CN107303284A - Prepare the method and Tadalafei tablet of Tadalafei tablet - Google Patents
Prepare the method and Tadalafei tablet of Tadalafei tablet Download PDFInfo
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- CN107303284A CN107303284A CN201610261606.XA CN201610261606A CN107303284A CN 107303284 A CN107303284 A CN 107303284A CN 201610261606 A CN201610261606 A CN 201610261606A CN 107303284 A CN107303284 A CN 107303284A
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- tadalafei
- tablet
- mixture
- micro mist
- method described
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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
- A61K31/395—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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- 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
-
- 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
Abstract
Offer of the present invention prepares the method and Tadalafei tablet of Tadalafei tablet, wherein, this method includes：(1) Tadalafei and surfactant are mixed, and resulting mixture is subjected to micronization processes, obtain micro mist mixture；(2) by the micro mist mixture and filler, disintegrant, adhesive, glidant and mix lubricant, and resulting mixture is subjected to tabletting, obtains the Tadalafei tablet.The stripping property of the Tadalafei tablet prepared be improved significantly, and by adjusting the particle diameter for the micro mist mixture that micronization processes are obtained, the stripping property of Tadalafei tablet can be controlled, and preparation process is simple, process is time-consuming shorter.
Description
Technical field
The present invention relates to pharmaceutical technology field, in particular it relates to prepare the method and Tadalafei tablet of Tadalafei tablet.
Background technology
It is well known that Tadalafei can be used as treating erectile dysfunction, listing preparation is tablet, is a kind of general thin bag
Garment piece.However, Tadalafei is insoluble drug, bioavilability is than relatively low, therefore the ineffective dose taken is than larger,
A variety of bad put can be produced to answer, Irrational Use of Drugs can cause vision impairment or forfeiture.Carried for the pharmaceutical preparation of Tadalafei
The bioavilability of high medicine, reduces the research of the generation of adverse reaction, is clinically widely used in controlling for Tadalafei
Treat male sexual disfunction particularly important.
Thus, the research of current Tadalafei related preparations still has much room for improvement.
The content of the invention
It is contemplated that at least solving one of technical problem in correlation technique to a certain extent.Therefore, one of the present invention
Purpose is to propose that a kind of dissolution rate is high, bioavilability is good, step is simple or processing procedure takes short Tadalafei tablet
Preparation method.
The present invention is the following discovery based on inventor and completed：
In correlation technique, Tadalafei tablet is prepared using wet granulation technology, supplementary material processing, mixing, system is generally included
The processes such as grain, drying, whole grain, total mixed, tabletting, coating, are about 9 hours during chief engineer, take longer, economic benefit
It is not good.Therefore, while inventor attempts to look for a kind of guarantee Tadalafei tablet quality and performance, step is simple, time-consuming
The shorter method for preparing Tadalafei tablet.By experimental verification, inventor has found that powder vertical compression method can be used for preparing
Tadalafei tablet, but the Tadalafei tablet stripping property that conventional powder vertical compression method is prepared is poor, does not reach requirement.
On this basis, inventor is further furtherd investigate, and is explored by many experiments and repeatedly, inventor it was unexpectedly observed that
Tadalafei and surfactant are mixed and micronization processes are carried out in advance, is then mixed again with other auxiliary materials, powder is carried out
Direct tablet compressing, the stripping property of obtained Tadalafei tablet is greatly improved, and meets related request, and compared to existing wet granulation
Technique, enormously simplify preparation process, shorten processing time.
In view of this, in one aspect of the invention, the invention provides a kind of method for preparing Tadalafei tablet.According to
Embodiments of the invention, this method includes：(1) Tadalafei and surfactant are mixed, and by resulting mixture
Micronization processes are carried out, micro mist mixture is obtained；(2) by the micro mist mixture and filler, disintegrant, adhesive,
Glidant and mix lubricant, and resulting mixture is subjected to tabletting, obtain the Tadalafei tablet.Invention human hair
It is existing, the Tadalafei tablet that stripping property is good, bioavilability is high can fast and effeciently be prepared by this method, especially
It is pointed out that inventor in experimentation it was unexpectedly observed that by the way that Tadalafei and surfactant are mixed in advance
And micronization processes are carried out, then mixed again with other raw materials, carry out direct powder compression, the tadalafil tablet prepared
The stripping property of agent be improved significantly, and by adjusting the particle diameter for the micro mist mixture that micronization processes are obtained, he can be reached
The stripping property of non-tablet is drawn to be controlled.In addition, relative to wet granulation technology, method and step of the invention is simple, operation
Easily, and take shorter, better economy.
Embodiments in accordance with the present invention, according to weight ratio are 4 by the Tadalafei and surfactant in step (1)：
1 ratio mixing.
Embodiments in accordance with the present invention, the particle diameter of the micro mist mixture is 1~3 micron.
Embodiments in accordance with the present invention, the feed pressure of the micronization processes is 0.2-0.3MPa, crushes pressure and is
0.3-0.4MPa, blanking frequency is 75Hz.
Embodiments in accordance with the present invention, the surfactant is lauryl sodium sulfate.
Embodiments in accordance with the present invention, the filler be selected from lactose, starch, microcrystalline cellulose, mannitol at least one
Kind.
Embodiments in accordance with the present invention, the disintegrant is fine selected from PVPP, sodium carboxymethyl starch, cross-linked carboxymethyl
The plain sodium of dimension, at least one of hydroxypropylcellulose.
Embodiments in accordance with the present invention, described adhesive be selected from PVP K30, hydroxypropylcellulose, methylcellulose extremely
Few one kind.
Embodiments in accordance with the present invention, the glidant is silica.
Embodiments in accordance with the present invention, the lubricant is in magnesium stearate, calcium stearate, stearic acid, superfine silica gel powder
At least one.
Embodiments in accordance with the present invention, in step (2), the method progressively increased using equivalent by the micro mist mixture with it is described
Filler, disintegrant, adhesive, glidant and mix lubricant.
In another aspect of this invention, the invention provides a kind of Tadalafei tablet.Embodiments in accordance with the present invention, this he
Da Lafei tablets are prepared by foregoing method.The Tadalafei tablet has all special of foregoing method
Seek peace advantage, do not repeating one by one herein.
Brief description of the drawings
Fig. 1 shows the schematic flow sheet of the method according to an embodiment of the invention for preparing Tadalafei tablet.
Embodiment
Embodiments of the invention are described below in detail.The embodiments described below is exemplary, is only used for explaining the present invention,
And be not considered as limiting the invention.Unreceipted particular technique or condition in embodiment, according to document in the art
Described technology or condition are carried out according to product description.Agents useful for same or the unreceipted production firm person of instrument, be
Can be by the conventional products of acquisition purchased in market.
In one aspect of the invention, the invention provides a kind of method for preparing Tadalafei tablet.According to the reality of the present invention
Apply example, reference picture 1, this method comprises the following steps：
S100：Tadalafei and surfactant are mixed, and resulting mixture is subjected to micronization processes, obtains micro-
Powder mixture.
Embodiments in accordance with the present invention,, can before progress micronization processes after Tadalafei and surfactant are mixed
To carry out sieving processing to the mixture of Tadalafei and surfactant in advance.The mesh number of sieving can be entered according to actual needs
Row selection, in some embodiments of the invention, can cross 60 mesh sieves to the mixture of Tadalafei and surfactant in advance.
Thus, the progress of subsequent step is conducive to.
Embodiments in accordance with the present invention, according to weight ratio are 4 by Tadalafei and surfactant in step (1)：1
Ratio mixing.Thereby, it is possible to significantly improve the dissolving out capability of Tadalafei tablet, and then improve the biology profit of Tadalafei
Expenditure.If the ratio of Tadalafei and surfactant is too high or too low, result of extraction is undesirable.
Embodiments in accordance with the present invention, in step (1), the particle diameter of obtained micro mist mixture can be 1~3 micron.Hair
A person of good sense has found that Tadalafei tablet made from the micro mist mixture of particle diameter within the range has preferable after many experiments
Dissolving out capability, can play a role better than the micro mist mixture of other particle diameters.
Embodiments in accordance with the present invention, in step (1), the actual conditions of micronization processes is not particularly limited, this area
Technical staff can be selected as needed.In some embodiments of the invention, the charging of micronization processes can be selected
Pressure is 0.2-0.3MPa, and crushing pressure is 0.3-0.4MPa, and blanking frequency is 75Hz.Thus, the micro mist mixture of acquisition
With most suitable particle diameter, the stripping property of the Tadalafei tablet prepared preferably, is conducive to improving the biology of Tadalafei
Availability.
Embodiments in accordance with the present invention, the specific species of surfactant is not particularly limited, and is reached as long as can effectively disperse him
Draw non-, in the specific example of the present invention, surfactant can be lauryl sodium sulfate.Thereby, it is possible to enter one
Step improves the result of extraction and bioavilability of Tadalafei tablet.
S200：By micro mist mixture and filler, disintegrant, adhesive, glidant and mix lubricant, and will be resulting
Mixture carry out tabletting, obtain the Tadalafei tablet.
Embodiments in accordance with the present invention, the specific species of filler is not particularly limited, and those skilled in the art can be according to reality
Border needs flexible selection.In some embodiments of the invention, filler can be selected from lactose, starch, microcrystalline cellulose,
At least one of mannitol.Thus, it is possible to tablet weight and divided dose are effectively increased, and beneficial to shaping.
Embodiments in accordance with the present invention, the specific species of disintegrant is not particularly limited, and those skilled in the art can be according to need
Flexibly to select.In some embodiments of the invention, disintegrant can be selected from PVPP, sodium carboxymethyl starch,
At least one of Ac-Di-Sol, hydroxypropylcellulose.Thus, be conducive to improving the dissolution effect of Tadalafei tablet
Fruit and bioavilability.
Embodiments in accordance with the present invention, the specific species of adhesive is not particularly limited, and those skilled in the art can be according to need
Flexibly to select.In some embodiments of the invention, adhesive is fine selected from PVP K30, hydroxypropylcellulose, methyl
Tie up at least one of element.Thus, it is molded beneficial to Tadalafei tablet.
Embodiments in accordance with the present invention, the specific species of glidant is not particularly limited, and those skilled in the art can be according to need
Flexibly to select.In some embodiments of the invention, glidant can be silica.Thus, it is possible to so that supplementary material
Mixture has good mobility, it is easy to process, and powder can be prevented to be layered.
Embodiments in accordance with the present invention, the specific species of lubricant is not particularly limited, and those skilled in the art can be according to need
Flexibly to select.In some embodiments of the invention, lubricant can be selected from magnesium stearate, calcium stearate, stearic acid,
At least one of superfine silica gel powder.As long as thus, it is possible to so that during supplementary material there is suitable mobility, not with processing
Equipment is adhered, and may be such that obtained Tadalafei tablet has smooth, good outward appearance.
Embodiments in accordance with the present invention, in step (2), the method progressively increased using equivalent by micro mist mixture and filler,
Disintegrant, adhesive, glidant and mix lubricant.Specifically, first other auxiliary materials with micro mist mixture equivalent are mixed
Close, obtain mixture, then other auxiliary materials of the mixture equivalent obtained with upper step mix again, the like extremely it is all auxiliary
Material mixing is finished.Inventor is had found, micro mist mixture is mixed with other auxiliary materials by this method, is conducive to mixing material
Uniformly, the stripping property and bioavilability of obtained Tadalafei tablet are improved.
Inventor is had found, the Ta Dala that stripping property is good, bioavilability is high can be fast and effeciently prepared by this method
Non- tablet, it is accordingly required in particular to, it is noted that inventor in experimentation it was unexpectedly observed that by advance by Tadalafei and table
Face activating agent mixes and carries out micronization processes, is then mixed again with other raw materials, carries out direct powder compression, prepares
Tadalafei tablet stripping property be improved significantly, and by adjusting the particle diameter for the micro mist mixture that micronization processes are obtained,
The stripping property of Tadalafei tablet can be controlled.In addition, relative to wet granulation technology, method and step of the invention
Simply, it is easy to operate, and takes shorter, better economy.
This method of the present invention enormously simplify preparation section, shorten preparation time compared with to wet granulation technology,
Economy is preferable.The process of two kinds of technique and man-hour contrast are by table 1 below.
The process of 1 two kinds of distinct methods of table and man-hour compare
As can be seen from Table 1, powder vertical compression technique of the present invention is compared with wet granulation technology, reduce granulation, drying,
Whole grain, the always process such as mixed, greatly reduce man-hour, have saved artificial, have directly reduced energy consumption.
In another aspect of this invention, the invention provides a kind of Tadalafei tablet.Embodiments in accordance with the present invention, this he
Da Lafei tablets are prepared by foregoing method.The Tadalafei tablet has all special of foregoing method
Seek peace advantage, this is no longer going to repeat them.
Embodiments of the invention are described below in detail.
Embodiment 1：
Prescription
| Material | Weight (mg) |
| Tadalafei | 20 |
| Lauryl sodium sulfate | 5 |
| Lactose | 235 |
| Microcrystalline cellulose | 59 |
| Hydroxypropylcellulose | 6.5 |
| Ac-Di-Sol | 24 |
| Silica | 3 |
| Magnesium stearate | 3 |
Preparation technology：
Experimental group 1：After Tadalafei is mixed with lauryl sodium sulfate, 60 mesh sieves are crossed, then by the mixture after sieving
Micronization processes are carried out, particle diameter are obtained micro- by what is obtained for 1~3 micron of micro mist mixture, then the method progressively increased by equivalent
Powder mixture is well mixed with other auxiliary materials, tabletting, is coated, is produced Tadalafei tablet.Wherein, micronization processes are carried out
Feed pressure 0.2-0.3Mpa, crush pressure 0.3-0.4Mpa, blanking frequency 75Hz.
Experimental group 2：Preparation technology is not carry out micronization processes with experimental group 1, difference.
Experimental group 3：Preparation technology is Tadalafei individually carrying out micronization processes, then again will with experimental group 1, difference
Tadalafei after micronizing is mixed with other auxiliary materials.
Control group：Former triturate, is prepared using wet granulation technology, is comprised the following steps that：Will be made particle medicine and
Excipient sieves, then, by Tadalafei and lactose, hydroxypropylcellulose and Ac-Di-Sol dry mixed.With
High shear granulator suitable one Powrex or other, with the aqueous solution of lauryl sodium sulfate by the mixture of powders of acquisition
Granulation, adds extra water to reach the terminal of needs, grinds the agglomerate of wet granular with a grinding machine and it is easily dried.
Wet particle is dried with a liquefaction bed dryer or a drying box, once material is dried, can be sieved any big to eliminate
Agglomerate.Microcrystalline cellulose, Ac-Di-Sol and magnesium stearate is sieved safely and be added to the appropriate of the drying
In the particle of size.These excipient are mixed with a bulging roll-over, ribbon mixer or other suitable mixing apparatus and described
Dry particle is until uniform.The mixed process can be divided into two sections.In the first stage by microcrystalline cellulose, cross-linked carboxymethyl
Sodium cellulosate and the dry particle are added in blender and mixed, and then magnesium stearate is added in the particle, into second
Individual mix stages.Then, well mixed material is subjected to tabletting, enrobing processes successively, obtains Tadalafei tablet.
30 minutes dissolution rates of Tadalafei tablet made from above-mentioned each experimental group and control group, knot are determined using HPLC methods
Fruit is shown in Table 2.
Table 2：Tablet its dissolution rate difference prepared by raw material that different disposal technique is obtained
It can be seen that by the result of table 2, the tablet that the technique of powder vertical compression of the invention is obtained is suitable with former triturate result of extraction,
And from the above-mentioned result of table 1, powder vertical compression method preparation process of the invention is greatly simplified, and process takes and greatly shortened.
Embodiment 2：
Embodiment is subjected to influence factor experiment in 30 days in tadalafil tablet prepared by middle experimental group 1, is specially：By Ta Dala
Non-slice is placed 30 days under the conditions of high temperature (60 DEG C), high humidity (92.5%), illumination (4500lx) respectively, then observes him
Up to the outward appearance for drawing non-slice, and the relevant material and content for passing through high performance liquid chromatography (HPLC) method measure tadalafil tablet.Survey
Surely 3, table 4, table 5 be the results are shown in Table.
Table 3：Tadalafil tablet place 30 days under the conditions of the high temperature (60 DEG C) after measurement result
The tadalafil tablet of table 4 place 30 days under the conditions of the high humidity (RH 92.5%) after measurement result
The tadalafil tablet of table 5 place 30 days under the conditions of the illumination (4500lx) after measurement result
Shown by the result of table 3, table 4, table 5, during 0 to 30 day investigates, Tadalafei tablet of the invention compares
Stable, the total impurities of medicine does not show obvious variation tendency, and the content of medicine does not show obvious variation tendency, table
It is tadalafil tablet steady quality that bright the method for the invention is prepared, controllable.
Embodiment 3：
Preparation technology according to the prescription in embodiment 1 and experimental group 1 prepares Tadalafei tablet, wherein, micro mist mixture
Particle diameter be respectively 1,2,3,5,10,15,25 microns, then determine different Ta Dala according to the middle method of embodiment 1
30 minutes dissolution rates of non-tablet, as a result see the table below 6.
Table 6
| D50(μm) | 30 minutes dissolution rates (%) |
| 25 | 30 |
| 15 | 50 |
| 10 | 65 |
| 5 | 75 |
| 3 | 85 |
| 2 | 91 |
| 1 | 95 |
As shown in Table 6, the particle diameter of control micro mist mixture is at 1-3 microns, the tablet tool of obtained Tadalafei
There is preferable result of extraction, the micro mist mixture in the particle size range can be played better than the micro mist mixture of other particle diameters to be made
With.
In the description of this specification, reference term " one embodiment ", " some embodiments ", " example ", " specific example ",
Or the description of " some examples " etc. means to combine specific features, structure, material or the feature bag that the embodiment or example are described
It is contained at least one embodiment of the present invention or example.In this manual, to the schematic representation of above-mentioned term necessarily
It is directed to identical embodiment or example.Moreover, specific features, structure, material or the feature of description can be any
Combined in an appropriate manner in individual or multiple embodiments or example.In addition, in the case of not conflicting, the skill of this area
Not be the same as Example or the feature of example and non-be the same as Example or example described in this specification can be combined by art personnel
And combination.
Although embodiments of the invention have been shown and described above, it is to be understood that above-described embodiment be it is exemplary,
It is not considered as limiting the invention, one of ordinary skill in the art within the scope of the invention can be to above-described embodiment
It is changed, changes, replacing and modification.
Claims (7)
1. a kind of method for preparing Tadalafei tablet, it is characterised in that including：
(1) Tadalafei and surfactant are mixed, and resulting mixture is subjected to micronization processes, obtain micro mist
Mixture；
(2) by the micro mist mixture and filler, disintegrant, adhesive, glidant and mix lubricant, and by gained
The mixture arrived carries out tabletting, obtains the Tadalafei tablet.
2. according to the method described in claim 1, it is characterised in that in step (1), by the Tadalafei and table
Face activating agent is 4 according to weight ratio：1 ratio mixing.
3. according to the method described in claim 1, it is characterised in that the particle diameter of the micro mist mixture is 1~3 micron.
4. according to the method described in claim 1, it is characterised in that the feed pressure of the micronization processes is 0.2-0.3MPa,
Crushing pressure is 0.3-0.4MPa, and blanking frequency is 75Hz.
5. according to the method described in claim 1, it is characterised in that the surfactant is lauryl sodium sulfate；
The filler be selected from lactose, starch, microcrystalline cellulose, mannitol at least one；
The disintegrant is selected from PVPP, sodium carboxymethyl starch, Ac-Di-Sol, hydroxypropylcellulose
It is at least one；
Described adhesive be selected from PVP K30, hydroxypropylcellulose, methylcellulose at least one；
The glidant is silica；
The lubricant is selected from least one of magnesium stearate, calcium stearate, stearic acid, superfine silica gel powder.
6. according to the method described in claim 1, it is characterised in that in step (2), the method progressively increased using equivalent
By the micro mist mixture and the filler, disintegrant, adhesive, glidant and mix lubricant.
7. a kind of Tadalafei tablet, it is characterised in that prepared by the method any one of claim 1-6.
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| CN201610261606.XA CN107303284A (en) | 2016-04-25 | 2016-04-25 | Prepare the method and Tadalafei tablet of Tadalafei tablet |
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| CN201610261606.XA CN107303284A (en) | 2016-04-25 | 2016-04-25 | Prepare the method and Tadalafei tablet of Tadalafei tablet |
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| CN110638768A (en) * | 2019-10-25 | 2020-01-03 | 株洲千金药业股份有限公司 | Preparation method of medicine for treating male erectile dysfunction |
| CN110638770A (en) * | 2019-10-25 | 2020-01-03 | 株洲千金药业股份有限公司 | Tadalafil tablet preparation method and tablet prepared by same |
| CN110664766A (en) * | 2019-10-10 | 2020-01-10 | 甘肃普安制药股份有限公司 | Tadalafil tablet and preparation method thereof |
| CN110812336A (en) * | 2018-08-07 | 2020-02-21 | 迪沙药业集团（天津）药物研究有限公司 | Tadalafil tablet composition |
| CN111329842A (en) * | 2020-03-30 | 2020-06-26 | 苏州弘森药业股份有限公司 | Tadalafil tablet and direct powder pressing production process thereof |
| CN113855639A (en) * | 2021-11-04 | 2021-12-31 | 昆明源瑞制药有限公司 | Tadalafil tablet and preparation method thereof |
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| CN110638768B (en) * | 2019-10-25 | 2024-04-16 | 株洲千金药业股份有限公司 | Preparation method of medicine for treating male erectile dysfunction |
| CN111329842A (en) * | 2020-03-30 | 2020-06-26 | 苏州弘森药业股份有限公司 | Tadalafil tablet and direct powder pressing production process thereof |
| CN115154429A (en) * | 2021-04-06 | 2022-10-11 | 南京科默生物医药有限公司 | Tadalafil oral disintegrating composition |
| CN113855639A (en) * | 2021-11-04 | 2021-12-31 | 昆明源瑞制药有限公司 | Tadalafil tablet and preparation method thereof |
| WO2023232215A1 (en) * | 2022-06-02 | 2023-12-07 | Rontis Hellas S.A. | Improved pharmaceutical composition containing tadalafil and process for the preparation thereof |
| CN117505021A (en) * | 2023-11-28 | 2024-02-06 | 诺泽流体科技(上海)有限公司 | Air flow crushing method applied to tadalafil bulk drug |
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