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A kind of valsartan amlodipine tablet and preparation method thereof

The technology of valsartan amlodipine tablet and amlodipine besylate is applied in the field of medicine, and can solve the problems such as the huge difference in the content of valsartan and amlodipine, the complicated tablet process, and the difficulty in mixing the auxiliary materials evenly.

Active Publication Date: 2020-07-07
HUNAN QIANJIN XIELI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Because valsartan has the characteristics of light texture, poor fluidity, easy to generate static electricity, easy to accumulate into agglomerates, and difficult to mix evenly with excipients, the process for preparing tablets is relatively complicated.
In addition, the hydrophobicity of valsartan is extremely strong, and the content of valsartan and amlodipine in the preparation is quite different. Using conventional excipients and preparation methods, the dissolution rate and uniformity of the drug are difficult to meet the requirements
Amlodipine besylate is unstable to humidity, and it is easy to hydrolyze to produce impurities under high humidity conditions, which will affect product stability

Method used

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  • A kind of valsartan amlodipine tablet and preparation method thereof
  • A kind of valsartan amlodipine tablet and preparation method thereof
  • A kind of valsartan amlodipine tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] A kind of valsartan amlodipine tablet, its composition and the content of each composition are as shown in table 1 below. Its preparation method is as follows:

[0041] (1) mixing and pulverizing valsartan and colloidal silicon dioxide to obtain micronized valsartan;

[0042] (2) Amlodipine besylate and microcrystalline cellulose PH103 are uniformly mixed by equal increment method to obtain premix 1;

[0043] (3) Mix the micronized valsartan and crospovidone XL-10 (internal addition) obtained in step (1) with the premix 1 obtained in step (2) and put them into a dry granulator to prepare Get the core;

[0044] (4) The tablet core prepared in step (3), crospovidone XL (additional), magnesium stearate and colloidal silicon dioxide (additional) are mixed evenly, and valsartan amlodipine is obtained after tableting piece.

[0045] The equal increasing method in step (2) is to firstly mix 6.94mg amlodipine besylate and 6.94mg microcrystalline cellulose PH103 to obtain 13...

Embodiment 2

[0081] A valsartan amlodipine tablet, the preparation method of which is the same as that of Example 1, except that the amount of disintegrant is different, see Table 4 below for specific differences.

Embodiment 3

[0094] A kind of valsartan amlodipine tablet, its component and the content of each component are as shown in Table 6 below. Its preparation method is as follows:

[0095] (1) Mixing and pulverizing valsartan and colloidal silicon dioxide to obtain micronized valsartan; wherein, the D50 of micronized valsartan is 3.0 μm, and the D90 is 9.0 μm;

[0096] (2) Amlodipine besylate and microcrystalline cellulose PH103 are uniformly mixed by equal increment method to obtain premix 1;

[0097] (3) Mix the micronized valsartan and crospovidone XL-10 (internal addition) obtained in step (1) with the premix 1 obtained in step (2) and put them into a dry granulator to prepare Get the core;

[0098] (4) Manually mix the tablet core prepared in step (3), crospovidone XL (additional), magnesium stearate and colloidal silicon dioxide (additional), take a sample for detection, calculate the weight of the tablet, and press the tablet Obtain valsartan amlodipine tablet afterward.

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Abstract

The invention discloses a valsartan and amlodipine tablet, which comprises a tablet core and a coating outside the tablet core. The tablet core comprises the following ingredients (by weight): 8-12 parts of valsartan, 0.8-1 part of amlodipine besylate, 8-12 parts of microcrystalline cellulose, 0.4-0.6 part of a disintegrating agent and 0.1-0.2 part of colloidal silicon dioxide. The coating comprises the following ingredients (by weight): 0.2-0.4 part of a disintegrating agent, 0.1-0.2 part of colloidal silicon dioxide and 0.4-0.6 part of magnesium stearate. The invention also correspondingly provides a preparation method of the valsartan and amlodipine tablet. The valsartan and amlodipine tablet of the invention has good disintegration and dissolution and good dispersion uniformity of active ingredients. In addition, the technology of the invention is simple and easy to operate and is suitable for industrial production.

Description

technical field [0001] The invention belongs to the technical field of medicines, in particular to a valsartan medicament and a preparation method thereof. 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] Because valsartan has the characteristics of light texture, poor fluidity, easy to generate static electricity, easy to accumulate into agglomerates, and difficult to mix evenly with auxiliary materials, the process for preparing tablets is more complicated. In addition, valsartan is extremely hydrophobic, and the content of valsartan and amlodipine in the preparation is quite diff...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/36A61K47/32A61K47/04A61K47/38A61K31/41A61K31/4422A61P9/12
CPCA61K9/2009A61K9/2027A61K9/2054A61K9/2813A61K9/284A61K31/41A61K31/4422A61K2300/00
Inventor 钟林波谭喜平张泽昀何爽
Owner HUNAN QIANJIN XIELI PHARMA CO LTD
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