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A technology of azilsartan tablets and lactose, which is applied in the field of medicine, can solve the problems of large dust production, complex process, and slight toxicity, and achieve the effects of improving dissolution rate, ensuring drug safety, and ensuring stability
Active Publication Date: 2020-05-05
北京阳光诺和药物研究股份有限公司
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Problems solved by technology
[0007] For example, in order to improve the dissolution rate of azilsartan, Chinese patent CN101528262A discloses a stable pharmaceutical composition with excellent dissolution properties, which is characterized in that it contains an oily substance with a low melting point and a low-viscosity binder. Its main features are The use of low-viscosity binders to improve the dissolution of azilsartan, but the use of low-viscosity binders to improve the dissolution of azilsartan in vitro is often limited;
[0008] Chinese patent CN102895205A discloses a fast-dissolving azilsartan pharmaceutical preparation, which is characterized in that in order to further improve the dissolution rate, azilsartan is micronized. Although the in vitro dissolution rate is improved to a certain extent, the process is complicated. The amount of dust produced is large, which is not conducive to environmental protection and industrial production;
However, it introduces a new solvent, diethylene glycol monoethyl ether, which has a high boiling point and is slightly toxic. It may remain in the pellets after being adsorbed by fumed silica, which greatly affects the safety of medication;
Method used
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Embodiment 1
[0026] Embodiment 1, prepare 5000 pieces of azilsartan tablets of 20mg
[0028] Prepared by a method comprising the steps of:
[0029] 1) Azilsartan is crushed through a 60-mesh sieve, lactose, corn starch, low-substituted hydroxypropyl cellulose, and microcrystalline cellulose PH101 are passed through a 60-mesh sieve, magnesium stearate is passed through a 80-mesh sieve, and set aside;
[0030] 2) Dissolving hydroxypropyl cellulose and copovidone S630 in ethanol to obtain a solution 1 with a concentration of 5% (W / V);
[0031] 3) Put corn starch, polyethylene glycol 6000, microcrystalline cellulose PH101, azilsartan, lactose and 40% low-substituted hydr...
Embodiment 2
[0035] Embodiment 2, prepare 5000 pieces of azilsartan tablets of 20mg
[0036] Azilsartan 100g, lactose 120g, corn starch 220 parts, hydroxypropyl cellulose 10 parts, copovidone S6301 parts, hypromellose acetate succinate HF 1, polyethylene glycol 6000 25 parts, low substitution 160 parts of hydroxypropyl cellulose, 7 parts of microcrystalline cellulose PH101, 6 parts of magnesium stearate, 65 parts of film coating premix (gastric soluble type).
[0037] The preparation process is the same as in Example 1.
Embodiment 3
[0038] Embodiment 3, prepare 5000 pieces of azilsartan tablets of 20mg
[0039] Azilsartan 100g, lactose 140g, corn starch 210 parts, hydroxypropyl cellulose 6 parts, copovidone S6304 parts, hypromellose acetate succinate HF 3, polyethylene glycol 6000 24 parts, low substitution 150 parts of hydroxypropyl cellulose, 7 parts of microcrystalline cellulose PH101, 6 parts of magnesium stearate, 65 parts of film coating premix (gastric soluble type).
[0040] The preparation process is the same as in Example 1.
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Abstract
The invention relates to a preparation method of azilsartan tablets. The preparation method comprises the steps of dissolving hydroxypropyl cellulose and copovidone S630 with ethanol to obtain a solution 1 of which the concentration is 3%-8%; putting corn starch, Macrogol 6000, microcrystalline cellulose PH101, azilsartan, lactose and 40% of low substituted hydroxypropy cellulose in a wet granulation machine; performing premixing, adding the solution 1, performing stirring, and performing granulation; placing prepared granules in a multi-functional fluidized bed, performing drying, wherein thetemperature of inlet wind is 60-65 DEG C, performing sampling for moisture detection, and if moisture is smaller than 4 %, stopping heating; taking out the dried granules, adding 50% of hydroxypropylmethylcellulose acetate succinate, uniformly mixing the remaining low substituted hydroxypropy cellulose and magnesium stearate, and performing tabletting; and compounding a film coating premix agentinto a coating solution of which the mass concentration is 13%, with purified water, adding the remaining hydroxypropyl methylcellulose acetate succinate to the obtained coating solution, and performing coating on the prepared tablets.
Description
[0001] This application is a divisional application with the application number 201910772903.4, the application date is August 21, 2019, and the invention name is "Azilsartan tablet and its preparation method". technical field [0002] The invention belongs to the field of medicine, and in particular relates to a preparation method of azilsartan tablets. Background technique [0003] Azilsartan English name: Azilsartan, is a new generation of selective AT1 subtype angiotensin II receptor antagonist antihypertensive drugs. Azilsartan tablets were officially launched in Japan by Takeda Industry Co., Ltd. in April 2012, with market specifications of 20 mg and 40 mg. In May 2014, Takeda Industry Co., Ltd. of Japan launched 10 mg tablets. [0004] Azilsartan is an angiotensin II receptor inhibitor that lowers blood pressure by blocking the activity of angiotensin II receptors. For many patients, only inhibiting the activity of the renin-aldosterone system (RAS) among the multipl...
Claims
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Application Information
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