Kitasamycin tablet and preparation method thereof

Abstract

The preparation method comprises the following steps: firstly, preparing dextrin slurry as an adhesive, adding a filler, kitasamycin and a disintegrating agent I into a fluidized bed, then adding the dextrin slurry for boiling granulation, and after granulation is finished, adding a lubricant and a disintegrating agent II for size stabilization and mixing; after mixing is finished, using a punching die to press tablets; and coating the tablet core. The kitasamycin tablet prepared by the method has good dissolution performance and tablet weight difference. The method is especially suitable for preparation of kitasamycin, and ensures that the medicine has stable curative effect and good dissolution behavior in the storage and taking processes. The method is simple to operate, does not need special reaction conditions and equipment, is more suitable for industrial production, and conforms to the concept of green development.

Description

Technical Field

[0001] This invention belongs to the field of tylosin tablets technology, specifically relating to a tylosin tablet and its preparation method. Background Technology

[0002] Clinical applications of timomycin: Timomycin is a macrolide antibiotic with significant inhibitory effects against Gram-positive bacteria (such as Staphylococcus aureus and Streptococcus pneumoniae), and is widely used in the treatment of respiratory tract infections. With the development of modern pharmaceutical technology, the preparation of timomycin formulations with good stability, controlled release, and patient compliance has become one of the current research priorities.

[0003] Existing technical problems: Traditional tylosin tablets suffer from low dissolution, poor stability (e.g., high hygroscopicity), and bitter taste; inappropriate selection of disintegrants in existing preparation processes leads to insufficient bioavailability; To overcome the limitations of existing tylosin tablet manufacturing processes, new technical approaches and component formulations need to be designed and validated. This technological background lays the foundation for the development of new tylosin tablets and their preparation methods, and provides the motivation and direction for the research and development of this patent.

[0004] In view of this, the present invention is hereby proposed. Summary of the Invention

[0005] The purpose of this invention is to provide a tylosin tablet and its preparation method. This invention uses only dextrin slurry, tylosin, filler, binder, lubricant and disintegrant as raw materials and excipients. Through appropriate proportions and optimized processes, it solves the problems of complex preparation methods and low dissolution and large deviation of the obtained product for tylosin tablets.

[0006] To achieve the above objectives, the present invention adopts the following technical solution: A method for preparing tylosin tablets includes the following steps: (1) Dissolve dextrin in purified water to obtain dextrin slurry; (2) First, set the material temperature to 55~65℃ and the fan frequency to 50~60Hz. Add the filler, binder, tylosin, and disintegrant I to the boiling pot. When the material temperature reaches 40~50℃, keep the atomization pressure at 0.10MPa~0.30MPa and the peristaltic pump speed at 20~50rpm. Start spraying dextrin slurry for granulation. When half to two-thirds of the dextrin slurry has been sprayed, increase the fan frequency to 38Hz~40Hz and continue spraying dextrin slurry until the dextrin slurry is completely sprayed. Then dry for 45~50min. (3) Add lubricant and disintegrant II to the dried material in step (2), and granulate it using a V-shaped sieve; after granulation, mix for 5 to 30 minutes. (4) The mixed granules are compressed into tablets, with a core hardness of 4.0~8.0 kg, a core thickness of 4.2~4.7 mm, and a weight difference of ±6.5%. (5) After coating the tablet core, guitarmycin tablets are obtained.

[0007] Further, in step (1), the temperature of the purified water is ≥80℃, and the concentration of dextrin in the dextrin slurry is 5 wt%~15wt%.

[0008] Further, in step (2), the filler is at least one of mannitol, corn starch, microcrystalline cellulose, lactose and pregelatinized starch.

[0009] Further, in step (2), the adhesive is at least one of hydroxypropyl methylcellulose, corn starch and pregelatinized starch.

[0010] Further, in step (2), the disintegrant I is at least one of corn starch, low-substituted hydroxypropyl cellulose, crospovidone, sodium carboxymethyl starch, microcrystalline cellulose, dextrin and crospovidone carboxymethyl cellulose.

[0011] Further, in step (2), the mass ratio of the dextrin, filler, binder, tylosin and disintegrant I is (80~90):(250~300):(100~150):(0.5~1):(200~250).

[0012] Further, in step (3), the lubricant is at least one of magnesium stearate, stearic acid and polyethylene glycol.

[0013] Further, in step (3), the disintegrant II is at least one of corn starch, low-substituted hydroxypropyl cellulose, sodium carboxymethyl starch, microcrystalline cellulose, silicon dioxide, and croscarmellose sodium.

[0014] Further, in step (3), the mass ratio of the lubricant, disintegrant II and tylosin is (40~50):(10~20):(0.5~1.5).

[0015] Further, in step (3), the aperture of the V-shaped screen is 1.0~1.5mm.

[0016] Furthermore, in step (3), the granulation frequency is 8~15Hz, the mixing speed is 5~15rpm, and the mixing time is 10~30 minutes.

[0017] Furthermore, in step (4), a deep concave die with a specification of 8.0mm is used to press the mixed particles into tablets.

[0018] Furthermore, in step (5), the coating includes two types: film coating and sugar coating.

[0019] Furthermore, by directly coating the tablet core with a coating solution, tylosin tablets are obtained.

[0020] Furthermore, the mass ratio of the coating solution to the tylosin tablet core is (0.03~0.05):1; Furthermore, the coating solution is prepared by the following method: Further, hydroxypropyl methylcellulose (E15), lactose monohydrate, titanium dioxide, and triacetin are mixed evenly to obtain a coating premix; the coating premix is ​​added to purified water under stirring, stirred evenly, and passed through a 200-300 mesh steel wire sieve to obtain the coating solution.

[0021] Further, the mass ratio of hydroxypropyl methylcellulose (E15), lactose monohydrate, titanium dioxide, and triacetin in the coating premix is ​​(1.1~1.7):(1.1~1.5):(0.1~1):(0.1~1); and the mass ratio of purified water to the coating premix is ​​1:(0.1~0.2).

[0022] Furthermore, the sugar coating process includes the following steps: S1. Weigh the coating materials and prepare the syrup, mixed slurry and isolation layer slurry; S2. Coating the isolation layer: Set the pot speed to 6~10 rpm, and evenly pour the isolation layer slurry onto the rolling sheet in 4~6 portions. After each addition of the isolation layer slurry, dry for 3~10 minutes. Control the outlet temperature at 20℃~60℃. S3, Coating with Powder Layer: After the isolation layer coating is completed, set the pot speed to 3~12 rpm, and pour the slurry into the rolling sheet in 15~25 batches. After each addition of slurry, dry for 2~15 minutes, and control the outlet temperature at 20℃~60℃. S4. Sugar coating: After the powder coating is completed, set the air outlet temperature control to 20~50℃, and pour the syrup onto the rotating sheet in 15~25 batches, drying for 2~15 minutes after each addition of syrup. S5. Polishing: After the sugar coating is completed, set the pot speed to 1-5 rpm, turn off the heating, and dry for 10-30 minutes. After drying, set the pot speed to 5-10 rpm, add beeswax and dimethicone, stir evenly, and then sprinkle it onto the rolling tablet bed in batches. After adding all the ingredients, wait 2-3 minutes to obtain tylosin tablets.

[0023] As a further technical solution, the preparation method of the syrup, mixture, and isolation layer slurry includes the following steps: a. Syrup preparation: Add purified water to the weighed sucrose to make the sucrose concentration reach 67%~72wt% to obtain syrup; b. Mixing: Weigh out the talcum powder and syrup according to the mass ratio of talcum powder to syrup = 1: (1~3). After weighing, add talcum powder to the syrup and stir evenly to obtain the mixed syrup. c. Separating layer slurry: Weigh hydroxypropyl methylcellulose (E5) and 90%~100% ethanol at a mass ratio of 1:(8~12). Add hydroxypropyl methylcellulose to the weighed 90%~100% ethanol and stir evenly to obtain the separating layer slurry.

[0024] As a further technical solution, when the sugar coating is applied, the total weight of the coating material and the mass ratio of the core of the tylosin tablet are (84~110):(80~140).

[0025] As a further technical solution, the mass ratio of sucrose, hydroxypropyl methylcellulose E5, 990%~100% ethanol, talc, beeswax, and dimethicone in the coating material is (545~930):(2~4):(30~45):(240~400):(2~4):(0.1~0.7).

[0026] Another object of the present invention is to provide tylosin tablets prepared by any of the above methods. Testing has shown that the tylosin tablets prepared by the method of the present invention exhibit high dissolution rate and excellent product quality, with minimal batch-to-batch variation, demonstrating outstanding drug dissolution performance.

[0027] Compared with the prior art, the technical solution of the present invention has the following advantages: 1. The preparation method of the tylosin tablets provided by the present invention is simple and easy to produce. The tylosin tablets prepared by this method have high dissolution and stable content of each component in the drug.

[0028] 2. The present invention uses a fluidized bed granulation method for granulation because the fluidized bed granulation process can improve the uniformity of particles and reduce the risk of large differences in mixing uniformity. Detailed Implementation

[0029] To enable those skilled in the art to better understand the present invention, the present invention will be further described in detail below with reference to specific embodiments, but it should be understood that the scope of protection of the present invention is not limited to the specific embodiments.

[0030] This invention provides a tylosin tablet and its preparation method, solving the problems of complex preparation methods, low production efficiency, and poor product quality of tylosin tablets in the prior art.

[0031] The technical solution of this application will be described in detail below through specific embodiments: Unless otherwise specified, the technical means used in this invention are conventional means well known to those skilled in the art. All raw materials, reagents, instruments, and equipment used in this invention can be purchased commercially or prepared using existing methods. Unless otherwise specified, all reagents used in this invention are of analytical grade. In Examples 1-2 of this invention, the coating solution was prepared by the following method: Hydroxypropyl methylcellulose (E15), lactose monohydrate, titanium dioxide, and triacetin were mixed evenly in a mass ratio of 1.32:1.2:0.75:0.35 to obtain a coating premix. Slowly add the coating premix to purified water while stirring, with a mass ratio of purified water to coating premix of 1:0.15. Stir until homogeneous, then filter through a 200-mesh wire screen to obtain the coating solution. During use, the coating solution should be stirred slowly and uniformly to minimize or eliminate foaming.

[0032] In Examples 3-4, the syrup, mixture, and separating layer slurry used were prepared by the following methods: Syrup preparation: Add purified water to the weighed sucrose to achieve a sucrose concentration of 70 wt%. Mixing: Weigh out talcum powder and syrup according to a mass ratio of 1:2. After weighing, add talcum powder to the syrup and stir evenly to obtain the mixing. Divide the mixing into 20 equal portions according to mass.

[0033] Separating layer slurry: Weigh hydroxypropyl methylcellulose E5 and 95% ethanol according to a mass ratio of 1:10. Add hydroxypropyl methylcellulose E5 to the weighed 95% ethanol and stir evenly to obtain the separating layer slurry.

[0034] Example 1: Preparation of tylosin tablets (tablet specification 100mg, hardness 4.0-8.0kg) Add 83.6g of dextrin to purified water at 100℃ and stir for 20 minutes to prepare a dextrin slurry with a concentration of 10wt%. First, set the material temperature to 60℃ and the fan frequency to 55Hz. Then, vacuum-pump the 270g pregelatinized starch (filler), 140g corn starch (binder), 1g tylosin, 60g low-substituted hydroxypropyl cellulose (disintegrant I), and 185g dextrin (disintegrant I) into the boiling kettle in the following order: 270g pregelatinized starch (filler), 140g corn starch (binder), 1g tylosin, 60g low-substituted hydroxypropyl cellulose (disintegrant I), and 185g dextrin (disintegrant I). Reduce the fan frequency to 36Hz. When the material temperature reaches 45℃, set the atomization pressure to 0.20MPa and the peristaltic pump speed to 30rpm to start spraying and granulation. When about half of the dextrin slurry has been sprayed in, increase the fan frequency to 38Hz and continue spraying until the spraying is finished. Then, dry for 45 minutes. Add 12g magnesium stearate (lubricant) and 45g sodium carboxymethyl starch (disintegrant II) to the dried material. Granulate the granules using a V-shaped sieve with 1.0mm aperture at a granulation frequency of 10Hz. After granulation, mix the granules at 9rpm for 20 minutes. Compress the granules using an 8.0mm deep concave die, ensuring a core hardness of 4.0-8.0kg, a core thickness of 4.2-4.7mm, and a weight variation of ±5.0%. Add the coating solution and tylosin tablet cores at a mass ratio of 0.04:1 to a coating pan for coating. During coating, control the material temperature (tablet bed temperature) at 38-42℃. The tylosin tablets are then obtained after coating.

[0035] Example 2: Preparation of tylosin tablets (100mg tablet strength, 4.0-8.0kg hardness) Add 83.6g of dextrin to purified water (100℃) and stir for 20 minutes to prepare a 10wt% dextrin slurry. Set the material temperature to 60℃ and the fan frequency to 55Hz. Vacuum-pumpedly add 270g of pregelatinized starch, 140g of corn starch, 1g of tylosin, and 240g of low-substituted hydroxypropyl cellulose into the boiling kettle. Reduce the fan frequency to 36Hz. When the material temperature reaches 45℃, maintain the atomization pressure at 0.20MPa and the peristaltic pump speed at 30rpm to begin granulation. When about half of the dextrin slurry has been sprayed, increase the fan frequency to 38Hz and continue spraying until completion. Then dry for 45 minutes. Add 12g of magnesium stearate and 45g of sodium carboxymethyl starch to the dried material and granulate using a 1.2mm V-shaped sieve at a granulation frequency of 10Hz. After granulation, the granules are mixed at 9 rpm for 20 minutes. An 8.0 mm deep concave die is used to compress the mixed granules into tablets, with a core hardness of 4.0-8.0 kg, a core thickness of 4.2-4.7 mm, and a weight difference of ±5.0%. The coating solution and the tylosin tablet core are added to the coating pan at a mass ratio of 0.04:1 for coating. During the coating process, the material temperature (tablet bed temperature) is controlled at 38-42℃. The tylosin tablets are obtained after coating.

[0036] Example 3: Preparation of tylosin tablets (tablet specification 100mg, hardness 4.0-8.0kg) Add 83.6g of dextrin to purified water (100℃) and stir for 20 minutes to prepare a 10wt% dextrin slurry. Set the material temperature to 60℃ and the fan frequency to 55Hz. Vacuum-pumped 270g of gelatinized starch, 140g of corn starch, 1g of tylosin, 60g of low-substituted hydroxypropyl cellulose, and 185g of dextrin into a boiling kettle. Reduce the fan frequency to 36Hz. When the material temperature reaches 45℃, maintain the atomization pressure at 0.20MPa and the peristaltic pump speed at 30rpm to begin granulation. When about half of the dextrin slurry has been sprayed in, increase the fan frequency to 38Hz and continue spraying until completion. Then dry for 45 minutes. Add 12g of magnesium stearate and 45g of sodium carboxymethyl starch to the dried material and granulate using a 1.0mm V-shaped sieve at a granulation frequency of 10Hz. After granulation, the granules are mixed at 9 rpm for 20 minutes. An 8.0mm deep concave die is then used to compress the mixed granules into tablets. The required core hardness is 4.0-8.0 kg, core thickness is 4.2-4.7 mm, and weight variation is ±5.0%. The coating material was weighed according to the total weight of the coating material and the mass ratio of the core of the tylosin tablets, which was 8:13. The mass ratio of sucrose, hydroxypropyl methylcellulose E5, 95% ethanol, talc, beeswax, and dimethicone in the coating material was 800:2.3:40:240.5:2.5:0.3.

[0037] Insulation layer coating: Set the pot speed to 8 rpm, divide the insulation layer slurry into 5 equal portions, and evenly pour one portion of the slurry onto the rotating sheet bed, ensuring the sheets are spread out and do not stick together; dry for 5 minutes, controlling the outlet temperature at 50℃. Repeat this process to coat the remaining insulation layer slurry.

[0038] Powder coating: After the isolation layer coating is completed, set the pot speed to 10 rpm, divide the slurry into 20 equal portions, take one portion and evenly pour it onto the rotating sheet bed. Wait until the sheets are separated and no longer stick together, then dry for 15 minutes, controlling the outlet temperature at 50℃. Repeat this process to coat the remaining slurry.

[0039] Sugar coating: After the powder coating is completed, set the air outlet temperature control to 50℃. Divide the remaining syrup from the mixed syrup preparation into 20 equal portions. Take one portion and evenly pour it onto a rotating sheet bed, ensuring the sheets are spread out and do not stick together. Dry for 7 minutes. Repeat this process until all the sheets are coated with syrup.

[0040] Lighting: After the sugar coating is completed, set the pot speed to 3 rpm, turn off the heating and dry for 30 minutes. After drying, set the pot speed to 7 rpm, add beeswax and dimethicone, stir evenly, and then sprinkle it onto the rolling tablet bed in 3 batches. After adding all the tablets, wait 3 minutes to obtain tylosin tablets.

[0041] Example 4: Preparation of tylosin tablets (tablet specification 100mg, hardness 4.0-8.0kg) Add 83.6g of dextrin to purified water (100℃) and stir for 20 minutes to prepare a 10wt% dextrin slurry. Set the material temperature to 60℃ and the fan frequency to 55Hz. Vacuum-pumped 270g of gelatinized starch, 140g of corn starch, 1g of tylosin, and 240g of dextrin into a boiling kettle. Reduce the fan frequency to 36Hz. When the material temperature reaches 45℃, maintain the atomization pressure at 0.20MPa and the peristaltic pump speed at 30rpm to begin granulation. When about half of the dextrin slurry has been sprayed in, increase the fan frequency to 38Hz and continue spraying until completion. Then dry for 45 minutes. Add 12g of magnesium stearate and 45g of sodium carboxymethyl starch to the dried material and granulate using a 1.0mm V-shaped sieve at a granulation frequency of 10Hz. After granulation, the granules are mixed at 9 rpm for 20 minutes. An 8.0mm deep concave die is then used to compress the mixed granules into tablets. The required core hardness is 4.0-8.0 kg, core thickness is 4.2-4.7 mm, and weight variation is ±5.0%. The coating material was weighed according to the total weight of the coating material and the mass ratio of the core of the tylosin tablets, which was 8:13. The mass ratio of sucrose, hydroxypropyl methylcellulose E5, 95% ethanol, talc, beeswax, and dimethicone in the coating material was 800:2.3:40:240.5:2.5:0.3.

[0042] Insulation layer coating: Set the pot speed to 8 rpm, divide the insulation layer slurry into 5 equal portions, and evenly pour one portion of the slurry onto the rotating sheet bed, ensuring the sheets are spread out and do not stick together; dry for 10 minutes, controlling the outlet temperature at 50℃. Repeat this process to coat the remaining insulation layer slurry.

[0043] Powder coating: After the isolation layer coating is completed, set the pot speed to 7 rpm, divide the slurry into 20 equal portions, take one portion and evenly pour it onto the rotating sheet bed. Wait until the sheets are separated and no longer stick together, then dry for 10 minutes, controlling the outlet temperature at 55℃. Repeat this process to coat the remaining slurry.

[0044] Sugar coating: After the powder coating is completed, set the outlet temperature to 50℃. Divide the remaining syrup from the mixed syrup into 20 equal portions. Take one portion and evenly pour it onto a rotating sheet bed, ensuring the sheets are spread out and do not stick together. Dry for 10 minutes. Repeat this process until all the sheets are coated with syrup.

[0045] Lighting: After the sugar coating is completed, set the pot speed to 3 rpm, turn off the heating and dry for 15 minutes. After drying, set the pot speed to 7 rpm, add beeswax and dimethicone, stir evenly, and then sprinkle it onto the rolling tablet bed in 3 batches. After adding all the tablets, wait 3 minutes to obtain tylosin tablets.

[0046] Example of effect The tylosin tablets of this invention underwent in vitro release tests and other experiments, and the results are as follows: I. Identification (1) Take an appropriate amount of the fine powder of this product (approximately equivalent to 10,000 units of tylosin, 1 mg is approximately equal to 1,000 units), add 5 mL of 10 wt% sulfuric acid, shake slowly until well mixed, and the solution turns reddish-brown.

[0047] (2) In the chromatogram recorded under the determination of tylosin components, the test solution should show four chromatographic peaks with the same retention times as the tylosin A5, A4, A1 and A13 peaks in the tylosin standard solution.

[0048] result: II. Dissolution Method: Paddle technique Medium: 900mL water Speed: 75 rpm Dissolution medium: 1000 mL of phosphate buffer (pH 5.0) was used as the dissolution medium. Detection method: HPLC Limit: 80% of the labeled amount (45 min) result: III. Component Determination Test method: Refer to the requirements of the 2020 edition of the Chinese Pharmacopoeia. result: IV. Weight Difference For the test method, take 20 tablets of the sample, accurately weigh the total weight, calculate the average tablet weight, and then accurately weigh each tablet separately. Compare the weight of each tablet with the average tablet weight (for tablets without content determination or for traditional Chinese medicine tablets with labeled tablet weight, the weight of each tablet should be compared with the labeled tablet weight). According to the table, no more than 2 tablets should exceed the weight difference limit, and no tablet should exceed the limit by more than 100%. V. Conclusion Examples 1-4 show that the substances are homogeneous and stable, with good dissolution, stable components, and small weight differences, indicating that these examples have excellent drug dissolution performance.

[0049] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the specific implementation of the present invention and not to limit it. Those skilled in the art should understand that any equivalent substitutions or obvious modifications made to the implementation of the present invention without changing its performance or use, without departing from the spirit of the present invention, should be covered within the scope of protection claimed by the present invention.

Claims

1. A method for preparing tylosin tablets, characterized in that, Includes the following steps: (1) Dissolve dextrin in purified water to obtain dextrin slurry; (2) First, set the material temperature to 55~65℃ and the fan frequency to 50~60Hz. Add the filler, binder, tylosin, and disintegrant I to the boiling pot. When the material temperature reaches 40~50℃, keep the atomization pressure at 0.10MPa~0.30MPa and the peristaltic pump speed at 20~50rpm. Start spraying dextrin slurry for granulation. When half to two-thirds of the dextrin slurry has been sprayed, increase the fan frequency to 38Hz~40Hz and continue spraying dextrin slurry until the dextrin slurry is completely sprayed. Then dry for 45~50min. (3) Add lubricant and disintegrant II to the dried material in step (2), and granulate it using a V-shaped sieve; after granulation, mix for 5 to 30 minutes. (4) The mixed granules are compressed into tablets, with a core hardness of 4.0~8.0 kg, a core thickness of 4.2~4.7 mm, and a weight difference of ±6.5%. (5) After coating the tablet core, guitarmycin tablets are obtained.

2. The method for preparing tylosin tablets as described in claim 1, characterized in that, In step (2), the filler is at least one of mannitol, corn starch, microcrystalline cellulose, lactose and pregelatinized starch; the binder is at least one of hydroxypropyl methylcellulose, corn starch and pregelatinized starch; the disintegrant I is at least one of corn starch, low-substituted hydroxypropyl cellulose, crospovidone, sodium carboxymethyl starch, microcrystalline cellulose, dextrin and crospovidone carboxymethyl cellulose; the mass ratio of dextrin, filler, binder, tylosin and disintegrant I is (80~90):(250~300):(100~150):(0.5~1):(200~250).

3. The method for preparing tylosin tablets as described in claim 1, characterized in that, In step (3), the lubricant is at least one of magnesium stearate, stearic acid, and polyethylene glycol; the disintegrant II is at least one of corn starch, low-substituted hydroxypropyl cellulose, sodium carboxymethyl starch, microcrystalline cellulose, silica, and croscarmellose sodium; the mass ratio of the lubricant, disintegrant II, and tylosin is (40~50):(10~20):(0.5~1.5); and the aperture of the V-shaped screen is 1.0~1.5 mm.

4. The method for preparing tylosin tablets as described in claim 1, characterized in that, In step (5), the coating is a film coating or a sugar coating.

5. The method for preparing tylosin tablets as described in claim 4, characterized in that, The tablet core is directly coated with a coating solution to obtain tylosin tablets, wherein the mass ratio of the coating solution to the tylosin tablet core is (0.03~0.05):1; The coating solution is prepared by the following process: Hydroxypropyl methylcellulose, lactose monohydrate, titanium dioxide, and triacetin are mixed evenly to obtain a coating premix. The coating premix is ​​added to purified water under stirring, stirred evenly, and passed through a 200-300 mesh sieve to obtain the coating solution. The mass ratio of hydroxypropyl methylcellulose, lactose monohydrate, titanium dioxide, and triacetin in the coating premix is ​​(1.1-1.7):(1.1-1.5):(0.1-1):(0.1-1); the mass ratio of purified water to coating premix is ​​1:(0.1-0.2).

6. The method for preparing tylosin tablets as described in claim 4, characterized in that, The sugar coating process includes the following steps: S1. Weigh the coating materials and prepare the syrup, mixed slurry and isolation layer slurry; S2. Coating the isolation layer: Set the pot speed to 6~10 rpm, and evenly pour the isolation layer slurry onto the rolling sheet in 4~6 portions. After each addition of the isolation layer slurry, dry for 3~10 minutes. Control the outlet temperature at 20℃~60℃. S3, Coating with Powder Layer: After the isolation layer coating is completed, set the pot speed to 3~12 rpm, and pour the slurry into the rolling sheet in 15~25 batches. After each addition of slurry, dry for 2~15 minutes, and control the outlet temperature at 20℃~60℃. S4. Sugar coating: After the powder coating is completed, set the air outlet temperature control to 20~50℃, and pour the syrup onto the rotating sheet in 15~25 batches, drying for 2~15 minutes after each addition of syrup. S5. Polishing: After the sugar coating is completed, set the pot speed to 1-5 rpm, turn off the heating, and dry for 10-30 minutes. After drying, set the pot speed to 5-10 rpm, add beeswax and dimethicone, stir evenly, and then sprinkle it onto the rolling tablet bed in batches. After adding all the ingredients, wait 2-3 minutes to obtain tylosin tablets.

7. The method for preparing tylosin tablets as described in claim 6, characterized in that, In step S1, the preparation method of the syrup, the mixed syrup, and the separating layer syrup includes the following steps: a. Syrup preparation: Add purified water to the weighed sucrose to make the sucrose concentration reach 67%~72wt% to obtain syrup; b. Mixing: Weigh out the talcum powder and syrup according to the mass ratio of talcum powder to syrup = 1: (1~3). After weighing, add talcum powder to the syrup and stir to disperse it evenly in the syrup. Stir evenly to obtain the mixed syrup. c. Separating layer slurry: Weigh hydroxypropyl methylcellulose and 90%~100% ethanol according to a mass ratio of 1:(8~12). Add hydroxypropyl methylcellulose to the weighed 90%~100% ethanol and stir evenly to obtain the separating layer slurry.

8. The method for preparing tylosin tablets as described in claim 4, characterized in that, When the sugar coating is applied, the total weight of the coating material and the mass ratio of the core of the tylosin tablet are (84~110):(80~140).

9. The method for preparing tylosin tablets as described in claim 7, characterized in that, The mass ratio of sucrose, hydroxypropyl methylcellulose, 90%~100% ethanol, talc, beeswax, and dimethicone in the coating material is (545~930):(2~4):(30~45):(240~400):(2~4):(0.1~0.7).

10. The tylosin tablets prepared by the method according to any one of claims 1-9.

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