CN111374953A - Paracetamol tablet and preparation process thereof - Google Patents
Paracetamol tablet and preparation process thereof Download PDFInfo
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- CN111374953A CN111374953A CN201811650269.9A CN201811650269A CN111374953A CN 111374953 A CN111374953 A CN 111374953A CN 201811650269 A CN201811650269 A CN 201811650269A CN 111374953 A CN111374953 A CN 111374953A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
- A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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 belongs to the technical field of pharmacy, and particularly relates to a paracetamol tablet and a preparation process thereof. The preparation process adopts alginic acid dispersed in adhesive or crospovidone adopting internal and external modes or fluidized bed granulation to improve the dissolution rate of the paracetamol tablet. Compared with the original tablet, the paracetamol tablet prepared by the preparation process has higher dissolution speed, so that the drug effect is better.
Description
Technical Field
The invention belongs to the technical field of pharmacy, and particularly relates to a paracetamol tablet and a preparation process thereof.
Background
Paracetamol is a commonly used analgesic and antipyretic drug, which has been available worldwide for over 40 years. Extensive experience has demonstrated that it is a standard antipyretic and analgesic for mild to moderate pain states. Acetaminophen is sold in many countries in a variety of dosage forms, including liquids, suppositories, capsules and tablets.
After ingestion of paracetamol in solid form, e.g. as a tablet or capsule, the rate of drug absorption and the onset of pharmacological activity varies from patient to patient. There are data that demonstrate that absorption of paracetamol in tablet form is largely influenced by food and that minimal therapeutic concentrations of paracetamol cannot be achieved, thereby affecting analgesic and antipyretic effects without enabling the drug to be effective.
Disclosure of Invention
Compared with the prior art, the acetaminophen tablet prepared by the preparation process has higher dissolution speed, so that the drug effect is better.
The technical scheme adopted by the invention is as follows:
(1) a preparation method of acetaminophen tablets comprises premixing, adhesive preparation, granulation, drying, total mixing and tabletting, and is characterized in that a disintegrating agent is added in the total mixing step, wherein the disintegrating agent is crospovidone.
(2) The preparation method according to the above (1), characterized in that the total mixing step is to add the dried dry granules to crospovidone, mix them uniformly and then add colloidal silicon dioxide and magnesium stearate.
(3) A process for preparing paracetamol tablet includes such steps as premixing, preparing adhesive, granulating, drying, mixing and tabletting, and features that alginic acid is added in the step of preparing adhesive.
(4) A preparation method of paracetamol tablets comprises the steps of premixing, adhesive preparation, granulation, drying, total mixing and tabletting, and is characterized in that the granulation adopts fluidized bed granulation.
(5) The preparation method according to the step (4), characterized in that the inlet air temperature of the fluidized bed granulation is 65 ℃, the air speed is 20Hz, the pumping speed of the peristaltic pump is 10-25rpm, and the physicochemical pressure is 0.25 MPa.
(6) The production method according to (1) or (2), characterized in that alginic acid is added in the binder formulation step.
(7) The production method according to (1) or (2) or (3) or (6), characterized in that the granulation is fluidized bed granulation.
(8) The preparation method according to any one of (1) to (7), characterized in that the premixing comprises uniformly mixing acetaminophen, pregelatinized starch, colloidal silicon dioxide, crospovidone and calcium carbonate.
(9) The method according to (1) or (2) or (4) or (5), wherein the binder is prepared by dissolving PVP K25 in a proper amount of purified water, and stirring until clear; then adding the ethyl p-hydroxybenzoate sodium, the methyl p-hydroxybenzoate sodium and the propyl p-hydroxybenzoate sodium respectively, and stirring for dissolving.
(10) The production method according to any one of (1) to (9), characterized by further comprising a coating step.
(11) The preparation method according to any one of (1) to (10), characterized in that the granularity of the acetaminophen is not less than 80 meshes, and the granularity of other internally added auxiliary materials is not less than 40 meshes.
(12) The preparation method according to any one of (1) to (11), characterized in that the mass percentage of PVP K25 in the prepared adhesive is not less than 5%.
(13) The paracetamol tablet prepared by the preparation method in the (10).
(14) The acetaminophen tablet of (13), wherein the hardness of the tablet is not less than 100N.
By improving the process, the dissolution rate is improved, and the aim of quickly taking effect of the medicine is fulfilled.
DETAILED DESCRIPTION OF EMBODIMENT (S) OF INVENTION
Comparative example 1
A preparation process of acetaminophen tablets comprises the following steps:
step 1, weighing acetaminophen, pregelatinized starch, colloidal silicon dioxide, crospovidone and calcium carbonate according to the prescription amount, sieving by a 40-mesh sieve, and uniformly mixing;
step 2, adhesive preparation: dissolving PVP K25 in a proper amount of purified water, stirring until the solution is clear to obtain a 10% PVP K25 solution, then respectively adding ethyl p-hydroxybenzoate sodium, methyl p-hydroxybenzoate sodium and propyl p-hydroxybenzoate sodium, stirring for dissolving, then slowly adding alginic acid, and fully stirring and dispersing to obtain a required mixed solution;
step 3, granulating: slowly pouring the suspension adhesive, wherein the stirring speed of a granulator is 60rpm, the speed of a cutting knife is 1200rpm, and the granulation time is 120 s;
and 4, drying: drying by adopting a fluidized bed, wherein the air inlet temperature is 60 ℃, and drying until the water content is not more than 3%;
step 5, total mixing: adding colloidal silicon dioxide into the dry granules, mixing for 2min, adding magnesium stearate, and mixing for 3 min;
step 6, tabletting: the rotating speed of a tablet press is 10rpm, the tablet hardness is not less than 100N, the filling amount is adjusted firstly, and then the pressure is adjusted to control the weight difference and hardness of the tablets within a qualified range;
step 7, coating and polishing: after the tablets are coated in a high-efficiency coating machine, keeping the temperature at about 40 ℃, adding the carnauba wax with the prescription amount, and rotating for 10 min.
The concrete ingredients are shown in Table 1
TABLE 1
Example 1
A preparation process of acetaminophen tablets comprises the following steps:
step 1, weighing acetaminophen, pregelatinized starch, colloidal silicon dioxide, crospovidone and calcium carbonate according to the prescription amount, sieving by a 40-mesh sieve, and uniformly mixing;
step 2, adhesive preparation: dissolving PVP K25 in a proper amount of purified water, and stirring until the solution is clear to obtain a 10% PVP K25 solution; then respectively adding sodium ethyl p-hydroxybenzoate, sodium methyl p-hydroxybenzoate and sodium propyl p-hydroxybenzoate, stirring for dissolving, slowly adding alginic acid, and stirring thoroughly for dispersing to obtain the required mixed solution;
step 3, granulating: slowly pouring the suspension adhesive, wherein the stirring speed of a granulator is 60rpm, the speed of a cutting knife is 1200rpm, and the granulation time is 120 s;
and 4, drying: drying by adopting a fluidized bed, wherein the air inlet temperature is 60 ℃, and drying until the water content is not more than 3%;
step 5, total mixing: adding crospovidone into the dry granules, mixing for 3min, adding colloidal silicon dioxide and magnesium stearate, and mixing;
step 6, tabletting: the rotating speed of a tablet press is 10rpm, the tablet hardness is not less than 100N, the filling amount is adjusted firstly, and then the pressure is adjusted to control the weight difference and hardness of the tablets within a qualified range;
step 7, coating and polishing: after the tablets are coated in a high-efficiency coating machine, keeping the temperature at about 40 ℃, adding the carnauba wax with the prescription amount, and rotating for 10 min.
The concrete ingredients are shown in Table 2
TABLE 2
The acetaminophen tablets prepared in comparative example 1 and example 1 were tested for dissolution, and the test results are shown in table 3.
TABLE 3
Comparative example 2
A preparation process of acetaminophen tablets comprises the following steps:
step 1, weighing acetaminophen, pregelatinized starch, colloidal silicon dioxide, crospovidone and calcium carbonate according to the prescription amount, sieving by a 40-mesh sieve, and uniformly mixing;
step 2, adhesive preparation: dissolving PVP K25 in a proper amount of purified water, and stirring until the solution is clear to obtain a 10% PVP K25 solution; then adding sodium ethyl p-hydroxybenzoate, sodium methyl p-hydroxybenzoate and sodium propyl p-hydroxybenzoate respectively, stirring and dissolving to obtain the required adhesive;
step 3, granulating: slowly pouring the adhesive, wherein the stirring speed of the granulator is 60rpm, the speed of the cutting knife is 1200rpm, and the granulation time is 150 s;
and 4, drying: drying by adopting a fluidized bed, wherein the air inlet temperature is 60 ℃, and drying until the water content is not more than 3%;
step 5, total mixing: adding crospovidone and alginic acid into the dry granules, mixing for 5min, adding colloidal silicon dioxide and magnesium stearate, mixing for 5min, and mixing;
step 6, tabletting: the rotating speed of a tablet press is 10rpm, the tablet hardness is not less than 100N, the filling amount is adjusted firstly, and then the pressure is adjusted to control the weight difference and hardness of the tablets within a qualified range;
step 7, coating and polishing: after the tablets are coated in a high-efficiency coating machine, keeping the temperature at about 40 ℃, adding the carnauba wax with the prescription amount, and rotating for 10 min.
The concrete ingredients are shown in Table 4
TABLE 4
Comparative example 3
A preparation process of acetaminophen tablets comprises the following steps:
step 1, weighing acetaminophen, pregelatinized starch, alginic acid, colloidal silicon dioxide, crospovidone and calcium carbonate according to the prescription amount, sieving by a 40-mesh sieve, and uniformly mixing;
step 2, adhesive preparation: dissolving PVP K25 in a proper amount of purified water, and stirring until the solution is clear to obtain a 10% PVP K25 solution; then adding sodium ethyl p-hydroxybenzoate, sodium methyl p-hydroxybenzoate and sodium propyl p-hydroxybenzoate respectively, stirring and dissolving to obtain the required adhesive;
step 3, granulating: slowly pouring the adhesive, wherein the stirring speed of the granulator is 60rpm, the speed of the cutting knife is 1200rpm, and the granulation time is 150 s;
and 4, drying: drying by adopting a fluidized bed, wherein the air inlet temperature is 60 ℃, and drying until the water content is not more than 3%;
step 5, total mixing: adding crospovidone into the dry granules, mixing for 3min, adding colloidal silicon dioxide and magnesium stearate, mixing for 5min, and mixing;
step 6, tabletting: the rotating speed of a tablet press is 10rpm, the tablet hardness is not less than 100N, the filling amount is adjusted firstly, and then the pressure is adjusted to control the weight difference and hardness of the tablets within a qualified range;
step 7, coating and polishing: after the tablets are coated in a high-efficiency coating machine, keeping the temperature at about 40 ℃, adding the carnauba wax with the prescription amount, and rotating for 10 min.
The concrete ingredients are shown in Table 5
TABLE 5
Example 2
A preparation process of acetaminophen tablets comprises the following steps:
step 1, weighing acetaminophen, pregelatinized starch, colloidal silicon dioxide, crospovidone and calcium carbonate according to the prescription amount, sieving by a 40-mesh sieve, and uniformly mixing;
step 2, adhesive preparation: dissolving PVP K25 in a proper amount of purified water, and stirring until the solution is clear to obtain a 10% PVP K25 solution; then respectively adding sodium ethyl p-hydroxybenzoate, sodium methyl p-hydroxybenzoate and sodium propyl p-hydroxybenzoate, stirring for dissolving, slowly adding alginic acid, and stirring thoroughly for dispersing to obtain the required mixed solution;
step 3, granulating: slowly pouring the suspension adhesive, wherein the stirring speed of a granulator is 60rpm, the speed of a cutting knife is 1200rpm, and the granulation time is 150 s;
and 4, drying: drying by adopting a fluidized bed, wherein the air inlet temperature is 60 ℃, and drying until the water content is not more than 3%;
step 5, total mixing: adding crospovidone into the dry granules, mixing for 3min, adding colloidal silicon dioxide and magnesium stearate, mixing for 5min, and mixing;
step 6, tabletting: the rotating speed of a tablet press is 10rpm, the tablet hardness is not less than 100N, the filling amount is adjusted firstly, and then the pressure is adjusted to control the weight difference and hardness of the tablets within a qualified range;
step 7, coating and polishing: after the tablets are coated in a high-efficiency coating machine, keeping the temperature at about 40 ℃, adding the carnauba wax with the prescription amount, and rotating for 10 min.
The concrete ingredients are shown in Table 6
TABLE 6
The acetaminophen tablets prepared in comparative example 2, comparative example 3 and example 2 were tested for dissolution, and the results are shown in table 7.
TABLE 7
Example 3
A preparation process of acetaminophen tablets comprises the following steps:
step 1, weighing acetaminophen, pregelatinized starch, colloidal silicon dioxide, crospovidone and calcium carbonate according to the prescription amount, sieving by a 40-mesh sieve, and uniformly mixing;
step 2, adhesive preparation: dissolving PVP K25 in a proper amount of purified water, and stirring until the solution is clear to obtain a 10% PVP K25 solution; then respectively adding sodium ethyl p-hydroxybenzoate, sodium methyl p-hydroxybenzoate and sodium propyl p-hydroxybenzoate, stirring for dissolving, slowly adding alginic acid, and stirring thoroughly for dispersing to obtain the required mixed solution;
step 3, granulating: granulating by using a fluidized bed, wherein the air inlet temperature is 65 ℃, the air speed is 20Hz, the pumping speed of a peristaltic pump is 10-25rpm, and the physicochemical pressure is 0.25 MPa;
and 4, drying: drying by a fluidized bed, wherein the air inlet temperature is 65 ℃, and drying until the water content is not more than 3%;
step 5, total mixing: adding crospovidone into the dry granules, mixing for 3min, adding colloidal silicon dioxide and magnesium stearate, mixing for 5min, and mixing;
step 6, tabletting: the rotating speed of a tablet press is 10rpm, the tablet hardness is not less than 100N, the filling amount is adjusted firstly, and then the pressure is adjusted to control the weight difference and hardness of the tablets within a qualified range;
step 7, coating and polishing: after the tablets are coated in a high-efficiency coating machine, keeping the temperature at about 40 ℃, adding the carnauba wax with the prescription amount, and rotating for 10 min.
The concrete ingredients are shown in Table 8
TABLE 8
Dissolution tests were performed on the acetaminophen tablets prepared in examples 2 and 3, and the test results are shown in table 9.
TABLE 9
As can be seen from the comparison of the above examples and comparative examples, the acetaminophen tablet obtained by the preparation process of the present invention has good dissolution rate, and conforms to the regulations of Chinese pharmacopoeia.
The above-mentioned embodiments only express the concrete implementation mode of the present invention, but can not be understood as the limitation of the patent scope of the present invention, it should be noted that, for those skilled in the art, many variations and modifications can be made without departing from the concept of the present invention, and these all fall into the protection scope of the present invention.
Claims (14)
1. A preparation method of acetaminophen tablets comprises premixing, adhesive preparation, granulation, drying, total mixing and tabletting, and is characterized in that a disintegrating agent is added in the total mixing step, wherein the disintegrating agent is crospovidone.
2. The method of claim 1, wherein the total mixing step comprises adding the dried dry granules to crospovidone, mixing uniformly, and adding colloidal silicon dioxide and magnesium stearate.
3. A process for preparing paracetamol tablet includes such steps as premixing, preparing adhesive, granulating, drying, mixing and tabletting, and features that alginic acid is added in the step of preparing adhesive.
4. A preparation method of paracetamol tablets comprises the steps of premixing, adhesive preparation, granulation, drying, total mixing and tabletting, and is characterized in that the granulation adopts fluidized bed granulation.
5. The preparation method according to claim 4, wherein the inlet air temperature of the fluidized bed granulation is 65 ℃, the air speed is 20Hz, the pumping speed of the peristaltic pump is 10-25rpm, and the physicochemical pressure is 0.25 MPa.
6. The method of claim 1 or 2, wherein alginic acid is added during the binder formulation step.
7. The process according to claim 1 or 2 or 3 or 6, wherein the granulation is carried out by fluidized bed granulation.
8. The method according to any one of claims 1 to 7, wherein the pre-mixing is performed by uniformly mixing acetaminophen, pregelatinized starch, colloidal silicon dioxide, crospovidone, and calcium carbonate.
9. The method of claim 1, 2, 4 or 5, wherein the adhesive is formulated by first dissolving the PVPK25 in an appropriate amount of purified water and stirring until clear; then adding the ethyl p-hydroxybenzoate sodium, the methyl p-hydroxybenzoate sodium and the propyl p-hydroxybenzoate sodium respectively, and stirring for dissolving.
10. The method of any one of claims 1 to 8, further comprising a coating step.
11. The method according to any one of claims 1 to 10, wherein the acetaminophen has a particle size of not less than 80 mesh, and the other internal excipients have a particle size of not less than 40 mesh.
12. The method according to any one of claims 1 to 11, wherein the binder is prepared such that PVP K25 is present in an amount of not less than 5% by mass.
13. Paracetamol tablets obtainable by the process according to claim 10.
14. The acetaminophen tablet of claim 13, wherein the plain tablet hardness is not less than 100N.
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| CN201811650269.9A CN111374953A (en) | 2018-12-31 | 2018-12-31 | Paracetamol tablet and preparation process thereof |
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| CN201811650269.9A CN111374953A (en) | 2018-12-31 | 2018-12-31 | Paracetamol tablet and preparation process thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114432256A (en) * | 2021-12-31 | 2022-05-06 | 陕西必康制药集团控股有限公司 | Paracetamol coated tablet and preparation method thereof |
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| US20030017198A1 (en) * | 2001-05-01 | 2003-01-23 | Ta-Shuong Yeh | Process for the preparation of direct tabletting formulations and aids |
| CN101466359A (en) * | 2006-04-07 | 2009-06-24 | 史密丝克莱恩比彻姆公司 | Fast release paracetamol tablets |
| CN102872173A (en) * | 2012-10-22 | 2013-01-16 | 济南百鸣生物制药有限公司 | Compound acetaminophen orally disintegrating tablet for beasts and birds and preparation method for compound acetaminophen orally disintegrating tablet |
| CN108451916A (en) * | 2018-06-19 | 2018-08-28 | 重庆国泰康宁制药有限责任公司 | A kind of paracetamol drug combination preparation and preparation method thereof |
-
2018
- 2018-12-31 CN CN201811650269.9A patent/CN111374953A/en active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1374862A (en) * | 1999-09-16 | 2002-10-16 | 罗狄亚公司 | Directly compressible, ultra fine acetaminophen compositions and process for producing same |
| US20030017198A1 (en) * | 2001-05-01 | 2003-01-23 | Ta-Shuong Yeh | Process for the preparation of direct tabletting formulations and aids |
| CN101466359A (en) * | 2006-04-07 | 2009-06-24 | 史密丝克莱恩比彻姆公司 | Fast release paracetamol tablets |
| CN102872173A (en) * | 2012-10-22 | 2013-01-16 | 济南百鸣生物制药有限公司 | Compound acetaminophen orally disintegrating tablet for beasts and birds and preparation method for compound acetaminophen orally disintegrating tablet |
| CN108451916A (en) * | 2018-06-19 | 2018-08-28 | 重庆国泰康宁制药有限责任公司 | A kind of paracetamol drug combination preparation and preparation method thereof |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114432256A (en) * | 2021-12-31 | 2022-05-06 | 陕西必康制药集团控股有限公司 | Paracetamol coated tablet and preparation method thereof |
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