CN104367561A - Preparation method of bezoar ursodesoxycholic acid preparation - Google Patents
Preparation method of bezoar ursodesoxycholic acid preparation Download PDFInfo
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- CN104367561A CN104367561A CN201410650450.5A CN201410650450A CN104367561A CN 104367561 A CN104367561 A CN 104367561A CN 201410650450 A CN201410650450 A CN 201410650450A CN 104367561 A CN104367561 A CN 104367561A
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Abstract
The invention discloses a preparation method of bezoar ursodesoxycholic acid preparation. The preparation method of the bezoar ursodesoxycholic acid preparation comprises the following steps: sieving a bezoar ursodesoxycholic acid raw material and an auxiliary material for later use, wherein particle size distribution D90 of the raw material is required to be less than 150 microns, and the particle size distribution D90 of the auxiliary material is required to be less than 120 microns; mixing bezoar ursodesoxycholic acid, a diluent and a disintegrating agent, collecting a material accounting for about 10-15% of production lot size to be taken as (a) for later use; adding a lubricating agent accounting for 85-90% of the production lot size, mixing, and collecting material taken as (b) for later use; carrying out dry granulation on the material (b); straightening the material obtained in the step 3, sieving, mixing the sieved material with the material (a), carrying out dry granulation on the mixed material, and then straightening and sieving; adding the material obtained in the step 4 into the rest lubricating agent, mixing, and collecting a material; and preparing the preparation by adopting the material obtained in the step 5. The preparation method of the bezoar ursodesoxycholic acid preparation has the advantages that the problem of material fluidity can be solved and the phenomenon that no initial burst release of the bezoar ursodesoxycholic acid preparation is caused under the specified dissolution condition can be avoided.
Description
Technical field
The present invention relates to a kind of preparation method of tauroursodeoxycholic acid preparation, belong to field of pharmaceutical preparations.
Background technology
Tauroursodeoxycholic acid (TUDCA) chemical name is 3 α, and 7 beta-dihydroxy cholane acyl-N-taurines are by the conjugated bile acids shunk between the carboxyl of ursodesoxycholic acid (UDCA) and the amino of taurine.Within 1902, in Fel Ursi, find TUDCA, it is primary bile acid in Fel Ursi, has the effects such as spasmolytic, convulsion, antiinflammatory and molten cholelithiasis.Tauroursodeoxycholic acid (tauroursodeoxycholic acid, 1) be the effective ingredient of Fel Ursi, chemistry 2-[[(3 α by name, 5 β, 7 β)-3, 7-dihydroxy-2, 4-oxo cholestane-24-base] amino] ethane sulfonic acid dihydrate, developed by the large pharmaceutical factory of Italian Bei Sidi, within 1991, go on the market in Italy first, within 2007, get permission to sell in China with trade name flood rood (taurolite), clinical being mainly used in treats gallbladder cholesterol calculus, primary sclerosing cholangitis, Primary biliary cirrhosis and chronic HCV etc.Clinical research shows, 1 compared with ursodesoxycholic acid, and lithodialysis speed is accelerated, complete molten rate improves, and without obvious untoward reaction.
Tauroursodeoxycholic acid crude drug is not very stable to high humidity, high temperature, and moisture absorption is serious, and this characteristic is that this crude drug chemical stability character determines, if need to make preparation, can not adopt conventional wet process technique; If adopt full powder to produce, but tauroursodeoxycholic acid accounts for about 72% of recipe quantity in product prescription, the non-constant of the mobility due to crude drug, and moisture absorption, cannot produce.And the screw rod vertical compression filling method that current surging rood capsule is employing is produced, require very high to capsule filling machine, this equipment price is expensive, and need import, limit domestic production enterprise and adopt domestic capsule filling machine, adopt full powder technology to produce this capsule product, cause In Vitro Dissolution behavior cannot be consistent with reference preparation.
Summary of the invention
For above-mentioned technical problem, the object of the present invention is to provide one can solve Flow of Goods and Materials sex chromosome mosaicism, and the preparation method of the tauroursodeoxycholic acid preparation without prominent situation about releasing of preparation under the leaching condition of regulation can be solved.
Above-mentioned purpose of the present invention is achieved by the following technical solution: a kind of preparation method of tauroursodeoxycholic acid preparation, comprises the steps:
1) by tauroursodeoxycholic acid stock and adjunct sieving for standby, raw material granularity distribution D90 < 150 μm is required; Adjuvant particle size distribution D90 < 120 μm;
2) get the mixing of tauroursodeoxycholic acid, diluent and disintegrating agent, collect the material of about production lot 10% ~ 15% as (a), for subsequent use; Separately get batch volume of production 85% ~ 90% lubricant and add mixing, collection material is as (b), for subsequent use;
3) material (b) is got by dry granulation;
4) by step 3 gained material granulate, sieve, after sieving, material mixes with material (a), and after mixing, material is again according to step 3 dry granulation, then granulate, screening;
5) step 4 gained material is added rest lubricant, rewinding after mixing;
6) by step 5 gained material preparation.
In the present invention, step 1 preferred mistake 100 mesh sieve; Described adjuvant refers to diluent, disintegrating agent and lubricant; Wherein said diluent refers to the inert substance in order to dilution, specifically, is selected from one or more in lactose monohydrate, mannitol or microcrystalline Cellulose; Described disintegrating agent refers in pharmaceutical composition, tablet is made to split rapidly the material being broken into fine particle, thus make the rapid solution absorption of functional component, play a role, include but not limited to dried starch (such as corn starch or potato starch), carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, crospolyvinylpyrrolidone, cross-linking sodium carboxymethyl cellulose, microcrystalline Cellulose (PH101); Described lubricant refers in pharmaceutical composition, increase the mobility of (or powder) grain, reduce the material of (or powder) frictional force between grain and punch die, include but not limited to magnesium stearate, micropowder silica gel, Pulvis Talci, magnesium laurylsulfate etc.In a preferred embodiment of the present invention, described diluent, disintegrating agent and lubricant are lactose monohydrate, microcrystalline Cellulose (PH101), corn starch and magnesium stearate.
In the present invention, hybrid described in step 2 carries out in multinomial movement mixer, and preferred incorporation time is 5 ~ 10 minutes.
In the present invention, the condition of step 3 dry granulation is preferably pressed dry granulating machine S.O.P. and is confirmed that equipment is normal, open facility for granulating, conditioning equipment, oil pressure is risen to 1.5MPa, add the material (b) of mix homogeneously, according to compacting medicine bulk strength and machine operation, regulate extrusion wheel velocity (3.6 ~ 5.3rpm), feeding spiro rod rotating speed (12 ~ 4rpm), oil cylinder working-pressure (oil cylinder working-pressure with 1.0MPa ~ 2.0MPa for degree), its three is effectively coordinated, moderate (so that the moderate granule of hardness can be made for degree to compacting medicine block hardness, such as medicine block hardness is at 2 ~ 5kg), rewinding.
In the present invention, step 4 is that step 3 gained material is carried out granulate with being provided with 24 order steel-wire screen rocking type granule-finishing machines; Granulate is complete, removes thick head with 24 mesh sieves, removes fine powder with 100 mesh sieves; Collect thick head and fine powder, again go up machine [repeating (3) step production technology] and granulate, and carry out granulate with 24 order steel-wire screen rocking type granule-finishing machines, and granule is sieved.The fine powder amount crossing 100 mesh sieves reaches whole particulate matter doses 35 ~ 45%; preferably 40%; get the uniform material (a) of mixing of materials and cross after the granule of 100 mesh sieves mixes about 5 minutes; again go up machine [repeating (3) step production technology] to granulate; and carry out granulate with 24 order steel-wire screen rocking type granule-finishing machines, and granule is sieved.The fine powder amount crossing 100 mesh sieves reaches whole particulate matter doses about 15%, stops granulating, and collects whole granule.
In the present invention, step 5 is put in mixer by satisfactory granule, adds the magnesium stearate of recipe quantity residue 10 ~ 15%, mix 5 minutes, rewinding.
In the present invention, the preparation described in step 6 can make fill become capsule or be pressed into tablet.
In the present invention, in described preparation, tauroursodeoxycholic acid and adjuvant preferably have following proportioning:
Further, described tauroursodeoxycholic acid (dihydrate) preferably 150 ~ 250 weight portions; Described microcrystalline Cellulose (PH101) preferably 36 ~ 48 weight portions; More select 40 ~ 48 weight portions; Described lactose monohydrate is 8.2 ~ 19 weight portions preferably, more select 15 ~ 19 weight portions; Described corn starch is 6 ~ 13 weight portions preferably; More preferably 8 ~ 13 weight portions; Described magnesium stearate is 5 ~ 12.8 weight portions preferably; More preferably 8 ~ 12.8 weight portions.
In an instantiation of invention; described tauroursodeoxycholic acid and adjuvant preferably have following proportioning: tauroursodeoxycholic acid (dihydrate) 250 weight portion; microcrystalline Cellulose (PH101) 48 weight portion; lactose monohydrate 15 weight portion; corn starch 5 weight portion, magnesium stearate 2 weight portion.
In another instantiation of invention; described tauroursodeoxycholic acid and adjuvant preferably have following proportioning: tauroursodeoxycholic acid (dihydrate) 250 weight portion; microcrystalline Cellulose (PH101) 40 weight portion; lactose monohydrate 19 weight portion; corn starch 6 weight portion, magnesium stearate 5 weight portion.
In another instantiation of invention; described tauroursodeoxycholic acid and adjuvant preferably have following proportioning: tauroursodeoxycholic acid (dihydrate) 250 weight portion; microcrystalline Cellulose (PH101) 24 weight portion; lactose monohydrate 30 weight portion; corn starch 8 weight portion, magnesium stearate 8 weight portion.
In another instantiation of invention; described tauroursodeoxycholic acid and adjuvant preferably have following proportioning: tauroursodeoxycholic acid (dihydrate) 250 weight portion; microcrystalline Cellulose (PH101) 36 weight portion; lactose monohydrate 8.2 weight portion; corn starch 13 weight portion, magnesium stearate 12.8 weight portion.
In another instantiation of invention; described tauroursodeoxycholic acid and adjuvant preferably have following proportioning: tauroursodeoxycholic acid (dihydrate) 250 weight portion; microcrystalline Cellulose (PH101) 36 weight portion; lactose monohydrate 6 weight portion; corn starch 13 weight portion, magnesium stearate 15 weight portion.
Beneficial effect of the present invention is: adopt dry granulation production technology, solve the problem of direct compression mobility of particle difference, solve material simultaneously and cannot adopt wet process technique problem, to preparation produce provide a kind of can the production technology of products quality guarantee, define the particle size range of main constituent simultaneously, cooperated technique for producing, reaches the object consistent with reference preparation dissolved corrosion.
Accompanying drawing explanation
Fig. 1 is capsule and the reference preparation Dissolution profiles of embodiment of the present invention 1-5.
Fig. 2 is tablet and the reference preparation Dissolution profiles of embodiment of the present invention 1-5.
Fig. 3 is the tablet of the embodiment of the present invention 7, capsule and reference preparation Dissolution profiles.
Detailed description of the invention
Embodiment 1
The employing of prescription 1 general, the dry granulation production technology of pharmaceutical factory routine is as follows: this technological operation is simple, without special technological parameter requirement.
(1), by supplementary material all 80 mesh sieves are crossed, for subsequent use;
(2), tauroursodeoxycholic acid dihydrate, microcrystalline Cellulose (PH101), lactose monohydrate, corn starch are put multinomial movement mixer 20min;
(3), dry granulating machine on mixed material is got, regulate extrusion wheel velocity (3.6 ~ 5.3rpm), feeding spiro rod rotating speed (12 ~ 24rpm), oil cylinder working-pressure (oil cylinder working-pressure with 1.0MPa ~ 2.0MPa for degree), its three is effectively coordinated, to compacting medicine block hardness moderate (can make the moderate granule of hardness for degree), rewinding;
(4), material is carried out granulate with being provided with 24 order steel-wire screen rocking type granule-finishing machines;
(5), always mix: satisfactory granule is put in mixer, adds people's magnesium stearate, mix 5 minutes, rewinding;
(6), by the capsule of granule filling dimension be pressed into tablet.
Embodiment 2 ~ 5
According to prescription 2 ~ 5, adopt method preparation described in 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, through 30 minutes time, gets solution, and filter, the mensuration of drug level is HPLC method.
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％ |
Compare with reference preparation (surging rood) from prescription 1 ~ 5 capsule and tablet, all reach more than 75% at 10min stripping quantity, do not meet the evaluation requirement of clinical biochemical availability.Illustrate that pressure does not affect product stripping.
But from the discovery that prescription 4 and 5 is surprised, after in prescription, the amount of magnesium stearate promotes, in the safety range of supplementary product consumption, the stripping quantity in 10min is low compared with other prescriptions.
Find based on this, we adjust dry granulation processing parameter, again adopt prescription 5 to be prepared the adjustment of method.
Embodiment 7
The adjustment of dry granulation processing parameter
(1), by supplementary material all 100 mesh sieves are crossed, for subsequent use.Require crude drug particle size distribution D90 < 150 μm; Adjuvant particle size distribution D90 < 120 μm;
(2) get tauroursodeoxycholic acid, microcrystalline Cellulose and lactose, after corn starch puts multinomial movement mixer, mix 10 minutes; Collect the material (a) of about 15%, for subsequent use; In addition, get recipe quantity 85% magnesium stearate and add in mixer, mix 5 ~ 10 minutes, collection material (b), for subsequent use;
(3) confirm that equipment is normal by dry granulating machine S.O.P., open facility for granulating, conditioning equipment, oil pressure is risen to 1.5MPa, add the material (b) of mix homogeneously, according to compacting medicine bulk strength and machine operation, regulate extrusion wheel velocity (3.6 ~ 5.3rpm), feeding spiro rod rotating speed (12 ~ 24rpm), oil cylinder working-pressure (oil cylinder working-pressure with 1.0MPa ~ 2.0MPa for degree), its three is effectively coordinated, to compacting medicine block hardness moderate (can make the moderate granule of hardness for degree), rewinding;
(4), material is carried out granulate with being provided with 24 order steel-wire screen rocking type granule-finishing machines; Granulate is complete, removes thick head with 24 mesh sieves, removes fine powder with 100 mesh sieves; Collect thick head and fine powder, again go up machine [repeating (3) step production technology] and granulate, and carry out granulate with 24 order steel-wire screen rocking type granule-finishing machines, and granule is sieved.The fine powder amount crossing 100 mesh sieves reaches whole particulate matter doses about 40% (35 ~ 45%); get the uniform material (a) of mixing of materials and cross after the granule of 100 mesh sieves mixes about 5 minutes; again go up machine [repeating (3) step production technology] to granulate; and carry out granulate with 24 order steel-wire screen rocking type granule-finishing machines, and granule is sieved.The fine powder amount crossing 100 mesh sieves reaches whole particulate matter doses about 15%, stops granulating, and collects whole granule;
(5), satisfactory granule is put in mixer, add the magnesium stearate of people's recipe quantity residue 15%, mix 5 minutes, rewinding; (6) by the capsule of granule filling dimension and be pressed into tablet.
| Product | 10min | 20min | 30min | 45min | 60min |
| Flood rood | 31.4％ | 51.1％ | 79.2％ | 89.9％ | 99.1％ |
| Self-control capsule | 35.4％ | 56.8％ | 83.4％ | 92.1％ | 98.9％ |
| Self-control tablet | 27.9％ | 47.9％ | 78.9％ | 86.9％ | 98.5％ |
Claims (10)
1. a preparation method for tauroursodeoxycholic acid preparation, comprises the steps:
1) by tauroursodeoxycholic acid stock and adjunct sieving for standby, raw material granularity distribution D90 < 150 μm is required; Adjuvant particle size distribution D90 < 120 μm;
2) get the mixing of tauroursodeoxycholic acid, diluent and disintegrating agent, collect the material of production lot 10%-15% as (a), for subsequent use; Separately get batch volume of production 85%-90% lubricant and add mixing, collection material is as (b), for subsequent use;
3) material (b) is got by dry granulation;
4) by step 3 gained material granulate, sieve, after sieving, material mixes with material (a), and after mixing, material is again according to step 3 dry granulation, then granulate, screening;
5) step 4 gained material is added rest lubricant, rewinding after mixing;
6) by step 5 gained material preparation.
2. preparation method, wherein step 1 preferred mistake 100 mesh sieve as claimed in claim 1; Described adjuvant is diluent, disintegrating agent and lubricant; Described diluent is selected from one or more in lactose monohydrate, mannitol or microcrystalline Cellulose; Described disintegrating agent is selected from one or more in corn starch, potato starch, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, crospolyvinylpyrrolidone, cross-linking sodium carboxymethyl cellulose or microcrystalline Cellulose (PH101); One or more in described magnesium stearate lubricant, micropowder silica gel, Pulvis Talci or magnesium laurylsulfate.
3. preparation method as claimed in claim 1 or 2, hybrid wherein described in step 2 carries out in multinomial movement mixer, and preferred incorporation time is 5 ~ 10 minutes.
4. the preparation method as described in any one of claim 1-3, wherein the condition of step 3 dry granulation preferably adopts dry granulation, conditioning equipment oil pressure rises to 1.5MPa, add the material (b) of mix homogeneously, according to compacting medicine bulk strength and machine operation, regulate extrusion wheel velocity 3.6-5.3rpm, feeding spiro rod rotating speed 4-12rpm, oil cylinder working-pressure 1.0MPa ~ 2.0MPa, rewinding after compacting medicine block hardness 2 ~ 5kg.
5. the preparation method as described in any one of claim 1-4, wherein step 4 is that step 3 gained material is carried out granulate; Granulate is complete, removes thick head with 24 mesh sieves, removes fine powder with 100 mesh sieves; Collect thick head and fine powder; re-start step 3 to granulate, and carry out granulate, and granule is sieved; the fine powder amount crossing 100 mesh sieves reaches whole particulate matter doses 35 ~ 45%; preferably 40%, get after the uniform material (a) of mixing of materials mixes about 5 minutes with the granule crossing 100 mesh sieves, re-start step 3 and granulate; and carry out granulate; sieve granule, the fine powder amount crossing 100 mesh sieves reaches whole particulate matter doses 15% and stops granulating, and collects whole granule.
6. the preparation method as described in any one of claim 1-5, wherein step 5 is put in mixer by satisfactory granule, adds residue magnesium stearate, mixes 5 minutes, rewinding.
7. the preparation method as described in any one of claim 1-6, the preparation fill wherein described in step 6 becomes capsule or is pressed into tablet.
8. the preparation method as described in any one of claim 1-7, in wherein said preparation, tauroursodeoxycholic acid and adjuvant preferably have following proportioning:
9. preparation method as claimed in claim 8, tauroursodeoxycholic acid (dihydrate) preferably 150 ~ 250 weight portions in wherein said preparation; Described microcrystalline Cellulose (PH101) preferably 36 ~ 48 weight portions; More select 40 ~ 48 weight portions; Described lactose monohydrate is 8.2 ~ 19 weight portions preferably, more select 15 ~ 19 weight portions; Described corn starch is 6 ~ 13 weight portions preferably; More preferably 8 ~ 13 weight portions; Described magnesium stearate is 5 ~ 12.8 weight portions preferably; More preferably 8 ~ 12.8 weight portions.
10. preparation method as claimed in claim 8 or 9, in described wherein said preparation, tauroursodeoxycholic acid and adjuvant preferably have following proportioning: tauroursodeoxycholic acid (dihydrate) 250 weight portion, microcrystalline Cellulose (PH101) 48 weight portion, lactose monohydrate 15 weight portion, corn starch 5 weight portion, magnesium stearate 2 weight portion;
Or tauroursodeoxycholic acid (dihydrate) 250 weight portion, microcrystalline Cellulose (PH101) 40 weight portion, lactose monohydrate 19 weight portion, corn starch 6 weight portion, magnesium stearate 5 weight portion;
Or tauroursodeoxycholic acid (dihydrate) 250 weight portion, microcrystalline Cellulose (PH101) 24 weight portion, lactose monohydrate 30 weight portion, corn starch 8 weight portion, magnesium stearate 8 weight portion;
Or tauroursodeoxycholic acid (dihydrate) 250 weight portion, microcrystalline Cellulose (PH101) 36 weight portion, lactose monohydrate 8.2 weight portion, corn starch 13 weight portion, magnesium stearate 12.8 weight portion;
Or sulphur ursodesoxycholic acid (dihydrate) 250 weight portion, microcrystalline Cellulose (PH101) 36 weight portion, lactose monohydrate 6 weight portion, corn starch 13 weight portion, magnesium stearate 15 weight portion.
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| CN107095858A (en) * | 2017-06-27 | 2017-08-29 | 石家庄学院 | A kind of urso 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 |
| 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 |
| 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 |
| CN115671073A (en) * | 2021-07-22 | 2023-02-03 | 华益泰康药业股份有限公司 | 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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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107095858A (en) * | 2017-06-27 | 2017-08-29 | 石家庄学院 | A kind of urso 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 |
| CN115671073A (en) * | 2021-07-22 | 2023-02-03 | 华益泰康药业股份有限公司 | 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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| CN104367561B (en) | 2017-10-13 |
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