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Compound amlodipine and valsartan solid preparation and preparation method thereof

A technology for compound amlodipine-valsartan solid preparation is applied in the field of compound amlodipine-valsartan solid preparation and preparation thereof, and can solve the problems of affecting the dissolution of amlodipine, the disparity of amlodipine doses, and the high energy consumption of dry granulation , to achieve the effect of good liquidity, good industrial production value, and low equipment requirements

Inactive Publication Date: 2010-06-23
YANGTZE RIVER PHARM GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, dry granulation has the disadvantages of high energy consumption, small adaptability, high requirements for equipment or the need for workshop renovation, and certain dust pollution.
[0011] The doses of valsartan and amlodipine in the preparation are very different, and they are almost insoluble in water. The presence of large doses of valsartan affects the dissolution of amlodipine

Method used

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  • Compound amlodipine and valsartan solid preparation and preparation method thereof
  • Compound amlodipine and valsartan solid preparation and preparation method thereof
  • Compound amlodipine and valsartan solid preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0062] Preparation of Compound Amlodipine-Valsartan Tablets

[0063] The prescription is (per 1000 tablets):

[0064] A: Amlodipine besylate 6.93g *

[0065] B: micronized silica gel 5g

[0066] C: Croscarmellose Sodium 8g

[0067] D: Valsartan 160g

[0068] E: Microcrystalline Cellulose 110g

[0069] F: Lactose 50g

[0070] G: Magnesium stearate 2g

[0071] H: Croscarmellose Sodium 4g

[0072] I: Polyvinylpyrrolidone (K30) 37g

[0073] J: distilled water 900g

[0074] *: Corresponds to 5 g of amlodipine.

[0075] Grind materials A~C, pass through a 100-mesh sieve, and mix uniformly to obtain mixture I; crush materials D~F, pass through a 100-mesh sieve, and mix evenly to obtain mixture II; add mixture I to In mixture II, mix evenly to obtain mixture III; completely dissolve I: polyvinylpyrrolidone (K30) in J: distilled water to obtain a binder; use this binder to granulate mixture II, and control the drying temperature at 45 °C, the water content of the granules i...

Embodiment 2

[0079] Preparation of compound amlodipine valsartan besylate capsules

[0080] The prescription is (per 1000 capsules):

[0081] A: Amlodipine besylate 6.93g *

[0082] B: micronized silica gel 5g

[0083] C: Croscarmellose Sodium 8g

[0084] D: Valsartan 160g

[0085] E: Microcrystalline Cellulose 110g

[0086] F: Lactose 50g

[0087] G: Magnesium stearate 4g

[0088] H: medicinal talcum powder 2g

[0089] I: Polyvinylpyrrolidone (K30) 37g

[0090] J: distilled water 900g

[0091] *: Corresponds to 5 g of amlodipine.

[0092] Grind materials A~C, pass through a 100-mesh sieve, and mix uniformly to obtain mixture I; crush materials D~F, pass through a 100-mesh sieve, and mix evenly to obtain mixture II; add mixture I to the mixture in equal increments In II, mix evenly to obtain mixture III; completely dissolve I: polyvinylpyrrolidone (K30) in H: distilled water to obtain a binder; use this binder to granulate mixture II, and control the drying temperature at 45°C ...

Embodiment 3

[0095] Preparation of Compound Amlodipine-Valsartan Tablets

[0096] The prescription is (per 1000 tablets):

[0097] A: Amlodipine besylate 3.47g *

[0098] B: micronized silica gel 4g

[0099] C: Crospovidone 6g

[0100] D: Valsartan 80g

[0101] E: Microcrystalline cellulose 80g

[0102] F: Lactose 30g

[0103] G: Magnesium stearate 2g

[0104] H: Low-substituted hydroxypropyl cellulose 2g

[0105] I: Hypromellose (E4M) 21g

[0106] J: Distilled water 700g

[0107] *: Corresponds to 2.5 g of amlodipine.

[0108]Grind materials A~C, pass through a 100-mesh sieve, and mix uniformly to obtain mixture I; crush materials D~F, pass through a 100-mesh sieve, and mix evenly to obtain mixture II; add mixture I to In mixture II, mix evenly to obtain mixture III; completely dissolve I: polyvinylpyrrolidone (K30) in J: distilled water to obtain a binder; use this binder to granulate mixture II, and control the drying temperature at 45 °C, the water content of the granules i...

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Abstract

The invention discloses a compound amlodipine and valsartan solid preparation and a preparation method thereof. The preparation can be a tablet or a capsule and contains 2.5-10g of amlodipine or pharmaceutically acceptable salt thereof (calculated according to the amlodipine) and 40-640g of valsartan or pharmaceutically acceptable salt thereof (calculated according to the valsartan). The preparation method of the compound amlodipine and valsartan solid preparation comprises the steps of mixing the two medicines and the corresponding medicinal auxiliary materials according to the proportion, mixing with the corresponding lubricant or glidant after granulating in a wet method, and pressing into a tablet or filling into a capsule so as to obtain the compound amlodipine and valsartan solid preparation. In the invention, the tablet or the capsule is prepared after the two active substances with unequal doses are granulated in the wet method, and the method is simple and convenient, is easy to control the quality and is suitable for the industrialized production. More than 85% of the amlodipine in the preparation is dissolved out within 30 minutes, and the invention has favorable market popularization prospect.

Description

technical field [0001] The invention belongs to the technical field of medicine, in particular to a compound amlodipine valsartan solid preparation and a preparation method thereof. Background technique [0002] Cardiovascular and cerebrovascular diseases are the second "killer" that endangers human health after tumors. Hypertension is a common cardiovascular disease and can induce or aggravate other related diseases. At present, about 2 / 3 of hypertensive patients need to take two or more antihypertensive drugs to control blood pressure. Compound amlodipine valsartan solid preparation can significantly reduce blood pressure while providing two powerful antihypertensive drugs. Adverse reactions, and easy to take, improve patient compliance. [0003] Amlodipine is an antihypertensive drug belonging to the dihydropyridine class of calcium antagonists (calcium ion antagonists or slow channel blockers). Commonly used amlodipine besylate English name is Amlodipine Besylate, chem...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4422A61K31/41A61K9/32A61K9/48A61J3/10A61J3/07A61P9/12
Inventor 范文源孙田江张玉斌罗永惠王延松魏春燕陆宏国
Owner YANGTZE RIVER PHARM GRP CO LTD
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