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Preparation process of compound valsartan amlodipine solid preparation

A technology for solid valsartan amlodipine and amlodipine besylate, applied in the field of medicine, can solve the problems of short shelf life, low dissolution rate, low density of raw materials, etc., and achieves good stability, simple operation and high dissolution rate. high effect

Active Publication Date: 2013-05-08
TIANJIN CHASE SUN PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0015] We have found through experiments that the preparations prepared by the above methods all have problems such as unstable quality, short shelf life, and low dissolution rate.
In addition, we also found that because the fluidity of amlodipine and valsartan solid preparation powders is not suitable for production by direct compression method, when the materials are directly mixed and filled into capsules, the fluidity of the materials is not good. Good, it will lead to problems such as obvious difference in the filling capacity of the capsules, which is not suitable for industrial production
[0016] At present, because amlodipine is clinically used in smaller specifications, generally three specifications of 2.5mg, 5mg, and 10mg, if it is added as a solid raw material, it will not be easy to mix
At the same time, the clinical specifications of valsartan are relatively large, generally 80mg, 160mg, and 320mg, but the raw material has a low density. It is customary to dry granulate it with other materials to increase its density, and then perform tableting or Capsule filling operation, but dry granulation is easy to cause dust to fly. Flying dust is a potential threat to operators, which greatly increases the probability of occupational diseases, increases the difficulty of operation for operators, and reduces production safety. sex

Method used

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  • Preparation process of compound valsartan amlodipine solid preparation
  • Preparation process of compound valsartan amlodipine solid preparation
  • Preparation process of compound valsartan amlodipine solid preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0056] Embodiment 1, tablet prescription and technology:

[0057]

[0058] Process:

[0059] 1) Take the valsartan raw material, pulverize it, pass through a 200-mesh sieve, and set aside.

[0060] 2) Take an appropriate amount of 50% ethanol aqueous solution, add the prescribed amount of amlodipine besylate, stir to dissolve. As an adhesive, set aside.

[0061] 3) Take valsartan and microcrystalline cellulose in a fluidized bed granulator, turn on the hot air, control the temperature at 75±5°C, boil the material, and dissolve 50% ethanol with amlodipine besylate The aqueous solution is atomized through a spray gun, sprayed into the mixed material containing valsartan and microcrystalline cellulose, and granulated. After granulation, continue to keep hot air for about 20 minutes, and dry the obtained granules.

[0062] 4) Take out the dry granules from the fluidized bed granulator, size the granules, calculate the yield, add crospovidone, micronized silica gel, magnesium...

Embodiment 2

[0066] Embodiment 2, capsule prescription and technology:

[0067]

[0068] Process:

[0069] 1) Take the valsartan raw material, pulverize it, pass through a 200-mesh sieve, and set aside.

[0070] 2) Take an appropriate amount of 50% ethanol aqueous solution, add the prescribed amount of amlodipine besylate, stir to dissolve. As an adhesive, set aside.

[0071] 8) Take valsartan and microcrystalline cellulose in a fluidized bed granulator, turn on the hot air, control the temperature at 75±5°C, boil the material, and dissolve 50% ethanol with amlodipine besylate The aqueous solution is atomized through a spray gun, sprayed into the mixed material containing valsartan and microcrystalline cellulose, and granulated. After granulation, continue to keep hot air for about 20 minutes, and dry the obtained granules.

[0072] 3) Take out the dry granules from the fluidized bed granulator, granulate, calculate the yield, add crospovidone, micronized silica gel, magnesium steara...

Embodiment 3

[0075] Embodiment 3, tablet

[0076]

[0077] Preparation method is with embodiment 1.

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Abstract

The invention belongs to the field of medical technology, and particularly relates to a compound valsartan amlodipine solid preparation, and a preparation process as well as application of the compound valsartan amlodipine solid preparation. The preparation process comprises the following steps of: 1) dissolving amlodipine in an ethanol aqueous solution by adopting a fluidized bed pelletizing technology, atomizing and spraying the solution on a pharmaceutically acceptable auxiliary material which includes the valsartan so as to prepare medicine carrying particles containing the two main medicines; and 2) crushing the valsartan and sieving by using a 200-mesh sieve to increase the density of the raw material.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a compound valsartan amlodipine solid preparation and its preparation process and application. Background technique [0002] Valsartan is an orally effective and specific angiotensin II (AT1) receptor antagonist, which selectively acts on AT1 receptor subtypes, blocking the combination of Ang II and AT1 receptors (its specific antagonism The effect of AT1 receptors is about 20,000 times greater than that of AT2 receptors), thereby inhibiting vasoconstriction and the release of aldosterone, resulting in a hypotensive effect. This product does not act on angiotensin-converting enzyme (ACE), renin and other receptors, and does not inhibit ion channels related to blood pressure and sodium balance; this product has no inhibitory effect on angiotensin-converting enzyme, and does not affect bradycardia Peptide levels, thus causing fewer side effects of coughing than angiot...

Claims

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Application Information

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IPC IPC(8): A61K31/4422A61K31/41A61P9/12
Inventor 董凯李宝齐孙长海姚小青
Owner TIANJIN CHASE SUN PHARM CO LTD
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