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Moxifloxacin hydrochloride pharmaceutical composition and preparation method thereof

A technology of moxifloxacin hydrochloride and its composition, which is applied in the field of medicine, can solve problems such as difficult control, complex process, and uneven coating film, and achieve the goals of saving usage and cost, good quality stability, and shortening coating time Effect

Inactive Publication Date: 2014-05-07
SHENZHEN SALUBRIS PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0015] The invention of US2011293717 provides a moxifloxacin hydrochloride pharmaceutical composition prepared by a dry method. The coating agent is a mixture of low-viscosity hypromellose, titanium dioxide, polyethylene glycol and iron oxide. It is found in practice that the tablet core It is prepared by dry method, the process is relatively complicated, difficult to control, and the reproducibility is poor. The hypromellose in the coating agent is coated with phamacoat 603, and the coating film is incomplete and the uniformity is poor.
[0016] Although the prior art discloses the prescription composition and preparation method of moxifloxacin hydrochloride pharmaceutical compositions in various dosage forms, it has been found in practice that due to the poor water solubility of moxifloxacin hydrochloride and the large weight ratio in the pharmaceutical composition, especially tablets The pharmaceutical composition of the dosage form is coated with a low-viscosity HPMC and polyethylene glycol, or Opadry, which often has uneven coating film, long coating time, poor dissolution effect or tablet drug Problems such as poor composition stability

Method used

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  • Moxifloxacin hydrochloride pharmaceutical composition and preparation method thereof
  • Moxifloxacin hydrochloride pharmaceutical composition and preparation method thereof
  • Moxifloxacin hydrochloride pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] Embodiment 1 moxifloxacin hydrochloride pharmaceutical composition

[0053]

[0054] Tablet core preparation method: mix moxifloxacin hydrochloride, microcrystalline cellulose, croscarmellose sodium, and pregelatinized starch evenly, add moxifloxacin hydrochloride, microcrystalline cellulose, and croscarmellose Sodium and water with 45% of the total weight of pregelatinized starch are wet granulated. After drying and granulating, the dry granules are mixed with magnesium stearate evenly, and the tablet core is obtained by pressing according to the content of the granules. Each tablet is equivalent to molybdenum. Cifloxacin 400mg;

[0055] Coating: Mix two kinds of hypromellose, polyethylene glycol 6000, titanium dioxide and red iron oxide evenly, add them to absolute ethanol to disperse evenly, and then add purified water under stirring conditions to obtain a coating solution , place the tablet core in a coating pan, control the temperature of the material at 40°C f...

Embodiment 2

[0056] Embodiment 2 moxifloxacin hydrochloride pharmaceutical composition

[0057]

[0058] Tablet core preparation method: mix moxifloxacin hydrochloride, microcrystalline cellulose, croscarmellose sodium, and pregelatinized starch evenly, add moxifloxacin hydrochloride, microcrystalline cellulose, and croscarmellose Sodium and water with 50% of the total weight of pregelatinized starch are wet granulated. After drying and granulating, the dry granules are mixed with magnesium stearate evenly, and the tablet core is obtained by pressing according to the content of the granules. Each tablet is equivalent to molybdenum. Cifloxacin 400mg;

[0059] Coating: Mix two kinds of hypromellose, macrogol 6000, titanium dioxide and red iron oxide evenly, add them to the mixed solvent of absolute ethanol and purified water to disperse evenly, stir to prepare the coating solution, and Tablet cores were placed in a coating pan, the temperature of the material was controlled at 50°C for c...

Embodiment 3

[0060] Embodiment 3 moxifloxacin hydrochloride pharmaceutical composition

[0061]

[0062]

[0063] Tablet core preparation method: mix moxifloxacin hydrochloride, calcium phosphate, and cross-linked polyvinylpyrrolidone evenly, add water with 40% of the total weight of moxifloxacin hydrochloride, calcium phosphate, and cross-linked polyvinylpyrrolidone, perform wet granulation, and dry the granules Finally, mix the dry granules with stearic acid evenly, press into tablets according to the content of the granules to obtain tablet cores, and each tablet is equivalent to containing 400 mg of moxifloxacin;

[0064] Coating: mix two kinds of hypromellose, macrogol 6000, titanium dioxide and red iron oxide evenly, add to purified water and disperse evenly, stir to obtain coating liquid, put the tablet core in the coating pan Inside, control the temperature of the material at 50°C for coating, the weight gain of the coating is 1.0%, stop the coating, and dry to obtain moxiflo...

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Abstract

The invention provides a moxifloxacin hydrochloride pharmaceutical composition and preparation method thereof. The invention is characterized in that: tablet core is prepared by moxifloxacin hydrochloride, more than one excipient and a coating material, wherein, the weight of moxifloxacin hydrochloride is 60-70% of that of the tablet core, and the weight of excipients is 30-40% of that of the tablet core, and the weight of the coating material which is used for coating the tablet core and is composed of hypromellose with two or more than two viscosities is 1.0-4.0% of that of the pharmaceutical composition tablet core, and the weight ratio between hypromellose with viscosity of 40-120mPa.s and hypromellose with viscosity of 2.5-1.8mPa.s is 1:5-1:2. The pharmaceutical composition has the advantages of good stability, simple preparation technology and easy reproduction; the preparation method is suitable for industrial production.

Description

technical field [0001] The invention relates to a pharmaceutical composition and a preparation method thereof in the technical field of medicine, in particular to a moxifloxacin hydrochloride pharmaceutical composition and a preparation method thereof. Background technique [0002] Moxifloxacin Hydrochloride, English name: Moxifloxacin Hydrochloride, is light yellow to yellow crystalline powder, slightly soluble in water and methanol, slightly soluble in ethanol, almost insoluble in acetone, the structural formula is as follows: [0003] [0004] Moxifloxacin hydrochloride is the fourth-generation broad-spectrum 8-methoxyfluoroquinolone antibacterial drug. It is an antibacterial drug widely used in clinical practice in recent years, and it is also a relatively new class of synthetic antibacterial drug. Moxifloxacin hydrochloride can directly fight Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis, which is different from the currently used fluoroq...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4709A61K47/38A61K9/36A61P31/04
Inventor 李凤李洪
Owner SHENZHEN SALUBRIS PHARMA CO LTD
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