A pharmaceutical sucrose pellet core and a preparation method thereof

Abstract

The application discloses a medicinal sucrose pill core, which comprises the following raw materials in parts by weight: sucrose 65-85 parts, and starch 15-35 parts; a 50%-70%(W / W) aqueous solution of sucrose and starch with the same proportion as the raw materials is used as a binder; the raw materials are premixed, crushed, sieved and mixed, a mother nucleus is obtained by adopting fluidized bed side spraying and spraying the binder, the mother nucleus is dried and sieved, and the mother nucleus is enlarged by adopting fluidized bed side spraying and spraying the binder, so that the sucrose pill core is prepared. The medicinal sucrose pill core has the advantages of simple formula, convenient operation and low cost. Through improvement of the composition of the binder, the same composition of the binder as the raw materials is adopted, so that the problems of low yield, unqualified pill cores that cannot be treated and large batch content difference in the preparation process of the sucrose pill core are solved, and the prepared sucrose pill core has more uniform content.

Description

Technical Field

[0001] This invention relates to a sucrose core, and more particularly to a pharmaceutical sucrose core and its preparation method. Background Technology

[0002] Pellets are spherical or near-spherical solid dosage forms with a diameter ranging from 0.5 to 1.0 mm. They can also be encapsulated, compressed into tablets, or formulated into different types such as sustained-release and enteric-coated pellets. Pellets are a multi-unit oral dosage form, typically consisting of tens to hundreds of pellets for a single dose. Compared to granules, pellets have unique characteristics in terms of appearance, manufacturing process, and applications.

[0003] 1. Attractive appearance and good flowability. Microspheres do not require flow aids when filling capsules, and the weight difference is smaller compared to filling capsules with powder. They are often used to prepare compound preparations.

[0004] 2. Wide drug loading range;

[0005] 3. It can be used to formulate sustained-release and controlled-release formulations. Mixing various pellets with different release rates can yield the desired drug release rate. Microparticle coating is easy to implement, produces reliable, or targeted release formulations with good batch-to-batch reproducibility.

[0006] 4. Stable drug release. After oral administration of the micro-pellets, the effects of gastric emptying are minimal, resulting in a uniform drug absorption rate.

[0007] 5. It facilitates drug absorption and has high bioavailability.

[0008] 6. It can improve drug stability, such as avoiding incompatibilities between multiple drugs and slowing down drug degradation.

[0009] 7. Reduces drug irritation to the digestive tract and masks the unpleasant taste of certain drugs. Microparticles have a larger contact area with body fluids than tablets and other formulations after reaching the body. They are widely distributed in the gastrointestinal tract, preventing adverse reactions and local irritation caused by excessively high local drug concentrations.

[0010] The most commonly used microcapsule preparation process is the powder layering method, which requires blank capsule cores as carriers. Commonly used blank capsule cores include sucrose capsule cores, microcrystalline cellulose capsule cores, and starch capsule cores.

[0011] In the production of sucrose pellet cores, commonly used binders include sucrose, starch paste, hydroxypropyl methylcellulose, dextrin, and povidone, with a 50% sucrose solution being the most frequently used. Due to the high requirements for controlling the roundness, hardness, and particle size of the sucrose pellet cores, the industry faces significant problems such as low target pellet core qualification rates, unusable waste during production, and uneven sucrose content with large deviations. Summary of the Invention

[0012] The purpose of this invention is to provide a pharmaceutical sucrose pellet core and its preparation method, which solves the problems of low yield of target pellet core, large deviation of sucrose content, and high cost.

[0013] The objective of this invention is achieved through the following technical solution:

[0014] A pharmaceutical sucrose pellet core comprises the following raw materials in parts by weight: 65-85 parts sucrose and 15-35 parts starch. A slurry of 50%-70% (w / w) is prepared with sucrose and starch in the same proportion as the raw materials as a binder. The raw materials are first premixed, crushed, sieved, and mixed. The binder is then sprayed into the pellet using a fluidized bed side spraying method to obtain a core. The core is then dried, sieved, and the binder is sprayed into the pellet using a fluidized bed side spraying method to amplify the core and prepare the sucrose pellet core.

[0015] Preferably, the sucrose core comprises the following raw materials in parts by weight: 70-80 parts sucrose and 20-30 parts starch.

[0016] More preferably, the sucrose core comprises the following raw materials in parts by weight: 80 parts sucrose and 20 parts starch.

[0017] The total amount of sucrose and starch is 100 parts by weight.

[0018] The starch mentioned is corn starch.

[0019] A method for preparing a pharmaceutical sucrose pellet core includes the following steps:

[0020] Step (1), Premixing: Premix sucrose and starch according to the ratio to obtain premixed powder;

[0021] Step (2), Grinding: Grind the above premixed powder into 150 mesh;

[0022] Step (3), Mixing: The pulverized material obtained in step (2) is mixed in a mixer for 30±5 minutes to obtain mixed powder;

[0023] Step (4) Preparation of adhesive: Take the mixed powder obtained in step (3), use water as solvent, and prepare a slurry with a concentration of 50%-70% (W / W) as an adhesive;

[0024] Step (5) Preparation of the mother core: Add the mixed powder into the fluidized bed and set the parameters as follows: turntable speed 500-1300 rpm, air inlet temperature 60-80℃, fan frequency 20-35Hz, atomization pressure 0.2-0.3Mpa; use the side spray function of the fluidized bed, turn on the spray gun, spray the adhesive, maintain the spraying speed at 40-90 rpm for 1-2 hours, and then stop spraying; maintain the turntable speed at 500-1300 rpm for 10-20 minutes to make a mother core with a diameter of 0.18-0.425mm;

[0025] Step (6), Drying: Use a fluidized bed to dry the mother core, control the inlet air temperature to 60-80℃, and dry for 30±5 min;

[0026] Step (7), sieving: Use a vibrating screen to sieve the dried material, sieving out fine powder and large particles to obtain sucrose pellet cores with a diameter of 0.18-0.425mm;

[0027] Step (8) Core Scale-up: Take the 0.18-0.5 mm sucrose pellet core cores obtained in step (7), put them into a fluidized bed, and set the parameters: turntable speed 500-1300 rpm, air inlet temperature 60-80℃, fan frequency 20-35 Hz, atomization pressure 0.2-0.3 MPa; use the fluidized bed side spray function, turn on the spray gun, spray the adhesive, maintain the spraying speed at 40-90 rpm, take samples and monitor until the pellet cores of the required particle size range are obtained, and stop spraying; keep the turntable speed at 500-1300 rpm for 10-20 minutes to make sucrose pellet cores with a diameter of 0.3-1.2 mm;

[0028] Step (9): Use a fluidized bed to dry the sucrose pellet cores, control the inlet air temperature to 65-85℃, and dry for 30±5 min;

[0029] Step (10), sieving: Use a vibrating screen to sieve the material dried in step (9) to remove large particles and fine powder, and obtain sucrose pellet core products with a suitable particle size range.

[0030] In step (1), premixing is performed at room temperature. The premixing method is manual premixing. Specifically, the premixing time is 3 minutes.

[0031] In step (2), the premixed powder is pulverized at room temperature using a platform pulverizer with a 150-mesh internal screen.

[0032] In step (6), the mother nucleus is dried using a fluidized bed top spray process, or a boiling dry bed process can be used.

[0033] In step (7), water is used as a solvent to prepare a 50%-70% (W / W) slurry from the sieved fine powder and large particles as a binder.

[0034] In step (9), the sucrose pellet core is dried using a fluidized bed top spray process, or a boiling dryer can be used.

[0035] In step (10), the large particles and fine powder sieved out are used to prepare the adhesive.

[0036] As a preferred embodiment of the present invention, while ensuring that the concentration of the adhesive is 50%-70% (W / W), the concentration of the adhesive used to prepare the core is 10%-15% (W / W) higher than the concentration of the adhesive used for core amplification, preferably 10% (W / W). By increasing the adhesive concentration, the water content in the system can be reduced, which on the one hand reduces the spraying time and improves efficiency, and on the other hand increases the viscosity of the adhesive, thereby improving the hardness of the pharmaceutical sucrose pellet core.

[0037] The moisture content of the sucrose core product described in this invention is about 3%.

[0038] Considering the insufficient roundness and brittleness of the mother core, it is necessary to scale up the mother core to obtain the finished sucrose pellet core. The particle size (diameter) of the mother core is widely distributed. After scale-up according to requirements, it is screened into different specifications to make sucrose pellet core products. The diameter of the sucrose pellet core products is distributed in 0.3-1.2mm. According to specific needs, it is screened again to further subdivide into sucrose pellet core products of different particle sizes.

[0039] The beneficial effects of this invention are:

[0040] (1) The present invention uses an adhesive with the same composition as the raw materials, so that the components are uniformly increased from the raw material mixing powder to the final sucrose pellet core formation process. Therefore, the waste in the production process can also be reused, which solves the problems of low yield, unqualified pellet cores that cannot be processed, and large batch-to-batch content differences in the preparation of sucrose pellet cores. The cumulative finished product yield can reach more than 95%.

[0041] (2) The binder and raw material components are the same, and the content of the prepared sucrose pellet core is more uniform.

[0042] (3) The adhesive has the same components as the raw materials, making the process simpler, easier to operate, and cheaper. It also reduces the risk of cross-contamination and the risk of incorrect material addition, which is conducive to industrial production. Detailed Implementation

[0043] The technical solution of the present invention will be further described below through specific embodiments.

[0044] The starch used in the examples is corn starch, which meets the pharmacopoeia standards and has a moisture content of ≤4.0%.

[0045] The mixer used in this embodiment is a three-dimensional motion mixer with a mixing frequency of 30 Hz.

[0046] Example 1

[0047] A pharmaceutical sucrose core comprises the following raw materials in parts by weight: 70 parts sucrose and 30 parts starch; the binder component is in the same proportion as the raw materials.

[0048] The specific preparation method of pharmaceutical sucrose core is as follows:

[0049] Step (1), Premixing: At room temperature, sucrose and starch are manually premixed according to the ratio for 3 minutes to obtain premixed powder;

[0050] Step (2), pulverization: At room temperature, the above premixed powder is pulverized using a platform pulverizer (with an internal 150-mesh sieve);

[0051] Step (3), Mixing: The pulverized material obtained in step (2) is mixed in a mixer for 30 minutes to obtain mixed powder;

[0052] Step (4) Preparation of adhesive: Using water as a solvent, take the mixed powder obtained in step (3) and prepare a 50% (W / W) slurry as an adhesive;

[0053] Step (5) Preparation of the mother core: 10 kg of the mixed powder obtained in step (3) is put into the fluidized bed and the parameters are set as follows: the turntable speed is 1200 rpm, the air inlet temperature is 70℃, the fan frequency is 30 Hz, and the atomization pressure is 0.25 MPa. The fluidized bed side spray function is used. The spray gun is turned on and a 50% (W / W) adhesive is sprayed in. The spraying speed is maintained at 50 rpm for 1.5 h. Then the spraying is stopped. The turntable speed is maintained at 800 rpm for 15 min to make a mother core with a diameter of 0.18-0.425 mm.

[0054] Step (6), Drying: The mother nucleus is dried using a fluidized bed top spraying process, with the inlet air temperature controlled at 80℃ and the drying time at 30 min;

[0055] Step (7), sieving: The dried material is sieved using a vibrating screen to remove fine powder and large particles, resulting in sucrose pellet cores with a diameter of 0.18-0.3 mm;

[0056] Step (8) Core Scale-up: Take the fine powder and large particles sieved out in step (7) and prepare a 60% (W / W) slurry as a binder; take 5 kg of the sucrose pellet core core obtained in step (7) and put it into a fluidized bed. Set the parameters: turntable speed 1200 rpm, air inlet temperature 80℃, fan frequency 35 Hz, atomization pressure 0.3 MPa; use the fluidized bed side spray function, turn on the spray gun, spray in the binder with a concentration of 60% (W / W), maintain the spraying speed at 70 rpm for 2 hours, and stop spraying; maintain the turntable speed at 800 rpm for 15 minutes to make sucrose pellet cores with a diameter of 0.3-1.2 mm;

[0057] Step (9): Dry the sucrose pellet core obtained in step (8) using a fluidized bed top spray process, controlling the air inlet temperature at 80℃ and drying for 30±5 min.

[0058] Step (10), sieving: Use a vibrating screen to sieve the material dried in step (9) to remove large particles and fine powder, and obtain sucrose pellet core products with a suitable particle size range.

[0059] Example 2

[0060] A pharmaceutical sucrose core comprises the following raw material ratios by weight: 70 parts sucrose and 30 parts starch. The binder component is in the same ratio as the raw materials.

[0061] The specific preparation method of pharmaceutical sucrose core is as follows:

[0062] Step (1), Premixing: At room temperature, sucrose and starch are manually premixed according to the ratio for 3 minutes to obtain premixed powder;

[0063] Step (2), pulverization: At room temperature, the above premixed powder is pulverized using a platform pulverizer (with an internal 150-mesh sieve);

[0064] Step (3), Mixing: The pulverized material obtained in step (2) is mixed in a mixer for 30 minutes to obtain mixed powder;

[0065] Step (4) Preparation of adhesive: Using water as a solvent, take the mixed powder obtained in step (3) and prepare a 50% (W / W) slurry as an adhesive;

[0066] Step (5), preparation of the mother core: 10 kg of the mixed powder obtained in step (3) is put into the fluidized bed and the parameters are set as follows: the rotation speed of the turntable is 1200 rpm, the air inlet temperature is 70℃, the fan frequency is 30 Hz, and the atomization pressure is 0.25 MPa; the side spray function of the fluidized bed is used, the spray gun is turned on, and the 50% (W / W) adhesive is sprayed in, and the spraying speed is maintained at 50 rpm for 1.5 h; the spraying is stopped, and the turntable is kept running at 800 rpm for 15 min to make a mother core with a diameter of 0.18-0.425 mm;

[0067] Step (6), Drying: Use fluidized bed top spraying process to dry the mother core, control the inlet air temperature to 80℃, and dry for 30 minutes;

[0068] Step (7), sieving: The material dried in step (6) is sieved using a vibrating screen to remove fine powder and large particles, and sucrose pellet cores with a diameter of 0.18-0.3 mm are obtained.

[0069] Step (8) Core Scale-up: Using water as a solvent, take the fine powder and large particles sieved out in step (7) and prepare a 60% (W / W) slurry as a binder; put 5 kg of sucrose pellet cores obtained in step (7) into a fluidized bed and set the parameters: turntable speed 1200 rpm, air inlet temperature 80℃, fan frequency 35 Hz, atomization pressure 0.3 MPa; using the fluidized bed side spray function, turn on the spray gun and spray in a 60% (W / W) binder, maintain the spraying speed at 60-80 rpm for 2 hours, stop spraying, and maintain the turntable speed at 800 rpm for 15 minutes to make sucrose pellet cores with a diameter of 0.3-1.2 mm;

[0070] Step (9): Dry the sucrose pellet core obtained in step (8) using a fluidized bed top spray process, controlling the air inlet temperature at 80℃ and drying for 30±5 min.

[0071] Step (10), sieving: Use a vibrating screen to sieve the material dried in step (9) to remove large particles and fine powder, and obtain sucrose pellet core products with a suitable particle size range.

[0072] Example 3

[0073] A pharmaceutical sucrose core comprises the following raw material ratios by weight: 80 parts sucrose and 20 parts starch. The binder component is in the same ratio as the raw materials.

[0074] The specific preparation method of pharmaceutical sucrose core is as follows:

[0075] Step (1), Premixing: At room temperature, sucrose and starch are manually premixed according to the ratio for 3 minutes to obtain premixed powder;

[0076] Step (2), pulverization: At room temperature, the above premixed powder is pulverized using a platform pulverizer (with an internal 150-mesh sieve);

[0077] Step (3), Mixing: The pulverized material obtained in step (2) is mixed in a mixer for 30 minutes to obtain mixed powder;

[0078] Step (4) Preparation of adhesive: Using water as a solvent, take the mixed powder obtained in step (3) and prepare a 50% (W / W) slurry as an adhesive;

[0079] Step (5) Preparation of the mother core: 10 kg of the mixed powder obtained in step (3) is put into the fluidized bed and the parameters are set as follows: the turntable speed is 1200 rpm, the air inlet temperature is 70℃, the fan frequency is 30 Hz, and the atomization pressure is 0.25 MPa. The fluidized bed side spray function is used. The spray gun is turned on and a 50% (W / W) adhesive is sprayed in. The spraying speed is maintained at 50 rpm for 1.5 h. Then the spraying is stopped. The turntable speed is maintained at 800 rpm for 15 min to make a mother core with a diameter of 0.18-0.425 mm.

[0080] Step (6), Drying: The mother nucleus is dried using a fluidized bed top spraying process, with the inlet air temperature controlled at 80℃ and the drying time at 30 min;

[0081] Step (7), sieving: The material dried in step (6) is sieved using a vibrating screen to remove fine powder and large particles, and sucrose pellet cores with a diameter of 0.18-0.3 mm are obtained.

[0082] Step (8) Core Scale-up: Using water as a solvent, take the fine powder and large particles sieved out in step (7) and prepare a 60% (W / W) slurry as a binder; put 5 kg of sucrose pellet cores obtained in step (7) into a fluidized bed and set the parameters: turntable speed 1200 rpm, air inlet temperature 80℃, fan frequency 35 Hz, atomization pressure 0.3 MPa; using the fluidized bed side spray function, turn on the spray gun and spray in a 60% (W / W) binder, maintain the spraying speed at 70 rpm for 2 hours, stop spraying, and maintain the turntable speed at 800 rpm for 15 minutes to make sucrose pellet cores of 0.3-1.2 mm;

[0083] Step (9): Dry the sucrose pellet core obtained in step (8) using a fluidized bed top spray process, controlling the air inlet temperature at 85℃ and drying for 30±5 min.

[0084] Step (10), sieving: Use a vibrating screen to sieve the material dried in step (9) to remove large particles and fine powder, and obtain sucrose pellet core products with a suitable particle size range.

[0085] Content detection: Take about 10g of this product according to the pharmacopoeia standard, grind it into a fine powder, and place it in a 100ml volumetric flask. Add an appropriate amount of water, shake to dissolve the sucrose, dilute with water to the mark, shake well, centrifuge at 10,000 rpm for 30 minutes, take the supernatant, and determine the optical rotation according to the method (General Rule 0621). Calculate the content of C in this product using the following formula. 12 H 22 O 11 Percentage content (%).

[0086] Sucrose (%) = (10 4×α) / ((66.5×l×m×(100%-H))×100%

[0087] In the formula, α is the optical rotation; 66.5 is the specific rotation of sucrose at 20℃; l is the length of the test tube, dm; m is the sample weight, g; and H is the loss on drying, %.

[0088] Table 1. Relative Standard Deviation (RSD) of Sucrose Content in Sucrose Pellets

[0089]

[0090]

[0091] Note: Commercially available sucrose core 1 (Yuekang Pharmaceutical Group Anhui Natural Pharmaceutical Co., Ltd., batch number: 2001001), commercially available sucrose core 2 (Changzhou Famatech Pharmaceutical Excipients Co., Ltd., batch number: 1901002), the same below.

[0092] Conclusion: The RSD of sucrose content in the sucrose pellet core prepared by this invention is lower than that of commercially available products, indicating that the sucrose content is more uniform.

[0093] Friability test: Take 6.5g of micro-pellets according to the pharmacopoeia specifications, blow off the loose powder with a blower, weigh accurately, place in a cylinder, and rotate 100 times. Remove, remove the powder using the same method, weigh accurately, and the weight loss should not exceed 1%, and no broken, cracked, or pulverized pieces should be detected. This test is generally performed only once. If the weight loss exceeds 1%, it can be repeated 2 times, and the average weight loss of the 3 tests should not exceed 1%, and no broken, cracked, or pulverized pieces should be detected.

[0094] Table 2. Crumbliness of Sugar Cane Core

[0095] Example 1 0.23％ Example 2 0.25％ Example 3 0.33％ Commercially available sugar pellet core 1 0.38％ Commercially available sugar pellet core 2 0.27％

[0096] Conclusion: The sucrose pellet core prepared by this invention has a similar brittleness to commercially available pellets, and both meet the requirements.

[0097] Loss on drying: Take this product according to the pharmacopoeia, dry it at 105℃ for 4 hours, and the weight loss shall not exceed 4.0% (General Rule 0831).

[0098] Table 3. Loss on drying of sucrose pellet cores

[0099] Example 1 2.61％ Example 2 2.73％ Example 3 2.55％ Commercially available sugar pellet core 1 2.80％ Commercially available sugar pellet core 2 3.09％

[0100] Conclusion: The drying loss of the sucrose pellet core prepared by this invention is similar to that of commercially available products, and both meet the requirements.

[0101] Table 4. Yield of sucrose pellet cores

[0102] Example 1 96.3％ Example 2 97.5％ Example 3 98.0％

Claims

1. A medicinal sucrose core, characterized in that, The ingredients include the following parts by weight: 70 parts sucrose, 30 parts starch, and the binder components are in the same proportion as the raw materials; The specific preparation method of pharmaceutical sucrose core is as follows: Step (1), Premixing: At room temperature, sucrose and starch are manually premixed according to the ratio for 3 minutes to obtain premixed powder; Step (2), crushing: At room temperature, a platform crusher with an internal 150-mesh screen is used to crush the above premixed powder; Step (3), Mixing: The pulverized material obtained in step (2) is mixed in a mixer for 30 minutes to obtain mixed powder; Step (4) Preparation of adhesive: Using water as a solvent, take the mixed powder obtained in step (3) and prepare a 50% W / W slurry as an adhesive; Step (5) Preparation of the mother core: 10 kg of the mixed powder obtained in step (3) is put into the fluidized bed and the parameters are set as follows: the turntable speed is 1200 rpm, the air inlet temperature is 70℃, the fan frequency is 30 Hz, and the atomization pressure is 0.25 MPa. The fluidized bed side spray function is used. The spray gun is turned on and the 50% W / W adhesive is sprayed in. The spraying speed is maintained at 50 rpm for 1.5 h. Then the spraying is stopped. The turntable speed is maintained at 800 rpm for 15 min to make a mother core with a diameter of 0.18-0.425 mm. Step (6), Drying: The mother nucleus is dried using a fluidized bed top spraying process, with the inlet air temperature controlled at 80℃ and the drying time at 30 min; Step (7), sieving: The dried material is sieved using a vibrating screen to remove fine powder and large particles, resulting in sucrose pellet cores with a diameter of 0.18-0.3 mm; Step (8) Core Magnification: Take the fine powder and large particles sieved out in step (7) and prepare a 60% W / W slurry as a binder; take 5 kg of the sucrose pellet core core obtained in step (7) and put it into a fluidized bed. Set the parameters: turntable speed 1200 rpm, air inlet temperature 80℃, fan frequency 35 Hz, atomization pressure 0.3 MPa; use the fluidized bed side spray function, turn on the spray gun, spray in the binder with a concentration of 60% W / W, maintain the spraying speed at 70 rpm for 2 hours, and stop spraying; maintain the turntable speed at 800 rpm for 15 minutes to make sucrose pellet cores with a diameter of 0.3-1.2 mm. Step (9): Dry the sucrose pellet core obtained in step (8) using a fluidized bed top spray process, controlling the air inlet temperature at 80℃ and drying for 30±5 min. Step (10), sieving: Use a vibrating screen to sieve the material dried in step (9) to remove large particles and fine powder, and obtain sucrose pellet core products with a suitable particle size range.

2. A medicinal sucrose core, characterized in that, The raw material composition includes the following parts by weight: 70 parts sucrose, 30 parts starch, and the binder component is in the same proportion as the raw material composition; The specific preparation method of pharmaceutical sucrose core is as follows: Step (1), Premixing: At room temperature, sucrose and starch are manually premixed according to the ratio for 3 minutes to obtain premixed powder; Step (2), crushing: At room temperature, a platform crusher with an internal 150-mesh screen is used to crush the above premixed powder; Step (3), Mixing: The pulverized material obtained in step (2) is mixed in a mixer for 30 minutes to obtain mixed powder; Step (4) Preparation of adhesive: Using water as a solvent, take the mixed powder obtained in step (3) and prepare a 50% W / W slurry as an adhesive; Step (5), preparation of the mother core: 10 kg of the mixed powder obtained in step (3) is put into the fluidized bed and the parameters are set as follows: the rotation speed of the turntable is 1200 rpm, the air inlet temperature is 70℃, the fan frequency is 30 Hz, and the atomization pressure is 0.25 MPa; the side spray function of the fluidized bed is used, the spray gun is turned on, and the adhesive with a concentration of 50% W / W is sprayed in, and the spraying speed is maintained at 50 rpm for 1.5 h; the spraying is stopped, and the turntable is kept running at 800 rpm for 15 min to make a mother core with a diameter of 0.18-0.425 mm; Step (6), Drying: Use fluidized bed top spraying process to dry the mother core, control the inlet air temperature to 80℃, and dry for 30 minutes; Step (7), sieving: The material dried in step (6) is sieved using a vibrating screen to remove fine powder and large particles, and sucrose pellet cores with a diameter of 0.18-0.3 mm are obtained. Step (8) Core Scale-up: Using water as a solvent, take the fine powder and large particles sieved out in step (7) and prepare a 60% W / W slurry as a binder; put 5 kg of the sucrose pellet core core obtained in step (7) into a fluidized bed and set the parameters: turntable speed 1200 rpm, air inlet temperature 80℃, fan frequency 35 Hz, atomization pressure 0.3 MPa; using the fluidized bed side spray function, turn on the spray gun and spray in the binder with a concentration of 60% W / W, keep the spraying speed at 60-80 rpm for 2 hours, stop the spraying, keep the turntable speed at 800 rpm for 15 minutes to make sucrose pellet cores with a diameter of 0.3-1.2 mm; Step (9): Dry the sucrose pellet core obtained in step (8) using a fluidized bed top spray process, controlling the air inlet temperature at 80℃ and drying for 30±5 min. Step (10), sieving: Use a vibrating screen to sieve the material dried in step (9) to remove large particles and fine powder, and obtain sucrose pellet core products with a suitable particle size range.

3. A medicinal sucrose core, characterized in that, The raw material composition includes the following parts by weight: 80 parts sucrose, 20 parts starch, and the binder component is in the same proportion as the raw material composition; The specific preparation method of pharmaceutical sucrose core is as follows: Step (1), Premixing: At room temperature, sucrose and starch are manually premixed according to the ratio for 3 minutes to obtain premixed powder; Step (2), crushing: At room temperature, a platform crusher with an internal 150-mesh screen is used to crush the above premixed powder; Step (3), Mixing: The pulverized material obtained in step (2) is mixed in a mixer for 30 minutes to obtain mixed powder; Step (4) Preparation of adhesive: Using water as a solvent, take the mixed powder obtained in step (3) and prepare a 50% W / W slurry as an adhesive; Step (5) Preparation of the mother core: 10 kg of the mixed powder obtained in step (3) is put into the fluidized bed and the parameters are set as follows: the turntable speed is 1200 rpm, the air inlet temperature is 70℃, the fan frequency is 30 Hz, and the atomization pressure is 0.25 MPa. The fluidized bed side spray function is used. The spray gun is turned on and the adhesive with a concentration of 50% W / W is sprayed in. The spraying speed is maintained at 50 rpm for 1.5 h and then the spraying is stopped. The turntable speed is maintained at 800 rpm for 15 min to make a mother core with a diameter of 0.18-0.425 mm. Step (6), Drying: The mother nucleus is dried using a fluidized bed top spraying process, with the inlet air temperature controlled at 80℃ and the drying time at 30 min; Step (7), sieving: The material dried in step (6) is sieved using a vibrating screen to remove fine powder and large particles, and sucrose pellet cores with a diameter of 0.18-0.3 mm are obtained. Step (8) Core Scale-up: Using water as a solvent, take the fine powder and large particles sieved out in step (7) and prepare a 60% W / W slurry as a binder; put 5 kg of sucrose pellet cores obtained in step (7) into a fluidized bed and set the parameters: turntable speed 1200 rpm, air inlet temperature 80℃, fan frequency 35 Hz, atomization pressure 0.3 MPa; using the fluidized bed side spray function, turn on the spray gun and spray in the binder with a concentration of 60% W / W, keep the spraying speed at 70 rpm for 2 hours, stop the spraying, keep the turntable speed at 800 rpm for 15 minutes to make sucrose pellet cores of 0.3-1.2 mm; Step (9): Dry the sucrose pellet core obtained in step (8) using a fluidized bed top spray process, controlling the air inlet temperature at 85℃ and drying for 30±5 min. Step (10), sieving: Use a vibrating screen to sieve the material dried in step (9) to remove large particles and fine powder, and obtain sucrose pellet core products with a suitable particle size range.

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