosis. Atorvastatin also has a certain effect in the treatment of diabetic foot.

[0003] In the tableting process of the existing compound amlodipine atorvastatin calcium tablets, the mixing uniformity of the total mixed particles (and the corresponding tablet content uniformity) is poor due to the large difference in particle size between the atorvastatin calcium layer particles and the amlodipine layer. When prepared into double-layer tablets, it often leads to poor content uniformity of the API in the second layer of the tablets and a decrease in the overall yield of the plain tablets. Therefore, the production process and dosage form development of amlodipine atorvastatin calcium tablets need to be further developed and enriched. Summary of the invention

[0004] In order to overcome the shortcomings mentioned in the above technical background, the present invention provides a compound amlodipine and atorvastatin calcium tablet and a production mixing device.

[0005] Technical solution: A compound amlodipine atorvastatin calcium tablet, which is a core-wrapped tablet, comprising an inner core containing atorvastatin calcium and an outer layer containing amlodipine besylate, wherein the components of the inner core further include meglumine and sodium lauryl sulfate, wherein the mass ratio of the meglumine to the sodium lauryl sulfate is 0.5-5:1, and the mass of the meglumine accounts for 1-3% of the total mass of the inner core, and the components of the inner core further include a filler accounting for 35%-45% of the total mass of the inner core, and an outer layer containing amlodipine besylate. The present invention relates to a tablet comprising a tablet of the invention comprising: a stabilizer accounting for % to 38% of the total mass of the inner layer tablet core, a disintegrant accounting for 2% to 8% of the total mass of the inner layer tablet core, a binder accounting for 1% to 5% of the total mass of the inner layer tablet core, a surfactant accounting for 0.1% to 1% of the total mass of the inner layer tablet core, a lubricant accounting for 0.5% to 2% of the total mass of the inner layer tablet core, and a coating material accounting for 2% to 5% of the total mass of the inner layer tablet core, and the components of the outer layer tablet layer include a filler accounting for 80% to 92% of the total mass of the outer layer tablet layer, a disintegrant accounting for 2% to 12% of the total mass of the outer layer tablet layer, and a lubricant accounting for 0.5% to 2.5% of the total mass of the outer layer tablet layer.

[0006] A mixing device for producing compound amlodipine atorvastatin calcium tablets is applied to compound amlodipine atorvastatin calcium tablets, comprising: a frame; a mixing tank fixedly connected to the frame, the mixing tank being provided with a first feed pipe, a second feed pipe and a discharge pipe; a first guide plate and a second guide plate, both fixedly connected to the mixing tank; a third guide plate fixedly connected to the mixing tank, the third guide plate being provided with first through holes arranged at intervals, the first guide plate, the second guide plate and the third guide plate are all truncated cone-shaped, and the three are arranged in sequence from top to bottom for guiding passing materials, and there are gaps between the frame and the first guide plate and the third guide plate; a stirring mechanism is provided on the mixing tank for mixing materials in the mixing tank.

[0007] Preferably, the stirring mechanism includes: a motor installed in the mixing tank, the output shaft of the motor is fixedly connected to the main shaft, and there is a gap between the second guide plate and the main shaft; a rotating plate and a rotating member, both of which are rotatably connected in the mixing tank, and the rotating plate and the rotating member are fixedly connected to the main shaft; a plurality of vertical rods arranged at intervals, each of which is arranged between the rotating plate and the rotating member; a plurality of fixing members arranged at intervals, each of which is respectively arranged on adjacent vertical rods, and the fixing member is fixedly connected to a stirring rod.

[0008] Preferably, it also includes: a spur gear ring fixedly connected in the mixing tank, the vertical rod and the rotating plate are rotatably connected to the rotating member, the vertical rod is fixedly connected with a spur gear, and the spur gear is meshed with the spur gear ring.

[0009] Preferably, it also includes: a first material passing piece and a second material passing piece, both of which are rotatably connected to the mixing tank, the second material passing piece is fixedly connected to the main shaft, the first material passing piece is provided with second through holes arranged at intervals, and the second material passing piece is provided with third through holes arranged at intervals; a rotating shaft, rotatably connected to the mixing tank, the rotating shaft and the output shaft of the motor are connected via a pulley belt transmission, and the rotating shaft and the first material passing piece are connected via a gear set transmission.

[0010] Preferably, the diameter of the third through hole is greater than the diameter of the second through hole, so that more material passes through the third through hole than passes through the second through hole per unit time.

[0011] Preferably, it also includes: a plurality of limiting members arranged at intervals, which are rotatably connected to adjacent fixing members, the fixing members are spline-connected to adjacent vertical rods, the limiting members are provided with limiting protrusions, and a limiting groove is provided in the mixing tank, and the limiting groove is used to limit the limiting protrusions.

[0012] Preferably, the limiting groove is composed of a first groove, a second groove, a third groove and a fourth groove connected end to end, and the first groove and the third groove have different heights in the mixing tank, so as to change the positions of adjacent limiting protrusions.

[0013] Preferably, it further comprises: a plurality of pocket shells arranged at intervals and respectively fixedly connected to adjacent fixing members, and the pocket shells are provided with a fourth through hole.

[0014] Preferably, the material pocket shell is in a truncated cone shape to reduce the resistance of the material it encounters.

[0015] Compared with the prior art, the present invention has the following beneficial effects: the present invention realizes effective isolation of two active ingredients in the same tablet by preparing amlodipine and atorvastatin calcium into core pieces, and significantly improves the compatibility of atorvastatin calcium and amlodipine besylate; at the same time, since the core pieces are granulated separately for the inner and outer layers before tableting, the problem of poor mixing uniformity of the total mixed particles in the preparation of conventional tablets is effectively solved; the materials are repeatedly dispersed and gathered by the first guide plate, the second guide plate and the third guide plate, so that different materials are mixed to a certain extent during the feeding process, thereby reducing the difficulty of subsequent mixing and improving the mixing efficiency; the fixing member is used to drive the adjacent stirring The mixing rod rotates clockwise together, so that the stirring rod rotates clockwise (rotation) while rotating counterclockwise (revolution), so that the stirring rod rotates as a whole and partially in the mixing tank, thereby strengthening the stirring degree of the materials, increasing the contact probability between the materials, and thus improving the mixing effect and mixing efficiency of the materials; the materials are continuously arranged in a "ring shape" in the mixing tank through the first material passing piece and the second material passing piece, which is convenient for "premixing" between different materials, so that the materials are relatively evenly distributed on the first guide plate, thereby improving the effect of premixing of the materials; the material in the mixing tank is repeatedly "turned" by using the material bag shell, thereby increasing the contact probability between the materials, and thus improving the mixing effect of the materials. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 It is a schematic diagram of the overall three-dimensional structure of the present invention; Figure 2 It is a three-dimensional structural schematic diagram of the mixing tank and its internal parts of the present invention; Figure 3 It is a three-dimensional structural cross-sectional view of the first guide plate, the second guide plate and the third guide plate of the present invention; Figure 4 It is a three-dimensional structural exploded diagram of the main shaft and the parts thereon of the present invention; Figure 5 It is a schematic diagram of the three-dimensional structure when the rotating member and the vertical rod of the present invention rotate relative to each other; Figure 6It is a three-dimensional structural cross-sectional view of the mixing tank of the present invention; Figure 7 It is a three-dimensional structural exploded view of the fixing member and the parts thereon of the present invention.

[0017] Explanation of the accompanying drawings: 1-frame, 2-mixing tank, 3-first guide plate, 4-second guide plate, 5-third guide plate, 6-first through hole, 701-motor, 702-spindle, 703-rotating plate, 704-rotating member, 705-vertical pole, 706-fixed member, 707-stirring rod, 708-spur gear ring, 709-spur gear, 801-first material passing member, 802-second material passing member, 803-second through hole, 804-third through hole, 805-rotating shaft, 901-limiting member, 902-limiting protrusion, 903-limiting groove, 9031-first groove, 9032-second groove, 9033-third groove, 9034-fourth groove, 1001-material shell, 1002-fourth through hole. DETAILED DESCRIPTION

[0018] Those skilled in the art can refer to the contents of this article and appropriately improve the process parameters. It should be particularly pointed out that all similar replacements and modifications are obvious to those skilled in the art, and they all fall within the scope of protection of the present invention. The methods and applications of the present invention have been described through preferred embodiments, and relevant personnel can obviously modify or appropriately change and combine the methods and applications of this article without departing from the content, spirit and scope of the present invention to implement and apply the technology of the present invention.

[0019] A compound amlodipine atorvastatin calcium tablet, which is a core-wrapped tablet, comprising an inner core containing atorvastatin calcium and an outer layer containing amlodipine besylate, the components of the inner core further comprising meglumine and sodium lauryl sulfate, the mass ratio of meglumine to sodium lauryl sulfate being 0.5-5:1, the mass of meglumine accounting for 1-3% of the total mass of the inner core, the components of the inner core further comprising a filler accounting for 35%-45% of the total mass of the inner core, and an outer layer containing amlodipine besylate. The composition of the present invention comprises a stabilizer accounting for 2% to 38% of the total mass of the inner layer tablet core, a disintegrant accounting for 2% to 8% of the total mass of the inner layer tablet core, a binder accounting for 1% to 5% of the total mass of the inner layer tablet core, a surfactant accounting for 0.1% to 1% of the total mass of the inner layer tablet core, a lubricant accounting for 0.5% to 2% of the total mass of the inner layer tablet core and a coating material accounting for 2% to 5% of the total mass of the inner layer tablet core, and the components of the outer layer tablet layer include a filler accounting for 80% to 92% of the total mass of the outer layer tablet layer, a disintegrant accounting for 2% to 12% of the total mass of the outer layer tablet layer and a lubricant accounting for 0.5% to 2.5% of the total mass of the outer layer tablet layer.

[0020] In the above scheme, by preparing amlodipine and atorvastatin calcium into coated core pieces, effective isolation of the two active ingredients in the same tablet is achieved, and the compatibility of atorvastatin calcium and amlodipine besylate is significantly improved; at the same time, since the inner and outer layers of the coated core pieces are granulated separately before tableting, the problem of poor mixing uniformity of the total mixed particles in conventional tablet preparation is effectively solved.

[0021] like Figure 1-Figure 3 As shown, it is an embodiment of the present invention, which proposes a mixing device for the production of compound amlodipine atorvastatin calcium tablets to solve the problem that the existing mixing technology directly pours different materials into the mixing tank 2, resulting in uneven mixing of different materials in the initial state and reducing the subsequent mixing efficiency. The device comprises: a frame 1; a mixing tank 2, which is fixedly connected to the frame 1, and is provided with a first feed pipe, a second feed pipe and a discharge pipe; a first guide plate 3 and a second guide plate 4, both of which are fixedly connected to the mixing tank 2; a third guide plate 5, which is fixedly connected to the mixing tank 2, and is provided with first through holes 6 arranged at intervals. The first guide plate 3, the second guide plate 4 and the third guide plate 5 are all conical, and the three are arranged in sequence from top to bottom for guiding the passing materials, and there are gaps between the frame 1 and the first guide plate 3 and the third guide plate 5; a stirring mechanism, which is provided on the mixing tank 2, and is used to mix the materials in the mixing tank 2.

[0022] In the above scheme, the frame 1 is welded from steel to ensure stability during the mixing process. The first feed pipe and the second feed pipe are respectively connected to different external discharge devices, and the discharge pipe is connected to an external collection device. The first guide plate 3, the second guide plate 4 and the third guide plate 5 are coaxial (the first guide plate 3, the second guide plate 4 and the third guide plate 5 can also be "spirally arranged", and the three are not coaxial, so as to increase the movement diversity of the materials passing through the three), the diameters of the first guide plate 3 and the third guide plate 5 gradually increase from top to bottom, and the diameter of the second guide plate 4 gradually decreases from top to bottom, which is used to repeatedly gather and disperse the materials, thereby increasing the contact area between different materials, thereby improving the uniformity of mixing between the materials and reducing the difficulty of subsequent mixing. A feeding hole is provided on the lower side of the second guide plate 4, and the maximum diameter of the second guide plate 4 is greater than the maximum diameter of the first guide plate 3 (the second guide plate 4 completely "covers" the first guide plate 3 in horizontal projection), which is used to comprehensively collect the materials, and add two different materials into the mixing tank 2 through the first feed pipe and the second feed pipe. , then the two materials move in free fall to the left in the mixing tank 2 until the materials contact the first guide plate 3, and then the materials begin to move downward along the first guide plate 3 (the materials are gradually dispersed and the density is reduced in this process), until the materials pass through the gap between the first guide plate 3 and the frame 1 and continue to fall freely downward, and then the materials are received by the second guide plate 4, and under the gathering effect of the second guide plate 4, the materials begin to gather again, and then the materials separate from the second guide plate 4 and contact the third guide plate 5, and then the materials move downward along the third guide plate 5, and when the materials move to the first through hole 6, they fall downward, in the process of the materials moving through the first through hole 6, part of the materials fall directly downward through the first through hole 6, and the rest of the materials continue to move downward along the third guide plate 5 until all the materials are separated from the third guide plate 5, and then the materials are accumulated in the lower part of the mixing tank 2, and subsequent mixing is carried out through the stirring mechanism, and the materials are repeatedly dispersed and gathered in the above process, so that different materials have been mixed to a certain extent in the process of feeding, thereby reducing the difficulty of subsequent mixing and improving the mixing efficiency.

[0023] like Figure 3 , Figure 5 and Figure 7 As shown, the stirring mechanism includes: a motor 701, which is installed in the mixing tank 2, and the output shaft of the motor 701 is fixedly connected to the main shaft 702, and there is a gap between the second guide plate 4 and the main shaft 702; a rotating plate 703 and a rotating member 704, which are both rotatably connected in the mixing tank 2, and the rotating plate 703 and the rotating member 704 are both fixedly connected to the main shaft 702; a plurality of vertical rods 705 are arranged at intervals, and are all arranged between the rotating plate 703 and the rotating member 704; a plurality of fixed members 706 are arranged at intervals, and are respectively arranged on adjacent vertical rods 705, and the fixed member 706 is fixedly connected to a stirring rod 707.

[0024] In the above scheme, the diameter of the material passing hole on the second guide plate 4 is larger than the diameter of the main shaft 702, so that the material can pass through. The distance between the lower edge of the second guide plate 4 and the main shaft 702 varies in the circumferential direction, so that the rotating main shaft 702 disturbs the material passing through the second guide plate 4, thereby increasing the contact probability between different materials and thus increasing the mixing effect of the materials. The main shaft 702 is driven to rotate counterclockwise (by Figure 3 Taking the top view as an example), the main shaft 702 drives the rotating plate 703 and the rotating member 704 to rotate counterclockwise together, and the rotating plate 703 and the rotating member 704 jointly drive the multiple vertical rods 705 to rotate counterclockwise together. The vertical rods 705 drive the adjacent stirring rods 707 to rotate counterclockwise together through the adjacent fixing members 706, thereby stirring and mixing the materials in the mixing tank 2.

[0025] like Figure 3-Figure 5 and Figure 7 As shown, it also includes: a spur gear ring 708, which is fixedly connected to the mixing tank 2, the vertical rod 705 and the rotating plate 703 are all rotatably connected to the rotating member 704, the vertical rod 705 is fixedly connected to a spur gear 709, and the spur gear 709 is meshed with the spur gear ring 708.

[0026] In the above scheme, when the rotating member 704 drives the vertical rod 705 to rotate counterclockwise, the vertical rod 705 drives the adjacent spur gear 709 to rotate counterclockwise (revolution), and the spur gear 709 begins to roll along the spur gear ring 708 (in Figure 5 Taking the top view direction as an example, clockwise rotation), the spur gear 709 drives the adjacent vertical rod 705 to rotate clockwise together, and the vertical rod 705 drives the adjacent stirring rod 707 to rotate clockwise together through the adjacent fixing member 706, so that the materials in the mixing tank 2 are further stirred and mixed, and the stirring rod 707 rotates clockwise (rotates) while rotating counterclockwise (revolution), so that the stirring rod 707 rotates as a whole and partially in the mixing tank 2, thereby strengthening the stirring degree of the materials, increasing the contact probability between the materials, and thereby improving the mixing effect and mixing efficiency of the materials.

[0027] like Figure 2-Figure 4As shown, it also includes: a first material passing member 801 and a second material passing member 802, both of which are rotatably connected to the mixing tank 2, the second material passing member 802 is fixedly connected to the main shaft 702, the first material passing member 801 is provided with second through holes 803 arranged at intervals, and the second material passing member 802 is provided with third through holes 804 arranged at intervals, the diameter of the third through holes 804 is larger than the diameter of the second through holes 803, which is used to make the material passing through the third through holes 804 more than the material passing through the second through holes 803 per unit time, so that the amount of material from the third through holes 804 when moving to the bottom of the first material passing member 801 on the first guide plate 3 matches the amount of material from the second through holes 803; a rotating shaft 805, which is rotatably connected to the mixing tank 2, the rotating shaft 805 and the output shaft of the motor 701 are connected by a pulley belt transmission, and the rotating shaft 805 and the first material passing member 801 are connected by a gear set transmission.

[0028] In the above scheme, the first feed pipe is located above the first feed piece 801, and the second feed pipe is located above the second feed piece 802. The axes of the first feed piece 801 and the second feed piece 802 coincide with each other, so as to allow the materials passing through the two to enter the mixing tank 2 in a relatively chaotic state, thereby improving the pre-mixing effect. The gear set between the rotating shaft 805 and the first feed piece 801 is composed of a gear and a gear ring. The gear is fixedly connected to the rotating shaft 805, and the gear ring is fixedly connected to the first feed piece 801. The transmission ratio of the gear and the gear ring is greater than 1, so as to make the amount of material discharged from the second through hole 803 the same as the amount of material discharged from the third through hole 804. During the counterclockwise rotation of the main shaft 702, the main shaft 702 drives the second feed piece 802 to rotate counterclockwise together. 702 transmits torque to the rotating shaft 805 through the pulley belt, and the rotating shaft 805 drives the first feeding piece 801 to start rotating clockwise through the gear set. During the process, the first feeding pipe and the second feeding pipe continue to pass materials, and then the materials enter the first feeding piece 801 and the second feeding piece 802 respectively, and then the materials are discharged from the adjacent second through hole 803 and the adjacent third through hole 804. During the counterclockwise rotation of the first feeding piece 801 (the second feeding piece 802), the materials are continuously discharged from the second through hole 803 (the third through hole 804), that is, the materials are distributed in a "ring shape" when entering the mixing tank 2, which facilitates the "premixing" of different materials, so that the materials are relatively evenly distributed on the first guide plate 3, thereby improving the effect of material premixing.

[0029] like Figure 3 and Figure 5-Figure 7As shown, it also includes: a limit member 901, which is a plurality of spaced-apart members, and is rotatably connected to adjacent fixing members 706, respectively; the fixing members 706 are spline-connected to adjacent vertical rods 705; the limit member 901 is provided with a limit protrusion 902; a limit groove 903 is provided in the mixing tank 2; the limit groove 903 is used to limit the limit protrusion 902; the limit groove 903 is composed of a first groove 9031, a second groove 9032, a third groove 9033 and a fourth groove 9034 connected end to end in sequence; and the first groove 9031 and the third groove 9033 are at different heights in the mixing tank 2, and are used to change the position of adjacent limit protrusions 902.

[0030] In the above scheme, the first groove 9031 and the third groove 9033 are both horizontal arc grooves, and the second groove 9032 and the fourth groove 9034 are both spatial arc grooves, which are used to smoothly connect the first groove 9031 and the third groove 9033, and the second groove 9032 and the fourth groove 9034 are inclined in opposite directions. During the counterclockwise rotation (revolution) of the fixing member 706, the fixing member 706 drives the limiting member 901 to rotate counterclockwise together, and the limiting protrusion 902 begins to slide in the limiting groove 903. Figure 5 As an example, the position of the limiting protrusion 902 shown in the figure is taken as an example (at this time, the limiting protrusion 902 slides in the first groove 9031). After the limiting protrusion 902 enters the fourth groove 9034, under the limiting action of the fourth groove 9034, the limiting protrusion 902 moves upward while revolving counterclockwise. The limiting protrusion 902 drives the fixing member 706 to move upward together through the limiting member 901, and the fixing member 706 slides relatively with the vertical rod 705. The fixing member 706 drives the stirring rod 707 to move upward together, so that the stirring rod 707 changes vertically in the stirring area of ​​the mixing tank 2, thereby further increasing the mixing. The stirring degree of the materials in the tank 2 increases the probability of contact and collision between different materials, thereby improving the mixing effect of the materials. As the fixing member 706 continues to rotate counterclockwise (revolution), after the limiting protrusion 902 enters the second groove 9032, under the limiting action of the second groove 9032, the limiting protrusion 902 begins to move downward, and the limiting protrusion 902 drives the fixing member 706 to move downward through the limiting member 901, and the fixing member 706 drives the stirring rod 707 to move downward together, and as the limiting protrusion 902 continues to slide on the limiting groove 903, and repeatedly moves up and down, until the mixing work is completed.

[0031] like Figure 5-Figure 7 As shown, it also includes: a plurality of material pocket shells 1001 arranged at intervals and respectively fixedly connected to adjacent fixing members 706. The material pocket shells 1001 are truncated cone-shaped to reduce the resistance of the material thereto. The material pocket shells 1001 are provided with a fourth through hole 1002.

[0032] In the above scheme, the outer diameter of the material pocket shell 1001 gradually decreases from top to bottom, so as to reduce the resistance encountered by the material pocket shell 1001 when it enters the bottom of the mixing tank 2 to accumulate materials, thereby reducing energy consumption, and reducing the squeezing force on the materials in the vertical direction, thereby avoiding material damage. The number of the fourth through holes 1002 on the material pocket shell 1001 is multiple, and the multiple fourth through holes 1002 are distributed circumferentially. During the downward movement of the fixing member 706, the fixing member 706 drives the material pocket shell 1001 to move downward together, and when the upper side of the material pocket shell 1001 is lower than the mixing tank 2, the material begins to enter the material pocket shell 1001, and then during the upward movement of the fixing member 706, the material pocket shell 1001 also moves upward until the limiting protrusion 902 enters the third groove 9033, at which time the material pocket shell 1001 has been out of contact with the material in the mixing tank 2, and then the material in the material pocket shell 1001 passes through the fourth through hole 1002 and falls downward to be mixed with the material in the mixing tank 2 again. During the process, the material in the mixing tank 2 is repeatedly "turned over", thereby increasing the contact probability between the materials, thereby improving the mixing effect of the materials.

[0033] The above embodiments are only for illustrating the technical concept and features of the present invention, and their purpose is to enable people familiar with the technology to understand the content of the present invention and implement it accordingly, and they cannot be used to limit the protection scope of the present invention. Any equivalent changes made according to the spirit of the present invention should be included in the protection scope of the present invention.

Claims

1. A compound amlodipine and atorvastatin calcium tablet, characterized in that: The compound amlodipine atorvastatin calcium tablet is a core-wrapped tablet, which includes an inner core containing atorvastatin calcium and an outer layer containing amlodipine besylate. The components of the inner core also include meglumine and sodium lauryl sulfate. The mass ratio of the meglumine to the sodium lauryl sulfate is 0.5-5:1, and the mass of the meglumine accounts for 1-3% of the total mass of the inner core. The components of the inner core also include a filler accounting for 35%-45% of the total mass of the inner core, a stabilizer accounting for 30%-38% of the total mass of the inner core, The composition of the outer layer tablet layer includes 2% to 8% of the total mass of the disintegrant, 1% to 5% of the total mass of the inner layer tablet core, 0.1% to 1% of the total mass of the surfactant, 0.5% to 2% of the total mass of the lubricant, and 2% to 5% of the total mass of the inner layer tablet core. The composition of the outer layer tablet layer includes 80% to 92% of the total mass of the outer layer tablet layer, 2% to 12% of the disintegrant, and 0.5% to 2.5% of the total mass of the outer layer tablet layer.

2. A mixing device for producing compound amlodipine atorvastatin calcium tablets, applied to the compound amlodipine atorvastatin calcium tablets according to claim 1, characterized in that: Included are: Frame (1); A mixing tank (2) is fixedly connected to the frame (1), and the mixing tank (2) is provided with a first feed pipe, a second feed pipe and a discharge pipe; The first guide plate (3) and the second guide plate (4) are both fixedly connected to the mixing tank (2); A third guide plate (5) is fixedly connected to the mixing tank (2), the third guide plate (5) is provided with first through holes (6) arranged at intervals, the first guide plate (3), the second guide plate (4) and the third guide plate (5) are all truncated cone-shaped, and are arranged in sequence from top to bottom, and are used to guide passing materials, and there are gaps between the frame (1) and the first guide plate (3) and the third guide plate (5); A stirring mechanism is arranged on the mixing tank (2) and is used to mix the materials in the mixing tank (2).

3. A mixing device for producing compound amlodipine atorvastatin calcium tablets according to claim 2, characterized in that: The stirring mechanism comprises: A motor (701) is installed in the mixing tank (2); an output shaft of the motor (701) is fixedly connected to a main shaft (702); and a gap exists between the second guide plate (4) and the main shaft (702); The rotating plate (703) and the rotating member (704) are both rotatably connected to the mixing tank (2); the rotating plate (703) and the rotating member (704) are both fixedly connected to the main shaft (702); A plurality of vertical rods (705) are arranged at intervals and are all disposed between the rotating plate (703) and the rotating member (704); The fixing members (706) are multiple and arranged at intervals, and are respectively provided on adjacent vertical poles (705). The fixing members (706) are fixedly connected to stirring rods (707).

4. A mixing device for producing compound amlodipine atorvastatin calcium tablets according to claim 3, characterized in that: Also included are: The spur gear ring (708) is fixedly connected in the mixing tank (2); the vertical rod (705) and the rotating plate (703) are all rotatably connected to the rotating member (704); the vertical rod (705) is fixedly connected with a spur gear (709); and the spur gear (709) is meshed with the spur gear ring (708).

5. A mixing device for producing compound amlodipine and atorvastatin calcium tablets according to claim 4, characterized in that: Also included are: A first material passing member (801) and a second material passing member (802) are both rotatably connected to the mixing tank (2); the second material passing member (802) is fixedly connected to the main shaft (702); the first material passing member (801) is provided with second through holes (803) arranged at intervals; and the second material passing member (802) is provided with third through holes (804) arranged at intervals; The rotating shaft (805) is rotatably connected to the mixing tank (2); the rotating shaft (805) is connected to the output shaft of the motor (701) via a pulley belt transmission; and the rotating shaft (805) is connected to the first material transfer member (801) via a gear set transmission.

6. A mixing device for producing compound amlodipine and atorvastatin calcium tablets according to claim 5, characterized in that: The diameter of the third through hole (804) is greater than the diameter of the second through hole (803), so that more material passes through the third through hole (804) than through the second through hole (803) per unit time.

7. A mixing device for producing compound amlodipine and atorvastatin calcium tablets according to claim 6, characterized in that: Also included are: The limiting members (901) are multiple and arranged at intervals, and are rotatably connected to adjacent fixing members (706) respectively. The fixing members (706) are spline-connected to adjacent vertical rods (705). The limiting members (901) are provided with limiting protrusions (902). The mixing tank (2) is provided with limiting grooves (903). The limiting grooves (903) are used to limit the limiting protrusions (902).

8. The mixing device for producing compound amlodipine and atorvastatin calcium tablets according to claim 7, characterized in that: The limiting groove (903) is composed of a first groove (9031), a second groove (9032), a third groove (9033) and a fourth groove (9034) connected end to end, and the first groove (9031) and the third groove (9033) are at different heights in the mixing tank (2), so as to change the position of adjacent limiting protrusions (902).

9. A mixing device for producing compound amlodipine and atorvastatin calcium tablets according to claim 8, characterized in that: Also included are: The pocket shells (1001) are multiple and arranged at intervals, and are respectively fixedly connected to adjacent fixing members (706), and the pocket shells (1001) are provided with fourth through holes (1002).

10. The mixing device for producing compound amlodipine and atorvastatin calcium tablets according to claim 9, characterized in that: The material pocket shell (1001) is in the shape of a truncated cone, and is used to reduce the resistance of the material it encounters.

Images