CN110393709B - Azilsartan tablets and preparation method thereof - Google Patents
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- 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
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Abstract
The invention relates to an azilsartan tablet and a preparation method thereof. The raw materials comprise the following substances in parts by mass: 100 parts of azilsartan, 140 parts of lactose 120-. The auxiliary materials are added with the copovidone S630 and the hydroxypropyl methylcellulose acetate succinate HF which have synergistic effect with the hydroxypropyl cellulose, the corn starch, the polyethylene glycol 6000, the microcrystalline cellulose PH101 and the like, so that the dissolution rate of the azilsartan is effectively improved, the stability of the azilsartan tablets in the storage process is ensured, and the medication safety is ensured.
Description
Technical Field
The invention belongs to the field of medicines, and particularly relates to azilsartan tablets and a preparation method thereof.
Background
The English name of azilsartan is: azilsartan, a new generation of antihypertensive drugs with selective AT1 subtype angiotensin II receptor antagonist. Azilsartan tablets were officially marketed in japan by wutian industries, 2012 and 4 months, at specifications of 20mg and 40mg, and 10mg tablets were marketed in japan wutian industries, 5 months 2014 and 5 months.
Azilsartan belongs to angiotensin II receptor inhibitors, and achieves the effect of lowering blood pressure by blocking the activity of angiotensin II receptors. For many patients, inhibition of Renin Aldosterone System (RAS) activity alone does not provide good control of blood pressure and reduce the risk of cardiovascular disease and diabetes in many of the ARBs already on the market. Compared with Angiotensin Converting Enzyme Inhibitors (ACEI) antihypertensive drugs, the new-generation selective AT1 subtype angiotensin II receptor antagonist azilsartan has the advantages of stable antihypertensive and no dry cough.
Azilsartan, as a new generation of dual-function ARBs, not only antagonizes angiotensin II type 1 receptors (AT1 receptors), but also reduces the risk of cardiovascular disease and diabetes through a variety of mechanisms. Clinical tests prove that the azilsartan has the characteristics of good curative effect, low adverse reaction incidence rate and good compliance.
Azilsartan is hardly dissolved in water, the solubility of azilsartan in water is less than 9ug/ml, and when insoluble drugs are prepared into pharmaceutical preparations, special treatment is often needed, so that the in vitro dissolution speed of azilsartan is improved, the drugs can reach effective concentration in blood, and the expected clinical curative effect is realized.
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 by containing an oily substance with a low melting point and a binder with a low viscosity, and is mainly characterized in that the binder with a low viscosity is used to improve the dissolution rate of azilsartan, but the use of the binder with a low viscosity to improve the dissolution rate of azilsartan in vitro is limited;
chinese patent CN102895205A discloses a fast-dissolving azilsartan pharmaceutical preparation, which is characterized in that azilsartan is micronized in order to further improve the dissolution rate, although the in vitro dissolution rate is improved to a certain extent, the process is complex, the dust yield is large, and the process is not beneficial to environmental protection and industrial production;
chinese patent CN103705510A discloses a preparation method of an azilsartan medoxomil solid composition, which is characterized in that azilsartan medoxomil is prepared into a suspension solution and then is subjected to wet grinding, and the suspension solution is added into auxiliary materials by adopting a spraying method and is dried to prepare particles and powder of an azilsartan medoxomil pharmaceutical composition; finally, the granules and the powder are prepared into the azilsartan preparation. Because the azilsartan structure contains amido bonds and is sensitive to humidity, the adoption of wet grinding can cause the rapid increase of azilsartan related substances and influence the medication safety;
chinese patent CN104523632A discloses an azilsartan tablet, which is characterized in that the azilsartan tablet is dissolved in diethylene glycol monoethyl ether, adsorbed by fumed silica, mixed with other auxiliary materials and tabletted to obtain the azilsartan tablet. However, a new solvent of diethylene glycol monoethyl ether is introduced, so that the high boiling point and the slight toxicity are realized, and the diethylene glycol monoethyl ether can remain in the pellets after being adsorbed by gas phase silicon dioxide, thereby greatly influencing the medication safety;
therefore, a preparation method of azilsartan medoxomil tablet which can improve the dissolution rate of azilsartan medoxomil, avoid the introduction of toxic solvents and maintain the stability of azilsartan medoxomil is urgently needed.
Disclosure of Invention
The invention aims to provide azilsartan tablets and a preparation method thereof.
The azilsartan tablets provided by the invention comprise the following raw materials in parts by mass: 100 parts of azilsartan, 140 parts of lactose 120-.
Specifically, the azilsartan tablets comprise the following raw materials in parts by mass: 100 parts of azilsartan, 135 parts of lactose, 215 parts of corn starch, 8 parts of hydroxypropyl cellulose, 6302 parts of copovidone, 2 parts of hydroxypropyl methylcellulose acetate succinate HF, 600023 parts of polyethylene glycol, 155 parts of low-substituted hydroxypropyl cellulose, 1015 parts of microcrystalline cellulose PH, 5 parts of magnesium stearate and 65 parts of film-coated premix (gastric-soluble).
The azilsartan tablets are prepared by a method comprising the following steps:
1) pulverizing Azilsartan, sieving with a 60-mesh sieve, sieving lactose, corn starch, low-substituted hydroxypropyl cellulose and microcrystalline cellulose PH101 with a 60-mesh sieve, and sieving magnesium stearate with a 80-mesh sieve for later use;
2) dissolving hydroxypropyl cellulose and copovidone S630 in ethanol to obtain a solution 1 with the concentration of 3-8% (W/V);
3) putting corn starch, polyethylene glycol 6000, microcrystalline cellulose PH101, azilsartan, lactose and 40% of low-substituted hydroxypropyl cellulose into a wet granulator; premixing for 3-8min, adding solution 1, stirring, and granulating;
4) drying the prepared granules in a multifunctional fluidized bed at the air inlet temperature of 60-65 ℃, sampling and detecting the moisture, and stopping heating if the moisture is less than 4%;
5) taking out the dried granules, adding 50% hydroxypropyl methylcellulose acetate succinate, mixing the rest low-substituted hydroxypropyl cellulose and magnesium stearate, and tabletting;
6) preparing a film coating premix (gastric-soluble type) into a coating solution with the mass concentration of 13% by using purified water, adding the rest hydroxypropyl methylcellulose acetate succinate into the obtained coating solution, and coating the prepared tablet.
The weight increment of the coating is controlled between 2% and 4%.
According to the invention, the co-povidone S630 and the hydroxypropyl methyl cellulose acetate succinate HF are added into the auxiliary materials of the azilsartan tablet, and the adjuvant and hydroxypropyl cellulose, corn starch, polyethylene glycol 6000, microcrystalline cellulose PH101 and the like have synergistic effects, so that the dissolution rate of the azilsartan is effectively improved, the stability of the azilsartan tablet in the storage process is ensured, and the medication safety is ensured.
Detailed Description
The present invention will be described below with reference to specific examples, but the present invention is not limited thereto.
The experimental methods used in the following examples are all conventional methods unless otherwise specified; reagents, materials and the like used in the following examples are commercially available unless otherwise specified.
Example 1 preparation of 5000 tablets of 20mg azilsartan tablet
100g of azilsartan, 135g of lactose, 215g of corn starch, 8g of hydroxypropyl cellulose, polyvidone S6302 g, HF 2g of hydroxypropyl methylcellulose acetate succinate, 600023 g of polyethylene glycol, 155g of low-substituted hydroxypropyl cellulose, microcrystalline cellulose PH 1015 g, 5g of magnesium stearate and 65g of film-coated premix (gastric-soluble).
Prepared by a process comprising the steps of:
1) pulverizing Azilsartan, sieving with a 60-mesh sieve, sieving lactose, corn starch, low-substituted hydroxypropyl cellulose and microcrystalline cellulose PH101 with a 60-mesh sieve, and sieving magnesium stearate with a 80-mesh sieve for later use;
2) dissolving hydroxypropyl cellulose and copovidone S630 in ethanol to obtain a solution 1 with the concentration of 5% (W/V);
3) putting corn starch, polyethylene glycol 6000, microcrystalline cellulose PH101, azilsartan, lactose and 40% of low-substituted hydroxypropyl cellulose into a wet granulator; premixing for 8min, adding the solution 1, stirring, and granulating;
4) drying the prepared granules in a multifunctional fluidized bed at the air inlet temperature of 60-65 ℃, sampling and detecting the moisture, and stopping heating if the moisture is less than 4%;
5) taking out the dried granules, adding 50% hydroxypropyl methylcellulose acetate succinate, mixing the rest low-substituted hydroxypropyl cellulose and magnesium stearate, and tabletting;
6) preparing a film coating premix (gastric-soluble type) into a coating solution with the mass concentration of 13% by using purified water, adding the rest hydroxypropyl methylcellulose acetate succinate into the obtained coating solution, and coating the prepared tablet.
Example 2 preparation of 5000 tablets of 20mg azilsartan tablets
100g of azilsartan, 120g of lactose, 220 parts of corn starch, 10 parts of hydroxypropyl cellulose, 6301 parts of copovidone, HF 1 parts of hydroxypropyl methylcellulose acetate succinate, 600025 parts of polyethylene glycol, 160 parts of low-substituted hydroxypropyl cellulose, PH 1017 parts of microcrystalline cellulose, 6 parts of magnesium stearate and 65 parts of film coating premix (gastric-soluble).
The preparation process is the same as in example 1.
Example 3 preparation of 5000 tablets of 20mg azilsartan tablets
100g of azilsartan, 140g of lactose, 210 parts of corn starch, 6 parts of hydroxypropyl cellulose, 6304 parts of copovidone, HF 3 parts of hydroxypropyl methylcellulose acetate succinate, 600024 parts of polyethylene glycol, 150 parts of low-substituted hydroxypropyl cellulose, PH 1017 parts of microcrystalline cellulose, 6 parts of magnesium stearate and 65 parts of film-coated premix (gastric-soluble).
The preparation process is the same as in example 1.
Comparative example 1 preparation of 5000 Azilsartan tablets of 20mg
100 parts of azilsartan, 135 parts of lactose, 215 parts of corn starch, 10 parts of hydroxypropyl cellulose, 600025 parts of polyethylene glycol, 155 parts of low-substituted hydroxypropyl cellulose, 1015 parts of microcrystalline cellulose, 5 parts of magnesium stearate and 65 parts of film coating premix (gastric soluble).
Prepared by a process comprising the steps of:
1) pulverizing Azilsartan, sieving with a 60-mesh sieve, sieving lactose, corn starch, low-substituted hydroxypropyl cellulose and microcrystalline cellulose PH101 with a 60-mesh sieve, and sieving magnesium stearate with a 80-mesh sieve for later use;
2) dissolving hydroxypropyl cellulose in ethanol to obtain a solution 1 with the concentration of 5% (W/V);
3) putting corn starch, polyethylene glycol 6000, microcrystalline cellulose PH101, azilsartan, lactose and 40% of low-substituted hydroxypropyl cellulose into a wet granulator; premixing for 8min, adding the solution 1, stirring, and granulating;
4) drying the prepared granules in a multifunctional fluidized bed at the air inlet temperature of 60-65 ℃, sampling and detecting the moisture, and stopping heating if the moisture is less than 4%;
5) taking out the dried granules, adding the rest low-substituted hydroxypropyl cellulose and magnesium stearate, uniformly mixing, and tabletting;
6) the film coating premix (gastric soluble type) is prepared into coating liquid with mass concentration of 13% by using purified water, and the prepared tablets are coated.
Comparative examples 2,
100 parts of azilsartan, 135 parts of lactose, 215 parts of corn starch, 8 parts of hydroxypropyl cellulose, 6302 parts of copovidone, 600025 parts of polyethylene glycol, 155 parts of low-substituted hydroxypropyl cellulose, 1015 parts of microcrystalline cellulose PH, 5 parts of magnesium stearate and 65 parts of film coating premix (gastric soluble).
Prepared by a process comprising the steps of:
1) pulverizing Azilsartan, sieving with a 60-mesh sieve, sieving lactose, corn starch, low-substituted hydroxypropyl cellulose and microcrystalline cellulose PH101 with a 60-mesh sieve, and sieving magnesium stearate with a 80-mesh sieve for later use;
2) dissolving hydroxypropyl cellulose and copovidone S630 in ethanol to obtain a solution 1 with the concentration of 5% (W/V);
3) putting corn starch, polyethylene glycol 6000, microcrystalline cellulose PH101, azilsartan, lactose and 40% of low-substituted hydroxypropyl cellulose into a wet granulator; premixing for 8min, adding the solution 1, stirring, and granulating;
4) drying the prepared granules in a multifunctional fluidized bed at the air inlet temperature of 60-65 ℃, sampling and detecting the moisture, and stopping heating if the moisture is less than 4%;
5) taking out the dried granules, adding the rest low-substituted hydroxypropyl cellulose and magnesium stearate, uniformly mixing, and tabletting;
6) the film coating premix (gastric soluble type) is prepared into coating liquid with mass concentration of 13% by using purified water, and the prepared tablets are coated.
Comparative examples 3,
100 parts of azilsartan, 135 parts of lactose, 215 parts of corn starch, 10 parts of hydroxypropyl cellulose, HF 2g of hydroxypropyl methylcellulose acetate succinate, 600023 parts of polyethylene glycol, 155 parts of low-substituted hydroxypropyl cellulose, 1015 parts of microcrystalline cellulose PH, 5 parts of magnesium stearate and 65 parts of film-coated premix (gastric-soluble).
Prepared by a process comprising the steps of:
1) pulverizing Azilsartan, sieving with a 60-mesh sieve, sieving lactose, corn starch, low-substituted hydroxypropyl cellulose and microcrystalline cellulose PH101 with a 60-mesh sieve, and sieving magnesium stearate with a 80-mesh sieve for later use;
2) dissolving hydroxypropyl cellulose in ethanol to obtain a solution 1 with the concentration of 5% (W/V);
3) putting corn starch, polyethylene glycol 6000, microcrystalline cellulose PH101, azilsartan, lactose and 40% of low-substituted hydroxypropyl cellulose into a wet granulator; premixing for 8min, adding the solution 1, stirring, and granulating;
4) drying the prepared granules in a multifunctional fluidized bed at the air inlet temperature of 60-65 ℃, sampling and detecting the moisture, and stopping heating if the moisture is less than 4%;
5) taking out the dried granules, adding hydroxypropyl methylcellulose acetate succinate, the rest low-substituted hydroxypropyl cellulose and magnesium stearate, mixing uniformly, and tabletting;
6) the film coating premix (gastric soluble type) is prepared into coating liquid with mass concentration of 13% by using purified water, and the prepared tablets are coated.
Comparative examples 4,
100 parts of azilsartan, 135 parts of lactose, 215 parts of corn starch, 10 parts of hydroxypropyl cellulose, HF 2g of hydroxypropyl methylcellulose acetate succinate, 600023 parts of polyethylene glycol, 155 parts of low-substituted hydroxypropyl cellulose, 1015 parts of microcrystalline cellulose PH, 5 parts of magnesium stearate and 65 parts of film-coated premix (gastric-soluble).
Prepared by a process comprising the steps of:
1) pulverizing Azilsartan, sieving with a 60-mesh sieve, sieving lactose, corn starch, low-substituted hydroxypropyl cellulose and microcrystalline cellulose PH101 with a 60-mesh sieve, and sieving magnesium stearate with a 80-mesh sieve for later use;
2) dissolving hydroxypropyl cellulose in ethanol to obtain a solution 1 with the concentration of 5% (W/V);
3) putting corn starch, polyethylene glycol 6000, microcrystalline cellulose PH101, azilsartan, lactose and 40% of low-substituted hydroxypropyl cellulose into a wet granulator; premixing for 8min, adding the solution 1, stirring, and granulating;
4) drying the prepared granules in a multifunctional fluidized bed at the air inlet temperature of 60-65 ℃, sampling and detecting the moisture, and stopping heating if the moisture is less than 4%;
5) taking out the dried granules, adding the rest low-substituted hydroxypropyl cellulose and magnesium stearate, uniformly mixing, and tabletting;
6) preparing a film coating premix (gastric-soluble type) into a coating solution with the mass concentration of 13% by using purified water, adding hydroxypropyl methylcellulose acetate succinate into the obtained coating solution, and coating the prepared tablet.
The azilsartan medoxomil tablets (namely tablets before coating) prepared in the above examples and comparative examples are examined for dissolution curves, and according to the dissolution conditions of the azilsartan medoxomil tablets in different pH media, a phosphate buffer solution with pH6.8 is selected as a dissolution medium, and the dissolution method is shown in 0931 of the four-part general rules of the Chinese pharmacopoeia 2015 edition.
The dissolution data of each tablet in phosphate buffer at ph6.8 are shown in table 1:
dissolution data of each tablet in phosphate buffer at pH6.8
The tablets prepared in examples 1 to 3 and comparative examples 1 to 4 were compared in terms of the substances in accelerated tests (40 ℃ C., RH 75%) for 6 months, as shown in Table 2.
Table 2 impurity content of azilsartan tablets
Claims (1)
1. The azilsartan tablets comprise the following raw materials in parts by mass: 100 parts of azilsartan, 135 parts of lactose, 215 parts of corn starch, 8 parts of hydroxypropyl cellulose, 6302 parts of copovidone, HF 2 parts of hydroxypropyl methylcellulose acetate succinate, 600023 parts of polyethylene glycol, 155 parts of low-substituted hydroxypropyl cellulose, 1015 parts of microcrystalline cellulose PH, 5 parts of magnesium stearate and 65 parts of a film-coated premix;
the film coating premix is gastric soluble.
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| CN113209036B (en) * | 2021-06-04 | 2023-02-21 | 扬子江药业集团上海海尼药业有限公司 | Azilsartan tablets and preparation method and application thereof |
| CN113750067B (en) * | 2021-08-25 | 2022-12-02 | 海南海灵化学制药有限公司 | Preparation process of levofloxacin tablets |
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| WO2013162114A1 (en) * | 2012-04-27 | 2013-10-31 | 씨제이제일제당 주식회사 | Sustained-release preparation using gastroretentive drug delivery system |
| CN105030711A (en) * | 2015-09-11 | 2015-11-11 | 江苏中邦制药有限公司 | Preparation method of Azilsartan tablets |
| CN108553433A (en) * | 2018-05-30 | 2018-09-21 | 扬子江药业集团上海海尼药业有限公司 | A kind of Azilsartan piece and preparation method thereof |
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| CN103933000B (en) * | 2014-05-06 | 2021-11-12 | 山东新时代药业有限公司 | Azilsartan tablet and preparation method thereof |
| CN104306344B (en) * | 2014-10-22 | 2016-09-07 | 南京正大天晴制药有限公司 | A kind of Azilsartan tablet and preparation technology thereof |
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| WO2013162114A1 (en) * | 2012-04-27 | 2013-10-31 | 씨제이제일제당 주식회사 | Sustained-release preparation using gastroretentive drug delivery system |
| CN105030711A (en) * | 2015-09-11 | 2015-11-11 | 江苏中邦制药有限公司 | Preparation method of Azilsartan tablets |
| CN108553433A (en) * | 2018-05-30 | 2018-09-21 | 扬子江药业集团上海海尼药业有限公司 | A kind of Azilsartan piece and preparation method thereof |
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