CN110604724A - A kind of enteric-coated mesalazine sustained-release tablet and preparation method thereof - Google Patents

Abstract

The invention discloses an enteric-coated mesalazine sustained-release tablet and a preparation method thereof. The sustained-release tablet is composed of the following raw materials: 1.2g of mesalazine, 0.1-0.3g of a sustained-release material, and 0.004-g of a lubricant 0.03g, coating powder 0.02-0.1g, sodium starch glycolate 0.004-0.03g, binding agent 0.004-0.03g; release tablet prepared by the present invention does not have any disintegration in ph1.0 buffer solution for 2 hours, then There is no disintegration in ph6.8 buffer for 2 hours, and finally it is released quickly in ph7.8 buffer; it can prevent dissolution in the upper part of the digestive tract such as the stomach and small intestine, and quickly dissolve and release in the colon, so as to ensure that it is in the colon lesion. The local concentration is high, which exerts a good therapeutic effect; the added sodium starch glycolate has strong water absorption and expansion properties, and can quickly bubble up in cold water, and after absorbing water, the particles swell and do not dissolve, and do not form a colloidal solution. It does not hinder the further infiltration of water and affect the further disintegration of the tablet.

Description

A kind of enteric-coated mesalazine sustained-release tablet and preparation method thereof

technical field

The invention relates to the technical field of pharmaceutical preparations, in particular to an enteric-coated mesalazine sustained-release tablet and a preparation method thereof.

Background technique

Mesalazine is a commonly used drug for the treatment of inflammatory colitis. Due to its excellent therapeutic efficacy, it is widely used in the world. However, due to its structure with three active reactive groups, hydroxyl and carboxyl, it can A variety of reactions are easily oxidized and invalidated during the production process, thereby affecting the therapeutic effect. Therefore, it is necessary to control the temperature and humidity to reduce the occurrence of chemical reactions, protect the content of active ingredients, and reduce the production of related substances.

Chinese patent application CN201010563009.5 discloses a mesalazine enteric-coated tablet and its preparation method. The advantages of this invention are: 1. Reduce the breakage of the tablet and improve the yield; The impact is reduced, which is conducive to improving the quality of medicines; 3. The moisture-proof performance is good, which increases the stability of the medicine; 4. The dissolution rate of the tablet is increased, so that the medicine disintegrates quickly, has a quick effect, and improves bioavailability and clinical curative effect; but This invention also has the following defects: the tablet cannot prevent dissolving in the front part of the digestive tract such as the stomach and the small intestine, but dissolves and releases rapidly in the colon, thereby ensuring that it has a high local concentration in the lesion of the colon and exerts a better therapeutic effect; In the process of tablet compression, manual compression is labor-intensive and inefficient, and the tablets cannot be dried.

Contents of the invention

In order to overcome the above-mentioned technical problems, the object of the present invention is to provide an enteric-coated mesalazine sustained-release tablet and a preparation method thereof;

The release tablet prepared by the present invention does not have any disintegration in ph1.0 buffer (imitating gastric juice) for 2 hours, then does not disintegrate in ph6.8 buffer (imitating the environment such as small intestine) for 2 hours, and finally pH7.8 buffer Rapid release (within 15 minutes) in the liquid (imitating the colon); it can prevent dissolution in the front part of the digestive tract such as the stomach and small intestine, and dissolve and release rapidly in the colon, thereby ensuring its high local concentration in the colonic lesion and exerting a better therapeutic effect ;

The invention is equipped with a tablet machine, and the setting of the discharge pipe is convenient for stabilizing the filling; the setting of the upper and lower extruding rods is convenient for pressing and forming the raw materials; Drying, the whole process is highly automated, easy to operate, and highly practical; it can realize continuous work and improve work efficiency; there are deflectors, first partitions, second partitions, and first inclined plates in the drying box And the second slanting plate, so that the hot air stays in the drying box for a longer time, more uniformly, and the drying effect is better.

The purpose of the present invention can be achieved through the following technical solutions:

An enteric-coated mesalazine sustained-release tablet, the sustained-release tablet is composed of the following ingredients and raw materials: 1.2g of mesalazine, 0.1-0.3g of sustained-release material, 0.004-0.03g of lubricant, and 0.02g of coating powder -0.1g, sodium starch glycolate 0.004-0.03g, binder 0.004-0.03g;

The sustained-release tablet is prepared through the following steps:

Step 1. Weigh the above-mentioned raw materials, mix evenly the mesalazine, the sustained-release material and the binder, and then add 0.003-0.02g of lubricant and mix evenly to obtain a mixed powder;

Step 2, adding the mixed powder into a granulator for wet granulation to obtain granules, and then drying the granules to obtain whole granules;

Step 3, adding the obtained granules, carboxymethyl starch sodium and remaining lubricant into the storage barrel of the press machine, starting the first rotating motor to work, driving the screw to rotate, the screw to drive the stirring rod to rotate, and mixing evenly to obtain the mixture; then Start the servo motor to work, drive the screw to rotate, and then drive the slider to descend, and then drive the storage barrel and discharge pipe to descend until the discharge pipe is inserted into the through hole, open the electric control valve, and discharge the mixture into a through hole ;Close the valve, and drive the storage barrel and discharge pipe to rise and reset;

Step 4: Drive the second rotating motor to drive the first turntable and the second turntable to rotate. When a through hole is located directly below the lower extruding rod, drive the third cylinder to drive the connecting block down, and then drive the lower extruding rod down. Cooperate with the upper extrusion rod to extrude the mixture in the through hole to compress the tablet;

Step 5, preparing the coating powder into a coating liquid, which is sprayed on the tablet for coating.

As a further solution of the present invention: the slow-release material is selected from at least one of HPMCK4M and HPMCK100M.

As a further solution of the present invention: the lubricant is magnesium stearate, one of micropowder silica gel.

As a further solution of the present invention: the binder is corn starch.

As a further solution of the present invention: a preparation method of enteric-coated mesalazine sustained-release tablets, comprising the following steps:

S1. Mix 1.2g of mesalamine, 0.1-0.3g of slow-release material and 0.004-0.03g of adhesive, and then add 0.003-0.02g of lubricant and mix to obtain a mixed powder;

S2. Add the mixed powder to the granulator for wet granulation to obtain granules, and then dry the granules to obtain whole granules;

S3. Add the obtained granules and the remaining lubricant into the storage barrel of the press machine, start the first rotating motor to work, drive the screw to rotate, and the screw drives the stirring rod to rotate, mix evenly, and obtain the mixture; then start the servo motor to work and drive The screw rod rotates, and then drives the slider down, and then drives the storage barrel and the discharge pipe down, until the discharge pipe is inserted into the through hole, opens the electric control valve, and discharges the mixture into a through hole; closes the valve, and drives Storage barrel and discharge pipe rise and reset;

S4. Drive the second rotating motor to drive the first turntable and the second turntable to rotate. When a through hole is located directly below the lower extruding rod, drive the third cylinder to drive the connecting block down, and then drive the lower extruding rod to descend. The upper extrusion rod cooperates to squeeze the mixture in the through hole to compress the tablet; when the tablet turns to the bottom of the push plate, it drives the first cylinder, drives the upper extrusion rod to jack up the tablet, and drives the fourth cylinder , to drive the push plate down to be at the same level as the tablet, then drive the second cylinder, push the rocker arm to move through the piston rod, and then push the moving rod to move, and then push the tablet to the chute through the push plate, and slide into the oven in dry box;

S5. The hot air blower blows the hot air into the drying box, and the drying box is equipped with a deflector, a first partition, a second partition, a first inclined plate and a second inclined plate to make the hot air stay longer in the drying box. Longer, the tablet is dried and finally discharged from the discharge port;

S6. Put the dried tablets into the host, set the host speed to 3-4RPM, adjust the heating temperature to 100-120°C, the intake fan speed to 600RPM, the exhaust fan speed to 1350RPM, and the pressure difference to be greater than 100Pa; When the temperature reaches 45°C, after adjusting the spray gun, open the compressed air valve, and the pressure difference is 100-150Pa; then use 0.02-0.1g of coating powder to prepare a coating solution and spray it on the tablets, and the flow rate of the coating solution is 260-380mL/ min, after the coating solution is sprayed, reduce the speed of the coating pot to 1RPM, the speed of the inlet fan is 600RPM, the speed of the exhaust fan is 1350RPMM, the pressure of the compressed air is 0.45MPa-0.65MPa, and the tablet is released after drying in the coating pot for 30min; coating The slices are stored in a dry and clean plastic bag and placed in a clean turnover bucket.

As a further solution of the present invention: the weight of the coated tablet is 0.4g.

As a further solution of the present invention: the pressing machine includes an operating table, a rotating seat is fixedly installed at the center of the top of the operating table, a second rotating motor is fixedly installed inside the rotating seat, and the output of the second rotating motor The shaft passes through the rotating seat and is fixedly connected to the bottom of the first turntable. The top of the first turntable is equipped with a plurality of first cylinders in a circumferential shape, and an upper extruding rod is installed on the top of each of the first cylinders. The center of the top of the first turntable is connected to the second turntable through a pillar, and the top of the second turntable is circumferentially provided with a plurality of through holes, each of which corresponds to an upper extruding rod;

An inverted L-shaped side plate is fixedly installed on the top of the swivel seat, and a third cylinder is fixedly installed on the top of the L-shaped side plate, and the piston rod of the third cylinder passes through the L-shaped side plate and is connected with the connecting block. The connecting block and the L-shaped side plate are connected by a guide rod, and a lower extruding rod is fixedly installed on the bottom of the connecting block, and both the lower extruding rod and the upper extruding rod are adapted to the through hole; the second extruding rod One side of the three cylinders is fixedly installed with a second cylinder, the piston rod of the second cylinder is movably connected with the rocker arm, and the end of the rocker arm away from the second cylinder is equipped with a vertically arranged moving rod, which passes through the The L-shaped side plate is connected with the fourth cylinder, the L-shaped side plate is provided with a horizontal groove for moving the moving rod, and a push plate is installed on the piston rod of the fourth cylinder;

A slide rail is fixedly mounted on one end of the top of the console, a servo motor is fixedly mounted on the slide rail, a screw rod is fixedly mounted on the output shaft of the servo motor, and a slide block is threadedly connected to the screw rod. The top of the slider is fixedly equipped with a first rotating motor, the output shaft of the first rotating motor extends through the slider into the storage barrel, and is connected with the screw provided inside the storage barrel, and both sides of the screw are equipped with Stirring rod, the stirring rod is triangular and inclined to the screw rod, the top of the storage barrel is provided with a feeding port, the bottom of the storage barrel is equipped with a discharge pipe, and the discharge pipe is equipped with an electric control a valve, the discharge pipe is adapted to the through hole;

The other end of the top of the console is fixedly installed with a support rod, and the top of the support rod is connected to a chute through an elastic member, and the chute extends into a drying box installed on one side of the console, and the drying box A hot air blower is fixedly installed on the top of the oven, and the hot air pipe of the hot air blower extends into the drying box, and the drying box is sequentially provided with a deflector, a first partition and a second partition from top to bottom. The deflector is arranged obliquely, the first slanting plate is evenly arranged on the first partition, the second slanting plate is evenly arranged on the second partition, and the first slanting plate and the second sloping plate are both It is a hollow structure, and the inclination directions of the first slant plate and the second slant plate are opposite; the drying box is provided with two driving rollers, which are driven by a motor, and the two driving rollers are covered with a conveyor belt, and the conveyor belt Two discharge plates are arranged obliquely below, and a discharge port is arranged between the two discharge plates.

Beneficial effects of the present invention: the release tablet prepared by the present invention does not have any disintegration in ph1.0 buffer solution (imitating gastric juice) for 2 hours, then does not disintegrate in ph6.8 buffer solution (imitation small intestine and other environments) for 2 hours, Finally, it is quickly released (within 15 minutes) in a pH7.8 buffer (imitating the colon); it can prevent dissolution in the front part of the digestive tract such as the stomach and small intestine, and quickly dissolve and release in the colon, thereby ensuring its local concentration in the colonic lesion. Play a better therapeutic effect; the added sodium carboxymethyl starch has strong water absorption and expansion properties, and can quickly swell in cold water, and after absorbing water, the particles swell and do not dissolve, do not form a colloidal solution, and do not hinder the absorption of water Continue to infiltrate and affect the further disintegration of the tablet; cornstarch has good adhesion.

In the present invention, in the tableting process, the obtained granules and the remaining magnesium stearate are added to the storage barrel of the press machine, the first rotating motor is started to work, and the screw is driven to rotate, and the screw drives the stirring rod to rotate, and the mixture is evenly mixed to obtain a mixture. Then start the servo motor to work, drive the screw to rotate, and then drive the slider to descend, and then drive the storage barrel and discharge pipe to descend until the discharge pipe is inserted into the through hole, open the electric control valve, and discharge the mixture into a In the through hole, during the discharge process, drive the discharge pipe to rise slowly until the through hole is filled with the mixture; finally close the valve, and drive the storage cylinder and the discharge pipe to rise and reset to avoid the process of filling the mixture. , the mixture is spilled, causing waste;

Drive the second rotating motor to drive the first turntable and the second turntable to rotate. When a through hole is located directly below the lower extrusion rod, drive the third cylinder to drive the connecting block down, and then drive the lower extrusion rod to descend, and the upper extrusion rod The compression rod cooperates to squeeze the mixture in the through hole to compress the tablet; when the tablet turns to the bottom of the push plate, the first cylinder is driven to drive the upper extrusion rod to lift the tablet, and the fourth cylinder is driven to drive the tablet. The push plate is lowered to be at the same level as the tablet, and then the second cylinder is driven to move the rocker arm through the piston rod, and then push the moving rod to move, and then the tablet is pushed into the chute through the push plate and slides into the drying box Inside, the whole process has a high degree of automation, simple operation and strong practicability; there are multiple through holes on the second turntable, which can realize continuous work and improve work efficiency;

The hot air blower blows the hot air into the drying box, and the drying box is equipped with a deflector, a first partition, a second partition, a first inclined plate and a second inclined plate, so that the hot air stays in the drying box for a longer period of time. Longer, more uniform, and better drying effect, the tablets are dried and finally discharged from the discharge port.

Description of drawings

The present invention will be further described below in conjunction with the accompanying drawings.

Fig. 1 is a schematic diagram of the overall structure of the pressing machine of the present invention;

Fig. 2 is the structural representation of pressing machine front view in the present invention;

Fig. 3 is a schematic diagram of the overall structure of the slide rail in the present invention;

Fig. 4 is a schematic diagram of the side view structure of the slide rail in the present invention;

Fig. 5 is a schematic diagram of the internal structure of the storage barrel in the present invention;

Fig. 6 is a schematic diagram of the overall structure of the rotating seat in the present invention;

Fig. 7 is a schematic diagram of the overall structure of the second cylinder in the present invention;

Fig. 8 is a schematic diagram of the front view structure of the rotating seat in the present invention;

Fig. 9 is a schematic diagram of the internal structure of the drying box in the present invention.

In the figure: 1. Operating table; 2. Swivel seat; 3. Slide rail; 4. L-shaped side plate; 5. Chute; 6. Drying box; 7. Support rod; 8. Slider; 9. Servo motor ;10, the first rotating motor; 11, storage barrel; 110, feeding port; 12, electric control valve; 13, discharge pipe; 14, screw mandrel; 15, screw rod; 16, stirring rod; Motor; 18, first turntable; 19, first cylinder; 20, second turntable; 21, pillar; 22, through hole; 23, upper extruding rod; 24, second cylinder; 25, third cylinder; 26, Guide rod; 27, connecting block; 28, lower extruding rod; 29, fourth cylinder; 30, push plate; 31, moving rod; 32, rocker arm; 35, discharge plate; 36, discharge port; 37, hot air blower; 38, deflector; 39, first partition; 40, second partition; 41, transmission roller; 42, conveyor belt.

Detailed ways

The following will clearly and completely describe the technical solutions in the embodiments of the present invention with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only some, not all, embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by persons of ordinary skill in the art without creative efforts fall within the protection scope of the present invention.

Please refer to Fig. 1-9, the present invention provides a technical solution:

Example 1:

An enteric-coated mesalazine sustained-release tablet, the sustained-release tablet is made up of the following ingredient raw materials: Mesalazine 1.2g, hypromellose (K4M) 0.3g, magnesium stearate 0.03g, enteric Dissolving coating powder 0.1g, sodium starch glycolate 0.03g, corn starch 0.03g;

A preparation method of enteric-coated mesalazine sustained-release tablet, comprising the following steps:

S1. Mix 1.2g mesalazine, 0.3g hypromellose (K4M) and 0.03g cornstarch uniformly, then add 0.003g magnesium stearate and mix uniformly to obtain a mixed powder;

S2. Add the mixed powder to the granulator for wet granulation to obtain granules, and then dry the granules to obtain whole granules;

S3. Add the obtained granules and the remaining magnesium stearate into the storage barrel of the press machine, start the first rotating motor to work, drive the screw to rotate, and the screw drives the stirring rod to rotate, mix evenly, and obtain the mixture; then start the servo motor to work , to drive the screw to rotate, and then to drive the slider down, and then to drive the storage barrel and the discharge pipe down, until the discharge pipe is inserted into the through hole, open the electric control valve, and discharge the mixture into a through hole; close the valve, And drive the storage barrel and discharge pipe to rise and reset;

S4. Drive the second rotating motor to drive the first turntable and the second turntable to rotate. When a through hole is located directly below the lower extruding rod, drive the third cylinder to drive the connecting block down, and then drive the lower extruding rod to descend. The upper extrusion rod cooperates to squeeze the mixture in the through hole to compress the tablet; when the tablet turns to the bottom of the push plate, it drives the first cylinder, drives the upper extrusion rod to jack up the tablet, and drives the fourth cylinder , to drive the push plate down to be at the same level as the tablet, then drive the second cylinder, push the rocker arm to move through the piston rod, and then push the moving rod to move, and then push the tablet to the chute through the push plate, and slide into the oven in dry box;

S5. The hot air blower blows the hot air into the drying box, and the drying box is equipped with a deflector, a first partition, a second partition, a first inclined plate and a second inclined plate to make the hot air stay longer in the drying box. Longer, the tablet is dried and finally discharged from the discharge port;

S6. Put the dried tablet into the main machine, set the main machine speed to 2RPM, adjust the heating temperature to 120°C, the intake fan speed to 600RPM, the exhaust fan speed to 1350RPM, and the pressure difference to be greater than 100Pa; when the tablet bed temperature reaches a temperature of 45°C, after adjusting the spray gun, open the compressed air valve, and the pressure difference is 150Pa; then use 0.1g of coating powder to prepare a coating solution and spray it on the tablets, the flow rate of the coating solution is 380mL/min, after the coating solution is sprayed, reduce The speed of the coating pot is 1RPM, the speed of the inlet fan is 600RPM, the speed of the exhaust fan is 1350RPMM, and the pressure of the compressed air is 0.65MPa. After drying in the coating pot for 30min, the tablets are released; the coated tablets are stored in a dry and clean plastic bag and placed clean in the turnover bucket.

Example 2:

An enteric-coated mesalazine sustained-release tablet, the sustained-release tablet is made up of the following ingredient raw materials: Mesalazine 1.2g, hypromellose (K4M) 0.1g, magnesium stearate 0.004g, enteric Dissolving coating powder 0.02g, sodium starch glycolate 0.004g, corn starch 0.004g;

A preparation method of an enteric-coated mesalazine sustained-release tablet, comprising the following steps: the preparation method is the same as in Example 1.

Example 3:

An enteric-coated mesalazine sustained-release tablet, the sustained-release tablet is made up of the following ingredient raw materials: Mesalazine 1.2g, hypromellose (K15M) 0.3g, magnesium stearate 0.004g, enteric Dissolving coating powder 0.1g, sodium starch glycolate 0.004g, corn starch 0.03g;

A preparation method of an enteric-coated mesalazine sustained-release tablet, comprising the following steps: the preparation method is the same as in Example 1.

The release tablet prepared by the embodiment 1-3 and the traditional process is tested, and different buffer solutions are used to simulate the situation in the human digestive tract, and the indicators such as its dissolution are detected; the test results are as follows:

As can be seen from the above table, the release tablet prepared by the present invention can prevent dissolution in the front part of the digestive tract such as the stomach and small intestine, and dissolve and release rapidly in the colon, thereby ensuring that it has a high local concentration in the colon lesion and exerts a better therapeutic effect.

Please refer to Figs. 1-9, the pressing machine includes an operating table 1, a rotating base 2 is fixedly installed at the center of the top of the operating table 1, and a second rotating motor 17 is fixedly installed inside the rotating base 2, so The output shaft of the second rotating motor 17 passes through the rotating base 2 and is fixedly connected to the bottom of the first turntable 18. The top of the first turntable 18 is circumferentially equipped with a plurality of first cylinders 19, and each of the first cylinders 19 are equipped with an upper extruding rod 23, the top center of the first turntable 18 is connected to the second turntable 20 through a pillar 21, and the top of the second turntable 20 is provided with a plurality of through holes 22 in a circular shape. , each through hole 22 is in one-to-one correspondence with an upper extrusion rod 23;

An inverted L-shaped side plate 4 is fixedly installed on the top of the rotating seat 2, and a third cylinder 25 is fixedly installed on the top of the L-shaped side plate 4, and the piston rod of the third cylinder 25 runs through the L-shaped side plate 4 It is connected with the connecting block 27, and the connecting block 27 is connected with the L-shaped side plate 4 through the guide rod 26. The bottom of the connecting block 27 is fixedly equipped with a lower extruding rod 28, and the lower extruding rod 28 is connected with the upper The extrusion rods 23 are all adapted to the through holes 22; the second cylinder 24 is fixedly installed on one side of the third cylinder 25, and the piston rod of the second cylinder 24 is movably connected with the rocker arm 32, and the rocker arm 32 An end far away from the second cylinder 24 is equipped with a vertically arranged moving rod 31, the moving rod 31 passes through the L-shaped side plate 4 and is connected with the fourth cylinder 29, and the L-shaped side plate 4 is provided with a moving rod 31 A moving horizontal groove, a push plate 30 is installed on the piston rod of the fourth cylinder 29;

A slide rail 3 is fixedly installed on one end of the top of the console 1, a servo motor 9 is fixedly installed on the slide rail 3, a screw mandrel 14 is fixedly installed on the output shaft of the servo motor 9, and a screw mandrel 14 is fixedly installed on the screw mandrel 14. A slide block 8 is threaded, and the top of the slide block 8 is fixedly equipped with a first rotating motor 10, and the output shaft of the first rotating motor 10 penetrates the slide block 8 and extends into the storage barrel 11, and is connected with the storage barrel 11. The internal screw rod 15 is connected, and both sides of the screw rod 15 are equipped with stirring rods 16. The stirring rods 16 are triangular and inclined to the screw rod 15. The top of the storage barrel 11 is provided with a feeding port 110. A discharge pipe 13 is installed on the bottom of the storage barrel 11, and an electric control valve 12 is installed on the discharge pipe 13, and the discharge pipe 13 is adapted to the through hole 22;

The other end of the top of the console 1 is fixedly equipped with a support rod 7, and the top of the support rod 7 is connected with the chute 5 through an elastic member, and the chute 5 extends into the drying box 6 installed on one side of the console 1 Among them, a hot air blower 37 is fixedly installed on the top of the drying box 6, and the hot air pipe of the hot air blower 37 extends into the drying box 6, and the drying box 6 is sequentially provided with flow guides from top to bottom. plate 38, the first partition 39 and the second partition 40, the deflector 38 is arranged obliquely, the first slant plate 33 is uniformly arranged on the first partition 39, and the second partition 40 is evenly arranged A second slant plate 34 is provided, the first slant plate 33 and the second slant plate 34 are both hollow structures, and the inclination directions of the first slant plate 33 and the second slant plate 34 are opposite, so that the hot air stays longer in the equipment. long, and make the tablet be heated more evenly; the drying box 6 is provided with two drive rollers 41, the drive rollers 41 are driven by a motor, the two drive rollers 41 are covered with a conveyor belt 42, and the conveyor belt 42 is inclined below Two discharge plates 35 are provided, and a discharge opening 36 is provided between the two discharge plates 35 .

The working principle of the present invention: add the obtained granules and the remaining magnesium stearate into the storage barrel of the press machine, start the first rotating motor to work, drive the screw to rotate, and the screw drives the stirring rod to rotate, mix evenly, and obtain the mixture; then Start the servo motor to work, drive the screw to rotate, and then drive the slider to descend, and then drive the storage barrel and discharge pipe to descend until the discharge pipe is inserted into the through hole, open the electric control valve, and discharge the mixture into a through hole , during the discharge process, drive the discharge pipe to rise slowly until the through hole is filled with the mixture; finally close the valve, and drive the storage cylinder and discharge pipe to rise and reset, so as to avoid the mixture being filled during the process of filling the mixture. to spill, to waste;

Drive the second rotating motor to drive the first turntable and the second turntable to rotate. When a through hole is located directly below the lower extrusion rod, drive the third cylinder to drive the connecting block down, and then drive the lower extrusion rod to descend, and the upper extrusion rod The compression rod cooperates to squeeze the mixture in the through hole to compress the tablet; when the tablet turns to the bottom of the push plate, the first cylinder is driven to drive the upper extrusion rod to lift the tablet, and the fourth cylinder is driven to drive the tablet. The push plate descends to be at the same level as the tablet, and then drives the second cylinder to move the rocker arm through the piston rod, and then pushes the moving rod to move, and then pushes the tablet into the chute through the reciprocating motion of the push plate, and then slides into the drying chamber. In the dry box, the whole process has a high degree of automation, simple operation and strong practicability;

The hot air blower blows the hot air into the drying box, and the drying box is equipped with a deflector, a first partition, a second partition, a first inclined plate and a second inclined plate, so that the hot air stays in the drying box for a longer period of time. Longer, more uniform, and better drying effect, the tablets are dried and finally discharged from the discharge port.

In the description of this specification, descriptions with reference to the terms "one embodiment", "example", "specific example" and the like mean that the specific features, structures, materials or characteristics described in conjunction with the embodiment or example are included in at least one embodiment of the present invention. In an embodiment or example. In this specification, schematic representations of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials or characteristics described may be combined in any suitable manner in any one or more embodiments or examples.

The above content is only an example and description of the present invention. Those skilled in the art will make various modifications or supplements to the described specific embodiments or replace them in similar ways, as long as they do not deviate from the invention or exceed the rights of the present invention. The scope defined in the claims should all belong to the protection scope of the present invention.

Claims (6)

1. An enteric mesalazine sustained-release tablet is characterized by comprising the following raw materials: 1.2g of mesalazine, 0.1-0.3g of slow release material, 0.004-0.03g of lubricant, 0.02-0.1g of coating powder, 0.004-0.03g of carboxymethyl starch sodium and 0.004-0.03g of adhesive;

the sustained-release tablet is prepared by the following steps:

step one, weighing the raw materials, uniformly mixing mesalazine, the slow release material and the adhesive, adding 0.003-0.02g of lubricant, and uniformly mixing to obtain mixed powder;

step two, adding the mixed powder into a granulator for wet granulation to obtain granules, and then drying the granules to obtain whole granules;

adding the obtained whole granules, the carboxymethyl starch sodium and the residual lubricant into a material storage barrel of a pressing machine, starting a first rotating motor to work, driving a screw to rotate, driving a stirring rod to rotate by the screw, and uniformly mixing to obtain a mixture; then starting a servo motor to work, driving a screw rod to rotate, further driving a sliding block to descend, further driving a material storage barrel and a material discharge pipe to descend until the material discharge pipe is inserted into the through hole, and opening an electric control valve to discharge the mixture into one through hole; closing the valve and driving the material storage barrel and the material discharge pipe to ascend and reset;

driving a second rotating motor to drive the first rotating disc and the second rotating disc to rotate, driving a third air cylinder to drive the connecting block to descend when one through hole is positioned under the lower extrusion rod, further driving the lower extrusion rod to descend, and extruding the mixture in the through hole by matching with the upper extrusion rod to press tablets;

and step five, preparing the coating powder into a coating solution, and spraying the coating solution on the tablets for coating.

2. The enteric mesalazine sustained-release tablet according to claim 1, wherein the sustained-release material is at least one selected from the group consisting of HPMCK4M and HPMCK 100M.

3. The enteric mesalazine sustained-release tablet according to claim 1, wherein the lubricant is one of magnesium stearate and aerosil.

4. The enteric mesalazine sustained-release tablet according to claim 1, wherein the binder is corn starch.

5. The preparation method of the enteric mesalazine sustained-release tablet is characterized by comprising the following steps:

s1, uniformly mixing 1.2g of mesalazine, 0.1-0.3g of slow-release material and 0.004-0.03g of adhesive, adding 0.003-0.02g of lubricant, and uniformly mixing to obtain mixed powder;

s2, adding the mixed powder into a granulator for wet granulation to obtain granules, and then drying the granules to obtain whole granules;

s3, adding the obtained whole granules and the residual lubricant into a material storage barrel of a pressing machine, starting a first rotating motor to work, driving a screw to rotate, driving a stirring rod to rotate by the screw, and uniformly mixing to obtain a mixture; then starting a servo motor to work, driving a screw rod to rotate, further driving a sliding block to descend, further driving a material storage barrel and a material discharge pipe to descend until the material discharge pipe is inserted into the through hole, and opening an electric control valve to discharge the mixture into one through hole; closing the valve and driving the material storage barrel and the material discharge pipe to ascend and reset;

s4, driving a second rotating motor to drive a first rotating disc and a second rotating disc to rotate, driving a third air cylinder to drive a connecting block to descend when a through hole is located right below a lower extrusion rod, further driving the lower extrusion rod to descend, and extruding the mixture in the through hole by matching with the upper extrusion rod to press tablets; when the tablets rotate to the position below the push plate, the first air cylinder is driven to drive the upper extrusion rod to jack the tablets, the fourth air cylinder is driven to drive the push plate to descend to be positioned at the same horizontal position with the tablets, then the second air cylinder is driven to drive the rocker arm to move through the push rod, and further the moving rod is driven to move, so that the tablets are pushed into the sliding groove through the push plate and slide into the drying box;

s5, blowing hot air into a drying box by a hot air blower, wherein a guide plate, a first partition plate, a second partition plate, a first inclined plate and a second inclined plate are arranged in the drying box, so that the hot air is kept in the drying box for a longer time, and the tablets are dried and finally discharged from a discharge port;

s6, putting the dried tablets into a host, setting the rotation speed of the host to be 3-4RPM, adjusting the heating temperature to be 100-120 ℃, the rotation speed of an air inlet machine to be 600RPM, the rotation speed of an exhaust fan to be 1350RPM and the pressure difference to be more than 100 Pa; when the temperature of the slice bed reaches 45 ℃, opening a compressed air valve after the spray gun is adjusted, and controlling the pressure difference to be 100-150 Pa; then 0.02-0.1g of coating powder is used for preparing coating liquid which is sprayed on the tablets, the flow rate of the coating liquid is 260-; the coated tablets are stored in a clean turnover barrel after being bound in a dry clean plastic bag.

6. The method for preparing an enteric mesalazine sustained-release tablet according to claim 5, wherein the weight of the coated tablet is 0.4 g.