Moxifloxacin capsules, and preparation method thereof

A technology of moxifloxacin hydrochloride and capsules, applied in the field of medicine, can solve problems such as inability to be equivalent, slow dissolution and the like

Inactive Publication Date: 2014-06-18
NANJING CHANGAO PHARMA SCI & TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The inventor found that the embodiment of patent CN100363001C has two defects: 1. Although the cellulose capsule shell can reach 90% in 0.1M hydrochloric acid for 45 minutes, the dissolution is slow in the first 15 minutes, and the f2 factor method cannot be compared with the original research tablet. 2. The current drug regulations "Guiding Principles for Dissolution Test of Oral Solid Preparations" require that generic drugs and modified dosage forms should undergo 4 dissolution curves

Method used

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  • Moxifloxacin capsules, and preparation method thereof
  • Moxifloxacin capsules, and preparation method thereof
  • Moxifloxacin capsules, and preparation method thereof

Examples

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reference example

[0022] Adopt the embodiment 2 of patent CN200510021739.1 to prepare samples,

[0023] Prescription composition:

[0024]

[0025] Preparation method: Take the raw materials and auxiliary materials in the above components, mix them well, make granules by dry method, and fill the hydroxypropyl cellulose capsule shell to get the product.

Embodiment 1

[0027] Prescription composition:

[0028]

[0029] Preparation:

[0030] ① Mix moxifloxacin hydrochloride and carboxymethyl starch sodium uniformly according to the method of equal volume addition, then mix with microcrystalline cellulose evenly, and take internally added magnesium stearate and mix evenly;

[0031] ②Start the dry granulator, adjust the distance between the rollers to 0.2 mm, the feeding speed to 72 revolutions / min, the speed of the pressing wheel to 2 revolutions / min, and the screen mesh to be 10-18 meshes, pour the above materials into the feeding hopper, and The material is received at the outlet.

[0032] ③Mix the dry granulated granules and magnesium stearate evenly, fill them into No. 0 gelatin capsules with capsule filler, and obtain the product.

Embodiment 2

[0034] Prescription composition:

[0035]

[0036]

[0037] Preparation:

[0038] Thoroughly mix moxifloxacin hydrochloride with auxiliary materials microcrystalline cellulose, sodium carboxymethyl starch and magnesium stearate to make granules by dry method, fill them in gelatin capsules, and obtain the product.

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Abstract

The invention belongs to the field of pharmaceutical industry, and relates to moxifloxacin capsules. A content of the moxifloxacin capsules comprises moxifloxacin hydrochloride, microcrystalline cellulose, sodium carboxymethyl starch, and magnesium stearate; the ingredients above are mixed, an obtained mixture is made into particles, and the particles are packaged by gelatin capsules so as to obtain the moxifloxacin capsules. Novel prescription and novel technology adopted by a preparation method of the moxifloxacin capsules are capable of avoiding reduction of dissolubility in storage processes, and ensuring f2 equivalence of the moxifloxacin capsules in four dissolution mediums with original grinded capsules.

Description

technical field [0001] The invention belongs to the technical field of medicine and relates to a pharmaceutical preparation containing moxifloxacin hydrochloride (moxifloxacin HCl), in particular to a capsule of moxifloxacin hydrochloride and a preparation method thereof. Background technique [0002] Moxiflaxacin is a new generation of fluoroquinolone antimicrobials. Currently, this variety has been listed in tablets and injections for upper and lower respiratory tract infections caused by sensitive microorganisms, such as acute exacerbation of chronic bronchial inflammation, community-acquired pneumonia, acute Treatment of bacterial sinusitis and uncomplicated skin and soft tissue infections. [0003] The patent CN114993C is a preparation patent researched by the original manufacturer Bayer, focusing on the protection of tablet prescriptions. The prescription is described as moxifloxacin, microcrystalline cellulose, lactose, croscarmellose sodium, magnesium stearate, and ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/4709A61K47/38A61P31/04
Inventor 吴小涛黄洋杨晓兵李战李纬霍立茹
Owner NANJING CHANGAO PHARMA SCI & TECH CO LTD
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