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Moxifloxacin hydrochloride pharmaceutical composition and its preparation method

A technology of moxifloxacin hydrochloride and composition, applied in the preparation of the pharmaceutical composition, the field of pharmaceutical compositions containing moxifloxacin hydrochloride, mannitol and other excipients, can solve the problem of unstable product quality, batch It can reduce the operating time and labor, and achieve the effect of good compressibility and good fluidity.

Active Publication Date: 2011-10-05
CHINA RESOURCES SAIKE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in the wet granulation process, factors such as the amount of binder added, the drying time of granules, and the sieving time of granulation should be considered. The number of machines required for production is large and the space is large, and because some factors need to be judged by experience, it may cause Unstable product quality, large differences between batches, etc.
And with the prolongation of storage time, there may be problems such as slowing down of dissolution rate
[0005] The usual dry granulation technology is completed through compression, crushing, sieving, granulation and other processes. The operation is relatively complicated. When there are too many subdivisions or the particles are unqualified, repeated operations and re-granulation are required.
This increases labor intensity, time and energy

Method used

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

Examples

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Effect test

Embodiment 1

[0042] Take by weighing 500 parts by weight of moxifloxacin hydrochloride, 30 parts by weight of mannitol, 36 parts by weight of croscarmellose sodium, 180 parts by weight of microcrystalline cellulose and 4 parts by weight of magnesium stearate, press with oval Large pieces, the tablets are broken, passed through a 16-mesh sieve, and made into dry granules, and the prepared granules are added to the remaining 4 parts by weight of magnesium stearate to mix, compressed into tablets, and then used Film coated.

Embodiment 2

[0044] Take by weighing 500 parts by weight of moxifloxacin hydrochloride, 10 parts by weight of mannitol, 50 parts by weight of sodium starch glycolate, 100 parts by weight of lactose and 5 parts by weight of talcum powder, press large tablets with oval punching, and tablet is broken into pieces, Pass through a 16-mesh sieve to make dry granules, add the prepared granules to the remaining 5 parts by weight of talcum powder and mix, compress into tablets, and use Film coated.

Embodiment 3

[0046]Take by weighing 500 parts by weight of moxifloxacin hydrochloride, 50 parts by weight of mannitol, 10 parts by weight of polyvinylpolypyrrolidone, 150 parts by weight of starch and 1 part by weight of micropowdered silica gel, press large tablets with oval punching, and smash the tablets, Pass through a 16-mesh sieve to make dry granules, add the prepared granules to the remaining 1 weight part of micropowder silica gel and mix, press into tablets, and then use Film coated.

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Abstract

The invention provides a moxifloxacin hydrochloride pharmaceutical composition and its preparation method. The composition comprises moxifloxacin hydrochloride, mannitol and other excipients. The preparation method employs a dry-method granulating technology for preparing medicament particles, and then preparing a medicinal preparation.

Description

【Technical field】 [0001] The invention belongs to the technical field of pharmaceutical preparations, and more specifically, the invention relates to a pharmaceutical composition containing moxifloxacin hydrochloride, mannitol and other excipients, and also relates to a preparation method of the pharmaceutical composition. 【Background technique】 [0002] Moxifloxacin Hydrochloride (Moxifloxacin Hydrochloride), its chemical name is 1-cyclopropyl-7-(S,S-2,8-diazo-bicyclo[4.3.0]nonan-8-yl)-6- Fluoro-8-methoxy-1,4-dihydro-4-oxo-3-quinoline carboxylic acid hydrochloride is a new type of broad-spectrum high-efficiency fluoroquinolone antibacterial drug researched and developed by German Bayer company. "Fule" was launched in Germany in September 1999, and was approved by FDA in the United States in December of the same year. Tablets are mainly used clinically at present. [0003] Due to the large size of moxifloxacin hydrochloride and the small space for adding excipients, it is ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/047A61K31/4709A61P31/04A61K9/28A61K9/48
Inventor 王文峰王再全刘博雅刘喜纲杨琰刘蕴秀
Owner CHINA RESOURCES SAIKE PHARMA
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