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Composition containing candesartan and amlodipine, preparation process, testing process and application thereof

A kind of technology of amlodipine and candesartan, applied in the field of compositions, can solve problems such as high cost, unsatisfactory product index, unstable quality and the like

Active Publication Date: 2012-09-19
SICHUAN SUNNYHOPE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] Another technical problem solved by the present invention is to provide a variety of clinically acceptable preparations or preparation methods for finished products, especially by granulating the composition into dosage forms such as granules, tablets, capsules, and Solve problems such as unsatisfactory product indicators, high cost, and unstable quality

Method used

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  • Composition containing candesartan and amlodipine, preparation process, testing process and application thereof
  • Composition containing candesartan and amlodipine, preparation process, testing process and application thereof
  • Composition containing candesartan and amlodipine, preparation process, testing process and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0071] The sample preparation and inspection of embodiment 1, composition powder

[0072] Preparation: Take 6g of candesartan cilexetil, 7g of amlodipine, 80g of mannitol, 6g of croscarmellose calcium, and 6g of cornstarch, mix evenly, make a powder, and pack it into 1000 bags.

[0073] Inspection: 【Inspection】Related substances of candesartan cilexetil take this product, accurately weigh an appropriate amount of fine powder (approximately equivalent to 18 mg of candesartan cilexetil), put it in a 50ml measuring bottle, add acetonitrile-water (2:3) for ultrasonic treatment Dissolve and dilute to the mark, filter, take the subsequent filtrate as the test solution; accurately weigh about 22 mg of the candesartan cilexetil reference substance and put it in a 50ml measuring bottle, add acetonitrile-water (2:3) to dissolve and dilute to the mark , shake well, filter, accurately measure 1ml, put it in a 100ml measuring bottle, add acetonitrile-water (2:3) to dilute to the mark, shak...

Embodiment 2

[0082] Embodiment 2, preparation and inspection of composition capsule

[0083]Preparation: get 10kg candesartan, 2.5kg amlodipine, 100kg mannitol, 5kg croscarmellose sodium, 35kg microcrystalline cellulose and mix evenly, mix with 2% hypromellose ethanol (ethanol concentration 30%) solution about 20L to make soft materials, granulate with a 20-mesh sieve with an aperture, dry at 58°C, granulate with a 16-mesh sieve with an aperture, mix the granules with 0.5kg magnesium stearate evenly, and pack 1,000,000 capsules Grains, that is.

[0084] Inspection: [Inspection] Candesartan-related substances take 10 capsules of this product, accurately weigh the contents, grind finely, and accurately weigh an appropriate amount of fine powder (approximately equivalent to 22mg of candesartan), put it in a 50ml measuring bottle and add acetonitrile -Water (4: 1) sonication makes dissolving and dilutes to the scale, filters, and gets the subsequent filtrate as the test solution; accurately w...

Embodiment 3

[0093] Embodiment 3, preparation and inspection of composition granules

[0094] Preparation: Mix 8kg of candesartan cilexetil, 2.5kg of amlodipine besylate, 95kg of mannitol, 3kg of croscarmellose sodium, 18kg of microcrystalline cellulose and an appropriate amount of starch as a base material, and mix them with an appropriate amount of water One-step granulation for the wetting agent, divided into 500,000 bags, 1g per bag, to obtain.

[0095] Inspection: [Inspection] Take 10 bags of related substances of candesartan cilexetil, accurately weigh them, grind them finely, accurately weigh an appropriate amount of fine powder (approximately equivalent to 20 mg of candesartan cilexetil), put it in a 50ml measuring bottle and add acetonitrile -Water (3: 2) sonication makes dissolving and dilutes to scale, filters, and gets the subsequent filtrate as the test solution; Accurately weighs 20 mg of candesartan cilexetil reference substance and puts it in a 50ml measuring bottle, adds a...

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Abstract

The invention relates to a composition and a preparation process, a testing process and an application thereof. The composition comprises a therapeutically effective amount of candesartan or pharmaceutically acceptable ester or salt, a therapeutically effective amount of amlodipine or other pharmaceutically acceptable salt, 70-150 parts of mannitol or lactose, 2-5 parts of croscarmellose sodium or cross-calcium carboxymethyl cellulose and 5-40 parts of microcrystalline cellulose or corn starch. The composition is easy to prepare, low in production cost, utilizes accessories of unique prescription, and the like, can be prepared into oral preparation in forms of tablets, capsules, granules and the like by means of pharmaceutics, can be checked by different checking processes, has high quality, has functions of treating hypertension, angina pectoris and kidney diseases and has effect of myocardial protection.

Description

technical field [0001] The present invention relates to a composition, in particular to a composition comprising candesartans, amlodipine and auxiliary materials. The invention also relates to the preparation method, testing method and application of the composition. Background technique [0002] High blood pressure, or hypertensive disease, is an abnormal condition in which arterial blood pressure exceeds normal values. In 1999, the World Health Organization stipulated that the index of hypertension is systolic blood pressure ≥ 140mmHg and / or diastolic blood pressure ≥ 90mmHg. Hypertension is not only an independent disease, but also an important risk factor for cardiovascular and cerebrovascular diseases, leading to damage to heart, brain, kidney and other important organs and the occurrence of related diseases, the most common of which are stroke, myocardial infarction and renal failure etc. [0003] The average prevalence of hypertension in the national census in 1959...

Claims

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Application Information

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IPC IPC(8): A61K31/4422A61K9/20A61K9/48A61K47/38A61K31/4184A61P9/12A61P9/04A61P9/10A61P13/12G01N30/88
Inventor 郭成辉廖远征黄筱萍颜霞
Owner SICHUAN SUNNYHOPE PHARM CO LTD
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