WO2013020302A1 - Diclofenac sodium sustained release tablet and preparation process therefor - Google Patents

Abstract

A diclofenac sodium sustained release tablet and a preparation process therefor. The diclofenac sodium sustained release tablet comprises the following components: diclofenac sodium 16.5-39.0%, a sustained-release agent 10.0-35.5%, a filler 33.5-65.0%, a glidant 2.01-8.0%, a lubricant 0-2.5%, and a binder 0-8.0%. The diclofenac sodium sustained release tablet is prepared by a full-powder direct tabletting process, which prevents coagulation of particles, and at the same time does not use high-concentration alcohol.

Description

 Diclofenac sodium sustained-release tablet and preparation process thereof

 This application claims priority to Chinese Patent Application No. 201110228244.1, entitled "Diclofenac Sodium Sustained Release Tablets and Preparation Process" thereof, filed on August 10, 2011, the entire contents of which are incorporated herein by reference. In the application. Technical field

 The present invention relates to the field of medical technology, and in particular to a diclofenac sodium sustained-release tablet and a preparation process thereof

Diclofenac sodium, chemical name is [o-(2,6-dichloroaniline)] sodium phenylacetate, the molecular formula is Cl ₄ H ₁₀ Cl ₂ NNaO ₂ , the molecular weight is 318.13, and the molecular structural formula is as follows:

Diclofenac is light yellow crystal, odorless, soluble in water, non-polar organic solvents such as ethanol. It is a non-steroidal anti-inflammatory analgesic derived from phenylacetic acid, which can inhibit cyclooxygenase activity. Thereby blocking the conversion of arachidonic acid to prostaglandins; at the same time, it can also promote the combination of arachidonic acid and triglyceride (triacylglycerol), reduce the concentration of intracellular free arachidonic acid, and indirectly inhibit leukotrienes, The production of products such as bradykinin can exert antipyretic analgesic and anti-inflammatory effects.

In order to delay the release rate of the drug from the drug, reduce the absorption rate of the drug into the body, and achieve better analgesic and anti-inflammatory treatment effects, at present, the clinically mainly through the diclofenac sodium sustained release tablets for the treatment of various inflammations and pain, including : spondyloarthropathy, gouty arthritis, wind Acute exacerbation of chronic arthritis such as wet arthritis or persistent joint swelling and pain symptoms; various soft tissue rheumatic pain, such as shoulder pain, tenosynovitis, genital warts and post-exercise injury pain; acute light, Moderate pain such as: pain after surgery, trauma, strain, etc.; and primary dysmenorrhea, toothache, headache, etc.

 At present, the diclofenac sodium sustained-release tablets mostly use the wet granulation process, using hydroxypropyl fluorenyl cellulose as the framework material, adding calcium hydrogen phosphate, lactose, magnesium stearate, talc, etc., using high concentration of ethanol as a wetting agent. Granulation. However, the raw materials and processes of the diclofenac sodium sustained-release tablet make the granulation and drying time longer, and the hydroxypropyl fluorenyl cellulose becomes very viscous when exposed to water or alcohol, and is easily agglomerated, and the dried granules are very hard. It is not easy to granulate, the granulation process has many heads, the head is hard to recover, and the yield is not high, only 85% ~ 90%, or even lower; the difference in particle and fine powder content is large, the content uniformity is not easy to control; The obtained diclofenac sodium sustained-release tablets may have stains and pitting, and the appearance is poor, which affects the market promotion. At the same time, high concentration of ethanol easily causes operators to experience symptoms such as dizziness and fatigue during granulation, and ethanol is a flammable and explosive substance. The use of high concentration of ethanol in the granulation process poses a safety hazard.

 The whole powder direct compression method is different from the ordinary granulation tableting method, and the materials required for the tableting are all powdery fine powder, and the compressibility and fluidity of the material will determine the quality of the final product. In addition, the full powder direct compression method requires the tablet press to have an automatic sealing device, a good dust removal device, and a tight joint between the duster and the turntable. Due to the high requirements for excipients and preparation equipment, the industrial production application of the full powder direct compression method is subject to many limitations.

Therefore, a diclofenac sodium sustained-release tablet and a preparation process thereof are provided, which avoids the occurrence of particle coagulation after granulation drying and the negative impact of ethanol on human body and safety, and has practical significance. Summary of the invention

 In view of this, the present invention provides a sustained release tablet of diclofenac sodium and a preparation method thereof. The diclofenac sodium sustained-release tablet provided by the invention and the preparation process thereof can improve the recovery rate of the raw material to 98.0-100.0% by changing the raw material composition and preparation process of diclofenac sodium, and directly compressing the particles to avoid particle coagulation, and the surface of the tablet is flat, and at the same time Avoid the use of alcohol and reduce the safety during production |刍

In order to achieve the above object, the present invention provides the following technical solutions: The present invention provides a sustained release tablet of diclofenac sodium, in mass percentage, including the following groups

Diclofenac sodium 16.5 - 39.0 % Sustained release agent 10.0 - 35.5 % Filler 33.5 - 65.0 % Glidant 2.01 ~ 8.0 % Lubricant 0 ~ 2.5 % Adhesive 0 ~ 8.0 %.

 In the diclofenac sodium sustained-release tablet provided by the present invention, the diclofenac sodium component content is the mass fraction of diclofenac sodium in the whole component after the purification.

 Preferably, the raw material of the diclofenac sodium sustained release tablet provided by the present invention comprises diclofenac sodium having a mass fraction of 23.4 to 33.2%.

 The invention adopts a skeleton material to adjust the release time to achieve the purpose of sustained release or controlled release. In some embodiments of the present invention, the sustained release preparation of the diclofenac sodium sustained release tablet provided by the present invention comprises glyceryl monostearate, glyceryl behenate, hydroxypropyl fluorenyl cellulose, thiol cellulose, poly A mixture of one or more of a mixture of vinylpyrrolidone and vinyl acetate. Preferably, the slow release agent is one or a mixture of two or more of glyceryl behenate, hydroxypropyl decyl cellulose, polyvinylpyrrolidone and vinyl acetate. Among them, hydroxypropyl fluorenyl cellulose has excellent thickening ability, salt discharge, pH stability, water retention, dimensional stability, film formation, and extensive enzyme resistance, dispersibility and cohesiveness. The water can swell to form a viscous solution, and the heating and cooling can be mutually converted in the solution and the gel. Therefore, in some embodiments of the present invention, the sustained release tablet of the diclofenac sodium sustained release tablet provided by the present invention is hydroxy Propyl fluorenyl cellulose. In other embodiments provided by the present invention, the sustained release agent is a mixture of polyvinylpyrrolidone and vinyl acetate.

 In some embodiments of the present invention, the raw material of the diclofenac sodium sustained release tablet provided by the present invention comprises the sustained release agent having a mass fraction of 10.20 to 35.77 %.

In other embodiments of the present invention, the raw material of the diclofenac sodium sustained release tablet provided by the present invention comprises the sustained release agent having a mass fraction of 12.04 to 24.03%. In other embodiments provided by the present invention, the raw material of the diclofenac sodium sustained release tablet provided by the present invention comprises the sustained release agent having a mass fraction of 13.5 to 14.89%.

 Filler refers to an excipient that increases the weight and volume of the tablet and facilitates molding and dispensing. Preferably, in the sustained release tablet of diclofenac sodium provided by the present invention, the filler comprises one or a mixture of two or more of microcrystalline cellulose, lactose, mannitol, pregelatinized starch, carbonic acid carbonate, and calcium hydrogen phosphate. Preferably, in the sustained release tablet of diclofenac sodium provided by the present invention, the filler is one or a mixture of two or more of microcrystalline cellulose, lactose, pregelatinized starch, and calcium hydrogen phosphate.

 Preferably, the present invention provides a sustained release tablet of diclofenac sodium, the raw material comprising a mass fraction of

32.49 ~ 64.90% of the filler.

 More preferably, the present invention provides a sustained release tablet of diclofenac sodium, the raw material comprising a mass fraction of

35.6 ~ 53.83% of the filler.

 The glidant, which adheres to the surface of the granule or powder, fills the depression of the rough surface and separates the particles, reduces the friction between the particles, and improves the fluidity of the tablet. Preferably, in the sustained release tablet of diclofenac sodium provided by the present invention, the glidant comprises one or a mixture of talc, microsilica gel or both. Preferably, in the sustained release tablet of diclofenac sodium provided by the present invention, the flow aid is a micro powder.

 In some embodiments of the present invention, the raw material of the diclofenac sodium sustained release tablet provided by the present invention comprises 2.01 to 8.16% of the glidant.

 In some embodiments of the present invention, the raw material of the diclofenac sodium sustained release tablet provided by the present invention comprises 2.1 to 6.8% of the glidant.

 In still other embodiments of the present invention, the raw material of the diclofenac sodium sustained release tablet provided by the present invention comprises 2.3 to 4.57% of the glidant.

 In order to smoothly feed and release the sheet, reduce the sticking and reduce the friction between the particles and the particles, the tablet and the wall of the die hole, so that the surface is smooth and beautiful, and the particles (or crystal) are generally required before the tableting. Add a suitable lubricant to it. Preferably, in the sustained release tablet of diclofenac sodium provided by the present invention, the lubricant comprises a mixture of stearic acid, stearic acid 4 bow, magnesium stearate, or a mixture of two or more thereof. Preferably, in the sustained release tablet of diclofenac sodium provided by the present invention, the lubricant is magnesium stearate.

In some embodiments of the present invention, the present invention provides a sustained release tablet of diclofenac sodium, the raw material comprising 0 to 2.90% of the lubricant. In still other embodiments of the present invention, the present invention provides a sustained release tablet of diclofenac sodium, the raw material comprising 0.2 to 1.26% of the lubricant.

 Adhesive refers to a viscous solid powder or viscous liquid that allows a non-tacky or less viscous material to aggregate and bond into granules or compression molded. Preferably, the present invention provides a diclofenac sodium sustained release tablet, the binder comprising one or a mixture of hydroxypropyl decyl cellulose and polyvinyl pyrrolidone.

 In some embodiments of the present invention, the raw material of the diclofenac sodium sustained release tablet provided by the present invention further comprises 0 to 8.16% of a binder.

 In still other embodiments of the present invention, the raw material of the diclofenac sodium sustained release tablet provided by the present invention further comprises 0.06 to 1.37% of a binder.

 Preferably, in the sustained release tablet of diclofenac sodium provided by the present invention, the film-coated material comprises a cellulose derivative and an acrylic resin.

 In some embodiments provided by the present invention, the diclofenac sodium sustained release tablet, by mass percent, comprises the following components:

 Diclofenac sodium 16.5 - 39.0 % Sustained release agent 13·5~14·9 % Filler 33.5 ~ 65.0 % Promoter 2.01 ~ 8.0 % Lubricant 0 - 2.5 % Adhesive 0 ~ 8.0 %.

 Wherein the sustained release agent is a mixture of one or more of a mixture of glyceryl behenate, hydroxypropyl decyl cellulose, polyvinylpyrrolidone and vinyl acetate; the filler is microcrystalline cellulose, lactose, pre a mixture of one or more of gelatinized starch and calcium hydrogen phosphate; the glidant is a micronized silica gel; the lubricant is magnesium stearate; the diclofenac sodium sustained release tablet provided by the invention, the binder is hydroxypropyl Sulfhydryl cellulose, polyvinylpyrrolidone; the coating film material is hydroxypropyl fluorenyl cellulose or acrylic resin.

 The present invention also provides a process for preparing the above-mentioned diclofenac sodium sustained-release tablet, which comprises, by mass percentage, a prescription comprising the following components:

Diclofenac sodium 16.5 - 39.0 % Sustained release agent 10.0 - 35.5 % Filler 33.5 - 65.0 % Glidant 2.01 ~ 8.0 % Lubricant 0 ~ 2.5 % Adhesive 0 ~ 8.0 %.

 Take diclofenac sodium, glidant over 80 ~ 120 mesh sieve to mix evenly (in order to make the flow aid evenly adhere to the surface of diclofenac sodium), add filler, slow release agent, adhesive mixed for 10 ~ 60min, then After adding the lubricant for 3 to 15 minutes, the diclofenac sodium sustained-release tablets were prepared after tableting.

 In the preparation process of the diclofenac sodium sustained-release tablet provided by the invention, the content of the diclofenac sodium component in the raw material is the mass fraction of the diclofenac sodium in the whole component after the reduction.

 The diclofenac sodium is mixed with the glidant to a uniformity in order to completely disperse the flow aid into the diclofenac sodium, thereby improving the fluidity of the diclofenac sodium, and it can be continuously mixed by sieving, preferably 1 to 3 times. After adding filler, slow release agent and binder, mix for 10 ~ 60min to mix the materials evenly. Then add the lubricant, after sieving, mix for 3 ~ 15min, sieving can prevent the internal accumulation of the lubricant, break up the large particles, the mixture can mix the lubricant with other materials evenly, after the tableting, the invention provides Sustained-release tablets of diclofenac sodium.

 Preferably, in the preparation process of the diclofenac sodium sustained-release tablet provided by the present invention, the raw material comprises diclofenac sodium having a mass fraction of 23.4 to 33.2%.

 Preferably, the present invention provides a process for preparing a sustained release tablet of diclofenac sodium, the sustained release agent comprising glyceryl monostearate, glyceryl behenate, hydroxypropyl fluorenyl cellulose, thiol cellulose, polyvinylpyrrolidone and One or a mixture of two or more of vinyl acetate mixtures.

 Preferably, in the preparation process of the diclofenac sodium sustained release tablet provided by the present invention, the sustained release agent is hydroxypropyl fluorenyl cellulose.

 Preferably, the present invention provides a process for preparing a sustained release tablet of diclofenac sodium, wherein the raw material comprises the sustained release agent having a mass fraction of 10.20 to 35.77 %.

 Preferably, the present invention provides a process for preparing a sustained release tablet of diclofenac sodium, wherein the raw material comprises the sustained release agent having a mass fraction of 12.04 to 24.03%.

More preferably, the preparation process of the diclofenac sodium sustained-release tablet provided by the present invention, the raw material comprises The sustained release agent is prepared with a mass fraction of 13.5 to 14.89%.

 Preferably, in the preparation process of the diclofenac sodium sustained-release tablet provided by the present invention, the filler comprises one or more of microcrystalline cellulose, lactose, mannitol, pregelatinized starch, carbonated carbon, and calcium hydrogen phosphate. mixture.

 Preferably, the preparation process of the diclofenac sodium sustained-release tablet provided by the invention comprises the filler having a mass fraction of 33.51 ~ 64.90%.

 More preferably, the preparation process of the diclofenac sodium sustained-release tablet provided by the present invention comprises the filler having a mass fraction of 35.6 to 53.83 %.

 Preferably, in the preparation process of the diclofenac sodium sustained-release tablet provided by the present invention, the glidant comprises one or a mixture of talc, microsilica gel or both.

 Preferably, the preparation process of the diclofenac sodium sustained-release tablet provided by the invention comprises 2.01 to 8.16% of the glidant.

 Preferably, the preparation process of the diclofenac sodium sustained-release tablet provided by the invention comprises 2.1 to 6.8% of the glidant.

 More preferably, the preparation process of the diclofenac sodium sustained-release tablet provided by the invention comprises the raw materials

2.35 ~ 4.57% of the glidant.

 Preferably, in the preparation process of the diclofenac sodium sustained-release tablet provided by the present invention, the lubricant comprises one or a mixture of two or more of stearic acid, calcium stearate, and magnesium stearate.

 Preferably, the preparation process of the diclofenac sodium sustained-release tablet provided by the invention comprises 0 to 2.90% of the lubricant.

 More preferably, the preparation process of the diclofenac sodium sustained-release tablet provided by the invention comprises 0.2 to 1.26% of the lubricant.

 Preferably, the present invention provides a process for preparing a sustained release tablet of diclofenac sodium, the binder comprising one or a mixture of hydroxypropyl fluorenyl cellulose and polyvinylpyrrolidone.

 Preferably, the preparation process of the diclofenac sodium sustained release tablet provided by the invention further comprises

0 ~ 8.16% binder.

 More preferably, the preparation process of the diclofenac sodium sustained-release tablet provided by the invention further comprises 0.06 ~ 1.37% of the binder.

Preferably, the preparation process of the diclofenac sodium sustained-release tablet provided by the invention is further after tableting A step of including a film coating.

 Preferably, in the preparation process of the diclofenac sodium sustained-release tablet provided by the present invention, the film coating material required for the film coating comprises a cellulose derivative and an acrylic resin.

 Preferably, in the preparation process of the diclofenac sodium sustained-release tablet provided by the present invention, the film coating material required for the film coating is 2.1 to 8.0% of the total mass of the raw material.

 In some embodiments provided by the present invention, the preparation process of the diclofenac sodium sustained release tablet, by mass percent, comprises the following components:

 Diclofenac sodium 16.5 - 39.0 % sustained release agent 13.5~14.9 % filler 33.5 ~ 65.0 % adjuvant 2.01 ~ 8.0 % lubricant 0 - 2.5 % binder 0 ~ 8·0 %.

 Wherein, the sustained release agent is a mixture of one or more of a mixture of glyceryl behenate, hydroxypropyl decyl cellulose, polyvinylpyrrolidone and vinyl acetate; the filler is microcrystalline cellulose, lactose, pre-glue One or a mixture of two or more of the starch and the calcium hydrogen phosphate; the glidant is a micro-silica gel; the lubricant is one or more of stearic acid, stearic acid 4 bow, magnesium stearate Mixture; the present invention provides a sustained release tablet of diclofenac sodium, the binder is hydroxypropyl decyl cellulose or polyvinylpyrrolidone; the coating material is hydroxypropyl fluorenyl cellulose or acrylic resin.

 Take diclofenac sodium, glidant over 80 mesh, less than or equal to 120 mesh sieve, mix until uniform, add filler, slow release agent, adhesive for 10 ~ 60min, then add lubricant for 3 ~ 15min, then press A sustained release tablet of diclofenac sodium was prepared after tableting.

 The present invention also provides a sustained release tablet of diclofenac sodium prepared by the above preparation process.

The diclofenac sodium sustained-release tablet provided by the invention and the preparation process thereof improve the yield to 98.0-100.0% by changing the prescription composition and the preparation process. The process of the invention is easy to operate, and only the diclofenac sodium and the auxiliary materials are uniformly mixed, and then directly pressed, and the granulation and drying processes are omitted by changing the components and the preparation process, thereby avoiding particle condensation and eliminating the generation of the head. At the same time, avoid the use of alcohol and reduce the safety hazards in the production process. The granulating and drying process is omitted, and the time is short, the production efficiency is greatly improved, and the production cost is saved from 21.9 to 48.8%. Intermediate material The fluidity and compressibility are good, the content is good, and it can meet the requirements of tableting; the surface of the tablet is flat, and the product has undergone quality research and stability investigation, which proves that the quality of the whole powder direct compression method is stable and reliable; , to meet the market requirements. detailed description

 The invention discloses a diclofenac sodium sustained-release tablet and a preparation method thereof, and those skilled in the art can learn from the contents of the paper and appropriately improve the process parameters. It is to be noted that all such alternatives and modifications are obvious to those skilled in the art and are considered to be included in the present invention. The method and the application of the present invention have been described by the preferred embodiments, and it is obvious that the method and application described herein may be modified or appropriately modified and combined without departing from the scope of the present invention. The technique of the present invention is applied.

 The diclofenac sodium and the pharmaceutically acceptable excipients in the examples of the present invention can be purchased from the market.

 The present invention will be further illustrated below in conjunction with the embodiments: Example 1

 Recipe:

 Diclofenac sodium 1000.0 g Hydroxypropyl fluorenyl cellulose 567.5 g Sulfhydryl cellulose 403.0 g Calcium hydrogen phosphate 1341.1 g Microsilica gel 152.0 g Talc powder 50.0g Magnesium stearate 70.6 g Preparation process:

Accurately weigh 1000.0 g of diclofenac sodium, 567.5 g of hydroxypropyl fluorenyl cellulose, 403.0 g of thiol cellulose, 1341.1 g of calcium hydrogen phosphate, 152.0 g of silica gel, 50.0 g of talc, 70.6 g of magnesium stearate, Generation (film material is hydroxypropyl fluorenyl cellulose) 100.0 g, spare. Diclofenac sodium, micro-powder silica gel, talc powder was mixed through 80 mesh sieve to uniformity, adding calcium hydrogen phosphate, hydroxypropyl decyl cellulose, sulfhydryl cellulose for 30 min, then adding magnesium stearate for 5 min, then tableting After coating with Opadry, 10,000 tablets of diclofenac sodium sustained-release tablets were prepared, the specification was 0.36 g, and the yield was 98.23%. Example 2

 Recipe:

 Diclofenac sodium 1000.0 g Hydroxypropyl decyl cellulose 390.5 g Microcrystalline cellulose 895.4 g Microsilica gel 51.5 g Stearic acid 67.3 g Polyvinylpyrrolidone 159.1 g„ Preparation process:

 Accurately weighed 1000.0 g of diclofenac sodium, 390.5 g of hydroxypropyl fluorenyl cellulose, 895.4 g of microcrystalline cellulose, 51.5 g of micronized silica gel, 67.3 g of stearic acid, and 159.1 g of polyvinylpyrrolidone.

 Diclofenac sodium, micro-powder silica gel was mixed through 100 mesh sieve to homogeneity, microcrystalline cellulose, hydroxypropyl decyl cellulose, polyvinylpyrrolidone was added for 60 min, then stearic acid was added for 5 min, and then diclofenac was prepared after tableting. 10000 tablets of sustained-release tablets have a specification of 0.26 g and a yield of 99.14%. Example 3

 Recipe:

Diclofenac sodium 1000.0 g Hydroxypropyl decyl cellulose 439.6 g Lactose 2459.2 g Micropowder silica gel 251.7 g lOO.Og

59.0 g _c preparation process:

 Accurately weigh 1000.0 g of diclofenac sodium, 439.6 g of hydroxypropyl decyl cellulose, 2459.2 g of lactose, 251.7 g of silica gel, 100.0 g of talc, 59.0 g of polyvinylpyrrolidone, and Utech (film coating is acrylic resin) 60.0 g , spare.

Diclofenac sodium, micro-powder silica gel, talc powder was mixed through a 120 mesh sieve to uniformity, and lactose, hydroxypropyl decyl cellulose and polyvinylpyrrolidone were added for 10 min, and then compressed, and coated with acrylic resin to obtain sustained release of diclofenac sodium. The film was 10,000 pieces with a specification of 0.43 g and a yield of 98.47%.

 Recipe:

 Diclofenac sodium 500 .0g

 Glyceryl citrate 173.1 g

 Hydroxypropyl fluorenyl cellulose H4.7g

 Microcrystalline cellulose 456.0 g

 Micronized silica gel 26.9 g

 Calcium stearate 2.6 g

 Kollidon VA64 7.7 g o Preparation process:

 Accurately weigh 500.0 g of diclofenac sodium, 173.1 g of glyceryl behenate, 114.7 g of hydroxypropyl fluorenyl cellulose, 456.0 g of microcrystalline cellulose, 26.9 g of silica gel, 4 2.6 g of stearic acid, Kollidon VA64 (effective The composition is polyvinylpyrrolidone) 7.7 g, spare.

Diclofenac sodium, micro-powder silica gel was mixed through 100 mesh sieve to homogeneity, microcrystalline cellulose, glyceryl behenate, hydroxypropyl decyl cellulose, Kollidon VA64 was mixed for 30 min, then calcium stearate was added for 8 min. After, tableting, 10,000 tablets of diclofenac sodium sustained-release tablets, specifications It was 0.13 g, and the yield was 98.79%.

Example 5

 Recipe:

 Diclofenac sodium 500.0 g Hydroxypropyl decyl cellulose 755.9 g Calcium carbonate 756.5 g Microsilica gel 49.6 g Hard acid 51.1 g „ Preparation process:

 Accurately weigh diclofenac sodium 500.0 g, hydroxypropyl decyl cellulose 755.9 g, carbonic acid 4 丐 756.5 g, micro powder silica gel 49.6 g, hard acid acid 51.1 g, spare.

 Take diclofenac sodium, micro-powder silica gel through a 120 mesh sieve to mix until uniform, add calcium carbonate, hydroxypropyl fluorenyl cellulose for 20min, then add stearic acid for 10 min, then tablet, to produce diclofenac sodium sustained release tablets 10000 The tablet has a specification of 0.21 g and a yield of 99.42%. Example 6

 Recipe:

 Diclofenac sodium 500.0g Mixture of vinyl acetate and polyvinylpyrrolidone 636.3 g

Hydroxypropyl fluorenyl cellulose 91.3 g Microcrystalline cellulose 1616.0 g Micropowder silica gel 78.4 g Talc powder 60.0g Magnesium stearate 20.3 g Preparation process: Accurately weigh 500.0 g of diclofenac sodium, a mixture of vinyl acetate and polyvinylpyrrolidone (a mixture of vinyl acetate and polyvinylpyrrolidone, the mass fraction of vinyl acetate is 80%, and the mass fraction of polyvinylpyrrolidone is 19 %) 636.3 g , hydroxypropyl mercapto cellulose 91.3 g, microcrystalline cellulose 1616.0 g, micro powder silica gel 78.4 g, talc powder 60.0 g, magnesium stearate 20.3 g, spare.

 Diclofenac sodium, micro-powder silica gel, talc powder was mixed through a 100 mesh sieve to uniformity, and microcrystalline cellulose, a mixture of vinyl acetate and polyvinylpyrrolidone, and hydroxypropyl fluorenyl cellulose were mixed for 30 minutes, and then magnesium stearate was added. After mixing for 13 minutes, tableting was carried out to obtain 10,000 tablets of diclofenac sodium sustained-release tablets having a specification of 0.30 g and a yield of 99.13%. Example 7

 Recipe:

 Diclofenac sodium 750.0g Hydroxypropyl decyl cellulose 231.4g Pregelatinized starch 644.0 g Micronized silica gel 146.1 g Magnesium stearate 36.5 g Polyvinylpyrrolidone 114.0 g „ Preparation process:

 Accurately weighed diclofenac sodium 750.0 g, hydroxypropyl decyl cellulose 231.4 g, pregelatinized starch 644.0g, micronized silica gel 146.1 g, magnesium stearate 36.5 g, povidone 114.0 g, spare.

 Take diclofenac sodium, micro-powder silica gel over 100 mesh sieve and mix until uniform, add pre-gelatinized starch, hydroxypropyl decyl cellulose, polyvinylpyrrolidone for 40 min, then add magnesium stearate for 9 min, then compress, 10,000 tablets of sustained-release tablets of diclofenac sodium were prepared, and the specification was 0.19 g, and the yield was 98.53%. Example 8

formula: Diclofenac sodium 750.0 g

 Kolldion SR 188.5 g Hydroxypropyl fluorenyl cellulose 292.8 g Microcrystalline cellulose 1767.5 g Talc 40.0 g Microsilica gel 79.0 g Magnesium stearate 12.9 g

 Vinyl pyrrolidone 101.8 go Preparation process:

 Accurately weighed diclofenac sodium 750.0 g, Kolldion SR (mixture of vinyl acetate and polyvinylpyrrolidone, vinyl acetate mass fraction of 80%, polyvinylpyrrolidone mass fraction of 19%) 188.5 g, hydroxypropyl fluorenyl fiber 292.8 g, microcrystalline cellulose 1767.5 g, talc powder 40.0 g, fine powder silica gel 79.0 g magnesium stearate 12.9 g, polyvinylpyrrolidone 101.8 g, spare.

 Take diclofenac sodium, micro-silica gel, talc powder through a 120 mesh sieve and mix until uniform, add microcrystalline cellulose, Kolldion SR, hydroxypropyl decyl cellulose, polyvinylpyrrolidone for 50 min, then add magnesium stearate to mix l lmin Thereafter, tableting was carried out to obtain 10,000 tablets of diclofenac sodium sustained-release tablets, the specification was 0.32 g, and the yield was 98.85 %. Example 9

 Recipe:

 Diclofenac sodium 750.0 g

Kolldion SR 613.3 g microcrystalline cellulose 2753.0 g micropowder silica gel 234.0 g magnesium stearate 70.9 g hydroxypropyl decyl cellulose 121.8 g. Preparation Process:

 Accurately weighed diclofenac sodium 750.0 g, Kolldion SR (mixture of vinyl acetate and polyvinylpyrrolidone, vinyl acetate mass fraction of 80%, polyvinylpyrrolidone mass fraction of 19%) 613.3 g, microcrystalline cellulose 2753.0 g , micro powder silica gel 234.0 g, magnesium stearate 70.9 g, hydroxypropyl decyl cellulose 121.8 g, spare.

 Diclofenac sodium, micro-powder silica gel was mixed through 100 mesh sieve to homogeneity, microcrystalline cellulose, Kolldion SR, hydroxypropyl fluorenyl cellulose was added for 60 min, then magnesium stearate was added for 4 min, and then tableted to obtain diclofenac. 10000 tablets of sustained-release tablets, the specification is 0.45g, and the yield is 99.21%. Example 10

 Recipe:

 Diclofenac sodium 1000.0 g Hydroxypropyl fluorenyl cellulose 634.2 g Microcrystalline cellulose 2931.0 g Mannitol lOOO.Og Microsilica gel 411.9 g Stearic acid 76.3 g

 Kollidon VA64 3.6 go Preparation process:

 Accurately weigh 1000.0 g of diclofenac sodium, 634.2 g of hydroxypropyl decyl cellulose, 2931.0 g of microcrystalline cellulose, 1000.0 g of mannitol, 411.9 g of silica gel, 76.3 g of stearic acid, Kollidon VA64 (the active ingredient is polyvinylpyrrolidone) ) 3.6g, spare.

Take diclofenac sodium, micro-powder silica gel through a 100 mesh sieve to mix until uniform, add microcrystalline cellulose, mannitol, Kollidon VA64, hydroxypropyl fluorenyl cellulose for 45min, then add stearic acid mixed lOmin, then tablet 1200 tablets of sustained-release tablets of diclofenac sodium were obtained, the specification was 0.61 g, and the yield was 98.35 %. Example 11

 Recipe:

 Diclofenac sodium 1000.0 g glyceryl monostearate 723.8 g calcium hydrogen phosphate 1071.3 g micropowder silica gel 137.6 g calcium stearate 38.0 g hydroxypropyl fluorenyl cellulose 41.3 g. Preparation Process:

 Accurately weighed 1000.0 g of diclofenac sodium, 723.8 g of glyceryl monostearate, 1071.3 g of calcium hydrogen phosphate, 137.6 g of micronized silica gel, 38.0 g of calcium stearate, and 41.3 g of hydroxypropyl fluorenyl cellulose.

 Take diclofenac sodium, micro-powder silica gel through a 120 mesh sieve to mix evenly, add calcium hydrogen phosphate, glyceryl monostearate, hydroxypropyl decyl cellulose for 55 min, then add calcium stearate for 10 min, then compress, 10,000 tablets of diclofenac sodium sustained-release tablets were prepared, the specification was 0.30 g, and the yield was 98.4%. Example 12

 Recipe:

 Diclofenac sodium 1000.0 g Hydroxypropyl decyl cellulose 218.4 g Glyceryl citrate 302.2 g Microcrystalline cellulose 1931.8 g Microsilica gel 348.8 g Magnesium stearate 124.0 g

Kollidon VA64 348.7 go Preparation process: Accurately weigh 1000.0 g of diclofenac sodium, 218.4 g of hydroxypropyl fluorenyl cellulose, 302.2 g of glyceryl behenate, 1931.8 g of microcrystalline cellulose, 348.8 g of microsilica gel, 124.0 g of magnesium stearate, Kollidon VA64 (active ingredient For polyvinylpyrrolidone) 348.7 g, spare.

 Take diclofenac sodium, micro-powder silica gel through a 120 mesh sieve to mix until uniform, add microcrystalline cellulose, hydroxypropyl decyl cellulose, glyceryl behenate, Kollidon VA64 mixed for 40min, then add magnesium stearate for 8min, Tableting, 10,000 tablets of diclofenac sodium sustained-release tablets were prepared, the specification was 0.43 g, and the yield was 98.37%. Example 13

 Control group: Diclofenac sodium sustained-release tablets prepared by a conventional wet granulation process.

 Recipe:

 Diclofenac sodium 1000.0 g

 Hydroxypropyl fluorenyl cellulose 1200.0 g

 Calcium hydrogen phosphate 300.0g

 Lactose 800.0 g

 Magnesium stearate 15.0 g

 Talc powder 15.0g

 95% alcohol 30.0g. Preparation Process:

 Accurately weigh 1000.0 g of diclofenac sodium, 1200.0 g of hydroxypropyl decyl cellulose, 300.0 g of calcium hydrogen phosphate, 800.0 g of lactose, 15.0 g of magnesium stearate, 15.0 g of talc, and an appropriate amount of alcohol.

All materials were pretreated through a 100 mesh sieve, and diclofenac sodium, calcium hydrogen phosphate, lactose and hydroxypropyl cellulose were put into a mixing granulator and mixed for 10 minutes. 95% ethanol was sprayed into the soft material, 20 mesh sieve. Granulation, drying at 50 ° C for 3 hours. The dry granules were sieved through a 20 mesh sieve, and then magnesium stearate and talc powder were added, mixed in a mixer for 10 minutes, and then tableted to obtain a sustained release tablet of diclofenac sodium, and the yield was 85.24%. Product prescription costs (10,000 pieces) are shown in Table 1, energy consumption and labor costs (10,000 pieces) are shown in Table 2. Table 1 Prescription cost of control products (10,000 tablets)

Table 2 Energy consumption and labor costs of the control group (10,000 tablets):

The diclofenac sodium sustained-release tablet prepared in Example 1 of the present invention has a product prescription cost (10000 pieces) as shown in Table 3, and energy consumption and labor cost (10000 pieces) are shown in Table 4. Table 3 The price of the diclofenac sodium sustained-release tablet product prepared in Example 1 of the present invention (component/kg) Prescription content (g) Prescription cost (yuan) Diclofenac sodium 60 1000.0 60.0

 Hydroxypropyl fluorenyl cellulose 330 567.5 187.3

 Mercapto cellulose 210 403.0 84.6

 Calcium hydrogen phosphate 72 1341.1 96.5

 Micronized silica gel 130 152.0 19.8

 Talc powder 1.8 50.0 0.09

 Magnesium stearate 15 70.6 1.0

A total of 10,000 tablets 449.29 Table 4 Energy consumption and labor cost of diclofenac sodium sustained release tablets prepared in Example 1 of the present invention

 The production cost of the product of the present invention decreased by 21.9% compared with the control group. The diclofenac sodium sustained-release tablets prepared in Example 2 of the present invention, the product prescription cost (10000 tablets) are shown in Table 5, and the energy consumption and labor costs (10000 tablets) are shown in Table 6. Table 5 The prescription cost of the diclofenac sodium sustained-release tablet product prepared in Example 2 of the present invention

Table 6 Energy consumption and labor cost of diclofenac sodium sustained release tablets prepared in Example 2 of the present invention

Compared with the control group, the production cost of the product of the present invention decreased by 48.8%. The diclofenac sodium sustained-release tablet prepared in Example 3 of the present invention has a product prescription cost (10000 pieces) as shown in Table 7. Energy consumption and labor cost (10000 pieces) are shown in Table 8. Table 7 Prescription cost of diclofenac sodium sustained release tablet product prepared in Example 3 of the present invention

 Compared with the control group, the production cost of the present invention decreased by 41.6%.

 Compared with the diclofenac sodium sustained-release tablets prepared in the control group, the production cost of the diclofenac sodium sustained-release tablets provided in Examples 4 to 12 of the present invention decreased by 31.2 to 48.8%. In summary, the production cost of the diclofenac sodium sustained release tablet provided by the present invention was reduced by 21.9 - 48.8% compared with the control group.

 Example 14 Test of diclofenac sodium sustained release tablets provided by the present invention

 Release test:

Taking the diclofenac sodium sustained-release tablets prepared in Examples 1 to 12 of the present invention, according to the release method (Chinese Pharmacopoeia 2010 edition two appendix XD first method), using the dissolution method (Chinese Pharmacopoeia 2010 edition two appendix XC) The first method), using phosphate buffer (pH 7.4) 900mL as solvent, the rotation speed is 100 rpm, operate according to law, take 5mL solution in 2, 6 and 12h, and immediately operate the container. Add 5mL of the above solvent; separately measure 2mL of each filtrate, place each 10mL volumetric flask, dilute to the mark with the above solvent, shake, and spectrophotometry (Chinese Pharmacopoeia 2010 edition two appendix IV A), at 276nm The absorbance is measured at the wavelength of the difference; the diclofenac sodium control which is dried to constant weight at 105 °C is accurately weighed. Amount of goods, and the solvent plus solvent dissolves the above prepared each containing about _20μ β lmL of quantitative dilution, absorption of the same method, were calculated at different times of the elution amount per tablet. The dissolution amount of the diclofenac sodium sustained-release tablets prepared in Examples 1 to 12 of the present invention at 2, 6, and 12 h should be correspondingly 15 to 40%, 40 to 70%, and 70% of the labeled amount, respectively. The dissolution rates of the diclofenac sodium sustained-release tablets prepared in Examples 1 to 12 of the present invention at 2, 6, and 12 h were respectively 27.2 to 32.0%, 57.0 to 61.5%, and 86.0 to 91.3% of the corresponding scalars, which were all in compliance with the regulations. Related substance testing:

 Use octylsilane bonded silica as a filler, sterol-phosphate buffer solution (0.01mol/L phosphoric acid and 0.01mol/L sodium dihydrogen phosphate in equal amounts, adjust the pH value to 3.0 X 60 with sodium hydroxide solution) : 40 ) , the detection wavelength is 254nm. Take the appropriate amount of diclofenac sodium control and diethyl phthalate, dissolve it with sterol-water (7:3) and make a solution containing 60 g and 20 g per 1 mL, and measure 20 μΙ^, infusion The chromatogram, the chromatogram, the theoretical plate number should be not less than 2000 according to the peak of diclofenac sodium, the separation of diclofenac sodium peak and diethyl phthalate peak should be greater than 8.

 Take the appropriate amount of diclofenac sodium sustained-release tablet prepared in the present invention (about equivalent to diclofenac sodium 75mg), into a lOOmL volumetric flask, add about 70mL of mobile phase, shake for 30min, add mobile phase to the mark, shake, Filtration, take the filtrate as the test solution; Precisely measure the sample solution lmL, into the lOOmL volumetric flask, add the mobile phase to the mark, shake well, as a control solution. Take the control solution 2 (^L into the liquid chromatograph, adjust the detection sensitivity, so that the peak height of the main peak is about 10~20% of the full scale, then accurately measure the solution solution for 20μ, inject into the liquid chromatograph, record the chromatogram Figure 3 to the retention time of the main peak of the test solution. Calculate the content of impurities in the test sample by self-control method, and examine the amount of individual maximum and total impurities of the sample. The limit refers to the limit requirement of the related substances in the BP (self-control) In the method, the substance peak is less than 5 parts per million of the main peak. The results show that the relevant substances in the sustained-release tablets of diclofenac sodium prepared in the examples of the present invention are 0.041 to 0.138%, and the total is 0.064 to 0.232%, which are all in accordance with the method. Regulations. Microbiological limit check:

The microbial limit test of the diclofenac sodium sustained-release tablets prepared in the examples of the present invention was carried out in accordance with the Chinese Pharmacopoeia 2010 Edition 2 Appendix IX J Microbial Limit Test. Force speed test:

 The diclofenac sodium sustained-release tablets prepared in Examples 1 to 12 of the present invention were placed in a stability tester according to a commercially available package (aluminum plastic) at a temperature of 40 ± 2 ° C and a relative humidity of 75 ± 5%. Leave it for 6 months. Samples were taken at 0, 1, 2, 3, and 6 months after lofting, and the traits, release, average tablet weight, related substances, contents, and microbial limits of the samples were determined according to the results, and compared with the results of the 0-day samples. The test results are shown in Table 9. Table 9 Accelerated test results of diclofenac sodium sustained-release tablets (40±2°C, RH75±5%) Releases Relevant substances (%)

 Time implementation average weight

 Character single content (%)

(month) Example 2h 6h 12h total ( g )

 Big

 1 white piece 29.4 57.0 88.8 0.076 0.105 0.3478 102.8

2 white film 30.2 58.4 91.3 0.073 0.092 0.2532 101.7

3 white film 28.5 57.2 89.1 0.041 0.072 0.4370 101.3

4 white film 28.2 60.0 89.3 0.078 0.110 0.1337 102.3

5 white film 27.6 59.5 90.3 0.072 0.112 0.2064 101.5

6 white piece 30.1 59.7 89.0 0.080 0.093 0.2980 102.4

0

 7 white film 28.5 59.8 89.3 0.071 0.119 0.1872 102.3

8 white film 29.7 59.4 90.5 0.091 0.134 0.3177 102.4

9 white film 28.5 59.0 91.2 0.066 0.156 0.4464 102.7

10 white film 30.3 60.6 88.6 0.069 0.095 0.6060 102.0

11 white film 29.5 61.1 89.8 0.067 0.131 0.2987 100.4

12 white film 28.1 57.4 88.9 0.068 0.090 0.4288 100.4

1 1 white film 30.2 60.7 90.3 0.105 0.145 0.3495 101.8

2 white film 28.9 59.4 88.5 0.091 0.112 0.2663 100.2

3 white tablets 29.5 60.5 87.5 0.064 0.099 0.4379 100.7

4 white film 28.0 59.6 90.3 0.082 0.135 0.1342 100.9 //〇/-οποίζ>1M

9 white film 28.8 58.2 90.5 0.097 0.198 0.4521 100.6

10 white film 28.4 61.5 89.5 0.121 0.156 0.6151 99.3

11 white film 30.2 59.4 88.1 0.107 0.215 0.3024 99.5

12 white film 29.8 60.4 89.2 0.108 0.210 0.4361 99.3

1 white film 30.5 59.1 88.4 0.121 0.171 0.3688 99.1

2 white film 28.1 58.3 88.7 0.135 0.183 0.2671 98.9

3 white film 28.6 61.5 89.6 0.106 0.212 0.4375 98.3

4 white piece 30.2 60.0 89.7 0.127 0.224 0.1359 99.6

5 white film 28.7 59.1 90.6 0.128 0.204 0.2167 100.0

6 white piece 28.3 60.2 90.8 0.125 0.179 0.3091 99.3

6

 7 white film 28.9 58.2 91.3 0.117 0.218 0.1954 100.8

8 white film 29.1 59.1 88.4 0.138 0.214 0.3237 99.9

9 white tablets 30.0 59.7 87.9 0.137 0.228 0.4569 99.8

10 white film 30.4 58.3 91.8 0.137 0.211 0.6173 99.2

11 white film 28.3 60.4 89.2 0.132 0.222 0.3048 99.3

12 White tablets 29.1 57.9 90.2 0.123 0.232 0.4389 99.1 The results showed that the sustained release tablets of diclofenac sodium prepared in Examples 1 to 12 of the present invention were subjected to an accelerated test for 6 months, and the properties, release degree, average tablet weight, related substances, The content and microbiological examination were in compliance with the regulations; the data of the first, second, third and sixth months were compared with the results of the 0-day, and there were no significant differences in traits, release, average weight, content, and microbiological examination, and the relevant substances were accelerated at 6 months. Slightly increase the strength. Long-term sample test:

Taking the diclofenac sodium sustained-release tablets prepared in Examples 1 to 12 of the present invention, according to the commercially available packaging (aluminum plastic) at a temperature of 25 ± 2 ° C and a relative humidity of RH 60 ± 10%, respectively, at 0, 3, Samples were taken at 6, 9 and 12 months, and the traits, release, related substances, contents, and microbial limits of the samples were determined according to the law, and compared with the results of the 0-day samples. The results of the 12-month long-term test are shown in Table 10. Table 10 Long-term test results of diclofenac sodium sustained-release tablets (25±2 °C, RH60±5%) Time release related substances (%)

 Examples traits average tablet weight (g) content (%)

(month) 2h 6h 12h single maximum total

 1 white piece 29.4 57.0 88.8 0.076 0.105 0.3478 102.8

2 white film 30.2 58.4 91.3 0.073 0.092 0.2532 101.7

3 white film 28.5 57.2 89.1 0.041 0.072 0.4370 101.3

4 white film 28.2 60.0 89.3 0.078 0.110 0.1337 102.3

5 white film 27.6 59.5 90.3 0.072 0.112 0.2064 101.5

6 white piece 30.1 59.7 89.0 0.080 0.093 0.2980 102.4

0

 7 white film 28.5 59.8 89.3 0.071 0.119 0.1872 102.3

8 white film 29.7 59.4 90.5 0.091 0.134 0.3177 102.4

9 white film 28.5 59.0 91.2 0.066 0.156 0.4464 102.7

10 white film 30.3 60.6 88.6 0.069 0.095 0.6060 102.0

11 white film 29.5 61.1 89.8 0.067 0.131 0.2987 100.4

12 white film 28.1 57.4 88.9 0.068 0.090 0.4288 100.4

1 white piece 30.8 60.7 89.2 0.068 0.088 0.3570 102.8

2 white film 29.5 59.3 87.0 0.070 0.077 0.2619 102.0

3 white tablets 29.0 57.5 90.1 0.064 0.091 0.4377 102.2

4 white tablets 29.0 59.4 87.1 0.083 0.095 0.1349 101.2

5 white piece 27.2 60.0 86.6 0.072 0.090 0.2097 101.6

6 white film 29.9 58.2 88.1 0.080 0.101 0.3014 101.8

3

 7 white film 27.4 59.4 87.5 0.076 0.085 0.1899 101.7

8 white film 28.2 60.4 87.7 0.071 0.094 0.3196 100.9

9 white film 28.2 57.9 87.2 0.066 0.105 0.4488 101.8

10 white film 28.8 57.9 88.2 0.078 0.087 0.6072 101.7

11 white film 28.1 58.7 91.2 0.065 0.082 0.3011 101.8

12 white film 30.1 60.4 88.3 0.080 0.087 0.4308 100.7 //〇/-οποίζ>1Μ

5 white film 27.4 58.7 86.8 0.102 0.126 0.2127 99.4

6 white tablets 28.9 59.0 90.7 0.121 0.132 0.3051 99.3

7 white piece 27.2 57.1 87.5 0.111 0.131 0.1951 100.0

8 white film 29.1 57.9 87.0 0.097 0.123 0.3241 99.4

9 white tablets 27.5 59.9 89.8 0.090 0.132 0.4558 99.8

10 white film 27.6 58.8 90.6 0.115 0.111 0.6176 100.8

11 white film 28.6 58.5 88.1 0.111 0.126 0.3064 99.4

12 White tablets 29.2 59.1 88.6 0.120 0.128 0.4375 99.8 The results showed that the sustained release tablets of diclofenac sodium prepared in Examples 1 to 12 of the present invention were subjected to an accelerated test for 6 months, and the properties, release degree, average tablet weight, related substances, The content and microbiological examination were in compliance with the regulations; there was no significant difference between the data of the 3rd, 6th, 9th and 12th months and the 0-day result.

 The results of the above stability test show that: the diclofenac sodium sustained-release tablets prepared in Examples 1 to 12 of the present invention are in compliance with the specifications in the 6-month accelerated test and the 12-month long-term test, and compared with the 0-day results. The traits, the average tablet weight, the content, the release degree, and the like were not significantly different; and the results of the related substances showed that the diclofenac sodium sustained-release tablets prepared in Examples 1 to 12 of the present invention have good stability, low impurity amount, and substantially no Changes, only due to measurement differences, the data have normal fluctuations, the results of accelerated 6 months and long-term 12 months are in line with the requirements (self-control method, single less than 0.2%, total less than 0.5%). Thus, the formulation process of the diclofenac sodium sustained-release tablets prepared in Examples 1 to 12 of the present invention is feasible, and the prepared sustained-release tablets have good stability. The above detailed description of the diclofenac sodium sustained-release tablets and the preparation process thereof provided by the present invention are only for helping to understand the method of the present invention and its core idea. It should be noted that those skilled in the art can make various modifications and changes to the present invention without departing from the spirit and scope of the invention.

-I-

Claims

Rights request

1. A sustained-release tablet of diclofenac sodium, characterized by, by mass percentage, the following components: diclofenac sodium 16.5 - 39.0% sustained release agent 10.0 ~ 35.5% filler 33.5 ~ 65.0% auxiliary agent 2.01 ~ 8.0% lubrication Agent 0 - 2.5 % Adhesive 0 ~ 8.0%.

 The sustained-release tablet of diclofenac sodium according to claim 1, wherein the sustained release agent comprises glyceryl monostearate, glyceryl behenate, hydroxypropyl fluorenyl cellulose, sulfhydryl cellulose. And one or a mixture of two or more of a mixture of polyvinylpyrrolidone and vinyl acetate.

 The diclofenac sodium sustained-release tablet according to claim 1, wherein the filler comprises one of microcrystalline cellulose, lactose, mannitol, pregelatinized starch, carbonic acid 4 bow, and calcium hydrogen phosphate. Or a mixture of two or more.

 The diclofenac sodium sustained-release tablet according to claim 1, wherein the glidant comprises one or a mixture of talc, microsilica gel, or both.

 The diclofenac sodium sustained-release tablet according to claim 1, wherein the lubricant comprises one or a mixture of two or more of stearic acid, calcium stearate, and magnesium stearate.

 The diclofenac sodium sustained-release tablet according to claim 1, wherein the binder comprises one or a mixture of hydroxypropyl fluorenyl cellulose and polyvinyl pyrrolidone.

 7. The process for preparing a diclofenac sodium sustained release tablet according to claim 1, wherein the prescription comprises the following components in mass percentage:

Diclofenac sodium 16.5 -39.0% slow release agent 10.0 ~ 35.5% filler 33.5 ~ 65.0% additive 2.01 ~ 8.0% Lubricant 0 - 2.5 % Adhesive 0 ~ 8.0 % Take diclofenac sodium, glidant mixed with 80 ~ 120 mesh sieve, add filler, slow release agent, binder for 10 ~ 60min, then add lubricant to mix After 3 ~ 15 minutes, the diclofenac sodium sustained-release tablets were prepared after tableting.

 8. The preparation process according to claim 7, wherein the step of coating the film coat is further included after the tableting.

 9. The preparation process according to claim 8, wherein the film coating material required for the film coating comprises a cellulose derivative, an acrylic resin.

 10. A sustained release tablet of diclofenac sodium prepared by the preparation process according to claims 7 to 9.