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Oral medicinal formulation of moxifloxacin and its preparation method

A pharmaceutical preparation, the technology of moxifloxacin hydrochloride, which is applied in the field of pharmaceutical preparations and its preparation, can solve the problems of red impurities and achieve the effect of maintaining yellow color, good hardness and ensuring quality

Active Publication Date: 2010-12-08
JIANGSU TIANYISHI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0019] The purpose of the present invention is to solve the problem that moxifloxacin produces red impurities in the preparation process, especially in the tablet process, and provide a stable oral pharmaceutical preparation of moxifloxacin, especially a tablet, and a preparation method of the pharmaceutical preparation , the prepared tablets have good hardness and dissolution properties

Method used

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  • Oral medicinal formulation of moxifloxacin and its preparation method
  • Oral medicinal formulation of moxifloxacin and its preparation method
  • Oral medicinal formulation of moxifloxacin and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0065] Components: Moxifloxacin Hydrochloride 218.4mg

[0066] Microcrystalline cellulose 124.6mg

[0067] Pregelatinized starch 37.0mg

[0068] Sodium starch glycolate 7.0mg

[0069] Croscarmellose Sodium 7.0mg

[0070] Magnesium stearate 4.7mg

[0071] HPMC(90SH 100) 1.3mg

[0072] Total weight 400.0mg

[0073] Take the above-mentioned ingredients and the auxiliary materials (except magnesium stearate and HPMC) and mix them thoroughly, use 1.0% HPMC aqueous solution to make granules, add magnesium stearate and mix evenly after drying, and press tablets to obtain. The punch and die used in tablet pressing are made of stainless steel.

[0074] The prepared tablet cores can be conventionally coated, or they can be directly sealed and packaged without coating.

[0075] The quality of the tablets was examined immediately after the preparation was completed and two years later. The results are shown in Table 6.

Embodiment 2

[0077] Components: Moxifloxacin Hydrochloride 218.4mg

[0078] Microcrystalline cellulose 124.6mg

[0079] Pregelatinized starch 34.3mg

[0080] Sodium starch glycolate 7.0mg

[0081] Croscarmellose Sodium 7.0mg

[0082] Magnesium stearate 4.7mg

[0083] HPMC(90SH 100) 4.0mg

[0084] Total weight 400.0mg

[0085] Take the above-mentioned ingredients and auxiliary materials (except magnesium stearate and HPMC) and mix them thoroughly, use 3.0% HPMC dilute ethanol solution (dilute ethanol is 50% ethanol) to make granules, and add magnesium stearate to mix after drying. Press the tablet and get it. The punch and die used in tablet pressing are made of stainless steel.

[0086] The prepared tablet core can be coated by a conventional method, or it can be directly sealed and packaged without coating.

[0087] The quality of the tablets was examined immediately after the preparation was completed and two years later, and the results are shown in Table 6.

Embodiment 3

[0089] Components: Moxifloxacin Hydrochloride 218.4mg

[0090] Microcrystalline cellulose 124.6mg

[0091] Pregelatinized starch 31.5mg

[0092] Sodium starch glycolate 7.0mg

[0093] Croscarmellose Sodium 7.0mg

[0094] Magnesium stearate 4.3mg

[0095] HPMC(90SH 100) 7.2mg

[0096] Total weight 400.0mg

[0097] Take the above-mentioned ingredients and the auxiliary materials (except magnesium stearate and HPMC) and mix them thoroughly, prepare granules with 4.5% HPMC aqueous solution, add magnesium stearate and mix evenly after drying, and then press tablets to obtain. The punch and die used for tableting are made of stainless steel.

[0098] The prepared tablet core can be coated by a conventional method, or it can be directly sealed and packaged without coating.

[0099] The quality of the tablets was examined immediately after the preparation was completed and two years later. The results are shown in Table 6.

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Abstract

The invention relates to an oral medicinal formulation of moxifloxacin and its preparation method, which comprises Moxifloxacin or its salt and / or its hydrate, and at least one film forming material for preparing intermediate particles of the preparation selected from hydroxy propyl methyl cellulose, hydroxy ethyl methyl cellulose, cellulose methyl, hydroxy propyl cellulose, hydroxy ethyl cellulose, sodium carboxymethyl cellulose, polyacrylic resins, polyethylene glycol, polyvinyl pyrrolidon-vinyl acetate copolymer, polyvinyl alcohol-polyethylene glycol grafted copolymer, carbopol, gelatine, poloxamer and polyvinyl pyrrolidon. The invention also discloses the process for preparing the pharmaceutical preparation.

Description

Technical field [0001] The present invention relates to a pharmaceutical preparation and a preparation method thereof. In particular, the present invention relates to a stable oral pharmaceutical preparation of moxifloxacin or its salt and / or its hydrate and a preparation method of the pharmaceutical preparation. Background technique [0002] Moxifloxacin is a new generation of fluoroquinolone antibacterial drug. At present, moxifloxacin hydrochloride has been approved for upper and lower respiratory tract infections caused by sensitive microorganisms, such as acute attacks of chronic bronchitis, community-acquired pneumonia, acute bacterial sinusitis and Treatment of uncomplicated skin and soft tissue infections. [0003] Moxifloxacin hydrochloride tablets were first registered in Mexico in February 1999, and they were first listed in Germany in September 1999. The infusion solution was first listed in the United States and Germany in December 2001. The product is now available in...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/4709A61K9/20A61P31/04A61P11/00
Inventor 傅雪琦赵邦爱赵冰奇
Owner JIANGSU TIANYISHI PHARMA
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