An enteric microcapsule of aceclofenac and a method for preparing the same

Abstract

The present application provides a kind of aceclofenac enteric microcapsule and its preparation method, the microcapsule includes core and coating, the core includes pill core, aceclofenac, adhesive;The coating includes enteric coating material, plasticizer, anti-adhesive. By screening and optimizing the type and proportion of adhesive and enteric material, optimizing and controlling the preparation process parameters, effectively improve the stability and long-term stability of aceclofenac sustained-release microcapsule, block the release of drug in mouth and stomach, direct the drug to small intestine and slowly release, and the release effect is long-acting and durable.

Description

Technical Field

[0001] This invention belongs to the field of pharmaceutical preparations, specifically relating to an enteric-coated microcapsule of aceclofenac and its preparation method. Background Technology

[0002] Aceclofenac is a novel, potent oral nonsteroidal anti-inflammatory drug (NSAID) first marketed by the Spanish company Prodesfarma in 1992. As an NSAID, aceclofenac exerts various pharmacological effects at the site of lesion and is primarily used to treat various types of rheumatoid arthritis, osteoarthritis, and spondylitis. It can also be used for pain and fever caused by various diseases.

[0003] Microencapsulation technology is essentially an encapsulation technique that creates microcapsules by encapsulating liquids or solids with film-forming materials, resulting in sealed or semi-permeable capsules. The contents of these microcapsules are isolated from the external environment, protecting them from environmental influences and maintaining stability. With appropriate methods, controlled release can be achieved, and microcapsules hold broad application prospects in fields such as biology, medicine, and agriculture.

[0004] Existing aceclofenac dosage forms include aceclofenac tablets, sustained-release tablets, enteric-coated tablets, and enteric-coated capsules. While these technologies are relatively mature, they still have several drawbacks. For example, tablet compression is affected by factors such as pressure and powder flowability, making it difficult to determine the optimal process later. Coated tablets suffer from poor sustained / controlled-release stability due to the difficulty in accurately controlling the coating thickness. Directly encapsulating enteric-coated capsules often results in inconsistent performance between capsules from different manufacturers due to material limitations, leading to poor reproducibility. Aceclofenac enteric-coated microcapsules, which are made by converting aceclofenac into enteric microcapsules, can be further compressed into tablets or capsules, effectively avoiding the above problems.

[0005] Chinese patent CN103961336A discloses an aceclofenac enteric-coated microcapsule and its preparation method. It is prepared by filling aceclofenac enteric-coated microcapsules into a capsule shell. The aceclofenac enteric-coated microcapsules consist of a blank core and a coating layer surrounding the blank core, arranged from the inside out as a main drug layer, an isolation layer, and an enteric coating layer. While the isolation layer between the main drug layer and the enteric coating layer ensures the stability of the drug, it also complicates the preparation process. Furthermore, the centrifugal method used to coat the isolation layer cannot guarantee uniform coverage, making it unsuitable for industrial production. Summary of the Invention

[0006] Overcoming the shortcomings of existing technologies, this invention provides an aceclofenac enteric-coated microcapsule. With a preferred formulation and preparation process, an aceclofenac enteric-coated microcapsule is obtained that can be directed to release drugs in the small intestine, reduce gastrointestinal irritation, increase drug efficacy, improve patient compliance, and has high stability, making it easy to industrially produce.

[0007] The first objective of this invention is to provide an enteric-coated microcapsule of aceclofenac, comprising a core and a coating layer. The core includes a pellet, aceclofenac, and an adhesive. The coating layer includes an enteric coating material, a plasticizer, and an anti-adhesive.

[0008] Furthermore, the core material comprises, by weight: 20-50 parts of core, 40-100 parts of aceclofenac, and 12-36 parts of adhesive; the coating layer comprises, by weight: 10-40 parts of enteric coating material, 2-15 parts of plasticizer, and 2-15 parts of anti-adhesion agent.

[0009] Specifically, the core of the pellet is selected from one or more of sucrose, starch, microcrystalline cellulose, mannitol, hydroxypropyl methylcellulose, and silicon dioxide, preferably microcrystalline cellulose and silicon dioxide, in a weight ratio of 2:1.

[0010] Specifically, the adhesive is selected from one or more of starch, sucrose, povidone, methylcellulose, ethylcellulose, and tragacanth gum, preferably tragacanth gum and povidone, in a weight ratio of 1:1-3.

[0011] Specifically, the enteric coating material is selected from one or more of ethyl cellulose aqueous dispersion, Acryl-EZE 93A, methacrylic acid copolymer, and acrylic resin, preferably ethyl cellulose aqueous dispersion and Acryl-EZE 93A, with a weight ratio of 1:1-2.

[0012] Specifically, the plasticizer is triacetin or diethyl phthalate; the anti-adhesive is selected from one or more of talc, micronized silica gel, magnesium stearate, and sodium alginate.

[0013] Furthermore, the core material comprises, by weight:

[0014] 20-50 parts by weight of pellet core

[0015] 40-100 parts by weight of aceclofenac

[0016] 12-36 parts by weight of tragacanth gum and povidone

[0017] The coating layer comprises, by weight, the following:

[0018] Ethyl cellulose aqueous dispersion and Acryl-EZE 93A 10-40 parts by weight

[0019] Triacetin 2-15 parts by weight

[0020] 2-15 parts by weight of talc

[0021] Preferably,

[0022] 30 parts by weight of microcrystalline cellulose-silica pellet core

[0023] 60 parts by weight of aceclofenac

[0024] 24 parts by weight of tragacanth gum and povidone

[0025] The coating layer comprises, by weight, the following:

[0026] Ethyl cellulose aqueous dispersion and Acryl-EZE 93A 25 parts by weight

[0027] Triacetin 3 parts by weight

[0028] 3 parts by weight of talc

[0029] The second objective of this invention is to provide the application of the aforementioned aceclofenac enteric-coated microcapsules in the preparation of formulations containing aceclofenac. The aceclofenac enteric-coated microcapsules of this invention can be used as a formulation intermediate and can be further processed into various formulations. The dosage forms of the formulations include tablets, capsules, injections, patches, aerosols, and suspensions.

[0030] A third objective of this invention is to provide a method for preparing aceclofenac enteric-coated microcapsules, characterized by comprising the following steps:

[0031] (1) Preparation of core material: Aceclofenac is dissolved in an appropriate amount of solvent by stirring, binder is added and stirred to obtain a solution, which is then pumped into a fluidized bed and sprayed onto the pellet core to prepare the core material;

[0032] (2) Coating: Add appropriate amount of purified water to plasticizer and anti-adhesion agent and mix evenly. Add enteric coating material and stir to prepare a coating solution with a solid content of 18-22%. Pump it into a fluidized bed for fluidized coating.

[0033] (3) Drying and aging yields the finished microcapsules.

[0034] Specifically, in step (1), the solvent is selected from one or more of water, ethanol, and propylene glycol; the inlet air temperature is 35℃-40℃, the material temperature is 30-36℃, the spray rate is 1.5-2.5ml / min, the spray pressure is 0.2-0.4MPa, the fan frequency is 15-18HZ, and the inlet air volume is 28-32m³ / min. 3 / h;

[0035] The stirring time in step (2) is 20-40 min, the inlet air temperature is 30℃-36℃, the material temperature is 28-33℃, the spraying rate is 1.0-2.0 ml / min, the spraying pressure is 0.15-0.35 MPa, the fan frequency is 14-17 Hz, and the inlet air volume is 28-32 m³ / min. 3 / h;

[0036] The aging temperature in step (3) is 35-45℃, and the aging time is 5-9h.

[0037] The beneficial effects of this invention are:

[0038] 1) Screening and optimizing the type and ratio of adhesives, using tragacanth gum and povidone in a weight ratio of 1:1-3 yields the best results, effectively improving the stability and long-term stability of aceclofenac sustained-release microcapsules.

[0039] 2) Select the type and proportion of enteric-coated material to block the release of drugs in the mouth and stomach, and direct the drugs to the small intestine for slow release, resulting in a long-lasting and sustained release effect.

[0040] 3) Spherical or near-spherical drug-containing microparticles were prepared using a fluidized bed and further coated with an enteric coating to form aceclofenac enteric-coated microcapsules. Process parameters were controlled to improve the uniformity and drug loading rate of the enteric coating membrane. Attached Figure Description

[0041] Figure 1 The in vitro cumulative drug release curves for Examples 1-5 are shown.

[0042] Figure 2 For comparison of the in vitro cumulative drug release curves of Examples 1-4 Detailed Implementation

[0043] To make the objectives and technical solutions of this invention clearer, the following embodiments are provided for further explanation. However, the scope of protection of this invention is not limited to these embodiments; the embodiments are merely for illustrative purposes. Those skilled in the art should understand that any changes or equivalent substitutions that do not depart from the concept of this invention are included within the scope of protection of this invention. The invention is further described below with reference to embodiments, but this invention is not limited to the embodiments.

[0044] Example 1:

[0045] The prescription consists of the following components (unit: g):

[0046]

[0047] The preparation method is as follows:

[0048] (1) Preparation of microcapsule cores: The pellet cores were placed in a Wurster fluidized bed granulation and coating equipment as the core particles for granulation; aceclofenac was dissolved in 80% ethanol by stirring, and the prescribed amount of binder was added and stirred to dissolve. The resulting solution was pumped into the fluidized bed and sprayed onto the core particles to prepare smooth and round cores; the inlet air temperature was 38℃, the material temperature was 34℃, the spraying rate was 2.0 ml / min, the spraying pressure was 0.3 MPa, the fan frequency was 16 Hz, and the inlet air volume was 30 m³ / min. 3 / h.

[0049] (2) Preparation of enteric coating solution: Add plasticizer and anti-adhesion agent to an appropriate amount of purified water and mix evenly. Add enteric polymer coating material and stir for 30 minutes to prepare a coating solution with a solid content of 20%.

[0050] (3) Coating: The core material from step (1) is pumped into the fluidized bed and coated with the coating solution prepared in step (2), resulting in a 5% weight gain. The inlet air temperature is 34℃, the material temperature is 30℃, the spray rate is 1.5ml / min, the spray pressure is 0.25MPa, the fan frequency is 16HZ, and the inlet air volume is 30m³. 3 / h.

[0051] (4) The microcapsules were aged in a drying oven at 40°C for 7 hours to obtain the finished microcapsules.

[0052] Example 2:

[0053] The prescription consists of the following components (unit: g):

[0054]

[0055] The preparation method is as follows:

[0056] (1) Preparation of microcapsule cores: The pellet cores were placed in a Wurster fluidized bed granulation and coating equipment as the core particles for granulation; aceclofenac was dissolved in 80% ethanol by stirring, and the prescribed amount of binder was added and stirred to dissolve. The resulting solution was pumped into the fluidized bed and sprayed onto the core particles to prepare smooth and round cores; the inlet air temperature was 35℃, the material temperature was 30℃, the spraying rate was 1.5ml / min, the spraying pressure was 0.2MPa, the fan frequency was 15HZ, and the inlet air volume was 28m³. 3 / h.

[0057] (2) Preparation of enteric coating solution: Add plasticizer and anti-adhesion agent to an appropriate amount of purified water and mix evenly. Add enteric polymer coating material and stir for 30 minutes to prepare a coating solution with a solid content of 20%.

[0058] (3) Coating: The core material from step (1) is pumped into the fluidized bed and coated with the coating solution prepared in step (2), resulting in a 5% weight gain. The inlet air temperature is 30℃, the material temperature is 28℃, the spray rate is 1.0ml / min, the spray pressure is 0.15MPa, the fan frequency is 14HZ, and the inlet air volume is 28m³. 3 / h.

[0059] (4) The microcapsules were aged in a drying oven at 35°C for 9 hours to obtain the finished microcapsules.

[0060] Example 3:

[0061] The prescription consists of the following components (unit: g):

[0062]

[0063] The preparation method is as follows:

[0064] (1) Preparation of microcapsule cores: The pellet cores were placed in a Wurster fluidized bed granulation and coating equipment as the core particles for granulation; aceclofenac was dissolved in 80% ethanol by stirring, and the prescribed amount of binder was added and stirred to dissolve. The resulting solution was pumped into the fluidized bed and sprayed onto the core particles to prepare smooth and round cores; the inlet air temperature was 40℃, the material temperature was 36℃, the spraying rate was 2.5ml / min, the spraying pressure was 0.4MPa, the fan frequency was 18HZ, and the inlet air volume was 32m³. 3 / h.

[0065] (2) Preparation of enteric coating solution: Add plasticizer and anti-adhesion agent to an appropriate amount of purified water and mix evenly. Add enteric polymer coating material and stir for 30 minutes to prepare a coating solution with a solid content of 20%.

[0066] (3) Coating: The core material from step (1) is pumped into the fluidized bed and coated with the coating solution prepared in step (2), resulting in a 5% weight gain. The inlet air temperature is 36℃, the material temperature is 33℃, the spray rate is 2.0ml / min, the spray pressure is 0.35MPa, the fan frequency is 17HZ, and the inlet air volume is 32m³ / min. 3 / h.

[0067] (4) The microcapsules were aged in a drying oven at 45°C for 7 hours to obtain the finished microcapsules.

[0068] Example 4:

[0069] The prescription consists of the following components (unit: g):

[0070]

[0071] The preparation method is as follows:

[0072] (1) Preparation of microcapsule cores: The pellet cores were placed in a Wurster fluidized bed granulation and coating equipment as the core particles for granulation; aceclofenac was dissolved in 80% ethanol by stirring, and the prescribed amount of binder was added and stirred to dissolve. The resulting solution was pumped into the fluidized bed and sprayed onto the core particles to prepare smooth and round cores; the inlet air temperature was 38℃, the material temperature was 34℃, the spraying rate was 2.0 ml / min, the spraying pressure was 0.3 MPa, the fan frequency was 16 Hz, and the inlet air volume was 30 m³ / min. 3 / h.

[0073] (2) Preparation of enteric coating solution: Add plasticizer and anti-adhesion agent to an appropriate amount of purified water and mix evenly. Add enteric polymer coating material and stir for 30 minutes to prepare a coating solution with a solid content of 20%.

[0074] (3) Coating: The core material from step (1) is pumped into the fluidized bed and coated with the coating solution prepared in step (2), resulting in a 5% weight gain. The inlet air temperature is 34℃, the material temperature is 30℃, the spray rate is 1.5ml / min, the spray pressure is 0.25MPa, the fan frequency is 16HZ, and the inlet air volume is 30m³. 3 / h.

[0075] (4) The microcapsules were aged in a drying oven at 40°C for 7 hours to obtain the finished microcapsules.

[0076] Example 5:

[0077] The prescription consists of the following components (unit: g):

[0078]

[0079] The preparation method is as follows:

[0080] (1) Preparation of microcapsule cores: The pellet cores were placed in a Wurster fluidized bed granulation and coating equipment as the core particles for granulation; aceclofenac was dissolved in 80% ethanol by stirring, and the prescribed amount of binder was added and stirred to dissolve. The resulting solution was pumped into the fluidized bed and sprayed onto the core particles to prepare smooth and round cores; the inlet air temperature was 38℃, the material temperature was 34℃, the spraying rate was 2.0 ml / min, the spraying pressure was 0.3 MPa, the fan frequency was 16 Hz, and the inlet air volume was 30 m³ / min. 3 / h.

[0081] (2) Preparation of enteric coating solution: Add plasticizer and anti-adhesion agent to an appropriate amount of purified water and mix evenly. Add enteric polymer coating material and stir for 30 minutes to prepare a coating solution with a solid content of 20%.

[0082] (3) Coating: The core material from step (1) is pumped into the fluidized bed and coated with the coating solution prepared in step (2), resulting in a 5% weight gain. The inlet air temperature is 34℃, the material temperature is 30℃, the spray rate is 1.5ml / min, the spray pressure is 0.25MPa, the fan frequency is 16HZ, and the inlet air volume is 30m³. 3 / h.

[0083] (4) The microcapsules were aged in a drying oven at 40°C for 7 hours to obtain the finished microcapsules.

[0084] Comparative Example 1

[0085] The prescription consists of the following components (unit: g):

[0086]

[0087] Preparation method:

[0088] The preparation method is the same as in Example 1.

[0089] Comparative Example 2:

[0090] The prescription consists of the following components (unit: g):

[0091]

[0092] Preparation method:

[0093] The preparation method is the same as in Example 1.

[0094] Comparative Example 3:

[0095] The prescription consists of the following components (unit: g):

[0096]

[0097] Preparation method:

[0098] The preparation method is the same as in Example 1.

[0099] Comparative Example 4:

[0100] The prescription consists of the following components (unit: g):

[0101]

[0102] Preparation method:

[0103] (1) Preparation of core material: Sucrose-starch-microcrystalline cellulose pellets were placed in a Wurster fluidized bed granulation and coating equipment as the core particles for granulation; aceclofenac was dissolved in 80% ethanol and the prescribed amounts of microcrystalline cellulose, propyl hydroxy-β-cyclodextrin, and sodium stearoyl lactylate were added and dissolved. The resulting solution was pumped into the fluidized bed and sprayed onto the core particles to prepare smooth and round core materials; the inlet air temperature was 38℃, the material temperature was 34℃, the spraying rate was 2.0 ml / min, the spraying pressure was 0.3 MPa, the fan frequency was 16 Hz, and the inlet air volume was 30 m³ / min. 3 / h.

[0104] (2) Preparation of the isolation layer: Micronized silica gel and hydroxypropyl methylcellulose E5 are dissolved in an ethanol solution, pumped into a fluidized bed and sprayed onto the core material to form an isolation layer;

[0105] (3) Preparation of enteric coating solution: Add L30D-55, lecithin, sodium hydroxide and magnesium stearate to an appropriate amount of purified water and mix evenly. Add enteric polymer coating material and stir for 30 minutes to prepare a coating solution with a solid content of 20%.

[0106] (4) Coating: The core material from step (1) is pumped into the fluidized bed and coated with the coating solution prepared in step (2), resulting in a 5% weight gain. The inlet air temperature is 34℃, the material temperature is 30℃, the spray rate is 1.5ml / min, the spray pressure is 0.25MPa, the fan frequency is 16HZ, and the inlet air volume is 30m³. 3 / h.

[0107] (5) The microcapsules were aged in a drying oven at 40°C for 7 hours to obtain the finished microcapsules.

[0108] Verification of Examples

[0109] The inventors would like to clarify that only some of the experimental data for the verification embodiments are listed here. Other experiments on the effectiveness of the verification embodiments can also prove that the technical solution provided by this invention is excellent, and they will not be listed here one by one.

[0110] 1. Determination of drug loading and encapsulation efficiency

[0111] An appropriate amount of the prepared aceclofenac enteric-coated microcapsules was taken, and the content of aceclofenac in the microcapsules was determined by the content assay method. The results are shown in Table 1. Encapsulation efficiency = drug content encapsulated in microcapsules / total drug content encapsulated and unencapsulated in microcapsules.

[0112] Table 1. Encapsulation efficiency measurement results for each embodiment.

[0113]

[0114]

[0115] 2. In vitro cumulative release experiment

[0116] Accurately weigh an appropriate amount of aceclofenac microcapsules and place them in 750 ml of 0.1 mol / L HCl (pH 1.2) artificial gastric fluid at 37℃. The stirring speed is 50 rpm. Samples are taken at 1 h, 1.5 h, and 2 h to detect the release rate.

[0117] Take an appropriate amount of the dissolution solution from the test sample solution, filter it, and accurately measure an appropriate amount of the filtrate.

[0118] For the reference solution, accurately weigh approximately 10 mg of aceclofenac reference standard, place it in a 100 ml volumetric flask, add 10 ml of methanol to dissolve it, dilute to the mark with the dissolution medium, and shake well. Accurately measure 5 ml of the solution, place it in a 20 ml volumetric flask, dilute to the mark with 0.1 mol / L hydrochloric acid solution, and shake well.

[0119] Immediately add 250 ml of 0.2 mol / L sodium phosphate solution preheated to 37℃ ± 0.5℃ to the solution after 2 hours of dissolution in the artificial gastric fluid, mix well (adjust the pH to 6.8 with 2 mol / L sodium hydroxide solution or 2 mol / L hydrochloric acid solution if necessary), and rotate at 50 rpm, following the procedure. Sampling time intervals were: 0.5 h, 1.0 h, 2.0 h, 3.0 h, 4.0 h, 5 h, and 6 h.

[0120] Take an appropriate amount of the dissolution solution from the test sample solution, filter it, and collect the filtrate.

[0121] Accurately measure 5 ml of the reference solution from the artificial gastric juice dissolution section and place it in a 20 ml volumetric flask. Dilute to the mark with the dissolution medium (0.1 mol / L hydrochloric acid solution and 0.2 mol / L sodium phosphate solution, mixed thoroughly at a ratio of 3:1; if necessary, adjust the pH to 6.8 with 2 mol / L sodium hydroxide solution or 2 mol / L hydrochloric acid solution), and shake well.

[0122] The results are shown in Tables 2 and 3. Figure 1 , Figure 2 (In the figure, 0-2h represents the microcapsules being in artificial gastric fluid; 2.5-8h represents the microcapsules being in artificial intestinal fluid).

[0123] Table 2. Results of in vitro release experiments of aceclofenac enteric-coated microcapsules in each example.

[0124]

[0125]

[0126] Table 3. Results of in vitro release experiments of aceclofenac enteric-coated microcapsules for each comparative example.

[0127]

[0128] 3. Detection of related substances in aceclofenac enteric microcapsules

[0129] Related substances were determined according to high performance liquid chromatography (General Rule 0512). Solvent: Mobile phase A-Mobile phase B (30:70). Test solution: Accurately weigh about 50 mg of this product, place it in a 25 ml volumetric flask, dissolve and dilute to the mark with solvent, and shake well. Reference solution: Accurately weigh an appropriate amount of diclofenac sodium reference standard, dissolve and quantitatively dilute with solvent to prepare a solution containing about 0.4 mg of diclofenac per ml. Reference solution: Accurately measure 2 ml of the test solution, place it in a 10 ml volumetric flask, dilute to the mark with solvent, and shake well. Accurately measure 1 ml of the solution, place it in a 100 ml volumetric flask, accurately add 1 ml of the reference solution, dilute to the mark with solvent, and shake well. Chromatographic conditions: Octadecylsilane-bonded silica gel was used as the stationary phase; 0.112% (w / v) phosphoric acid solution (adjusted to pH 7.0 with sodium hydroxide solution) was used as mobile phase A, and acetonitrile-water (90:10) was used as mobile phase B, with gradient elution according to the table below; the detection wavelength was 275 nm; the injection volume was 10 μl. Calculated by peak area using the external standard method, the concentration of diclofenac should not exceed 0.2%, the peak area of ​​any other individual impurity should not exceed the peak area of ​​aceclofenac in the control solution (0.2%), and the sum of the peak areas of other impurities should not exceed 2.5 times (0.5%) the peak area of ​​aceclofenac in the control solution. (Accelerated stability conditions: temperature 40℃, relative humidity: 75% ± 5%). Results are shown in Table 4.

[0130] Table 4. Results of detection of related substances in aceclofenac enteric microcapsules

[0131]

[0132]

[0133] The aceclofenac enteric-coated microcapsules prepared in each embodiment of this invention all meet the requirements. They are insoluble in gastric juice (pH=1.2) but soluble in intestinal juice (pH=6.8). The aceclofenac enteric-coated microcapsules release almost no drug in gastric juice for 2 hours, allowing the drug to be released in the intestinal juice, thus eliminating irritation to the gastrointestinal tract. Simultaneously, the drug is released slowly, prolonging the duration of action. They can also be used as a drug delivery system for the preparation of various dosage forms such as tablets, capsules, injections, patches, aerosols, and suspensions. The process is simple and stable, suitable for industrial production.

Claims

1. An enteric-coated microcapsule of aceclofenac, characterized in that, The product comprises a core and a coating layer. The core, by weight, consists of: 20-50 parts by weight of pellet core, 40-100 parts by weight of aceclofenac, and 12-36 parts by weight of binder. The coating layer, by weight, consists of: 10-40 parts by weight of enteric coating material, 2-15 parts by weight of plasticizer, and 2-15 parts by weight of anti-adhesion agent. The binder is tragacanth gum and povidone in a weight ratio of 1:1-3. The pellet core is microcrystalline cellulose and silica in a weight ratio of 2:

1. The enteric coating material is ethyl cellulose aqueous dispersion and Acryl-EZE 93A in a weight ratio of 1:1-2.

2. The aceclofenac enteric-coated microcapsules according to claim 1, characterized in that, The plasticizer is triacetin or diethyl phthalate; the anti-adhesive is selected from one or more of talc, micronized silica gel, magnesium stearate, and sodium alginate.

3. The aceclofenac enteric-coated microcapsules according to claim 1, characterized in that, The core material comprises, by weight, the following: 20-50 parts by weight of pellet core 40-100 parts by weight of aceclofenac 12-36 parts by weight of tragacanth gum and povidone The coating layer comprises, by weight, the following: Ethyl cellulose aqueous dispersion and Acryl-EZE 93A 10-40 parts by weight Triacetin 2-15 parts by weight 2-15 parts by weight of talc.

4. The application of the aceclofenac enteric-coated microcapsules according to any one of claims 1-3 in the preparation of formulations containing aceclofenac; wherein the dosage form of the formulation includes tablets and capsules.

5. A method for preparing the aceclofenac enteric-coated microcapsules of claim 1, characterized in that, Includes the following steps: (1) Preparation of core material: Aceclofenac is dissolved in an appropriate amount of solvent by stirring, and binder is added and stirred to obtain a solution. The solution is pumped into a fluidized bed and sprayed onto the core to prepare the core material. (2) Coating: Add appropriate amount of purified water to plasticizer and anti-adhesion agent and mix evenly. Add enteric coating material and stir to prepare a coating solution with a solid content of 18-22%. Pump it into a fluidized bed to fluidize and coat the core material. (3) Drying and aging yields the finished microcapsules.

6. The preparation method according to claim 5, characterized in that, In step (1), the solvent is selected from one or more of water, ethanol, and propylene glycol; the inlet air temperature is 35℃-40℃, the material temperature is 30-36℃, the spray rate is 1.5-2.5ml / min, the spray pressure is 0.2-0.4MPa, the fan frequency is 15-18HZ, and the inlet air volume is 28-32m³ / min. 3 / h; the stirring time in step (2) is 20-40 min, the air inlet temperature is 30℃-36℃, the material temperature is 28-33℃, the spraying rate is 1.0-2.0 ml / min, the spraying pressure is 0.15-0.35 MPa, the fan frequency is 14-17 HZ, and the air inlet volume is 28-32 m³ / min. 3 / h; the aging temperature of step (3) is 35-45℃ and the aging time is 5-9h.

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