CN107049975A - The formula and its production technology of a kind of fenofibrate dispersible tablet - Google Patents
The formula and its production technology of a kind of fenofibrate dispersible tablet Download PDFInfo
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- CN107049975A CN107049975A CN201710322424.3A CN201710322424A CN107049975A CN 107049975 A CN107049975 A CN 107049975A CN 201710322424 A CN201710322424 A CN 201710322424A CN 107049975 A CN107049975 A CN 107049975A
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- Prior art keywords
- fenofibrate
- medicine
- production technology
- auxiliary material
- formula
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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
- A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
- A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
- A61K31/216—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acids having aromatic rings, e.g. benactizyne, clofibrate
-
- 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
- A61K9/2004—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
-
- 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
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Emergency Medicine (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
Disperse slice prescription and its production technology the invention discloses a kind of fenofibrate, including the fenofibrate main material medicine after micronizing and the auxiliary material for meeting medicinal standard, auxiliary material is by filler, wetting agent, adhesive, disintegrant and lubricant composition, main material and auxiliary material are sequentially passed through into wet granulation by corresponding production equipment, dry, whole grain, mixing, tabletting, it is aluminum-plastic packaged, the main production process such as outer packing, make full use of solid dispersion technology, medicine is set to form high degree of dispersion state in water soluble polymer carrier, the solubility and dissolution rate of insoluble drug can effectively be increased, so as to improve the bioavilability of medicine, it is scattered by solid, add disintegrant and be prepared into particle, allow medicament to the fater disintegration in 3min, improve the bioavilability of medicine.
Description
Technical field
The present invention relates to pharmaceutical technology field, the formula and its production technology of specially a kind of fenofibrate dispersible tablet.
Background technology
With our people's living-pattern preservation, crowd's average serum TC levels are just stepped up, thus China's drop blood
The dilatation year by year of the market scale of fat medicine, 2002-2011, China's hypolipidemic charges for drug compound growth rate is up to 19.1%.By
This is visible, and hypolipidemic turns into the principal item of China's policlinic.For many years, the mankind to the seeking of lipid lowering agent, visit
Suo Congwei is terminated, and the attention of height is caused in many countries, and domestic and international many pharmacy corporations also determine the product structure of company
Positioned at this cardiovascular field, the road of professional development is walked, so as to promote the quick hair of cardiovascular and lipid lowering agent
Exhibition.
Traditional therapeutic modality is consisted predominantly of：Control ideal body weight, increase motion exercise, give up smoking, keep on a diet and
Drug therapy.It is traditionally many by the way of medicine carries out aiding in other modes to be treated, current clinical alternative tune
Fat medicine mainly have Statins, fibrates, nicotinic acid class, resinae, cholesterol absorption inhibitor and other.The total courage of serum is reduced to consolidate
There are Statins and resinae based on alcohol and LDL-C；Medicine based on reduction serum triacylglycerol has fibrates and nicotinic acid
Class；Fenofibrate is the Representative Cultivars of fibrates.Therapeutic modality main at present is carried out by medicine, other therapeutic modalities
Aided in, so require to be maximized the drug effect of medicine.
The fenofibrate product traditionally made is formed into the mode of tablet, this kind of production method, the poor controllability of process,
And because fenofibrate is practically insoluble in water, the product disintegration rate of this type structure made in a conventional manner is slow,
Time is longer, generally more than 15 minutes, causes bioavilability low, and the performance of its clinical efficacy is influenceed to a certain extent, suppression
Therapeutic effect is made.
The content of the invention
It is an object of the invention to provide a kind of formula of fenofibrate dispersible tablet and its production technology, by changing medicine
The structure of preparation method and medicine, realizes the lifting of performance, and can effective improving production efficiency, reduce production cost,
The bioavilability of medicine can be effectively lifted, improves drug effect, therapeutic effect is lifted, has positive to treatment hyperlipidemia and hypertension
Effect and important meaning, to solve the problems mentioned in the above background technology.
To achieve the above object, the present invention provides following technical scheme：A kind of formula of fenofibrate dispersible tablet, including it is micro-
Fenofibrate main material medicine after efflorescence and the auxiliary material for meeting medicinal standard, auxiliary material by filler, wetting agent, adhesive,
Disintegrant and lubricant composition.
It is preferred that, the filler includes starch, dextrin, lactose, calcium sulfate, calcium monohydrogen phosphate, magnesia, magnesium carbonate, hydrogen
Aluminum oxide.
It is preferred that, the wetting agent and adhesive include purified water, medicinal alcohol, PVP ethanol solutions, starch slurry, carboxylic first
Base cellulose, low-substituted hydroxypropyl cellulose, lauryl sodium sulfate.
It is preferred that, the disintegrant be microcrystalline cellulose, amylum pregelatinisatum, sodium carboxymethylcellulose, sodium carboxymethyl starch,
PVPP, low-substituted hydroxypropyl cellulose.
It is preferred that, particle diameter≤50 μm of the fenofibrate main material medicine after the micronizing.
The present invention provides the production technology that another technical scheme disperses slice prescription for a kind of fenofibrate, including following step
Suddenly：
S1：Dispensing；The quantitative auxiliary material first weighed in addition to ethanol, water, then weigh the main original of fenofibrate after micronizing
Material, and leave concentratedly by purposes standby；
S2：Premix；Successively by the microcrystalline cellulose in auxiliary material, carboxyrnethyl starch sodium, low-substituted hydroxypropyl cellulose, pre- glue
Change starch, lauryl sodium sulfate and fenofibrate to add into mixed-hopper, be well mixed；
S3：Adhesive is prepared；It is 40% ethanol solution (w/w) to add purified water compound concentration into medicinal alcohol；
S4：Pre-composition in S2 is added in wet granulator, and the adhesive added in S3, granulation；
S5：Dry；Wet granular in S4 is transferred into heated-air circulation oven to dry, drying temperature≤60 DEG C；
S6：Dry method whole grain；With mobile sieving machine whole grain；
S7：It is total mixed；By dry particl, mix 15 minutes；
S8：Tabletting；
S9：It is aluminum-plastic packaged；
S10：Outer packing.
It is preferred that, raw material is pre-processed before the dispensing, negated nobert crushed 180 mesh sieves respectively, crystallite is fine
Dimension element, pregelatinized starch, hydroxypropylcellulose, sodium carboxymethyl starch, lauryl sodium sulfate crushed 100 mesh sieves.
It is preferred that, the aluminum-plastic packaged forming temperature control is at 105-125 DEG C, and heat-sealing temperature is controlled at 200-220 DEG C.
It is preferred that, the corresponding production equipment model of the production technology has：Wet granulator PMA600, heated-air circulation oven
CT-C-I, mobile sieving machine Coniwitt-207, mixer HTD-1000, tablet press machine P2020, Aluminium-coating Packer B1330.
It is preferred that, drying, total mixed, tabletting in the production technology, aluminum-plastic packaged and outer packing technique are equipped with IPC and taken
Sample is examined and QC is examined.
Compared with prior art, the beneficial effects of the invention are as follows：
1st, this fenofibrate disperses slice prescription and its production technology, using bulk drug micronization technology, by controlling non-promise
The particle diameter of shellfish spy's bulk drug, makes bulk drug powder be uniformly dispersed in solids, is effectively increased the insoluble drug in water
Solubility, improve the bioavilability of medicine.
2nd, this fenofibrate disperses slice prescription and its production technology, and many proportioning skills of supplementary material are used by designing
Art, makes the selection kind of auxiliary material less, lifts the security of medicine.
3rd, this fenofibrate disperses slice prescription and its production technology, using barrier and the compound bubble-cap of hot-stretch excellent performance
Thin-film material is packed, and packaging process is maintained relatively low temperature, can effectively be ensured outside medicine effect, and product
Fineness is seen, lucifuge, humidity resistance are good, it is ensured that product quality is stable.
4th, this fenofibrate disperses slice prescription and its production technology, and increase surfactant is used as auxiliary material in formula design
Mode, be effectively increased the solubility of insoluble drug in vivo, promote the absorption of medicine in vivo.
5th, this fenofibrate disperses slice prescription and its production technology, is carried out by way of fluid bed convective drying, effectively
Control particle moisture, improve and the stability of medicine and ensure that the quality of medicine.
Brief description of the drawings
Fig. 1 is overall structure flow chart of the invention.
Embodiment
Below in conjunction with the accompanying drawing in the embodiment of the present invention, the technical scheme in the embodiment of the present invention is carried out clear, complete
Site preparation is described, it is clear that described embodiment is only a part of embodiment of the invention, rather than whole embodiments.It is based on
Embodiment in the present invention, it is every other that those of ordinary skill in the art are obtained under the premise of creative work is not made
Embodiment, belongs to the scope of protection of the invention.
Referring to Fig. 1, a kind of formula of fenofibrate dispersible tablet, including fenofibrate main material medicine and symbol after micronizing
Close the auxiliary material of medicinal standard, particle diameter≤50 μm of the fenofibrate main material medicine after micronizing, by the way that raw material is carried out into micro mist
Change, add dispersiveness of the bulk drug powder in prescription preparation, it is ensured that the fater disintegration of medicine and absorption；Auxiliary material is by filling
Agent, wetting agent, adhesive, disintegrant and lubricant composition, use many proportion techniques of supplementary material by designing, make auxiliary material
Selection kind it is less, lift the security of medicine；Filler includes starch, dextrin, lactose, calcium sulfate, calcium monohydrogen phosphate, oxygen
Change magnesium, magnesium carbonate, aluminium hydroxide；Wetting agent and adhesive include purified water, medicinal alcohol, PVP ethanol solutions, starch slurry, carboxylic
Methylcellulose, low-substituted hydroxypropyl cellulose, lauryl sodium sulfate；Disintegrant is microcrystalline cellulose, amylum pregelatinisatum, carboxylic
Sodium carboxymethylcellulose pyce, sodium carboxymethyl starch, PVPP, low-substituted hydroxypropyl cellulose, it is scattered by solid,
Add disintegrant and be prepared into particle, allow medicament to the fater disintegration in 3min, improve the bioavilability of medicine.
A kind of fenofibrate disperses the production technology of slice prescription, comprises the following steps：
The first step：Dispensing；The quantitative auxiliary material first weighed in addition to ethanol, water, then weigh the fenofibrate after micronizing
Main material, and leave concentratedly by purposes standby；Wherein, raw material is pre-processed before dispensing, negated nobert crushed 180 mesh
Sieve, the fenofibrate main material medicine after must being micronized；Microcrystalline cellulose, pregelatinized starch, hydroxypropylcellulose, carboxymethyl is taken to form sediment again
Powder sodium, lauryl sodium sulfate crushed 100 mesh sieves.
Second step：Premix；Successively by the microcrystalline cellulose in auxiliary material, carboxyrnethyl starch sodium, low-substituted hydroxypropyl cellulose,
Pregelatinized starch, lauryl sodium sulfate and fenofibrate are added into mixed-hopper, are well mixed；
3rd step：Adhesive is prepared；It is 40% ethanol solution (w/w) to add purified water compound concentration into medicinal alcohol；
4th step：Pre-composition in S2 is added in wet granulator, and the adhesive added in S3, granulation；
5th step：Dry；Wet granular in S4 is transferred into heated-air circulation oven to dry, drying temperature≤60 DEG C；
6th step：Dry method whole grain；With mobile sieving machine whole grain；
7th step：It is total mixed；By dry particl, mix 15 minutes；
8th step：Tabletting；Tabletting is carried out by the way of shallow hole falls punch die；
9th step：It is aluminum-plastic packaged；Packed, made using the compound vacuole cover film material of barrier and hot-stretch excellent performance
Packaging process can maintain relatively low temperature, can effectively ensure medicine effect, and product appearance is exquisite, lucifuge, moisture resistance
Can be good, it is ensured that product quality is stable；Aluminum-plastic packaged forming temperature control is at 105-125 DEG C, and heat-sealing temperature is controlled in 200-220
℃；
11st step：Outer packing.
In summary：This fenofibrate disperses slice prescription and its production technology, and corresponding production equipment model has：Wet method system
Grain machine PMA600, heated-air circulation oven CT-C-I, mobile sieving machine Coniwitt-207, mixer HTD-1000, tablet press machine
P2020, Aluminium-coating Packer B1330, wet method system is sequentially passed through by above-mentioned production equipment by the main material and auxiliary material in formula
The main production process such as grain, drying, whole grain, mixing, tabletting, aluminum-plastic packaged, outer packing, makes full use of solid dispersion technology, makes
Medicine forms high degree of dispersion state in water soluble polymer carrier, can effectively increase the solubility of insoluble drug and molten
Go out speed, so as to improve the bioavilability of medicine, fenofibrate prepared composition discrete piece can be efficiently solved into fenofibrate
The problem of bioavilability is low, adds dispersiveness of the bulk drug powder in prescription preparation, it is ensured that the fater disintegration of medicine and
Absorb；Secondly, it is scattered by solid, add disintegrant and be prepared into particle, allow medicament to the fater disintegration in 3min, improve medicine
The bioavilability of thing.
The foregoing is only a preferred embodiment of the present invention, but protection scope of the present invention be not limited thereto,
Any one skilled in the art the invention discloses technical scope in, technique according to the invention scheme and its
Inventive concept is subject to equivalent substitution or change, should all be included within the scope of the present invention.
Claims (10)
1. a kind of formula of fenofibrate dispersible tablet, it is characterised in that including the fenofibrate main material medicine and symbol after micronizing
The auxiliary material of medicinal standard is closed, auxiliary material is made up of filler, wetting agent, adhesive, disintegrant and lubricant.
2. the formula of a kind of fenofibrate dispersible tablet according to claim 1, it is characterised in that the filler includes forming sediment
Powder, dextrin, lactose, calcium sulfate, calcium monohydrogen phosphate, magnesia, magnesium carbonate, aluminium hydroxide.
3. the formula of a kind of fenofibrate dispersible tablet according to claim 1, it is characterised in that the wetting agent and bonding
Agent includes purified water, medicinal alcohol, PVP ethanol solutions, starch slurry, carboxymethyl cellulose, low-substituted hydroxypropyl cellulose, 12
Sodium alkyl sulfate.
4. the formula of a kind of fenofibrate dispersible tablet according to claim 1, it is characterised in that the disintegrant is crystallite
Cellulose, amylum pregelatinisatum, sodium carboxymethylcellulose, sodium carboxymethyl starch, PVPP, low substituted hydroxy-propyl
Cellulose.
5. the formula of a kind of fenofibrate dispersible tablet according to claim 1, it is characterised in that non-after the micronizing
Particle diameter≤50 μm of nobert main material medicine.
6. a kind of fenofibrate according to claim 1 disperses the production technology of slice prescription, it is characterised in that including following
Step：
S1：Dispensing；The quantitative auxiliary material first weighed in addition to ethanol, water, then the fenofibrate main material after micronizing is weighed, and
Left concentratedly by purposes standby；
S2：Premix；The microcrystalline cellulose in auxiliary material, carboxyrnethyl starch sodium, low-substituted hydroxypropyl cellulose, pregelatinated are formed sediment successively
Powder, lauryl sodium sulfate and fenofibrate are added into mixed-hopper, are well mixed；
S3：Adhesive is prepared；It is 40% ethanol solution (w/w) to add purified water compound concentration into medicinal alcohol；
S4：Pre-composition in S2 is added in wet granulator, and the adhesive added in S3, granulation；
S5：Dry；Wet granular in S4 is transferred into heated-air circulation oven to dry, drying temperature≤60 DEG C；
S6：Dry method whole grain；With mobile sieving machine whole grain；
S7：It is total mixed；By dry particl, mix 15 minutes；
S8：Tabletting；
S9：It is aluminum-plastic packaged；
S10：Outer packing.
7. a kind of fenofibrate according to claim 6 disperses the production technology of slice prescription, it is characterised in that the dispensing
Preceding that raw material is pre-processed, negated nobert crushed 180 mesh sieves, microcrystalline cellulose, pregelatinized starch, hydroxypropyl fiber respectively
Element, sodium carboxymethyl starch, lauryl sodium sulfate crushed 100 mesh sieves.
8. a kind of fenofibrate according to claim 6 disperses the production technology of slice prescription, it is characterised in that the plastic-aluminum
The forming temperature control of packaging is at 105-125 DEG C, and heat-sealing temperature is controlled at 200-220 DEG C.
9. a kind of fenofibrate according to claim 6 disperses the production technology of slice prescription, it is characterised in that the production
The corresponding production equipment model of technique has：Wet granulator PMA600, heated-air circulation oven CT-C-I, mobile sieving machine
Coniwitt-207, mixer HTD-1000, tablet press machine P2020, Aluminium-coating Packer B1330.
10. a kind of fenofibrate according to claim 6 disperses the production technology of slice prescription, it is characterised in that the life
Drying, total mixed, tabletting in production. art, aluminum-plastic packaged and outer packing technique are equipped with IPC inspections by sampling and QC is examined.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710322424.3A CN107049975A (en) | 2017-05-09 | 2017-05-09 | The formula and its production technology of a kind of fenofibrate dispersible tablet |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710322424.3A CN107049975A (en) | 2017-05-09 | 2017-05-09 | The formula and its production technology of a kind of fenofibrate dispersible tablet |
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| Publication Number | Publication Date |
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| CN107049975A true CN107049975A (en) | 2017-08-18 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN201710322424.3A Pending CN107049975A (en) | 2017-05-09 | 2017-05-09 | The formula and its production technology of a kind of fenofibrate dispersible tablet |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110354087A (en) * | 2019-08-23 | 2019-10-22 | 东莞市金美济药业有限公司 | A kind of fenofibrate dispersible tablet and preparation method thereof |
| CN116327716A (en) * | 2023-03-23 | 2023-06-27 | 东莞市金美济药业有限公司 | Fenofibrate dispersible tablet and preparation method thereof |
-
2017
- 2017-05-09 CN CN201710322424.3A patent/CN107049975A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110354087A (en) * | 2019-08-23 | 2019-10-22 | 东莞市金美济药业有限公司 | A kind of fenofibrate dispersible tablet and preparation method thereof |
| CN116327716A (en) * | 2023-03-23 | 2023-06-27 | 东莞市金美济药业有限公司 | Fenofibrate dispersible tablet and preparation method thereof |
| CN116327716B (en) * | 2023-03-23 | 2023-12-01 | 东莞市金美济药业有限公司 | Fenofibrate dispersible tablet and preparation method thereof |
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| WD01 | Invention patent application deemed withdrawn after publication |
Application publication date: 20170818 |
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| WD01 | Invention patent application deemed withdrawn after publication |