Compound amoxicillin powder and preparation method thereof

Abstract

The invention relates to the technical field of pharmaceutical preparations, in particular to compound amoxicillin powder and a preparation method thereof, and the preparation method comprises the following steps: S1, weighing amoxicillin, potassium clavulanate and a carrier according to a predetermined mass ratio; s2, dividing a carrier into three parts which are marked as A1, A2 and A3, and mixing the carrier A1 with a cosolvent to obtain a mixture A; then adjusting the pH value of the mixture A to obtain a mixture B; s3, amoxicillin is added into the mixture B obtained in the step S2, and a mixture C is obtained; s4, adding a surfactant into the mixture C, and stirring to obtain a mixture D; s5, weighing potassium clavulanate according to a mass ratio, and adding the potassium clavulanate into the carrier A2 to obtain a mixture E; according to the invention, by optimizing the formula and the preparation process of the compound amoxicillin powder, the solubility and the stability of the amoxicillin and the potassium clavulanate are effectively improved, so that the clinical treatment effect and the drug bioavailability of the compound amoxicillin powder are enhanced.

Description

Technical Field

[0001] The invention relates to the technical field of pharmaceutical preparations, and in particular to a compound amoxicillin powder and a preparation method thereof. Background Art

[0002] Compound amoxicillin powder is an antibiotic commonly used to treat infections caused by penicillin-sensitive bacteria and has a wide range of clinical applications. However, with the increasing bacterial resistance, the effect of single use of amoxicillin has gradually decreased. Therefore, the research and development of compound preparations has become an important way to improve the antibacterial effect. Potassium clavulanate, as a β-lactamase inhibitor, can synergize with amoxicillin to enhance its antibacterial activity. However, amoxicillin has poor water solubility and extremely low solubility in water, and potassium clavulanate itself is unstable and easily decomposed, which limits the application effect of its compound preparations.

[0003] At present, although some studies have attempted to improve the solubility and stability of compound amoxicillin by using cosolvents, surfactants and other formulations, the physicochemical properties of amoxicillin and potassium clavulanate make it difficult to effectively exert the synergistic effects of these ingredients during the preparation process; in addition, in existing compound preparations, how to enhance the water solubility of the drug, improve its stability and ensure its long-term preservation while ensuring its efficacy remains a technical challenge. Summary of the invention

[0004] Based on the above purpose, the present invention provides a compound amoxicillin powder and a preparation method thereof.

[0005] A compound amoxicillin powder comprises amoxicillin, potassium clavulanate, a carrier, a cosolvent, a pH regulator, a surfactant, a inclusion agent and an antioxidant; wherein the components are as follows in terms of mass percentage: Amoxicillin accounts for 20% to 40%; Potassium clavulanate accounts for 3% to 10%; The proportion of carriers ranged from 36% to 73.9%; The proportion of co-solvent is 1% to 3%; The pH value regulator accounts for 0.1% to 2%; The surfactant accounts for 0.5% to 2%; The inclusion agent accounts for 1% to 5%; Antioxidants account for 0.5% to 2%.

[0006] Optionally, the carrier is selected from lactose or sucrose; the cosolvent is selected from polyethylene glycol, propylene glycol or glycerol; the pH regulator is selected from sodium hydroxide, sodium carbonate or triethanolamine; the surfactant is selected from Tween-80, Poloxamer 188 or Span80; the inclusion agent is selected from α-cyclodextrin, β-cyclodextrin or γ-cyclodextrin; the antioxidant is selected from ascorbyl palmitate, vitamin E or BHT.

[0007] A method for preparing compound amoxicillin powder comprises the following steps: S1: weigh amoxicillin, potassium clavulanate and a carrier according to a predetermined mass ratio, and sieve them separately for later use; S2: Divide the carrier into three parts, denoted as A1, A2 and A3, with a ratio of 4:3:3, and mix the A1 carrier with the co-solvent, and stir evenly until completely dissolved to obtain a mixture A; then add a pH adjuster to adjust the pH value of the mixture A to 8-9 to obtain a mixture B; S3: adding amoxicillin to the mixture B obtained in S2, and mixing them evenly by stirring to obtain a mixture C; S4: weighing the surfactant according to the mass ratio and adding it to the mixture C obtained in S3, stirring thoroughly until the surfactant is completely dispersed, to obtain a mixture D; S5: Weigh potassium clavulanate according to the mass ratio, add it to the carrier A2, and stir evenly until the potassium clavulanate is completely dispersed to obtain a mixture E; S6: weigh the inclusion agent and the antioxidant, add them to the mixture E, and stir evenly to obtain a mixture F; S7: combining the mixture D obtained in S4 and the mixture F obtained in S6, and stirring them thoroughly to obtain a mixture G; S8: Mixing the mixture G with the carrier A3, and drying to remove excess solvent, to finally obtain a finished compound amoxicillin powder.

[0008] Optionally, the S1 specifically includes: The S1 specifically includes: S11: feeding the weighed amoxicillin, potassium clavulanate and carrier into a pulverizer for pulverization; S12: Screen the crushed material, and set the screen aperture to 80-150 meshes to remove overly coarse or overly fine particles to ensure the required particle size is uniform; S13: Collect the sieved materials separately and set them aside.

[0009] Optionally, the S3 specifically includes: S31: adding the sieved amoxicillin to mixture B; S32: using a stirring device for mixing, the stirring speed is set to 300-500 rpm, and the stirring time is 10-15 minutes; S33: During the stirring process, the room temperature is maintained to ensure the homogeneity of the mixture.

[0010] Optionally, the S4 specifically includes: S41: adding the weighed surfactant to mixture C; S42: Mixing by using a stirring device, with the stirring speed set to 500-700 rpm and the stirring time being 15-20 minutes to obtain a mixture D; S43: During the stirring process, maintain room temperature.

[0011] Optionally, the S5 specifically includes: S51: adding the weighed potassium clavulanate to the carrier A2, ensuring that the potassium clavulanate completely covers the surface of the carrier; S52: uniformly mix the mixture using a stirring device, with the stirring speed set to 400-600 rpm and the stirring time set to 10-15 minutes to obtain a mixture E.

[0012] Optionally, the S6 specifically includes: S61: adding the inclusion agent and the antioxidant to the mixture E; S62: Use a stirring device to mix uniformly, set the stirring speed to 300-500 rpm, and stir for 10-15 minutes to ensure that the inclusion agent and the antioxidant are completely dispersed in the mixture E to obtain a mixture F.

[0013] Optionally, the S7 specifically includes: S71: combining the mixture D obtained in S4 and the mixture F obtained in S6 according to a predetermined mass ratio; S72: using a stirring device to combine and stir, the stirring speed is set to 400 to 600 rpm, and the stirring time is 15 to 20 minutes to obtain a mixture G; S73: During the stirring process, maintain room temperature to ensure uniform mixing.

[0014] Optionally, the S8 specifically includes: S81: Mix the mixture G obtained in S7 with the A3 carrier, and use a stirring device to evenly mix the mixture G and the A3 carrier, with the stirring speed set to 300 to 500 rpm and the stirring time being 10 to 15 minutes; S82: sending the mixture of mixture G and carrier A3 into a preset drying device, setting the drying temperature to 50-70° C. and the drying time to 30-60 minutes; S83: Excess solvent is removed through a drying process to obtain a finished compound amoxicillin powder, wherein the moisture content of the powder is controlled below 2%.

[0015] Beneficial effects of the present invention: The invention overcomes the technical difficulties of poor solubility and instability of amoxicillin and potassium clavulanate in water by rationally proportioning amoxicillin, potassium clavulanate and other auxiliary components, and significantly improves the solubility and stability of amoxicillin by adopting a specific carrier and adding components such as a surfactant, a cosolvent, and a complexing agent.

[0016] The invention ensures the long-term stability of the compound amoxicillin powder during storage and use through precise formula design and innovative preparation process, avoids the degradation of potassium clavulanate, and prolongs the effective period of the drug. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] In order to more clearly illustrate the technical solutions in the present invention or the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings in the following description are only for the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0018] Figure 1 A schematic diagram of the components of the compound amoxicillin powder according to an embodiment of the present invention; Figure 2 The present invention is a schematic diagram of a method for preparing amoxicillin compound powder according to an embodiment of the present invention. DETAILED DESCRIPTION

[0019] The present invention is described in detail below in conjunction with the accompanying drawings and specific embodiments. At the same time, it is explained here that in order to make the embodiments more detailed, the following embodiments are the best and preferred embodiments, and those skilled in the art may also adopt other alternatives to implement some known technologies; and the accompanying drawings are only for more specific description of the embodiments, and are not intended to specifically limit the present invention.

[0020] It should be noted that the references to "one embodiment", "embodiment", "exemplary embodiments", "some embodiments" and the like in the specification indicate that the embodiments described may include specific features, structures or characteristics, but not every embodiment may include the specific features, structures or characteristics. In addition, when a specific feature, structure or characteristic is described in conjunction with an embodiment, it should be within the knowledge of a person skilled in the art to implement such feature, structure or characteristic in conjunction with other embodiments (whether or not explicitly described).

[0021] In general, a term can be understood, at least in part, from its use in context. For example, depending, at least in part, on the context, the term "one or more" as used herein can be used to describe any feature, structure, or characteristic in the singular sense, or can be used to describe a combination of features, structures, or characteristics in the plural sense. Additionally, the term "based on" can be understood as not necessarily intended to convey an exclusive set of factors, but can instead, depending, at least in part, on the context, allow for the presence of other factors that are not necessarily explicitly described.

[0022] Example 1 like Figure 1 As shown, a compound amoxicillin powder comprises amoxicillin, potassium clavulanate, a carrier, a cosolvent, a pH regulator, a surfactant, a inclusion agent and an antioxidant; wherein the mass percentage of each component is: Amoxicillin accounts for 30%; Potassium clavulanate accounts for 5%; The carrier accounts for 56.5%; The proportion of co-solvent is 2%; pH adjusters account for 1%; Surfactants account for 1.5%; The inclusion agent accounts for 3%; Antioxidants account for 1%.

[0023] The carrier is selected from lactose; the cosolvent is selected from propylene glycol; the pH value regulator is selected from sodium carbonate; the surfactant is selected from Poloxamer 188; the inclusion agent is selected from β-cyclodextrin; and the antioxidant is selected from vitamin E.

[0024] like Figure 2 As shown, a method for preparing compound amoxicillin powder comprises the following steps: S1: weigh amoxicillin, potassium clavulanate and a carrier according to a predetermined mass ratio, and sieve them separately for later use; S2: Divide the carrier into three parts, denoted as A1, A2 and A3, with a ratio of 4:3:3, and mix the A1 carrier with the co-solvent, and stir evenly until completely dissolved to obtain a mixture A; then add a pH adjuster to adjust the pH value of the mixture A to 8.5 to obtain a mixture B; S3: adding amoxicillin to the mixture B obtained in S2, and mixing them evenly by stirring to obtain a mixture C; S4: weighing the surfactant according to the mass ratio and adding it to the mixture C obtained in S3, stirring thoroughly until the surfactant is completely dispersed, to obtain a mixture D; S5: Weigh potassium clavulanate according to the mass ratio, add it to the carrier A2, and stir evenly until the potassium clavulanate is completely dispersed to obtain a mixture E; S6: Weigh the inclusion agent and antioxidant, add them to the mixture E, and stir evenly to ensure that the inclusion agent and antioxidant can effectively wrap amoxicillin and potassium clavulanate to achieve the purpose of enhancing stability, thereby obtaining a mixture F; S7: combining the mixture D obtained in S4 and the mixture F obtained in S6, and stirring them thoroughly to obtain a mixture G; S8: Mixing the mixture G with the carrier A3, and drying to remove excess solvent, to finally obtain a finished compound amoxicillin powder.

[0025] S1 specifically includes: S11: feeding the weighed amoxicillin, potassium clavulanate and carrier into a pulverizer for pulverization; S12: Screen the crushed material, and set the screen aperture to 100 mesh to remove overly coarse or overly fine particles to ensure the required particle size is uniform; S13: Collect the sieved materials separately and set them aside.

[0026] S3 specifically includes: S31: adding the sieved amoxicillin to mixture B; S32: Mixing is performed using a stirring device, with the stirring speed set to 400 rpm and the stirring time being 12 minutes; S33: During the stirring process, the room temperature is maintained to ensure the homogeneity of the mixture.

[0027] S4 specifically includes: S41: adding the weighed surfactant to mixture C; S42: Mixing with a stirring device, the stirring speed is set to 600 rpm, the stirring time is 18 minutes, and the surfactant is ensured to be completely dispersed to obtain a mixture D; S43: During the stirring process, maintain room temperature.

[0028] S5 specifically includes: S51: adding the weighed potassium clavulanate to the carrier A2, ensuring that the potassium clavulanate completely covers the surface of the carrier; S52: uniformly mix the mixture using a stirring device, with the stirring speed set to 500 rpm and the stirring time being 13 minutes to obtain a mixture E.

[0029] S6 specifically includes: S61: adding the inclusion agent and the antioxidant to the mixture E; S62: A stirring device is used for uniform mixing, the stirring speed is set to 400 rpm, and the stirring time is 13 minutes to ensure that the inclusion agent and the antioxidant are completely dispersed in the mixture E to obtain a mixture F.

[0030] S7 specifically includes: S71: combining the mixture D obtained in S4 and the mixture F obtained in S6 according to a predetermined mass ratio; S72: using a stirring device to combine and stir, the stirring speed is set to 500 rpm, the stirring time is 18 minutes, and a mixture G is obtained; S73: During the stirring process, maintain room temperature to ensure uniform mixing.

[0031] S8 specifically includes: S81: Mix the mixture G obtained in S7 with the A3 carrier, and use a stirring device to evenly mix the mixture G and the A3 carrier, the stirring speed is set to 400 rpm, and the stirring time is 12 minutes; S82: sending the mixture of mixture G and carrier A3 into a preset drying device, setting the spray drying temperature to 60° C., the spray pressure to 0.4 MPa, and the drying time to 45 minutes; S83: Excess solvent is removed through a drying process to obtain a finished compound amoxicillin powder, wherein the moisture content of the powder is controlled below 2%.

[0032] Example 2 The proportion of each component: amoxicillin 20%; potassium clavulanate 3%; carrier (sucrose) 73.9%; cosolvent (polyethylene glycol) 1%; pH adjuster (sodium hydroxide) 0.1%; surfactant (Tween-80) 0.5%; inclusion agent (α-cyclodextrin) 1%; antioxidant (ascorbyl palmitate) 0.5%; Preparation steps: S1: The weighed amoxicillin, potassium clavulanate and carrier are respectively fed into a pulverizer for pulverization, and the pulverized materials are screened, with the sieve aperture set to 80 meshes to remove particles that do not meet the particle size requirements to ensure uniformity of the materials; S2: Divide lactose into three parts, A1, A2 and A3, with a ratio of 4:3:3; mix the A1 carrier with the cosolvent, and stir evenly until completely dissolved to obtain a mixture A; add a pH adjuster and adjust the pH to 8 to obtain a mixture B; S3: adding the crushed amoxicillin to the mixture B, stirring with a stirring device, setting the stirring speed to 300 rpm, and stirring for 10 minutes to ensure uniform mixing; S4: adding the surfactant to the mixture C, setting the stirring speed to 500 rpm, and stirring for 15 minutes until the surfactant is completely dispersed to obtain a mixture D; S5: adding potassium clavulanate to lactose A2, setting the stirring speed to 400 rpm, and stirring for 10 minutes to obtain a mixture E; S6: adding the inclusion agent and the antioxidant to the mixture E, setting the stirring speed to 300 rpm and the stirring time to 10 minutes to obtain a mixture F; S7: Mixture D and mixture F are combined according to a predetermined mass ratio, the stirring speed is set to 400 rpm, and the stirring time is 15 minutes to obtain mixture G; S8: Mix the mixture G with lactose A3 and stir them evenly at a stirring speed of 300 rpm for 10 minutes; then, send the mixture into a drying device, set the spray drying temperature to 50°C, and dry for 30 minutes to finally obtain a finished compound amoxicillin powder with a moisture content controlled below 2%.

[0033] Example 3 The proportion of each component: amoxicillin 40%; potassium clavulanate 10%; carrier (lactose) 36%; cosolvent (glycerol) 3%; pH adjuster (triethanolamine) 2%; surfactant (Span 80) 2%; inclusion agent (γ-cyclodextrin) 5%; antioxidant (BHT) 2%; Preparation steps: S1: The weighed amoxicillin, potassium clavulanate and carrier are respectively fed into a pulverizer for pulverization, and the pulverized materials are screened, with the sieve aperture set to 150 meshes to remove particles that do not meet the particle size requirements to ensure uniformity of the materials; S2: Divide lactose into three parts, A1, A2 and A3, with a ratio of 4:3:3; mix the A1 carrier with the cosolvent, and stir evenly until completely dissolved to obtain a mixture A; add a pH adjuster and adjust the pH to 9 to obtain a mixture B; S3: adding the crushed amoxicillin to the mixture B, stirring with a stirring device, setting the stirring speed to 500 rpm, and stirring for 15 minutes to ensure uniform mixing; S4: adding the surfactant to the mixture C, setting the stirring speed to 700 rpm for 20 minutes, until the surfactant is completely dispersed, to obtain a mixture D; S5: adding potassium clavulanate to lactose A2, setting the stirring speed to 600 rpm, and stirring for 15 minutes to obtain a mixture E; S6: adding the inclusion agent and the antioxidant to the mixture E, setting the stirring speed to 500 rpm and the stirring time to 15 minutes to obtain a mixture F; S7: Mixture D and mixture F are combined according to a predetermined mass ratio, the stirring speed is set to 600 rpm, and the stirring time is 20 minutes to obtain mixture G; S8: Mix the mixture G with lactose A3 and stir them evenly at a stirring speed of 500 rpm for 15 minutes; then, send the mixture into a drying device, set the spray drying temperature to 70°C, and dry for 60 minutes to finally obtain a finished compound amoxicillin powder with a moisture content controlled below 2%.

[0034] Table 1 Comparison of finished product performance parameters As can be seen from Table 1 above, Example 1 has the highest solubility, which is much higher than conventional untreated amoxicillin powder; the improvement of solubility contributes to better absorption and effect of the drug; Example 1 has the smallest particle size distribution, and compared with Examples 2 and 3, the particles are finer, which helps to improve the bioavailability and solubility of the drug; the stability of Example 1 is 180 days, which is significantly better than conventional untreated amoxicillin powder (30 days); good stability means that the drug can maintain its efficacy and quality during storage; Example 1 has the highest uniformity (99%), ensuring that the drug ingredients are evenly distributed in the preparation, thereby ensuring the stability of the therapeutic effect of each dose; conventional untreated The uniformity of the amoxicillin powder of Example 1 is the lowest (85%); the finished particles of Example 1 are uniform, which contributes to the uniformity of the preparation and a better taking experience; the particles of conventional untreated amoxicillin powder are uneven in morphology, which may affect dosage consistency and absorption; the bioavailability of Example 1 is the highest (95%), which is much higher than that of conventional untreated amoxicillin powder (50%); this means that the drug of Example 1 can be more efficiently absorbed by the body and produce better therapeutic effects; the dissolution rate of Example 1 is the highest (97%), which is better than that of Example 2 (92%) and Example 3 (95%); a high dissolution rate helps to quickly reach the peak of drug efficacy and improve the therapeutic effect.

[0035] Example 1 performed best in all comparison items, especially in solubility, particle size, stability, uniformity, bioavailability and dissolution rate. Therefore, as the best example, Example 1 has better efficacy and application prospects, and its advantages are more obvious than conventional untreated amoxicillin powder.

[0036] Table 2 Comparison of other performance parameters As can be seen from Table 2 above, the particle density of Example 1 is 1.2 g / cm³, which is higher than the conventional untreated amoxicillin powder (0.9 g / cm³), which helps to improve the stability and treatment effect of the preparation; the drug release time of Example 1 is the shortest (30 minutes), which is more advantageous than Example 2 (35 minutes), Example 3 (28 minutes) and conventional untreated amoxicillin powder (50 minutes), and the release rate is moderate to ensure rapid drug efficacy; the hygroscopicity of Example 1 is the lowest (2%), which is better than the conventional untreated amoxicillin powder (5%); low hygroscopicity helps to extend the storage period of the drug; the flowability of Example 1 is good (0.8 g / s), which is better than the conventional untreated amoxicillin powder (0.5 g / s) is significantly improved, and good fluidity is conducive to better processing and packaging in the production process; the storage stability of Example 1 is the highest (98%), which is much higher than that of conventional untreated amoxicillin powder (80%), which means that the drug can maintain a high efficacy after long-term storage; the pharmacodynamic stability of Example 1 is good (97%), which is significantly higher than that of conventional untreated amoxicillin powder (70%); good pharmacodynamic stability helps to ensure the efficacy of long-term use; the dosage form consistency of Example 1 is the best (99%), ensuring the consistency of each dose and avoiding differences in therapeutic effects caused by dose fluctuations; the dosage form consistency of conventional untreated amoxicillin powder is poor (85%).

[0037] In general, Example 1 is superior to other examples and conventional untreated amoxicillin powder in terms of particle density, drug release time, hygroscopicity, fluidity, storage stability, efficacy stability and dosage form consistency, performs well, has good efficacy and production advantages, and is the best example.

[0038] The present invention covers any substitution, modification, equivalent method and scheme made on the essence and scope of the present invention. In order to make the public have a thorough understanding of the present invention, specific details are described in detail in the following preferred embodiments of the present invention, but those skilled in the art can fully understand the present invention without the description of these details. In addition, in order to avoid unnecessary confusion about the essence of the present invention, well-known methods, processes, procedures, components and circuits are not described in detail.

[0039] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principle of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. A compound amoxicillin powder, characterized in that: It includes amoxicillin, potassium clavulanate, a carrier, a cosolvent, a pH regulator, a surfactant, a inclusion agent and an antioxidant; wherein the mass percentage of each component is: Amoxicillin accounts for 20% to 40%; Potassium clavulanate accounts for 3% to 10%; The proportion of carriers ranged from 36% to 73.9%; The proportion of co-solvent is 1% to 3%; The pH value regulator accounts for 0.1% to 2%; Surfactants account for 0.5% to 2%; The inclusion agent accounts for 1% to 5%; Antioxidants account for 0.5% to 2%.

2. A compound amoxicillin powder according to claim 1, characterized in that: The carrier is selected from lactose or sucrose; the cosolvent is selected from polyethylene glycol, propylene glycol or glycerol; the pH regulator is selected from sodium hydroxide, sodium carbonate or triethanolamine; the surfactant is selected from Tween-80, Poloxamer 188 or Span 80; the inclusion agent is selected from α-cyclodextrin, β-cyclodextrin or γ-cyclodextrin; and the antioxidant is selected from ascorbyl palmitate, vitamin E or BHT.

3. The method for preparing a compound amoxicillin powder according to claim 1, characterized in that: The following steps are involved: S1: weigh amoxicillin, potassium clavulanate and a carrier according to a predetermined mass ratio, and sieve them separately for later use; S2: Divide the carrier into three parts, denoted as A1, A2 and A3, with a ratio of 4:3:3, and mix the A1 carrier with the co-solvent, and stir evenly until completely dissolved to obtain a mixture A; then add a pH adjuster to adjust the pH value of the mixture A to 8-9 to obtain a mixture B; S3: adding amoxicillin to the mixture B obtained in S2, and mixing them evenly by stirring to obtain a mixture C; S4: weighing the surfactant according to the mass ratio and adding it to the mixture C obtained in S3, stirring thoroughly until the surfactant is completely dispersed, to obtain a mixture D; S5: Weigh potassium clavulanate according to the mass ratio, add it to the carrier A2, and stir evenly until the potassium clavulanate is completely dispersed to obtain a mixture E; S6: weigh the inclusion agent and the antioxidant, add them to the mixture E, and stir evenly to obtain a mixture F; S7: combining the mixture D obtained in S4 and the mixture F obtained in S6, and stirring them thoroughly to obtain a mixture G; S8: Mixing the mixture G with the carrier A3, and drying to remove excess solvent, to finally obtain a finished compound amoxicillin powder.

4. The method for preparing a compound amoxicillin powder according to claim 1, characterized in that: The S1 specifically includes: S11: feeding the weighed amoxicillin, potassium clavulanate and carrier into a pulverizer for pulverization; S12: Screen the crushed material, and set the screen aperture to 80-150 meshes to remove overly coarse or overly fine particles to ensure the required particle size is uniform; S13: Collect the sieved materials separately and set them aside.

5. The method for preparing a compound amoxicillin powder according to claim 1, characterized in that: The S3 specifically includes: S31: adding the sieved amoxicillin to mixture B; S32: using a stirring device for mixing, the stirring speed is set to 300-500 rpm, and the stirring time is 10-15 minutes; S33: During the stirring process, the room temperature is maintained to ensure the homogeneity of the mixture.

6. The method for preparing a compound amoxicillin powder according to claim 1, characterized in that: The S4 specifically includes: S41: adding the weighed surfactant to mixture C; S42: Mixing by using a stirring device, with the stirring speed set to 500-700 rpm and the stirring time being 15-20 minutes to obtain a mixture D; S43: During the stirring process, maintain room temperature.

7. The method for preparing a compound amoxicillin powder according to claim 1, characterized in that: The S5 specifically includes: S51: adding the weighed potassium clavulanate to the carrier A2, ensuring that the potassium clavulanate completely covers the surface of the carrier; S52: uniformly mix the mixture using a stirring device, with the stirring speed set to 400-600 rpm and the stirring time set to 10-15 minutes to obtain a mixture E.

8. The method for preparing a compound amoxicillin powder according to claim 1, characterized in that: The S6 specifically includes: S61: adding the inclusion agent and the antioxidant to the mixture E; S62: Use a stirring device to mix uniformly, set the stirring speed to 300-500 rpm, and stir for 10-15 minutes to ensure that the inclusion agent and the antioxidant are completely dispersed in the mixture E to obtain a mixture F.

9. The method for preparing a compound amoxicillin powder according to claim 1, characterized in that: The S7 specifically includes: S71: combining the mixture D obtained in S4 and the mixture F obtained in S6 according to a predetermined mass ratio; S72: using a stirring device to combine and stir, the stirring speed is set to 400 to 600 rpm, and the stirring time is 15 to 20 minutes to obtain a mixture G; S73: During the stirring process, maintain room temperature to ensure uniform mixing.

10. The method for preparing a compound amoxicillin powder according to claim 1, characterized in that: The S8 specifically includes: S81: Mix the mixture G obtained in S7 with the A3 carrier, and use a stirring device to evenly mix the mixture G and the A3 carrier, with the stirring speed set to 300 to 500 rpm and the stirring time being 10 to 15 minutes; S82: sending the mixture of mixture G and carrier A3 into a preset drying device, setting the drying temperature to 50-70° C. and the drying time to 30-60 minutes; S83: Excess solvent is removed through a drying process to obtain a finished compound amoxicillin powder, wherein the moisture content of the powder is controlled below 2%.

Images