Fluvastatin Sodium Sustained Release Tablets and Preparation Method

Abstract

The present invention relates to the field of pharmaceutical technology, and discloses fluvastatin sodium sustained-release tablets and a preparation method. The weight ratio of the raw materials of the sustained-release tablets is as follows: 25-29 parts of cellulose derivatives; 5-9 parts of polyethylene substances; 20-24 parts of fluvastatin sodium; 20-25 parts of fillers; 1-3 parts of binders; 1-1.2 parts of disintegrants; 2-3 parts of lubricants. Weigh all the raw material components according to the raw material ratio, and mix the above components evenly in sequence. Granulate the powder mixed in the previous step by dry granulation to form uniform granules. Use a fluidized bed coating device to evenly coat the coating material on the surface of the granules to form a moisture-proof and sustained-release functional coating layer. Put the coated granules into a tablet press and press them into the shape and thickness of the tablets preset by the manufacturer, and control the pressure and temperature at the same time to prepare the sustained-release tablets. Conduct quality inspection on the prepared fluvastatin sodium sustained-release tablets. Finally, perform aluminum-plastic packaging on the qualified sustained-release tablets after quality inspection and store them in a cool and dry place.

Description

Technical Field

[0001] The present invention relates to the field of pharmaceutical technology, and specifically to fluvastatin sodium sustained-release tablets and a preparation method thereof. Background Art

[0002] Fluvastatin sodium is a drug used to reduce cholesterol, mainly reducing the synthesis of cholesterol in the body by inhibiting HMG-CoA reductase. However, there are some problems with existing fluvastatin sodium tablets, such as poor moisture-proof performance. These problems may affect the efficacy and safety of the drug, so further improvement and optimization are needed. Summary of the Invention

[0003] Aiming at the deficiencies of the prior art, the present invention provides fluvastatin sodium sustained-release tablets and a preparation method thereof, which have the advantages of moisture absorption and degradation resistance, few impurities and sustained release, and solve the problem of poor moisture-proof performance of existing fluvastatin sodium tablets.

[0004] To achieve the above object, the present invention provides the following technical solution: Fluvastatin sodium sustained-release tablets are prepared from the following raw materials in parts by weight: 25-29 parts of cellulose derivatives; 5-9 parts of polyethylene substances; 20-24 parts of fluvastatin sodium; 20-25 parts of fillers; 1-3 parts of binders; 1-1.2 parts of disintegrants; 2-3 parts of lubricants.

[0005] Preferably, the cellulose derivatives are composed of hydroxypropyl methylcellulose phthalate, carboxymethyl cellulose and ethyl cellulose in a mass ratio of 1:1 - 1.5:2 - 2.5.

[0006] Preferably, the polyethylene substances are composed of a polyvinyl alcohol-polyethylene glycol copolymer and polyvinyl alcohol in a mass ratio of 3:5 - 6.

[0007] Preferably, for the fluvastatin sodium sustained-release tablets and the preparation method, according to the weight ratio of the raw materials of the above-mentioned fluvastatin sodium sustained-release tablets for preparation, the preparation steps of the sustained-release tablets are as follows:

[0008] Step 1, Mix the raw materials: Weigh fluvastatin sodium and excipients according to the raw material ratio and mix them evenly;

[0009] Step 2, Prepare the matrix: Granulate the powder mixed in Step 1 by dry granulation to form uniform granules;

[0010] Step 3, Coating treatment: Mix the cellulose derivatives and polyethylene substances, disperse them in water to obtain a coating material solution, and evenly coat the coating material solution on the surface of the granules to form coated granules;

[0011] Step 4, Tablet pressing preparation: Put the coated granules into a tablet press to press tablets to obtain fluvastatin sodium sustained-release tablets.

[0012] Preferably, the order and conditions for mixing the raw materials in Step 1 are as follows:

[0013] S11. Mix fluvastatin sodium with fillers and disintegrants and disperse them evenly.

[0014] S12. Add a binder accounting for 1 / 2 of the mass, and mix at a speed of 50 r / min for 25 - 30 min at a temperature of 40°C - 45°C.

[0015] S13. Add lubricants and the remaining binder accounting for 1 / 2 of the mass, and mix at a speed of 50 r / min for 5 - 8 min at a temperature of 20°C - 25°C.

[0016] Preferably, the process of dry granulation in Step 2 is as follows:

[0017] S2. Put the powder mixed in Step 1 into a granulator. The pressure of the granulator is 5 MPa, collect the granules, and the granulation is completed.

[0018] Preferably, the process of coating treatment in Step 3 is as follows:

[0019] S31. Prepare the coating solution: Mix coating materials such as hydroxypropyl methylcellulose phthalate, carboxymethylcellulose, ethylcellulose, polyvinyl alcohol - polyethylene glycol copolymer, and polyvinyl alcohol according to the raw material ratio, and add pure water in the raw material ratio to prepare a uniform coating solution.

[0020] S32. Set the parameters of the fluidized bed coating equipment: First, turn on the equipment, heat the fluidized bed coating equipment to 50°C, after preheating for 30 min, set the inlet air temperature of the fluidized bed coating equipment to 50°C, the spray pressure to 0.5 MPa, the spray rate to 50 - 100 g / min, and then put the particles to be coated into the fluidized bed coating equipment.

[0021] S33. Spray coating: Spray the prepared coating solution evenly onto the surface of the particles through the spray system of the fluidized bed coating equipment to form a continuous coating layer. When the spray volume reaches 1 / 4, adjust the spray rate from 60 m 3 / s to 50 m 3 / s. When the spray volume reaches 1 / 2, adjust the spray rate from 50 m 3 / s to 30 m 3 / s, and continuously adjust the spray parameters.

[0022] S34. Curing: After coating is completed, put the coated particles into a fluidized bed dryer for curing treatment at a temperature of 60°C for 1 h.

[0023] Preferably, the conditions for tablet pressing in step four are as follows: adjust the pressure of the tablet press to be between 15 MPa and 20 MPa, and adjust the temperature to be between 35 °C and 40 °C.

[0024] Preferably, the preparation method further includes:

[0025] Step five, quality inspection: conduct quality inspection on the prepared fluvastatin sodium sustained-release tablets;

[0026] Step six, packaging and storage: perform aluminum-plastic packaging on the sustained-release tablets that pass the quality inspection.

[0027] Compared with the prior art, the present invention provides a fluvastatin sodium sustained-release tablet and a preparation method, having the following beneficial effects:

[0028] 1. In the present invention, by reasonably matching the proportions of fluvastatin sodium, filler, and binder, the particle size distribution, shape, and hardness of the skeleton are improved. This step not only enhances the stability of the drug but also lays a foundation for the subsequent coating process. In the aggregate preparation step, raw materials are added in different sequences, and at the same time, the temperature, stirring speed, and stirring time are adjusted. The improvement of this step makes the coated particles smoother and crack-free in appearance, and the film thickness is more uniform, which also helps to improve the release rate. By applying a mixture of combined proportions in cellulose derivatives, the outer quality and moisture-proof performance of the coating layer are further improved. Considering the above-mentioned preparation process and improvement steps, the method of the present invention not only improves the overall quality of the fluvastatin sodium sustained-release tablet but also ensures its stability and effectiveness during storage and use, thus solving the problem of poor moisture-proof ability of the existing fluvastatin sodium tablets. Description of the Drawings

[0029] Figure 1 It is a preparation step diagram of the present invention; Detailed Embodiments

[0030] The following will clearly and completely describe the technical solutions in the embodiments of the present invention with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention. Embodiment 1

[0031] Please refer to Figure 1 . The weight percentages of the following raw materials used are as follows: 250 g of cellulose derivative, 50 g of polyethylene-based substance, 200 g of fluvastatin sodium, 200 g of filler, 10 g of binder, 10 g of disintegrant, 20 g of lubricant, and 1000 g of water.

[0032] The filler is specifically corn starch, the binder is specifically povidone, the disintegrant is specifically sodium carboxymethyl starch, and the lubricant is specifically magnesium stearate.

[0033] The cellulose derivative is composed of hydroxypropyl methylcellulose phthalate, carboxymethyl cellulose and ethyl cellulose in a mass ratio of 1:1:2.

[0034] The polyethylene-based substance is composed of a polyvinyl alcohol-polyethylene glycol copolymer and polyvinyl alcohol in a mass ratio of 3:5. In the polyvinyl alcohol-polyethylene glycol copolymer, the mass proportion of the polyvinyl alcohol unit is 75%, the mass proportion of the polyethylene glycol unit is 25%, and the molecular weight is 30,000.

[0035] Step 1. Mix raw materials: Mix fluvastatin sodium, filler, binder, disintegrant and lubricant evenly.

[0036] Step 2. Prepare the skeleton: Granulate the powder mixed in Step 1 by dry granulation to form uniform granules, which will be used as the skeleton material of the sustained-release tablets to help control the drug release rate.

[0037] Step 3. Mix the cellulose derivative and the polyethylene-based substance, disperse them in water to obtain a coating material solution, and evenly coat the coating material solution on the surface of the granules to form coated granules.

[0038] Step 4. Tablet pressing preparation: Put the coated granules into a tablet press and press them into the shape and thickness of the tablets preset by the manufacturer. At the same time, control the pressure and temperature to make the sustained-release tablets, ensuring that the quality of each tablet is consistent.

[0039] Step 5. Quality inspection: Conduct quality inspection on the prepared fluvastatin sodium sustained-release tablets.

[0040] Step 6. Packaging and storage: Aluminum-plastic package the sustained-release tablets with qualified quality inspection to ensure their stability and moisture resistance, and store them in a cool and dry place to prevent moisture and light.

[0041] Specifically, the order and conditions for mixing raw materials in Step 1 are as follows:

[0042] S11. Mix fluvastatin sodium with the filler and disintegrant and disperse them evenly.

[0043] S12. Add 1 / 2 of the binder by mass, and mix at a speed of 50 r / min at a temperature of 40 °C for 25 min.

[0044] S13. Add the lubricant and the remaining 1 / 2 of the binder by mass, and mix at a speed of 50 r / min at a temperature of 20 °C for 5 min.

[0045] The advantages are as follows: Through the above steps, it can be ensured that the raw materials of the fluvastatin sodium sustained-release tablets are mixed in the correct proportion and sequence, thereby guaranteeing the uniform quality of the final product.

[0046] Specifically, the process of dry granulation in Step 2 is as follows:

[0047] S2. Put the powder mixed in Step 1 into a granulator. The pressure of the granulator is 5 MPa. Collect the granules to complete granulation.

[0048] Specifically, the process of film coating in Step 3 is as follows:

[0049] S31. Prepare the film coating solution: Mix film coating materials such as hydroxypropyl methylcellulose phthalate, carboxymethyl cellulose, ethyl cellulose, polyvinyl alcohol-polyethylene glycol copolymer and polyvinyl alcohol according to the proportion of raw materials, and add pure water in the proportion of raw materials to prepare a uniform film coating solution;

[0050] S32. Set the parameters of the fluidized bed film coating equipment: First, turn on the equipment and heat the fluidized bed film coating equipment to 50 °C. After preheating for 30 min, set the inlet air temperature of the fluidized bed film coating equipment to 50 °C, the spray pressure to 0.5 MPa, and the spray rate to 50 g / min. Then put the granules to be film coated into the fluidized bed film coating equipment;

[0051] S33. Spray film coating: Spray the prepared film coating solution evenly onto the surface of the granules through the spray system of the fluidized bed film coating equipment to form a continuous film coating layer. When the spray volume reaches 1 / 4, adjust the spray rate from 60 m 3 / s to 50 m 3 / s. When the spray volume reaches 1 / 2, adjust the spray rate from 50 m 3 / s to 30 m 3 / s. By continuously adjusting the spray parameters, ensure the uniformity and quality of the film coating layer;

[0052] S34. Curing: After film coating is completed, put the film-coated granules into a fluidized bed dryer for curing treatment at a temperature of 60 °C for 1 h to enhance the moisture-proof performance and sustained-release function of the film coating layer.

[0053] Specifically, the conditions for tableting preparation in Step 4 are as follows: Select a rotary tablet press, select the shape of the tablet press and set the thickness parameter of the tablet press according to the shape and thickness of the tablets preset by the manufacturer, adjust the pressure of the tablet press between 15 MPa, and adjust the temperature between 35 °C.

[0054] Specifically, the items for quality inspection in Step 5 are: content determination, impurity inspection, release test, appearance inspection, identification test, and moisture-proof test. Example 2

[0055] The weight percentages of the raw materials used below are as follows: 290 g of cellulose derivative, 90 g of polyethylene-based substance, 240 g of fluvastatin sodium, 250 g of filler, 30 g of binder, 12 g of disintegrant, 30 g of lubricant, and 1000 g of water.

[0056] Specifically, the filler is corn starch, the binder is povidone, the disintegrant is sodium carboxymethyl starch, and the lubricant is magnesium stearate.

[0057] The cellulose derivative is composed of hydroxypropyl methylcellulose phthalate, carboxymethyl cellulose, and ethyl cellulose with a mass ratio of 1:1:2.

[0058] The polyethylene-based substance is composed of a polyvinyl alcohol-polyethylene glycol copolymer and polyvinyl alcohol with a mass ratio of 3:5. In the polyvinyl alcohol-polyethylene glycol copolymer, the mass fraction of the polyvinyl alcohol unit is 75%, the mass fraction of the polyethylene glycol unit is 25%, and the molecular weight is 30000.

[0059] Step 1. Mix the raw materials: Mix fluvastatin sodium, filler, binder, disintegrant, and lubricant evenly.

[0060] Step 2. Prepare the skeleton: Granulate the powder mixed in Step 1 by dry granulation to form uniform granules, which will be used as the skeleton material of the sustained-release tablets to help control the drug release rate.

[0061] Step 3. Mix the cellulose derivative and the polyethylene-based substance, disperse them in water to obtain a coating material solution, and evenly coat the coating material solution on the surface of the granules to form coated granules.

[0062] Step 4. Tablet pressing preparation: Put the coated granules into a tablet press and press them into the shape and thickness of the tablets preset by the manufacturer. At the same time, control the pressure and temperature to make the sustained-release tablets, ensuring that the quality of each tablet is consistent.

[0063] Step 5. Quality inspection: Conduct quality inspection on the prepared fluvastatin sodium sustained-release tablets.

[0064] Step 6. Packaging and storage: Aluminum-plastic package the sustained-release tablets that pass the quality inspection to ensure their stability and moisture resistance, and store them in a cool and dry place to prevent moisture and light.

[0065] Specifically, the order and conditions for mixing the raw materials in Step 1 are as follows:

[0066] S11. Mix fluvastatin sodium with the filler and disintegrant and disperse them evenly.

[0067] S12. Add half of the mass of the binder and mix at a temperature of 45 °C at a speed of 50 r / min for 25 min.

[0068] S13. Add lubricant and the remaining binder accounting for 1 / 2 of the mass, and mix at a speed of 50 r / min for 8 min at a temperature of 25°C.

[0069] Advantages: Through the above steps, it can ensure that the raw materials of the fluvastatin sodium sustained-release tablets are mixed in the correct proportion and sequence, thus ensuring the uniform quality of the final product.

[0070] Specifically, the process of dry granulation in step two is as follows:

[0071] S2. Put the powder mixed in step one into a granulator, with the pressure of the granulator being 5 MPa, collect the granules, and the granulation is completed.

[0072] Specifically, the process of film coating treatment in step three is as follows:

[0073] S31. Prepare the film coating solution: Mix film coating materials such as hydroxypropyl methylcellulose phthalate, carboxymethylcellulose, ethylcellulose, polyvinyl alcohol-polyethylene glycol copolymer and polyvinyl alcohol according to the proportion of raw materials, and add pure water in the proportion of raw materials to prepare a uniform film coating solution;

[0074] S32. Set the parameters of the fluidized bed film coating equipment: First, turn on the equipment, heat the fluidized bed film coating equipment to a temperature of 50°C, after preheating for 30 min, set the inlet air temperature of the fluidized bed film coating equipment to 50°C, the spray pressure to 0.5 MPa, the spray rate to 100 g / min, and then put the granules to be film coated into the fluidized bed film coating equipment;

[0075] S33. Spray film coating: Spray the prepared film coating solution evenly onto the surface of the granules through the spray system of the fluidized bed film coating equipment to form a continuous film coating layer. When the spray volume reaches 1 / 4, adjust the spray rate from 60 m 3 / s to 50 m 3 / s. When the spray volume reaches 1 / 2, adjust the spray rate from 50 m 3 / s to 30 m 3 / s. By continuously adjusting the spray parameters, ensure the uniformity and quality of the film coating layer;

[0076] S34. Curing: After film coating is completed, put the film-coated granules into a fluidized bed dryer for curing treatment at a temperature of 60°C for 1 h to enhance the moisture-proof performance and sustained-release function of the film coating layer.

[0077] Specifically, the conditions for tableting preparation in step four are: Select a rotary tablet press, select the shape of the tablet press and set the thickness parameter of the tablet press according to the shape and thickness of the tablets preset by the manufacturer, adjust the pressure of the tablet press between 15 MPa, and adjust the temperature between 35°C.

[0078] Specifically, the items for quality inspection in step five are: content determination, impurity inspection, dissolution test, character inspection, identification test, and moisture-proof test.

[0079] Comparative Example 1

[0080] In Comparative Example 1, the polyvinyl substance in Example 1 consists only of polyvinyl alcohol, and the preparation is carried out according to the preparation steps of Example 1.

[0081] Comparative Example 2

[0082] In Comparative Example 2, the cellulose derivative in Example 1 consists only of ethyl cellulose, and the preparation is carried out according to the preparation steps of Example 1.

[0083] Comparative Example 3

[0084] Change the preparation steps: Comparative Example 3 uses the raw material formula of Example 1. For the way of mixing raw materials in step one of Example 1, all raw materials are mixed in the same beaker at a temperature of 40°C at a speed of 100 r / min, and the other steps remain unchanged.

[0085] Finished product test

[0086] The finished products of fluvastatin sodium sustained-release tablets prepared in Examples 1-2 and Comparative Examples 1-3 are detected. The detection items include hardness, dissolution, and impurity content.

[0087] The hardness test is carried out using a tablet hardness tester, and the results are shown in Table 1.

[0088] Table 1

[0089] Example 1 Example 2 Comparative Example 1 Comparative Example 2 Comparative Example 3 28N 27N 26N 26N 20N

[0090] By comparing the test data in Table 1 of Examples 1-2 and Comparative Examples 1-3, it can be seen that appropriate preparation steps can effectively prepare fluvastatin sodium sustained-release tablets with qualified hardness.

[0091] The dissolution test uses water containing % w / v Tween 80 as the release medium, and the dissolution after 60 min of release is tested. The results are shown in Table 2.

[0092] Table 2

[0093] Example 1 Example 2 Comparative Example 1 Comparative Example 2 Comparative Example 3 101.03% 100.48% 92.52% 93.49% 97.20%

[0094] By comparing the test data of Examples 1-2 and Comparative Examples 1-3, it can be seen that appropriate coating materials, polyvinyl substances and cellulose derivatives, can obtain higher dissolution.

[0095] The test results of impurity content are shown in Table 3.

[0096] Table 3

[0097] Example 1 Example 2 Comparative Example 1 Comparative Example 2 Comparative Example 3 0.49% 0.53% 0.88% 0.74% 0.96%

[0098] By comparing the test data in Table 1 of Examples 1-2 and Comparative Examples 1-3, it can be seen that appropriate preparation steps can effectively prepare fluvastatin sodium sustained-release tablets with qualified impurity content.

[0099] In addition, to test the moisture-proof performance of the fluvastatin sodium sustained-release tablets, the dissolution test was carried out after the long-term test of the fluvastatin sodium sustained-release tablets. The conditions for the long-term test were to place them at a temperature of 40 °C and a relative humidity of 75% RH for 6 months. The dissolution results after the long-term test are shown in Table 4.

[0100] Table 4

[0101] Example 1 Example 2 Comparative Example 1 Comparative Example 2 Comparative Example 3 100.53% 100.02% 87.33% 88.25% 94.37%

[0102] It can be seen that after the long-term test, the fluvastatin sodium sustained-release tablets have excellent moisture-proof performance, so that the dissolution can still be maintained at a high level.

[0103] Although the embodiments of the present invention have been shown and described, for those of ordinary skill in the art, it can be understood that various changes, modifications, substitutions and variations can be made to these embodiments without departing from the principle and spirit of the present invention. The scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A sustained-release tablet of fluvastatin sodium, characterized in that, Prepared from the following raw materials in parts by weight: 25 - 29 parts of cellulose derivative; 5 - 9 parts of polyethylene - like substance; 20 - 24 parts of fluvastatin sodium; 20 - 25 parts of filler; 1 - 3 parts of binder; 1 - 1.2 parts of disintegrant; 2 - 3 parts of lubricant; The cellulose derivative is composed of hydroxypropyl methylcellulose phthalate, carboxymethyl cellulose and ethyl cellulose with a mass ratio of 1:1 - 1.5:2 - 2.5; The polyethylene - like substance is composed of a polyvinyl alcohol - polyethylene glycol copolymer and polyvinyl alcohol with a mass ratio of 3:5 - 6; The preparation method of the fluvastatin sodium sustained - release tablets includes Step 1, mixing raw materials: Weigh fluvastatin sodium and excipients according to the raw material ratio and mix them evenly; The sequence and conditions of mixing raw materials in Step 1 are: S11. Mix fluvastatin sodium with filler and disintegrant and disperse them evenly; S12. Add 1 / 2 of the binder by mass, and mix at a speed of 50 r / min at a temperature of 40℃ - 45℃ for 25 min - 30 min; S13. Add lubricant and the remaining 1 / 2 of the binder by mass, and mix at a speed of 50 r / min at a temperature of 20℃ - 25℃ for 5 min - 8 min.

2. Preparation method of fluvastatin sodium sustained-release tablets, characterized in that, Prepared according to the weight ratio of raw materials of the fluvastatin sodium sustained - release tablets described in Claim 1, the preparation steps of the sustained - release tablets are: Step 1, mixing raw materials: Weigh fluvastatin sodium and excipients according to the raw material ratio and mix them evenly; Step 2, preparing the skeleton: Granulate the powder mixed in Step 1 by dry granulation to form uniform granules; Step 3, coating treatment: Mix the cellulose derivative and the polyethylene - like substance, disperse them in water to obtain a coating material solution, and evenly coat the coating material solution on the surface of the granules to form coated granules; Step 4, tablet pressing preparation: Put the coated granules into a tablet press to press tablets to obtain fluvastatin sodium sustained - release tablets.

3. The preparation method of the fluvastatin sodium sustained-release tablets according to claim 2, characterized in that: The sequence and conditions of mixing raw materials in Step 1 are: S11. Mix fluvastatin sodium with filler and disintegrant and disperse them evenly; S12. Add ½ of the binder by mass, and mix at a speed of 50 r / min at a temperature of 40℃ - 45℃ for 25 min - 30 min; S13. Add lubricant and the remaining ½ of the binder by mass, and mix at a speed of 50 r / min at a temperature of 20℃ - 25℃ for 5 min - 8 min.

4. The preparation method of the fluvastatin sodium sustained-release tablets according to claim 3, characterized in that: [[ID=⑧]]The process of dry granulation in Step 2 is: S2. Put the powder mixed in Step 1 into a granulator, the pressure of the granulator is 5 MPa, collect the granules, and the granulation is completed.

5. The preparation method of the fluvastatin sodium sustained-release tablets according to claim 2, wherein: The process of film coating treatment in step three is as follows: S31. Prepare the film coating solution: Mix hydroxypropyl methylcellulose phthalate, carboxymethyl cellulose, ethyl cellulose, polyvinyl alcohol-polyethylene glycol copolymer and polyvinyl alcohol film coating materials according to the raw material ratio, and add pure water in the raw material ratio to prepare a uniform film coating solution; S32. Set the parameters of the fluidized bed coating equipment: First, turn on the equipment, heat the fluidized bed coating equipment to 50 °C, after preheating for 30 min, set the inlet air temperature of the fluidized bed coating equipment to 50 °C, the spray pressure to 0.5 MPa, the spray rate to 50 - 100 g / min, and then put the particles to be coated into the fluidized bed coating equipment; S33. Spray coating: Spray the prepared film coating solution evenly onto the particle surface through the spray system of the fluidized bed coating equipment to form a continuous film coating layer. When the spray volume reaches 1 / 4, adjust the spray rate from 60 m 3 / s to 50 m 3 / s. When the spray volume reaches 1 / 2, adjust the spray rate from 50 m 3 / s to 30 m 3 / s by continuously adjusting the spray parameters; S34. Curing: After film coating is completed, put the film-coated particles into a fluidized bed dryer for curing treatment at a temperature of 60 °C for 1 h.

6. The preparation method of the fluvastatin sodium sustained-release tablets according to claim 2, characterized in that: [[ID=⑨]]The conditions of tablet pressing preparation in Step 4 are: Adjust the pressure of the tablet press between 15 MPa - 20 MPa and adjust the temperature between 35℃ - 40℃.

7. The preparation method of the fluvastatin sodium sustained-release tablets according to claim 2, wherein: [[ID=⑩]]The preparation method further includes: Step 5, quality inspection: Conduct quality inspection on the prepared fluvastatin sodium sustained - release tablets; Step 6, packaging and storage: Aluminum - plastic package the sustained - release tablets that pass the quality inspection.

Images