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Preparation method of valsartan amlodipine tablet and valsartan amlodipine tablet

A technology of valsartan amlodipine tablet and dipine tablet, applied in the field of medicine, can solve the problems of difficult moisture control, poor particle fluidity and the like, and achieve the effect of improving stability

Active Publication Date: 2021-05-25
HAINAN HUALON PHARM
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The invention provides a preparation method of valsartan and amlodipine tablets and valsartan and amlodipine tablets, which are used to solve the difficulty of moisture in the preparation process of valsartan and amlodipine tablets in the existing technological environment with high humidity. control, and the technical problem of poor particle fluidity during mixing

Method used

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  • Preparation method of valsartan amlodipine tablet and valsartan amlodipine tablet
  • Preparation method of valsartan amlodipine tablet and valsartan amlodipine tablet
  • Preparation method of valsartan amlodipine tablet and valsartan amlodipine tablet

Examples

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Embodiment 1

[0033] An embodiment of a method for preparing valsartan and amlodipine tablets provided by the present invention, the types of components included in the tablet core and the weight ratio of each component are:

[0034]

[0035] The unit of the above parts by weight is mg / tablet.

[0036] The preparation process is as follows:

[0037] (1) Premixing for the first time: add microcrystalline cellulose PH102, amlodipine besylate, crospovidone and silicon dioxide into the mixer in sequence, at a speed of 10 rpm, and mix for 5 minutes to obtain the first premix;

[0038] (2) Premixing for the second time: turn on the mixer, then add valsartan and magnesium stearate to the first premix in sequence, at a speed of 10 rpm, and mix for 10 minutes to obtain the second premix;

[0039] (3) Sieve: add the second premix into the oscillating granulator, and pass through a 40-mesh sieve twice;

[0040] (4) The third premixing: put the sieved material into the mixer at a speed of 10rpm, a...

Embodiment 2

[0050] As a further improvement to Example 1, the type of constituents included in the tablet core and the weight ratio of each constituent are:

[0051]

[0052]

[0053] The unit of the above parts by weight is mg / tablet.

[0054] The preparation process is as follows:

[0055] (1) Premixing for the first time: add microcrystalline cellulose PH102, amlodipine besylate, crospovidone and silicon dioxide into the mixer in sequence, at a speed of 10 rpm, and mix for 5 minutes to obtain the first premix;

[0056] (2) Premixing for the second time: turn on the mixer, then add valsartan and magnesium stearate to the first premix in sequence, at a speed of 10 rpm, and mix for 10 minutes to obtain the second premix;

[0057] (3) Sieve: add the second premix into the oscillating granulator, and pass through a 40-mesh sieve twice;

[0058] (4) The third premixing: put the sieved material into the mixer at a speed of 10rpm, and mix for 15min;

[0059] (5) Dry granulation: add t...

Embodiment 3

[0097] The present application also provides an embodiment of the valsartan and amlodipine tablets prepared according to the preparation method of the valsartan and amlodipine tablets of embodiment 1 or embodiment 2, the valsartan and amlodipine tablet core includes The component types and the weight ratio of each component are:

[0098] 80 parts by weight of valsartan;

[0099] The amlodipine besylate of 6.93 parts by weight;

[0100] 60 parts by weight of microcrystalline cellulose PH102;

[0101] The crospovidone of 20 weight parts;

[0102] 3 parts by weight of silicon dioxide;

[0103] 4.5 parts by weight of magnesium stearate.

[0104] Wherein, 4.5 parts by weight of magnesium stearate includes 3 parts by weight of internally added magnesium stearate and 1.5 parts by weight of externally added magnesium stearate, silicon dioxide is silicon dioxide SH-QX1, and crospovidone is crospovidone. Lipovidone XL.

[0105] The valsartan and amlodipine tablets provided in the ex...

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Abstract

The present invention provides a preparation method of a valsartan amlodipine tablet and a valsartan amlodipine tablet. Raw materials and auxiliary materials are sequentially added into a mixer in batches in a premixing mode to be mixed, in the first premixing process, amlodipine besylate and microcrystalline cellulose PH102 are mixed, due to the fact that the water content of the microcrystalline cellulose PH102 is low, meanwhile, the silicon dioxide can be used as a drying agent and can improve the stability of the amlodipine besylate in a high-humidity environment, the microcrystalline cellulose PH102 and the amlodipine besylate are added in the first premixing, so that the amlodipine besylate can be mixed with other materials more uniformly, rhe disintegration speed of the valsartan amlodipine tablet is increased by adding a disintegrating agent polyvinylpolypyrrolidone, and the fluidity of particles in the first premixing process is increased by internally adding silicon dioxide, so that the first premix is uniformly mixed, and the problems that in an existing process environment with relatively high humidity, the water content in the preparation process of the valsartan amlodipine tablet is difficult to control, and the flowability of particles is poor in the mixing process.

Description

technical field [0001] The invention belongs to the technical field of medicines, in particular to a preparation method of valsartan amlodipine tablets and valsartan amlodipine tablets. Background technique [0002] Valsartan is an orally effective and specific angiotensin II (AT1) receptor antagonist that selectively acts on AT1 receptor subtypes, blocking the binding of Ang II to AT1 receptors (its specificity The effect of antagonizing the AT1 receptor is about 20,000 times greater than that of the AT2 receptor), thereby inhibiting vasoconstriction and the release of aldosterone, resulting in a hypotensive effect. [0003] Amlodipine (usually using its besylate salt, i.e. amlodipine besylate) is a calcium channel blocker, which mainly exerts antihypertensive and antianginal effects by blocking the extracellular calcium ion channels of cardiac muscle and vascular smooth muscle cells. effect. [0004] Valsartan and Amlodipine Tablets include two antihypertensive active in...

Claims

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Application Information

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IPC IPC(8): A61K31/4422A61K9/28A61K47/38A61K47/04A61K47/32A61K47/12A61J3/06A61P9/10A61P9/12A61K31/41
CPCA61K31/41A61K31/4422A61K9/2013A61K9/2054A61K9/2009A61K9/28A61J3/06A61P9/12A61P9/10A61K2300/00
Inventor 陈益智史江永李军
Owner HAINAN HUALON PHARM