Empagliflozin composition and preparation method thereof

Abstract

The invention relates to the field of pharmaceutical preparations, in particular to an empagliflozin composition and a preparation method thereof. The empagliflozin composition provided by the invention is prepared from the following components in parts by weight: 3-5 parts of empagliflozin, 15-30 parts of an adsorbent, 1-3 parts of inorganic salt, 40-60 parts of a filling agent, 3-7 parts of a disintegrating agent, 1-2 parts of a flow aid and 0.5-1.5 parts of a lubricating agent. Wherein the adsorbent is selected from a cellulose high polymer material with a microscopic net shape and relatively large steric hindrance; the inorganic salt is selected from a strong electrolyte inorganic salt which can be dissolved in water and is beneficial to eliminating electrostatic charges of empagliflozin particles separated out from the solution; the filling agent is a co-treated substance of lactose and microcrystalline cellulose; the disintegrating agent is cross-linked sodium carboxymethyl cellulose; the flow aid is colloidal silicon dioxide; and the lubricant is magnesium stearate. Compared with the prior art, the composition provided by the invention can reach a dissolution platform faster, the dissolution rate of the dissolution platform is higher, and the dissolution speed and degree are not changed under long-term and accelerated conditions.

Description

Technical Field

[0001] The present invention relates to the field of pharmaceutical preparations, and in particular to an empagliflozin composition and a preparation method thereof. Background Art

[0002] Sodium-glucose cotransporters (SGLTs) are a class of glucose transporters found in the small intestinal mucosa and renal proximal tubules, mainly including SGLT1 protein and SGLT2 protein. Among them, SGLT2 protein has a higher expression level in the kidney and is mainly responsible for the regulation of the renal reuptake of glucose. That is, glucose in urine can actively attach to renal tubular epithelial cells when passing through glomerular filtration and be transported into the cell for reuse through SGLT2 protein. In this process, SGLT2 is responsible for 90% of the reabsorption process, and the remaining 10% is completed by SGLT1. Since this process does not intervene in the metabolism of glucose, it avoids or reduces the occurrence of adverse reactions of hypoglycemia and reduces the risk of causing cardiovascular diseases. Therefore, SGLTs have become one of the ideal potential targets for the treatment of diabetes.

[0003] CN102387783A discloses a pyranose glucopyranosyl diphenylmethane derivative and a composition thereof, which was later named empagliflozin, and is a SGLT2 inhibitor that inhibits SGLT2 protein, reduces glucose reabsorption in the kidney, lowers the renal glucose threshold, and promotes glucose excretion from urine, thereby improving blood sugar control in patients with type 2 diabetes. Empagliflozin was approved for marketing in 2014 and is suitable for the treatment of adult patients with type 2 diabetes who have not achieved adequate blood sugar control with diet and exercise, and the marketed dosage form is tablets.

[0004] Empagliflozin is a poorly soluble drug. Generally speaking, the microscopic size of a poorly soluble solid API, that is, the particle size, is inversely proportional to its absorption difficulty. The larger the particle size, the smaller and slower the absorption. On the contrary, the smaller the particle size, the larger and faster the absorption. However, due to the reduction in the particle size of the powder, the compressibility of the powder will deteriorate, the surface area will increase, the surface energy will increase, the static electricity will increase, etc., which will cause its dissolution performance or bioavailability to show the opposite trend. In CN115531332B, empagliflozin is highly dispersed in hydrophilic polyethylene glycol to achieve the purpose of enhancing the dispersion effect, increasing the speed and degree of drug dissolution, and improving bioavailability. However, although this technology temporarily improves the dissolution rate and extent of the drug, due to the highly hydrophilic properties of polyethylene glycol and the electrostatic charge of the poorly soluble drug empagliflozin dispersed therein during processing, during the storage of the composition, as the hydrophilic matrix absorbs moisture, the dispersed drugs will inevitably aggregate again, resulting in a downward trend in the dissolution of the drug in the composition, further affecting the bioavailability of the drug. Summary of the invention

[0005] In response to the above-mentioned existing technical problems, the present invention provides an empagliflozin composition and a preparation method thereof. The empagliflozin composition prepared by this method has a high dissolution rate and the dissolution rate and degree do not change under long-term conditions and accelerated conditions.

[0006] The present invention discloses an empagliflozin composition, comprising the following components in parts by weight:

[0007] 3-5 parts of empagliflozin, 15-30 parts of adsorbent, 1-3 parts of inorganic salt, 40-60 parts of filler, 3-7 parts of disintegrant, 1-2 parts of glidant, and 0.5-1.5 parts of lubricant.

[0008] Preferably, the adsorbent is hydroxypropyl methylcellulose, hydroxypropyl cellulose or ethyl cellulose.

[0009] Preferably, the preferred material of the adsorbent is hydroxypropyl cellulose, the weight average molecular weight of the hydroxypropyl cellulose is in the range of 40,000 to 80,000; and the viscosity of the hydroxypropyl cellulose is in the range of 0.3 to 0.6 Pa·S.

[0010] Preferably, the inorganic salt is a strong electrolyte inorganic salt that can dissolve in water and helps to eliminate the static charge of the empagliflozin microparticles precipitated in the solution; it can be a sodium salt, a potassium salt or a calcium salt.

[0011] Preferably, the inorganic salt is a monovalent metal salt, more preferably sodium chloride.

[0012] Preferably, the filler is starch, lactose, microcrystalline cellulose or a co-processed product of the above excipients.

[0013] Preferably, the filler is a co-processed product of lactose and microcrystalline cellulose in a mass ratio of 3:1.

[0014] The present invention also discloses a method for preparing an empagliflozin composition, comprising the following steps:

[0015] S1 mixing: dissolving empagliflozin in ethanol and placing it in a container with a high-speed pneumatic stirring device, adding an adsorbent after starting stirring, and then dissolving an inorganic salt in purified water to prepare an inorganic salt solution, slowly adding the prepared inorganic salt solution to the above container to form a white opalescent emulsion, placing the emulsion in a fluidized bed for spray drying to obtain a white powder;

[0016] S2 tableting: the white powder obtained in step S1 is added to a mixer with a filler, a disintegrant, a retention aid and a lubricant for mixing. After stirring evenly, the mixture is put into a tablet press for tableting to obtain an empagliflozin composition.

[0017] Preferably, in the mixing step S1, the rotation speed of the stirring device is 2000-3000 rpm.

[0018] Preferably, in the S1 mixing step, the pressure of the fluidized bed is 0.2-0.4 MPa; and the temperature is 69-71°C.

[0019] Compared with the prior art, the present invention has the following beneficial effects:

[0020] The present invention dissolves empagliflozin in ethanol in a molecular state, and adds a cellulose ether polymer material having a network microstructure and high steric hindrance to the solution, and gradually supersaturates empagliflozin by slowly adding a certain amount of water to the solution. Under high-speed stirring and the presence of an adsorbent in the solution, extremely small crystals are precipitated and adsorbed in the network structure of the cellulose ether. At the same time, since the water contains strong electrolytes, the static charge of the particles can be eliminated, and the aggregation of the particles can be inhibited during storage, so that the particles can maintain a low particle size and a highly dispersed state for a long time, thereby improving the dissolution rate and dissolution degree of the composition, and further ensuring that the bioavailability of empagliflozin in the composition is not reduced.

[0021] Compared with the prior art, the composition provided by the present invention can reach the dissolution platform faster, the dissolution rate of the dissolution platform is higher, and the dissolution rate and degree will not change under long-term conditions and accelerated conditions. DETAILED DESCRIPTION

[0022] The following examples are provided for a better understanding of the present invention, but are not intended to limit the best mode of implementation, nor to limit the content and protection scope of the present invention. Any product identical or similar to the present invention obtained by anyone under the inspiration of the present invention or by combining the features of the present invention with other prior arts shall fall within the protection scope of the present invention.

[0023] If no specific experimental steps or conditions are specified in the examples, the conventional experimental steps or conditions described in the literature in the field can be used. If no manufacturer is specified for the reagents or instruments used, they are all conventional reagent products that can be obtained commercially.

[0024] Example 1: An empagliflozin composition comprising the following components in parts by weight:

[0025] 3 parts of empagliflozin, 15 parts of hydroxypropyl cellulose, 1 part of sodium chloride, 40 parts of co-processed lactose-microcrystalline cellulose, 3 parts of cross-linked sodium carboxymethyl cellulose, 1 part of colloidal silicon dioxide, and 0.5 parts of magnesium stearate. Among them, the mass ratio of lactose to microcrystalline cellulose in the co-processed lactose-microcrystalline cellulose is 3:1; the weight average molecular weight of hydroxypropyl cellulose is 40,000; and the viscosity of hydroxypropyl cellulose is 0.3 Pa·S.

[0026] A method for preparing an empagliflozin composition comprises the following steps:

[0027] S1 mixing: dissolve empagliflozin in ethanol and place it in a container with a high-speed pneumatic stirring device, start stirring and add adsorbent, the stirring speed is 2500rpm, then dissolve sodium chloride in 3 parts of purified water to prepare an inorganic salt solution, slowly add the prepared inorganic salt solution to the above container to form a white opalescent emulsion, place the emulsion in a fluidized bed for spray drying, set the pressure of the fluidized bed to 0.3MPa, and the inlet air temperature to 70°C, and obtain a white powder after drying;

[0028] S2 tableting: the white powder obtained in step S1 is added to a mixer and mixed with the co-processed product of lactose microcrystalline cellulose, cross-linked sodium carboxymethyl cellulose, colloidal silicon dioxide and magnesium stearate. After stirring evenly, the mixture is put into a tablet press for tableting to obtain an empagliflozin composition.

[0029] Example 2: An empagliflozin composition comprising the following components in parts by weight:

[0030] 4 parts of empagliflozin, 20 parts of hydroxypropyl cellulose with a degree of substitution of 16 to 53.4%, 2 parts of sodium chloride, 50 parts of a co-processed product of lactose and microcrystalline cellulose, 5 parts of cross-linked sodium carboxymethyl cellulose, 1 part of colloidal silicon dioxide, and 1 part of magnesium stearate. Among them, the mass ratio of lactose to microcrystalline cellulose in the co-processed product of lactose and microcrystalline cellulose is 3:1; the weight average molecular weight of hydroxypropyl cellulose is 60,000; and the viscosity of hydroxypropyl cellulose is 0.45 Pa·S.

[0031] The preparation method of an empagliflozin composition has the same steps and parameters as those in Example 1.

[0032] Example 3: An empagliflozin composition comprising the following components in parts by weight:

[0033] 5 parts of empagliflozin, 30 parts of hydroxypropyl cellulose with a degree of substitution of 16 to 53.4%, 3 parts of sodium chloride, 60 parts of a co-processed product of lactose and microcrystalline cellulose, 7 parts of cross-linked sodium carboxymethyl cellulose, 2 parts of colloidal silicon dioxide, and 1.5 parts of magnesium stearate. Among them, the mass ratio of lactose to microcrystalline cellulose in the co-processed product of lactose and microcrystalline cellulose is 3:1; the weight average molecular weight of hydroxypropyl cellulose is 80,000; and the viscosity of hydroxypropyl cellulose is 0.6 Pa·S.

[0034] The preparation method of an empagliflozin composition has the same steps and parameters as those in Example 1.

[0035] Example 4: An empagliflozin composition comprising the following components in parts by weight:

[0036] 4 parts of empagliflozin, 20 parts of hydroxyethyl cellulose, 2 parts of potassium chloride, 50 parts of lactose, 5 parts of cross-linked carboxymethyl cellulose sodium, 1 part of colloidal silicon dioxide, and 1 part of magnesium stearate.

[0037] The preparation method of an empagliflozin composition has the same steps and parameters as those in Example 1.

[0038] Example 5: An empagliflozin composition comprising the following components in parts by weight:

[0039] 4 parts of empagliflozin, 20 parts of hydroxypropyl methylcellulose, 2 parts of sodium sulfate, 50 parts of microcrystalline cellulose, 5 parts of cross-linked sodium carboxymethyl cellulose, 1 part of colloidal silicon dioxide, and 1 part of magnesium stearate.

[0040] The preparation method of an empagliflozin composition has the same steps and parameters as those in Example 1.

[0041] Example 6: An empagliflozin composition comprising the following components in parts by weight:

[0042] 4 parts of empagliflozin, 20 parts of ethyl cellulose, 2 parts of calcium chloride, 50 parts of starch, 5 parts of cross-linked sodium carboxymethyl cellulose, 1 part of colloidal silicon dioxide, and 1 part of magnesium stearate.

[0043] The preparation method of an empagliflozin composition has the same steps and parameters as those in Example 1.

[0044] Example 7: An empagliflozin composition comprising the following components in parts by weight:

[0045] 4 parts of empagliflozin, 20 parts of hydroxypropyl cellulose, 2 parts of sodium chloride, 50 parts of co-processed lactose-microcrystalline cellulose, 5 parts of cross-linked sodium carboxymethyl cellulose, 1 part of colloidal silicon dioxide, and 1 part of magnesium stearate. Among them, the mass ratio of lactose to microcrystalline cellulose in the co-processed lactose-microcrystalline cellulose is 3:1; the weight average molecular weight range of hydroxypropyl cellulose is 40,000 to 80,000; and the viscosity range of hydroxypropyl cellulose is 0.3 to 0.6 Pa·S.

[0046] A method for preparing an empagliflozin composition comprises the following steps:

[0047] S1 mixing: dissolve empagliflozin in ethanol and place it in a container with a high-speed pneumatic stirring device, start stirring and add adsorbent, the stirring speed is 2000rpm, then dissolve inorganic salt in purified water to prepare inorganic salt solution, slowly add the prepared inorganic salt solution to the above container to form a white opalescent emulsion, place the emulsion in a fluidized bed for spray drying, set the pressure of the fluidized bed to 0.2MPa, the inlet air temperature to 65°C, and obtain white powder after drying;

[0048] S2 tableting: the white powder obtained in step S1 is added to a mixer and mixed with the co-processed product of lactose microcrystalline cellulose, cross-linked sodium carboxymethyl cellulose, colloidal silicon dioxide and magnesium stearate. After stirring evenly, the mixture is put into a tablet press for tableting to obtain an empagliflozin composition.

[0049] Example 8: An empagliflozin composition comprising the following components in parts by weight:

[0050] 4 parts of empagliflozin, 20 parts of hydroxypropyl cellulose, 2 parts of sodium chloride, 50 parts of co-processed lactose-microcrystalline cellulose, 5 parts of cross-linked sodium carboxymethyl cellulose, 1 part of colloidal silicon dioxide, and 1 part of magnesium stearate. Among them, the mass ratio of lactose to microcrystalline cellulose in the co-processed lactose-microcrystalline cellulose is 3:1; the weight average molecular weight range of hydroxypropyl cellulose is 40,000 to 80,000; and the viscosity range of hydroxypropyl cellulose is 0.3 to 0.6 Pa·S.

[0051] A method for preparing an empagliflozin composition comprises the following steps:

[0052] S1 mixing: dissolve empagliflozin in ethanol and place it in a container with a high-speed pneumatic stirring device, start stirring and add adsorbent, the stirring speed is 3000rpm, then dissolve inorganic salt in purified water to prepare inorganic salt solution, slowly add the prepared inorganic salt solution to the above container to form a white opalescent emulsion, place the emulsion in a fluidized bed for spray drying, set the pressure of the fluidized bed to 0.4MPa, the inlet air temperature to 75°C, and obtain white powder after drying;

[0053] S2 tableting: the white powder obtained in step S1 is added to a mixer and mixed with the co-processed product of lactose microcrystalline cellulose, cross-linked sodium carboxymethyl cellulose, colloidal silicon dioxide and magnesium stearate. After stirring evenly, the mixture is put into a tablet press for tableting to obtain an empagliflozin composition.

[0054] The dissolution curves of the empagliflozin composition prepared in Examples 1 to 8; the empagliflozin composition placed under long-term conditions of 25°C ± 2°C, RH 60% ± 10% for 12 weeks; and the empagliflozin composition placed under accelerated conditions of 40°C ± 2°C, RH 75% ± 5% for 12 weeks in a pH 6.8 phosphate buffer medium were compared under these three experimental conditions. The experimental results are shown in Table 1:

[0055] Table 1

[0056]

[0057]

[0058] Examples 1 to 3 screen the weight of the raw materials; Examples 4 to 6 screen the adsorbent, inorganic salt and filler in the raw materials; Examples 7 and 8 adjust the parameters in the preparation method. From the data in Table 1, it can be seen that the data of Example 2 is the best. It can be seen that the adsorbent is most preferably hydroxypropyl cellulose with a weight average molecular weight range of 4000 to 8000 and a viscosity of 0.3 to 0.6 Pa·S; the inorganic salt is most preferably sodium chloride, and the filler is most preferably a co-processed product of lactose and microcrystalline cellulose.

[0059] Comparative Example 1: An empagliflozin composition comprising the following components in parts by weight:

[0060] 4 parts of empagliflozin, 20 parts of hydroxypropyl cellulose, 50 parts of co-processed lactose-microcrystalline cellulose, 5 parts of cross-linked sodium carboxymethyl cellulose, 1 part of colloidal silicon dioxide, and 1 part of magnesium stearate. Among them, the mass ratio of lactose to microcrystalline cellulose in the co-processed lactose-microcrystalline cellulose is 3:1; the weight average molecular weight range of hydroxypropyl cellulose is 40,000 to 80,000; and the viscosity range of hydroxypropyl cellulose is 0.3 to 0.6 Pa·S.

[0061] The preparation method of an empagliflozin composition has the same steps and parameters as those in Example 1.

[0062] Comparative Example 2: An empagliflozin composition comprising the following components in parts by weight:

[0063] 4 parts of empagliflozin, 2 parts of sodium chloride, 50 parts of a co-processed product of lactose and microcrystalline cellulose, 5 parts of cross-linked sodium carboxymethyl cellulose, 1 part of colloidal silicon dioxide, and 1 part of magnesium stearate. The mass ratio of lactose to microcrystalline cellulose in the co-processed product of lactose and microcrystalline cellulose is 3:1.

[0064] The preparation method of an empagliflozin composition has the same steps and parameters as those in Example 1.

[0065] Comparative Example 3: An empagliflozin tablet is composed of the following prescription (CN102387783A):

[0066] Empagliflozin 10 mg / tablet; lactose monohydrate 162.5 mg / tablet; microcrystalline cellulose (added internally) 50 mg / tablet; hydroxypropyl cellulose 7.5 mg / tablet; cross-linked sodium carboxymethyl cellulose 5 mg / tablet; microcrystalline cellulose (added externally) 12.5 mg / tablet; colloidal silicon dioxide 1.25 mg / tablet; magnesium stearate 1.25 mg / tablet; film coating premix 7 mg / tablet.

[0067] A preparation method of empagliflozin tablets: the particle size of empagliflozin is X90=39.2 μm, empagliflozin, hydroxypropyl cellulose, cross-linked sodium carboxymethyl cellulose, microcrystalline cellulose (added internally), and lactose monohydrate are put into a high-efficiency wet mixing granulator according to the above composition, and mixed at a stirring speed of 120 rpm and a shear speed of 1200 rpm for 10 minutes, an appropriate amount of purified water is added, and the mixture is stirred and granulated at a stirring speed of 150 rpm and a shear speed of 1500 rpm, and the mixture is dried in a fluidized bed until the drying loss weight on an infrared rapid moisture meter is ≤1.5%, the dried particles are passed through a dry granulator with a 2.0 mm screen, and then transferred to a square cone mixer, and the added microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate are added to the square cone mixer, mixed at a speed of 10 rpm for 10 minutes, and tableted. The tablet hardness is 70N, and a film coating agent OPADRY YELLOW with a solid content of 15% is prepared. 02B38190 aqueous solution, and apply the film coating to the tablet core using a high-efficiency coating machine according to the conventional coating process to obtain yellow film-coated tablets.

[0068] Comparative Example 4: An empagliflozin tablet is composed of the following prescription (CN115531332B):

[0069] Empagliflozin 10 mg / tablet; PEG6000 15 mg / tablet; dimethicone 15 mg / tablet; lactose monohydrate 35 mg / tablet; microcrystalline cellulose 30 mg / tablet; polyvinylpyrrolidone 10 mg / tablet; hydroxypropyl cellulose (EF) 3 mg / tablet; magnesium stearate 2 mg / tablet.

[0070] A preparation method of empagliflozin tablets: first, empagliflozin, dimethicone, and PEG6000 are fully stirred and mixed in a molten state at 60 degrees, cooled and passed through an 80-mesh sieve, and then wet-mixed with a prescribed amount of lactose, microcrystalline cellulose, cross-linked polyvinylpyrrolidone (PPVP), and a binder (3% hydroxypropylcellulose (EF) aqueous solution) through a 24-mesh sieve for granulation, dried below 60°C, dried to a moisture content of less than 4.8%, and then granulated through a 24-mesh sieve, and a lubricant, magnesium stearate, was added, mixed and uniformly pressed into tablets, and the tablet hardness was 60-120N.

[0071] The dissolution curves of the empagliflozin compositions prepared in Example 2 and Comparative Examples 1 to 4 in a pH 6.8 phosphate buffer medium were compared, and the experimental results are shown in Table 2:

[0072] Table 2

[0073]

[0074]

[0075] The empagliflozin compositions prepared in Example 2 and Comparative Examples 1 to 4 were placed under long-term conditions of 25°C ± 2°C and RH of 60% ± 10% for 12 weeks, and then their dissolution curves in a phosphate buffer medium with a pH of 6.8 were compared. The experimental results are shown in Table 3:

[0076] Table 3

[0077]

[0078] The empagliflozin compositions prepared in Example 2 and Comparative Examples 1 to 4 were placed under accelerated conditions of 40°C ± 2°C and RH of 75% ± 5% for 12 weeks, and then their dissolution curves in a phosphate buffer medium with a pH of 6.8 were compared. The experimental results are shown in Table 4:

[0079] Table 4

[0080]

[0081] Comparative Example 1 does not add inorganic salt to the raw material; Comparative Example 2 does not add filler to the raw material; Comparative Examples 3 and 4 prepare the empagliflozin composition according to the prior art. From the experimental data in Tables 2 to 4, the empagliflozin composition prepared in Example 2 has a higher dissolution rate, reaches the dissolution platform faster, and can show good dissolution rate and solubility after long-term storage and long-term storage at high temperature. This is because in Example 2, empagliflozin is dissolved in ethanol in a molecular state, and a cellulose ether polymer material having a network microstructure and high steric hindrance is added to the solution. A certain amount of water is slowly added to the solution to gradually supersaturate empagliflozin. Under high-speed stirring and the presence of an adsorbent in the solution, extremely small crystals are precipitated and adsorbed in the network structure of the cellulose ether. At the same time, since the water contains strong electrolytes, the static charge of the particles can be eliminated, and the aggregation of the particles can be inhibited during storage, so that the particles can maintain a low particle size and highly dispersed state for a long time, thereby improving the dissolution rate and dissolution degree of the composition, and further ensuring that the bioavailability of empagliflozin in the composition is not reduced.

[0082] Obviously, the above embodiments are merely examples for the purpose of clear explanation, and are not intended to limit the implementation methods. For those skilled in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to list all the implementation methods here. The obvious changes or modifications derived from these are still within the scope of protection of the invention.

Claims

1. An empagliflozin composition, characterized in that: It includes the following ingredients by weight: 3-5 parts of empagliflozin, 15-30 parts of adsorbent, 1-3 parts of inorganic salt, 40-60 parts of filler, 3-7 parts of disintegrant, 1-2 parts of glidant, and 0.5-1.5 parts of lubricant.

2. An empagliflozin composition according to claim 1, characterized in that: The adsorbent is hydroxypropyl methylcellulose, hydroxyethyl cellulose, hydroxypropyl cellulose or ethyl cellulose.

3. An empagliflozin composition according to claim 2, characterized in that: The material selected for the adsorbent is hydroxypropyl cellulose, the weight average molecular weight of the hydroxypropyl cellulose is in the range of 40000 to 80000; the viscosity of the hydroxypropyl cellulose is in the range of 0.3 to 0.6 Pa·S.

4. The empagliflozin composition according to claim 1, characterized in that: The inorganic salt is a strong electrolyte inorganic salt that can dissolve in water and helps to eliminate the static charge of the empagliflozin microparticles precipitated in the solution, and is a sodium salt, a potassium salt or a calcium salt.

5. The empagliflozin composition according to claim 4, characterized in that: The inorganic salt is a monovalent metal salt, and further sodium chloride is selected.

6. The empagliflozin composition according to claim 1, characterized in that: The filler is starch, lactose, microcrystalline cellulose or a co-processed product of the above auxiliary materials.

7. The empagliflozin composition according to claim 1, characterized in that: The filler is a co-processed product composed of lactose and microcrystalline cellulose in a mass ratio of 3:

1.

8. A method for preparing an empagliflozin composition, characterized in that: The following steps are involved: S1 mixing: dissolving empagliflozin in ethanol and placing it in a container with a high-speed pneumatic stirring device, adding an adsorbent after starting stirring, and then dissolving an inorganic salt in purified water to prepare an inorganic salt solution, slowly adding the prepared inorganic salt solution to the above container to form a white opalescent emulsion, placing the emulsion in a fluidized bed for spray drying to obtain a white powder; S2 tableting: the white powder obtained in step S1 is added to a mixer with a filler, a disintegrant, a retention aid and a lubricant for mixing. After stirring evenly, the mixture is put into a tablet press for tableting to obtain an empagliflozin composition.

9. The method for preparing an empagliflozin composition according to claim 8, characterized in that: In the S1 mixing step, the rotation speed of the stirring device is 2000-3000 rpm.

10. The method for preparing an empagliflozin composition according to claim 8, characterized in that: In the S1 mixing step, the pressure of the fluidized bed is 0.2-0.4 MPa; the temperature is 69-71°C.

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