CN113893227B - Raw material and method for preparing ibuprofen tablet and ibuprofen tablet - Google Patents

Raw material and method for preparing ibuprofen tablet and ibuprofen tablet Download PDF

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CN113893227B
CN113893227B CN202111366179.9A CN202111366179A CN113893227B CN 113893227 B CN113893227 B CN 113893227B CN 202111366179 A CN202111366179 A CN 202111366179A CN 113893227 B CN113893227 B CN 113893227B
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ibuprofen
tablet
microcrystalline cellulose
raw material
ibuprofen tablet
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CN113893227A (en
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毕京哲
贺敦伟
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Shandong Hi Qual Pharmatech Co ltd
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Shandong Hi Qual Pharmatech Co ltd
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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
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
    • 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
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/04—Drugs for skeletal disorders for non-specific disorders of the connective tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • 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]

Abstract

The invention provides a preparation raw material and a preparation method of an ibuprofen tablet and the ibuprofen tablet, and relates to the technical field of pharmaceutical preparations. The raw materials for preparing the ibuprofen tablet comprise the auxiliary agent, the ibuprofen with the D90 particle size range of 100-180 mu m and the microcrystalline cellulose with the drying weight loss of less than 3wt%, and the ibuprofen tablet prepared from the raw materials is not easy to be sticky and stamped, so that the problem that the sticky and stamped ibuprofen tablet is easy to generate in the production process is solved. The preparation method of the ibuprofen tablet provided by the invention is simple and easy to produce, and the ibuprofen tablet prepared by the method has complete appearance and good quality.

Description

Raw material and method for preparing ibuprofen tablet and ibuprofen tablet
Technical Field
The invention relates to the technical field of pharmaceutical preparations, in particular to a raw material and a preparation method for an ibuprofen tablet and the ibuprofen tablet.
Background
The ibuprofen tablet is a medicament which is already on the market, and has the following indications:
1. can be used for relieving acute stage or persistent joint swelling and pain of various chronic arthritis such as rheumatoid arthritis, osteoarthritis, rheumatic arthritis, and gouty arthritis, without treating and controlling disease course.
2. Treating various soft tissue rheumatalgia of non-articular type, such as shoulder pain, tenosynovitis, bursitis, myalgia, etc.
3. Acute mild and moderate pain, such as postoperation, post-trauma, toothache, headache, etc.
4. Has antipyretic effect on fever of adults and children.
The conventional process for producing ibuprofen tablets is a wet granulation process or a mixed powder direct compression process, but the problem of easy sticking and punching in the tabletting process exists in any preparation process, so that the invention of the preparation process of the ibuprofen tablets, which is easy to produce and operate, stable in process and difficult to stick and punch, is an urgent need in the technical field.
In view of the above, the present invention is particularly proposed.
Disclosure of Invention
The first purpose of the invention is to provide a raw material for preparing ibuprofen tablets, so as to solve at least one of the problems.
The second purpose of the invention is to provide a preparation method of ibuprofen tablets, which is simple and easy to produce.
The third purpose of the invention is to provide an ibuprofen tablet.
In a first aspect, the invention provides raw materials for preparing an ibuprofen tablet, which comprise ibuprofen, microcrystalline cellulose and an auxiliary agent;
the particle size of D90 of the ibuprofen is 100-180 mu m;
the drying weight loss of the microcrystalline cellulose is less than 3wt%.
As a further technical scheme, the mass ratio of the ibuprofen, the microcrystalline cellulose and the auxiliary agent is (60-70): (20 to 30): (3-6).
As a further technical scheme, the auxiliary agent comprises a disintegrating agent, a glidant and a lubricant.
As a further technical scheme, the mass ratio of the disintegrating agent to the glidant to the lubricant is (1-2): (1-2): (1-2).
As a further technical scheme, the disintegrating agent comprises at least one of starch, sodium carboxymethyl starch, crospovidone or croscarmellose sodium.
As a further technical solution, the flow aid comprises at least one of silicon dioxide, talc powder or aluminum silicate.
As a further aspect, the lubricant comprises at least one of magnesium stearate, stearic acid, or polyethylene glycol.
In a second aspect, the invention provides a preparation method of ibuprofen tablets, which comprises the following steps: and mixing the ibuprofen, the microcrystalline cellulose and the auxiliary agent, and tabletting to obtain the ibuprofen tablet.
As a further technical solution, the step of mixing comprises: mixing ibuprofen, microcrystalline cellulose, a disintegrating agent and a flow aid for the first time, and then mixing the mixture and a lubricating agent for the second time;
and after tabletting, coating and packaging to prepare the ibuprofen tablet.
In a third aspect, the invention provides an ibuprofen tablet, which is prepared by adopting the preparation method.
Compared with the prior art, the invention has the following beneficial effects:
the raw materials for preparing the ibuprofen tablet comprise the auxiliary agent, the ibuprofen with the D90 particle size range of 100-180 mu m and the microcrystalline cellulose with the drying weight loss of less than 3wt%, and the ibuprofen tablet prepared by the raw materials is not easy to stick and impact, so that the problem that the sticking and impact are easy to occur in the production of the ibuprofen tablet is solved.
The preparation method of the ibuprofen tablet provided by the invention is simple and easy to produce, and the ibuprofen tablet prepared by the method has complete appearance and good quality.
Detailed Description
Embodiments of the present invention will be described in detail below with reference to embodiments and examples, but those skilled in the art will understand that the following embodiments and examples are only illustrative of the present invention and should not be construed as limiting the scope of the present invention. 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. Those who do not specify the conditions are performed according to the conventional conditions or the conditions recommended by the manufacturer. The reagents or instruments used are not indicated by the manufacturer, and are all conventional products available commercially.
The inventor of the invention researches a preparation method of ibuprofen tablets, which has the advantages of simple and stable process, difficulty in sticking and dissolving out and rapidness, aiming at the problems and the defects of the existing preparation process of the ibuprofen tablets.
In a first aspect, the invention provides raw materials for preparing an ibuprofen tablet, which comprise ibuprofen, microcrystalline cellulose and an auxiliary agent;
the D90 particle size of the ibuprofen may be, for example, but not limited to, 100 μm, 110 μm, 120 μm, 130 μm, 140 μm, 150 μm, 160 μm, 170 μm or 180 μm;
the weight loss on drying of the microcrystalline cellulose is below 3wt%, and may be, for example, but not limited to, 0.5wt%, 1wt%, 1.5wt%, 2wt%, 2.5wt%, or 3wt%.
Due to the low melting point and poor compressibility of the ibuprofen, the ibuprofen is easy to generate heat in the tabletting process, so that the sticking phenomenon occurs in the tabletting process. When the D90 particle size of the ibuprofen is controlled to be 100-180 mu m and the drying weight loss of the microcrystalline cellulose is controlled to be below 3wt%, the sticking phenomenon can be effectively avoided.
Accordingly, the invention provides a raw material for preparing ibuprofen tablets, which comprises an auxiliary agent, ibuprofen with the D90 particle size range of 100-180 mu m and microcrystalline cellulose with the drying weight loss of less than 3wt%, wherein the ibuprofen tablets prepared from the raw material are not easy to be sticky and impact, and the problem that the sticky and impact easily occurs in the production of the ibuprofen tablets is solved.
In some preferred embodiments, the ibuprofen, the microcrystalline cellulose and the auxiliary are mixed in a mass ratio of (60-70): (20 to 30): (3 to 6), for example, but not limited to, 60.
In the present invention, the mass ratio of the ibuprofen, the microcrystalline cellulose and the auxiliary agent is preferably controlled to (60-70): (20 to 30): (3-6), and in the range, the prepared ibuprofen tablet is stable and is not easy to stick and impact in the preparation process.
In some preferred embodiments, the adjuvants include, but are not limited to, disintegrants, glidants, and lubricants, or other adjuvants well known to those skilled in the art.
The disintegrant is a substance which can rapidly disintegrate a tablet into fine particles in gastrointestinal fluids, so that functional ingredients are rapidly dissolved and absorbed to exert effects, and most of the disintegrants have good water absorption and swelling properties to achieve disintegration of a drug.
In some preferred embodiments, the disintegrant includes, but is not limited to, at least one of starch, sodium carboxymethyl starch, crospovidone, or croscarmellose sodium, or other disintegrants well known to those of skill in the art.
The glidant is a common auxiliary material in pharmaceutical preparations or food in order to smoothly feed and discharge tablets during tabletting, reduce sticking and impact and reduce friction between granules and between tablets and the wall of a die hole so that the tablet surface is smooth and attractive.
In some preferred embodiments, the glidant includes, but is not limited to, at least one of silicon dioxide, talc, or aluminum silicate, or other glidants known to those skilled in the art.
The lubricant can reduce the friction force among tabletting granules (or powder particles), increase the fluidity of the granules (or the powder particles) and reduce the difference of tablet weight; avoiding the attachment of powder particles on the surfaces of the punching die and the die and ensuring the smoothness of the sheet surface; the friction force between the powder particles or tablets and the punch and the die is reduced, the normal tabletting is facilitated, the tablets are easy to discharge, and the abrasion of the punch and the die is reduced.
In some preferred embodiments, the lubricant includes, but is not limited to, at least one of magnesium stearate, stearic acid, or talc, or other lubricants known to those skilled in the art.
In some preferred embodiments, the mass ratio of the disintegrant, the glidant and the lubricant is (1-2): (1-2): (1-2), for example, but not limited to, 1.
In the invention, the mass ratio of the disintegrating agent, the flow aid and the lubricant is further optimized and adjusted, so that the tabletting is facilitated, the sticking is avoided, the disintegrability of the tablet is improved, and the absorption of the medicament is promoted.
In a second aspect, the invention provides a preparation method of ibuprofen tablets, which comprises the following steps: mixing the ibuprofen, the microcrystalline cellulose and the auxiliary agent, and tabletting to obtain the ibuprofen tablet.
The ibuprofen tablet provided by the invention is simple in preparation method and easy to produce.
In some preferred embodiments, the step of mixing comprises: ibuprofen, microcrystalline cellulose, a disintegrating agent and a flow aid are mixed for the first time, and then mixed with a lubricating agent for the second time.
By adopting the mixing mode, the uniform mixing of materials can be ensured, and the phenomenon that the compressibility of the materials is deteriorated or the melting curve is reduced due to excessive lubrication caused by long-time mixing of the lubricant can be avoided.
And after tabletting, coating and packaging to prepare the ibuprofen tablet.
The coating process of the present invention is not particularly limited, and includes, but is not limited to, pan coating, suspension coating, tube-embedded spray tumbling coating, press coating, and the like.
In a third aspect, the invention provides an ibuprofen tablet which is prepared by the preparation method and has complete appearance and good quality.
The present invention is further illustrated by the following specific examples and comparative examples, but it should be understood that these examples are for illustrative purposes only and are not to be construed as limiting the invention in any way.
Example 1
The raw materials for preparing the ibuprofen tablet comprise ibuprofen, microcrystalline cellulose, a disintegrating agent, a flow aid and a lubricating agent, wherein the mass ratio of the ibuprofen tablet to the microcrystalline cellulose is (65);
the particle size of the ibuprofen D90 is 100 mu m, and the drying weight loss of the microcrystalline cellulose is 1%;
wherein the disintegrating agent is starch, the glidant is silicon dioxide, and the lubricant is magnesium stearate.
Example 2
The raw material for preparing the ibuprofen tablet is different from the raw material in the embodiment 1 in that the particle size range of ibuprofen is controlled to be 100 mu m at D90, and the drying weight loss of microcrystalline cellulose is controlled to be 3%.
Example 3
The raw material for preparing the ibuprofen tablet is different from the raw material in the embodiment 1 in that the particle size range of ibuprofen is controlled to be 105 mu m at D90, and the weight loss on drying is controlled to be 1% by microcrystalline cellulose.
Example 4
The raw material for preparing the ibuprofen tablet is different from the raw material in the embodiment 1 in that the particle size range of ibuprofen is controlled to be 105 mu m at D90, and the drying weight loss of microcrystalline cellulose is controlled to be 3%.
Example 5
The raw material for preparing the ibuprofen tablet is different from the raw material in the embodiment 1 in that the particle size of ibuprofen is controlled within the D90 range and is 140 mu m, and the drying weight loss of microcrystalline cellulose is controlled to be 1%.
Example 6
The raw material for preparing the ibuprofen tablet is different from the raw material in the embodiment 1 in that the particle size range of ibuprofen is controlled to be 140 mu m at D90, and the drying weight loss of microcrystalline cellulose is controlled to be 3%.
Example 7
The raw material for preparing the ibuprofen tablet is different from the raw material in the embodiment 1 in that the particle size range of ibuprofen is controlled to be D90 and is 180 mu m, and the weight loss on drying of microcrystalline cellulose is controlled to be 1%.
Example 8
The raw material for preparing the ibuprofen tablet is different from the raw material in the embodiment 1 in that the particle size range of ibuprofen is controlled to be D90 and is 180 mu m, and the drying weight loss of microcrystalline cellulose is controlled to be 3%.
Comparative example 1
The raw material for preparing the ibuprofen tablet is different from the raw material in the embodiment 1 in that the particle size range of ibuprofen is controlled to be D90 and is 60 mu m, and the drying weight loss of microcrystalline cellulose is controlled to be 1%.
Comparative example 2
The raw material for preparing the ibuprofen tablet is different from the raw material in the embodiment 1 in that the particle size range of ibuprofen is controlled to be D90 and is 60 mu m, and the drying weight loss of microcrystalline cellulose is controlled to be 3%.
Comparative example 3
The raw material for preparing the ibuprofen tablet is different from the raw material in the embodiment 1 in that the particle size range of ibuprofen is controlled to be D90 of 60 mu m, and the drying weight loss of microcrystalline cellulose is controlled to be 5%.
Comparative example 4
The raw material for preparing the ibuprofen tablet is different from the raw material in the embodiment 1 in that the particle size range of ibuprofen is controlled to be 100 mu m at D90, and the drying weight loss of microcrystalline cellulose is controlled to be 5%.
Comparative example 5
The raw material for preparing the ibuprofen tablet is different from the raw material in example 1 in that the particle size range of ibuprofen is controlled to be 105 mu m at D90, and the weight loss on drying is controlled to be 5% by microcrystalline cellulose.
Comparative example 6
The raw material for preparing the ibuprofen tablet is different from the raw material in the embodiment 1 in that the particle size range of ibuprofen is controlled to be 140 mu m at D90, and the weight loss on drying is controlled to be 5% by microcrystalline cellulose.
Comparative example 7
The raw material for preparing the ibuprofen tablet is different from the raw material in the embodiment 1 in that the particle size of ibuprofen is controlled within the D90 range and is 180 mu m, and the drying weight loss of microcrystalline cellulose is controlled to be 5%.
Comparative example 8
The raw material for preparing the ibuprofen tablet is different from the raw material in the embodiment 1 in that the particle size range of ibuprofen is controlled to be 220 mu m at D90, and the drying weight loss of microcrystalline cellulose is controlled to be 1%.
Comparative example 9
The raw material for preparing the ibuprofen tablet is different from the raw material in the embodiment 1 in that the particle size range of ibuprofen is controlled to be 220 mu m at D90, and the drying weight loss of microcrystalline cellulose is controlled to be 3%.
Comparative example 10
The raw material for preparing the ibuprofen tablet is different from the raw material in the embodiment 1 in that the particle size range of ibuprofen is controlled to be 220 mu m at D90, and the weight loss on drying is controlled to be 5% by microcrystalline cellulose.
Example 9
The ibuprofen tablet is prepared from the following raw materials in part by weight compared with the ibuprofen tablet prepared in the example 1: the mass ratio of the ibuprofen, the microcrystalline cellulose, the disintegrant, the glidant and the lubricant is 60.
Example 10
The ibuprofen tablet is prepared from the following raw materials, and the difference from the example 1 is that: the mass ratio of ibuprofen, microcrystalline cellulose, disintegrant, glidant and lubricant is 70.
Comparative example 11
The ibuprofen tablet is prepared from the following raw materials, and the difference from the example 1 is that: the mass ratio of ibuprofen, microcrystalline cellulose, disintegrant, glidant and lubricant is 30.
Comparative example 12
The ibuprofen tablet is prepared from the following raw materials, and the difference from the example 1 is that: the mass ratio of ibuprofen, microcrystalline cellulose, disintegrant, glidant and lubricant is 95.
Example 11
The raw material for preparing the ibuprofen tablet is different from that in the embodiment 1, the disintegrating agent is sodium carboxymethyl starch.
Example 12
The raw material for preparing the ibuprofen tablet is different from that in example 1 in that the glidant is talcum powder.
Example 13
The ibuprofen tablet is prepared from raw materials, and is different from the ibuprofen tablet in that the lubricant is stearic acid.
Test example 1
The ibuprofen tablets of examples 1 to 13 and comparative examples 1 to 12 were prepared from the starting materials, respectively, according to the following process:
[1] adding ibuprofen, microcrystalline cellulose, disintegrant and glidant into a mixer, mixing for 15min, adding lubricant, and continuously mixing for 5min;
[2] pressing the mixed powder obtained in the step (1) into tablets by using a high-speed tablet press;
[3] and (3) performing film coating on the material obtained in the step (2), and packaging to obtain a finished product.
The sticking frequency in the preparation process was counted, and the results are shown in table 1.
TABLE 1
Figure BDA0003360893380000091
Note: microcrystalline cellulose moisture refers to the mass percent of moisture in microcrystalline cellulose.
As can be seen from Table 1, in the preparation process of the ibuprofen tablet, when the D90 particle size of the ibuprofen is controlled to be 100-180 μm and the drying weight loss of the microcrystalline cellulose is controlled to be below 3wt%, the sticking frequency is 0 times/h, and the sticking phenomenon can be effectively avoided.
Finally, it should be noted that: the above embodiments are only used to illustrate the technical solution of the present invention, and not to limit the same; while the invention has been described in detail and with reference to the foregoing embodiments, it will be understood by those skilled in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some or all of the technical features may be equivalently replaced; and the modifications or the substitutions do not make the essence of the corresponding technical solutions depart from the scope of the technical solutions of the embodiments of the present invention.

Claims (9)

1. The raw materials for preparing the ibuprofen tablet are characterized by comprising ibuprofen, microcrystalline cellulose and an auxiliary agent;
the particle size of D90 of the ibuprofen is 100-180 mu m;
the drying weight loss of the microcrystalline cellulose is less than 3 wt%;
the mass ratio of the ibuprofen, the microcrystalline cellulose and the auxiliary agent is (60-70): (20 to 30): (3-6).
2. The raw material for producing ibuprofen tablets according to claim 1, wherein the auxiliary agents include a disintegrant, a glidant and a lubricant.
3. The raw material for preparing the ibuprofen tablet according to claim 2, wherein the mass ratio of the disintegrant, the glidant and the lubricant is (1-2): (1-2): (1-2).
4. The raw material for the preparation of ibuprofen tablet according to claim 2, wherein the disintegrant comprises at least one of starch, sodium carboxymethyl starch, crospovidone, or croscarmellose sodium.
5. The starting material for producing ibuprofen tablets according to claim 2, wherein the glidant comprises at least one of silicon dioxide, talc or aluminum silicate.
6. The starting material for the production of ibuprofen tablets according to claim 2, wherein the lubricant comprises at least one of magnesium stearate, stearic acid or polyethylene glycol.
7. The preparation method of the ibuprofen tablet is characterized by comprising the following steps: mixing the ibuprofen as claimed in any of claims 1 to 6, microcrystalline cellulose and adjuvants, tabletting to obtain ibuprofen tablet.
8. The method of preparing ibuprofen tablets according to claim 7, wherein the mixing step comprises: mixing ibuprofen, microcrystalline cellulose, a disintegrating agent and a flow aid for the first time, and then mixing the mixture and a lubricating agent for the second time;
and after tabletting, coating and packaging processes are also carried out, so that the ibuprofen tablet is prepared.
9. An ibuprofen tablet, characterized by being prepared by the preparation method of claim 7 or 8.
CN202111366179.9A 2021-11-18 2021-11-18 Raw material and method for preparing ibuprofen tablet and ibuprofen tablet Active CN113893227B (en)

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US4361580A (en) * 1980-06-20 1982-11-30 The Upjohn Manufacturing Company Aluminum ibuprofen pharmaceutical suspensions
EP1575487B1 (en) * 2002-05-14 2019-08-14 DuPont Nutrition USA, Inc. Coattrited microcrystalline cellulose hydrocolloid compositions and method for manufacture
CH693586A8 (en) * 2002-10-14 2003-12-15 Roche Consumer Health Ag Formulation of ibuprofen sodium.
US9303918B2 (en) * 2013-03-15 2016-04-05 Monosol Rx, Llc Process for drying a wet film with control of loss on drying
GB201502077D0 (en) * 2015-02-09 2015-03-25 Cubic Pharmaceuticals Ltd And Delta Pharmaceuticals Ltd Improved hme technology

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