Compound tablet containing artificial bovine bezoar and preparation process thereof

Abstract

The application discloses a kind of artificial cow-bezoar-containing compound tablets and its preparation process, belong to the field of pharmaceutical processing, the tablet is composed of chlorpheniramine maleate, artificial cow-bezoar and diclofenac sodium, first diclofenac sodium is mixed with filling agent, slow-release agent, disintegrating agent, obtain diclofenac sodium granules by wet granulation, then artificial cow-bezoar, chlorpheniramine maleate, filling agent, disintegrating agent are put into wet granulator, after drying whole granule control granularity distribution obtains artificial cow-bezoar-chlorpheniramine maleate granules, finally diclofenac sodium granules, artificial cow-bezoar-chlorpheniramine maleate granules are mixed with lubricant, after tabletting coating is obtained.The tablet prepared by the process is good in quality, high in stability, reduces the amplitude of the decrease of the content of effective components during storage, by controlling relevant process parameters, the dissolution rate of artificial cow-bezoar in unit time is ensured, the effectiveness of the tablet is greatly improved.

Description

Technical Field

[0001] This invention belongs to the field of pharmaceutical processing, specifically relating to a compound tablet containing artificial bezoar and its preparation process. Background Technology

[0002] Artificial bezoar is almost insoluble in water, requiring formulation to increase its solubility and thus improve its bioavailability in the human body, allowing for better absorption of its active ingredients. Drug dissolution is a key factor affecting absorption; monitoring dissolution profiles allows understanding of drug release behavior in the gastrointestinal tract, thereby assessing its pharmacodynamic and pharmacokinetic characteristics. Improving the solubility of artificial bezoar in water ensures its efficacy. Current methods for improving solubility include pulverizing the raw material, modifying the drug dosage form, adding solubilizers, preparing solid dispersions, and forming nanoparticles.

[0003] Existing technologies are generally complex to operate, require large equipment investment, and generate excessive dust during the pulverization process, which can affect health. Furthermore, since artificial bezoar is a complex of traditional Chinese medicine, it is difficult to select substances that can form water-soluble intermolecular complexes, double salts, or associations with it in accordance with the principles of chemical drugs. Summary of the Invention

[0004] In view of the shortcomings of the existing technology, the purpose of this invention is to propose a compound tablet containing artificial bezoar and its preparation process.

[0005] To achieve the above objectives, the technical solution adopted by the present invention is as follows:

[0006] The first aspect of this invention is to provide a preparation process for compound tablets containing artificial bezoar, comprising the following steps:

[0007] S1: After sieving, diclofenac sodium is mixed with filler, slow-release agent and disintegrant and fed into a wet granulation machine to obtain diclofenac sodium granules;

[0008] S2: Artificial bezoar, chlorpheniramine maleate, filler, and disintegrant are put into a wet granulation machine, stirred, heated, and mixed, and then a binder is sprayed in. After granulation, wet granules are obtained.

[0009] S3: The wet granules are put into a dryer and dried to obtain artificial bezoar-chlorpheniramine maleate granules; wherein the particle size distribution of the artificial bezoar-chlorpheniramine maleate granules is: 5-25% of the granules have a particle size greater than 80 mesh, 60-70% of the granules have a particle size of 80-150 mesh, and 15-25% of the granules have a particle size less than 150 mesh.

[0010] S4: Mix diclofenac sodium granules, artificial bezoar-chlorpheniramine maleate granules with a lubricant to obtain mixed granules;

[0011] S5: Compress and coat the mixed granules to obtain compound tablets containing artificial bezoar.

[0012] It should be noted that the size of artificial bezoar-chlorpheniramine maleate granules affects the dissolution rate and final dissolution degree of the active ingredient. A smaller particle size significantly increases the specific surface area, thereby accelerating the contact speed between the drug and the dissolution medium, increasing the dissolution rate, and also increasing the porosity between tablets or granules, promoting the swelling of the disintegrant after absorbing water and the capillary effect, thus accelerating disintegration. However, excessively small particles may aggregate due to van der Waals forces or electrostatic effects, which would reduce the effective surface area and lead to excessively strong interparticle binding forces, prolonging the disintegration time. Therefore, it is essential to keep the particles within a certain particle size range.

[0013] First, the particle size range selected in this invention can improve particle flowability. Small-diameter particles can fill the gaps between large-diameter particles, making the overall particle packing more compact and uniform, reducing friction and interaction forces between particles. Second, this particle size distribution can improve particle filling performance. After mixing particles of different sizes, they can better adapt to the shape and space of the die cavities, achieving more complete filling. In addition, this particle size distribution can also enhance the compressibility between particles. Large-diameter particles provide a supporting framework, while small-diameter particles fill the gaps between large particles, increasing the contact area and binding force between particles. Finally, this invention can regulate drug release performance by controlling the particle distribution of artificial bezoar-chlorpheniramine maleate particles. Large-diameter particles can form certain pores and channels inside the tablet, while small-diameter particles can adjust the size and distribution of pores.

[0014] Based on the properties and formulation requirements of artificial bezoar, this invention controls the particle size distribution of artificial bezoar-chlorpheniramine maleate granules. 5-25% of the particles have a diameter greater than 80 mesh, 60-70% have a diameter of 80-150 mesh, and 15-25% have a diameter less than 150 mesh. Under this particle size distribution, particles smaller than 150 mesh effectively improve the flowability, compressibility, and filling properties of large particles, while particles larger than 80 mesh form an effective supporting framework and create channels, allowing 80-150 mesh particles to be released at a certain rate, thereby increasing the final release rate. This significantly improves the dissolution rate of artificial bezoar per unit time, enhances the release rate and extent of the drug in vivo, and also facilitates tableting and production.

[0015] In some embodiments, the parameters of the wet granulator in S1 are: impeller speed 90-110 rpm, cutter speed 1000-1400 rpm, and stirring time 25-40 min.

[0016] In some embodiments, the stirring-heating-mixing step in S2 is specifically as follows: First, stir for 1-3 minutes at a stirring paddle speed of 90-110 rpm and a cutting blade speed of 800-1200 rpm. After stirring, turn off the stirring paddle and the cutting blade, heat the material to a temperature of 65-70°C, and then turn on the stirring paddle and the cutting blade, stirring for 25-40 minutes at a stirring paddle speed of 90-110 rpm and a cutting blade speed of 800-1200 rpm.

[0017] By stirring and then heating, the temperature of the particles is increased, which increases the movement of particle molecules and allows for better formation of uniform particles when the adhesive is sprayed in later.

[0018] In some embodiments, when the adhesive is sprayed in S2, the parameters of the wet granulator are: agitator speed 100-140 rpm, cutter speed 1000-1400 rpm; atomization pressure 0.04-0.06 MPa, spray flow rate 100-150 g / min, and granulation time 2-4 min.

[0019] In some embodiments, the adhesive is selected from at least one of sodium carboxymethyl cellulose, povidone K30, and hydroxypropyl cellulose.

[0020] In some embodiments, the dryer parameters in S3 are: inlet air temperature of 70-100℃, outlet air temperature of 35-65℃; drying time of 30-70 min; drying until particle weight loss is 1.5-4.5%.

[0021] In some implementations, the mixing time in S4 is 5-10 min; and the tableting in S5 is compressed to a core hardness of 4.0-9.0 kg.

[0022] In some embodiments, the filler is selected from at least one of dicalcium phosphate, microcrystalline cellulose, dextrin, mannitol, starch, and pregelatinized starch; the sustained-release agent is selected from at least one of hydroxypropyl cellulose, hydroxypropyl methylcellulose, and ethyl cellulose; the disintegrant is selected from at least one of starch, sodium carboxymethyl starch, and calcium carboxymethyl cellulose; and the lubricant is selected from at least one of magnesium stearate, calcium stearate, stearic acid, and hydrogenated vegetable oil.

[0023] In some embodiments, the raw material of the compound tablet containing artificial bezoar is composed of chlorpheniramine maleate, artificial bezoar, and diclofenac sodium; wherein the mass ratio of dicalcium phosphate to the raw material is 0.6-1.4:1, the mass ratio of hydroxypropyl methylcellulose to the raw material is 0.02-0.04:1, the mass ratio of sodium carboxymethyl starch to the raw material is 0.4-0.8:1, the mass ratio of microcrystalline cellulose to the raw material is 0.2-0.4:1, the mass ratio of mannitol to the raw material is 0.3-0.8:1, the mass ratio of binder to the raw material is 0.006-0.012:1, and the mass ratio of magnesium stearate to the raw material is 0.02-0.04:1.

[0024] It should be noted that dicalcium phosphate, besides being a filler, also acts as a pH regulator. Diclofenac sodium's dissolution is pH-dependent; dicalcium phosphate helps maintain the pH of diclofenac sodium within the granules, thereby increasing its solubility. A suitable pH value can also reduce raw material degradation. Artificial bezoar, being in powder form, has poor flowability and is easily unevenly mixed. Adding mannitol and heating with stirring can improve the uniformity and flowability of the artificial bezoar, thus increasing its solubility in water. The proportions of each excipient not only maintain the flowability and compressibility of the granules but also determine their hardness and the uniformity of raw material content, further improving the final dissolution rate of artificial bezoar in the tablets.

[0025] A second aspect of the present invention is to provide a compound tablet containing artificial bezoar.

[0026] The present invention has the following beneficial effects:

[0027] This invention improves the dissolution rate of artificial bezoar per unit time by controlling relevant process parameters, thus ensuring the dissolution rate of artificial bezoar per unit time and enabling its effective components to be better absorbed in the body.

[0028] Compared with other processes, the compound tablets containing artificial bezoar prepared by the process provided by this invention show a significantly smaller decrease in the content of the active ingredients diclofenac sodium, chlorpheniramine maleate, and artificial bezoar during storage, which greatly improves the quality and stability of the tablets. Attached Figure Description

[0029] Figure 1 This is a comparison chart of the dissolution data of artificial bezoar in the examples and comparative examples in the dissolution test. Detailed Implementation

[0030] The present invention will now be described in further detail with reference to the accompanying drawings. The embodiments described with reference to the drawings are exemplary and intended to explain the present invention, but should not be construed as limiting the present invention.

[0031] Example 1

[0032] A preparation process for a compound tablet containing artificial bezoar includes the following steps:

[0033] S1: After being sieved through a rotary granulator, diclofenac sodium is mixed with dicalcium phosphate, hydroxypropyl methylcellulose, and 1 / 2 of the total amount of sodium carboxymethyl starch and then fed into a wet granulator. The mixture is stirred for 30 minutes at a speed of 100 rpm for the stirring paddle and 1200 rpm for the cutting blade to obtain diclofenac sodium granules with a particle size of 80-150 mesh.

[0034] S2: Add artificial bezoar, chlorpheniramine maleate, microcrystalline cellulose, the remaining sodium carboxymethyl starch, and mannitol into a wet granulator. Stir for 1 minute at a speed of 100 rpm for the agitator and 1000 rpm for the cutter. After stirring, turn off the agitator and cutter and heat the material to 65°C. Then turn on the agitator and cutter and stir for 30 minutes at a speed of 100 rpm for the agitator and 1000 rpm for the cutter. Spray sodium carboxymethyl cellulose at a speed of 120 rpm for the agitator and 1200 rpm for the cutter. Granulate for 2 minutes to obtain wet granules.

[0035] S3: Put the wet granules into a dryer and dry them for 40 minutes at an inlet air temperature of 75℃ and an outlet air temperature of 55℃ until the granules lose 2.5% of their weight, thus obtaining artificial bezoar-chlorpheniramine maleate granules.

[0036] S4: Add diclofenac sodium granules, artificial bezoar-chlorpheniramine maleate granules and magnesium stearate to a mixer and mix for 8 minutes to obtain mixed granules;

[0037] S5: The mixed granules are compressed into tablets using a Φ6mm shallow concave die. The tablet core hardness is 6.5kg. After film coating, a compound tablet containing artificial bezoar is obtained.

[0038] The particle size distribution of artificial bezoar-chlorpheniramine maleate particles in S3 is shown in Table 1 below:

[0039] Table 1. Particle size distribution of artificial bezoar-chlorpheniramine maleate particles in Example 1

[0040] granularity Proportion Particle size > 50 mesh 0.02％ Particle size 50-65 mesh 2.13％ Particle size 65-80 mesh 12.51％ Particle size 80-100 mesh 21.52％ Particle size 100-120 mesh 27.21％ Particle size 120-150 mesh 21.26％ Particle size 150-200 mesh 7.60％ Particle size <200 mesh 7.75％

[0041] The formulation of the compound tablets containing artificial bezoar prepared by the process described in Example 1 above is shown in Table 2 below:

[0042] Table 2. Amounts of raw materials and excipients for compound tablets containing artificial bezoar in Example 1.

[0043]

[0044] Example 2

[0045] The preparation steps are the same as in Example 1, except that:

[0046] The particle size distribution of the artificial bezoar-chlorpheniramine maleate particles in S3 is shown in Table 3 below:

[0047] Table 3. Particle size distribution of artificial bezoar-chlorpheniramine maleate particles in Example 2

[0048] granularity Proportion Particle size > 50 mesh 0.03％ Particle size 50-65 mesh 3.14％ Particle size 65-80 mesh 8.32％ Particle size 80-100 mesh 16.11％ Particle size 100-120 mesh 27.71％ Particle size 120-150 mesh 26.18％ Particle size 150-200 mesh 10.41％ Particle size <200 mesh 8.10％

[0049] The prescriptions for compound tablets containing artificial bezoar are shown in Table 4 below:

[0050] Table 4. Amounts of raw materials and excipients for compound tablets containing artificial bezoar in Example 2.

[0051]

[0052]

[0053] Example 3

[0054] The preparation steps are the same as in Example 1, except that:

[0055] The particle size distribution of artificial bezoar-chlorpheniramine maleate particles in S3 is shown in Table 5 below:

[0056] Table 5. Particle size distribution of artificial bezoar-chlorpheniramine maleate particles in Example 3.

[0057] granularity Proportion Particle size > 50 mesh 0.03％ Particle size 50-65 mesh 2.83％ Particle size 65-80 mesh 8.42％ Particle size 80-100 mesh 16.32％ Particle size 100-120 mesh 28.07％ Particle size 120-150 mesh 25.59％ Particle size 150-200 mesh 10.54％ Particle size <200 mesh 8.20％

[0058] The prescriptions for compound tablets containing artificial bezoar are shown in Table 6 below:

[0059] Table 6. Amounts of raw materials and excipients for compound tablets containing artificial bezoar in Example 3.

[0060]

[0061]

[0062] Example 4

[0063] The preparation steps are the same as in Example 1, except that:

[0064] The particle size distribution of artificial bezoar-chlorpheniramine maleate particles in S3 is shown in Table 7 below:

[0065] Table 7. Particle size distribution of artificial bezoar-chlorpheniramine maleate particles in Example 4.

[0066] granularity Proportion Particle size > 50 mesh 0.29％ Particle size 50-65 mesh 1.85％ Particle size 65-80 mesh 2.86％ Particle size 80-100 mesh 16.32％ Particle size 100-120 mesh 30.09％ Particle size 120-150 mesh 23.59％ Particle size 150-200 mesh 15.58％ Particle size <200 mesh 9.42％

[0067] Example 5

[0068] The preparation steps are the same as in Example 1, except that:

[0069] The particle size distribution of artificial bezoar-chlorpheniramine maleate particles in S3 is shown in Table 8 below:

[0070] Table 8. Particle size distribution of artificial bezoar-chlorpheniramine maleate particles in Example 5.

[0071] granularity Proportion Particle size > 50 mesh 2.85％ Particle size 50-65 mesh 9.14％ Particle size 65-80 mesh 13.01％ Particle size 80-100 mesh 17.32％ Particle size 100-120 mesh 19.07％ Particle size 120-150 mesh 23.61％ Particle size 150-200 mesh 7.82％ Particle size <200 mesh 7.18％

[0072] Comparative Example 1

[0073] A preparation process for a compound tablet containing artificial bezoar includes the following steps:

[0074] S1 Pretreatment: Diclofenac sodium, dicalcium phosphate, sodium carboxymethyl starch, and microcrystalline cellulose are passed through a 40-mesh sieve;

[0075] S2: Add the sieved diclofenac sodium, dicalcium phosphate, and half the total amount of sodium carboxymethyl starch to the multi-functional fluidized bed hopper, and adjust the air volume to 120m³ / h. 3 / h, adjust the peristaltic pump speed to 30rpm, the atomization pressure to 2.0bar, spray 0.6% corn starch solution into the fluidized bed granulator through the peristaltic pump, set the material temperature to 42℃, granulate and dry at the same time, control the moisture content to below 3.0%, discharge the material to obtain mixed granules A;

[0076] S3: Slowly add sodium carboxymethyl cellulose to water and stir to obtain the binder;

[0077] S4: Add the sieved artificial bezoar, chlorpheniramine maleate, the remaining sodium carboxymethyl starch, and microcrystalline cellulose to the multi-functional fluidized bed hopper, and adjust the air volume to 120m³ / h. 3 / h, adjust the peristaltic pump speed to 30rpm, the atomization pressure to 2.0bar, and spray the binder into the fluidized bed granulator through the peristaltic pump. Set the material temperature to 42℃, granulate and dry at the same time, control the moisture content to below 2.0%, and discharge to obtain mixed granules B; wherein the particle size distribution of mixed granules B is: 70% of 50-80 mesh, less than 10% of >50 mesh, and about 20-30% of <80 mesh;

[0078] S5: Mix particles A and B with magnesium stearate to obtain mixed particles C, which are then compressed and coated to obtain chlorpheniramine maleate tablets.

[0079] The formulation of the compound tablets containing artificial bezoar prepared in Comparative Example 1 is shown in Table 9 below:

[0080] Table 9. Raw material and excipient dosage for compound tablets containing artificial bezoar (Comparative Example 1)

[0081]

[0082] Comparative Example 2

[0083] The preparation steps and the amount of raw materials used are the same as in Example 1, with the only difference being:

[0084] The particle size distribution of artificial bezoar-chlorpheniramine maleate particles in S3 is shown in Table 10 below:

[0085] Table 10. Particle size distribution of artificial bezoar-chlorpheniramine maleate particles in Comparative Example 2.

[0086] granularity Proportion Particle size > 50 mesh 4.13％ Particle size 50-65 mesh 11.52％ Particle size 65-80 mesh 13.61％ Particle size 80-100 mesh 20.32％ Particle size 100-120 mesh 26.58％ Particle size 120-150 mesh 10.49％ Particle size 150-200 mesh 7.60％ Particle size <200 mesh 5.75％

[0087] Comparative Example 3

[0088] The preparation steps and the amount of raw materials used are the same as in Example 1, with the only difference being:

[0089] In S3, the particle size of the artificial bezoar-chlorpheniramine maleate granules is 80-100 mesh.

[0090] 1. Dissolution test

[0091] To further demonstrate the superiority of the present invention, the dissolution rate of the finished products obtained in Examples 1-5 and the comparative examples was tested, using cholic acid as an indicator to indirectly reflect the dissolution rate and dissolution curve of artificial bezoar. All experiments were repeated three times, and the specific data are shown in Table 11 below:

[0092] Table 11 Dissolution test results

[0093]

[0094]

[0095] From Table 11 and Figure 1 As can be seen, the preparation process and formulation provided by this invention can greatly improve the dissolution rate of artificial bezoar. The average dissolution rate of Example 1 reached 82.6% within 45 minutes, and Examples 2-5 also showed high dissolution rates, while the average dissolution rate of Comparative Example 1 was only 68.3% within 45 minutes. The dissolution rates of artificial bezoar in the examples were much higher than those in the comparative examples, indicating that the preparation process, particle distribution, and proportion of raw and auxiliary materials used in this application can ensure the dissolution rate of artificial bezoar per unit time.

[0096] Comparative Examples 2 and 3 altered the particle size distribution of the artificial bezoar-chlorpheniramine maleate granules. The particle size distribution of Comparative Example 2 did not conform to the limitations of this application, resulting in a decrease in the dissolution rate of artificial bezoar. Comparative Example 3, on the other hand, used a process with uniform particle size, and the average dissolution rate of artificial bezoar was only 78.0%, which was lower than that of Comparative Example 2. Furthermore, it was prone to tablet cracking. This may be because the overly uniform particle size exacerbated the elastic recovery during tableting, leading to tablet cracking. This further illustrates that the particle size distribution of the artificial bezoar-chlorpheniramine maleate granules as defined in this application plays a crucial role in the dissolution rate of artificial bezoar and can greatly improve the dissolution rate of artificial bezoar.

[0097] 2. Stability test

[0098] To further demonstrate the superiority of the present invention, stability tests were conducted on the finished products obtained in Examples 1-3 and Comparative Examples 1-3 of the present invention. The levels of the three raw materials in the tablets—diclofenac sodium, chlorpheniramine maleate, and artificial bezoar—were measured at 0 months, 1 month, 2 months, 3 months, and 6 months during the storage period. Specifically, the levels of diclofenac sodium, chlorpheniramine maleate, and artificial bezoar were determined to be 90.0%–110.0% of the labeled amount. The bilirubin content (0.55 mg / g) was used as the detection index for artificial bezoar. Each tablet weighed approximately 0.09 g. Specific data are shown in Table 12 below.

[0099] Table 12 Stability Experiment Data

[0100]

[0101] Comparing the experimental data of Examples 1-3 and Comparative Example 1 in Table 12, it can be seen that the preparation process and formulation ratio of the present invention can significantly reduce the decrease in the content of active ingredients such as diclofenac sodium, chlorpheniramine maleate, and artificial bezoar (bilirubin) during storage, greatly improving the quality and stability of the active substances in chlorpheniramine maleate tablets. Comparative Examples 2 and 3 only changed the particle size of the artificial bezoar-chlorpheniramine maleate particles; the formulation ratio and preparation process remained unchanged. Therefore, the stability of the active ingredients was consistent with the examples, remaining at a high level.

[0102] The above are merely some embodiments of the present invention. For those skilled in the art, various modifications and improvements can be made without departing from the inventive concept of the present invention, and these all fall within the protection scope of the present invention.

Claims

1. A preparation process for a compound tablet containing artificial bezoar, characterized in that, Includes the following steps: S1: After sieving, diclofenac sodium is mixed with filler, slow-release agent and disintegrant and fed into a wet granulation machine to obtain diclofenac sodium granules; S2: Artificial bezoar, chlorpheniramine maleate, filler, and disintegrant are put into a wet granulation machine, stirred, heated, and mixed, and then a binder is sprayed in. After granulation, wet granules are obtained. S3: The wet granules are put into a dryer and dried to obtain artificial bezoar-chlorpheniramine maleate granules; wherein the particle size distribution of the artificial bezoar-chlorpheniramine maleate granules is: 5-25% of the granules have a particle size greater than 80 mesh, 60-70% of the granules have a particle size of 80-150 mesh, and 15-25% of the granules have a particle size less than 150 mesh. S4: Mix diclofenac sodium granules, artificial bezoar-chlorpheniramine maleate granules with a lubricant to obtain mixed granules; S5: Compress and coat the mixed granules to obtain compound tablets containing artificial bezoar.

2. The preparation process according to claim 1, characterized in that, In S1, the parameters of the wet granulator are: stirring paddle speed 90-110 rpm, cutting blade speed 1000-1400 rpm, and stirring time 25-40 min.

3. The preparation process according to claim 1, characterized in that, In S2, the stirring-heating-mixing step is as follows: First, stir for 1-3 minutes at a stirring paddle speed of 90-110 rpm and a cutting blade speed of 800-1200 rpm. After stirring, turn off the stirring paddle and the cutting blade, heat the material to a temperature of 65-70℃, and then turn on the stirring paddle and the cutting blade, stirring for 25-40 minutes at a stirring paddle speed of 90-110 rpm and a cutting blade speed of 800-1200 rpm.

4. The preparation process according to claim 1, characterized in that, In step S2, the parameters of the wet granulator when the adhesive is sprayed in are: stirring paddle speed 100-140 rpm, cutting blade speed 1000-1400 rpm; atomization pressure 0.04-0.06 MPa, spray flow rate 100-150 g / min, and granulation time 2-4 min.

5. The preparation process according to claim 1, characterized in that, The adhesive is selected from at least one of sodium carboxymethyl cellulose, polyvinyl ketone K30, and hydroxypropyl cellulose.

6. The preparation process according to claim 1, characterized in that, In S3, the dryer parameters are: inlet air temperature of 70-100℃, outlet air temperature of 35-65℃; drying time of 30-70 min; and drying until particle weight loss is 1.5-4.5%.

7. The preparation process according to claim 1, characterized in that, In step S4, the mixing time is 5-10 min; in step S5, the tablet is compressed until the core hardness is 4.0-9.0 kg.

8. The preparation process according to claim 1, characterized in that, The filler is selected from at least one of dicalcium phosphate, microcrystalline cellulose, dextrin, mannitol, starch, and pregelatinized starch; the slow-release agent is selected from at least one of hydroxypropyl cellulose, hydroxypropyl methylcellulose, and ethyl cellulose; the disintegrant is selected from at least one of starch, sodium carboxymethyl starch, and calcium carboxymethyl cellulose; and the lubricant is selected from at least one of magnesium stearate, calcium stearate, stearic acid, and hydrogenated vegetable oil.

9. The preparation process according to claim 8, characterized in that, The compound tablet raw material containing artificial bezoar is composed of chlorpheniramine maleate, artificial bezoar, and diclofenac sodium; wherein, the mass ratio of dicalcium phosphate to the raw material is 0.6-1.4:1, the mass ratio of hydroxypropyl methylcellulose to the raw material is 0.02-0.04:1, the mass ratio of sodium carboxymethyl starch to the raw material is 0.4-0.8:1, the mass ratio of microcrystalline cellulose to the raw material is 0.2-0.4:1, the mass ratio of mannitol to the raw material is 0.3-0.8:1, the mass ratio of the binder to the raw material is 0.006-0.012:1, and the mass ratio of magnesium stearate to the raw material is 0.02-0.04:

1.

10. A compound tablet containing artificial bezoar prepared by the preparation process according to any one of claims 1-9.

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