CN104367561B - A kind of preparation method of Tauro ursodesoxy cholic acid preparation - Google Patents
A kind of preparation method of Tauro ursodesoxy cholic acid preparation Download PDFInfo
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Abstract
The invention discloses a kind of preparation method of Tauro ursodesoxy cholic acid preparation, including by Tauro ursodesoxy cholic acid raw material and auxiliary material sieving for standby, it is desirable to 150 μm of raw material granularity distribution D90 ＜；120 μm of auxiliary material particle diameter distribution D90 ＜；Tauro ursodesoxy cholic acid, diluent and disintegrant mixing are taken, the material of intensive production batch 10%~15% is received as (a), it is standby；Another to take batch lubricant of output 85%~90% to add mixing, collection material is standby as (b)；Material (b) is taken by dry granulation；By step 3 resulting material whole grain, sieving, material is mixed with material (a) after sieving, and material is according still further to step 3 dry granulation after mixing, and then whole grain, is sieved；Step 4 resulting material is added into rest lubricant, rewinding after mixing；The step of with by step 5 resulting material preparation.The method of the present invention can solve the problem that Flow of Goods and Materials sex chromosome mosaicism, and can solve the prominent situation about releasing of nothing of the preparation under defined leaching condition.
Description
Technical field
The present invention relates to a kind of preparation method of Tauro ursodesoxy cholic acid preparation, belong to field of pharmaceutical preparations.
Background technology
Tauro ursodesoxy cholic acid (TUDCA) chemical name is 3 α, and 7 beta-dihydroxy cholane acyl-N- taurines, are deoxygenated by bear
The conjugated bile acidses shunk between the carboxyl of cholic acid (UDCA) and the amino of taurine.Found from bear gall within 1902
TUDCA, it is primary bile acid in bear gall, with the effect such as spasmolysis, anticonvulsion, anti-inflammatory and molten cholelith.Tauro ursodesoxy cholic acid
(tauroursodeoxycholic acid, 1) is the active ingredient of bear gall juice, chemical entitled 2- [[(3 α, 5 β, 7 β) -3,7- bis-
Hydroxyl -2,4- oxo cholestane -24- bases] amino] ethane sulfonic acid dihydrate, developed by the big pharmaceutical factories of Italian Bei Sidi, 1991
Year, first in Italy's listing, is approved in China's sale, clinic is mainly used in for 2007 with the surging rood (taurolite) of trade name
Treat gallbladder cholesterol calculus, primary sclerosing cholangitis, Primary biliary cirrhosis and chronic HCV etc..Face
Bed research shows that 1 compared with urso, and molten stone speed is accelerated, complete molten rate is improved, and without obvious adverse reaction.
Tauro ursodesoxy cholic acid bulk drug is not very stable to high humidity, high temperature, and moisture absorption is serious, and this characteristic is this
What individual bulk drug chemical stability property was determined, preparation is made if desired, it is impossible to using conventional wet process technique；Such as
Fruit is produced using full powder, but Tauro ursodesoxy cholic acid accounts for 72% of recipe quantity or so in product prescription, due to bulk drug
Mobility it is excessively poor, and moisture absorption, it is impossible to produced.And surging rood capsule is that the screw rod vertical compression filling method used is entered at present
Row production, requires very high, this equipment price is expensive, and needs import, limits domestic production enterprise and adopts to capsule filling machine
Domestic capsule filling machine is used, this capsule product is produced using full powder technology, causes In Vitro Dissolution behavior can not be with reference preparation
It is consistent.
The content of the invention
For above-mentioned technical problem, Flow of Goods and Materials sex chromosome mosaicism is can solve the problem that it is an object of the invention to provide one kind, and
The preparation method of the Tauro ursodesoxy cholic acid preparation of the prominent situation about releasing of nothing of the preparation under defined leaching condition can be solved.
The above-mentioned purpose of the present invention is achieved by the following technical solution：A kind of preparation of Tauro ursodesoxy cholic acid preparation
Method, comprises the following steps：
1) by Tauro ursodesoxy cholic acid raw material and auxiliary material sieving for standby, it is desirable to 150 μm of raw material granularity distribution D90 ＜；Auxiliary material
120 μm of particle diameter distribution D90 ＜；
2) Tauro ursodesoxy cholic acid, diluent and disintegrant mixing are taken, the material of intensive production batch 10%~15% is received
It is standby as (a)；Another to take batch lubricant of output 85%~90% to add mixing, collection material is standby as (b)；
3) material (b) is taken by dry granulation；
4) by step 3 resulting material whole grain, sieving, material is mixed with material (a) after sieving, and material is according still further to step after mixing
Rapid 3 dry granulation, then whole grain, is sieved；
5) step 4 resulting material is added into rest lubricant, rewinding after mixing；
6) by step 5 resulting material preparation.
In the present invention, the preferred mesh sieve of mistake 100 of step 1；Described auxiliary material refers to diluent, disintegrant and lubricant；Its
Described in diluent refer to the inert substance that dilutes, specifically, in lactose monohydrate, mannitol or microcrystalline cellulose
One or more；The disintegrant refers in pharmaceutical composition, tablet is split the material for being broken into fine particle rapidly, so that
Make the rapid solution absorption of functional component, play a role, including but not limited to dried starch (such as cornstarch or potato starch), carboxylic
Methyl starch sodium, low-substituted hydroxypropyl cellulose, PVPP, Ac-Di-Sol, microcrystalline cellulose
Plain (PH101)；The lubricant refers in pharmaceutical composition, increases the mobility of (or powder) grain, reduces (or powder) grain
The material of frictional force between punch die, including but not limited to magnesium stearate, superfine silica gel powder, talcum powder, magnesium laurylsulfate etc..
In the preferred embodiment of the present invention, the diluent, disintegrant and lubricant are lactose monohydrate, microcrystalline cellulose
(PH101), cornstarch and magnesium stearate.
In the present invention, hybrid described in step 2 is carried out in multinomial movement mixer, preferably incorporation time be 5~
10 minutes.
In the present invention, the condition of step 3 dry granulation is preferably to confirm equipment by dry granulating machine S.O.P.
Normally, facility for granulating is opened, oil pressure is risen to 1.5MPa, adds well mixed material (b) by adjustment equipment, according to compacting medicine
Bulk strength and machine operation, regulation extrusion wheel velocity (3.6~5.3rpm), feeding spiro rod rotating speed (12~4rpm), oil cylinder
Pressure (oil cylinder working-pressure is using 1.0MPa~2.0MPa as degree), makes its three effectively coordinate, moderate (that can make to compacting medicine block hardness
It is degree into the moderate particle of hardness, such as medicine block hardness is in 2~5kg), rewinding.
In the present invention, step 4 be by step 3 resulting material be provided with 24 mesh steel-wire screen rocking type granule-finishing machines carry out it is whole
Grain；Whole grain is finished, and thick head is removed with 24 mesh sieves, and fine powder is removed with 100 mesh sieves；Thick head and fine powder are collected, upper machine [repeats the again
(3) step production technology] pelletized, and whole grain is carried out with 24 mesh steel-wire screen rocking type granule-finishing machines, and particle is sieved.Cross
The fine powder amount of 100 mesh sieves reaches whole particulate matter doses 35~45%, preferably 40%, take the well mixed material (a) of material with
Cross 100 mesh sieves particle mix about 5 minutes after, upper machine [repeating (3) step production technology] granulation again, and with 24 mesh piano-wire screens
Net rocking type granule-finishing machine carries out whole grain, and particle is sieved.The fine powder amount for crossing 100 mesh sieves reaches whole particulate matter doses about
15%, stop granulation, collect whole particles.
In the present invention, step 5 is to put satisfactory particle in mixer, adds recipe quantity residue 10~15%
Magnesium stearate, is mixed 5 minutes, rewinding.
In the present invention, the preparation described in step 6 can make filling into capsule or tabletted.
In the present invention, in the preparation, Tauro ursodesoxy cholic acid preferably has following proportioning with auxiliary material：
Further, Tauro ursodesoxy cholic acid (dihydrate) preferably 150~250 parts by weight；The microcrystalline cellulose
Plain (PH101) preferably 36~48 parts by weight；More select 40~48 parts by weight；The lactose monohydrate preferably 8.2~19 parts by weight, more
Select 15~19 parts by weight；The cornstarch preferably 6~13 parts by weight；More preferably 8~13 parts by weight；The magnesium stearate is excellent
Select 5~12.8 parts by weight；More preferably 8~12.8 parts by weight.
In an instantiation of invention, the Tauro ursodesoxy cholic acid preferably has following proportioning with auxiliary material：Ox sulphur
The parts by weight of urso (dihydrate) 250, the parts by weight of microcrystalline cellulose (PH101) 48, the parts by weight of lactose monohydrate 15, corn
The parts by weight of starch 5, the parts by weight of magnesium stearate 2.
In another instantiation of invention, the Tauro ursodesoxy cholic acid preferably has following proportioning with auxiliary material：Ox
The parts by weight of sulphur urso (dihydrate) 250, the parts by weight of microcrystalline cellulose (PH101) 40, the parts by weight of lactose monohydrate 19 are beautiful
The parts by weight of rice starch 6, the parts by weight of magnesium stearate 5.
In another instantiation of invention, the Tauro ursodesoxy cholic acid preferably has following proportioning with auxiliary material：Ox
The parts by weight of sulphur urso (dihydrate) 250, the parts by weight of microcrystalline cellulose (PH101) 24, the parts by weight of lactose monohydrate 30 are beautiful
The parts by weight of rice starch 8, the parts by weight of magnesium stearate 8.
In another instantiation of invention, the Tauro ursodesoxy cholic acid preferably has following proportioning with auxiliary material：Ox
The parts by weight of sulphur urso (dihydrate) 250, the parts by weight of microcrystalline cellulose (PH101) 36, the parts by weight of lactose monohydrate 8.2,
The parts by weight of cornstarch 13, the parts by weight of magnesium stearate 12.8.
In another instantiation of invention, the Tauro ursodesoxy cholic acid preferably has following proportioning with auxiliary material：Ox
The parts by weight of sulphur urso (dihydrate) 250, the parts by weight of microcrystalline cellulose (PH101) 36, the parts by weight of lactose monohydrate 6 are beautiful
The parts by weight of rice starch 13, the parts by weight of magnesium stearate 15.
The beneficial effects of the present invention are：Using dry granulation production technology, direct tablet compressing mobility of particle is solved poor
The problem of, while solving the problems, such as that material can not use wet process technique, product can be ensured by providing one kind to preparation production
The production technology of quality, while defining the particle size range of principal component, cooperated technique for producing reaches and reference preparation dissolved corrosion
Consistent purpose.
Brief description of the drawings
Capsule and reference preparation Dissolution profiles that Fig. 1 is 1-5 of the embodiment of the present invention.
Tablet and reference preparation Dissolution profiles that Fig. 2 is 1-5 of the embodiment of the present invention.
Fig. 3 is tablet, capsule and the reference preparation Dissolution profiles of the embodiment of the present invention 7.
Embodiment
Embodiment 1
The dry granulation production technology that the use of prescription 1 is general, pharmaceutical factory is conventional is as follows：The technological operation is simple, no spy
Different technological parameter requirement.
(1) supplementary material, is crossed into 80 mesh sieves, it is standby；
(2), by Tauro ursodesoxy cholic acid dihydrate, microcrystalline cellulose (PH101), lactose monohydrate, cornstarch
Put multinomial movement mixer 20min；
(3) dry granulating machine on mixed material, is taken, regulation extrusion wheel velocity (3.6~5.3rpm), feeding spiro rod turn
Fast (12~24rpm), oil cylinder working-pressure (oil cylinder working-pressure is using 1.0MPa~2.0MPa as degree), make its three effectively coordinate, to compacting
Medicine block hardness is moderate (so that the moderate particle of hardness can be made as degree), rewinding；
(4) material, is subjected to whole grain with 24 mesh steel-wire screen rocking type granule-finishing machines are provided with；
(5), total mixing：Satisfactory particle is put in mixer, plus people's magnesium stearate, mix 5 minutes, rewinding；
(6), by the capsule of granule filling dimension and tabletted.
Embodiment 2~5
According to prescription 2~5, prepared using the methods described of embodiment 1.
Embodiment 6
The detection method of dissolution in vitro：
Paddle method, dissolution medium is aqueous solution 900ml, and rotating speed is 100 revs/min, and dissolution medium temperature is 37 DEG C ± 0.5
DEG C, during through 30 minutes, solution is taken, is filtered, the measure of drug concentration is HPLC methods.
The capsule dissolubility curve determination data of prescription 1~5：
| Prescription | 10min | 20min | 30min | 45min |
| 1 | 94.4% | 96.8% | 99.0% | 99.1% |
| 2 | 93.1% | 97.9% | 98.4% | 99.5% |
| 3 | 90.8% | 98.4% | 99.1% | 99.7% |
| 4 | 86.1% | 92.4% | 98.9% | 99.6% |
| 5 | 79.4% | 93.6% | 99.7% | 99.9% |
| Reference preparation | 31.4% | 51.1% | 61.3% | 83.9% |
The Dissolution of Tablet curve determination data of prescription 1~5：
| Prescription | 10min | 20min | 30min | 45min |
| 1 | 92.8% | 97.9% | 98.1% | 99.8% |
| 2 | 93.9% | 98.6% | 98.9% | 99.9% |
| 3 | 90.4% | 97.3% | 98.7% | 99.5% |
| 4 | 84.5% | 93.6% | 97.5% | 98.9% |
| 5 | 77.4% | 95.6% | 97.9% | 98.8% |
| Reference preparation | 31.4% | 51.1% | 61.3% | 83.9% |
Compared from the capsule of prescription 1~5 and tablet with reference preparation (surging rood), 75% has all been reached in 10min stripping quantities
More than, do not meet the evaluation requirement of clinical biochemical availability.Illustrate that pressure does not influence on product dissolution.
But had surprisingly found that from prescription 4 and 5, in prescription after the amount lifting of magnesium stearate, in the safe range of supplementary product consumption
Interior, the stripping quantity in 10min is low compared with other prescriptions.
Based on this discovery, we adjust dry granulation processing parameter, carry out the tune of preparation method using prescription 5 again
It is whole.
Embodiment 7
The adjustment of dry granulation processing parameter
(1) supplementary material, is crossed into 100 mesh sieves, it is standby.It is required that 150 μm of bulk drug size distribution D90 ＜；Auxiliary material particle diameter point
120 μm of cloth D90 ＜；
(2) take Tauro ursodesoxy cholic acid, microcrystalline cellulose and lactose, cornstarch to put after multinomial movement mixer, mix
10 minutes；The material (a) of collection about 15%, it is standby；In addition, take the magnesium stearate of recipe quantity 85% to add in mixer, mixing 5~
10 minutes, collection material (b) was standby；
(3) confirm that equipment is normal by dry granulating machine S.O.P., open facility for granulating, adjustment equipment, by oil pressure
1.5MPa is risen to, well mixed material (b) is added, according to compacting medicine block intensity and machine operation, regulation extruding rotation
Fast (3.6~5.3rpm), feeding spiro rod rotating speed (12~24rpm), oil cylinder working-pressure (oil cylinder working-pressure using 1.0MPa~2.0MPa as
Degree), its three is effectively coordinated, rewinding moderate (so that the moderate particle of hardness can be made as degree) to compacting medicine block hardness；
(4) material, is subjected to whole grain with 24 mesh steel-wire screen rocking type granule-finishing machines are provided with；Whole grain is finished, and is gone with 24 mesh sieves
Except thick head, fine powder is removed with 100 mesh sieves；Thick head and fine powder are collected, upper machine [repeating (3) step production technology] is made again
Grain, and whole grain is carried out with 24 mesh steel-wire screen rocking type granule-finishing machines, and particle is sieved.The fine powder amount for crossing 100 mesh sieves reaches
Whole particulate matter doses about 40% (35~45%), take the well mixed material (a) of material to be mixed about with crossing the particle of 100 mesh sieves
After 5 minutes, upper machine [repeating (3) step production technology] granulation, and whole grain is carried out with 24 mesh steel-wire screen rocking type granule-finishing machines again,
And particle is sieved.The fine powder amount for crossing 100 mesh sieves reaches whole particulate matter doses about 15%, stops granulation, collects all
Particle；
(5), satisfactory particle is put in mixer, plus people's recipe quantity residue 15% magnesium stearate, mix 5 points
Clock, rewinding；(6) by the capsule of granule filling dimension and tabletted.
| Product | 10min | 20min | 30min | 45min | 60min |
| Surging rood | 31.4% | 51.1% | 79.2% | 89.9% | 99.1% |
| Make capsule by oneself | 35.4% | 56.8% | 83.4% | 92.1% | 98.9% |
| Make tablet by oneself | 27.9% | 47.9% | 78.9% | 86.9% | 98.5% |
Claims (9)
1. a kind of preparation method of Tauro ursodesoxy cholic acid preparation, comprises the following steps：
1) that Tauro ursodesoxy cholic acid raw material and auxiliary material are crossed into 100 mesh sieves is standby, it is desirable to 150 μm of raw material granularity distribution D90 ＜；Auxiliary material
120 μm of particle diameter distribution D90 ＜；
2) Tauro ursodesoxy cholic acid raw material, diluent and disintegrant mixing are taken, the material for collecting production batch 10%~15% is made
It is standby for (a)；Another to take batch lubricant of output 85%~90% to add mixing, collection material is standby as (b)；
3) material (b) is taken by dry granulation；
4) by step 3) resulting material whole grain, the fine powder amount that was screened to 100 mesh sieves reach whole particulate matter doses 35~45%,
Take sieving after material mixed with material (a), material is according still further to step 3 after mixing) dry granulation, then whole grain, be sized to 100
The fine powder amount of mesh sieve reaches whole particulate matter doses 10~15%；
5) by step 4) resulting material addition rest lubricant, rewinding after mixing；
6) by step 5) resulting material preparation；
Wherein, the Tauro ursodesoxy cholic acid raw material is the parts by weight of Tauro ursodesoxy cholic acid dihydrate 150~300；
The disintegrant is the parts by weight of microcrystalline cellulose PH101 24~48；With
The parts by weight of cornstarch 5~13；
The diluent is the parts by weight of lactose monohydrate 6~30；
The lubricant is the parts by weight of magnesium stearate 2~15,
Wherein step 2) described in mixing be to be carried out in multinomial movement mixer, incorporation time is 5~10 minutes.
2. preparation method as claimed in claim 1, wherein step 3) condition of dry granulation is uses dry granulation, and regulation is set
Standby oil pressure rises to 1.5MPa, adds well mixed material (b), and according to compacting medicine block intensity and machine operation, regulation is squeezed
3.6~5.3rpm of pinch roller rotating speed, 4~12rpm of feeding spiro rod rotating speed, oil cylinder working-pressure 1.0MPa~2.0MPa, compacting medicine block hardness 2
Rewinding after~5kg.
3. preparation method as claimed in claim 1, wherein step 4) be by step 3) resulting material progress whole grain；Whole grain is complete
Finish, thick head is removed with 24 mesh sieves, fine powder is removed with 100 mesh sieves；Thick head and fine powder are collected, step 3 is re-started) granulation, go forward side by side
Row whole grain, and particle is sieved, the fine powder amount for crossing 100 mesh sieves reaches whole particulate matter doses 35~45%, takes material to mix
Close uniform material (a) and mixed with crossing the particle of 100 mesh sieves after 5 minutes, re-start step 3) granulation, and whole grain is carried out, it is right
Particle is sieved, and the fine powder amount for crossing 100 mesh sieves reaches that whole particulate matter doses 15% stop granulation, collects whole particles.
4. preparation method as claimed in claim 3, wherein step 4) be by step 3) resulting material progress whole grain；Whole grain is complete
Finish, thick head is removed with 24 mesh sieves, fine powder is removed with 100 mesh sieves；Thick head and fine powder are collected, step 3 is re-started) granulation, go forward side by side
Row whole grain, and particle is sieved, the fine powder amount for crossing 100 mesh sieves reaches whole particulate matter doses 40%.
5. preparation method as claimed in claim 1, wherein step 5) it is to put satisfactory particle in mixer, add surplus
Remaining magnesium stearate, is mixed 5 minutes, rewinding.
6. preparation method as claimed in claim 1, wherein step 6) described in preparation it is filling into capsule or tabletted.
7. preparation method as claimed in claim 1, wherein in the preparation Tauro ursodesoxy cholic acid dihydrate be 150~
250 parts by weight；The microcrystalline cellulose PH101 is 36~48 parts by weight；The lactose monohydrate is 8.2~19 parts by weight；It is described
Cornstarch is 6~13 parts by weight；The magnesium stearate is 5~12.8 parts by weight.
8. preparation method as claimed in claim 1, wherein microcrystalline cellulose PH101 described in the preparation is 40~48 weight
Part；The lactose monohydrate is 15~19 parts by weight；The cornstarch is 8~13 parts by weight；The magnesium stearate is 8~12.8
Parts by weight.
9. preparation method as claimed in claim 1, wherein Tauro ursodesoxy cholic acid dihydrate has with auxiliary material in the preparation
There is following proportioning：The parts by weight of Tauro ursodesoxy cholic acid dihydrate 250, microcrystalline cellulose
The parts by weight of PH101 48, the parts by weight of lactose monohydrate 15, the parts by weight of cornstarch 5, the parts by weight of magnesium stearate 2；
Or the parts by weight of Tauro ursodesoxy cholic acid dihydrate 250, the parts by weight of microcrystalline cellulose PH101 40, the weight of lactose monohydrate 19
Part, the parts by weight of cornstarch 6, the parts by weight of magnesium stearate 5；
Or the parts by weight of Tauro ursodesoxy cholic acid dihydrate 250, the parts by weight of microcrystalline cellulose PH101 24, the weight of lactose monohydrate 30
Part, the parts by weight of cornstarch 8, the parts by weight of magnesium stearate 8；
Or the parts by weight of Tauro ursodesoxy cholic acid dihydrate 250, the parts by weight of microcrystalline cellulose PH101 36, the weight of lactose monohydrate 8.2
Measure part, the parts by weight of cornstarch 13, the parts by weight of magnesium stearate 12.8；
Or the parts by weight of sulphur urso dihydrate 250, the parts by weight of microcrystalline cellulose PH101 36, the parts by weight of lactose monohydrate 6,
The parts by weight of cornstarch 13, the parts by weight of magnesium stearate 15.
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| CN107095858B (en) * | 2017-06-27 | 2020-04-10 | 石家庄学院 | Ursodeoxycholic acid capsule and preparation method thereof |
| CN109568288A (en) * | 2019-01-28 | 2019-04-05 | 四川迪菲特药业有限公司 | A kind of ursodesoxycholic acid capsule and preparation method thereof |
| CN114762650A (en) * | 2021-01-11 | 2022-07-19 | 廊坊新龙立机械制造有限公司 | Method for processing material with poor bulk density into medicament with predetermined specification |
| CN113425699A (en) * | 2021-07-14 | 2021-09-24 | 石家庄龙泽制药股份有限公司 | Ursodeoxycholic acid capsule and preparation method thereof |
| CN115671073B (en) * | 2021-07-22 | 2024-07-09 | 华益泰康药业股份有限公司 | Ursodeoxycholic acid capsule and preparation method thereof |
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