CN113499316A - Preparation method of moxifloxacin hydrochloride tablets - Google Patents
Preparation method of moxifloxacin hydrochloride tablets Download PDFInfo
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
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- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
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Abstract
The invention discloses a preparation method of moxifloxacin hydrochloride tablets, belonging to the technical field of pharmaceutical preparations, and the preparation method comprises the following steps: weighing raw materials: weighing moxifloxacin hydrochloride, microcrystalline cellulose, lactose, internal croscarmellose sodium, external croscarmellose sodium and magnesium stearate; and (3) granulating: placing the weighed moxifloxacin hydrochloride, microcrystalline cellulose, lactose and sodium croscarmellose into a wet granulator for granulation to obtain wet granules; and (3) drying: feeding the wet granules into a hot air circulating oven to obtain dry granules; finishing and total mixing: granulating the dry granules by a swing granulator, mixing the dry granules with the additional croscarmellose sodium by a mixing device, and adding magnesium stearate to continue to obtain total mixed granules; tabletting and coating: carrying out trial tabletting on the total mixed particles; and after tabletting is finished, coating and packaging to obtain the moxifloxacin hydrochloride tablets. The invention adopts wet granulation tabletting, and the method is simple and easy to operate.
Description
Technical Field
The invention relates to the technical field of pharmaceutical preparations, in particular to a preparation method of moxifloxacin hydrochloride tablets.
Background
Moxifloxacin hydrochloride is a quinolone antibacterial drug researched and developed by Bayer company in Germany, and has the trade name of 'baefule', is marketed in Germany in 9 months in 1999, and is approved by FDA in the United states in 12 months in the same year. At present, the clinical applications of the moxifloxacin hydrochloride tablet and the moxifloxacin hydrochloride sodium chloride injection are mainly. Moxifloxacin hydrochloride is an 8-methoxy fluoroquinolone antibacterial drug with broad spectrum and antibacterial activity. Moxifloxacin hydrochloride has broad-spectrum antibacterial activity against gram-positive bacteria, gram-negative bacteria, anaerobic bacteria, acid-fast bacteria, and atypical microorganisms such as mycoplasma, chlamydia and legionella. The mechanism of antibacterial action is interference with the II, IV topoisomerases, which are key enzymes in controlling DNA topology and in DNA replication, repair and transcription. The sterilization curve of moxifloxacin hydrochloride shows that moxifloxacin has concentration-dependent sterilization activity.
In the existing preparation process of moxifloxacin hydrochloride tablets, dry-method granule tabletting is generally adopted, and the main drug moxifloxacin hydrochloride has larger specification and small space for adding auxiliary materials, so that the direct tabletting of dry powder can cause poor tabletting quality, and the dry-method granule tabletting is not suitable. In view of the above, the invention provides a preparation method of a novel moxifloxacin hydrochloride tablet.
Disclosure of Invention
Aiming at the defects in the prior art, the invention aims to provide a preparation method of moxifloxacin hydrochloride tablets, so as to solve the problems.
In order to achieve the purpose, the invention provides the following technical scheme:
a preparation method of moxifloxacin hydrochloride tablets comprises the following steps:
s1, weighing raw materials
Weighing moxifloxacin hydrochloride, microcrystalline cellulose, lactose, internal croscarmellose sodium, external croscarmellose sodium and magnesium stearate;
s2, granulating
Placing the weighed moxifloxacin hydrochloride, microcrystalline cellulose, lactose and sodium croscarmellose into a wet granulator for granulation to obtain wet granules;
s3, drying
Spreading the wet particles in the step S2 on a baking pan, and feeding the wet particles into a hot air circulation baking oven to obtain dry particles with the moisture content of less than 3.0%;
s4, granulating and mixing
Granulating the dry granules in the step S3 by a swing granulator, mixing the granules with the additional croscarmellose sodium by a mixing device, adding magnesium stearate, and continuously mixing to obtain total mixed granules;
s5, tabletting and coating
Performing trial tabletting on the total mixed particles in the step S4, adopting 7 × 17mm capsule type punched tablets, and controlling the hardness to be 90-120N; and after tabletting is finished, coating and packaging to obtain the moxifloxacin hydrochloride tablets.
More preferably: the moxifloxacin hydrochloride, the microcrystalline cellulose, the lactose, the internal croscarmellose sodium, the external croscarmellose sodium and the magnesium stearate are weighed according to the following parts by weight: 400 portions of moxifloxacin hydrochloride; 100-200 parts of microcrystalline cellulose; 50-100 parts of lactose; 10-15 parts of croscarmellose sodium is added internally; 10-15 parts of additional croscarmellose sodium; 5-8 parts of magnesium stearate.
More preferably: in step S2, the stirring speed 40HZ is set, and stirring is started to premix for 10 min; then adding wetting agent purified water, continuing to start stirring and cutting to granulate, and granulating for 8 min.
More preferably: in step S4, the mixing device includes a mixing tank and a housing disposed on one side of the upper portion of the mixing tank, a feeding channel is disposed on one side of the upper portion of the mixing tank, a discharge port is disposed at the bottom of the mixing tank, a material pushing channel, a sliding channel, an air inlet channel, a connecting channel, and an air storage cavity are disposed in the housing, an air inlet pipe is connected to the air storage cavity, the air inlet pipe is connected to an air pump, the sliding channel, the air inlet channel, the connecting channel, and the air storage cavity are sequentially disposed, the material pushing channel is located above the sliding channel, and one end of the material pushing channel is communicated with the feeding channel;
a feeding hole is formed above the material pushing channel, a feeding hopper is arranged above the feeding hole, a material pushing mechanism is arranged in the material pushing channel, and the material pushing mechanism is used for pushing materials entering the material pushing channel through the feeding hole to the feeding channel;
the air storage device is characterized in that a sliding block is arranged in the sliding channel, a limiting mechanism and a plugging mechanism are arranged on the shell, the limiting mechanism is used for limiting the sliding block to slide towards the direction close to the plugging mechanism, and the sliding block is used for sliding towards the direction close to the plugging mechanism, so that the air storage cavity, the connecting channel, the air inlet channel and the material pushing channel are communicated, and materials in the air inlet channel are pushed into the mixing tank through air flow.
More preferably: the material pushing mechanism comprises a first cylinder, an upper push plate and a lower push plate;
the first air cylinder is used for pushing the upper push plate and the lower push plate to move towards or away from the direction of the feeding channel in the material pushing channel, the upper push plate is contacted with the top in the material pushing channel, the lower push plate is contacted with the bottom in the material pushing channel, the lower push plate is provided with a through hole, the bottom in the material pushing channel is provided with an air inlet hole, the air inlet hole is positioned at the top of the air inlet channel, and when the upper push plate and the lower push plate push materials to the feeding channel, the through hole and the air inlet hole vertically correspond to each other, so that the material pushing channel is communicated with the air inlet channel through the through hole and the air inlet hole;
the upper push plate is provided with a door plate at one end far away from the first cylinder, the upper side of the door plate is rotatably connected with the upper push plate, and the lower side of the door plate is in contact with the end face of the lower push plate;
the sliding block is kept away from one side of the plugging mechanism and is provided with a first spring, one end of the first spring is connected with the sliding block, the other end of the first spring is fixed with the side wall of the sliding channel, the upper portion of the sliding block is provided with an upward protruding part, an upper slotted hole is formed between the material pushing channel and the sliding channel, the bottom of the lower pushing plate is fixed with an upper limiting block, the upper end of the upper limiting block is fixed to the bottom of the lower pushing plate, the lower end of the upper limiting block penetrates through the upper slotted hole and is in contact with the protruding part, and the upper limiting block is used for driving the sliding block to be kept away from the plugging mechanism to slide.
More preferably: the plugging mechanism comprises a push rod, a second spring, a plug and an inserted rod;
a baffle is arranged between the sliding channel and the air inlet channel, a partition plate is arranged between the air inlet channel and the connecting channel, the second spring, the plug and the inserted rod are all positioned in the connecting channel, and a through hole is formed between the connecting channel and the air storage cavity;
the push rod with the inserted bar is fixed respectively the relative both sides of end cap, the second spring housing is established the inserted bar surface just supports tightly the end cap with between the interface channel lateral wall, first jack has been seted up on the baffle, be provided with the second jack on the baffle, first jack aperture is greater than the push rod diameter, the second jack with push rod looks adaptation, push rod one end with the end cap is connected, and the other end passes in proper order first jack, second jack and extend in the slide channel, the slider is used for promoting push rod, end cap are to being close to the second spring direction removes, so that inlet channel and interface channel pass through first jack intercommunication.
More preferably: the limiting mechanism comprises a driving motor, a fixing plate, a wheel disc, a first rotating shaft, a lever and a second rotating shaft;
the fixed plate is fixed at the bottom of the shell, the driving motor is installed on the fixed plate, the first rotating shaft is fixed on an output shaft of the driving motor, the wheel disc is fixed on the first rotating shaft, and an extending part which is bent upwards and is used for contacting with the bottom of the lever is arranged on the outer side of the wheel disc;
slotted hole has been seted up down to the sliding channel bottom, the slider bottom is fixed with down spacing piece, down spacing piece upper end with the slider bottom is fixed, and the lower extreme is inserted and is established in the slotted hole down, the second pivot is fixed just wear to establish on the fixed plate in the lever, lever one end is spacing end, and the other end is the trigger end, the extension with the contact of trigger end bottom surface, spacing end portion is provided with spacing portion, spacing portion be used for with down spacing piece contact, in order to restrict the slider is to being close to the shutoff mechanism direction slides, spacing end surface with distance between the second pivot is greater than the trigger end surface with distance between the second pivot.
More preferably: be provided with in the casing and prevent stifled mechanism, prevent stifled mechanism includes driving part and follower, the driving part is located push away in the material passageway, the follower is located just be used for becoming flexible in the feed inlet material in the feed inlet.
More preferably: the driving part comprises a second cylinder and a fixed rod, the second cylinder is fixed at the top of the lower push plate, the upper push plate is provided with a containing hole matched with the fixed rod, the lower end of the fixed rod is fixed with the second cylinder, the upper end of the fixed rod is inserted into the push hole, and the fixed rod is made of iron material;
the follower includes elasticity banding, magnet post, sleeve and third spring, the elasticity banding is fixed the feed inlet inner wall, the sleeve is located in the elasticity banding and fixes on the feed inlet inner wall, the magnet post is inserted and is established in the sleeve and with the sleeve is followed sleeve axial direction sliding fit, magnet post one end is located in the sleeve, the other end with elasticity banding internal surface contact, the third spring is located in the sleeve and one end with the feed inlet inner wall is fixed, the other end with the magnet post is fixed, the magnet post be used for with the dead lever magnetism is connected.
More preferably: and the top of the mixing tank is provided with an air outlet hole, and the air outlet hole is provided with filter cloth.
In conclusion, the invention has the following beneficial effects: the invention adopts a wet method for granulation and tabletting, and the moxifloxacin hydrochloride has moderate hardness, uniform granules and good compressibility, so that when the moxifloxacin hydrochloride is mixed with medicinal auxiliary materials (microcrystalline cellulose, lactose, sodium croscarmellose internally added, sodium croscarmellose externally added and magnesium stearate), the mixture is uniformly mixed and has good fluidity, and the prepared preparation (tablet) has attractive appearance and good dissolution uniformity. The release rate is better when 0.1N HCl is taken as a dissolution medium, the in vitro dissolution curve of the release agent is basically consistent with that of the marketed product 'baefule', the dissolution rate is high, and the release agent is basically completely dissolved after 40-50 minutes of dissolution. Meanwhile, the moxifloxacin hydrochloride tablet has good stability, and after the moxifloxacin hydrochloride tablet is accelerated for 6 months under the conditions that the temperature is 40 ℃ and the humidity is 75%, the dissolution rate does not change obviously, and all indexes meet the quality standard of USP (Universal Serial bus) for receiving and carrying the product. The preparation method of the moxifloxacin hydrochloride tablet provided by the invention is simple, easy to operate and suitable for industrial production.
Drawings
FIG. 1 is a block flow diagram of an embodiment, which is mainly used for embodying a preparation method of moxifloxacin hydrochloride tablets;
FIG. 2 is a schematic sectional view of an embodiment, which is mainly used for embodying the structure of a mixing device;
FIG. 3 is a schematic partial cross-sectional view of the embodiment, mainly used for embodying the internal structure of the housing;
FIG. 4 is a schematic view, partly in section, of an embodiment, primarily intended to embody the structure of a pusher mechanism;
FIG. 5 is a schematic view, partly in section, of an embodiment, mainly used to embody the internal structure of the housing;
fig. 6 is an enlarged view of the structure a in fig. 3, and is mainly used for embodying the structure of the follower.
In the figure, 1, a mixing tank; 2. a discharge port; 31. a stirring motor; 32. a stirring shaft; 33. a stirring paddle; 4. a feed channel; 5. a feed hopper; 6. a plugging mechanism; 61. a push rod; 62. a second spring; 63. a plug; 64. inserting a rod; 7. a material pushing mechanism; 71. a first cylinder; 72. a push plate is arranged; 73. a lower push plate; 74. a door panel; 75. an upper limit block; 76. perforating; 8. a limiting mechanism; 81. a fixing plate; 82. a wheel disc; 83. a first rotating shaft; 84. an extension portion; 85. a lever; 86. a second rotating shaft; 87. a limiting part; 9. an anti-blocking mechanism; 911. a second cylinder; 912. fixing the rod; 921. an elastic sealing band; 922. a magnetic column; 923. a sleeve; 924. a third spring; 10. a housing; 11. an air inlet pipe; 12. a gas storage cavity; 13. a through hole; 14. a material pushing channel; 15. a slide channel; 16. an upper slot; 17. a lower slot; 18. a first spring; 19. a slider; 20. a lower limiting block; 21. a connecting channel; 22. a buffer block; 23. an air intake passage; 24. an air inlet; 25. a partition plate; 26. an air outlet; 27. and (4) feeding a material inlet.
Detailed Description
The invention is described in detail below with reference to the figures and examples.
Example 1: a preparation method of moxifloxacin hydrochloride tablets is shown in figure 1 and comprises the following steps:
s1, weighing raw materials
Weighing 436.4mg of moxifloxacin hydrochloride, 134.0mg of microcrystalline cellulose, 67.4mg of lactose, 13.4mg of internal croscarmellose sodium, 13.4mg of external croscarmellose sodium and 5.4mg of magnesium stearate;
s2, granulating
Placing the weighed moxifloxacin hydrochloride, microcrystalline cellulose, lactose and sodium croscarmellose into a wet granulator for granulation to obtain wet granules; preferably, in the granulating process, setting the stirring speed to be 40HZ, starting stirring and premixing for 10 min; then adding a proper amount of purified water of a wetting agent, continuously starting stirring and cutting up for granulating, wherein the granulating time is 8 min;
s3, drying
Spreading the wet particles in the step S2 on a baking pan, feeding the wet particles into a hot air circulation baking oven, sampling and inspecting the dried particles to obtain dry particles with the moisture content of less than 3.0%;
s4, granulating and mixing
Granulating the dry granules in the step S3 by a swing granulator, mixing the granules with the additional croscarmellose sodium by a mixing device, adding magnesium stearate, and continuously mixing to obtain total mixed granules;
s5, tabletting and coating
Performing trial tabletting on the total mixed particles in the step S4, adopting 7 × 17mm capsule type punched tablets, controlling the hardness to be 90-120N, weighing the average tablet once every 30min in the tabletting process, and checking the appearance and the hardness of the tablet at any time; and after tabletting is finished, coating and packaging to obtain the moxifloxacin hydrochloride tablets.
Preferably, the coating solution is prepared by the following steps: the solid content was 15% (w/w), and the solvent was purified water. The coating powder (gastric soluble type 295F650005) and purified water are weighed according to the prescription amount, the purified water is firstly put into a stainless steel barrel, then the Opadry is slowly added into the barrel, and the stirring is carried out for at least 45 minutes, so that the coating powder is dissolved uniformly in color and has no agglomeration or caking phenomenon.
Tablet coating is carried out in a tablet coating machine, and after preheating is finished, the temperature of an air inlet is as follows: 90-110 ℃, air outlet temperature: and (2) starting homogenate, compressed air and a peristaltic pump in sequence at 35-45 ℃, starting liquid spraying, starting a spray gun, and adjusting a nozzle to ensure that the coating liquid is uniformly atomized, wherein the atomization pressure is as follows: 0.3-0.4Mpa, and spraying the atomized coating liquid on the surface of the rolling tablet core slowly and uniformly by a spray gun. At this time, the coating pan is set to have a low rotation speed, which is the slowest speed at which the tablet cores can flow uniformly from top to bottom, generally 5 rpm. The amount of the spray should be such that the core sheet below the spray zone is slightly moist but not sticky to the hand. Controlling the temperature of the tablet core at about 35-45 ℃, starting a coating layer to protect the tablet core after 30min, properly increasing the rotating speed to 6-8rpm, taking the coated tablet every 30min after coating for 1 h, visually observing the appearance, measuring the weight gain until the weight gain is about 3.0-3.5%, closing a spray gun, keeping hot air drying for 10min, closing a heating device, cooling the tablet to room temperature, and collecting the tablet.
Preferably, during the packaging process, the mold specification is checked and confirmed according to the packaging requirements, 12 sheets/plate. The packaging material is received, and the name, lot number and weight of the product are checked. Packaging with a blister packaging machine: upper and lower heating temperatures: 120 ℃ and 170 ℃; heat-sealing temperature: 230 ℃ to 250 ℃; blanking speed: 20-200 plates/min. In the production process, the heat sealing, batch number, blanking and appearance quality of the blister package need to be checked at any time, and phenomena such as reticulate pattern press-through, powder clamping and the like are avoided, so that the requirements are as follows: the heat sealing is tight, no air leakage exists, and the patterns are clear; the batch number is clear and accurate; the blanking is neat and has no tooth edge; the appearance is neat.
In the technical scheme, the moxifloxacin hydrochloride is prepared into the tablets by a wet method, and the moxifloxacin hydrochloride is moderate in hardness, uniform in particle and good in compressibility, so that when the moxifloxacin hydrochloride is mixed with pharmaceutical excipients (microcrystalline cellulose, lactose, internal croscarmellose sodium, external croscarmellose sodium and magnesium stearate), the uniform mixing and good fluidity are realized, and the prepared preparation (tablet) is attractive in appearance and good in dissolution uniformity. The release rate is better when 0.1N HCl is taken as a dissolution medium, the in vitro dissolution curve of the release agent is basically consistent with that of the marketed product 'baefule', the dissolution rate is high, and the release agent is basically completely dissolved after 40-50 minutes of dissolution. Meanwhile, the moxifloxacin hydrochloride tablet has good stability, and after the moxifloxacin hydrochloride tablet is accelerated for 6 months under the conditions that the temperature is 40 ℃ and the humidity is 75%, the dissolution rate does not change obviously, and all indexes meet the quality standard of USP (Universal Serial bus) for receiving and carrying the product. The preparation method of the moxifloxacin hydrochloride tablet provided by the invention is simple, easy to operate and suitable for industrial production.
Referring to fig. 2 to 6, in step S4, the mixing apparatus includes a mixing tank 1 and a case 10 provided at an upper side of the mixing tank 1. The mixing tank 1 is vertical cylindrical, a feeding channel 4 is arranged on one side of the upper portion of the mixing tank 1, a discharging port 2 is arranged in the center of the bottom of the mixing tank, a plurality of air outlet holes 26 used for discharging air outwards are formed in the top of the mixing tank 1, and filter cloth (not shown in the figure) is arranged on the air outlet holes 26 to prevent the materials from leaking out. Be provided with rabbling mechanism on the blending tank 1, the rabbling mechanism includes agitator motor 31, (mixing) shaft 32 and stirring rake 33, and agitator motor 31 installs at blending tank 1 top center. The stirring shaft 32 is positioned in the mixing tank 1, the upper end of the stirring shaft passes through the top of the mixing tank 1 and is connected with the output shaft of the stirring motor 31, and the lower end of the stirring shaft extends downwards and vertically and is close to the bottom in the mixing tank 1. The stirring paddle 33 is an inclined blade type blade, and the stirring paddle 33 is fixed on the stirring shaft 32 and used for stirring the materials in the mixing tank 1, so that the materials are uniformly mixed in the mixing tank 1.
Referring to fig. 2-6, a material pushing channel 14, a sliding channel 15, an air inlet channel 23, a connecting channel 21 and an air storage cavity 12 are arranged in the housing 10, the air storage cavity 12 is connected with an air inlet pipe 11, and the air inlet pipe 11 is connected with an air pump so as to charge air into the air storage cavity 12 through the air pump. The sliding channel 15, the air inlet channel 23, the connecting channel 21 and the air storage cavity 12 are all located below the material pushing channel 14 and are respectively and sequentially arranged, the material pushing channel 14 is communicated with the feeding channel 4, the bottom of the feeding channel 4 is inclined downwards towards the direction close to the mixing tank 1, so that materials can rapidly enter the mixing tank 1 along the feeding channel 4, and the air storage cavity 12 is located under the feeding channel 4. A feed inlet 27 is arranged above the material pushing channel 14, a feed hopper 5 is arranged above the feed inlet 27, and the feed inlet 27 is positioned right above the connecting channel 21. A material pushing mechanism 7 is arranged in the material pushing channel 14, and the material pushing mechanism 7 is used for pushing the material entering the material pushing channel 14 through the feeding hole 27 to the feeding channel 4. A slide block 19 is arranged in the slide channel 15, and the slide block 19 is connected with the side wall of the slide channel 15 in a sliding way. The shell 10 is provided with a limiting mechanism 8 and a plugging mechanism 6, and the limiting mechanism 8 is used for limiting the sliding of the sliding block 19 towards the direction close to the plugging mechanism 6. The sliding block 19 is used for sliding towards the direction close to the plugging mechanism 6, so that the air storage cavity 12, the connecting channel 21, the air inlet channel 23 and the material pushing channel 14 are communicated, and the materials in the feeding channel 4 are pushed into the mixing tank 1 through air flow.
In the technical scheme, the traditional mixing device is a mixing tank with stirring, the structure is simple, but the feeding is generally carried out once, namely, the materials are poured into the mixing tank once and then stirred, so that the stirring mechanism is not only provided with large stirring pressure, but also the phenomenon of feeding blockage is easy to occur. Therefore, the invention provides an intermittent feeding mixing device which can stir materials in the intermittent feeding process.
Referring to fig. 2 to 6, preferably, the pushing mechanism 7 includes a first cylinder 71, an upper push plate 72, and a lower push plate 73. The first cylinder 71 is used for pushing the upper push plate 72 and the lower push plate 73 to move towards or away from the direction of the feeding channel 4 in the material pushing channel 14, the upper push plate 72 is in contact with the top in the material pushing channel 14, and the lower push plate 73 is in contact with the bottom in the material pushing channel 14. The first cylinder 71 includes a piston rod, and the upper push plate 72 and the lower push plate 73 are fixed to the piston rod of the first cylinder 71. The lower pushing plate 73 is provided with a through hole 76, the bottom of the pushing channel 14 is provided with an air inlet 24, and the air inlet 24 is positioned at the top of the air inlet channel 23. When the upper push plate 72 and the lower push plate 73 push the material to the feeding channel 4, the through hole 76 and the air inlet hole 24 are just corresponding up and down, so that the pushing channel 14 is communicated with the air inlet channel 23 through the through hole 76 and the air inlet hole 24. In order to push the material from the lower part of the feeding hole 27 to the feeding channel 4, specifically, the upper pushing plate 72 is provided with a door plate 74 at one end far away from the first cylinder 71, the upper side of the door plate 74 is rotatably connected with the upper pushing plate 72, and the lower side of the door plate is in end surface contact with the lower pushing plate 73. In this way, when the upper push plate 72 and the lower push plate 73 move in the direction close to the feed channel 4, the door plate 74 pushes the material into the feed channel 4.
Referring to fig. 2-6, the slider 19 is provided with a first spring 18 on a side away from the plugging mechanism 6, one end of the first spring 18 is connected with the slider 19, and the other end is fixed with the side wall of the sliding channel 15. Specifically, the sliding block 19 and the sliding channel 15 are both provided with grooves, and two ends of the first spring 18 are respectively connected to the sliding block 19 and the sliding channel 15 in the grooves. The upper part of the slide block 19 is provided with a convex part protruding upwards, an upper slotted hole 16 is arranged between the material pushing channel 14 and the sliding channel 15, and the length direction of the upper slotted hole 16 is consistent with the sliding direction of the slide block 19. An upper limiting block 75 is fixed at the bottom of the lower push plate 73, the upper end of the upper limiting block 75 is fixed at the bottom of the lower push plate 73, the lower end of the upper limiting block passes through the upper slot 16 and contacts with one side of the protruding part close to the plugging mechanism 6, and the upper limiting block 75 is used for driving the sliding block 19 to slide towards the direction far away from the plugging mechanism 6.
In the above technical scheme, during feeding, a material is poured into the feeding hopper 5, at this time, the material enters the material pushing channel 14, then the first cylinder 71 is started, so that the upper push plate 72, the lower push plate 73 and the door plate 74 push the material to move towards the direction close to the material feeding channel 4, when the material is just pushed into the material feeding channel 4, the through hole 76 and the air inlet hole 24 just correspond up and down, so that the material pushing channel 14 is communicated with the air inlet channel 23 through the through hole 76 and the air inlet hole 24, at this time, air flow can enter the material pushing channel 14 through the air inlet channel 23, the air inlet hole 24 and the through hole 76, so that the material can be pushed to the mixing tank 1 from the material feeding channel 4, and finally the air flow is discharged outwards through the air outlet hole 26 on the mixing tank 1. When the upper push plate 72, the lower push plate 73 and the door plate 74 retract, the material in the feeding hole 27 falls into the material pushing channel 14 again, and the following steps are repeated, so that the intermittent feeding of the material can be realized, and the phenomenon that the stirring pressure is too high due to too much feeding at one time can be prevented.
Referring to fig. 2-6, the plugging mechanism 6 includes a push rod 61, a second spring 62, a plug 63, and an insert rod 64. A baffle is arranged between the sliding channel 15 and the air inlet channel 23, a partition plate 25 is arranged between the air inlet channel 23 and the connecting channel 21, the second spring 62, the plug 63 and the inserted rod 64 are all positioned in the connecting channel 21, and a circular through hole 13 for gas circulation is formed between the connecting channel 21 and the gas storage cavity 12. The push rod 61 and the insert rod 64 are respectively fixed on two opposite sides of the plug 63, and the second spring 62 is sleeved on the outer surface of the insert rod 64 and tightly propped between the plug 63 and the side wall of the connecting channel 21. The central axes of the push rod 61 and the inserted rod 64 are coincided with the central axis of the through hole 13, and the aperture of the through hole 13 is larger than the diameter of the inserted rod 64. First jack has been seted up on the baffle 25, is provided with the second jack on the baffle, and first jack aperture is greater than push rod 61 diameter, and second jack and push rod 61 looks adaptation, and second jack aperture is the same with push rod 61 diameter promptly. One end of the push rod 61 is connected with the plug 63, the other end of the push rod sequentially passes through the first jack and the second jack and extends into the sliding channel 15, and the plug 63 is used for plugging the first jack so as to block the communication between the air inlet channel 23 and the connecting channel 21. The sliding block 19 is used for pushing the push rod 61 and the plug 63 to move towards the direction close to the second spring 62, so that the air inlet channel 23 and the connecting channel 21 are communicated through the first insertion hole. For better buffering, preferably, a buffer block 22 for contacting with the sliding block 19 is fixed on the baffle, and the buffer block 22 is made of rubber or silica gel and is located on the side wall of the sliding channel 15.
In the above technical solution, when the upper push plate 72, the lower push plate 73 and the door plate 74 push the material to move toward the direction close to the feeding channel 4 until the material is just pushed into the feeding channel 4, at this time, the upper limit block 75 is not in contact with the protrusion on the slider 19, under the action of the first spring 18, the slider 19 will move toward the direction close to the push rod 61, thereby pushing the push rod 61 and the plug 63 to move toward the direction close to the second spring 62, so that the air inlet channel 23 and the connecting channel 21 are communicated through the first insertion hole, at this time, the air storage cavity 12, the connecting channel 21, the air inlet channel 23, the material pushing channel 14 and the feeding channel 4 will be communicated in sequence, and therefore the air flow in the air storage cavity 12 will pass through the air storage cavity 12, the connecting channel 21, the air inlet channel 23 and the material pushing channel 14 in sequence, thereby pushing the material into the mixing tank 1. When the push-up plate 72, the push-down plate 73 and the door 74 are retracted, the upper limit block 75 will push the slider 19 to move away from the push rod 61 via the protrusion, and the plug 63 will block the first insertion hole again under the action of the second spring 62, so as to block the communication between the connection channel 21 and the air inlet channel 23.
Referring to fig. 2 to 6, the limiting mechanism 8 includes a driving motor, a fixing plate 81, a wheel 82, a first rotating shaft 83, a lever 85, and a second rotating shaft 86. The fixed plate 81 is fixed at the bottom of the shell 10, the driving motor is installed on the fixed plate 81, the first rotating shaft 83 is fixed on the output shaft of the driving motor, and the wheel disc 82 is fixed on the first rotating shaft 83 and coaxially and rotatably arranged with the first rotating shaft. The outer side of the wheel 82 is provided with an extension 84 bent upward and for contacting the bottom of the lever 85. The bottom of the sliding channel 15 is provided with a lower slot hole 17, and the length direction of the lower slot hole 17 is consistent with the sliding direction of the sliding block 19. The bottom of the sliding block 19 is fixed with a lower limiting block 20, the upper end of the lower limiting block 20 is fixed with the bottom of the sliding block 19, and the lower end is inserted in the lower slotted hole 17. The second shaft 86 is fixed on the fixing plate 81 and penetrates the lever 85, one end of the lever 85 is a limiting end, the other end of the lever is a trigger end, and the extending portion 84 contacts with the bottom surface of the trigger end. The end part of the limit end is provided with a limit part 87, and the limit part 87 is used for contacting with the lower limit block 20 so as to limit the sliding of the slide block 19 to the direction close to the plugging mechanism 6. The distance between the end surface of the limit end and the second rotating shaft 86 is greater than the distance between the end surface of the trigger end and the second rotating shaft 86. When the slide block 19 is stopped at the other end of the slide passage 15 away from the plunger 64 by the upper stopper 75 and the stopper 87, the first spring 18 is in a compressed state.
In the above technical solution, during feeding, the first cylinder 71 is first started to separate the upper limiting block 75 from the sliding block 19, and then the driving motor is started to push the extending portion 84 upwards to push the lever 85, at this time, the sliding block 19 is separated from the upper limiting block 75 and the limiting portion 87, and under the action of the first spring 18, the sliding block 19 moves towards the direction close to the push rod 61, so as to push the push rod 61 and the plug 63 to move towards the direction close to the second spring 62, so that the air inlet channel 23 and the connecting channel 21 are communicated through the first insertion hole. After the feeding is completed, the first cylinder 71 is started to drive the slide block 19 to reset through the upper limiting block 75, and then the driving motor is started to make the limiting portion 87 extend into the lower slot hole 17 again to contact with the lower limiting portion 87.
Referring to fig. 2 to 6, the feed inlet 27 is a circular hole, the anti-blocking mechanism 9 is arranged in the housing 10, the anti-blocking mechanism 9 includes a driving part and a driven part, the driving part is located in the material pushing channel 14, and the driven part is located in the feed inlet 27 and used for loosening the material in the feed inlet 27. The driving part comprises a second cylinder 911 and a fixing rod 912, the second cylinder 911 is fixed at the top of the lower push plate 73, and the upper push plate 72 is provided with a containing hole matched with the fixing rod 912. The lower end of the fixing rod 912 is fixed with the second cylinder 911, the upper end of the fixing rod 912 is inserted into the push hole, and the fixing rod 912 is made of iron materials. The follower includes a resilient seal 921, a magnet post 922, a sleeve 923 and a third spring 924. Elasticity seal area 921 is fixed around feed inlet 27 inner wall, and sleeve 923 is located elasticity seal area 921 and fixes on feed inlet 27 inner wall, and magnet post 922 inserts and establishes in sleeve 923 and follow sleeve 923 axial direction sliding fit with sleeve 923. Magnet post 922 one end is located sleeve 923, and the other end and the interior surface contact of elastic seal area 921, and third spring 924 is located sleeve 923 and one end is fixed with feed inlet 27 inner wall, and the other end is fixed with magnet post 922. The magnet post 922 is magnetically coupled to the fixing rod 912. Be provided with a plurality of sleeves 923 in the elastic sealing area 921, a plurality of sleeves 923 are the equipartition setting along feed inlet 27 circumferencial direction, all is provided with a magnet post 922 in every sleeve 923. The sleeve 923 has an axial direction corresponding to the radial direction of the feed port 27.
In the above technical scheme, the push up plate 72, push down plate 73 and door plant 74 promote the material to moving to being close to feed channel 4 direction, when just being pushed into feed channel 4 until the material, dead lever 912 center pin at this moment just coincides with feed inlet 27 center pin, alright start second cylinder 911 this moment, thereby make dead lever 912 upward movement insert in the material of feed inlet 27 department, because magnet post 922 and dead lever 912 magnetic fit, consequently when dead lever 912 inserts in feed inlet 27, magnet post 922 in the sleeve 923 will move to feed inlet 27 middle part, thereby move through elastic sealing tape 921 and promote the material to move to feed inlet 27 middle part. When the push up plate 72, push down plate 73 and door plant 74 need withdraw, start second cylinder 911 earlier to make dead lever 912 reset, after dead lever 912 resets, magnet post 922 and elastic sealing tape 921 also will reset, thereby play the effect of the interior material of not hard up feed inlet 27, reduce the material jam in feed inlet 27.
Example 2: the difference between the preparation method of moxifloxacin hydrochloride tablets and the embodiment 1 is that the raw materials are weighed according to the mass ratio: 400mg of moxifloxacin hydrochloride, 100mg of microcrystalline cellulose, 50mg of lactose, 10mg of internal croscarmellose sodium, 10mg of external croscarmellose sodium and 5mg of magnesium stearate.
Example 3: the difference between the preparation method of moxifloxacin hydrochloride tablets and the embodiment 1 is that the raw materials are weighed according to the mass ratio: 500mg of moxifloxacin hydrochloride, 200mg of microcrystalline cellulose, 100mg of lactose, 15mg of internal croscarmellose sodium, 15mg of external croscarmellose sodium and 8mg of magnesium stearate.
The above description is only a preferred embodiment of the present invention, and the protection scope of the present invention is not limited to the above embodiments, and all technical solutions belonging to the idea of the present invention belong to the protection scope of the present invention. It should be noted that several improvements and modifications without departing from the principle of the present invention will occur to those skilled in the art, and such improvements and modifications should also be construed as within the scope of the present invention.
Claims (10)
1. A preparation method of moxifloxacin hydrochloride tablets is characterized by comprising the following steps: the method comprises the following steps:
s1, weighing raw materials
Weighing moxifloxacin hydrochloride, microcrystalline cellulose, lactose, internal croscarmellose sodium, external croscarmellose sodium and magnesium stearate;
s2, granulating
Placing the weighed moxifloxacin hydrochloride, microcrystalline cellulose, lactose and sodium croscarmellose into a wet granulator for granulation to obtain wet granules;
s3, drying
Spreading the wet particles in the step S2 on a baking pan, and feeding the wet particles into a hot air circulation baking oven to obtain dry particles with the moisture content of less than 3.0%;
s4, granulating and mixing
Granulating the dry granules in the step S3 by a swing granulator, mixing the granules with the additional croscarmellose sodium by a mixing device, adding magnesium stearate, and continuously mixing to obtain total mixed granules;
s5, tabletting and coating
Performing trial tabletting on the total mixed particles in the step S4, and adopting 7 × 17mm capsule type punched tablets, wherein the hardness is controlled to be 90-120N; and after tabletting is finished, coating and packaging to obtain the moxifloxacin hydrochloride tablets.
2. The method for preparing moxifloxacin hydrochloride tablets according to claim 1, which is characterized in that: the moxifloxacin hydrochloride, the microcrystalline cellulose, the lactose, the internal croscarmellose sodium, the external croscarmellose sodium and the magnesium stearate are weighed according to the following parts by weight: 400 portions of moxifloxacin hydrochloride; 100-200 parts of microcrystalline cellulose; 50-100 parts of lactose; 10-15 parts of croscarmellose sodium is added internally; 10-15 parts of additional croscarmellose sodium; 5-8 parts of magnesium stearate.
3. The method for preparing moxifloxacin hydrochloride tablets as claimed in claim 2, characterized in that: in step S2, the stirring speed 40HZ is set, and stirring is started to premix for 10 min; then adding wetting agent purified water, continuing to start stirring and cutting to granulate, and granulating for 8 min.
4. The method for preparing moxifloxacin hydrochloride tablets according to claim 1, which is characterized in that: in the step S4, the mixing device comprises a mixing tank (1) and a shell (10) arranged on one side of the upper portion of the mixing tank (1), a feeding channel (4) is arranged on one side of the upper portion of the mixing tank (1), a discharging hole (2) is formed in the bottom of the mixing tank, a material pushing channel (14), a sliding channel (15), an air inlet channel (23), a connecting channel (21) and an air storage cavity (12) are arranged in the shell (10), an air inlet pipe (11) is connected to the air storage cavity (12), the air inlet pipe (11) is connected with an air pump, the sliding channel (15), the air inlet channel (23), the connecting channel (21) and the air storage cavity (12) are sequentially arranged, the material pushing channel (14) is located above the sliding channel (15), and one end of the material pushing channel (14) is communicated with the feeding channel (4);
a feeding hole (27) is formed above the material pushing channel (14), a feeding hopper (5) is arranged above the feeding hole (27), a material pushing mechanism (7) is arranged in the material pushing channel (14), and the material pushing mechanism (7) is used for pushing the material entering the material pushing channel (14) through the feeding hole (27) to the feeding channel (4);
be provided with slider (19) in slide channel (15), be provided with stop gear (8) and shutoff mechanism (6) on casing (10), stop gear (8) are used for restricting slider (19) are to being close to shutoff mechanism (6) direction slides, slider (19) are used for to being close to shutoff mechanism (6) direction slides, so that gas storage chamber (12), connecting channel (21), inlet channel (23) and material pushing channel (14) intercommunication will through the air current the material in inlet channel (4) is pushed in blending tank (1).
5. The method for preparing moxifloxacin hydrochloride tablets as claimed in claim 4, characterized in that: the material pushing mechanism (7) comprises a first cylinder (71), an upper push plate (72) and a lower push plate (73);
the first air cylinder (71) is used for pushing the upper push plate (72) and the lower push plate (73) to move towards or away from the feeding channel (4) in the material pushing channel (14), the upper push plate (72) is contacted with the inner top of the material pushing channel (14), the lower push plate (73) is contacted with the inner bottom of the material pushing channel (14), the lower push plate (73) is provided with a through hole (76), the bottom in the material pushing channel (14) is provided with an air inlet hole (24), the air inlet hole (24) is positioned at the top of the air inlet channel (23), when the upper push plate (72) and the lower push plate (73) push the materials to the feeding channel (4), the through hole (76) and the air inlet hole (24) are vertically corresponding, so that the material pushing channel (14) is communicated with the air inlet channel (23) through the through hole (76) and the air inlet hole (24);
a door plate (74) is arranged at one end, far away from the first air cylinder (71), of the upper push plate (72), the upper side of the door plate (74) is rotatably connected with the upper push plate (72), and the lower side of the door plate is contacted with the end face of the lower push plate (73);
the sliding block (19) is far away from one side of the plugging mechanism (6) and is provided with a first spring (18), one end of the first spring (18) is connected with the sliding block (19), the other end of the first spring is fixed to the side wall of the sliding channel (15), the upper portion of the sliding block (19) is provided with a protruding portion protruding upwards, the material pushing channel (14) is provided with an upper slotted hole (16) between the sliding channel (15), the bottom of the lower pushing plate (73) is fixedly provided with an upper limiting block (75), the upper end of the upper limiting block (75) is fixed to the bottom of the lower pushing plate (73), the lower end of the upper slotted hole (16) is penetrated and is contacted with the protruding portion, and the upper limiting block (75) is used for driving the sliding block (19) to be far away from the direction of the plugging mechanism (6) to slide.
6. The method for preparing moxifloxacin hydrochloride tablets as claimed in claim 5, characterized in that: the plugging mechanism (6) comprises a push rod (61), a second spring (62), a plug (63) and an insert rod (64);
a baffle is arranged between the sliding channel (15) and the air inlet channel (23), a partition plate (25) is arranged between the air inlet channel (23) and the connecting channel (21), the second spring (62), the plug (63) and the inserted rod (64) are all positioned in the connecting channel (21), and a through hole (13) is formed between the connecting channel (21) and the air storage cavity (12);
the push rod (61) and the inserted rod (64) are respectively fixed at two opposite sides of the plug (63), the second spring (62) is sleeved on the outer surface of the inserted rod (64) and is tightly propped between the plug (63) and the side wall of the connecting channel (21), the baffle plate (25) is provided with a first jack, the baffle plate is provided with a second jack, the aperture of the first jack is larger than the diameter of the push rod (61), the second jack is matched with the push rod (61), one end of the push rod (61) is connected with the plug (63), the other end of the push rod sequentially penetrates through the first jack and the second jack and extends into the sliding channel (15), the sliding block (19) is used for pushing the push rod (61) and the plug (63) to move towards the direction close to the second spring (62), so that the air inlet passage (23) and the connection passage (21) communicate through the first insertion hole.
7. The method for preparing moxifloxacin hydrochloride tablets as claimed in claim 5, characterized in that: the limiting mechanism (8) comprises a driving motor, a fixing plate (81), a wheel disc (82), a first rotating shaft (83), a lever (85) and a second rotating shaft (86);
the fixing plate (81) is fixed at the bottom of the shell (10), the driving motor is installed on the fixing plate (81), the first rotating shaft (83) is fixed on an output shaft of the driving motor, the wheel disc (82) is fixed on the first rotating shaft (83), and an extending part (84) which is bent upwards and is used for being in contact with the bottom of the lever (85) is arranged on the outer side of the wheel disc (82);
the bottom of the sliding channel (15) is provided with a lower slotted hole (17), the bottom of the sliding block (19) is fixed with a lower limit block (20), the upper end of the lower limiting block (20) is fixed with the bottom of the sliding block (19), the lower end is inserted in the lower slotted hole (17), the second rotating shaft (86) is fixed on the fixing plate (81) and penetrates through the lever (85), one end of the lever (85) is a limiting end, the other end of the lever is a triggering end, the extension part (84) is contacted with the bottom surface of the triggering end, the end part of the limit end is provided with a limit part (87), the limit part (87) is used for contacting with the lower limit block (20), so as to limit the sliding block (19) to slide towards the direction close to the plugging mechanism (6), the distance between the limiting end face and the second rotating shaft (86) is larger than the distance between the triggering end face and the second rotating shaft (86).
8. The method for preparing moxifloxacin hydrochloride tablets as claimed in claim 5, characterized in that: be provided with in casing (10) and prevent stifled mechanism (9), prevent stifled mechanism (9) including driving part and follower, the driving part is located push away in material passageway (14), the follower is located just be used for becoming flexible in feed inlet (27) material in feed inlet (27).
9. The method for preparing moxifloxacin hydrochloride tablets according to claim 8, characterized in that: the driving part comprises a second cylinder (911) and a fixing rod (912), the second cylinder (911) is fixed to the top of the lower push plate (73), the upper push plate (72) is provided with a containing hole matched with the fixing rod (912), the lower end of the fixing rod (912) is fixed to the second cylinder (911), the upper end of the fixing rod (912) is inserted into the push hole, and the fixing rod (912) is made of iron materials;
the follower includes elasticity sealing band (921), magnet post (922), sleeve (923) and third spring (924), elasticity sealing band (921) is fixed feed inlet (27) inner wall, sleeve (923) are located in elasticity sealing band (921) and fix on feed inlet (27) inner wall, magnet post (922) are inserted and are established in sleeve (923) and with sleeve (923) are followed sleeve (923) axial direction sliding fit, magnet post (922) one end is located in sleeve (923), the other end with elasticity sealing band (921) internal surface contact, third spring (924) are located in sleeve (923) and one end with feed inlet (27) inner wall is fixed, the other end with magnet post (922) are fixed, magnet post (922) be used for with dead lever (912) magnetism is connected.
10. The method for preparing moxifloxacin hydrochloride tablets as claimed in claim 4, characterized in that: the top of the mixing tank (1) is provided with an air outlet (26), and the air outlet (26) is provided with filter cloth.
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