CN110585161A - Production process of clofenyellow sensitive tablet coating - Google Patents
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- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/196—Carboxylic acids, e.g. valproic acid having an amino group the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
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- A61K31/4402—Non condensed pyridines; Hydrogenated derivatives thereof only substituted in position 2, e.g. pheniramine, bisacodyl
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- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/282—Organic compounds, e.g. fats
- A61K9/2826—Sugars or sugar alcohols, e.g. sucrose; Derivatives thereof
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- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2893—Tablet coating processes
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
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Abstract
The invention relates to the field of production of diclofenac sodium tablets, in particular to a production process of diclofenac sodium tablets, which comprises the steps of material preparation, wet granulation, drying, whole grain total mixing, tabletting, separation layer size mixing, powder coating layer size mixing, simple syrup size mixing, separation layer, powder coating layer, sugar coating layer manufacturing, color coating layer manufacturing, polishing and the like.
Description
Technical Field
The invention relates to the field of production of diclofenac sodium tablets, and in particular relates to a production process of diclofenac sodium tablet coatings.
Background
The diclofenac sodium tablet is a common medicine for treating cold and fever, has good efficacy and low price, and is widely applicable to the public. The diclofenac sodium tablets produced by the company are sugar-coated tablets, the curative effect is unique and well appreciated by patients, and the demand is increasing. However, the traditional coating process adopted in the prior art has long production period and low efficiency, and dust flies during operation to cause environmental pollution.
Disclosure of Invention
In order to solve the problems in the prior art, the invention provides a production process of a clofenyellow sensitive tablet coating.
In order to achieve the purpose, the invention adopts the following technical scheme: a production process of a clofenyellow tablet coating comprises the following steps:
1) preparing materials: taking 15g of diclofenac sodium; 15g of artificial bezoar; chlorpheniramine maleate 2.5 g; adding appropriate amount of starch, dextrin, sucrose and ethanol as adjuvants, pulverizing sucrose into 100 mesh sugar powder, and making ethanol into 30% ethanol component;
2) preparing wet granules: adding the diclofenac sodium, the artificial bezoar, the chlorphenamine maleate and a proper amount of starch, dextrin and sucrose powder into a high-speed mixing granulator, dry-mixing for 5 minutes, adding the ethanol component, stirring and cutting for 2 minutes, stopping stirring when the soft material is uniform in color and proper in hardness, taking out, adding into a swing granulator, and granulating by using a 14-mesh screen to obtain granules A;
3) and (3) drying: taking the particles A, operating equipment according to the operating rules of a fluidized bed granulator, setting the temperature to be 60 ℃, controlling the air inlet temperature to be 50-80 ℃, controlling the material temperature to be 40-65 ℃, controlling the air outlet temperature to be 30-65 ℃, drying for 5-10 minutes, shutting down, taking out the particles, measuring the water content of the dry particles to be 6-9%, obtaining particles B, and putting the particles B into a clean container;
4) and (3) total mixing of whole grains: adding a proper amount of the obtained granules B into a granulator, operating equipment according to the operating specification of the granulator, sieving with a 14-mesh sieve to prepare granules C with uniform and loose sizes, weighing and recording, adding the granulated dry granules C and magnesium stearate into a one-dimensional motion mixer, operating according to the operating specification of the one-dimensional motion mixer, and mixing for 40 minutes; and (3) placing the particles D obtained by the total mixing in a clean container, attaching a material marking card, transferring to an intermediate station for storage, weighing and recording.
5) Tabletting: selecting an elliptical punching die with the size of 14mm multiplied by 7mm, installing a punching head, the punching die and cleaning, and pressing the particles D into plain tablets E by operating the tablet press according to the operation rules of the tablet press;
6) adding purified water into an electric heating jacketed kettle, starting heating, setting the temperature to be 150 ℃, adding gelatin, adding cane sugar when the gelatin is completely melted, boiling for about 2 minutes, taking out of the kettle, putting into a stirring barrel, adding talcum powder, stirring for 40-50 minutes to prepare an isolation layer pre-mixing coating solution, filtering a 100-mesh screen, and putting into a stainless steel barrel to obtain an isolation layer pre-mixing coating solution F for later use;
7) adding purified water into an electric heating interlayer pot, starting heating (setting at 150 ℃), adding cane sugar, boiling for about 2 minutes, taking out of the pot, putting into a stirring barrel, adding talcum powder, stirring for 40-50 minutes to prepare a powder coating layer pre-mixed coating solution, filtering a 100-mesh screen, and putting into a stainless steel barrel to obtain a powder coating layer pre-mixed coating solution G for later use;
8) preparing single syrup: heating purified water to boil, adding sucrose, completely melting and boiling for 2 min, taking out, and sieving with 100 mesh sieve to obtain simple syrup H;
9) an isolation layer and a coating layer: the coating machine operating parameters were as follows: setting an air inlet temperature of 60-110 ℃, controlling an air exhaust temperature of 50-70 ℃, controlling a pot rotating speed of 5-13 r/min, setting a spraying speed of 4-14, an air source pressure of 0.4-0.6 MPa, and keeping a negative pressure of 0.1-0.5 MPa, and spraying an isolation layer pre-mixing coating liquid F and a powder coating layer pre-mixing coating liquid G on a plain tablet E in sequence to obtain a tablet I;
10) and (3) making a sugar coating layer: uniformly scattering simple syrup H in a pot by using a measuring cup, scattering a small amount of talcum powder after all tablets I are scattered, closing a door of a coating pot, rotating for 1-2 minutes, then opening air exhaust to blow the tablets I dry for 20 minutes, and repeating the steps for 3-5 times;
11) preparing a color coating layer: weighing simple syrup H, weighing pigment, dissolving in the simple syrup H, and coating with the following operating parameters: setting the air inlet temperature to be 50-60 ℃, controlling the air exhaust temperature to be 40-50 ℃, controlling the rotating speed of a pot to be 7-13 r/min, setting the spraying speed to be 4-7, setting the air source pressure to be 0.4-0.6 MPa, keeping the negative pressure to be 0.1-0.3 MPa, and completely spraying the color clothing liquid;
12) polishing: and after the color coating layer is sprayed, closing hot air and exhausting air, weighing insect wax, slowly and uniformly spreading the insect wax into the pot at the rotating speed of 7-12 r/min, and polishing for about 20 minutes to ensure that the tablets are glossy. Blowing for about 10 minutes by using exhaust air, and taking out the pot.
Compared with the prior art, the invention has the beneficial effects that: the product produced by the invention has the effects of relieving fever and easing pain, is used for symptoms such as headache, fever, nasal obstruction, watery nasal discharge, pharyngalgia, excessive phlegm and the like caused by cold, and improves the efficiency, reduces pollution and enables the properties of finished products to be better and the market competitiveness of the variety by improving the technology of the diclofenac sodium tablets in order to meet the market demand.
Drawings
Other features, objects and advantages of the present invention will become more apparent upon reading of the following detailed description of non-limiting embodiments thereof, with reference to the accompanying drawings.
FIG. 1 is a schematic diagram of the process of the present invention.
Detailed Description
The present invention will be described in further detail with reference to the following examples, which are provided only for illustrating the present invention and are not intended to limit the scope of the present invention.
Please refer to fig. 1, which shows a process for producing a coating of diclofenac sodium tablets, comprising the following steps:
1) preparing materials: taking 15g of diclofenac sodium; 15g of artificial bezoar; chlorpheniramine maleate 2.5 g; adding appropriate amount of starch, dextrin, sucrose and ethanol as adjuvants, pulverizing sucrose into 100 mesh sugar powder, and making ethanol into 30% ethanol component;
2) preparing wet granules: adding the diclofenac sodium, the artificial bezoar, the chlorphenamine maleate and a proper amount of starch, dextrin and sucrose powder into a high-speed mixing granulator, dry-mixing for 5 minutes, adding the ethanol component, stirring and cutting for 2 minutes, stopping stirring when the soft material is uniform in color and proper in hardness, taking out, adding into a swing granulator, and granulating by using a 14-mesh screen to obtain granules A;
3) and (3) drying: taking the particles A, operating equipment according to the operating rules of a fluidized bed granulator, setting the temperature to be 60 ℃, controlling the air inlet temperature to be 50-80 ℃, controlling the material temperature to be 40-65 ℃, controlling the air outlet temperature to be 30-65 ℃, drying for 5-10 minutes, shutting down, taking out the particles, measuring the water content of the dry particles to be 6-9%, obtaining particles B, and putting the particles B into a clean container;
4) and (3) total mixing of whole grains: adding a proper amount of the obtained granules B into a granulator, operating equipment according to the operating specification of the granulator, sieving with a 14-mesh sieve to prepare granules C with uniform and loose sizes, weighing and recording, adding the granulated dry granules C and magnesium stearate into a one-dimensional motion mixer, operating according to the operating specification of the one-dimensional motion mixer, and mixing for 40 minutes; and (3) placing the particles D obtained by the total mixing in a clean container, attaching a material marking card, transferring to an intermediate station for storage, weighing and recording.
5) Tabletting: selecting an elliptical punching die with the size of 14mm multiplied by 7mm, installing a punching head, the punching die and cleaning, operating the tablet press according to the operating specification of the tablet press, pressing the particles D into plain tablets E, sampling once every 20 minutes by an operator, and checking that the weight of 10 tablets is not more than 10 tablets and is +/-1 percent of the tablet pressing weight; checking the inner and outer orbits once every two hours, respectively taking 10 tablets, wherein the weight of each tablet does not exceed the weight of the tablet plus or minus 6 percent, and the disintegration time limit is controlled to be less than or equal to 40 minutes.
6) Adding purified water into an electric heating jacketed kettle, starting heating (setting at 150 ℃), adding a proper amount of gelatin, adding cane sugar when the gelatin is completely melted, boiling for about 2 minutes, taking out of the kettle, putting into a stirring barrel, adding talcum powder, stirring for 40-50 minutes to prepare an isolation layer pre-mixing coating solution, filtering a 100-mesh screen, and putting into a stainless steel barrel to obtain an isolation layer pre-mixing coating solution F for later use;
7) adding purified water into an electric heating interlayer pot, starting heating (setting at 150 ℃), adding cane sugar, boiling for about 2 minutes, taking out of the pot, putting into a stirring barrel, adding talcum powder, stirring for 40-50 minutes to prepare a powder coating layer pre-mixed coating solution, filtering a 100-mesh screen, and putting into a stainless steel barrel to obtain a powder coating layer pre-mixed coating solution G for later use;
8) preparing single syrup: heating purified water to boil, adding sucrose, completely melting and boiling for 2 min, taking out, and sieving with 100 mesh sieve to obtain simple syrup H;
9) an isolation layer and a coating layer: the coating machine operating parameters were as follows: setting an air inlet temperature of 60-110 ℃, controlling an air exhaust temperature of 50-70 ℃, controlling a pot rotating speed of 5-13 r/min, setting a spraying speed of 4-14, an air source pressure of 0.4-0.6 MPa, and keeping a negative pressure of 0.1-0.5 MPa, and spraying an isolation layer pre-mixing coating liquid F and a powder coating layer pre-mixing coating liquid G on a plain tablet E in sequence to obtain a tablet I;
10) and (3) making a sugar coating layer: uniformly scattering simple syrup H in a pot by using a measuring cup (closing hot air and exhausting air when the simple syrup is added), scattering a small amount of talcum powder after all tablets I are scattered, closing a coating pot door, rotating for 1-2 minutes, then opening the exhausting air to blow the tablets I for 20 minutes, and repeating the steps for 3-5 times;
11) preparing a color coating layer: weighing simple syrup H, weighing pigment, dissolving in the simple syrup H, and coating with the following operating parameters: setting the air inlet temperature to be 50-60 ℃, controlling the air exhaust temperature to be 40-50 ℃, controlling the rotating speed of a pot to be 7-13 r/min, setting the spraying speed to be 4-7, setting the air source pressure to be 0.4-0.6 MPa, keeping the negative pressure to be 0.1-0.3 MPa, and completely spraying the color clothing liquid;
12) polishing: and after the color coating layer is sprayed, closing hot air and exhausting air, weighing insect wax, slowly and uniformly spreading the insect wax into the pot at the rotating speed of 7-12 r/min, and polishing for about 20 minutes to ensure that the tablets are glossy. Blowing for about 10 minutes by using exhaust air, and taking out the pot. The water content of the sugar-coated tablet is controlled to be less than or equal to 6 percent, and the disintegration time is controlled to be less than or equal to 50 minutes.
The key equipment is as follows:
the main technical indexes of the project product are as follows:
[ PROPERTIES ] the product is sugar-coated tablet, and appears pale yellow after coating is removed.
[ disintegration time ] not more than 60 minutes.
[ IDENTIFICATION ]
(1) The chemical reaction should be positive.
[ EXAMINATION ]
Content uniformity: the chlorpheniramine maleate content is determined with a limit of + -20%.
Total aerobic bacteria count: should not exceed 800cfu/g
Total number of mold and yeast: should not exceed 80cfu/g
Escherichia coli: cannot be detected
Salmonella: cannot be detected
[ MEASUREMENT OF CONTENT ]
The product contains diclofenac sodium (C14H10C12NaNO2) and chlorphenamine maleate (C16H19C1N2O.C4H4O4) which are respectively 90.0-110.0% of labeled amount, and the content of artificial bezoar (calculated by bilirubin) is not less than 0.055 mg.
The foregoing is directed to preferred embodiments of the present invention, other and further embodiments of the invention may be devised without departing from the basic scope thereof, and the scope thereof is determined by the claims that follow. However, any simple modification, equivalent change and modification of the above embodiments according to the technical essence of the present invention are within the protection scope of the technical solution of the present invention.
Claims (1)
1. A production process of a clofenyellow sensitive tablet coating is characterized by comprising the following steps: the method comprises the following steps:
1) preparing materials: taking 15g of diclofenac sodium; 15g of artificial bezoar; chlorpheniramine maleate 2.5 g; adding appropriate amount of starch, dextrin, sucrose and ethanol as adjuvants, pulverizing sucrose into 100 mesh sugar powder, and making ethanol into 30% ethanol component;
2) preparing wet granules: adding the diclofenac sodium, the artificial bezoar, the chlorphenamine maleate and a proper amount of starch, dextrin and sucrose powder into a high-speed mixing granulator, dry-mixing for 5 minutes, adding the ethanol component, stirring and cutting for 2 minutes, stopping stirring when the soft material is uniform in color and proper in hardness, taking out, adding into a swing granulator, and granulating by using a 14-mesh screen to obtain granules A;
3) and (3) drying: taking the particles A, operating equipment according to the operating rules of a fluidized bed granulator, setting the temperature to be 60 ℃, controlling the air inlet temperature to be 50-80 ℃, controlling the material temperature to be 40-65 ℃, controlling the air outlet temperature to be 30-65 ℃, drying for 5-10 minutes, shutting down, taking out the particles, measuring the water content of the dry particles to be 6-9%, obtaining particles B, and putting the particles B into a clean container;
4) and (3) total mixing of whole grains: adding a proper amount of the obtained granules B into a granulator, operating equipment according to the operating specification of the granulator, sieving with a 14-mesh sieve to prepare granules C with uniform and loose sizes, weighing and recording, adding the granulated dry granules C and magnesium stearate into a one-dimensional motion mixer, operating according to the operating specification of the one-dimensional motion mixer, and mixing for 40 minutes; placing the particles D obtained by the total mixing in a clean container, attaching a material marking card, transferring to an intermediate station for storage, weighing and recording;
5) tabletting: selecting an elliptical punching die with the size of 14mm multiplied by 7mm, installing a punching head, the punching die and cleaning, and pressing the particles D into plain tablets E by operating the tablet press according to the operation rules of the tablet press;
6) adding purified water into an electric heating jacketed kettle, starting heating, setting the temperature to be 150 ℃, adding gelatin, adding cane sugar when the gelatin is completely melted, boiling for about 2 minutes, taking out of the kettle, putting into a stirring barrel, adding talcum powder, stirring for 40-50 minutes to prepare an isolation layer pre-mixing coating solution, filtering a 100-mesh screen, and putting into a stainless steel barrel to obtain an isolation layer pre-mixing coating solution F for later use;
7) adding purified water into an electric heating interlayer pot, starting heating (setting at 150 ℃), adding cane sugar, boiling for about 2 minutes, taking out of the pot, putting into a stirring barrel, adding talcum powder, stirring for 40-50 minutes to prepare a powder coating layer pre-mixed coating solution, filtering a 100-mesh screen, and putting into a stainless steel barrel to obtain a powder coating layer pre-mixed coating solution G for later use;
8) preparing single syrup: heating purified water to boil, adding sucrose, completely melting and boiling for 2 min, taking out, and sieving with 100 mesh sieve to obtain simple syrup H;
9) an isolation layer and a coating layer: the coating machine operating parameters were as follows: setting an air inlet temperature of 60-110 ℃, controlling an air exhaust temperature of 50-70 ℃, controlling a pot rotating speed of 5-13 r/min, setting a spraying speed of 4-14, an air source pressure of 0.4-0.6 MPa, and keeping a negative pressure of 0.1-0.5 MPa, and spraying an isolation layer pre-mixing coating liquid F and a powder coating layer pre-mixing coating liquid G on a plain tablet E in sequence to obtain a tablet I;
10) and (3) making a sugar coating layer: uniformly scattering simple syrup H in a pot by using a measuring cup, scattering a small amount of talcum powder after all tablets I are scattered, closing a door of a coating pot, rotating for 1-2 minutes, then opening air exhaust to blow the tablets I dry for 20 minutes, and repeating the steps for 3-5 times;
11) preparing a color coating layer: weighing simple syrup H, weighing pigment, dissolving in the simple syrup H, and coating with the following operating parameters: setting the air inlet temperature to be 50-60 ℃, controlling the air exhaust temperature to be 40-50 ℃, controlling the rotating speed of a pot to be 7-13 r/min, setting the spraying speed to be 4-7, setting the air source pressure to be 0.4-0.6 MPa, keeping the negative pressure to be 0.1-0.3 MPa, and completely spraying the color clothing liquid;
12) polishing: and after the color coating layer is sprayed, closing hot air and exhausting air, weighing insect white wax, slowly and uniformly scattering the insect white wax into the pot at the rotating speed of 7-12 r/min, polishing for about 20 minutes to ensure that the tablets are glossy, and taking the tablets out of the pot after the exhaust air is blown for about 10 minutes.
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| WO2022093134A1 (en) * | 2020-10-26 | 2022-05-05 | Pharmactive Ilac Sanayi Ve Ticaret A.S. | Pharmaceutical compositions comprising diclofenac potassium and relevant excipients |
| CN112641746A (en) * | 2020-12-31 | 2021-04-13 | 重庆市药研院制药有限公司 | Coating method of sugar-coated tablets |
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