Olmesartan medoxomil amlodipine tablet and preparation method thereof

A technology of amlodipine ester amlodipine tablets and olmesartan medoxomil, applied in the field of medicine, can solve the problems of affecting drug dissolution and stability, reducing drug bioavailability, increasing drug cost, etc., achieving good clinical application prospects and compatibility The effect of reducing problems and dispersing quickly

Active Publication Date: 2019-09-17
安庆回音必制药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The current conventional preparation method of olmesartan medoxomil and amlodipine tablets is to crush and mix the two main ingredients and other auxiliary materials and then directly compress the tablet. Long-term contact will affect the dissolution and stability of the drug due to the compatibility problem between the main ingredients. Sexuality, which reduces the bioavailability of the drug, reduces the drug effect, and increases the cost of the drug

Method used

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  • Olmesartan medoxomil amlodipine tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] A kind of olmesartan medoxomil amlodipine tablet, its prescription contains the following components by weight: 40 parts of olmesartan medoxomil, 10 parts of amlodipine besylate, 60 parts of silicified microcrystalline cellulose, 30 parts of pregelatinized starch 4 parts of croscarmellose sodium, 30 parts of calcium hydrogen phosphate, 4 parts of sodium starch glycolate, 1 part of magnesium stearate, 0.5 parts of titanium dioxide, 0.5 parts of talc, 4 parts of coating premix .

[0033] The preparation method of described olmesartan medoxomil amlodipine sheet, comprises the following steps:

[0034] (1) Get olmesartan medoxomil and amlodipine besylate and pulverize through a 100-mesh sieve for subsequent use;

[0035] (2) Send olmesartan medoxomil powder, silicified microcrystalline cellulose, pregelatinized starch, and croscarmellose sodium into the mixer for full mixing, and then send it into the mixer with magnesium stearate and titanium dioxide The total mixing is ...

Embodiment 2

[0040] A kind of olmesartan medoxomil amlodipine tablet, its prescription contains the following components by weight: 50 parts of olmesartan medoxomil, 12 parts of amlodipine besylate, 65 parts of silicified microcrystalline cellulose, 30 parts of pregelatinized starch 5 parts, 5 parts of croscarmellose sodium, 30 parts of calcium hydrogen phosphate, 5 parts of sodium carboxymethyl starch, 2 parts of magnesium stearate, 0.6 parts of titanium dioxide, 0.6 parts of talcum powder, 5 parts of coating premix .

[0041] The preparation method of described olmesartan medoxomil amlodipine sheet, comprises the following steps:

[0042] (1) Get olmesartan medoxomil and amlodipine besylate and pulverize through a 100-mesh sieve for subsequent use;

[0043] (2) Send olmesartan medoxomil powder, silicified microcrystalline cellulose, pregelatinized starch, and croscarmellose sodium into the mixer for full mixing, and then send it into the mixer with magnesium stearate and titanium dioxid...

Embodiment 3

[0048] Dissolution Determination

[0049] Investigate under the same time, the average dissolution rate of each 1000 pieces of olmesartan medoxomil and amlodipine tablets of the present invention and common direct compression tablet under light, high temperature and high humidity conditions, as shown in table 1 Shown:

[0050] Table 1 Dissolution Determination

[0051]

[0052]As can be seen from the above table, the olmesartan medoxomil amlodipine tablet of the present invention has better dissolution rate under different conditions than the olmesartan medoxomil amlodipine tablet of common direct compression, and it can be seen that the preparation process is more effective. Help to ensure the effectiveness of the tablet.

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Abstract

The invention discloses an olmesartan medoxomil amlodipine tablet and a preparation method thereof. The olmesartan medoxomil amlodipine tablet is prepared by smashing, tabletting and coating olmesartan medoxomil, amlodipine besylate, silicified microcrystalline cellulose, pregelatinized starch, crosslinked sodium carboxymethyl cellulose, calcium hydrogen phosphate, sodium carboxymethyl starch, magnesium stearate, titanium dioxide, talcum powder, a coating premix and the like, has an ideal clinical therapeutic effect, and effectively improves the stability of the drug release of the compound medicine, the raw materials in the preparation process are all subjected to powder processing, the preparation process is simple, and the finally obtained olmesartan medoxomil amlodipine tablet has strong stability, fast dispersion, good absorption and a good clinical application prospect.

Description

technical field [0001] The invention belongs to the technical field of medicines, in particular to an olmesartan medoxomil amlodipine tablet and a preparation method thereof. Background technique [0002] Olmesartan medoxomil and amlodipine tablets are a compound antihypertensive drug composed of angiotensin II receptor blocker (ARB) olmesartan medoxomil and calcium ion channel blocker (CCB) amlodipine. Among them, olmesartan medoxomil is a prodrug, which is absorbed and hydrolyzed into olmesartan through the gastrointestinal tract. Olmesartan is a selective angiotensin II type 1 receptor (AT1) antagonist, which blocks the vasoconstrictive effect of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor of vascular smooth muscle. Its role is independent of the Ang II synthesis pathway. The affinity of olmesartan for AT1 is more than 12500 times greater than that for AT2. Amlodipine is a dihydropyridine calcium antagonist (also known as ca...

Claims

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Application Information

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IPC IPC(8): A61K31/4422A61K9/32A61K9/24A61P9/12A61K31/4178
CPCA61K31/4178A61K31/4422A61K9/2853A61K9/209A61P9/12A61K2300/00
Inventor 王大冲马继红翟绪武郭廷富张曦刘文韬
Owner 安庆回音必制药股份有限公司
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