CN108186586A - A kind of Allylestrenol tablet and preparation method thereof - Google Patents
A kind of Allylestrenol tablet and preparation method thereof Download PDFInfo
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- CN108186586A CN108186586A CN201810172722.3A CN201810172722A CN108186586A CN 108186586 A CN108186586 A CN 108186586A CN 201810172722 A CN201810172722 A CN 201810172722A CN 108186586 A CN108186586 A CN 108186586A
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- allylestrenol
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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
- A61K9/2095—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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- 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
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
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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
- A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
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Abstract
The present invention provides a kind of Allylestrenol tablet; it is made by Allylestrenol and auxiliary material through mixing and tabletting; it is characterized in that the auxiliary material is made of interior plus auxiliary material and additional auxiliary material; and first by Allylestrenol and Nei Jia auxiliary materials and mixings, medicine-containing particle or powder is made; mixing is carried out with additional auxiliary material and tabletting is made again; wherein, the interior plus auxiliary material is polyethylene glycols carrier material, and the additional auxiliary material is filler, disintegrant, adhesive, glidant or lubricant.The Allylestrenol tablet of the present invention, highly stable, high-quality, impurity is few, and dissolution characteristic grinds piece compared to original and is greatly improved, and dissolution rate is high and dissolution rate is fast, and obtained particle possesses good mobility and compressibility.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, specifically design a kind of Allylestrenol tablet and preparation method thereof.
Background technology
Allylestrenol (Allylestrenol)
Chemical name：(17 β) -17- (2- acrylic) female steroid -4- alkene -17- alcohol
(17)-17-(2-Propenyl)estr-4-en-17-ol
CAS:432-60-0
Structural formula：
Allylestrenol is a kind of artificial synthesized progestational hormone, is the orally active progestational hormone drug of synthesis.Allylestrenol
Progestin be significantly stronger than progesterone, have no androgenic activity, but can increase Trophocyte activity stimulation placental function,
Therefore can be used for threatened abortion, especially because anhormonia is miscarried.Allylestrenol makes its mouth close to natural chemical constitution
Clothes absorb effective, metabolic stability, to PgR high selectivity, no estrogen and androgen effect, can enhance oxytocinase
Concentration and activity reduce oxytocin level, mitigate stimulation of the oxytocins to uterus, uterus can be generated with antagonism prostaglandin
Stimulation.The blocking factor (PIBF) of progesterone induced is the key that embryo survival.Pregnant early stage PgR is activated to be formed
PIBF triggers embryo's protective immunoregulation：The generation of eliciting protective asymmetry antibody forms the protection based on Th2
Property cell immune response, the activity of suppression of natural killer cell.And Allylestrenol can trigger to form PIBF and embryo's protectiveness
Immunological regulation makes the immune response between parent and embryo switch to protect by repelling.
Allylestrenol started to apply to the treatment of spontaneous abortion and premature labor early in 1973 as synthetic progestin, in number
Ten country's listings.The original of Allylestrenol tablet is ground piece and is produced by the auspicious Jinlin University pharmaceutical factory of Hungary (Gedeon Richter Ltd.), in
2000 in China's registration and import listing, trade name：More power agates (Turinal).Every 5mg containing Allylestrenol.This product
Clinical practice is good since China lists, and receives an acclaim, and taken in China's basic medical insurance Drug catalogue.
CN103550179 discloses a kind of Allylestrenol tablet and preparation method thereof, by controlling Allylestrenol and pool Lip river
The content ratio of husky nurse is in particular range, and by wet-granulation process, Allylestrenol tablet obtained has rapid, complete molten
Go out characteristic.But there is no possess some special knowledge in the compressibility of product, uniformity of dosage units and stability etc. for the invention.
CN1271286A discloses a kind of coated dosage unit coatingization of composition, and the composition includes one kind in steroid
The upper dihydro steroid of 3, compounds of group skeleton, steroid therein include Allylestrenol, the coating
Process can prevent steroid from being migrated from composition.But there is no be really related to a kind of exploitation of Allylestrenol preparation.
CN107073127A discloses a kind of solid oral dosage form of lipophilic compound, and Allylestrenol also belongs to therein
A kind of lipophilic compound, the invention in prescription by adding the monoglycerides and/or long-chain fat that include long chain fatty acids
Certain fatty ingredients of the triglycerides of acid can realize the Lymphatic of specific lipophilic compound, further improve oral life
Object availability.Silica is used in the present invention as excipient to adsorb required amount of liquid, however, silica cannot
Compression well, obtained tablet compressibility may be poor, and supplementary product kind is more, and technique is cumbersome.
Allylestrenol tablet played an important role in terms for the treatment of spontaneous abortion and premature labor.But disclosed various existing
Have in technical solution, about the less of Allylestrenol tablet, developing Allylestrenol tablet mainly there are 2 difficulties：1. poorly water-soluble；
2. specification is small, only 5mg, uniformity of dosage units is easily unqualified.And prior art process mainly increases its dissolution by being micronized
Degree, the dust of generation can influence the health of staff.
Invention content
The object of the present invention is to provide a kind of Allylestrenol tablet, which overcomes prior art and leads in process of production
Dust influence staff health, the specification small technology for leading to problems such as mixing difficult can be generated by crossing micronizing when increasing dissolution rate
Defect, and the tablet quality is stablized, and dissolution rate is fast, and dissolution rate is high, improves the bioavilability of drug, reduces to medicament
Amount reduces adverse drug reaction, and simple production process is efficient, suitable for industrial applications.
The specific technical solution of the present invention is as follows：
A kind of Allylestrenol tablet, is made by Allylestrenol and auxiliary material through mixing and tabletting, it is characterised in that described is auxiliary
Material is made of interior plus auxiliary material and additional auxiliary material, and first by Allylestrenol and Nei Jia auxiliary materials and mixings, medicine-containing particle or powder is made,
Mixing is carried out with additional auxiliary material and tabletting is made again, wherein, the interior plus auxiliary material is in polyethylene glycols carrier material
One or more, one kind in filler, disintegrant, adhesive, glidant, lubricant of the additional auxiliary material or
It is two or more.
Allylestrenol tablet described above, wherein the interior plus auxiliary material is in solid polyethylene glycol class carrier material
One or more；Preferably, described interior plus auxiliary material be selected from PEG1000, PEG1500, PEG2000, PEG3000,
One or more of PEG4000, PEG6000, PEG8000, PEG20000；It is highly preferred that the interior plus auxiliary material choosing
More than from one or two kinds of in PEG4000, PEG6000, PEG8000.
Allylestrenol tablet described above, wherein Allylestrenol are 1 with interior plus auxiliary material weight ratio:2-200；It is preferred that
Ground, Allylestrenol are 1 with interior plus auxiliary material weight ratio:5-100；It is highly preferred that Allylestrenol is with interior plus auxiliary material weight ratio
1:5-50。
Allylestrenol tablet described above, wherein：The filler be selected from microcrystalline cellulose, lactose, Lactis Anhydrous,
It is one or more in sucrose, starch, pregelatinized starch, mannitol, sorbierite, xylitol, preferably microcrystalline cellulose, sweet dew
It is one or more in alcohol, lactose, starch, it is more preferably one or more in microcrystalline cellulose and lactose；The disintegration
It is fine that agent is selected from crospovidone, sodium carboxymethyl starch, croscarmellose sodium, hypromellose, low-substituted hydroxypropyl
Dimension is plain, one or more in microcrystalline cellulose, preferably crospovidone, sodium carboxymethyl starch, cross-linked carboxymethyl cellulose
It is one or more in sodium, more preferably crospovidone；The adhesive is selected from povidone, starch slurry, hydroxypropyl methyl
It is one or more in cellulose, hydroxypropyl cellulose, one preferably in povidone, starch slurry, hydroxypropyl methyl cellulose
Kind is a variety of, more preferably povidone；The lubricant is one or more in magnesium stearate, stearic acid, more preferably
For magnesium stearate；The glidant is one or more in silica, talcum powder, more preferably silica.
Preferably, Allylestrenol tablet described above, by weight percentage, Allylestrenol 0.1%~10%, poly- second
Glycols carrier material 1%~80%, filler 15%~98%, disintegrant 0.1%~30%, adhesive 0.1%~30%,
Lubricant 0~5% and glidant 0~5%.
As a specific embodiment, Allylestrenol tablet described above, wherein, the interior plus auxiliary material is poly- second two
Alcohol 4000, Macrogol 6000 or PEG 8000；The additional auxiliary material is microcrystalline cellulose, crospovidone, is gathered
Tie up ketone, magnesium stearate and silica.
Preferably, Allylestrenol tablet described above, wherein, by weight percentage, Allylestrenol 0.5%~
5%, polyethylene glycols carrier material 10~50%, crospovidone 1%~5%, povidone 1%~5%, microcrystalline cellulose
20%~80%, magnesium stearate 0.1%~2% and silica 0.1%~2%.
Allylestrenol tablet described above, wherein, by Allylestrenol and Nei Jia auxiliary materials and mixings, heating melting, after cooling
It smashes and medicine-containing particle or powder is made.Preferably, wherein heating and temperature control is 90~130 DEG C, more preferably 100~120 DEG C.
Preferably, above-mentioned Allylestrenol is melted with interior plus auxiliary material heating, and adjustment discharging speed is setting material
The residence time of standby warming portion is 20 seconds to 1 minute, more preferably 30 seconds to 50 seconds, the existing fine dispersion effect of material,
Avoid the risk that temperature causes impurity of the drug to occur.
Inventor is in Allylestrenol tablet research is carried out, by a large amount of contrast tests, surprisingly, it was found that using poly-
Ethylene glycol carrier material is as interior plus auxiliary material, by that first will add auxiliary material and Allylestrenol mixing in polyethylene glycol and drug containing is made
Grain or powder, then after being mixed with pharmaceutically acceptable auxiliary material as additional auxiliary material it is tabletted, gained tablet is very big
Ground improves drug solubility in water and dissolution rate, so as to increase absorption of the Allylestrenol in human body, improves biology
Availability increases curative effect.And unexpected effect is also obtained unexpectedly, that is, the Allylestrenol after melting contains hydroxyl
Base is good hydrogen-bond donor, can form hydrogen bond with polyethylene glycol carrier, the better melting mixing of the two energy obtains uniformity
To very big raising, and solid polyethylene glycol is close with the fusing point of Allylestrenol, controls suitable heating temperature that can both ensure
The two can melt completely, can also avoid that temperature is excessively high causes drug to decompose.
The tablet of the present invention in addition to greatly improving drug solubility in water and dissolution rate, improves drug
Bioavilability, increase curative effect, reduce drug administration dosage, reduce outside adverse drug reaction, but also efficiently solve
Allylestrenol tablet easy underproof problem of uniformity of dosage units when dosage is small.Also, production technology and the production of the present invention
Equipment is simple, and energy consumption is small, at low cost, yield is high, serialization, closed can produce, production process without dust pollution, without addition
Any organic solvent, is very suitable for industrialized production.
Description of the drawings
Fig. 1 is embodiment 1 and the former dissolution curve for grinding piece.
Specific embodiment
The following examples are used for the essence for illustrating and understanding the present invention, the model of but do not limit the invention in any way
It encloses.
Embodiment 1：
Allylestrenol tablet (5mg/ pieces) is prepared using the ingredient listed in table 1,1000.
Table 1：
Preparation process：
Allylestrenol raw material and Macrogol 6000 mixing are put into hot-melt extruded machine, heating and temperature control 100~
120 DEG C, adjustment discharging speed make material equipment warming portion residence time be 30~50 seconds.Extrudate is cut into segment simultaneously
Cooling.After being crushed with pulverizer, outer addition crospovidone, 30 POVIDONE K 30 BP/USP30, microcrystalline cellulose mixing, add silica and
Magnesium stearate mix 5 minutes, tabletting to get.
Embodiment 2：
Allylestrenol tablet (5mg/ pieces) is prepared using the ingredient listed in table 2,1000.
Table 2：
Preparation process：
Allylestrenol raw material and Macrogol 4000 mixing are put into hot-melt extruded machine, heating and temperature control 90~
130 DEG C, adjustment discharging speed make material equipment warming portion residence time be 20~60 seconds.Extrudate is cut into segment simultaneously
Cooling.After being crushed with pulverizer, outer addition sodium carboxymethyl starch, 30 POVIDONE K 30 BP/USP30, microcrystalline cellulose mixing, add silica
With magnesium stearate mix 5 minutes, tabletting to get.
Embodiment 3：
Allylestrenol tablet (5mg/ pieces) is prepared using the ingredient listed in table 3,1000.
Table 3：
Preparation process：
Allylestrenol raw material and Macrogol 6000 mixing are put into hot-melt extruded machine, heating and temperature control 90~
130 DEG C, adjustment discharging speed make material equipment warming portion residence time be 20~60 seconds.Extrudate is cut into segment simultaneously
Cooling.After being crushed with pulverizer, outer addition crospovidone, hydroxypropyl methyl cellulose, lactose mixing add silica
With magnesium stearate mix 5 minutes, tabletting to get.
Embodiment 4：
Allylestrenol tablet (5mg/ pieces) is prepared using the ingredient listed in table 4,1000.
Table 4：
Preparation process：
Allylestrenol raw material and PEG 8000 mixing are put into hot-melt extruded machine, heating and temperature control 100~
130 DEG C, adjustment discharging speed make material equipment warming portion residence time be 30~60 seconds.Extrudate is cut into segment simultaneously
Cooling.After being crushed with pulverizer, outer addition crospovidone, 30 POVIDONE K 30 BP/USP30, microcrystalline cellulose mixing, add silica and
Magnesium stearate mix 5 minutes, tabletting to get.
Embodiment 5：
Allylestrenol tablet (5mg/ pieces) is prepared using the ingredient listed in table 5,1000.
Table 5：
Preparation process：
Allylestrenol raw material and Macrogol 6000 mixing are put into hot-melt extruded machine, heating and temperature control 100~
120 DEG C, adjustment discharging speed make material equipment warming portion residence time be 30~50 seconds.Extrudate is cut into segment simultaneously
Cooling.After being crushed with pulverizer, outer addition crospovidone, 30 POVIDONE K 30 BP/USP30, microcrystalline cellulose mixing, add silica and
Magnesium stearate mix 5 minutes, tabletting to get.
Each embodiment grinds the investigation of piece accelerated stability with original
1. sample acceleration environment：It is relatively wet in 40 DEG C ± 2 DEG C of temperature after sample is placed in high-density polyethylene bottle packaging
Placed under conditions of degree 75% ± 5%, after accelerated test 6 months sampling carry out inspection character, dissolution rate, content and related object
Matter.
2. assay method：
1) dissolution method shines dissolution method (2,010 2 annex XC thirds methods of Chinese Pharmacopoeia), with dodecyl sulphur
Acid sodium solution (lauryl sodium sulfate 1g being taken, with water dissolution to 1000ml) 1000ml is dissolution medium, and temperature is 37 DEG C, rotating speed
It is 75 turns per minute, operates in accordance with the law, 60 minutes whens samples, and take subsequent filtrate as test solution；Every ml is configured to reference substance
Solution containing about 5 μ g of Allylestrenol is injected separately into liquid chromatograph as reference substance solution, molten with calculated by peak area by external standard method
Output.
2) content and related substance are all measured using high performance liquid chromatography (2,010 2 annex VD of Chinese Pharmacopoeia), with ten
Eight alkyl silane silica gel are filler, add guard column, and methanol is mobile phase, Detection wavelength 215nm.Theoretical cam curve is husky by thunder
Ji Lanfeng is calculated not less than 2000.Sample and reference substance are injected separately into liquid chromatograph, chromatogram is recorded, by external standard method with peak
Areal calculation.
3. stability data compares：It is shown in Table 6.
6 stability data comparison sheet of table：
Each embodiment particle proterties are compared with compressibility：It is shown in Table 7.
7 particle proterties of table and compressibility comparison sheet：
| Embodiment | Angle of repose (°) | Mobility | Unilateral finish | Weight differential (%) | Friability (%) |
| 1 | 33 | It is excellent | It is bright | 1.73 | 0.0523 |
| 2 | 37 | It is excellent | It is bright | 1.97 | 0.0826 |
| 3 | 38 | Well | It is bright | 2.21 | 0.0741 |
| 4 | 39 | Well | It is bright | 2.36 | 0.1037 |
| 5 | 35 | It is excellent | It is bright | 1.88 | 0.0614 |
Compared with each embodiment grinds piece dissolution characteristic with original：It is shown in Table 8.
8 dissolution characteristic comparison sheet of table：
Embodiment 1 is ground piece dissolution characteristic with original and is relatively shown in FIG. 1.
With upper table 6-8 and Fig. 1's the result shows that, Allylestrenol tablet of the invention, highly stable, high-quality, impurity is few,
And dissolution characteristic grinds piece compared to original and is greatly improved, and dissolution rate is high, and dissolution rate is fast, and obtained particle possesses well
Mobility and compressibility.
The above, only presently preferred embodiments of the present invention, not to the present invention in any form with substantial limitation,
It should be pointed out that for those skilled in the art, under the premise of the method for the present invention is not departed from, can also make
Several improvement and supplement, these are improved and supplement also should be regarded as protection scope of the present invention.All those skilled in the art,
Without departing from the spirit and scope of the present invention, when made using disclosed above technology contents it is a little more
Dynamic, modification and the equivalent variations developed, are the equivalent embodiment of the present invention；Meanwhile all substantial technologicals pair according to the present invention
The variation, modification and evolution of any equivalent variations that above-described embodiment is made still fall within the range of technical scheme of the present invention
It is interior.
Claims (10)
1. a kind of Allylestrenol tablet, is made by Allylestrenol and auxiliary material through mixing and tabletting, it is characterised in that the auxiliary material
Be made of interior plus auxiliary material and additional auxiliary material, and first by Allylestrenol and Nei Jia auxiliary materials and mixings, medicine-containing particle or powder is made, then
With additional auxiliary material mixing and tabletting is carried out to be made, wherein, the interior plus auxiliary material in polyethylene glycols carrier material one
Kind is two or more, the one kind or two of the additional auxiliary material in filler, disintegrant, adhesive, glidant, lubricant
Kind or more.
2. Allylestrenol tablet according to claim 1, wherein the interior plus auxiliary material is carried selected from solid polyethylene glycol class
One or more of body material；Preferably, described interior plus auxiliary material be selected from PEG1000, PEG1500, PEG2000,
One or more of PEG3000, PEG4000, PEG6000, PEG8000, PEG20000.
3. the Allylestrenol tablet according to claim 1-2, wherein Allylestrenol are 1 with interior plus auxiliary material weight ratio:2-
200；Preferably, Allylestrenol and interior plus auxiliary material weight ratio are 1:5-100；It is highly preferred that Allylestrenol and interior plus auxiliary material
Weight ratio is 1:10-50.
4. the Allylestrenol tablet according to claim 1-3, wherein：
The filler is selected from microcrystalline cellulose, lactose, Lactis Anhydrous, sucrose, starch, pregelatinized starch, mannitol, sorb
It is one or more in alcohol, xylitol；
The disintegrant is selected from crospovidone, sodium carboxymethyl starch, croscarmellose sodium, hydroxypropyl methylcellulose
It is one or more in element, low-substituted hydroxypropyl cellulose, microcrystalline cellulose；
The one kind or more of the adhesive in povidone, starch slurry, hydroxypropyl methyl cellulose, hydroxypropyl cellulose
Kind；
The lubricant is one or more in magnesium stearate, stearic acid；
The glidant is one or more in silica, talcum powder.
5. the Allylestrenol tablet according to claim 1-4, by weight percentage, Allylestrenol 0.1%~10% gathers
Glycols carrier material 1%~80%, filler 15%~98%, disintegrant 0.1%~30%, adhesive 0.1%~
30%, lubricant 0~5% and glidant 0~5%.
6. the Allylestrenol tablet according to claim 1-5, wherein, the interior plus auxiliary material is Macrogol 4000, gathers
Ethylene glycol 6000 or PEG 8000.
7. the Allylestrenol tablet according to claim 1-6, wherein, the additional auxiliary material is microcrystalline cellulose, crosslinking
Povidone, povidone, magnesium stearate and silica.
8. Allylestrenol tablet according to claim 7, wherein, by weight percentage, Allylestrenol 0.5%~5%,
Polyethylene glycols carrier material 10~50%, crospovidone 1%~5%, povidone 1%~5%, microcrystalline cellulose 20%~
80%, magnesium stearate 0.1%~2% and silica 0.1%~2%.
9. the Allylestrenol tablet according to claim 1-8, wherein, by Allylestrenol and Nei Jia auxiliary materials and mixings, heating is molten
Melt, smashed after cooling and medicine-containing particle or powder is made.
10. Allylestrenol tablet according to claim 9, wherein heating and temperature control are 90~130 DEG C, more preferably
100~120 DEG C.
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| CN201810172722.3A CN108186586B (en) | 2018-03-01 | 2018-03-01 | Allylestrenol tablet and preparation method thereof |
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2018
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| CN103550179A (en) * | 2013-10-31 | 2014-02-05 | 河北创健药业有限公司 | Allylestrenol tablet and preparation method thereof |
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