CN110898019A - Doxofylline tablet and preparation method thereof - Google Patents
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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
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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- 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
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
- A61K31/52—Purines, e.g. adenine
- A61K31/522—Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
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Abstract
The invention discloses a preparation method of doxofylline tablets, which comprises the following steps: mixing silicon dioxide, mannitol, a disintegrating agent, carboxymethyl starch sodium and talcum powder to obtain a first mixture; mixing doxofylline and magnesium stearate to obtain a second mixture; mixing the first mixture with the second mixture to obtain a third mixture; and tabletting the third mixture. The doxofylline tablet has the advantages of simple preparation, low cost and the like, and the doxofylline tablet prepared by the method has the advantages of good stability and remarkable treatment effect.
Description
FIELD
The invention relates to the technical field of medicines and medicine production, in particular to a doxofylline tablet and a preparation method thereof.
Background
Bronchial asthma is a common disease and frequently encountered disease, risk factors of the attack of the bronchial asthma comprise two aspects of genetic factors and environmental factors, and the bronchial asthma can be divided into an acute attack stage, a chronic duration stage and a clinical remission stage according to clinical manifestations; the common symptoms of patients with bronchial asthma are paroxysmal wheeze, shortness of breath, chest distress or cough, and the like, and a few patients may also show chest pain as the main symptom, the symptoms are often paroxysm after the patients are exposed to irritant gases or allergens such as smog, perfume, paint, dust, pets, pollen and the like, and the symptoms are easy to occur or aggravate at night or in the early morning. If a patient with bronchial asthma has serious acute attack, the patient may be fatal if the patient is not cured in time. Repeated asthma attacks can lead to complications such as chronic obstructive pulmonary disease, emphysema, pulmonary heart disease, heart failure, respiratory failure and the like.
Doxofylline, chemical name: 1, 3-dimethyl-7- (1, 3-dioxolan-2-yl) methyl-3, 7-dihydro-1H-purin-2, 6-dione. Doxofylline is a derivative of methylxanthine, which is a bronchodilator that acts directly on the bronchi, relaxing the smooth muscle of the bronchi. The effect of inhibiting asthma is achieved by relaxing smooth muscle through the action of inhibiting phosphodiesterase and the like in smooth muscle cells. Is clinically used for treating dyspnea caused by bronchial asthma, asthmatic chronic bronchitis and other bronchospasm.
Due to the poor stability of doxofylline, the prior art is difficult to solve or needs to add a lot of auxiliary materials and strict processes, and the means are complex, so that the clinical use of doxofylline is limited.
SUMMARY
In one aspect, the present disclosure relates to a method of making doxofylline tablets, comprising: mixing silicon dioxide, mannitol, a disintegrating agent, carboxymethyl starch sodium and talcum powder to obtain a first mixture;
mixing doxofylline and magnesium stearate to obtain a second mixture; mixing the first mixture with the second mixture to obtain a third mixture; and
tabletting said third mixture.
In another aspect, the present disclosure relates to a doxofylline tablet prepared based on the above-described method of preparing a doxofylline tablet.
Detailed description of the invention
In the following description, certain specific details are included to provide a thorough understanding of various disclosed embodiments. One skilled in the relevant art will recognize, however, that the embodiments can be practiced without one or more of the specific details, or with other methods, components, materials, and so forth.
Unless otherwise required by the disclosure, throughout the specification and the appended claims, the words "comprise", "comprising", and "have" are to be construed in an open, inclusive sense, i.e., "including but not limited to".
Reference throughout the specification to "one embodiment," "an embodiment," "in another embodiment," or "in certain embodiments" means that a particular reference element, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, the appearances of the phrases "in one embodiment" or "in an embodiment" or "in another embodiment" or "in certain embodiments" in various places throughout this specification are not necessarily all referring to the same embodiment, and furthermore, particular elements, structures, or features may be combined in any suitable manner in one or more embodiments.
Definition of
In the present disclosure, the term "mannitol" is used as a filler, making the active ingredient of the tablet more homogeneous, and also as a carrier material for the active drug, and having a certain compressibility.
In the present disclosure, the term "sodium carboxymethyl starch" is used as a binder to enable non-sticky or less sticky materials to be agglomerated into granules or to be compressed into a sticky solid powder.
In the present disclosure, the term "talc" is used as a glidant, primarily to increase the flowability of the granules and improve the filling state of the granules.
In the present disclosure, the term "magnesium stearate" is used as a lubricant, primarily to reduce the friction between particles and the punch and die walls, improving force transmission and distribution.
In the present disclosure, the term "disintegrant" refers to a substance that rapidly breaks up a tablet into fine particles in gastrointestinal fluids, thereby allowing a functional ingredient to be rapidly dissolved and absorbed for its effect.
In the present disclosure, mesh refers to the unit of measure, and the unit of measure mesh size refers to the size of the raw material particles, generally expressed as the maximum length of the particles. The mesh is the size representing the mesh size of a standard screen. In the taylor standard sieve, the so-called mesh is the number of sieve openings in a 1 inch length and is simply called mesh.
Detailed Description
The present disclosure relates to a method for preparing doxofylline tablets, comprising:
mixing silicon dioxide, mannitol, a disintegrating agent, carboxymethyl starch sodium and talcum powder to obtain a first mixture;
mixing doxofylline and magnesium stearate to obtain a second mixture;
mixing the first mixture with the second mixture to obtain a third mixture; and
tabletting said third mixture.
In certain embodiments, wherein the first mixture is made from, by weight parts, 10 to 20 parts silicon dioxide, 20 to 40 parts mannitol, 10 to 20 parts disintegrant, 10 to 20 parts sodium starch glycolate, 10 to 20 parts talc.
In certain embodiments, wherein the second mixture is prepared from 40 to 50 parts doxofylline, 40 to 50 parts magnesium stearate, by weight parts.
In certain embodiments, the disintegrant is selected from microcrystalline cellulose, low substituted hydroxypropylcellulose, or a mixture thereof.
In certain embodiments, the disintegrant is selected from microcrystalline cellulose.
Among them, microcrystalline cellulose is mainly used to eliminate binding force due to a binder or high compression, so that the tablet is rapidly disintegrated in gastrointestinal fluids.
In certain embodiments, the silica is also subjected to comminution prior to charging.
In certain embodiments, the particle size of the silica after comminution is from 20 to 100 mesh.
In certain embodiments, the particle size of the silica after comminution is from 20 to 50 mesh.
In certain embodiments, the particle size of the silica after comminution is 40 mesh.
In certain embodiments, the mannitol is also subjected to comminution prior to feeding.
In certain embodiments, the mannitol has a particle size after comminution of 20 to 100 mesh.
In certain embodiments, the mannitol has a particle size after comminution of 20 to 50 mesh.
In certain embodiments, the mannitol has a particle size of 40 mesh after comminution.
In certain embodiments, the disintegrant is also comminuted prior to dosing.
In certain embodiments, the particle size of the disintegrant after comminution is from 20 to 100 mesh.
In certain embodiments, the particle size of the disintegrant after comminution is from 20 to 50 mesh.
In certain embodiments, the particle size of the disintegrant after comminution is 40 mesh.
In certain embodiments, the sodium starch glycolate is also ground prior to being dosed.
In certain embodiments, the sodium starch glycolate has a particle size after pulverization of 20 to 100 mesh.
In certain embodiments, the sodium starch glycolate has a particle size after pulverization of 20 to 50 mesh.
In certain embodiments, the size of the milled carboxymethyl starch sodium is 40 mesh.
In certain embodiments, the talc powder is also subjected to comminution prior to dosing.
In certain embodiments, the talc powder has a particle size of 20 to 100 mesh after pulverization.
In certain embodiments, the talc powder has a particle size of 20 to 50 mesh after pulverization.
In certain embodiments, the talc powder has a particle size of 40 mesh after pulverization.
In certain embodiments, the first mixture is prepared by mixing in a mixer.
In certain embodiments, the mixing time is from 10 to 30 min.
In certain embodiments, the mixing time is 20 min.
In certain embodiments, the mixer speed is from 1 to 20 rpm.
In certain embodiments, the mixer speed is 8 rpm.
In certain embodiments, doxofylline is also ground prior to dosing.
In certain embodiments, the size of the doxofylline after comminution is from 20 to 100 mesh.
In certain embodiments, the size of the doxofylline after comminution is from 20 to 50 mesh.
In certain embodiments, the size of the doxofylline after grinding is 40 mesh.
In certain embodiments, the magnesium stearate is also comminuted prior to dosing.
In certain embodiments, the magnesium stearate has a particle size after comminution of 20 to 100 mesh.
In certain embodiments, the magnesium stearate has a particle size after comminution of 20 to 50 mesh.
In certain embodiments, the particle size of the magnesium stearate after comminution is 40 mesh.
In certain embodiments, the second mixture is prepared by mixing with a mixer.
In certain embodiments, the mixing time is 10 to 20 min.
In certain embodiments, the mixing time is 15 min.
In certain embodiments, the mixer speed is from 1 to 20 rpm.
In certain embodiments, the mixer speed is 8 rpm.
In certain embodiments, the first mixture is mixed with the second mixture by a mixer to provide a third mixture.
In certain embodiments, the mixing time is from 1 to 10 min.
In certain embodiments, the mixing time is 5 min.
In certain embodiments, the mixer speed is from 1 to 20 rpm.
In certain embodiments, the mixer speed is 8 rpm.
In certain embodiments, the tableting pressure is 40 to 65 KN.
In certain embodiments, the tableting speed is 3 to 8 kt/h.
The tabletting pressure is related to the hardness of the tablet, and has a critical point, when the tabletting pressure is too high, the tablet can be cracked, and when the tabletting pressure is too low, the tablet can be not compacted, and can be fragile and not formed.
In certain embodiments, the rotation speed of the filler during tabletting is 30 to 60 rpm.
Wherein, the filler is a feeding device, keeps in this rotational speed range, can ensure that powder can better add in the preforming mould.
In another aspect, the present invention relates to a doxofylline tablet prepared based on the above-described method for preparing a doxofylline tablet. The doxofylline tablet is white or off-white, has glossy surface, uniform color, no foreign matter, no unfilled corner, no rough edge and no sticking.
In certain embodiments, the doxofylline tablet has a hardness of 60 to 90N.
In certain embodiments, the doxofylline tablets have a friability of no more than 0.8%.
In certain embodiments, the tablet thickness of the doxofylline tablet is from 3.3 to 3.9 mm.
Wherein, after the tablet weight is determined, the thickness of the tablet is mainly adjusted by pressure, and the adjusted pressure is to ensure that the finally formed tablet has a friability meeting the requirement when disintegrating.
In certain embodiments, the doxofylline tablet has a disintegration time of 10min or less.
In certain embodiments, an aluminum-plastic inner packaging process is also included.
In certain embodiments, the heat seal temperature is from 190 to 230 ℃.
In certain embodiments, the lower forming shoe temperature is from 100 to 150 ℃.
In certain embodiments, the lower forming shoe temperature is from 100 to 150 ℃.
In certain embodiments, the speed of the aluminum plastic inner package is from 120 to 300 plates/min.
In certain embodiments, the batch print temperature is from 70 to 90 ℃.
In certain embodiments, an overwrapping process is also included, wherein the boxing speed is 60 to 150 boards/min.
Example 1
The embodiment discloses a doxofylline tablet, which is prepared by mixing a first mixture and a second mixture, wherein the first mixture is prepared from the following components in parts by weight: 10 parts of silicon dioxide, 20 parts of excipient, 10 parts of disintegrant, 10 parts of carboxymethyl starch sodium and 10 parts of talcum powder; the first mixture is prepared from the following components in parts by weight: 40 parts of doxofylline and 40 parts of magnesium stearate.
The preparation method comprises the following steps:
(1) putting silicon dioxide, mannitol, disintegrating agent, carboxymethyl starch sodium and talcum powder into a universal pulverizer, pulverizing, sieving with a 40-mesh sieve, and removing impurities;
(2) mixing silicon dioxide, mannitol, a disintegrating agent, sodium carboxymethyl starch and talcum powder by a mixer to obtain a first mixture, wherein the mixing time is 20min, and the rotating speed of the mixer is 8 rpm;
(3) putting doxofylline and magnesium stearate into a universal pulverizer, pulverizing, sieving with a 40-mesh sieve, and removing impurities;
(4) mixing doxofylline and magnesium stearate by a mixer to obtain a second mixture, wherein the mixing time is 15min, and the rotating speed of the mixer is 8 rpm;
(5) mixing the first mixture and the second mixture to obtain a third mixture, wherein the mixing time is 5min, and the rotating speed of a mixer is 8 rpm;
(6) tabletting the third mixture, wherein the tabletting pressure is 40KN, and the tabletting speed is 3 kt/h;
(7) the prepared doxofylline tablets are inspected and packaged, wherein the doxofylline tablets comprise an aluminum-plastic inner package and an outer package, and the outer package comprises 12 tablets/plates, 1 plate/box, 10 boxes/heat shrinkage units and 20 heat shrinkage units/boxes: each box should contain 1 aluminum plastic plate and 1 product specification, and each box contains 1 product certificate or 12 sheets/plate, 2 plates/box, 10 boxes/heat-shrinkable unit, 20 heat-shrinkable unit/box: each box should contain 2 aluminum-plastic plates and 1 product instruction, and each carton contains 1 product certificate.
Example 2
The embodiment discloses a doxofylline tablet, which is prepared by mixing a first mixture and a second mixture, wherein the first mixture is prepared from the following components in parts by weight: 15 parts of silicon dioxide, 30 parts of excipient, 15 parts of disintegrant, 15 parts of carboxymethyl starch sodium and 15 parts of talcum powder; the first mixture is prepared from the following components in parts by weight: 45 parts of doxofylline and 45 parts of magnesium stearate.
The preparation method comprises the following steps:
(1) putting silicon dioxide, mannitol, disintegrating agent, carboxymethyl starch sodium and talcum powder into a universal pulverizer, pulverizing, sieving with a 40-mesh sieve, and removing impurities;
(2) mixing silicon dioxide, mannitol, a disintegrating agent, sodium carboxymethyl starch and talcum powder by a mixer to obtain a first mixture, wherein the mixing time is 20min, and the rotating speed of the mixer is 8 rpm;
(3) putting doxofylline and magnesium stearate into a universal pulverizer, pulverizing, sieving with a 40-mesh sieve, and removing impurities;
(4) mixing doxofylline and magnesium stearate by a mixer to obtain a second mixture, wherein the mixing time is 15min, and the rotating speed of the mixer is 8 rpm;
(5) mixing the first mixture and the second mixture to obtain a third mixture, wherein the mixing time is 5min, and the rotating speed of a mixer is 8 rpm;
(6) tabletting the third mixture, wherein the tabletting pressure is 50KN, and the tabletting speed is 6 kt/h;
(7) packaging the prepared doxofylline tablets, wherein the doxofylline tablets comprise an aluminum-plastic inner package and an outer package, and the outer package comprises 12 tablets/plates, 1 plate/box, 10 boxes/heat shrinkage unit and 20 heat shrinkage units/box: each box should contain 1 aluminum plastic plate and 1 product specification, and each box contains 1 product certificate or 12 sheets/plate, 2 plates/box, 10 boxes/heat-shrinkable unit, 20 heat-shrinkable unit/box: each box should contain 2 aluminum-plastic plates and 1 product instruction, and each carton contains 1 product certificate.
Example 3
The embodiment discloses a doxofylline tablet, which is prepared by mixing a first mixture and a second mixture, wherein the first mixture is prepared from the following components in parts by weight: 20 parts of silicon dioxide, 40 parts of excipient, 20 parts of disintegrant, 20 parts of carboxymethyl starch sodium and 20 parts of talcum powder; the first mixture is prepared from the following components in parts by weight: 50 parts of doxofylline and 50 parts of magnesium stearate.
The preparation method comprises the following steps:
(1) putting silicon dioxide, mannitol, disintegrating agent, carboxymethyl starch sodium and talcum powder into a universal pulverizer, pulverizing, sieving with a 40-mesh sieve, and removing impurities;
(2) mixing silicon dioxide, mannitol, a disintegrating agent, sodium carboxymethyl starch and talcum powder by a mixer to obtain a first mixture, wherein the mixing time is 20min, and the rotating speed of the mixer is 8 rpm;
(3) putting doxofylline and magnesium stearate into a universal pulverizer, pulverizing, sieving with a 40-mesh sieve, and removing impurities;
(4) mixing doxofylline and magnesium stearate by a mixer to obtain a second mixture, wherein the mixing time is 15min, and the rotating speed of the mixer is 8 rpm;
(5) mixing the first mixture and the second mixture to obtain a third mixture, wherein the mixing time is 5min, and the rotating speed of a mixer is 8 rpm;
(6) tabletting the third mixture, wherein the tabletting pressure is 65KN, and the tabletting speed is 8 kt/h;
(7) packaging the prepared doxofylline tablets, wherein the doxofylline tablets comprise an aluminum-plastic inner package and an outer package, and the outer package comprises 12 tablets/plates, 1 plate/box, 10 boxes/heat shrinkage unit and 20 heat shrinkage units/box: each box should contain 1 aluminum plastic plate and 1 product specification, and each box contains 1 product certificate or 12 sheets/plate, 2 plates/box, 10 boxes/heat-shrinkable unit, 20 heat-shrinkable unit/box: each box should contain 2 aluminum-plastic plates and 1 product instruction, and each carton contains 1 product certificate.
The clinical curative effect and the safety of the doxofylline tablets are as follows:
according to various asthma patients, 500 patients with different causes, symptoms and disease degrees are selected to carry out clinical tests on the treatment effect of the medicine.
Randomly dividing 500 patients with bronchial asthma into two groups, wherein each group comprises 250 patients with bronchial asthma, and the control group comprises 120 male patients, 130 female patients, 40 patients aged 30 to 40 years, 80 patients aged 41 to 50 years, 78 patients aged 51 to 60 years, 46 patients aged 61 to 70 years, 6 patients aged 70 years and the course of the disease is 10 months to 7 years; in the treatment group, 120 men, 130 women, 32 patients aged 30 to 40 years, 76 patients aged 41 to 50 years, 72 patients aged 51 to 60 years, 60 patients aged 61 to 52 years, 10 patients aged 70 years and more, and the course of the disease is 10 months to 7 years.
The diagnosis of bronchial asthma in the guidelines for diagnosis and treatment of chronic obstructive pulmonary disease (revised 2013) was referred to for both cases.
The control group adopts the current common treatment method, 300g of commercially available doxofylline tablets are orally taken three times a day, and the treatment time is 10 days; the doxofylline tablets prepared in examples 1 to 3 of the present invention were administered to the treatment group once a day for 10 days. The clinical efficacy comparative ratio of the doxofylline tablets prepared in examples 1 to 3 to the commercially available doxofylline tablets is shown in table 1.
Treatment criteria were:
and (3) curing: cough, wheezing, chest distress and other symptoms and pulmonary whine sound disappear;
the effect is shown: normal physical signs, occasionally cough, wheeze and lung wheeze;
the method has the following advantages: the symptoms of cough, wheeze, chest distress and the like are relieved, and the attack frequency is reduced;
and (4) invalidation: the symptoms of wheezing, chest distress, breath, cough, etc. still exist.
Long-term stability of doxofylline tablets:
long-term stability tests (25 ℃ C. + -2 ℃ C., 60% + -5% RH) were conducted on the doxofylline tablets prepared in example 2 and the commercially available doxofylline tablets, and the results are shown in Table 2.
TABLE 1
TABLE 2
To sum up: the doxofylline tablets prepared by the method have the advantages of high treatment rate, obvious treatment effect and good stability, and compared with the common doxofylline tablets sold in the market, the doxofylline tablets can obviously improve the clinical symptoms such as cough, chest distress, wheezing and the like; meanwhile, as can be seen from the data of examples 1 to 3, the curative effect of the prepared doxofylline tablet tends to become better and then worse as the amount of doxofylline in the raw materials increases.
From the foregoing it will be appreciated that, although specific embodiments of the disclosure have been described herein for purposes of illustration, various modifications or improvements may be made by those skilled in the art without departing from the spirit and scope of the disclosure, and that such modifications or improvements are intended to be within the scope of the appended claims.
Claims (10)
1. A method for preparing doxofylline tablets, comprising:
mixing silicon dioxide, mannitol, a disintegrating agent, carboxymethyl starch sodium and talcum powder to obtain a first mixture;
mixing doxofylline and magnesium stearate to obtain a second mixture;
mixing the first mixture with the second mixture to obtain a third mixture; and
tabletting said third mixture.
2. The process for preparing a doxofylline tablet according to claim 1, wherein said first mixture is prepared, in parts by weight, from 10 to 20 parts of silicon dioxide, from 20 to 40 parts of excipients, from 10 to 20 parts of disintegrants, from 10 to 20 parts of sodium starch glycolate, from 10 to 20 parts of talc; the second mixture is prepared from 40 to 50 parts doxofylline, 40 to 50 parts magnesium stearate.
3. The process for producing a doxofylline tablet according to claim 1 or 2, wherein: the disintegrant is selected from microcrystalline cellulose, low-substituted hydroxypropyl cellulose or a mixture thereof; preferably the disintegrant is selected from microcrystalline cellulose.
4. A process for the preparation of a doxofylline tablet according to any one of claims 1 to 3, wherein: the silicon dioxide is also crushed before feeding, and the particle size after crushing is preferably 20 to 100 meshes, more preferably 20 to 50 meshes, and more preferably 40 meshes; the mannitol is also crushed before feeding, and the particle size after crushing is preferably 20 to 100 meshes, more preferably 20 to 50 meshes, and more preferably 40 meshes; the disintegrating agent is also crushed before feeding, and the particle size after crushing is preferably 20 to 100 meshes, more preferably 20 to 50 meshes, and more preferably 40 meshes; the sodium carboxymethyl starch is also crushed before feeding, and the particle size after crushing is preferably 20 to 100 meshes, more preferably 20 to 50 meshes, and more preferably 40 meshes; the talcum powder is also crushed before feeding, and the particle size after crushing is preferably 20-100 meshes, more preferably 20-50 meshes, and more preferably 40 meshes.
5. The process for the preparation of doxofylline tablet according to claim 4, wherein said first mixture is prepared by mixing in a mixer, preferably said mixing time is comprised between 10 and 30min, more preferably 20 min; preferably the mixer speed is from 1 to 20rpm, more preferably 8 rpm.
6. The process for producing a doxofylline tablet according to claim 4 or 5, wherein: the doxofylline is also crushed before feeding, and the particle size after crushing is preferably 20 to 100 meshes, more preferably 20 to 50 meshes, and more preferably 40 meshes; the magnesium stearate is also crushed before feeding, and the particle size after crushing is preferably 20 to 100 meshes, more preferably 20 to 50 meshes, and more preferably 40 meshes.
7. A process for the preparation of doxofylline tablets according to any one of claims 4 to 6, wherein said second mixture is prepared by mixing with a mixer, preferably for a time comprised between 10 and 20min, more preferably for 15 min; preferably the mixer speed is from 1 to 20rpm, more preferably 8 rpm.
8. The process for the preparation of doxofylline tablet according to claim 7, wherein said first mixture is mixed with said second mixture by means of a mixer to obtain said third mixture, preferably said mixing time is comprised between 1 and 10min, more preferably 5 min; preferably the mixer speed is from 1 to 20rpm, more preferably 8 rpm.
9. A process for the preparation of doxofylline tablets as claimed in claim 7 or 8, wherein the compression pressure is from 40 to 65KN and the compression speed is from 30 to 80 kt/h.
10. The doxofylline tablet prepared based on the method for preparing a doxofylline tablet according to any one of claims 1 to 9, preferably the hardness of the doxofylline tablet is 60N to 90N, preferably the friability of the doxofylline tablet is not more than 0.8%, preferably the tablet thickness of the doxofylline tablet is 3.3 to 3.9mm, preferably the disintegration time of the doxofylline tablet is less than or equal to 10 min.
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