CN110664769A - Lanthanum carbonate orally disintegrating tablet and preparation method thereof - Google Patents

Lanthanum carbonate orally disintegrating tablet and preparation method thereof Download PDF

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CN110664769A
CN110664769A CN201911136869.8A CN201911136869A CN110664769A CN 110664769 A CN110664769 A CN 110664769A CN 201911136869 A CN201911136869 A CN 201911136869A CN 110664769 A CN110664769 A CN 110664769A
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lanthanum carbonate
orally disintegrating
disintegrating tablet
copovidone
crospovidone
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CN110664769B (en
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胡国宜
胡锦平
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CHANGZHOU SUNLIGHT PHARMACEUTICAL Co Ltd
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CHANGZHOU SUNLIGHT PHARMACEUTICAL Co Ltd
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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
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/24—Heavy metals; Compounds thereof
    • A61K33/244—Lanthanides; Compounds thereof
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/12—Drugs for disorders of the urinary system of the kidneys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/12—Drugs for disorders of the metabolism for electrolyte homeostasis

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  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
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  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Urology & Nephrology (AREA)
  • Inorganic Chemistry (AREA)
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  • Obesity (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

The invention discloses a lanthanum carbonate orally disintegrating tablet and a preparation method thereof, the lanthanum carbonate orally disintegrating tablet is prepared by lanthanum carbonate hydrate, mannitol, copovidone, crospovidone, colloidal silicon dioxide and magnesium stearate, and the preparation method can adopt a powder direct tabletting method, an external disintegrating agent method and an internal disintegrating agent method. The orally disintegrating tablet is prepared by taking lanthanum carbonate hydrate as a medicinal effective component, taking crospovidone as a disintegrant and especially taking copovidone as an adhesive through a powder direct tabletting method or a dry granulation process, has better friability and short disintegration time, can effectively improve the compliance of chronic renal failure patients without chewing ability, has simple process operation, and is suitable for industrial production.

Description

Lanthanum carbonate orally disintegrating tablet and preparation method thereof
Technical Field
The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to a lanthanum carbonate orally disintegrating tablet and a preparation method thereof.
Background
Chronic kidney disease affects 5% to 10% of the world's population, with a decline in patient kidney function, changes in hormonal levels in the body circulation (e.g. parathyroid hormone, 25 hydroxyvitamin D, fibroblast growth factor 23), a gradual worsening of mineral balance in the body and bone metabolism, leading to the prevalence of hyperphosphatemia, becoming one of the most common complications of chronic kidney disease.
The medicine is simple and easy to operate for inhibiting the intestinal absorption of phosphorus, has obvious effect of reducing the blood phosphorus, and is a main measure for treating hyperphosphatemia at present. The phosphorus binders can be divided into two main classes, traditional phosphorus binders (containing aluminum or calcium) and non-aluminum, non-calcium phosphorus binders. The former is mainly aluminum salt, calcium salt and phosphorus binder. The aluminum-containing phosphorus binding agent (aluminum hydroxide) can effectively inhibit the absorption of phosphorus in the intestinal tract and is widely used once, but the aluminum-containing preparation taken for a long time can cause aluminum accumulation in the body, aluminum poisoning, bone diseases, anemia and toxic injury in skeletal muscles and central nerves, and the use of the aluminum-containing agent is avoided as much as possible. Oral administration of calcium-containing phosphate binders, most commonly including calcium carbonate and calcium acetate, increases the risk of hypercalcemia and its high calcium-phosphorus product by absorption of calcium not bound to the phosphate in the intestine, and in particular, patients taking vitamin D3 at the same time have more calcium absorption in the intestine, which promotes calcification of soft tissues such as cardiovascular and cerebrovascular vessels.
The lanthanum preparation is a novel phosphorus binding agent, has strong binding force with phosphorus, forms insoluble lanthanum salt which is not absorbed by the alimentary canal after being combined, does not influence the absorption of vitamin, has no obvious toxic effect, and has good clinical application. The lanthanum preparation mainly comprises: lanthanum chloride, lanthanum hydroxide, lanthanum carbonate and lanthanum polystyrene sulfonate. Wherein, the lanthanum carbonate has extremely low water solubility, almost no absorption in gastrointestinal tract, and better effectiveness and safety.
In 2004, lanthanum carbonate chewable tablets were marketed by charle (SHIRE) corporation in the united states under the trade name: fosrenol (Chinese is Fosrenot) is known from original patent literature CN1871018A, and the active ingredient lanthanum carbonate generally exists in the form of hydrate, and the structural general formula is: la2(CO3)3·xH2And O. However, chewable tablets are less compliant for chronic renal failure patients who are not chewy.
In addition, the tablets are inevitably subjected to vibration or friction in the processes of production, transportation and the like, the factors can cause the breakage of the tablets and influence the application, and the friability of the tablets is an index reflecting the shock resistance and wear resistance of the tablets.
Disclosure of Invention
The invention aims to solve the problems and provides a lanthanum carbonate orally disintegrating tablet with good compliance, short disintegration time limit and particularly good friability and a preparation method thereof.
The technical scheme for realizing the purpose of the invention is as follows: a lanthanum carbonate orally disintegrating tablet is prepared from lanthanum carbonate hydrate and medicinal excipient.
The lanthanum carbonate orally disintegrating tablet has disintegration time less than 1min and friability less than 0.5%.
The pharmaceutical excipients are mannitol, copovidone, crospovidone, colloidal silicon dioxide and magnesium stearate.
The lanthanum carbonate orally disintegrating tablet is preferably prepared from the following components in percentage by weight: 40-50% of lanthanum carbonate hydrate, 35-45% of mannitol, 1-5% of copovidone, 8-12% of crospovidone, 0.5-2% of colloidal silicon dioxide and 0.5-2% of magnesium stearate.
The lanthanum carbonate orally disintegrating tablet is most preferably prepared from the following components in percentage by weight: 45.4% of lanthanum carbonate hydrate, 39.6% of mannitol, 3% of copovidone, 10% of crospovidone, 1% of colloidal silicon dioxide and 1% of magnesium stearate.
The general structural formula of the lanthanum carbonate hydrate is La2(CO3)3·xH2O; wherein x is 3 to 8, preferably 4 to 5, and most preferably 4.
The lanthanum carbonate orally disintegrating tablet can be prepared by a direct powder tabletting method and can also be prepared by a dry granulation process.
The specific method of the powder direct compression method is as follows: firstly putting lanthanum carbonate hydrate, mannitol, copovidone and crospovidone into a mixer to be mixed for a period of time, then adding colloidal silicon dioxide and magnesium stearate, continuously mixing uniformly, and finally directly tabletting the mixed powder.
The dry granulation process can be divided into an external disintegrant method and an internal disintegrant method.
The specific method of the externally added disintegrating agent is as follows: firstly putting lanthanum carbonate hydrate, mannitol and copovidone into a mixer for uniform mixing, then putting the uniformly mixed materials into a dry granulating machine for dry granulation, then putting the prepared granules and the crospovidone into the mixer for mixing for a period of time, then adding colloidal silicon dioxide and magnesium stearate, continuously mixing uniformly, and finally tabletting the mixed materials.
The specific method of the internal disintegrating agent method is as follows: firstly putting lanthanum carbonate hydrate, mannitol, copovidone and crospovidone into a mixer to be uniformly mixed, then putting the uniformly mixed materials into a dry granulating machine to be granulated by a dry method, then putting the prepared granules, colloidal silicon dioxide and magnesium stearate into the mixer to be uniformly mixed, and finally tabletting the mixed materials.
The lanthanum carbonate orally disintegrating tablet is packaged by PTP bubble cap or high-density polyethylene bottle.
The invention has the following positive effects: the orally disintegrating tablet is prepared by taking lanthanum carbonate hydrate as a medicinal effective component, taking crospovidone as a disintegrant and especially taking copovidone as an adhesive through a powder direct tabletting method or a dry granulation process, has better friability and short disintegration time, can effectively improve the compliance of chronic renal failure patients without chewing ability, has simple process operation, and is suitable for industrial production.
Detailed Description
(example 1)
The lanthanum carbonate orally disintegrating tablets of this example are formulated as shown in table 1.
TABLE 1
Composition (I) Unit dose/mg 10000 tablets/kg Percent by weight/%)
Lanthanum carbonate hydrate La2(CO3)3·4H2O 954 9.54 45.4%
Lanthanum element in lanthanum carbonate hydrate 500 / /
Mannitol 831 8.31 39.6%
Co-polyvidone 63 0.63 3%
Cross-linked polyvidone 210 2.1 10%
Colloidal silica 21 0.21 1%
Magnesium stearate 21 0.21 1%
Total weight of tablet 2100 21 100
The preparation method of the lanthanum carbonate orally disintegrating tablet in the embodiment is an internal disintegrant method in a dry granulation process, and specifically comprises the following steps:
① lanthanum carbonate hydrate, mannitol, copovidone and crospovidone are put into a three-dimensional mixer (from Torontal pharmaceutical machinery of Zhejiang, model number HDA-100, the same below) according to the prescription amount, and mixed for 20min at the rotating speed of 10 r/min.
② and then putting the material mixed uniformly in step ① into a dry granulating machine (from Beijing Xinlongli science and technology Co., Ltd., type LGS200, the same below) for dry granulation, wherein the aperture of the granulating screen is 1.2 mm.
③ the granules obtained in step ② were then fed into a three-dimensional mixer with colloidal silicon dioxide and magnesium stearate and mixed for 5min at a speed of 10 r/min.
④ tabletting the mixed material obtained in step ③, wherein the tabletting punch is 18mm round flat punch, each lanthanum carbonate oral disintegrating tablet weighs 2100mg (total 10000 tablets), and PTP blister packaging is carried out on the pressed lanthanum carbonate oral disintegrating tablets, and each plate contains 10 tablets.
(example 2)
The lanthanum carbonate orally disintegrating tablets of this example are formulated as shown in table 2.
TABLE 2
Composition (I) Unit dose/mg 8000 pieces/kg Percent by weight/%)
Lanthanum carbonate hydrate La2(CO3)3·4H2O 1431 11.45 45.4%
Lanthanum element in lanthanum carbonate hydrate 750 / /
Mannitol 1246.5 9.97 39.6%
Co-polyvidone 94.5 0.76 3%
Cross-linked polyvidone 315 2.52 10%
Colloidal silica 31.5 0.25 1%
Magnesium stearate 31.5 0.25 1%
Total weight of tablet 3150 25.20 100%
The preparation method of the lanthanum carbonate orally disintegrating tablet of the embodiment is a powder direct tabletting method, which specifically comprises the following steps:
① lanthanum carbonate hydrate, mannitol, copovidone and crospovidone are put into a three-dimensional mixer according to the prescription amount, and mixed for 20min at the rotating speed of 10 r/min.
② the colloidal silicon dioxide and magnesium stearate are then fed into the three-dimensional mixer and mixing is continued for 5 min.
③ tabletting the mixed powder obtained in step ② directly, wherein the tabletting punch is 20mm round flat punch, each lanthanum carbonate orally disintegrating tablet weighs 3150mg (8000 tablets), and the pressed lanthanum carbonate orally disintegrating tablets are packaged in high density polyethylene bottles, 30 tablets in each bottle.
(example 3)
The lanthanum carbonate orally disintegrating tablets of this example are formulated as shown in table 3.
TABLE 3
Composition (I) Unit dose/mg 20000 tablets/kg Percent by weight/%)
Lanthanum carbonate hydrate La2(CO3)3·4H2O 477 9.54 45.4%
Lanthanum element in lanthanum carbonate hydrate 250 / /
Mannitol 415.5 8.31 39.6%
Co-polyvidone 31.5 0.63 3%
Cross-linked polyvidone 105 2.1 10%
Colloidal silica 10.5 0.21 1%
Magnesium stearate 10.5 0.21 1%
Total weight of tablet 1050 21 100%
The preparation method of the lanthanum carbonate orally disintegrating tablet in the embodiment is an additional disintegrant method in a dry granulation process, and specifically comprises the following steps:
① lanthanum carbonate hydrate, mannitol and copovidone are put into a three-dimensional mixer according to the prescription amount, and mixed for 20min at the rotating speed of 10 r/min.
② and then putting the material mixed uniformly in the step ① into a dry granulating machine for dry granulation, wherein the aperture of the granulating screen is 1.2 mm.
③ the granules prepared in step ② and crospovidone are put into a three-dimensional mixer, mixed for 20min at a speed of 10r/min, and then the colloidal silicon dioxide and magnesium stearate are put into the mixer and further mixed for 5 min.
④ tabletting the mixed material obtained in step ③, wherein the tabletting punch type is 13mm round flat punch, each lanthanum carbonate oral disintegrating tablet weighs 1050mg (total 20000 tablets), and the pressed lanthanum carbonate oral disintegrating tablets are packaged by PTP blister, and each plate contains 10 tablets.
(comparative examples 1 to 4)
The component amounts and preparation methods of the lanthanum carbonate orally disintegrating tablets of each comparative example are the same as those of example 1, except for the types of the binder and the disintegrant, which are shown in table 4.
TABLE 4
Example 1 Comparative example 1 Comparative example 2 Comparative example 3 Comparative example 4
Adhesive agent Co-polyvidone Povidone Polyethylene glycol Co-polyvidone Co-polyvidone
Disintegrating agent Cross-linked polyvidone Cross-linked polyvidone Cross-linked polyvidone Croscarmellose sodium Low-substituted hydroxypropyl cellulose
(test example 1)
The lanthanum carbonate orally disintegrating tablets prepared in examples 1 to 3 and comparative examples 1 to 4 and the commercial product foslino were subjected to determination of disintegration time limit and friability, respectively.
The disintegration time limit is measured by referring to the disintegration time limit inspection method of 0921 tablets in the four ministry of the national pharmacopoeia 2015 edition: fixing the stainless steel pipe on a support, immersing the stainless steel pipe in a 1000mL cup, containing 900mL of water with the temperature of 37 +/-l ℃, adjusting the water level to be high so that the screen is 15 +/-lmm below the water surface when the stainless steel pipe is at the lowest position, and starting an instrument; the 6 tablets were taken out, placed in the stainless steel tube and examined, and all tablets were disintegrated within 60 seconds and passed through a sieve, and if a small amount of tablets floated on the inner wall of the stainless steel tube or adhered to the sieve but no hard core was present, the results were in accordance with the regulations and shown in table 5.
The friability measurement method refers to the friability inspection method of 0923 tablets of the four ministry of communications on the 2015 edition of "chinese pharmacopoeia": taking 10 tablets, blowing off powder falling off from the tablets by using a blower, precisely weighing, placing in a cylinder, and rotating for 100 times; taking out, removing the powder by the same method, precisely weighing, and calculating the weight loss, and the result is still shown in Table 5.
TABLE 5
Disintegration time limit Degree of friability
Index requirement ＜1min ＜0.5%
Example 1 34～52s 0.3%
Example 2 41～50s 0.3%
Example 3 24～42s 0.2%
Comparative example 1 53～66s 1.3%
Comparative example 2 65～82s 1.6%
Comparative example 3 74～88s 0.8%
Comparative example 4 82～96s 0.7%
Fossilinuo pellets 11min～15min 0.9%
As can be seen from table 5: the lanthanum carbonate orally disintegrating tablets prepared by the invention have disintegration time limit less than 1min, and meet the requirements of Chinese pharmacopoeia on orally disintegrating tablets. The lanthanum carbonate orally disintegrating tablets prepared by the invention are not more than 0.5%, and broken, cracked and crushed tablets are not detected, so that the lanthanum carbonate orally disintegrating tablets prepared by the invention have higher friability than the commercially available preparation, complete appearance and convenient transportation.
(test example 2)
Dissolution rate of the lanthanum carbonate orally disintegrating tablets prepared in examples 1 to 3 and commercially available product foslinuo were determined respectively.
The determination method refers to the second method in the dissolution determination method of 0931 in the four general rules of the national pharmacopoeia 2015 edition: the dissolution medium is 0.25N HCl solution, the volume of the solution is 900mL, the rotating speed is 50r/min, the sampling time points are 10, 20, 30 and 45min, and the results are shown in Table 6.
TABLE 6
Example 1 Example 2 Example 3 Fossilinuo pellets
10min 47% 35% 64% 21%
20min 82% 69% 88% 47%
30min 91% 89% 95% 74%
60min 94% 92% 96% 91%
As can be seen from table 6: the lanthanum carbonate orally disintegrating tablet prepared by the invention can effectively improve the in vitro dissolution rate and dissolution rate (the dissolution rate is improved within 10 min) of the medicament, thereby improving the combination rate of the medicament and phosphorus and having commercial feasibility.
(test example 3)
The lanthanum carbonate orally disintegrating tablets obtained in examples 1 to 3 were subjected to stability examination under an acceleration condition of 40 ℃/RH75% for 6 months, and the results are shown in table 7.
TABLE 7
Performance parameter Index requirement Example 1 Example 2 Example 3
Degree of friability ＜0.5% Compliance with regulations Compliance with regulations Compliance with regulations
Disintegration time limit ＜1min Compliance with regulations Compliance with regulations Compliance with regulations
Noodle sheet Bright and clean Bright and clean Bright and clean Bright and clean
Lanthanum content 95%～105% 98% 99% 99%
Carbonate content 95%～105% 101% 100% 101%

Claims (8)

1. A lanthanum carbonate orally disintegrating tablet is prepared from lanthanum carbonate hydrate and medicinal excipient; the lanthanum carbonate orally disintegrating tablet has disintegration time less than 1min and friability less than 0.5%.
2. The lanthanum carbonate orally disintegrating tablet according to claim 1, characterized in that: the pharmaceutical excipients are mannitol, copovidone, crospovidone, colloidal silicon dioxide and magnesium stearate.
3. The lanthanum carbonate orally disintegrating tablet according to claim 2, characterized by being prepared from the following components in percentage by weight: 40-50% of lanthanum carbonate hydrate, 35-45% of mannitol, 1-5% of copovidone, 8-12% of crospovidone, 0.5-2% of colloidal silicon dioxide and 0.5-2% of magnesium stearate.
4. The lanthanum carbonate orally disintegrating tablet according to claim 3, characterized by being prepared from the following components in percentage by weight: 45.4% of lanthanum carbonate hydrate, 39.6% of mannitol, 3% of copovidone, 10% of crospovidone, 1% of colloidal silicon dioxide and 1% of magnesium stearate.
5. The lanthanum carbonate orally disintegrating tablet according to any of claims 1 to 4, characterized in that: the general structural formula of the lanthanum carbonate hydrate is La2(CO3)3·xH2O; wherein x is 4-5.
6. A process for preparing lanthanum carbonate orally disintegrating tablet as claimed in claims 2 to 5, wherein lanthanum carbonate hydrate, mannitol, copovidone and crospovidone are put into a mixer and mixed for a period of time, then colloidal silicon dioxide and magnesium stearate are added and mixed uniformly, and finally the mixed powder is directly tabletted.
7. A process for preparing lanthanum carbonate orally disintegrating tablets as claimed in any of claims 2 to 5, wherein lanthanum carbonate hydrate, mannitol and copovidone are put into a mixer and mixed uniformly, then the mixed material is put into a dry granulating machine for dry granulation, then the obtained granules and crospovidone are put into the mixer and mixed for a period of time, then colloidal silicon dioxide and magnesium stearate are added, mixing is continued, and finally the mixed material is tabletted.
8. A process for preparing lanthanum carbonate orally disintegrating tablets as claimed in any of claims 2 to 5, wherein lanthanum carbonate hydrate, mannitol, copovidone and crospovidone are put into a mixer and mixed uniformly, then the uniformly mixed material is put into a dry granulating machine for dry granulation, then the prepared granules, colloidal silicon dioxide and magnesium stearate are put into the mixer and mixed uniformly, and finally the mixed material is tabletted.
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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115813867A (en) * 2022-12-01 2023-03-21 山东齐都药业有限公司 Lanthanum carbonate freeze-dried tablet and preparation method thereof

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018210177A1 (en) * 2017-05-17 2018-11-22 西安棣加生物科技有限公司 Rapidly disintegrating oral tablet for treating hyperphosphatemia prepared by 3d printing technology, and preparation method therefor
JP2018193348A (en) * 2017-05-19 2018-12-06 ニプロ株式会社 Orally disintegrating tablet containing lanthanum carbonate

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018210177A1 (en) * 2017-05-17 2018-11-22 西安棣加生物科技有限公司 Rapidly disintegrating oral tablet for treating hyperphosphatemia prepared by 3d printing technology, and preparation method therefor
JP2018193348A (en) * 2017-05-19 2018-12-06 ニプロ株式会社 Orally disintegrating tablet containing lanthanum carbonate

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115813867A (en) * 2022-12-01 2023-03-21 山东齐都药业有限公司 Lanthanum carbonate freeze-dried tablet and preparation method thereof
CN115813867B (en) * 2022-12-01 2024-05-24 山东齐都药业有限公司 Lanthanum carbonate freeze-dried tablet and preparation method thereof

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