CN109157520A - Tadalafei tablet and preparation method thereof - Google Patents
Tadalafei tablet and preparation method thereof Download PDFInfo
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- CN109157520A CN109157520A CN201811040281.8A CN201811040281A CN109157520A CN 109157520 A CN109157520 A CN 109157520A CN 201811040281 A CN201811040281 A CN 201811040281A CN 109157520 A CN109157520 A CN 109157520A
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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
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/4985—Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
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- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
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- 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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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/10—Drugs for genital or sexual disorders; Contraceptives for impotence
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Abstract
The invention discloses a kind of Tadalafei tablet, the raw material including following parts by weight: 10-20 parts of Tadalafei, 40-60 parts of oligosaccharide, 5-10 parts of sodium alginate, 10-20 parts of superfine silica gel powder, 120-160 parts of microcrystalline cellulose, 20-40 parts of mannitol, 2-4 parts of magnesium stearate.Compared with prior art, the dissolution in vitro of tadalafil tablet prepared by the present invention is high, oral absorptivity is good, bioavilability is high, accordingly reduces the content of Tadalafei in tadalafil tablet, reduces the adverse reaction of drug to a certain extent.And the preparation process of tadalafil tablet of the present invention is simple, is suitble to industrialized production.
Description
Technical field
The present invention relates to pharmaceutical technology field, in particular to a kind of Tadalafei tablet and preparation method thereof.
Background technique
Tadalafei (tadalafil, molecular formula C22H19N3O4), chemical name are 6- (dioxy penta between 1,3- benzo
Ring -5- base) -2,3,6,7,12,12a- hexahydro pyrazines simultaneously [1 ', 2 ' -1,6]-pyrido [3,4-b] indoles-Isosorbide-5-Nitrae-diketone, belong to
In the selective reversible inhibitor of second generation phosphodiesterase 5 (PDE5).Ratify through FDA within 2003, Tadalafei is as treatment
The drug of Erectile Dysfunction (ED) lists in the U.S., trade name Xi Aili.With similar marketed drug silaenafil
It is compared with Vardenafil, has many advantages, such as that selectivity height, long half time, patient have bigger independence, be now used as erection function
The choice drug of energy obstacle.
But Tadalafei is insoluble drug, bioavilability is lower, therefore the ineffective dose taken is bigger, meeting
A variety of adverse reactions are generated, Irrational Use of Drugs can cause vision impairment or forfeiture.
It is main at present to be solved using reduction Tadalafei partial size for the problem of Tadalafei dissolubility difference, such as
Solid dispersion, raw material micronization etc., but there is the inferior technological deficiency of complex process, low efficiency.Therefore, it needs to research and develop a kind of work
The Tadalafei preparation process that skill is simple, dissolution is stable.
Summary of the invention
In view of the above-mentioned deficiencies in the prior art, the technical problem to be solved by the present invention is that providing a kind of Tadalafei
Tablet and preparation method thereof.
In order to solve the above technical problems, the technical solution adopted by the present invention is that: a kind of Tadalafei tablet, including it is following heavy
Measure the raw material of part: 10-20 parts of Tadalafei, 40-60 parts of oligosaccharide, 5-10 parts of sodium alginate, 10-20 parts of superfine silica gel powder, crystallite
120-160 parts of cellulose, 20-40 parts of mannitol, 2-4 parts of magnesium stearate.
Preferably, which includes the raw material of following parts by weight: 20 parts of Tadalafei, 60 parts of oligosaccharide,
7 parts of sodium alginate, 20 parts of superfine silica gel powder, 140 parts of microcrystalline cellulose, 30 parts of mannitol, 3 parts of magnesium stearate.
Preferably, the oligosaccharide be one of oligofructose, galactooligosaccharide, oligomeric synanthrin or xylo-oligosaccharide or
Person is several.
The present invention also provides a kind of preparation methods of Tadalafei tablet, comprising the following steps:
1) oligosaccharide and sodium alginate are dissolved in the water, Tadalafei, ultrasonic dissolution is added；Superfine silica gel powder is added,
After mixing evenly, dry, sieving obtains Tadalafei solid dispersions；
2) Tadalafei solid dispersions, microcrystalline cellulose, mannitol and the magnesium stearate mixing obtained step 1) is equal
Even, tabletting is to get Tadalafei tablet.
Preferably, in the step 1), the condition of ultrasonic dissolution are as follows: ultrasonic power 80-120W, ultrasonic time 10-
20min。
Preferably, in the step 1), dry temperature is 60-80 DEG C.
Preferably, in the step 1), 80-100 mesh is crossed after dry.
Preferably, in the step 2), tabletting under conditions of 20~30 DEG C of environment temperature, humidity 30~40%, pressure
Piece pressure is 35~40kN, and tablet press machine revolving speed is 10000~15000 tablets hs
The solubility of Tadalafei in water is very low, belongs to extremely difficult dissolution drug, and drug indissoluble just will affect drug in body
Interior release.For the drug of slightly solubility in water, it is difficult directly to produce suitable preparation.
To solve this problem, the present invention has carried out design preferably to the raw material prescription for preparing tadalafil tablet, and combines
The optimization of preparation process effectively increases the dissolution in vitro, oral absorptivity and bioavilability of tadalafil tablet.
In the raw material prescription of tadalafil tablet of the invention, oligosaccharide is to be formed by 2-10 monosaccharide with glucosides key connection,
The Tadalafei of slightly solubility is scattered in oligosaccharide polyhydroxy skeleton, reduces hydrophobicity, is conducive to dissolution, promotes dissolution, oligosaccharide
It is used cooperatively with sodium alginate, cross-linked structure can be formed using sodium alginate, to further improve Tadalafei
Dissolubility in water；Superfine silica gel powder is adsorbed as hydrophilic adsorbent；The mobility and compression forming of microcrystalline cellulose
Property is preferable；Mannitol not only acts as filling effect, and also acts as active influence to the stability of tablet.
In preparation process, Tadalafei is first dissolved in the aqueous solution of oligosaccharide and sodium alginate by the present invention, then is used
Hydrophilic adsorbent superfine silica gel powder is adsorbed, and is increased the specific surface area and hydrophily of slightly solubility Tadalafei, is increased medicine
The solubility of object accelerates the dissolution rate of drug, makes dissolution rate of the tadalafil tablet of preparation in dissolution medium significantly
It improves.On the preparation condition of tablet, environmental condition may cause direct influence to tabletting, when air humidity is excessively high, inhale
It is extremely obvious that the phenomenon that sticking occurs in the moist stronger drug granule of drug, and the present invention works as ring by a large amount of test discovery
Under conditions of 20~30 DEG C of border temperature, humidity 30~40% when tabletting, the good moldability of tablet is unilateral bright and clean, sticking does not occur
Phenomenon.When tableting pressure is excessive, the hardness of tablet is excessive, causes the prolonged disintegration of tablet, when pressure is too small, tablet hardness mistake
Small, tablet is not easily molded, and in 35~40kN, tablet press machine revolving speed is controlled 10000~15000 for tableting pressure control of the invention
The hardness of tablets h, the tablet of preparation is moderate, and mouldability is preferable.
By above-mentioned specific preparation prescription, in conjunction with the preferred of preparation process, tadalafil tablet prepared by the present invention is whole
On effect to show as dissolution rate fast, the quality of the pharmaceutical preparations is stablized, and places do not occur obvious moisture absorption phenomenon in air for a long time.
The beneficial effects of the present invention are: the dissolution in vitro of tadalafil tablet prepared by the present invention is high, oral absorptivity is good,
Bioavilability is high, accordingly reduces the content of Tadalafei in tadalafil tablet, reduces drug to a certain extent not
Good reaction.And the preparation process of tadalafil tablet of the present invention is simple, is suitble to industrialized production.
Specific embodiment
The present invention will be further described in detail below with reference to the embodiments, to enable those skilled in the art referring to specification
Text can be implemented accordingly.
It should be appreciated that such as " having ", "comprising" and " comprising " term used herein are not precluded one or more
The presence or addition of a other elements or combinations thereof.
A kind of Tadalafei tablet of the present embodiment, the raw material including following parts by weight: 10-20 parts of Tadalafei, oligomeric
It is 40-60 parts sugared, 5-10 parts of sodium alginate, 10-20 parts of superfine silica gel powder, 120-160 parts of microcrystalline cellulose, 20-40 parts of mannitol, hard
2-4 parts of fatty acid magnesium.
Wherein, the oligosaccharide is one of oligofructose, galactooligosaccharide, oligomeric synanthrin or xylo-oligosaccharide or several
Kind.
The present invention also provides a kind of preparation methods of Tadalafei tablet, comprising the following steps:
1) oligosaccharide and sodium alginate are dissolved in the water, Tadalafei, ultrasonic dissolution is added；Superfine silica gel powder is added,
After mixing evenly, dry, sieving obtains Tadalafei solid dispersions；
2) Tadalafei solid dispersions, microcrystalline cellulose, mannitol and the magnesium stearate mixing obtained step 1) is equal
Even, tabletting is to get Tadalafei tablet.
Specific embodiment presented below, with the present invention will be further described.
Test material used in the embodiment of the present invention and comparative example is the test material of this field routine, can be passed through
Commercial channel is commercially available.
Embodiment 1:
1. raw material prescription:
It is 20 grams of Tadalafei, 60 grams of oligofructose, 7 grams of sodium alginate, 20 grams of superfine silica gel powder, 140 grams of microcrystalline cellulose, sweet
Reveal 30 grams of alcohol, 3 grams of magnesium stearate.
2. preparation process:
(1) oligofructose of recipe quantity and sodium alginate are dissolved in the water, the Tadalafei of recipe quantity is added, ultrasound is molten
Solution, the condition of ultrasonic dissolution are as follows: ultrasonic power 100W, ultrasonic time 15min；Superfine silica gel powder is added, after mixing evenly, 70 DEG C
It is dry, it sieves with 100 mesh sieve, obtains Tadalafei solid dispersions.
(2) Tadalafei solid dispersions, microcrystalline cellulose, mannitol and magnesium stearate are uniformly mixed, in environment temperature
Tabletting under conditions of 20~30 DEG C of degree, humidity 30~40%, tableting pressure control exist in 35~40kN, the control of tablet press machine revolving speed
10000 tablets hs are to get Tadalafei tablet.
Embodiment 2:
1. raw material prescription:
10 grams of Tadalafei, 60 grams of galactooligosaccharide, 5 grams of sodium alginate, 20 grams of superfine silica gel powder, 120 grams of microcrystalline cellulose,
40 grams of mannitol, 2 grams of magnesium stearate.
2. preparation process:
(1) galactooligosaccharide of recipe quantity and sodium alginate are dissolved in the water, the Tadalafei of recipe quantity is added, ultrasound
Dissolution, the condition of ultrasonic dissolution are as follows: ultrasonic power 100W, ultrasonic time 15min；Add superfine silica gel powder, after mixing evenly, 70
DEG C drying, sieves with 100 mesh sieve, obtains Tadalafei solid dispersions.
(2) Tadalafei solid dispersions, microcrystalline cellulose, mannitol and magnesium stearate are uniformly mixed, in environment temperature
Tabletting under conditions of 20~30 DEG C of degree, humidity 30~40%, tableting pressure control exist in 35~40kN, the control of tablet press machine revolving speed
10000 tablets hs are to get Tadalafei tablet.
Embodiment 3:
1. raw material prescription:
20 grams of Tadalafei, 40 grams of oligomeric synanthrin, 10 grams of sodium alginate, 10 grams of superfine silica gel powder, 160 grams of microcrystalline cellulose,
20 grams of mannitol, 2 grams of magnesium stearate.
2. preparation process:
(1) the oligomeric synanthrin and sodium alginate of recipe quantity are dissolved in the water, the Tadalafei of recipe quantity is added, ultrasound is molten
Solution, the condition of ultrasonic dissolution are as follows: ultrasonic power 100W, ultrasonic time 15min；Superfine silica gel powder is added, after mixing evenly, 70 DEG C
It is dry, it sieves with 100 mesh sieve, obtains Tadalafei solid dispersions.
(2) Tadalafei solid dispersions, microcrystalline cellulose, mannitol and magnesium stearate are uniformly mixed, in environment temperature
Tabletting under conditions of 20~30 DEG C of degree, humidity 30~40%, tableting pressure control exist in 35~40kN, the control of tablet press machine revolving speed
10000 tablets hs are to get Tadalafei tablet.
Comparative example 1:
1. raw material prescription:
It is 20 grams of Tadalafei, 67 grams of oligofructose, 20 grams of superfine silica gel powder, 140 grams of microcrystalline cellulose, 30 grams of mannitol, hard
3 grams of fatty acid magnesium.
2. preparation process:
(1) oligofructose of recipe quantity is dissolved in the water, the Tadalafei of recipe quantity is added, ultrasonic dissolution is ultrasonic molten
The condition of solution are as follows: ultrasonic power 100W, ultrasonic time 15min；Superfine silica gel powder is added, after mixing evenly, 70 DEG C of dryings, mistake
100 meshes obtain Tadalafei solid dispersions.
(2) Tadalafei solid dispersions, microcrystalline cellulose, mannitol and magnesium stearate are uniformly mixed, in environment temperature
Tabletting under conditions of 20~30 DEG C of degree, humidity 30~40%, tableting pressure control exist in 35~40kN, the control of tablet press machine revolving speed
10000 tablets hs are to get Tadalafei tablet.
Comparative example 2:
1. raw material prescription:
It is 20 grams of Tadalafei, 67 grams of sodium alginate, 20 grams of superfine silica gel powder, 140 grams of microcrystalline cellulose, 30 grams of mannitol, hard
3 grams of fatty acid magnesium.
2. preparation process:
(1) sodium alginate of recipe quantity is dissolved in the water, the Tadalafei of recipe quantity is added, ultrasonic dissolution is ultrasonic molten
The condition of solution are as follows: ultrasonic power 100W, ultrasonic time 15min；Superfine silica gel powder is added, after mixing evenly, 70 DEG C of dryings, mistake
100 meshes obtain Tadalafei solid dispersions.
(2) Tadalafei solid dispersions, microcrystalline cellulose, mannitol and magnesium stearate are uniformly mixed, in environment temperature
Tabletting under conditions of 20~30 DEG C of degree, humidity 30~40%, tableting pressure control exist in 35~40kN, the control of tablet press machine revolving speed
10000 tablets hs are to get Tadalafei tablet.
Test example 1: the dissolution rate of Tadalafei tablet and related substance-measuring
1. dissolution determination:
Tadalafei tablet prepared by embodiment 1 and comparative example 1- comparative example 2 carries out dissolution determination.
Measuring method: it shines dissolution method (two the second methods of annex X C of Chinese Pharmacopoeia version in 2010), with 0.5% ten
Sodium dialkyl sulfate solution 1000ml is dissolution medium, and revolving speed 50rpm is operated according to methods, taken respectively at 5,10,15,30min molten
Liquid 10ml (while adding equality of temperature solvent 10ml), filtration, subsequent filtrate is as test solution；Separately take Tadalafei reference substance appropriate
(about 10mg), it is accurately weighed, it sets in 100ml measuring bottle, adds flowing phased soln and be diluted to scale, shake up, precision measures 4ml and sets
In 20ml measuring bottle, mobile phase is added to be diluted to scale, shaken up, as reference substance solution.Precision measures reference substance solution and test sample
Each 20ul of solution, is injected separately into liquid chromatograph, calculates accumulation dissolution rate by external standard method.
Mobile phase: -0.1% trifluoroacetic acid solution of acetonitrile (45:55, V:V).
Detection wavelength: 285nm.
It the results are shown in Table 1.
Table 1: dissolution determination result
2. in relation to substance-measuring:
It is appropriate that Tadalafei tablet prepared by embodiment 1 and comparative example 1- comparative example 2 is weighed respectively, adds 0.5% dodecane
Base metabisulfite solution is dissolved and is diluted, and is taken subsequent filtrate as test solution, is carried out related substance-measuring.It the results are shown in Table 2.
Table 2: related substance-measuring result
As can be seen from Table 2, its increasing in relation to substance (single miscellaneous, total miscellaneous) of the tadalafil tablet of 2 preparation of comparative example 1 and comparison
It is long to be significantly greater than tadalafil tablet provided by the present invention.It is indicated above that tadalafil tablet provided by the present invention is with more excellent
Good stability.
Although the embodiments of the present invention have been disclosed as above, but its is not only in the description and the implementation listed
With it can be fully applied to various fields suitable for the present invention, for those skilled in the art, can be easily
Realize other modification, therefore without departing from the general concept defined in the claims and the equivalent scope, the present invention is simultaneously unlimited
In specific details.
Claims (8)
1. a kind of Tadalafei tablet, which is characterized in that the raw material including following parts by weight: 10-20 parts of Tadalafei, oligosaccharide
40-60 parts, 5-10 parts of sodium alginate, 10-20 parts of superfine silica gel powder, 120-160 parts of microcrystalline cellulose, 20-40 parts of mannitol, tristearin
Sour magnesium 2-4 parts.
2. Tadalafei tablet according to claim 1, which is characterized in that the raw material including following parts by weight: Ta Dala
Non- 20 parts, 60 parts of oligosaccharide, 7 parts of sodium alginate, 20 parts of superfine silica gel powder, 140 parts of microcrystalline cellulose, 30 parts of mannitol, stearic acid
3 parts of magnesium.
3. Tadalafei tablet according to claim 1 or 2, which is characterized in that the oligosaccharide is oligofructose, oligomeric
One of galactolipin, oligomeric synanthrin or xylo-oligosaccharide are several.
4. a kind of preparation method of Tadalafei tablet as described in any one of claims 1-3, which is characterized in that including following
Step:
1) oligosaccharide and sodium alginate are dissolved in the water, Tadalafei, ultrasonic dissolution is added；Superfine silica gel powder is added, is stirred
Dry after uniformly, sieving obtains Tadalafei solid dispersions；
2) Tadalafei solid dispersions, microcrystalline cellulose, mannitol and the magnesium stearate for obtaining step 1) are uniformly mixed, pressure
Piece is to get Tadalafei tablet.
5. the preparation method of Tadalafei tablet according to claim 4, which is characterized in that in the step 1), ultrasound
The condition of dissolution are as follows: ultrasonic power 80-120W, ultrasonic time 10-20min.
6. the preparation method of Tadalafei tablet according to claim 4, which is characterized in that dry in the step 1)
Temperature be 60-80 DEG C.
7. the preparation method of Tadalafei tablet according to claim 4, which is characterized in that dry in the step 1)
80-100 mesh is crossed afterwards.
8. the preparation method of Tadalafei tablet according to claim 4, which is characterized in that in the step 2), in ring
Tabletting under conditions of 20~30 DEG C of border temperature, humidity 30~40%, tableting pressure are 35~40kN, and tablet press machine revolving speed is 10000
~15000 tablets hs.
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| CN201811040281.8A CN109157520B (en) | 2018-09-07 | 2018-09-07 | Tadalafil tablet and preparation method thereof |
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Cited By (3)
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| CN111110633A (en) * | 2020-01-21 | 2020-05-08 | 合肥医工医药股份有限公司 | Tadalafil spray and preparation method thereof |
| CN112773898A (en) * | 2019-11-11 | 2021-05-11 | 广州华真医药科技有限公司 | Application of phosphodiesterase 5 inhibitor in preparing anti-fibrosis disease medicine |
| CN113181185A (en) * | 2021-05-07 | 2021-07-30 | 苏州康恒研新药物技术有限公司 | Preparation method of tadalafil and dapoxetine hydrochloride mixed tablet |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112773898A (en) * | 2019-11-11 | 2021-05-11 | 广州华真医药科技有限公司 | Application of phosphodiesterase 5 inhibitor in preparing anti-fibrosis disease medicine |
| CN111110633A (en) * | 2020-01-21 | 2020-05-08 | 合肥医工医药股份有限公司 | Tadalafil spray and preparation method thereof |
| CN111110633B (en) * | 2020-01-21 | 2022-12-02 | 合肥医工医药股份有限公司 | Tadalafil spray and preparation method thereof |
| CN113181185A (en) * | 2021-05-07 | 2021-07-30 | 苏州康恒研新药物技术有限公司 | Preparation method of tadalafil and dapoxetine hydrochloride mixed tablet |
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| Publication number | Publication date |
|---|---|
| CN109157520B (en) | 2021-04-02 |
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