CN107823167A - A kind of silybin meglumine tablets and preparation method thereof - Google Patents
A kind of silybin meglumine tablets and preparation method thereof Download PDFInfo
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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
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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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
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/357—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having two or more oxygen atoms in the same ring, e.g. crown ethers, guanadrel
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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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
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Abstract
It is main composed of the following components the present invention relates to a kind of silybin meglumine tablets：Silibinin meglumine, pregelatinized starch, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, magnesium stearate, pharmaceutical films coating premix, purified water, ethanol.The present invention is according to the physicochemical property of silibinin meglumine itself, using " vacant granulation method ", avoids because product content material relatively low, relevant with dissolution rate is unqualified caused by silibinin meglumine draws moist (meeting water easily to decompose) the problems such as.Therefore, the silibinin meglumine for preparing of the present invention, relevant material and content before the deadline, without significantly changing, so as to improve the stability of product and quality controllability.
Description
Technical field
The invention belongs to Chinese medicine preparation field, and in particular to a kind of silybin meglumine tablets and preparation method thereof.
Background technology
The main component of silybin meglumine tablets is silibinin meglumine, and English is entitled：Silybin Meglumine
Tablets, chemical name are：2- [2,3-Dihydro-2- (4-hydroxy-3-methoxyphenyI) -3-
(hydroxymethyI)-Isosorbide-5-Nitrae-benzodixin-6-yI] -2,3-dihydro-3,5,7-trihydroxy-4H-1-
Benzopyran-4-one meglumine salt, chemical structural formula are：
It is mainly used in acute hepatitis, chronic hepatitis, first cirrhosis, the auxiliary treatment of toxic hepatic damage.
At present, the main component for producing silybin meglumine tablets is silibinin meglumine, and auxiliary material generally has lactose, carboxylic
First sodium starch, silica, ethanol etc., and be fabricated by processes such as granulation, tabletting, coating, packagings.Existing product by
Draw in main ingredient moist relatively strong, had a great influence by auxiliary material, its content and dissolution rate decline it is very fast, so can significantly shorten product
The term of validity.
The content of the invention
The technical problems to be solved by the invention are to overcome the shortcomings of to mention in background above technology and defect, there is provided one
Kind silybin meglumine tablets and preparation method thereof.The present invention is according to the physicochemical property of silibinin meglumine itself, comprehensive fortune
With " vacant granulation method ", product content and dissolution caused by silibinin meglumine draws moist (meeting water easily to decompose) are avoided
Spend the problems such as relatively low, relevant material is unqualified.
In order to solve the above technical problems, technical scheme proposed by the present invention is：
A kind of silybin meglumine tablets, mainly include each component of following mass fraction：
Above-mentioned silybin meglumine tablets, it is preferred that mainly include each component of following mass fraction：
Using silibinin meglumine as main ingredient, pregelatinized starch, microcrystalline cellulose are silybin meglumine tablets of the present invention
Filler, low-substituted hydroxypropyl cellulose are disintegrant, and magnesium stearate is lubricant, and ethanol is adhesive, then is aided with pharmaceutical films
It is coated premix and purified water collective effect and obtains.
The inventive concept total as one, this programme also provide a kind of preparation method of silybin meglumine tablets, including
Following steps：
(1) pregelatinized starch, microcrystalline cellulose, low-substituted hydroxypropyl cellulose for weighing the mass fraction put mixing granulation
Machine high speed stirs, and uniformly mixing, adds the purified water of the mass fraction, blank granules are made, and dries, obtains particle 1；
(2) silibinin meglumine of particle 1 and the mass fraction is put into the stirring of mixer-granulator high speed, mixing is equal
It is even, the alcohol granulation of the mass fraction is added, dries, obtains particle 2；
(3) magnesium stearate and particle 2 for taking the mass fraction mix, and according to pre- stator weight, carry out tabletting, obtain plain piece；
(4) plain piece is subjected to film coating using pharmaceutical films coating premix, silybin meglumine tablets is made.
Above-mentioned method, it is preferred that in the step (1), the pregelatinized starch, microcrystalline cellulose, low-substituted hydroxypropyl
80 mesh sieves are crossed before cellulose mixing.Sieving is the sieving because material may be lumpd during transport process and storage or aggregation
Material mixing can be made more uniform.Cross 60 mesh sieves can not effective mistake go out larger particles, influence mixing below.Cross 80 mesh sieves symbol
Close production requirement of the present invention.
Above-mentioned method, it is preferred that in the step (1), the time of the mixer-granulator high speed stirring is 5-15
Minute.Mixing time is too short to be well mixed, and stirring 5-15min just can be mixed sufficiently, it is not necessary to stir the longer time.
Above-mentioned method, it is preferred that in the step (1), the drying is fluidized drying, and it is 50- to control EAT
70 DEG C, fluidized drying 0.5-1.5 hours.EAT is too high, and drying time is long to make dry materials, and moisture is lower, influences
The mixing of silibinin meglumine；EAT is too low, and the time is too short, and moisture can be made high, influence silibinin meglumine content.
Above-mentioned method, it is preferred that the moisture in the particle 1 is 3.0%-5.0%.The too high influence of moisture
Silibinin meglumine content, the too low mixing for influenceing silibinin meglumine of moisture.
Above-mentioned method, it is preferred that in the step (2), the ethanol that the pelletization adds is volumetric concentration 75%
Ethanol.
Above-mentioned method, it is preferred that in the step (2), the drying is fluidized drying, and it is 40- to control EAT
50 DEG C, fluidized drying 10-20 minutes.It is preferred that 45 DEG C, temperature is too high, can cause the reduction of silibinin meglumine content, temperature mistake
It is low so that drying it is slack-off.
Above-mentioned method, it is preferred that the moisture in the particle 2 is 5%-7%.The too high influence fine grinding of moisture
The content of Ji guest's meglumine, moisture is too low to influence tabletting.
Compared with prior art, the advantage of the invention is that：
1st, the present invention, using " vacant granulation method ", is avoided because of water according to the physicochemical property of silibinin meglumine itself
Fly Ji guest's meglumine and draw that product content and dissolution rate caused by moist (meet water easily decompose) are relatively low, ask about material is unqualified etc.
Topic.Therefore, the silibinin meglumine for preparing of the present invention, relevant material and content before the deadline, without obvious change so that
Improve the stability and quality controllability of product；
2nd, the present invention improves the dissolution rate of silibinin meglumine using hydrophilic microcrystalline cellulose as main carriers；
3rd, the present invention uses mixer-granulator, main ingredient is uniformly mixed with auxiliary material, solves that medicament contg is uneven to ask
Topic；
4th, the present invention uses film-coated technique, reduces even influence of the isolation outside air, humiture to product, improves
Product stability；
5th, the auxiliary material that invention formulation uses is ordinary adjuvants, reduces cost of supplementary product.
Embodiment
For the ease of understanding the present invention, the present invention is done below in conjunction with preferred embodiment and more comprehensively, meticulously described,
But protection scope of the present invention is not limited to specific examples below.
Unless otherwise defined, all technical terms used hereinafter are generally understood that implication phase with those skilled in the art
Together.Technical term used herein is intended merely to describe the purpose of specific embodiment, is not intended to the limitation present invention's
Protection domain.
Unless otherwise specified, various raw material, reagent, the instrument and equipment etc. used in the present invention can pass through city
Field is commercially available or can be prepared by existing method.
Embodiment 1
First, composition
2nd, preparation method
Weigh the mass fraction pregelatinized starch, microcrystalline cellulose, low-substituted hydroxypropyl cellulose cross 80 mesh sieves after, mix
Close granulator high speed to stir 10 minutes, be slowly added to the purified water of the mass fraction, blank granules are made, by blank granules
It is sent into fluid bed granulator and dries, control EAT as 60 DEG C, fluidized drying 1 hour obtains particle 1, and the moisture in particle 1 contains
Measure as 4.1%；Particle 1 is put with the silibinin meglumine of the mass fraction and mixes 15 minutes in mixer-granulator, slowly
75% ethanol of the mass fraction is added, is pelletized, is sent into fluid bed granulator and dries, it is 45 DEG C to control EAT, boiling
Dry 15 minutes, obtain particle 2, the moisture in particle 2 is 6.6%；Take magnesium stearate and the particle 2 of the mass fraction mixed
It is even, according to pre- stator weight, tabletting is carried out, coating, silybin meglumine tablets S1 is made.
Embodiment 2
First, composition
2nd, preparation method
Weigh the mass fraction pregelatinized starch, microcrystalline cellulose, low-substituted hydroxypropyl cellulose cross 80 mesh sieves after, mix
Close granulator high speed to stir 15 minutes, be slowly added to the purified water of the mass fraction, blank granules are made, by blank granules
It is sent into fluid bed granulator and dries, control EAT as 60 DEG C, fluidized drying 1 hour obtains particle 1, and the moisture in particle 1 contains
Measure as 3.8%；Particle 1 is put with the silibinin meglumine of the mass fraction 10min is mixed in mixer-granulator, slowly added
Enter 75% ethanol of the mass fraction, pelletize, be sent into fluid bed granulator and dry, it is 45 DEG C to control EAT, and boiling is dry
Dry 15 minutes, obtain particle 2, the moisture in particle 2 is 5.9%；Take magnesium stearate and the particle 2 of the mass fraction mixed
It is even, according to pre- stator weight, tabletting is carried out, coating, silybin meglumine tablets S2 is made.
Embodiment 3
First, composition
2nd, preparation method
Weigh the mass fraction pregelatinized starch, microcrystalline cellulose, low-substituted hydroxypropyl cellulose cross 80 mesh sieves after, mix
Close granulator high speed to stir 15 minutes, be slowly added to the purified water of the mass fraction, blank granules are made, by blank granules
It is sent into fluid bed granulator and dries, control EAT as 60 DEG C, fluidized drying 1 hour obtains particle 1, and the moisture in particle 1 contains
Measure as 4.5%；Particle 1 is put with the silibinin meglumine of the mass fraction 20min is mixed in mixer-granulator, slowly added
Enter 75% ethanol of the mass fraction, pelletize, be sent into fluid bed granulator and dry, it is 45 DEG C to control EAT, and boiling is dry
Dry 15 minutes, obtain particle 2, the moisture in particle 2 is 6.3%；The magnesium stearate and particle 2 for taking the mass fraction mix, root
According to pre- stator weight, tabletting is carried out, coating, silybin meglumine tablets S3 is made.
Comparative example 1 (wet granulation)
First, composition
2nd, preparation method
Weigh silibinin meglumine, pregelatinized starch, microcrystalline cellulose, the low-substituted hydroxypropyl fiber of the mass fraction
After element crosses 80 mesh sieves, mixer-granulator high speed stirs 15 minutes, adds 75% ethanol of the mass fraction, particle is made,
Particle is sent into fluid bed granulator and dried, it is 45 DEG C to control EAT, fluidized drying 30 minutes, and granule moisture level is
5.9%；The magnesium stearate and particle for taking the mass fraction mix, and according to pre- stator weight, carry out tabletting, coating, fine grinding are made
Ji guest's meglumine tablets DS1.
Comparative example 2 (auxiliary material screening)
First, composition
2nd, preparation method
Weigh the mass fraction pregelatinized starch, lactose, low-substituted hydroxypropyl cellulose cross 80 mesh sieves after, mixing granulation
Machine high speed is stirred 10 minutes, is slowly added to the purified water of the mass fraction, blank granules are made, and blank granules are sent into and boiled
Rise in granulator and dry, control EAT as 60 DEG C, fluidized drying 1 hour obtains particle 1, and the moisture in particle 1 is
4.1%；Particle 1 is put with the silibinin meglumine of the mass fraction and mixed in mixer-granulator 15 minutes, is slowly added to
75% ethanol of the mass fraction, granulation, it is sent into fluid bed granulator and dries, it is 45 DEG C to control EAT, fluidized drying
15 minutes, obtain particle 2, the moisture in particle 2 is 6.8%；The magnesium stearate and particle 2 for taking the mass fraction mix,
According to pre- stator weight, tabletting is carried out, coating, silybin meglumine tablets DS2 is made.
Comparative example 3 (auxiliary material screening)
First, composition
2nd, preparation method
Weigh the mass fraction pregelatinized starch, dextrin, low-substituted hydroxypropyl cellulose cross 80 mesh sieves after, mixing granulation
Machine high speed is stirred 10 minutes, is slowly added to the purified water of the mass fraction, blank granules are made, and blank granules are sent into and boiled
Rise in granulator and dry, control EAT as 60 DEG C, fluidized drying 1 hour obtains particle 1, and the moisture in particle 1 is
4.4%；Particle 1 is put with the silibinin meglumine of the mass fraction and mixed in mixer-granulator 15 minutes, is slowly added to
75% ethanol of the mass fraction, granulation, it is sent into fluid bed granulator and dries, it is 45 DEG C to control EAT, fluidized drying
15 minutes, obtain particle 2, the moisture in particle 2 is 5.8%；The magnesium stearate and particle 2 for taking the mass fraction mix,
According to pre- stator weight, tabletting is carried out, coating, silybin meglumine tablets DS3 is made.
Comparative example 4 (selection of coating method)
First, composition
2nd, preparation method
Weigh the mass fraction pregelatinized starch, microcrystalline cellulose, low-substituted hydroxypropyl cellulose cross 80 mesh sieves after, mix
Close granulator high speed to stir 10 minutes, be slowly added to the purified water of the mass fraction, blank granules are made, by blank granules
It is sent into fluid bed granulator and dries, control EAT as 60 DEG C, fluidized drying 1 hour obtains particle 1, and the moisture in particle 1 contains
Measure as 4.0%；Particle 1 is put with the silibinin meglumine of the mass fraction and mixes 15 minutes in mixer-granulator, slowly
75% ethanol of the mass fraction is added, is pelletized, is sent into fluid bed granulator and dries, it is 45 DEG C to control EAT, boiling
Dry 15 minutes, obtain particle 2, the moisture in particle 2 is 6.2%；Take magnesium stearate and the particle 2 of the mass fraction mixed
It is even, according to pre- stator weight, tabletting is carried out, sugar coating, silybin meglumine tablets DS4 is made.
Comparative example 5 (plain piece)
First, composition
2nd, preparation method
Weigh the mass fraction pregelatinized starch, microcrystalline cellulose, low-substituted hydroxypropyl cellulose cross 80 mesh sieves after, mix
Close granulator high speed to stir 10 minutes, be slowly added to the purified water of the mass fraction, blank granules are made, by blank granules
It is sent into fluid bed granulator and dries, control EAT as 60 DEG C, fluidized drying 1 hour obtains particle 1, and the moisture in particle 1 contains
Measure as 4.3%；Particle 1 is put with the silibinin meglumine of the mass fraction and mixes 15 minutes in mixer-granulator, slowly
75% ethanol of the mass fraction is added, is pelletized, is sent into fluid bed granulator and dries, it is 45 DEG C to control EAT, boiling
Dry 15 minutes, obtain particle 2, the moisture in particle 2 is 6.1%；Take magnesium stearate and the particle 2 of the mass fraction mixed
It is even, according to pre- stator weight, tabletting is carried out, silybin meglumine tablets DS5 is made.
Experiment one：
Embodiment 1-3, comparative example 2, the dissolution rate and uniformity of dosage units of the products obtained therefrom of comparative example 3 are investigated in this experiment respectively.
Assay method determines according to method described in Chinese Pharmacopoeia 2015 editions, and result of the test is as shown in table 1.
The embodiment 1-3 of table 1, comparative example 2, the dissolution rate of the products obtained therefrom of comparative example 3 and content range pattern result
| Tested number | Dissolution rate % | Content % | Uniformity of dosage units (A+2.2S) |
| S1 | 91.2 | 99.5 | 4.1 |
| S2 | 91.6 | 99.9 | 3.9 |
| S3 | 93.1 | 100.0 | 4.5 |
| DS2 | 80.1 | 99.2 | 13.2 |
| DS3 | 75.4 | 98.9 | 15.4 |
The result of table 1 is shown, using microcrystalline cellulose as filler, dissolution rate and the content that can effectively lift main ingredient are uniform
Degree.Silybin meglumine tablets product prepared by the present invention conforms to quality requirements.
Experiment two：Draws moist test
According to the method for 2015 editions medicine draws moist test guidelines of Chinese Pharmacopoeia to embodiment 1, comparative example 1, contrast
Silybin meglumine tablets prepared by example 4, comparative example 5 carry out draws moist test, as a result as shown in table 2.
The embodiment 1 of table 2, comparative example 1, comparative example 4, the draws moist test result of the products obtained therefrom of comparative example 5
| S1 | DS1 | DS4 | DS5 | |
| Percentage weight increase % | 0.01 | 5.4 | 5.4 | 7.8 |
The result of upper table 2 shows, silybin meglumine tablets of the invention hardly draw wet, and comparative example 1, comparative example 4 are made
The plain piece of standby silybin meglumine tablets and comparative example 5 be respectively provided with it is stronger draw it is moist.
Experiment three：Stability test
The present invention is to silybin meglumine tablets and the element of comparative example 5 made from embodiment 1-3, comparative example 1, comparative example 4
Piece DS5 sample In Aluminium Foil Packings, 40 ± 2 DEG C are put into, runs and accelerates 6 months in the insulating box that relative humidity is 75% ± 5%, take
Sample determines；It is as shown in table 3 to investigate indices, the measurement result such as content, relevant material, dissolution rate.
The embodiment 1-3 of table 3, comparative example 1, comparative example 4 and plain piece DS5 sample acceleration for stabilization experiment investigations
The above results show, place 6 months under acceleration conditions, no matter outside silybin meglumine tablets of the invention
See, in terms of content or relevant material, it is unchanged, there is good storage stability, and comparative example 1, comparative example 4, plain piece
Sample is that appearance color is changed first, and reason causes for the moisture absorption, while HPLC detection purity finds containing for relevant material
Amount is also improved.
Experiment four：
Application of this experiment investigation this product in treatment hepatic sclerosis disease.
The foundation of Hepatocirrhosis Model：
Body weight 20-25g mouse 50, is divided into two groups, A groups 25, B groups 25.A groups use subcutaneous administrations, B groups
For control group.A groups are only given 20% carbon tetrachloride vegetable seed oil solution 2 weeks by 0.2mL/, weekly administration 2 times, 4 times altogether, simultaneously
Using 10% ethanol solution as drinking water.Is changed to using 20% ethanol solution as drinking water for 3-4 weeks, and the one 5-6 weeks molten with 30% ethanol
Liquid is drinking water, coinduction 6 weeks.Carbon tetrachloride rapeseed oil plays induction and produces fibrosis effect, and ethanol solution causes liver fiber
Change and hepatic sclerosis.
Experimental group and control group mice give plain particles forage feed, normal water；When experimental mice is administered, control
Group gives the physiological saline of equivalent.
Experimental animal randomly selected an animal at the 4th, 6 week and puts to death dissection respectively, and every animal of when dissected is weighed, liver
Dirty quality, calculate organ coefficient.Organ coefficient increases, and represents congested internal organs, oedema or hypertrophy etc.；Organ coefficient reduces,
Represent internal organs atrophy and other degenerative changes.
At the 6th week, two groups are randomly selected an animal blood letting, MAIN OUTCOME MEASURES：
(1) blood index：Glutamic-pyruvic transaminase (ALT), glutamic-oxalacetic transaminease (AST), total bilirubin (TBIL), albumin (Alb)；
(2) fibrosis indices in hepatic：Transparent resin acid (HA), laminin (LN), three layers of collagen peptide (PC III).
Result of the test is as follows：
The experimental animal of table 4 is respectively in the organ coefficient of the 4th, 6 week
| Group | The 3-4 weeks | The 5-6 weeks |
| A groups | 8.39 | 6.64 |
| B groups | 5.00 | 5.12 |
Blood index during table 5 the 6th week
| Project | ALT(IU/L) | AST(IU/L) | TBIL(μmol/L) | Alb(g/L) |
| A groups | 93.64±2.24 | 309.36±9.69 | 10.18±0.82 | 31.99±0.91 |
| B groups | 80.73±1.06 | 204.94±5.39 | 10.73±0.72 | 32.13±1.23 |
Hepatic fibrosis index during table 6 the 6th week
| Project | HA(ng/mL) | LN(ng/mL) | PCⅢ(μg/L) |
| A groups | 282.95±32.16 | 111.82±8.97 | 31.45±0.98 |
| B groups | 133.12±8.32 | 63.05±4.88 | 3.21±0.46 |
Silybin meglumine tablets zoopery：
Since the 7th week, by the administration of above-mentioned A groups mouse stomach (silybin meglumine tablets after the crushing of embodiment one), B
Blank (be free of silibinin meglumine) of the group gavage to equivalent, three times a day.Two groups of mouse give same plain particles
Forage feed, normal water.It is administered 6 weeks altogether, observes result.
Experimental animal randomly selected animal at the 10th, 12 week and puts to death dissection respectively, every animal of when dissected weighs,
Liver mass, calculate organ coefficient.At the 12nd week, two groups are randomly selected an animal blood letting, MAIN OUTCOME MEASURES：(1)
Blood index：Glutamic-pyruvic transaminase (ALT), glutamic-oxalacetic transaminease (AST), total bilirubin (TBIL), albumin (Alb)；(2) fibrosis refers to
Mark：Transparent resin acid (HA), laminin (LN), three layers of collagen peptide (PC III).
Result of the test is as follows：
The experimental animal of table 7 is respectively in the 10th, 12 week organ coefficient
| Group | 10th week | 12nd week |
| A groups | 6.02 | 5.31 |
| B groups | 5.06 | 5.01 |
Blood index during table 8 the 12nd week
| Project | ALT(IU/L) | AST(IU/L) | TBIL(μmol/L) | Alb(g/L) |
| A groups | 83.24±1.24 | 250.31±8.34 | 10.26±0.21 | 32.65±1.591 |
| B groups | 81.73±1.28 | 210.36±2.39 | 10.21±0.32 | 31.06±1.69 |
Hepatic fibrosis index during table 9 the 12nd week
| Project | HA(ng/mL) | LN(ng/mL) | PCⅢ(μg/L) |
| A groups | 163.96±10.58 | 85.34±6.95 | 9.58±0.75 |
| B groups | 135.62±1.32 | 64.47±4.89 | 2.81±0.76 |
Zoopery shows：For the silybin meglumine tablets of the present invention to hepatic sclerosis, liver fibrosis has obvious cure to imitate
Fruit.
Claims (10)
1. a kind of silybin meglumine tablets, it is characterised in that mainly include each component of following mass fraction：
2. silybin meglumine tablets according to claim 1, it is characterised in that mainly comprising each of following mass fraction
Component：
3. a kind of preparation method of silybin meglumine tablets as claimed in claim 1, it is characterised in that including following step
Suddenly：
(1) pregelatinized starch, microcrystalline cellulose, low-substituted hydroxypropyl cellulose for weighing the mass fraction are put in mixer-granulator
High-speed stirred, uniformly mixing, adds the purified water of the mass fraction, blank granules is made, and dries, obtains particle 1；
(2) silibinin meglumine of particle 1 and the mass fraction is put into the stirring of mixer-granulator high speed, is well mixed,
The alcohol granulation of the mass fraction is added, dries, obtains particle 2；
(3) magnesium stearate and particle 2 for taking the mass fraction mix, and according to pre- stator weight, carry out tabletting, obtain plain piece；
(4) plain piece is subjected to film coating using pharmaceutical films coating premix, silybin meglumine tablets is made.
4. preparation method according to claim 3, it is characterised in that：It is the pregelatinized starch, micro- in the step (1)
80 mesh sieves are crossed before crystalline cellulose, low-substituted hydroxypropyl cellulose mixing.
5. preparation method according to claim 3, it is characterised in that：It is high in the mixer-granulator in the step (1)
The time of speed stirring is 5-15 minutes.
6. preparation method according to claim 3, it is characterised in that：In the step (1), the drying is dry for boiling
Dry, it is 50-70 DEG C to control EAT, fluidized drying 0.5-1.5 hours.
7. preparation method according to claim 6, it is characterised in that：Moisture in the particle 1 is 3.0%-
5.0%.
8. preparation method according to claim 3, it is characterised in that：In the step (2), what the pelletization added
Ethanol is the ethanol of volumetric concentration 75%.
9. preparation method according to claim 3, it is characterised in that：In the step (2), the drying is dry for boiling
Dry, it is 40-50 DEG C to control EAT, fluidized drying 10-20 minutes.
10. preparation method according to claim 9, it is characterised in that：Moisture in the particle 2 is 5%-7%.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1413583A (en) * | 2001-10-08 | 2003-04-30 | 南京科源医药技术有限公司 | Low dose diclofenac sodium lozenge and its preparation method |
| CN1623539A (en) * | 2003-12-03 | 2005-06-08 | 孟繁浩 | Milk thistle silybum marianum long effect preparation and its preparation method |
| CN101810594A (en) * | 2010-03-16 | 2010-08-25 | 江苏中兴药业有限公司 | Production method of silybin meglumine tablets |
| CN102949372A (en) * | 2011-08-26 | 2013-03-06 | 山东方明药业集团股份有限公司 | Nicergoline pill and preparation method thereof |
| CN105310989A (en) * | 2014-07-03 | 2016-02-10 | 重庆安格龙翔医药科技有限公司 | Prasugrel oxalate tablet and preparation method of same |
| CN106214646A (en) * | 2016-07-22 | 2016-12-14 | 湖南千金协力药业有限公司 | A kind of silybin meglumine preparation |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1413583A (en) * | 2001-10-08 | 2003-04-30 | 南京科源医药技术有限公司 | Low dose diclofenac sodium lozenge and its preparation method |
| CN1623539A (en) * | 2003-12-03 | 2005-06-08 | 孟繁浩 | Milk thistle silybum marianum long effect preparation and its preparation method |
| CN101810594A (en) * | 2010-03-16 | 2010-08-25 | 江苏中兴药业有限公司 | Production method of silybin meglumine tablets |
| CN102949372A (en) * | 2011-08-26 | 2013-03-06 | 山东方明药业集团股份有限公司 | Nicergoline pill and preparation method thereof |
| CN105310989A (en) * | 2014-07-03 | 2016-02-10 | 重庆安格龙翔医药科技有限公司 | Prasugrel oxalate tablet and preparation method of same |
| CN106214646A (en) * | 2016-07-22 | 2016-12-14 | 湖南千金协力药业有限公司 | A kind of silybin meglumine preparation |
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