A compound amlodipine atorvastatin calcium tablet and a tablet press for its production

Abstract

The present invention relates to the technical field of drug preparation, and in particular to a compound amlodipine atorvastatin calcium tablet and a tablet press for its production. The tablet comprises: a mixture of 1-4% amlodipine and 3-12% atorvastatin calcium as active ingredients and pharmaceutically acceptable excipients based on the total weight of the tablet core; the pharmaceutically acceptable excipients are, based on the total weight of the tablet core, 13%-35% alkaline stabilizer, 40%-80% filler, appropriate amount of wetting agent, 3%-10% disintegrant, 0.4%-2% cosolvent, 0.2%-1.2% glidant and 0.2%-1.2% lubricant. The present invention maintains the stability of the drug after dissolution and reduces the surface tension of the drug particles through the cosolvent, so that the drug molecules are more easily dispersed in the solvent. The present invention not only makes the drug have excellent stability, but also can achieve rapid disintegration and fast dissolution rate.

Description

Technical Field

[0001] The invention relates to the technical field of drug preparation, in particular to a compound amlodipine and atorvastatin calcium tablet and a tablet press for producing the same. Background Art

[0002] Cardiovascular and cerebrovascular diseases are the main threats to human health. According to survey reports, more than 3 million people die from cardiovascular and cerebrovascular diseases in China each year, accounting for about 50% of the total number of deaths, and the age of onset of the disease is gradually getting younger. Hypertension and hyperlipidemia are not only important risk factors for cardiovascular and cerebrovascular diseases, but the two often occur in the same patient, forming a mutually influencing relationship. Many patients with hyperlipidemia also suffer from hypertension, and there is a causal relationship between the two. Compound amlodipine atorvastatin calcium tablets combine two drug ingredients with different mechanisms of action. They are mainly used to treat primary hypertension and dyslipidemia (such as hypercholesterolemia). By simultaneously managing blood pressure and lowering cholesterol levels in the blood, this compound preparation helps to significantly reduce the risk of cardiovascular disease. However, as a water-insoluble drug ingredient, atorvastatin calcium has poor solubility in the preparation, which usually leads to a low dissolution rate of atorvastatin calcium preparations. In addition, the dissolution rate of the preparation will further decrease over time. Therefore, in the preparation production process, ensuring good dissolution characteristics of atorvastatin calcium is a key challenge. Summary of the invention

[0003] In order to overcome the shortcomings mentioned in the above background technology, the present invention provides a compound amlodipine and atorvastatin calcium tablet and a tablet press for its production.

[0004] The technical implementation scheme of the present invention is: a compound amlodipine atorvastatin calcium tablet, comprising: A mixture of 1-4% amlodipine and 3-12% atorvastatin calcium as active ingredients and pharmaceutically acceptable excipients based on the total weight of the tablet core; The pharmaceutically acceptable excipients are, based on the total weight of the tablet core, 13% to 35% of an alkaline stabilizer, 40% to 80% of a filler, an appropriate amount of a wetting agent, 3% to 10% of a disintegrant, 0.4% to 2% of a solubilizer, 0.2% to 1.2% of a glidant and 0.2% to 1.2% of a lubricant; The alkaline stabilizer is selected from calcium carbonate or magnesium oxide; The filler is selected from one or more of corn starch, sorbitol, starch and lactose; The wetting agent is water; The disintegrant is selected from one or more of guar gum, cross-linked sodium carboxymethyl cellulose, and cross-linked polyvinylpyrrolidone; The cosolvent is selected from sodium lauryl sulfate; The glidant is silicon dioxide; The lubricant is calcium stearate or talc.

[0005] A compound amlodipine and atorvastatin calcium tablet pressing machine, comprising: Fixed frame; A power assembly is arranged on the fixing frame; A first gear is rotatably connected to the fixing frame, the first gear is spline-connected to a first spline shaft, and a first elastic element is disposed between the first gear and the first spline shaft; A first push block, fixedly connected to the first spline shaft, and the power assembly drives the first push block to move; A second spline shaft is rotatably connected to the first spline shaft, the fixing frame is fixedly connected to a stamping plate, a stamping hole is provided on the stamping plate, and the second spline shaft is used to squeeze the material in the stamping hole of the stamping plate; A demoulding assembly, arranged on the fixed frame, for pushing the tablets that have been compressed out of the punching holes on the punching plate; A detection drive assembly, disposed on the fixed frame, for detecting whether the punching hole on the punching plate is filled with material, and driving the first gear to rotate; A material discharge assembly is arranged on the stamping plate and is used for filling materials into the stamping holes of the stamping plate.

[0006] In addition, it is particularly preferred that the demoulding component includes: A connecting rod, slidably connected to the fixing frame, wherein a second elastic element is provided between the connecting rod and the fixing frame; A push shaft, arranged on the connecting rod, and used for pushing out the tablets in the punching holes on the punching plate; The transmission assembly is arranged on the fixing frame and is used for driving the connecting rod to move along the fixing frame.

[0007] In addition, it is particularly preferred that the transmission assembly includes: A second gear, rotatably connected to the fixing frame; a third spline shaft, spline-connected to the second gear; The second push block is fixedly connected to the third spline shaft, and the power assembly drives the second push block to move.

[0008] In addition, it is particularly preferred that the detection drive component includes: An electric slide rail, fixedly connected to the fixing frame; A rack frame, fixedly connected to the slider of the electric slide rail, the first gear and the second gear both meshing with the rack frame; The ultrasonic probe is fixedly connected to the fixing frame and is used to detect whether the punching holes on the punching plate are filled with materials.

[0009] In addition, it is particularly preferred that the blanking assembly includes: An electric push rod, fixedly connected to the stamping plate; A material discharge shell is fixedly connected to the telescopic end of the electric push rod, the material discharge shell is fitted with the stamping plate, and the material discharge shell is fixed and connected to a feed pipe; A vibration component is arranged on the material discharge shell and is used to change the state of the material in the material discharge shell.

[0010] In addition, it is particularly preferred that the vibration component includes: A sawtooth rod, fixedly connected to the fixing frame; A knocking block is slidably connected to the blanking shell, and a third elastic element is provided between the knocking block and the blanking shell; An extrusion rotary block is rotatably connected to the knocking block, the extrusion rotary block is fitted with the sawtooth rod, a fourth elastic element is arranged between the extrusion rotary block and the discharge shell, and the elastic coefficient of the fourth elastic element is greater than the elastic coefficient of the third elastic element.

[0011] In addition, it is particularly preferred that the invention further comprises: The kneading component is arranged on the fixed frame and is used to enhance the compaction degree of the tablets. The kneading component includes: The third gear has two parts, which are rotatably connected to the fixing frame and the stamping plate respectively, the push shaft and the second spline shaft are spline-connected to the adjacent third gears respectively, and the push shaft is rotatably connected to the connecting rod; There are two rotating drums, which are rotatably connected to the fixed frame and the stamping plate respectively, and the rotating drum is fixedly connected to a fourth gear, and the fourth gear is meshed with the adjacent third gear; The pushing assembly is arranged on the fixing frame and is used for driving the two rotating drums to rotate.

[0012] In addition, it is particularly preferred that the pushing component includes: A push rod is spline-connected to the fixed frame, the first push block is used to drive the push rod to move, and an inclined slide groove is provided in the rotating drum; a fifth elastic element, disposed between the push rod and the fixing frame; There are two protrusions, both of which are fixedly connected to the push rod, and the two protrusions are respectively located in adjacent inclined sliding grooves.

[0013] In addition, it is particularly preferred that the spiral directions of the inclined grooves in the two rotating drums are opposite to each other, so as to enable the two rotating drums to rotate in opposite directions.

[0014] The present invention has the following advantages: 1. The present invention maintains the stability of the drug after dissolution and reduces the surface tension of the drug particles through the co-solvent, making it easier for the drug molecules to disperse in the solvent. The present invention not only makes the drug have excellent stability, but also can achieve rapid disintegration and fast dissolution rate.

[0015] 2. Detect whether the raw material in the punching hole of the punching plate has reached the required content, and then cut off the pressing of the tablet according to the detection results to avoid the raw material being damp and unable to fill the punching hole in the punching plate, resulting in a high scrap rate of tablet pressing.

[0016] 3. The knocking block cyclically impacts the blanking shell, so that the blanking shell generates vibration force, and the vibration force drives the raw materials in the blanking shell to vibrate, thereby changing the state of the raw materials in the blanking shell, making it easier for the raw materials to enter and fill the punching hole of the punching plate.

[0017] 4. When the raw materials are pressed into sheets, the second spline shaft and the push shaft rotate in opposite directions, and the raw materials are subjected to opposite rotational kneading forces in the upper and lower directions, that is, the raw materials are kneaded into sheets, which improves the compaction uniformity of the raw materials and avoids uneven compaction due to moisture in the raw materials. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 It is a schematic diagram of the three-dimensional structure of the present invention; Figure 2 It is a schematic diagram of the three-dimensional structure of the connecting rod and the second elastic element of the present invention; Figure 3 It is a schematic diagram of the three-dimensional structure of the electric slide rail and the rack rack of the present invention; Figure 4 It is a schematic diagram of the three-dimensional structure of the blanking shell and the sawtooth rod of the present invention; Figure 5 It is a schematic diagram of the three-dimensional structure of the extrusion rotating block and the fourth elastic element of the present invention; Figure 6 It is a three-dimensional structural schematic diagram of the third gear and the rotating drum of the present invention; Figure 7 It is a schematic cross-sectional view of the three-dimensional structure of the rotating drum of the present invention.

[0019] In the figure: 1, fixed frame, 2, power assembly, 21, output motor, 22, rotating shaft, 23, driving plate, 24, driving rod, 3, first gear, 4, first spline shaft, 5, first elastic element, 6, first push block, 7, second spline shaft, 8, stamping plate, 201, connecting rod, 202, second elastic element, 203, push shaft, 204, second gear, 205, third spline shaft, 206, second push block, 301, electric slide Rail, 302, rack rack, 303, ultrasonic probe, 401, electric push rod, 402, unloading shell, 403, feeding pipe, 404, serrated rod, 405, knocking block, 406, third elastic element, 407, extrusion rotating block, 408, fourth elastic element, 501, third gear, 502, rotating drum, 503, fourth gear, 504, inclined slide groove, 505, push rod, 506, fifth elastic element, 507, bump. DETAILED DESCRIPTION

[0020] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0021] Due to its poor water solubility, atorvastatin calcium often exhibits low solubility in formulations, which generally results in a slower dissolution rate of pharmaceutical formulations containing this ingredient. In addition, the solubility of these formulations may further decrease with prolonged storage time.

[0022] A compound amlodipine and atorvastatin calcium tablet comprises: a mixture of 1-4% of amlodipine and 3-12% of atorvastatin calcium as active ingredients and pharmaceutically acceptable excipients, based on the total weight of the tablet core; the pharmaceutically acceptable excipients are, based on the total weight of the tablet core, 13%-35% of an alkaline stabilizer, 40%-80% of a filler, an appropriate amount of a wetting agent, 3%-10% of a disintegrant, 0.4%-2% of a solubilizing agent, 0.2%-1.2% of a glidant and 0.2%-1.2% of a lubricant; the alkaline stabilizer is selected from calcium carbonate or magnesium oxide; the filler is selected from one or more of corn starch, sorbitol, starch and lactose; the wetting agent is water; the disintegrant is selected from one or more of guar gum, cross-linked sodium carboxymethyl cellulose and cross-linked polyvinylpyrrolidone; the solubilizing agent is selected from sodium lauryl sulfate; the glidant is silicon dioxide; and the lubricant is calcium stearate or talc.

[0023] Since amlodipine raw materials easily absorb moisture when wet, external moisture can be easily absorbed by the amlodipine in the raw materials, thereby causing the fluidity of the raw materials to weaken. When the existing single-punch tablet press is tableting the raw materials, the raw materials are forced into the pressing mold by gravity in the material shell. When the fluidity of the raw materials is weakened by moisture, it is difficult for the raw materials to enter and fill the pressing mold by gravity, resulting in a reduction in the raw material content required for tableting, causing tableting failure.

[0024] A tablet press for producing compound amlodipine atorvastatin calcium tablets, such as Figure 1-Figure 3 As shown, it includes: a fixed frame 1; a power component 2, which is arranged on the fixed frame 1; a first gear 3, which is rotatably connected to the fixed frame 1, and the first gear 3 is spline-connected with the first spline shaft 4, and a first elastic element 5 is arranged between the first gear 3 and the first spline shaft 4; a first push block 6, which is fixedly connected to the first spline shaft 4, and the power component 2 drives the first push block 6 to move; a second spline shaft 7, which is rotatably connected to the first spline shaft 4, and the fixed frame 1 is fixedly connected with a stamping plate 8, and a stamping hole is arranged on the stamping plate 8, and the second spline shaft 7 is used to squeeze the material in the stamping hole of the stamping plate 8; a demoulding component, which is arranged on the fixed frame 1, and is used to push the tablets that have been pressed out of the stamping hole on the stamping plate 8; a detection drive component, which is arranged on the fixed frame 1, and is used to detect whether the material in the stamping hole on the stamping plate 8 is filled, and drives the first gear 3 to rotate; a blanking component, which is arranged on the stamping plate 8, and is used to fill the material into the stamping hole of the stamping plate 8.

[0025] In the above scheme, a control terminal for staff to operate is provided on the fixed frame 1, and the power assembly 2 includes an output motor 21, a rotating shaft 22, two driving disks 23, two driving rods 24 and a reversing gear box. The output motor 21 is electrically connected to the control terminal, the output motor 21 is fixedly connected to the upper plane of the fixed frame 1, the rotating shaft 22 is rotatably connected to the fixed frame 1, the reversing gear box is fixedly connected to the fixed frame 1, and the input end of the reversing gear box is fixedly connected to the output shaft of the output motor 21, the output end of the reversing gear box is fixedly connected to the rotating shaft 22, the two driving disks 23 are fixedly connected to the rotating shaft 22, the driving disks 23 are provided with guide grooves, the driving rods 24 are vertically slidably connected to the fixed frame 1, and the driving rods 24 are slidably connected to the guide grooves on the adjacent driving disks 23, and the rotating shaft 22 rotates through The two driving disks 23 drive the two driving rods 24 to move up and down, and the driving rod 24 on the right side moves downward before the driving rod 24 on the left side. Specifically, according to the shape of the guide groove on the driving disk 23 (the above is common knowledge in the field and will not be elaborated here), the first elastic element 5 is a spring, which is used to drive the first spline shaft 4 to reset, and the central axis of the second spline shaft 7 coincides with the central axis of the punching hole on the punching plate 8. The first push block 6 is fitted with the driving rod 24 on the right side. When the punching hole on the punching plate 8 is not filled with raw materials, the first gear 3 drives the first push block 6 to be misaligned with the driving rod 24 through the first spline shaft 4, thereby cutting off the power transmission of the driving rod 24 and canceling the tablet pressing this time. This avoids the raw materials being wet and unable to fill the punching holes in the punching plate 8, resulting in a high scrap rate for tablet pressing.

[0026] Specifically, Figure 1-Figure 3 As shown, the demoulding assembly includes: a connecting rod 201, which is slidably connected to the fixed frame 1, and a second elastic element 202 is arranged between the connecting rod 201 and the fixed frame 1; a push shaft 203, which is arranged on the connecting rod 201, and the push shaft 203 is used to push out the tablets in the punching holes on the punching plate 8; a transmission assembly, which is arranged on the fixed frame 1, and is used to drive the connecting rod 201 to move along the fixed frame 1.

[0027] In the above scheme, the bottom of the connecting rod 201 is in contact with the fixed frame 1, which is used to increase the supporting force of the push shaft 203 during tablet pressing. The second elastic element 202 is a spring, which is used to drive the push shaft 203 to reset through the connecting rod 201, and is used to make the push shaft 203 slide along the punching hole on the punching plate 8 to push the tablet out of the punching hole on the punching plate 8 after pressing.

[0028] Specifically, Figure 1-Figure 3 As shown, the transmission assembly includes: a second gear 204, rotatably connected to the fixed frame 1; a third spline shaft 205, spline-connected to the second gear 204; a second push block 206, fixedly connected to the third spline shaft 205, and the power assembly 2 drives the second push block 206 to move.

[0029] In the above scheme, the second push block 206 is fitted with the driving rod 24 on the left side, and is used to drive the third spline shaft 205 to move upward through the second push block 206. Through the rotation of the second push block 206, the power transmission between the second push block 206 and the left driving rod 24 is cut off, and the ejection of the tablet is cancelled, so that the raw material is always located in the punching hole on the punching plate 8 during the pressing process.

[0030] Specifically, Figure 1 and Figure 3 As shown, the detection drive assembly includes: an electric slide rail 301, fixedly connected to the fixed frame 1; a rack frame 302, fixedly connected to the slider of the electric slide rail 301, and the first gear 3 and the second gear 204 are both engaged with the rack frame 302; an ultrasonic probe 303, fixedly connected to the fixed frame 1, used to detect whether the punching holes on the punching plate 8 are filled with materials.

[0031] In the above scheme, the electric slide rail 301 and the ultrasonic probe 303 are both electrically connected to the control terminal. The ultrasonic probe 303 is located above the punching hole on the punching plate 8. The ultrasonic probe 303 is not affected by the color or transparency of the material and accurately measures the height of the material. A counting device can also be provided in the control terminal to record the number of consecutive times that the punching hole on the punching plate 8 is not filled, so as to determine whether the raw material is blocked. When the raw material is blocked, the output motor 21 is turned off and wait for the staff to come for maintenance.

[0032] Specifically, Figure 4 As shown, the material discharge component includes: an electric push rod 401, which is fixedly connected to the stamping plate 8; a material discharge shell 402, which is fixedly connected to the telescopic end of the electric push rod 401, the material discharge shell 402 is in contact with the stamping plate 8, and the material discharge shell 402 is fixed and connected to the feed pipe 403; a vibration component is arranged on the material discharge shell 402, and is used to change the state of the material in the material discharge shell 402.

[0033] In the above scheme, the electric push rod 401 is electrically connected to the control terminal, and the lower side surface of the discharge shell 402 is fitted with the upper side surface of the stamping plate 8 to prevent leakage of raw materials in the discharge shell 402. The punching hole on the stamping plate 8 is located on the moving path of the discharge shell 402. When the discharge shell 402 is aligned with the punching hole of the stamping plate 8, the raw material in the discharge shell 402 enters the punching hole of the stamping plate 8 under gravity. The feed pipe 403 is a flexible pipe for adapting to the position change of the discharge shell 402. At the same time, the feed pipe 403 is connected to an external feeding device to ensure the stable operation of the tableting work.

[0034] When it is necessary to prepare compound amlodipine atorvastatin calcium tablets, the staff fills the lower material shell 402 with raw materials through the feed pipe 403, and then starts the device to start the tableting operation. First, the telescopic end of the electric push rod 401 pushes the lower material shell 402 to move, so that the lower material shell 402 slides to the top of the punching hole of the punching plate 8. At this time, the material in the lower material shell 402 enters the punching hole of the punching plate 8 and fills the punching hole of the punching plate 8. Then, the telescopic end of the electric push rod 401 drives the lower material shell 402 to reset to the initial state, and then the device is started. The output motor 21 is started, and the output shaft of the output motor 21 drives the rotating shaft 22 to rotate through the reversing gear box, and the rotating shaft 22 drives the two driving disks 23 to rotate. First, the driving disk 23 located on the right side drives the adjacent driving rod 24 to move downward through the guide groove thereon, so that the right driving rod 24 drives the first push block 6 to move downward synchronously, so that the first push block 6 drives the second spline shaft 7 to move downward through the first spline shaft 4, and at the same time the first elastic element 5 is compressed, until the second spline shaft 7 enters the punching hole on the punching plate 8, and the raw material is pressed into tablets.

[0035] After the tablet is successfully compressed, the driving disc 23 on the right drives the adjacent driving rod 24 to reset, and at the same time, the first elastic element 5 drives the second spline shaft 7 to reset to the initial state through the first spline shaft 4, and then the driving disc 23 on the left drives the adjacent driving rod 24 to move upward. At this time, the driving rod 24 on the left drives the second push block 206 to move upward, so that the second push block 206 drives the push shaft 203 to move upward through the third spline shaft 205 and the connecting rod 201. At the same time, the second elastic element 202 is compressed, so that the push shaft 203 moves upward along the punching hole of the punching plate 8 to push the tablet upward, and at the same time, the electric push The telescopic end of the rod 401 drives the discharge shell 402 to move above the punching hole of the punching plate 8 and pushes the tablet forward at the same time. Then the driving disk 23 on the left drives the adjacent driving rod 24 to reset to the initial state. The second elastic element 202 resets and drives the third spline shaft 205 and the push shaft 203 to reset through the connecting rod 201, so that the material in the discharge shell 402 enters the punching hole of the punching plate 8 and fills the punching hole of the punching plate 8. Then the telescopic end of the electric push rod 401 drives the discharge shell 402 to reset to the initial state. The tablets are compressed in this cycle. The above are the basic steps for tablet compression.

[0036] When the raw materials in the lower material shell 402 are damp, the adsorption tension between the raw materials increases. At this time, the materials in the lower material shell 402 are difficult to fall and fill the punching holes of the punching plate 8, resulting in insufficient material content in the punching holes on the punching plate 8, making it difficult to press the raw materials into sheets, increasing the scrap rate. For this reason, when the lower material shell 402 adds raw materials to the punching holes on the punching plate 8, the ultrasonic probe 303 always detects whether the raw material content in the punching holes of the punching plate 8 is filled. When the raw materials are not filled, the ultrasonic probe 303 will send a signal to the control terminal to enable the control terminal to start the electric slide rail 301. The slider of the electric slide rail 301 drives the rack 302 to move, so that the rack 302 drives the first gear 3 and the second gear 204 to rotate, and the first gear 3 and the second gear 204 respectively drive the first spline shaft 4 and the third spline shaft 205 to rotate, so that the first spline shaft 4 and the third spline shaft 205 respectively drive the first push block 6 and the second push block 206 to rotate synchronously The first push block 6 and the second push block 206 are respectively separated from the adjacent driving rod 24, and the two driving rods 24 cannot press and demould the raw material in the punching hole of the punching plate 8 through the first push block 6 and the second push block 206, even if the raw material always stays in the punching hole of the punching plate 8, until the electric push rod 401 drives the unloading shell 402 to move to the top of the punching hole of the punching plate 8 for unloading, and at the same time, the electric slide rail 301 drives the rack rack 302 to reset, so that the rack rack 302 drives the first gear 3 and the second gear 204 to reset, that is, the first push block 6 and the second push block 206 are docked with the adjacent driving rod 24, when the ultrasonic probe 303 detects that the punching hole of the punching plate 8 is full of raw material, it starts to continue to press the raw material, and then cuts off the pressing of the tablet according to the detection situation by detecting whether the raw material in the punching hole of the punching plate 8 reaches the required content, so as to avoid the raw material being wet and unable to fill the punching hole in the punching plate 8, resulting in a high scrap rate of tablet pressing.

[0037] In this embodiment, the connection relationship between the connecting rod 201 and the push shaft 203 is a fixed connection, but it is limited to this embodiment. In other subsequent embodiments, the connection relationship between the connecting rod 201 and the push shaft 203 is a rotational connection. Please refer to the specific description in the subsequent embodiments.

[0038] In a further embodiment, Figure 4 and Figure 5 As shown, the vibration component includes: a sawtooth rod 404, fixedly connected to the fixed frame 1; a knocking block 405, slidably connected to the discharge shell 402, and a third elastic element 406 is arranged between the knocking block 405 and the discharge shell 402; an extrusion rotary block 407, rotatably connected to the knocking block 405, the extrusion rotary block 407 is fitted with the sawtooth rod 404, and a fourth elastic element 408 is arranged between the extrusion rotary block 407 and the discharge shell 402, and the elastic coefficient of the fourth elastic element 408 is greater than the elastic coefficient of the third elastic element 406.

[0039] In the above scheme, the sawtooth block on the sawtooth rod 404 has an inclined surface and a vertical surface, and the inclined surface is close to the electric push rod 401. The third elastic element 406 is a spring, which is used to drive the knocking block 405 to reset. The shape of the knocking block 405 can be freely set, which is used to change the knocking position of the unloading shell 402 for targeted knocking. The outside of the sawtooth rod 404 is electroplated with a wear-resistant coating, such as a chrome coating, to extend its service life. The outside of the extrusion rotary block 407 is electroplated with a wear-resistant coating to reduce the friction loss between it and the sawtooth rod 404, so as to extend its service life. The fourth elastic element 408 is a torsion spring, which is used to drive the extrusion rotary block 407 to reset, and the elastic coefficient of the fourth elastic element 408 is greater than the elastic coefficient of the third elastic element 406, which is used to make the third elastic element 406 preferentially compressed when the extrusion rotary block 407 slides along the inclined surface of the sawtooth rod 404.

[0040] In the process that the telescopic end of the electric push rod 401 drives the discharge shell 402 to move above the punching hole of the punching plate 8, the discharge shell 402 drives the knocking block 405 thereon to move synchronously, and the knocking block 405 drives the extrusion rotating block 407 to move synchronously, and the extrusion rotating block 407 moves along the sawtooth rod 404, so that the sawtooth block inclined surface of the sawtooth rod 404 squeezes the extrusion rotating block 407 to move upward, and the extrusion rotating block 407 drives the adjacent knocking block 405 to move upward synchronously, and at the same time the third elastic element 406 is compressed, so that after the extrusion rotating block 407 passes through the sawtooth block on the sawtooth rod 404, the third elastic element 406 is reset and drives the knocking block 405 to hit the discharge shell 402, so that the raw material in the discharge shell 402 vibrates, changes the state of the raw material, and is convenient for entering the punching The cycle continues until the material shell 402 moves to the punching hole of the punching plate 8. At this time, the raw material in the material shell 402 enters the punching of the punching plate 8, and then the telescopic end of the electric push rod 401 drives the material shell 402 to reset to the initial position. The material shell 402 drives the extrusion rotary block 407 to reset synchronously through the knocking block 405. At this time, the sawtooth block of the sawtooth rod 404 squeezes the extrusion rotary block 407 on the vertical surface, so that the extrusion rotary block 407 rotates along the knocking block 405 under the extrusion force, and the fourth elastic element 408 twists at the same time. After the material shell 402 is reset to the initial state, the fourth elastic element 408 drives the extrusion rotary block 407 to reset to the initial state. When the punching hole on the punching plate 8 is filled again, the above steps are repeated.

[0041] In a further embodiment, Figure 6 and Figure 7As shown, it also includes: a kneading component, which is arranged on the fixed frame 1 and is used to enhance the compaction degree of the tablets. The kneading component includes: a third gear 501, which has two, which are rotatably connected to the fixed frame 1 and the punching plate 8 respectively, the push shaft 203 and the second spline shaft 7 are spline-connected to the adjacent third gear 501 respectively, and the push shaft 203 is rotatably connected to the connecting rod 201; a rotating drum 502, which has two, which are rotatably connected to the fixed frame 1 and the punching plate 8 respectively, the rotating drum 502 is fixedly connected with the fourth gear 503, and the fourth gear 503 is meshed with the adjacent third gear 501; a pushing component, which is arranged on the fixed frame 1, and is used to drive the two rotating drums 502 to rotate.

[0042] In the above scheme, the third gear 501, rotating drum 502 and fourth gear 503 located at the top are used to drive the second spline shaft 7 to rotate, and the third gear 501, rotating drum 502 and fourth gear 503 located at the bottom are used to drive the push shaft 203 to rotate, and the central axes of the two rotating drums 502 coincide, and the two are connected in a close and rotatable manner.

[0043] Specifically, Figure 6 and Figure 7 As shown, the pushing assembly includes: a pushing rod 505, which is splined to the fixed frame 1, a first pushing block 6 is used to drive the pushing rod 505 to move, and an inclined slide groove 504 is arranged in the rotating drum 502; a fifth elastic element 506 is arranged between the pushing rod 505 and the fixed frame 1; there are two protrusions 507, both of which are fixedly connected to the pushing rod 505, and the two protrusions 507 are respectively located in adjacent inclined slide grooves 504, and the spiral directions of the inclined slide grooves 504 in the two rotating drums 502 are opposite, which is used to make the two rotating drums 502 rotate in opposite directions.

[0044] In the above scheme, the fifth elastic element 506 is a spring, which is used to drive the push rod 505 to reset. The outside of the protrusion 507 is electroplated with a wear-resistant coating to reduce the friction loss of sliding along the adjacent inclined slide groove 504 and extend the service life. When the raw material is pressed, the second spline shaft 7 and the push shaft 203 rotate in opposite directions, so that the raw material is subjected to opposite rotational kneading forces in the upper and lower directions, that is, the raw material is kneaded into sheets, thereby improving the compaction degree of the raw material.

[0045] When the right driving rod 24 drives the second spline shaft 7 to press the raw material through the first pushing block 6 and the first spline shaft 4, the right driving rod 24 drives the pushing rod 505 to move downward synchronously through the first pushing block 6, so that the pushing rod 505 moves downward along the fixing frame 1, and at the same time the fifth elastic element 506 is compressed, and the pushing rod 505 drives the two protrusions 507 thereon to move downward synchronously, so that the two protrusions 507 respectively drive the two rotating drums 502 to rotate in the opposite direction through the two inclined slide grooves 504, and the two rotating drums 502 drive the adjacent The fourth gear 503 rotates synchronously in the opposite direction, and the two fourth gears 503 respectively drive the adjacent third gears 501 to rotate, so that the two third gears 501 respectively drive the second spline shaft 7 and the push shaft 203 to rotate, and the rotation directions of the second spline shaft 7 and the push shaft 203 are opposite, so that when the second spline shaft 7 presses the raw material, the raw material is subjected to opposite rotational kneading forces in the upper and lower directions, that is, the raw material is kneaded into sheets, the compaction degree of the raw material is improved, and the raw material is prevented from being damp and having poor fluidity, and it is difficult to compact the material evenly by vertical pressure alone.

[0046] After the raw material is pressed into sheets, the second spline shaft 7 is in the process of resetting upward, and the second spline shaft 7 drives the first push block 6 to move upward through the first spline shaft 4. At this time, the fifth elastic element 506 is reset, and drives the push rod 505 to reset upward, so that the push rod 505 drives the two protrusions 507 to reset synchronously. At this time, the protrusion 507 drives the adjacent rotating drum 502 to rotate in the opposite direction and reset through the adjacent inclined slide groove 504. When the raw material is pressed into sheets again, the above steps are repeated.

[0047] The above descriptions are merely embodiments of the present invention and are not intended to limit the patent scope of the present invention. Any equivalent structure or equivalent process transformation made using the contents of the present invention specification, or directly or indirectly applied in other related technical fields, are also included in the patent protection scope of the present invention.

Claims

1. A compound amlodipine and atorvastatin calcium tablet, characterized in that it comprises: A mixture of 1-4% amlodipine and 3-12% atorvastatin calcium as active ingredients and pharmaceutically acceptable excipients based on the total weight of the tablet core; The pharmaceutically acceptable excipients are, based on the total weight of the tablet core, 13% to 35% of an alkaline stabilizer, 40% to 80% of a filler, an appropriate amount of a wetting agent, 3% to 10% of a disintegrant, 0.4% to 2% of a solubilizer, 0.2% to 1.2% of a glidant and 0.2% to 1.2% of a lubricant; The alkaline stabilizer is selected from calcium carbonate or magnesium oxide; The filler is selected from one or more of corn starch, sorbitol, starch and lactose; The wetting agent is water; The disintegrant is selected from one or more of guar gum, cross-linked sodium carboxymethyl cellulose, and cross-linked polyvinylpyrrolidone; The cosolvent is selected from sodium lauryl sulfate; The glidant is silicon dioxide; The lubricant is calcium stearate or talc.

2. A tablet press for producing compound amlodipine and atorvastatin calcium tablets, characterized in that it comprises: Fixed frame (1); A power assembly (2) is arranged on the fixing frame (1); A first gear (3) is rotatably connected to the fixing frame (1); the first gear (3) is spline-connected to a first spline shaft (4); and a first elastic element (5) is provided between the first gear (3) and the first spline shaft (4); A first push block (6) is fixedly connected to the first spline shaft (4), and the power assembly (2) drives the first push block (6) to move; A second spline shaft (7) is rotatably connected to the first spline shaft (4); the fixed frame (1) is fixedly connected to a punching plate (8); a punching hole is provided on the punching plate (8); and the second spline shaft (7) is used to squeeze the material in the punching hole of the punching plate (8); A demoulding assembly, arranged on the fixed frame (1), and used for pushing the tablets that have been pressed out of the punching holes on the punching plate (8); A detection drive assembly, arranged on the fixed frame (1), used to detect whether the punching hole on the punching plate (8) is filled with material, and to drive the first gear (3) to rotate; A material discharge assembly is arranged on the stamping plate (8) and is used for filling material into the stamping hole of the stamping plate (8).

3. A tablet press for producing compound amlodipine and atorvastatin calcium tablets according to claim 2, characterized in that: The demoulding component includes: A connecting rod (201) is slidably connected to the fixing frame (1), and a second elastic element (202) is provided between the connecting rod (201) and the fixing frame (1); A push shaft (203) is arranged on the connecting rod (201), and the push shaft (203) is used to push out the tablet in the punching hole on the punching plate (8); A transmission assembly is arranged on the fixing frame (1) and is used to drive the connecting rod (201) to move along the fixing frame (1).

4. A tablet press for producing compound amlodipine and atorvastatin calcium tablets according to claim 3, characterized in that: The transmission assembly comprises: A second gear (204) rotatably connected to the fixing frame (1); A third spline shaft (205), spline-connected to the second gear (204); The second push block (206) is fixedly connected to the third spline shaft (205), and the power assembly (2) drives the second push block (206) to move.

5. A tablet press for producing compound amlodipine and atorvastatin calcium tablets according to claim 4, characterized in that: The detection drive component includes: An electric slide rail (301) fixedly connected to the fixing frame (1); A rack frame (302) is fixedly connected to a slider of the electric slide rail (301), and the first gear (3) and the second gear (204) are both meshed with the rack frame (302); An ultrasonic probe (303) is fixedly connected to the fixing frame (1) and is used to detect whether the punching holes on the punching plate (8) are filled with material.

6. A tablet press for producing compound amlodipine and atorvastatin calcium tablets according to claim 5, characterized in that: The blanking assembly comprises: An electric push rod (401) fixedly connected to the stamping plate (8); A material discharge shell (402) is fixedly connected to the telescopic end of the electric push rod (401), the material discharge shell (402) is in contact with the stamping plate (8), and the material discharge shell (402) is fixed and connected to a feed pipe (403); A vibration component is arranged on the material discharge shell (402) and is used to change the state of the material in the material discharge shell (402).

7. A tablet press for producing compound amlodipine and atorvastatin calcium tablets according to claim 6, characterized in that: The vibration component comprises: A sawtooth rod (404) fixedly connected to the fixing frame (1); A knocking block (405) is slidably connected to the material discharge shell (402), and a third elastic element (406) is provided between the knocking block (405) and the material discharge shell (402); An extrusion rotary block (407) is rotatably connected to the striking block (405), the extrusion rotary block (407) is fitted with the sawtooth rod (404), and a fourth elastic element (408) is provided between the extrusion rotary block (407) and the discharge shell (402), and the elastic coefficient of the fourth elastic element (408) is greater than the elastic coefficient of the third elastic element (406).

8. A tablet press for producing compound amlodipine and atorvastatin calcium tablets according to claim 7, characterized in that: Also included are: A kneading component is arranged on the fixed frame (1) and is used to enhance the compaction degree of the tablets. The kneading component comprises: The third gear (501) has two gears, which are rotatably connected to the fixing frame (1) and the stamping plate (8) respectively; the push shaft (203) and the second spline shaft (7) are spline-connected to adjacent third gears (501) respectively; and the push shaft (203) is rotatably connected to the connecting rod (201); The rotating drum (502) has two parts, which are rotatably connected to the fixed frame (1) and the punching plate (8) respectively; the rotating drum (502) is fixedly connected to a fourth gear (503); the fourth gear (503) is meshed with the adjacent third gear (501); A pushing assembly is arranged on the fixing frame (1) and is used to drive the two rotating drums (502) to rotate.

9. A tablet press for producing compound amlodipine and atorvastatin calcium tablets according to claim 8, characterized in that: The pushing component comprises: A push rod (505) is spline-connected to the fixing frame (1); the first push block (6) is used to drive the push rod (505) to move; and an inclined slide groove (504) is provided in the rotating drum (502); a fifth elastic element (506), arranged between the pushing rod (505) and the fixing frame (1); There are two protrusions (507), both of which are fixedly connected to the push rod (505), and the two protrusions (507) are respectively located in adjacent inclined sliding grooves (504).

10. A tablet press for producing compound amlodipine and atorvastatin calcium tablets according to claim 9, characterized in that: The spiral directions of the inclined slide grooves (504) in the two rotating drums (502) are opposite, so as to enable the two rotating drums (502) to rotate in opposite directions.

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