CN102114015B - Solid oral preparation containing telmisartan and preparation method thereof - Google Patents
Solid oral preparation containing telmisartan and preparation method thereof Download PDFInfo
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- CN102114015B CN102114015B CN201010003643.3A CN201010003643A CN102114015B CN 102114015 B CN102114015 B CN 102114015B CN 201010003643 A CN201010003643 A CN 201010003643A CN 102114015 B CN102114015 B CN 102114015B
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- telmisartan
- orally ingestible
- solid orally
- alkaline reagent
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Abstract
The invention provides a solid oral preparation without a surfactant. The solid oral preparation comprises the following components in percentage by weight: 5-25% of telmisartan, an alkaline reagent and the balance of pharmaceutically acceptable vectors, wherein the weight of the alkaline reagent is equal to 7-20% of that of telmisartan. The invention also provides a method for preparing the solid oral preparation. The preparation prepared by the method can be quickly and sufficiently released in the psychophysical pH range of gastrointestinal tracts; and compared with the prior art, the preparation method has the advantages that the process is simpler, the quality of the soli oral preparation is more stable, the cost is greatly saved, and the efficiency is improved.
Description
Technical field
The present invention relates to a kind of solid orally ingestible comprising telmisartan, more specifically relate to the tablet comprising telmisartan.Present invention also offers the method preparing tablet of applicable suitability for industrialized production.
Background technology
Telmisartan is a kind of is treatment hypertension and other medical symptoms and the angiotensin ii receptor antagonist developed.Its chemical name is the common chemical name of 4 '-[2-n-pro-pyl-4-methyl-6-(1-tolimidazole-2-base) benzimidazole-1-ylmethyl] biphenyl-2-formic acid.CAS registration number is 144701-48-4.Molecular formula is C
33h
30n
4o
2, its molecular weight is 514.63.There is following structure.
Formula I
Telmisartan Tablets is the product developed by German Boehringer Ingelheim company, and commodity are called Micardis
preparation specification is 20mg/40mg/80mg sheet.Micardis
in 1999 in U.S.'s Initial Public Offering, within 2000, in Britain's listing, within 2002, in Discussion on Chinese Listed, go on the market in multiple countries and regions at present.Due to its there is good effect, persistent, side effect are little, receive extensive concern after listing on resisting hypertension market.
Telmisartan is supplied with the manufacture of free acid form usually.Disclosed in WO00/43370 patent, crystalline telmisartan exists with two kinds of polycrystalline forms with different melting points.Heat and humidity impact under, the polymorph A that be transformed into higher melt irreversible compared with the polymorph B of low melting point.All there is the water solubility of non-constant in the gastrointestinal physiology pH scope of two kinds of expressing character between pH1 to 7.
Raw material telmisartan provides with free acid form, and dissolubility is very poor, is being prepared in production process up to now, and existing multiple method is used to improve its dissolubility, and these methods all by pertinent literature and patent report.
EP1545467 discloses a kind of pharmaceutical composition, and it substantially increases the dissolubility of telmisartan.In pharmaceutical composition described in it, main dissolubility substrate is alkaline reagent, surfactant and most water-soluble diluent.This patent proposes the dosage form of Tablet and Capsula simultaneously, and sets forth fluidized bed granulation and spray-drying process.Surface agent poloxamer in pharmaceutical composition described in this patent and most water-soluble diluent are absolutely necessary.
WO2007061415 discloses a kind of pharmaceutical composition of telmisartan, and it substantially increases the dissolubility of telmisartan.Mainly comprise telmisartan, alkaline reagent, surfactant in pharmaceutical composition described in it and be less than the water-soluble diluent of 25% weight.Surfactant described in this patent is absolutely necessary.
CN200710041363.X discloses a kind of pharmaceutical composition of telmisartan, and it substantially increases the dissolubility of telmisartan.Pharmaceutical composition described in it mainly comprises telmisartan, alkaline reagent and polyvidone, and this patent is also set forth fluid bed preparation technology.The method improves the dissolubility of telmisartan by the method making solid dispersion together with telmisartan, alkaline reagent being dissolved in polyvidone.In the method telmisartan, alkaline reagent must be dissolved in polyvidone three together with form solution and carry out pelletize again, and the method neutral and alkali reagent dosage is more, and patient takes the rear gastric juice meta-alkali that can occur unavoidably and causes dyspeptic phenomenon.
Document " research of telmisartan Film coated tablets preparation technology " (Tian Jingxuan, Wei Jianping. modern biomedical is in progress, 2006,6 (10): 42-45) prescription of stable telmisartan Film coated tablets is proposed, it adopts alkaline reagent solubilising, and adopts spray-drying process.What the document adopted when preparing telmisartan tablet is than more laborious spray drying process.
Summary of the invention
The object of the present invention is to provide a kind of solid orally ingestible containing telmisartan, it does not need surface active agent solubilization just can make active substance quick and complete stripping of energy in gastrointestinal tract pH value environment, and steady quality, adopts ordinary fluidized bed granulation to prepare.
In practice process, inventor finds that telmisartan has poor dissolubility within the scope of gastrointestinal tract pH, must add suitable cosolvent if alkaline reagent or alkaline reagent and surfactant are to improve its dissolubility.Surface agent poloxamer in patent EP1545467 can increase the dissolubility of telmisartan greatly, but poloxamer is usually used in injectable emulsion and various gel, not the conventional adjuvant of tablet.Patent CN200710041363.X can improve for rice stripping as the method for binding agent pelletize really preferably by telmisartan, alkaline reagent being dissolved in together with polyvidone in aqueous solution or alcohol-water solution, but the method also exists two selects deficiency: first employ more alkaline reagent in the method, patient takes the rear gastric juice meta-alkali that can occur unavoidably and causes dyspeptic phenomenon; Secondly inventor finds the aqueous solution comparatively thickness of telmisartan and alkaline reagent in practice, add the viscosity that polyvidone then can aggravate this solution again, and to adopt the solution of this thickness to carry out fluidized bed prilling be very difficult, in technical process, the careless slightly bed that collapses that namely can cause causes pelletize failure, solve this problem and only have two kinds of methods, one is dilute aqueous solution, to lower solution viscosity, but do like this and can cause fluidized bed prilling time lengthening, lose the advantage that fluidized bed prilling is time saving and energy saving; Another kind is as the method for optimizing in patent is dissolved in high alcohol-water solution by telmisartan, alkaline reagent and polyvidone jointly, the method no doubt can lower solution viscosity greatly, but owing to employing the ethanol pelletize of high dose, add the risk of blasting in production, higher requirement is proposed to equipment and workshop.
By practice, if the present inventor finds to regulate prescription neutral and alkali reagent dosage between 7 ~ 20% of telmisartan weight, namely the dissolubility of telmisartan in water can be increased fully, to meet the needs of fluidized bed granulation, and without the need to increasing extra alkaline reagent or binding agent again, the granulation solution of this improvement formula, compared to granulation solution disclosed in CN200710041363.X, has lower viscosity, and there is not the risk of organic solvent blast.According to the present invention, adopt the technology controlling and process of fluidized bed granulation fairly simple, Granulation time is short, and efficiency is higher.And the tablet that active substance can fully discharge fast within the scope of gastrointestinal physiology pH can be obtained, and this tablet has better stability at storage process.
Based on above situation, the invention provides a kind of solid orally ingestible containing telmisartan, it does not need by surfactant hydrotropy or medicine is prepared into solid dispersion, only needs to add a small amount of alkaline reagent and appropriate disintegrating agent, adopts ordinary fluidized bed granulation to prepare.This solid orally ingestible comprises the telmisartan be scattered in substrate of 5 ~ 25%, and described substrate comprises: (a) is equivalent to the alkaline reagent of telmisartan weight 7 ~ 20%; B () and other pharmaceutically acceptable carriers, above all the components sum is 100%.
According to the preferred embodiments of the invention, the ratio that telmisartan consumption is equivalent to pharmaceutical composition gross weight is 5 ~ 25%, preferably 10 ~ 22%, more preferably 14 ~ 19%, be preferably 16 ~ 17%.
Applicable alkaline reagent of the present invention can be selected from one or more in alkali metal hydroxide or basic amino acid.In alkaline reagent of the present invention, alkali metal hydroxide selected from sodium hydroxide, potassium hydroxide or both mixture; Basic amino acid can be selected from meglumine (N-methyl-D-glucosamine), arginine or both mixture.Alkaline reagent is according to a preferred embodiment of the present invention sodium hydroxide.
According to the preferred embodiments of the invention, alkaline reagent consumption is be equivalent to telmisartan weight 7 ~ 20%, is 8 ~ 18% preferably, is better 9 ~ 15%, and best is 10 ~ 13%.
Be applicable to one or more in the optional Autoadhesive of other pharmaceutically acceptable carriers of the present invention, filler, disintegrating agent, lubricant, fluidizer, coloring agent.
According to the present invention, described filler can be selected from one or more in xylitol, sorbitol, mannitol, lactose, corn starch, pregelatinized Starch, microcrystalline Cellulose, Powderd cellulose, calcium hydrogen phosphate.
According to the present invention, described binding agent can be selected from one or more in hypromellose, hydroxypropyl cellulose, carboxymethyl cellulose, sodium carboxymethyl cellulose, vinylpyrrolidone vinyl acetate co-polymer (copolyvidone), pregelatinized Starch.
One or more according to the present invention, in the optional crospovidone of described disintegrating agent, carboxymethylcellulose calcium, cross-linking sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose, carboxymethyl starch sodium, corn starch, partially pregelatinized starch.According to the present invention, the feed postition of disintegrating agent adds in can selecting, additional or interior additional.
According to the present invention, described lubricant can be selected from one or more in stearic acid, magnesium stearate, calcium stearate, sodium stearyl fumarate, Glyceryl Behenate.
According to the present invention, described fluidizer can be selected from one or more in aerosil, Pulvis Talci, silicon dioxide.
One or more according to the present invention, in the optional autoxidation iron oxide red of described coloring agent, iron oxide yellow, food coloring, titanium dioxide.
According to the preferred embodiments of the invention, wherein the total consumption of pharmaceutically acceptable carrier is be equivalent to pharmaceutical composition gross weight 70 ~ 90%, and more excellent is 75 ~ 88%, and more excellent is 78 ~ 85%, and optimum is 79 ~ 83%.
Another object of the present invention is to the preparation method that a kind of solid orally ingestible containing telmisartan is provided, described method comprises: telmisartan, alkaline reagent dissolve in aqueous by (a), obtain homogeneous solution, b () mixing of being sieved by pharmaceutically acceptable carrier is placed in fluid bed, spray and granulate and drying with above-mentioned solution, c gained dried particles sieves and adds the pharmaceutic adjuvant mix homogeneously of Extra Section after granulate by (), then carry out tabletting.
Accompanying drawing illustrates:
Fig. 1 represents in pH1.0 hydrochloric acid medium, according to the same Micardis of Telmisartan Tablets prepared by embodiments of the invention 1
the Dissolution behaviours contrast of Telmisartan Tablets.
Fig. 2 represents in pH7.5 phosphate-buffered liquid medium, according to the same Micardis of Telmisartan Tablets prepared by embodiments of the invention 1
the Dissolution behaviours contrast of Telmisartan Tablets.
Detailed description of the invention:
In order to better understand the present invention, provide some one exemplary embodiment below as a reference, but the present invention is not limited to following examples.
Embodiment 1:
The telmisartan of 200g, 15.5g sodium hydroxide and 8.5g meglumine are dissolved in 200g water jointly and obtain homogeneous solution; 60g hypromellose, 681.8g mannitol, 180g corn starch, 36.0g polyvinylpolypyrrolidone are crossed the mixing of φ 2.0mm rotary screen, obtains granulate mixture; Granulate mixture is placed in fluid bed, sprays and obtain wet granular with above-mentioned homogeneous solution; The rear φ 2.0mm rotary screen granulate of crossing of wet granular 60 DEG C of dryings obtains dry granule; Dry granule adds the rear tabletting of magnesium stearate mixing.
According to dissolution method (Chinese Pharmacopoeia 2005 editions annex XC second methods), with the pH1.0 hydrochloric acid solution of 900ml for dissolution medium, rotating speed is 75rpm, to embodiment 1 slice, thin piece and telmisartan tablets (Micardis
, manufacturer: German Boehringer Ingelheim company) and carry out stripping mensuration, measurement result is in table 1 and Fig. 1.
Table 1:
According to dissolution method (Chinese Pharmacopoeia 2005 editions annex XC second methods), with the pH7.5 phosphate buffer of 900ml for dissolution medium, rotating speed is 75rpm, to embodiment 1 slice, thin piece and telmisartan tablets (Micardis
, manufacturer: German Boehringer Ingelheim company) and carry out stripping mensuration, measurement result is in table 2 and Fig. 2.
Table 2:
The comparative study of stripping curve shows, according to the Micardis that Telmisartan Tablets of the present invention and market are sold
telmisartan Tablets has identical In Vitro Dissolution behavior.
Embodiment 2
The telmisartan of 200g, 14.0g sodium hydroxide are jointly dissolved in about 400g water and obtain homogeneous solution; Cross the mixing of φ 2.0mm rotary screen by common to 8g hypromellose, 214g mannitol, 320g microcrystalline Cellulose and 40g cross-linking sodium carboxymethyl cellulose, obtain granulate mixture; Granulate mixture is placed in fluid bed, sprays and obtain wet granular with above-mentioned homogeneous solution; The rear φ 2.0mm rotary screen granulate of crossing of wet granular 60 DEG C of dryings obtains dry granule; Dry granule adds the rear tabletting of above-mentioned magnesium stearate mixing.
Embodiment 3
The telmisartan of 200g, 16.0g sodium hydroxide and 24.0g meglumine are dissolved in about 400g water jointly and obtain homogeneous solution; Cross the mixing of φ 2.0mm rotary screen by common to 2048g mannitol, 1600g microcrystalline Cellulose and 40.0g polyvinylpolypyrrolidone, obtain granulate mixture; Granulate mixture is placed in fluid bed, sprays and obtain wet granular with above-mentioned homogeneous solution; The rear φ 2.0mm rotary screen granulate of crossing of wet granular 60 DEG C of dryings obtains dry granule; Dry granule adds the rear tabletting of above-mentioned magnesium stearate mixing.
Embodiment 4
The telmisartan of 200g, 20.0g sodium hydroxide are jointly dissolved in about 400g purified water and obtain homogeneous solution; 874g mannitol, 200g corn starch are crossed the mixing of φ 2.0mm rotary screen, obtains granulate mixture; Granulate mixture is placed in fluid bed, sprays and obtain wet granular with above-mentioned homogeneous solution; The rear φ 2.0mm rotary screen granulate of crossing of wet granular 60 DEG C of dryings obtains dry granule; Dry granule adds above-mentioned magnesium stearate mixing tabletting again after adding the mixing of 15g polyvinylpolypyrrolidone.
Embodiment 5
The telmisartan of 200g, 15.5g sodium hydroxide, 10.5g meglumine are jointly dissolved in about 400g purification of aqueous solutions and obtain homogeneous solution; 71g hypromellose, 386g mannitol, 129g corn starch and 353g low-substituted hydroxypropyl cellulose are crossed the mixing of φ 2.0mm rotary screen, obtain granulate mixture; Granulate mixture is placed in fluid bed, sprays and obtain wet granular with above-mentioned homogeneous solution; The rear φ 2.0mm rotary screen granulate of crossing of wet granular 60 DEG C of dryings obtains dry granule; Dry granule adds the rear tabletting of above-mentioned magnesium stearate mixing.
Embodiment 6
The telmisartan of 200g, 15.5g sodium hydroxide and 10.5g meglumine are dissolved in about 400g purification of aqueous solutions jointly and obtain homogeneous solution; 48g copolyvidone, 544g mannitol, 182g corn starch and 97g low-substituted hydroxypropyl cellulose are crossed the mixing of φ 2.0mm rotary screen, obtain granulate mixture; Granulate mixture is placed in fluid bed, sprays and obtain wet granular with above-mentioned homogeneous solution; The rear φ 2.0mm rotary screen granulate of crossing of wet granular 60 DEG C of dryings obtains dry granule; Dry granule adds the rear tabletting of above-mentioned magnesium stearate mixing again after adding the mixing of 97g low-substituted hydroxypropyl cellulose.
Embodiment 7
By embodiment 1 slice, thin piece and Micardis
sheet is directly exposed to 60 DEG C and lower 10 days of 75% humidity, two kinds of environment respectively, and result display embodiment 1 has better appearance stability, the results are shown in Table 3.
Table 3:
Claims (8)
1. the solid orally ingestible not containing surfactant, it is characterized in that: it comprises the telmisartan be scattered in substrate being equivalent to total formulation weight amount 5 ~ 25%, wherein said substrate comprises: (a) is equivalent to the alkaline reagent of telmisartan weight 7 ~ 20%, and wherein alkaline reagent is one or both in sodium hydroxide or meglumine; (b) and other pharmaceutically acceptable carriers, above all the components sum is 100%, and the preparation method of telmisartan solid orally ingestible comprises the steps: that telmisartan, alkaline reagent dissolve in aqueous by (a), obtains homogeneous solution; B () mixing of being sieved by pharmaceutically acceptable carrier is placed in fluid bed, spray above-mentioned solution and to granulate and dry, and gained dried particles sieves and adds the pharmaceutic adjuvant mix homogeneously of Extra Section after granulate by (c), then carries out tabletting.
2. comprise the solid orally ingestible of telmisartan as claimed in claim 1, it is characterized in that alkaline reagent consumption is be equivalent to telmisartan weight 8 ~ 18%.
3. comprise the solid orally ingestible of telmisartan as claimed in claim 1, it is characterized in that one or more in the optional Autoadhesive of described pharmaceutically acceptable carrier, filler, disintegrating agent, lubricant, fluidizer, coloring agent.
4. comprise the solid orally ingestible of telmisartan as claimed in claim 1, it is characterized in that described solid orally ingestible is tablet.
5. comprise the solid orally ingestible of telmisartan as claimed in claim 3, it is characterized in that binding agent is selected from hypromellose, hydroxypropyl cellulose, carboxymethyl cellulose, sodium carboxymethyl cellulose, copolyvidone, pregelatinized Starch one or more.
6. comprise the solid orally ingestible of telmisartan as claimed in claim 3, it is characterized in that filler is selected from xylitol, sorbitol, mannitol, lactose, corn starch, pregelatinized Starch, microcrystalline Cellulose, Powderd cellulose, calcium hydrogen phosphate one or more.
7. comprise the solid orally ingestible of telmisartan as claimed in claim 3, it is characterized in that disintegrating agent is selected from polyvinylpolypyrrolidone, carboxymethylcellulose calcium, cross-linking sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose, carboxymethyl starch sodium, corn starch, partially pregelatinized starch one or more.
8. comprise the solid orally ingestible of telmisartan as claimed in claim 3, it is characterized in that lubricant is selected from stearic acid, magnesium stearate, calcium stearate, sodium stearyl fumarate, Glyceryl Behenate one or more.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201010003643.3A CN102114015B (en) | 2010-01-05 | 2010-01-05 | Solid oral preparation containing telmisartan and preparation method thereof |
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| CN201010003643.3A CN102114015B (en) | 2010-01-05 | 2010-01-05 | Solid oral preparation containing telmisartan and preparation method thereof |
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| CN102114015A CN102114015A (en) | 2011-07-06 |
| CN102114015B true CN102114015B (en) | 2015-07-08 |
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Families Citing this family (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103271908B (en) * | 2013-05-23 | 2019-02-12 | 浙江华海药业股份有限公司 | Oral tablet and preparation method thereof containing Telmisartan and Amlodipine Besylate Tablet |
| CN104826115A (en) * | 2015-04-19 | 2015-08-12 | 浙江巨泰药业有限公司 | Anti-heart failure pharmaceutical composition and preparation method thereof |
| JP5956034B1 (en) * | 2015-07-27 | 2016-07-20 | エルメッド エーザイ株式会社 | Telmisartan-containing pharmaceutical composition |
| CN107811984A (en) * | 2017-12-13 | 2018-03-20 | 南京双科医药开发有限公司 | A kind of preparation method of telmisartan tablet |
| CN107982232A (en) * | 2018-01-29 | 2018-05-04 | 威特(湖南)药业有限公司 | Telmisartan Tablets and preparation method thereof |
| CN110934848B (en) * | 2019-12-20 | 2022-02-15 | 江西杏林白马药业股份有限公司 | Telmisartan capsule and preparation method thereof |
| CN111265488B (en) * | 2020-03-18 | 2021-11-12 | 重庆康刻尔制药股份有限公司 | Telmisartan tablets and preparation method thereof |
| CN111700866A (en) * | 2020-06-30 | 2020-09-25 | 重庆康刻尔制药有限公司 | Preparation method of telmisartan tablets |
| CN115245497A (en) * | 2021-04-26 | 2022-10-28 | 武汉伯睿科医药科技有限公司 | Telmisartan capsule and preparation process thereof |
| CN114344294B (en) * | 2021-12-14 | 2023-07-14 | 上海现代制药股份有限公司 | Telmisartan oral solid preparation with stable product performance and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1409998A (en) * | 2002-12-03 | 2003-04-16 | 北京华源堂健康科技有限公司 | Calcium and iron nutrient supplement for food |
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2010
- 2010-01-05 CN CN201010003643.3A patent/CN102114015B/en active Active
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1409998A (en) * | 2002-12-03 | 2003-04-16 | 北京华源堂健康科技有限公司 | Calcium and iron nutrient supplement for food |
Non-Patent Citations (1)
| Title |
|---|
| 田景萱等.替米沙坦薄膜衣片制备工艺的研究.《现代生物医学进展》.2006,第6卷(第10期),第42-45页. * |
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