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Amlodipine besylate compound preparation and preparation method thereof

A technology of amlodipine besylate compound and amlodipine besylate, which is applied in the field of amlodipine besylate compound preparation and its preparation, and can solve the problem of lowering, short duration of action, increasing angiotensin II, etc. problems, to achieve the effect of less side effects, increase the antihypertensive effect, and offset the adverse reactions

Inactive Publication Date: 2010-07-07
BEIJING HOPE HUGE PHARM SCI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the pharmacodynamic effect of competitive receptor antagonists (such as eprosartan and losartan and their active metabolites) can be reduced by increasing the level of angiotensin II, so the duration of action is shorter. Besartan and losartan require twice-daily dosing to control blood pressure within 24 hours

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] Embodiment 1: specification 1000 pieces

[0015] Prescription: Amlodipine Besylate 10g

[0016] Olmesartan Medoxomil 15g

[0017] Lactose 25g

[0018] Microcrystalline Cellulose 40g

[0019] Mannitol 25g

[0020] Crospovidone 10g

[0021] Aspartame 0.1g

[0022] Fruit milk essence 0.1g

[0023] Micronized silica gel 0.75g

[0024] Magnesium stearate 0.75g

[0025] 30% ethanol solution of 8% povidone appropriate amount

[0026] Preparation method: Take the prescribed amount of amlodipine besylate, olmesartan medoxomil, microcrystalline cellulose, lactose, mannitol, crospovidone, sieve, mix well, add 30% of 8% povidone Add the ethanol solution to the above mixture to make a soft material, pass through a 20-mesh sieve to granulate, dry at 60°C for 6 hours, granulate with a 20-mesh sieve, add fruit milk essence, magnesium stearate, aspartame, micro-powdered silica gel, and use a 30-mesh sieve Sieve whole grains, mix well, compress into tablets or pack into capsule...

Embodiment 2

[0027] Embodiment 2: 1000 pieces of specifications

[0028] Amlodipine Besylate 10g

[0029] Olmesartan Medoxomil 10g

[0030] Microcrystalline Cellulose 50g

[0031] Sodium carboxymethyl starch 2.5g

[0032] Lactose 20g

[0033] Mannitol 20g

[0034] Crospovidone 9g

[0035] Aspartame 0.1g

[0036] Fruit milk essence 0.1g

[0037] Micronized silica gel 0.75g

[0038] Magnesium stearate 0.75g

[0039] 30% ethanol solution of 8% povidone appropriate amount

[0040] Preparation method: Take the prescribed amount of amlodipine besylate, olmesartan medoxomil, microcrystalline cellulose, sodium carboxymethyl starch, lactose, mannitol, and crospovidone, sieve, mix well, and use an appropriate amount of 8% Add 30% ethanol solution of povidone to the above mixture to make soft material, granulate through a 20-mesh sieve, dry at 60°C for 6 hours, granulate with a 20-mesh sieve, add fruit milk essence, magnesium stearate, aspartame, Micronized silica gel, granulated with 30-m...

Embodiment 3

[0041] Embodiment 3: 1000 pieces of specifications

[0042] Prescription: Amlodipine Besylate 10g

[0043] Olmesartan Medoxomil 10g

[0044] Lactose 25g

[0045] Microcrystalline Cellulose 40g

[0046] Mannitol 25g

[0047] Crospovidone 10g

[0048] Aspartame 0.1g

[0049] Fruit milk essence 0.1g

[0050] Micronized silica gel 0.75g

[0051] Magnesium stearate 0.75g

[0052] 30% ethanol solution of 8% povidone appropriate amount

[0053] Preparation method: Take the prescribed amount of amlodipine besylate, olmesartan medoxomil, microcrystalline cellulose, lactose, mannitol, crospovidone, sieve, mix well, add 30% of 8% povidone Add the ethanol solution to the above mixture to make a soft material, pass through a 20-mesh sieve to granulate, dry at 60°C for 6 hours, granulate with a 20-mesh sieve, add fruit milk essence, magnesium stearate, aspartame, micro-powdered silica gel, and use a 30-mesh sieve Sieve whole grains, mix well, compress into tablets or pack into cap...

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Abstract

The invention relates to the field of medicinal preparation, in particular to an amlodipine besylate compound preparation and a preparation method thereof. The preparation is characterized in that each unit preparation consists of 2 to 50mg of amlodipine besylate, 5 to 50mg of olmesartan medoxomil and auxiliary materials, and particularly, each unit preparation contains 10mg of amlodipine besylate and 10mg of olmesartan medoxomil. The invention also discloses a preparation method for the compound preparation. The preparation is used for curing primary hypertension, has good synergistic effect, and offsets adverse effect caused by respective medicament while increasing the effect of reducing hypertension.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an amlodipine besylate compound preparation and a preparation method thereof. Background technique [0002] Hypertension is one of the most common and important cardiovascular diseases in clinical practice. According to a recent report by the International Society of Hypertension, there are about 972 million people worldwide suffering from high blood pressure or high blood pressure, equivalent to 26.4% of the adult population. With the continuous improvement of people's living standards, the prevalence of hypertension in my country is also increasing year by year. According to the epidemiological statistics of hypertension, the prevalence rate of hypertension among adults in my country has risen from 5.1% in 1959 to 11.68% at present. On the one hand, hypertension can be a clinical manifestation caused by different reasons and diseases, and on the other hand, it can b...

Claims

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Application Information

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IPC IPC(8): A61K31/4422A61K31/4178A61P9/12
Inventor 王翰斌王翰腾闫文学
Owner BEIJING HOPE HUGE PHARM SCI
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