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Cinacalcet hydrochloride film-coated tablet composition

A technology for cinacalcet hydrochloride and film-coated tablets, which is applied in the field of cinacalcet hydrochloride film-coated tablet compositions, can solve the problems of high cost, long preparation time, special equipment, etc., achieve low cost, simple preparation process, The effect of simplifying the production process

Active Publication Date: 2015-06-24
仁合益康集团有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In existing technologies such as patent applications CN102198108A, CN102885792A, micronization is used, solid composites are made, or dry granulation is used, etc., all of which have defects such as requiring special equipment, long preparation time, and high cost.

Method used

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  • Cinacalcet hydrochloride film-coated tablet composition
  • Cinacalcet hydrochloride film-coated tablet composition
  • Cinacalcet hydrochloride film-coated tablet composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Embodiment 1 Cinacalcet hydrochloride film-coated tablet of the present invention

[0033] Chip layer:

[0034]

[0035]

[0036] Among them, the prescription composition of the film coating layer is: Opadry gastro-soluble film coating premix and purified water, the weight ratio is 1:10.

[0037] Preparation Process:

[0038] Take the raw and auxiliary materials and mix evenly, compress into tablets, and coat to obtain (25mg / tablet).

Embodiment 2

[0039] Embodiment 2 Cinacalcet hydrochloride film-coated tablet of the present invention

[0040] Chip layer:

[0041]

[0042] Among them, the prescription composition of the film coating layer is: Opadry stomach-soluble film coating premix and purified water, the weight ratio is 0.8:10.

[0043] Preparation Process:

[0044] Take the raw and auxiliary materials and mix evenly, compress into tablets, and coat to obtain (75mg / tablet).

Embodiment 3

[0045] Embodiment 3 Cinacalcet hydrochloride film-coated tablet of the present invention

[0046] Chip layer:

[0047]

[0048] Among them, the prescription composition of the film coating layer is: Opadry stomach-soluble film coating premix and purified water, the weight ratio is 1.2:10.

[0049] Preparation Process:

[0050] Take the raw and auxiliary materials and mix evenly, compress into tablets, and coat to obtain (25mg / tablet).

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PUM

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Abstract

The invention provides a cinacalcet hydrochloride film-coated tablet composition and a preparation method thereof. The cinacalcet hydrochloride film-coated tablet comprises cinacalcet hydrochloride, polacrilin potassium, microcrystalline cellulose, silicon dioxide, magnesium stearate and a film coating. The cinacalcet hydrochloride film-coated tablet has the advantages of simple process, low cost and good digestion.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a cinacalcet hydrochloride film-coated tablet composition. Background technique [0002] Cinacalcet Hydrochloride (Cinacalcet Hydrochlorid) chemical name N-((1R)-1-(1-naphthyl)ethyl)-3-(3-(trifluoromethyl)phenyl)propan-1-amine salt acid salt, formula C 22 h 22 f 3 N HCl, the structural formula is as follows: [0003] [0004] Hyperparathyroidism leads to elevated parathyroid hormone (PTH), changes in calcium and phosphorus metabolism, and may induce osteoporosis, coronary heart disease and other diseases. Elevated blood calcium levels can lead to confusion, lethargy, dehydration, nausea, and constipation. Cinacalcet hydrochloride is a calcimimetic agent that can reduce parathyroid hormone (PTH) and serum calcium levels in the body, regulate calcium and phosphorus metabolism, and treat hypercalcemia caused by parathyroid cancer. [0005] The dissolutio...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K31/137A61K47/32A61K47/04A61P5/20A61P35/00A61P5/22
Inventor 刘淑景
Owner 仁合益康集团有限公司
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