Febuxostat solid dispersion tablet as well as preparation method and application thereof
Febuxostat solid dispersion tablets were prepared by combining sucrose stearate and pullulan as a carrier, which solved the problems of slow dissolution and easy crystallization of febuxostat during storage, achieving high dissolution and long-term stability, and significantly improving clinical efficacy.
Patent Information
- Application Number
- CN202511741577.2
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-11-25
- Publication Date
- 2026-01-16
AI Technical Summary
In the prior art, febuxostat drugs have slow dissolution rates and poor bioavailability due to their extremely low water solubility. Furthermore, traditional carriers such as PVP and HPMC have problems with hygroscopicity and insufficient glass transition temperature during storage, making it difficult to improve both dissolution rate and physical stability at the same time.
Febuxostat solid dispersions were prepared by using a combination of sucrose stearate and pullulan as a carrier via solvent extraction or hot melt extrusion. The wetting and solubilizing effects of sucrose stearate and the high glass transition temperature of pullulan formed a stable polymer backbone, which together improved the drug's dissolution rate and long-term stability.
It significantly improves the dissolution rate and bioavailability of febuxostat tablets, with an in vitro dissolution rate of over 85% and a relative bioavailability of up to 160%. It is also rapidly absorbed in vivo and effectively inhibits drug recrystallization during storage, maintaining long-term stability.
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Figure CN121337746A_ABST
Abstract
Description
TECHNICAL FIELD
[0001] The application belongs to the technical field of pharmaceutical preparations, and particularly relates to a solid dispersion tablet of Febuxostat and a preparation method and application thereof. BACKGROUND
[0002] Febuxostat is a new non-purine selective xanthine oxidase inhibitor, which is widely used in the treatment of gout and hyperuricemia. However, the drug belongs to the biological pharmaceutical classification system (BCS) II drug, and its extremely low water solubility seriously limits its dissolution rate in the gastrointestinal tract, resulting in poor oral bioavailability. This inherent property becomes a key bottleneck restricting the development of its preparation and clinical efficacy.
[0003] The solid dispersion technology is one of the effective strategies for improving the dissolution and bioavailability of poorly soluble drugs. By dispersing the drug in a hydrophilic carrier, the physical state of the drug is changed (such as forming an amorphous state), so as to increase the specific surface area and wettability, thereby achieving the purpose of accelerating dissolution. At present, the commonly used solid dispersion carriers include polyvinylpyrrolidone (PVP), hydroxypropyl methyl cellulose (HPMC) and the like. However, these traditional carriers still have many limitations in practical application. For example, PVP has strong hygroscopicity, which is easy to absorb moisture during storage, resulting in drug recrystallization and preparation aging; and the glass transition temperature (Tg) of the cellulose carrier such as HPMC is relatively limited, and the support ability for the physical stability of amorphous drugs is insufficient. Therefore, developing a new type of solid dispersion carrier system that can simultaneously achieve high dissolution and excellent physical stability is still a technical problem to be solved in the field.
[0004] Sucrose stearate, as a safe, non-toxic, amphiphilic non-ionic surfactant, has been used as a solubilizer and wetting agent for pharmaceutical preparations. It has a certain carrier function, but studies have shown that when used alone, it has weak ability to inhibit the recrystallization of amorphous drugs during storage, and it is difficult to ensure the long-term stability of the solid dispersion.
[0005] Pullulan is a natural water-soluble linear polysaccharide produced by microbial fermentation, which is connected by maltotriose through α-1, 6-glycosidic bond, and has good film-forming property, water solubility and extremely high glass transition temperature (Tg), which makes it theoretically an ideal candidate material for stabilizing amorphous drugs. However, in the prior art, there are few systematic reports and successful precedents about the application of pullulan as a main carrier in the solid dispersion of poorly soluble drugs, especially for solving the dissolution and stability coordination problem of highly hydrophobic drugs such as Febuxostat.
[0006] Therefore, there is an urgent need in the art for a brand new formulation of febuxostat that can significantly improve the dissolution rate and extent of the drug without introducing the defects of the traditional carriers mentioned above, and fundamentally inhibit the recrystallization tendency of the drug during preparation and storage, so as to ensure the high bioavailability and excellent long-term stability of the formulation. SUMMARY
[0007] In view of the deficiencies of the prior art, the present application provides a febuxostat solid dispersion tablet and a preparation method and application thereof. Sucrose stearate and pullulan are combined, and the two have a significant synergistic effect on inhibiting the crystallization of febuxostat and stabilizing the amorphous form. The prepared solid dispersion not only has excellent dissolution performance, but also has long-term stability far superior to that of a solid dispersion using a single carrier. The present application successfully solves the two technical problems of "low dissolution" and "easy crystallization during storage" of febuxostat tablets at the same time through a unique combination of excipients, significantly improves the therapeutic effect, ensures the long-term stability of the product, and has excellent industrialization prospects.
[0008] The present application is realized by the following technical solutions:
[0009] A febuxostat solid dispersion tablet, comprising a febuxostat solid dispersion and a pharmaceutically acceptable excipient; the febuxostat solid dispersion is composed of an active ingredient febuxostat and sucrose stearate and pullulan; the mass ratio of the febuxostat, sucrose stearate and pullulan is 1:(0.5-2):(0.5-2).
[0010] Preferably, the mass ratio of the febuxostat, sucrose stearate and pullulan is 1:1:1.
[0011] Preferably, the excipient comprises a filler, a disintegrant and a lubricant; the filler is one or more of microcrystalline cellulose, lactose and mannitol; the disintegrant is one or more of crospovidone, croscarmellose sodium and low-substituted hydroxypropyl cellulose; and the lubricant is magnesium stearate or micro-powder silica.
[0012] Preferably, by weight, it comprises: 100-140 parts of febuxostat solid dispersion, 200-300 parts of filler, 8-12 parts of disintegrant, and 1-5 parts of lubricant.
[0013] Preferably, the specification of the solid dispersion tablet is 20 mg, 40 mg or 80 mg.
[0014] The preparation method of the above-mentioned febuxostat solid dispersion tablet comprises the following steps:
[0015] Step 1) preparing a solid dispersion of febuxostat, sucrose stearate and pullulan by a solvent method or a hot melt extrusion method;
[0016] Step 2) crushing and sieving the solid dispersion prepared in Step 1) to obtain solid dispersion granules;
[0017] Step 3) mixing the solid dispersion granules prepared in Step 2) with pharmaceutically acceptable excipients, and then directly compressing or granulating by dry method to obtain the tablet.
[0018] Preferably, in Step 1),
[0019] When the solvent method is used, the solvent is water, ethanol or aqueous ethanol, and the amount of solvent is sufficient to dissolve or highly disperse the raw materials, and the solvent is removed by rotary evaporation or spray drying;
[0020] When the hot melt extrusion method is used, the process parameters are as follows: the temperature of the feeding section is 100-130℃, the temperature of the melting section is 120-150℃, the temperature of the die is 130-150℃, and the screw rotation speed is 150-350 rpm.
[0021] Preferably, in Step 2), the sieving is through a 40-80 mesh sieve.
[0022] Preferably, in Step 3), the hardness of the tablet is 60-100 N.
[0023] The above-mentioned febuxostat solid dispersion tablet is used for preparing a medicine for treating gout or hyperuricemia.
[0024] The beneficial effects of the present application are as follows:
[0025] (1) The present application creatively combines sucrose stearate with good amphiphilicity and pullulan with good film-forming property and high glass transition temperature (Tg), and the two components produce an unexpected synergistic effect in the solid dispersion. Sucrose stearate provides excellent wetting and solubilizing effects, while pullulan forms a stable high-molecular skeleton, and the two components work together to highly disperse febuxostat in an amorphous state, greatly improving the dissolution rate and degree of the drug. In vitro dissolution test shows that the dissolution of the tablet of the present application can exceed 85% within 15 min. More importantly, the relative bioavailability of the tablet of the present application is as high as 160% or more than that of the reference preparation (commercially available febuxostat tablet Fibur ® ) and the time to peak (T max ) is significantly shortened, which indicates that the drug can be absorbed more quickly and fully in the body, thereby achieving better clinical efficacy.
[0026] (2) This invention has significant advantages over traditional solid dispersion technology, particularly in its superior physical stability and ability to effectively inhibit drug recrystallization. Pullulan's high Tg provides a robust rigid framework for amorphous drugs, effectively limiting drug molecule movement; while the molecular-level dispersion of sucrose stearate further hinders drug molecule migration and aggregation. The synergistic effect of both fundamentally solves the problem of physical instability of amorphous drugs during storage. Accelerated stability testing (40℃ / 75%RH, 3 months) fully demonstrates this: the dissolution retention rate of the tablets of this invention is over 97.5%, and no drug crystallization peaks appear in the X-ray powder diffraction (XRD) pattern. In contrast, the comparative tablets prepared using the traditional carrier PVP showed significant recrystallization under the same conditions, with a dissolution retention rate of only 90.3%. This comparison highlights the significant advantage of this invention in ensuring product shelf-life quality.
[0027] (3) The preparation methods provided by this invention, whether solvent method or hot melt extrusion method, are mature, stable and easy-to-scale formulation technologies. The process steps are simple, the key parameters are clear, and the reproducibility is good, making them very suitable for large-scale industrial production and possessing extremely high industrial transformation value.
[0028] (4) The core carriers selected in this invention—sucrose stearate and pullulan polysaccharide—are both recognized as GRAS pharmaceutical excipients. They are non-toxic, non-irritating, stable, and odorless, which significantly improves the safety of medication and improves patient compliance. Attached Figure Description
[0029] Figure 1 This is a comparison chart of the dissolution curves in the pH 6.8 medium of Test Example 1. Detailed Implementation
[0030] The present invention will now be described in further detail with reference to the accompanying drawings and specific embodiments.
[0031] Unless otherwise specified, the technical means used in the following embodiments are all conventional means well known to those skilled in the art, and the experimental methods without specific conditions are all conventional methods in the art.
[0032] Unless otherwise specified, all materials and reagents used in the following examples are commercially available.
[0033] A method for preparing febuxostat solid dispersion tablets, comprising the following specific steps:
[0034] (1) Febuxostat, sucrose stearate and pullulan are prepared into solid dispersions by solvent method or hot melt extrusion method.
[0035] The mass ratio of febuxostat, sucrose stearate and pullulan is 1:(0.5~2):(0.5~2), preferably 1:1:1.
[0036] When the solvent method is used, the solvent is water, ethanol, or an aqueous solution of ethanol. The amount of solvent used is sufficient to fully dissolve or highly disperse the raw material, and the solvent is removed by rotary evaporation or spray drying.
[0037] When using the hot melt extrusion method, the process parameters are: feeding section temperature 100~130℃, melting section temperature 120~150℃, die head temperature 130~150℃, and screw speed 150~350 rpm.
[0038] (2) The obtained solid dispersion is crushed and sieved to obtain solid dispersion particles.
[0039] (3) Mix the obtained solid dispersion powder with filler and disintegrant evenly to obtain a mixture.
[0040] The filler is one or more of microcrystalline cellulose, lactose, or mannitol.
[0041] The disintegrant is one or more of crospovidone, crospovidone sodium carboxymethyl cellulose, or low-substituted hydroxypropyl cellulose.
[0042] (4) Add lubricant to the mixture, mix and then directly compress into tablets, or perform dry granulation, granulation and then compress into tablets to obtain the final product.
[0043] The lubricant is magnesium stearate or micronized silica gel.
[0044] The prepared solid dispersion tablets are available in strengths of 20 mg, 40 mg, or 80 mg.
[0045] Example 1: Preparation of febuxostat solid dispersion (solvent method - rotary evaporation, preferred ratio)
[0046] A febuxostat solid dispersion, the composition of which is shown in Table 1, is prepared using the following process:
[0047] Febuxostat, sucrose stearate, and pullulan were dissolved in a 70% aqueous ethanol solution, and the solvent was removed using a rotary evaporator (water bath, 50°C). After vacuum drying, the mixture was pulverized through an 80-mesh sieve to obtain a solid dispersion powder.
[0048] Table 1. Formulation of febuxostat solid dispersions
[0049]
[0050] Example 2: Preparation of Febuxostat solid dispersion tablets (direct compression method)
[0051] A febuxostat solid dispersion tablet, the composition of which is shown in Table 2, is prepared using the following process:
[0052] Mix the solid dispersion powder obtained in Example 1, microcrystalline cellulose, lactose, and croscarmellose sodium for 15 min. Add magnesium stearate and mix for another 3 min. Compress the mixture using a single-punch tablet press, controlling the tablet hardness to 70-100 N.
[0053] Table 2. Ingredients of Febuxostat solid dispersion tablets (1000 tablets, each containing 40 mg of febuxostat)
[0054]
[0055] Example 3 Preparation of Febuxostat solid dispersion tablets (dry granulation followed by tableting)
[0056] A febuxostat solid dispersion tablet, the composition of which is shown in Table 2, is prepared using the following process:
[0057] The solid dispersion powder obtained in Example 1 was mixed with microcrystalline cellulose, lactose, and croscarmellose sodium, and then rolled, crushed, and granulated using a dry granulation machine. The resulting granules were then mixed with magnesium stearate and compressed into tablets, with the tablet hardness controlled at 60-100 N.
[0058] Example 4: Preparation of Febuxostat solid dispersion tablets (high proportion of pullulan).
[0059] A febuxostat solid dispersion tablet, the composition of which is shown in Table 2, is prepared using the same process as in Example 2. The difference is that a high proportion of pullulan is used to prepare the febuxostat solid dispersion (powder), the specific composition of which is shown in Table 3.
[0060] Table 3. Formulation of Febuxostat solid dispersions
[0061]
[0062] Example 5: Preparation of Febuxostat solid dispersion tablets (high proportion of sucrose stearate)
[0063] A febuxostat solid dispersion tablet, the composition of which is shown in Table 2, is prepared using the same process as in Example 2. The difference is that a high proportion of sucrose stearate is used to prepare the febuxostat solid dispersion (powder), the specific composition of which is shown in Table 4.
[0064] Table 4. Formulation of Febuxostat solid dispersions
[0065]
[0066] Example 6 Preparation of Febuxostat solid dispersion tablets (hot melt extrusion method)
[0067] A febuxostat solid dispersion tablet, the composition of which is shown in Tables 1 and 2, is prepared using the same process as in Example 2. The difference lies in that the febuxostat solid dispersion (powder) is prepared using a hot melt extrusion method, as detailed below:
[0068] Febuxostat, sucrose stearate and pullulan were physically mixed and then used to prepare solid dispersion strips using a twin-screw hot melt extruder (temperature settings: zone I 105℃, zone II 125℃, zone III 135℃, die head 130℃; screw speed 250 rpm). After cooling, the mixture was pulverized and passed through a 40-mesh sieve.
[0069] Comparative Example 1: Preparation of ordinary febuxostat tablets
[0070] A method for preparing febuxostat tablets, the components of which are shown in Table 5, and the specific steps are as follows:
[0071] Febuxostat active pharmaceutical ingredient (not prepared as a solid dispersion) is mixed with excipients and then directly compressed into tablets.
[0072] Table 5. Febuxostat Tablet Ingredients (1000 tablets, each containing 40 mg of febuxostat)
[0073]
[0074] Comparative Example 2: Preparation of Febuxostat solid dispersion tablets (PVP carrier)
[0075] A febuxostat solid dispersion tablet, the composition of which is shown in Table 2, is prepared using the same process as in Example 2. The difference is that PVP K30 is used instead of the composite carrier (sucrose stearate and pullulan) of the present invention to prepare the febuxostat solid dispersion (powder), and the specific composition is shown in Table 6.
[0076] Table 6. Formulation of Febuxostat solid dispersions
[0077]
[0078] Comparative Example 3: Preparation of Febuxostat solid dispersion tablets (single carrier sucrose stearate)
[0079] A febuxostat solid dispersion tablet, the composition of which is shown in Table 2, is prepared using the same process as in Example 2. The difference is that a single carrier, sucrose stearate, is used to prepare the febuxostat solid dispersion (powder), the specific composition of which is shown in Table 7.
[0080] Table 7. Formulation of Febuxostat solid dispersions
[0081]
[0082] Comparative Example 4: Preparation of Febuxostat solid dispersion tablets (single carrier pullulan).
[0083] A febuxostat solid dispersion tablet, the composition of which is shown in Table 2, is prepared using the same process as in Example 2. The difference is that a single carrier, pullulan, is used to prepare the febuxostat solid dispersion (powder), the specific composition of which is shown in Table 8.
[0084] Table 8. Formulation of febuxostat solid dispersions
[0085]
[0086] Test Example 1: Evaluation of Tablet Quality and In Vitro Dissolution
[0087] 1. Experimental Design
[0088] The tablets of Examples 2-6 and Comparative Examples 1-4 were subjected to quality checks (hardness, disintegration time).
[0089] Dissolution curves were plotted by measuring the dissolution rate of tablet samples at 0, 5, 10, 15, 30, 45, and 60 min using the paddle method (75 rpm), 37℃, and 900 mL of pH 6.8 phosphate buffer.
[0090] 2. Experimental Results and Analysis
[0091] Table 9 Key Quality Indicators for Tablets
[0092]
[0093] Table 10 Summary of Dissolution Curve Results
[0094]
[0095] As shown in Tables 9 and 10, Figure 1 As shown, the tablets prepared in Examples 2-6 all exhibited excellent disintegration and dissolution properties. In contrast, the disintegration time and dissolution rate of Comparative Example 2 were relatively slow; the dissolution rates of Comparative Example 3 (single carrier sucrose stearate) and Comparative Example 4 (single carrier pullulan) were significantly low. The raw material (febuxostat) of Comparative Example 1 was untreated, and the sample showed significantly slow disintegration time and dissolution rate.
[0096] The experimental results of this test case demonstrate the necessity of the composite carrier (sucrose stearate and pullulan) of the present invention.
[0097] Test Example 2 Stability Study
[0098] 1. Experimental Design
[0099] (1) Samples: Tablets prepared in Examples 2, 4, 6 and Comparative Examples 2-4.
[0100] (2) Conditions
[0101] Accelerated test: 40℃±2℃, 75% RH±5%, for 6 months;
[0102] Long-term experiment: 25℃±2℃, 60% RH±5%, for 6 and 12 months.
[0103] (3) Test items: dissolution rate, total impurities, appearance, crystal form.
[0104] 2. Experimental Results and Analysis
[0105] Table 11 Accelerated Experiment Results
[0106]
[0107] Table 12 Long-term experimental results
[0108]
[0109] As shown in Tables 11 and 12, the tablets prepared in Examples 2, 4, and 6 exhibited extremely excellent physical stability under harsh accelerated conditions, with dissolution retention rates far exceeding those of Comparative Examples 2-4. In contrast, the single carrier sucrose stearate (Comparative Example 3) showed weak crystallization inhibition and poor stability. Although the single carrier pullulan (Comparative Example 4) had good stability, it lacked effective immediate solubilization capabilities and had low bioavailability. This demonstrates the synergistic stabilizing effect of the composite carrier combination (sucrose stearate and pullulan) of the present invention in inhibiting drug recrystallization. This may be due to the abundant hydroxyl groups (-OH) on the pullulan chain, which can not only bind with water but also form intermolecular hydrogen bonds with the sucrose hydroxyl groups on sucrose stearate and the carbonyl groups or nitrogen atoms on febuxostat molecules. This hydrogen-bonded network can further enhance the compatibility of the ternary system, promoting uniform dispersion of the drug in an amorphous form rather than as tiny crystals. Simultaneously, during sample preparation, sucrose stearate may act as a plasticizer, lowering the glass transition temperature of pullulan, allowing the carrier mixture to form a homogeneous melt under milder processing conditions, which is beneficial for uniform drug dispersion. The final solid dispersion is likely to be a more homogeneous and stable single-phase amorphous system, rather than a simple physical mixture of drug and carrier.
[0110] Test Example 3: Pharmacokinetic Study in Beagle Dogs
[0111] 1. Experimental Design
[0112] (1) Experimental animals: Six healthy adult beagle dogs, weighing 10-12 kg, were fasted for 12 hours before the experiment and given free access to water.
[0113] (2) Experimental reagents
[0114] Test formulation (T): Tablets prepared in Example 2 (strength: 40 mg / tablet)
[0115] Reference formulation (R): Commercially available febuxostat tablets (brand name: febuxostat) ® Specification: 40 mg / tablet, Manufacturer: Astellas.
[0116] (3) Experimental method: A randomized, double-period, double-crossover experimental design was adopted. A two-week washout period was included between periods. Each dog was given the corresponding dose once, which was taken with 50 mL of water.
[0117] (4) Blood sample collection: About 2 mL of blood was collected from the forelimb vein before administration (0 h) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 h after administration. The blood was placed in a heparin sodium anticoagulant tube, centrifuged to separate the plasma, and stored at -80℃ for testing.
[0118] (5) Blood drug concentration determination: The concentration of febuxostat in plasma was determined using a well-validated LC-MS / MS method.
[0119] 2. Experimental Results and Analysis
[0120] Table 13 Comparison of major pharmacokinetic parameters in beagle dogs (n=6, x̄±s)
[0121]
[0122] The experimental results are shown in Table 13, and the specific analysis is as follows:
[0123] (1) Significantly improved bioavailability: The tablets prepared in Example 2 (test formulation T) showed a significantly higher peak concentration (C0) compared to the commercially available reference formulation (R). max Both the concentration and exposure (AUC) were increased by approximately 60%, and the relative bioavailability was approximately 160%. This indicates that the solid dispersion tablets of the present invention significantly promote the absorption of febuxostat.
[0124] (2) Faster onset of action: the time to peak concentration (T) of the test formulation (T) max Compared to the commercially available reference formulation (R), the onset time was significantly earlier, shortened from 3.0 h to 1.5 h, demonstrating its faster onset of action.
[0125] (3) Consistent elimination behavior: The half-life (t) of the test formulation (T) and the commercially available reference formulation (R) 1 / 2The lack of significant difference indicates that the solid dispersion tablets of the present invention alter the drug absorption process without affecting its elimination in vivo.
[0126] The above experimental results demonstrate that this invention successfully prepared high-quality febuxostat solid dispersion tablets through a specific carrier combination (sucrose stearate + pullulan) and process. These tablets not only exhibit excellent dissolution and bioavailability, but more importantly, their physical stability significantly surpasses that of the comparative example, effectively solving the stability problem of long-term storage of solid dispersion tablets in existing technologies.
[0127] The embodiments described above are only some, not all, of the embodiments of the present invention. The detailed description of the embodiments of the present invention is not intended to limit the scope of the claimed invention, but merely to illustrate selected embodiments. The scope of protection of the present invention is determined by the scope claimed in the claims. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without inventive effort are within the scope of protection of the present invention.
Claims
1. A febuxostat solid dispersion tablet characterized in that, The non-felbinac solid dispersion is prepared from the active ingredient non-felbinac, sucrose stearate and pullulan.
2. A febuxostat solid dispersion tablet according to claim 1, wherein, The mass ratio of the non-felbinac, sucrose stearate and pullulan is 1:1:
1.
3. A febuxostat solid dispersion tablet according to claim 1, wherein The auxiliary materials include a filler, a disintegrant and a lubricant; the filler is one or more of microcrystalline cellulose, lactose and mannitol; the disintegrant is one or more of cross-linked polyvinylpyrrolidone, cross-linked sodium carboxymethylcellulose and low-substituted hydroxypropyl cellulose; and the lubricant is magnesium stearate or micro-powder silica gel.
4. A febuxostat solid dispersion tablet according to claim 3, wherein The solid dispersion tablet comprises, by weight, 100-140 parts of non-felbinac solid dispersion, 200-300 parts of filler, 8-12 parts of disintegrant and 1-5 parts of lubricant.
5. A febuxostat solid dispersion tablet according to claim 4, wherein The solid dispersion tablet has a specification of 20 mg, 40 mg or 80 mg.
6. A process for the preparation of a febuxostat solid dispersion tablet according to any one of claims 1 to 5, characterized in that, The method comprises the following steps: Step 1) preparing a solid dispersion from non-felbinac, sucrose stearate and pullulan by a solvent method or a hot melt extrusion method; Step 2) crushing and sieving the solid dispersion prepared in Step 1) to obtain solid dispersion granules; Step 3) uniformly mixing the solid dispersion granules prepared in Step 2) with pharmaceutically acceptable auxiliary materials, directly compressing or granulating and then compressing to obtain the tablet.
7. The production method according to claim 6, characterized by, In Step 1), When the solvent method is used, the solvent is water, ethanol or an ethanol aqueous solution, and the amount of the solvent is sufficient to dissolve or highly disperse the raw materials, and the solvent is removed by rotary evaporation or spray drying; When the hot melt extrusion method is used, the process parameters are as follows: the temperature of the feeding section is 100-130℃, the temperature of the melting section is 120-150℃, the temperature of the die head is 130-150℃, and the screw rotation speed is 150-350 rpm.
8. The preparation method according to claim 6, characterized in that, In Step 2), the sieving is through a 40-80 mesh sieve.
9. The preparation method according to claim 6, characterized in that, In Step 3), the hardness of the tablet is 60-100 N.
10. Use of the non-felbinac solid dispersion tablet according to any one of claims 1-5 in the preparation of a medicament for treating gout or hyperuricemia.