CN115006360A - Diclofenac sodium sustained-release tablet placebo and preparation method thereof - Google Patents

Diclofenac sodium sustained-release tablet placebo and preparation method thereof Download PDF

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CN115006360A
CN115006360A CN202210778406.7A CN202210778406A CN115006360A CN 115006360 A CN115006360 A CN 115006360A CN 202210778406 A CN202210778406 A CN 202210778406A CN 115006360 A CN115006360 A CN 115006360A
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parts
placebo
sustained
diclofenac sodium
release tablets
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王廷春
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Boji Pharmaceutical Technology Co ltd
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Boji Pharmaceutical Technology Co ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin

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  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)

Abstract

The invention discloses a placebo for diclofenac sodium sustained-release tablets, which comprises the following raw materials in parts by weight: 20-30 parts of powdered sugar, 10-20 parts of dextrin, 4-7 parts of modified chitosan, 3-7 parts of starch additive, 12-15 parts of adhesive, 1-4 parts of flavoring agent and 1-3 parts of coloring agent. The placebo of the sustained-release tablet is prepared by matching the raw materials such as powdered sugar, dextrin and the like, adding the modified chitosan and the starch additive, and matching the modified chitosan and the starch additive, has an excellent simulation effect, has an optimal grading effect, optimizes the raw materials of the product after the chitosan is modified, is matched with the starch additive for further assistance, has similar appearance, color and taste of the prepared product to those of a test medicine, has a good simulation effect, does not have significant difference, and can effectively prevent the occurrence of bias or blindness in clinical tests; the prescription does not contain any test drugs or other active ingredients, is qualified in quality, safe and non-toxic through inspection, and does not influence clinical test results.

Description

Diclofenac sodium sustained-release tablet placebo and preparation method thereof
Technical Field
The invention relates to the technical field of diclofenac sodium sustained release, in particular to a placebo for diclofenac sodium sustained release tablets and a preparation method thereof.
Background
Placebo is a "simulated drug". The physical properties such as appearance, size, color, formulation, weight, taste and odor should be as similar as possible to those of the test drugs, but should not contain the active ingredients of the test drugs (e.g., tablets containing lactose or starch or physiological saline injections). Recent medical developments to date, with the popularity of evidence-based medicine, researchers have increasingly employed placebo as a control to verify the therapeutic effect of test drugs in clinical drug testing studies. The reasonable prescription and the preparation method are one of the prerequisites that the placebo can prevent blindness in clinical tests and reduce bias so as to ensure the successful clinical tests.
The existing placebo and pharmaceutical diclofenac sodium are required to be consistent in appearance, smell and color, which causes difficulty for experiments, and meanwhile, the existing placebo technology of the diclofenac sodium sustained-release tablet is immature and has poor simulation effect, so that the invention further improves and processes the diclofenac sodium sustained-release tablet.
Disclosure of Invention
Aiming at the defects of the prior art, the invention aims to provide a placebo of diclofenac sodium sustained-release tablets and a preparation method thereof, so as to solve the problems in the background art.
The technical scheme adopted by the invention for solving the technical problems is as follows:
the invention provides a placebo for diclofenac sodium sustained-release tablets, which comprises the following raw materials in parts by weight:
20-30 parts of powdered sugar, 10-20 parts of dextrin, 4-7 parts of modified chitosan, 3-7 parts of starch additive, 12-15 parts of adhesive, 1-4 parts of flavoring agent and 1-3 parts of coloring agent.
Preferably, the slow release tablet placebo comprises the following raw materials in parts by weight:
25 parts of powdered sugar, 15 parts of dextrin, 5.5 parts of modified chitosan, 5 parts of starch additive, 13.5 parts of adhesive, 2.5 parts of flavoring agent and 2 parts of coloring agent.
Preferably, the binder is methylcellulose.
Preferably, the flavour is sucrose octaacetate and the colour is cocoa shell colour.
Preferably, the preparation method of the modified chitosan comprises the following steps:
s01: firstly, dissolving chitosan in 5-7 times of citric acid to obtain a chitosan solution;
s02: placing the chitosan solution in sodium alginate solution with the total amount of 3-5 times, stirring at 55-65 ℃ for 10-20min at the stirring speed of 500-;
s03: and (3) freezing the S02 product at-20 ℃, and then drying to obtain the modified chitosan.
The inventor of the invention adopts the product of the invention, the average scores of smell, taste, granule color and granule dissolution appearance are highest, the evaluation scores are all lower without adding modified chitosan, and the evaluation scores are reduced without adding starch additive.
Preferably, the mass fraction of the sodium alginate solution is 10-15%.
Preferably, the drying treatment comprises the following steps: heating to 10-15 deg.C at a rate of 1-5 deg.C/min, maintaining for 5-10min, heating to 45-65 deg.C, maintaining for 10min, and air cooling to room temperature.
Preferably, the preparation method of the starch additive comprises the following steps: adding starch into 2-3 times of deionized water, gelatinizing at 55-65 deg.C for 10-20min, adding montmorillonite powder 5-10% of total amount of starch, and stirring to obtain starch additive.
Preferably, the particle size of the montmorillonite powder is 10-20 meshes.
The invention also provides a preparation method of the diclofenac sodium sustained-release tablet placebo, which comprises the following steps:
step one, adding sugar powder, dextrin, a flavoring agent and a coloring agent into water in sequence, and mixing and dissolving;
step two, continuously adding the modified chitosan, the starch additive and the adhesive into the product obtained in the step one, stirring and mixing fully, and then drying until the water content is lower than 5%;
and step three, crushing the mixture to pass through a 10-20-mesh sieve to obtain the diclofenac sodium sustained-release tablet placebo.
Compared with the prior art, the invention has the following beneficial effects:
the placebo of the sustained-release tablet is prepared by matching the raw materials such as powdered sugar, dextrin and the like, adding the modified chitosan and the starch additive, and matching the modified chitosan and the starch additive, has an excellent simulation effect, has an optimal grading effect, optimizes the raw materials of the product after the chitosan is modified, is matched with the starch additive for further assistance, has similar appearance, color and taste of the prepared product to those of a test medicine, has a good simulation effect, does not have significant difference, and can effectively prevent the occurrence of bias or blindness in clinical tests; the prescription does not contain any test drugs or other active ingredients, is qualified in quality, safe and nontoxic after being checked, and does not influence clinical test results.
Detailed Description
The technical solutions in the embodiments of the present invention are clearly and completely described below with reference to specific embodiments, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
The placebo for the diclofenac sodium sustained-release tablets comprises the following raw materials in parts by weight:
20-30 parts of powdered sugar, 10-20 parts of dextrin, 4-7 parts of modified chitosan, 3-7 parts of starch additive, 12-15 parts of adhesive, 1-4 parts of flavoring agent and 1-3 parts of coloring agent.
The sustained-release tablet placebo of the embodiment comprises the following raw materials in parts by weight:
25 parts of powdered sugar, 15 parts of dextrin, 5.5 parts of modified chitosan, 5 parts of starch additive, 13.5 parts of adhesive, 2.5 parts of flavoring agent and 2 parts of coloring agent.
The binder of this example is methyl cellulose.
The flavor of this example was sucrose octaacetate and the colorant was cocoa shell.
The preparation method of the modified chitosan of this example comprises:
s01: firstly, dissolving chitosan in 5-7 times of citric acid to obtain a chitosan solution;
s02: placing the chitosan solution in sodium alginate solution with the total amount of 3-5 times, stirring for 10-20min at 55-65 ℃ with the stirring speed of 500-1000r/min, and finishing stirring;
s03: and (3) freezing the S02 product at-20 ℃, and then drying to obtain the modified chitosan.
The mass fraction of the sodium alginate solution in the embodiment is 10-15%.
The drying process of this example includes the following steps: heating to 10-15 deg.C at a rate of 1-5 deg.C/min, maintaining for 5-10min, heating to 45-65 deg.C, maintaining for 10min, and air cooling to room temperature.
The preparation method of the starch additive of this example is as follows: adding starch into 2-3 times of deionized water, gelatinizing at 55-65 deg.C for 10-20min, adding montmorillonite powder 5-10% of total amount of starch, and stirring to obtain starch additive.
The particle size of the montmorillonite powder in this example is 10-20 mesh.
The preparation method of the placebo for diclofenac sodium sustained-release tablets comprises the following steps:
step one, adding sugar powder, dextrin, a flavoring agent and a coloring agent into water in sequence, and mixing and dissolving;
step two, continuously adding the modified chitosan, the starch additive and the adhesive into the product obtained in the step one, stirring and mixing fully, and then drying until the water content is lower than 5%;
and step three, crushing the mixture to 10-20 meshes to obtain the placebo of the diclofenac sodium sustained-release tablets.
Example 1.
The placebo for the diclofenac sodium sustained-release tablets comprises the following raw materials in parts by weight:
20 parts of powdered sugar, 10 parts of dextrin, 4 parts of modified chitosan, 3 parts of starch additive, 12 parts of adhesive, 1 part of flavoring agent and 1 part of coloring agent.
The binder of this example is methyl cellulose.
The flavor of this example was sucrose octaacetate and the colorant was cocoa shell.
The preparation method of the modified chitosan of this example comprises:
s01: firstly, dissolving chitosan in 5 times of citric acid to obtain a chitosan solution;
s02: placing the chitosan solution in sodium alginate solution with 3 times of total amount, stirring at 55 deg.C for 10min at stirring speed of 500r/min, and stirring;
s03: and (3) freezing the S02 product at-20 ℃, and then drying to obtain the modified chitosan.
The mass fraction of the sodium alginate solution in this example was 10%.
The drying process of this example includes the following steps: heating to 10 deg.C at a rate of 1 deg.C/min, maintaining the temperature for 5min, heating to 45 deg.C, maintaining the temperature for 10min, and air cooling to room temperature.
The preparation method of the starch additive of this example is as follows: and (2) feeding the starch into 2 times of deionized water, gelatinizing at 55 ℃ for 10min, adding montmorillonite powder accounting for 5% of the total amount of the starch after gelatinizing is finished, and continuously stirring and fully mixing to obtain the starch additive.
The particle size of the montmorillonite powder in this example was 10 mesh.
The preparation method of the placebo for the diclofenac sodium sustained-release tablets comprises the following steps:
step one, adding sugar powder, dextrin, a flavoring agent and a coloring agent into water in sequence, and mixing and dissolving;
step two, continuously adding the modified chitosan, the starch additive and the adhesive into the product obtained in the step one, stirring and mixing fully, and then drying until the water content is lower than 5%;
and step three, crushing and sieving by a 10-mesh sieve to obtain the diclofenac sodium sustained-release tablet placebo.
Example 2.
The placebo for the diclofenac sodium sustained-release tablets comprises the following raw materials in parts by weight:
30 parts of powdered sugar, 20 parts of dextrin, 7 parts of modified chitosan, 7 parts of starch additive, 15 parts of adhesive, 4 parts of flavoring agent and 3 parts of coloring agent.
The binder of this example is methyl cellulose.
The flavor of this example was sucrose octaacetate and the colorant was cocoa shell.
The preparation method of the modified chitosan of this example comprises:
s01: dissolving chitosan in 7 times of citric acid to obtain a chitosan solution;
s02: placing the chitosan solution in 5 times of sodium alginate solution, stirring at 65 deg.C for 20min at 1000r/min, and stirring;
s03: and (3) freezing the S02 product at-20 ℃, and then drying to obtain the modified chitosan.
The mass fraction of the sodium alginate solution in this example was 15%.
The drying process of this example includes the following steps: heating to 15 deg.C at a rate of 5 deg.C/min, maintaining the temperature for 10min, heating to 65 deg.C, maintaining the temperature for 10min, and air cooling to room temperature.
The preparation method of the starch additive of this example is as follows: and (2) feeding the starch into 3 times of deionized water, then gelatinizing for 20min at 65 ℃, adding montmorillonite powder accounting for 10% of the total amount of the starch after gelatinizing is finished, and continuously stirring and fully mixing to obtain the starch additive.
The particle size of the montmorillonite powder in this example was 20 mesh.
The preparation method of the placebo for the diclofenac sodium sustained-release tablets comprises the following steps:
step one, adding sugar powder, dextrin, a flavoring agent and a coloring agent into water in sequence, and mixing and dissolving;
step two, continuously adding the modified chitosan, the starch additive and the adhesive into the product obtained in the step one, stirring and mixing fully, and then drying until the water content is lower than 5%;
and step three, crushing and sieving the powder by a 20-mesh sieve to obtain the diclofenac sodium sustained-release tablet placebo.
Example 3.
The placebo for the diclofenac sodium sustained-release tablets comprises the following raw materials in parts by weight:
25 parts of powdered sugar, 15 parts of dextrin, 5.5 parts of modified chitosan, 5 parts of starch additive, 13.5 parts of adhesive, 2.5 parts of flavoring agent and 2 parts of coloring agent.
The binder of this example is methyl cellulose.
The flavor of this example was sucrose octaacetate and the colorant was cocoa shell.
The preparation method of the modified chitosan of this example comprises:
s01: firstly dissolving chitosan in 6 times of citric acid to obtain a chitosan solution;
s02: placing the chitosan solution in a sodium alginate solution with the total amount of 4 times, stirring at 60 deg.C for 15min at a rotation speed of 750r/min, and stirring;
s03: and (3) freezing the S02 product at-20 ℃, and then drying to obtain the modified chitosan.
The mass fraction of the sodium alginate solution in this example was 12.5%.
The drying process of this example includes the following steps: heating to 12.5 deg.C at a rate of 3 deg.C/min, maintaining for 7.5min, heating to 50 deg.C, maintaining for 10min, and air cooling to room temperature.
The preparation method of the starch additive of this example is as follows: and (2) feeding the starch into 2.5 times of deionized water, gelatinizing for 15min at 60 ℃, adding montmorillonite powder accounting for 5-10% of the total amount of the starch after gelatinizing is finished, and continuously stirring and fully mixing to obtain the starch additive.
The particle size of the montmorillonite powder in this example was 15 mesh.
The preparation method of the placebo for the diclofenac sodium sustained-release tablets comprises the following steps:
step one, adding sugar powder, dextrin, a flavoring agent and a coloring agent into water in sequence, and mixing and dissolving;
step two, continuously adding the modified chitosan, the starch additive and the adhesive into the product obtained in the step one, stirring and mixing fully, and then drying until the water content is lower than 5%;
and step three, crushing and sieving the mixture by a 15-mesh sieve to obtain the diclofenac sodium sustained-release tablet placebo.
Example 4.
The placebo for the diclofenac sodium sustained-release tablets comprises the following raw materials in parts by weight:
22 parts of powdered sugar, 12 parts of dextrin, 5 parts of modified chitosan, 4 parts of starch additive, 13 parts of adhesive, 2 parts of flavoring agent and 2 parts of coloring agent.
The binder of this example is methyl cellulose.
The flavor of this example was sucrose octaacetate and the colorant was cocoa shell.
The preparation method of the modified chitosan of this example comprises:
s01: firstly dissolving chitosan in 6 times of citric acid to obtain a chitosan solution;
s02: placing the chitosan solution in a sodium alginate solution with the total amount of 4 times, stirring at 57 ℃ for 12min at the stirring speed of 550r/min, and finishing stirring;
s03: and (3) freezing the S02 product at-20 ℃, and then drying to obtain the modified chitosan.
The mass fraction of the sodium alginate solution in this example was 12%.
The drying process of this example includes the following steps: heating to 12 deg.C at a rate of 2 deg.C/min, maintaining the temperature for 6min, heating to 48 deg.C, maintaining the temperature for 10min, and air cooling to room temperature.
The preparation method of the starch additive of this example is as follows: and (2) feeding the starch into 2.2 times of deionized water, gelatinizing at 58 ℃ for 12min, adding montmorillonite powder accounting for 6% of the total amount of the starch after gelatinizing is finished, and continuously stirring and fully mixing to obtain the starch additive.
Preferably, the particle size of the montmorillonite powder is 12 meshes.
The preparation method of the placebo for the diclofenac sodium sustained-release tablets comprises the following steps:
step one, adding sugar powder, dextrin, a flavoring agent and a coloring agent into water in sequence, and mixing and dissolving;
step two, continuously adding the modified chitosan, the starch additive and the adhesive into the product obtained in the step one, stirring and mixing fully, and then drying until the water content is lower than 5%;
and step three, crushing the mixture again and sieving the crushed mixture by a 12-mesh sieve to obtain the placebo of the diclofenac sodium sustained-release tablets.
Example 5.
The placebo for the diclofenac sodium sustained-release tablets comprises the following raw materials in parts by weight:
28 parts of powdered sugar, 18 parts of dextrin, 6 parts of modified chitosan, 6 parts of starch additive, 14 parts of adhesive, 3 parts of flavoring agent and 2 parts of coloring agent.
The binder of this example is methyl cellulose.
The flavor of this example was sucrose octaacetate and the colorant was cocoa shell.
The preparation method of the modified chitosan of this example comprises:
s01: firstly, dissolving chitosan in citric acid 6 times to obtain a chitosan solution;
s02: placing the chitosan solution in a sodium alginate solution with the total amount of 4 times, stirring at 62 ℃ for 18min at the stirring speed of 800r/min, and finishing stirring;
s03: and (3) freezing the S02 product at-20 ℃, and then drying to obtain the modified chitosan.
The mass fraction of the sodium alginate solution in this example was 14%.
The drying process of this example includes the following steps: heating to 14 deg.C at a rate of 4 deg.C/min, maintaining the temperature for 8min, heating to 62 deg.C, maintaining the temperature for 10min, and air cooling to room temperature.
The preparation method of the starch additive of the embodiment comprises the following steps: and (2) feeding starch into deionized water in an amount which is 3 times that of the starch, gelatinizing for 18min at 62 ℃, adding montmorillonite powder accounting for 8 percent of the total amount of the starch after gelatinizing is finished, and continuously stirring and fully mixing to obtain the starch additive.
The particle size of the montmorillonite powder in this example was 18 mesh.
The preparation method of the placebo for the diclofenac sodium sustained-release tablets comprises the following steps:
step one, adding sugar powder, dextrin, a flavoring agent and a coloring agent into water in sequence, and mixing and dissolving;
step two, continuously adding the modified chitosan, the starch additive and the adhesive into the product obtained in the step one, stirring and mixing fully, and then drying until the water content is lower than 5%;
and step three, crushing the mixture to 18 meshes to obtain the placebo of the diclofenac sodium sustained-release tablets.
Comparative example 1.
Unlike example 3, no modified chitosan was added.
Comparative example 2.
The difference from the example 3 is that the modified chitosan is not treated by the sodium alginate solution.
Comparative example 3.
The difference from example 3 is that the modified chitosan was not dried.
Comparative example 4.
In contrast to example 3, no starch additive was added.
Comparative example 5.
Different from the example 3, the preparation method of the starch additive is different;
and (2) feeding the starch into 3 times of deionized water, gelatinizing at 62 ℃ for 18min, adding 8% of talcum powder of the total amount of the starch after gelatinizing is finished, and continuously stirring and fully mixing to obtain the starch additive.
The placebo obtained in examples 1 to 3 and comparative examples 1 to 5 was evaluated by a professional for smell, taste, granule color, granule dissolution appearance (particle size, fine powder rate), etc. and scored 100 points;
the performance of the products of examples 1-3 and comparative examples 1-5 was tested as follows:
Figure 41729DEST_PATH_IMAGE001
as can be seen from comparative examples 1 to 5 and examples 1 to 3, the products of examples 1 to 3 had the highest average scores of odor, taste, pellet color and pellet dissolution appearance, while comparative example 1, in which no modified chitosan was added, had a lower score, and in which no starch additive was added, had a lower score.
Formula preliminary screening experiments preliminary evaluation of each example was performed on three factors, namely odor simulation, color simulation and bitterness simulation, to screen out one to two relatively superior formulas.
The results of the preliminary screening of the formulation (1, 0, -1 respectively represent three levels of good, fair and poor)
Figure 755607DEST_PATH_IMAGE002
As seen from examples 1-3 and comparative examples 1-5, the products of examples 1-3 had excellent simulation effect, while comparative examples 1-5 all showed different degrees of difference, and the placebo prepared by the formulation of the present invention had the best simulation effect.
It will be evident to those skilled in the art that the invention is not limited to the details of the foregoing illustrative embodiments, and that the present invention may be embodied in other specific forms without departing from the spirit or essential attributes thereof. The present embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.
Furthermore, it should be understood that although the present description refers to embodiments, not every embodiment may contain only a single embodiment, and such description is for clarity only, and those skilled in the art should integrate the description, and the embodiments may be combined as appropriate to form other embodiments understood by those skilled in the art.

Claims (10)

1. The placebo for the diclofenac sodium sustained-release tablets is characterized by comprising the following raw materials in parts by weight:
20-30 parts of powdered sugar, 10-20 parts of dextrin, 4-7 parts of modified chitosan, 3-7 parts of starch additive, 12-15 parts of adhesive, 1-4 parts of flavoring agent and 1-3 parts of coloring agent.
2. The placebo for sustained-release tablets of diclofenac sodium according to claim 1, wherein the placebo for sustained-release tablets comprises the following raw materials in parts by weight:
25 parts of powdered sugar, 15 parts of dextrin, 5.5 parts of modified chitosan, 5 parts of starch additive, 13.5 parts of adhesive, 2.5 parts of flavoring agent and 2 parts of coloring agent.
3. The placebo for sustained-release tablets of diclofenac sodium according to claim 1, wherein the binder is methylcellulose.
4. The placebo for sustained-release tablets of diclofenac sodium according to claim 1, wherein the flavoring agent is sucrose octaacetate and the coloring agent is cocoa shell.
5. The placebo for diclofenac sodium sustained-release tablets according to claim 1, wherein the preparation method of the modified chitosan comprises the following steps:
s01: firstly, dissolving chitosan in 5-7 times of citric acid to obtain a chitosan solution;
s02: placing the chitosan solution in sodium alginate solution with the total amount of 3-5 times, stirring at 55-65 ℃ for 10-20min at the stirring speed of 500-;
s03: and (3) freezing the S02 product at-20 ℃, and then drying to obtain the modified chitosan.
6. The placebo for sustained-release tablets of diclofenac sodium according to claim 5, wherein the mass fraction of the sodium alginate solution is 10-15%.
7. The placebo for diclofenac sodium sustained-release tablets according to claim 5, wherein the drying treatment comprises the following steps: heating to 10-15 deg.C at a rate of 1-5 deg.C/min, maintaining for 5-10min, heating to 45-65 deg.C, maintaining for 10min, and air cooling to room temperature.
8. The placebo for sustained-release tablets of diclofenac sodium according to claim 1, wherein the preparation method of the starch additive comprises: adding starch into 2-3 times of deionized water, gelatinizing at 55-65 deg.C for 10-20min, adding montmorillonite powder 5-10% of total amount of starch, and stirring to obtain starch additive.
9. The placebo of claim 8, wherein the particle size of the montmorillonite powder is 10-20 meshes.
10. A method for preparing the placebo for sustained-release tablets of diclofenac sodium according to any one of claims 1 to 9, which comprises the following steps:
step one, adding sugar powder, dextrin, a flavoring agent and a coloring agent into water in sequence, and mixing and dissolving;
step two, continuously adding the modified chitosan, the starch additive and the adhesive into the product obtained in the step one, stirring and mixing fully, and then drying until the water content is lower than 5%;
and step three, crushing the mixture to pass through a 10-20-mesh sieve to obtain the diclofenac sodium sustained-release tablet placebo.
CN202210778406.7A 2022-07-04 2022-07-04 Diclofenac sodium sustained-release tablet placebo and preparation method thereof Pending CN115006360A (en)

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CN116585205A (en) * 2023-04-24 2023-08-15 广州领衔生物科技有限公司 Freeze-dried powder preparation with relieving effect

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CN104337776A (en) * 2013-07-25 2015-02-11 青岛康地恩动物药业有限公司 Tablets containing diclofenac sodium and having analgesic effect on pets, and preparation method thereof

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116585205A (en) * 2023-04-24 2023-08-15 广州领衔生物科技有限公司 Freeze-dried powder preparation with relieving effect
CN116585205B (en) * 2023-04-24 2024-03-22 广州领衔生物科技有限公司 Freeze-dried powder preparation with relieving effect

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