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Oral medicinal formulation of moxifloxacin and its preparation method

A pharmaceutical preparation, moxifloxacin hydrochloride technology, applied in the field of pharmaceutical preparations and its preparation, can solve the problems of red impurities and achieve the effects of rapid dissolution, good hardness, and color retention

Active Publication Date: 2006-04-26
JIANGSU TIANYISHI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0017] 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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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0063] Ingredient: Moxifloxacin Hydrochloride 218.4mg

[0064] Microcrystalline Cellulose 124.6mg

[0065] Pregelatinized starch 37.0mg

[0066] Sodium starch glycolate 7.0mg

[0067] Croscarmellose Sodium 7.0mg

[0068] Magnesium Stearate 4.7mg

[0069] HPMC (90SH 100) 1.3mg

[0070] Total weight 400.0mg

[0071] Take the above-mentioned ingredients and auxiliary materials (except magnesium stearate and HPMC) and mix well, use 1.0% HPMC aqueous solution to make granules, add magnesium stearate after drying, mix evenly, and press into tablets to obtain. The punches and dies used in tableting are made of stainless steel.

[0072] The prepared tablet cores can be conventionally coated, or directly packed in a light-proof and airtight package without coating.

[0073] The tablet quality was inspected immediately after the preparation was completed and two years later, and the results are shown in Table 6.

Embodiment 2

[0075] Ingredient: Moxifloxacin Hydrochloride 218.4mg

[0076] Microcrystalline Cellulose 124.6mg

[0077] Pregelatinized starch 34.3mg

[0078] Sodium starch glycolate 7.0mg

[0079] Croscarmellose Sodium 7.0mg

[0080] Magnesium Stearate 4.7mg

[0081] HPMC (90SH 100) 4.0mg

[0082] Total weight 400.0mg

[0083] Take the above-mentioned components as raw materials and auxiliary materials (except magnesium stearate and HPMC) and mix well, use 3.0% HPMC dilute ethanol solution (dilute ethanol is 50% ethanol) to make granules, add magnesium stearate after drying, and mix evenly. Tablets, ready to use. The punches and dies used in tableting are made of stainless steel.

[0084] The prepared tablet cores can be coated by conventional methods, or directly packed in a light-proof seal without coating.

[0085] The quality of the tablet was inspected just after the preparation was completed and two years later, and the results are shown ...

Embodiment 3

[0087] Ingredient: Moxifloxacin Hydrochloride 218.4mg

[0088] Microcrystalline Cellulose 124.6mg

[0089] Pregelatinized starch 31.5mg

[0090] Sodium starch glycolate 7.0mg

[0091] Croscarmellose Sodium 7.0mg

[0092] Magnesium Stearate 4.3mg

[0093] HPMC (90SH 100) 7.2mg

[0094] Total weight 400.0mg

[0095] Take the raw materials and auxiliary materials (except magnesium stearate and HPMC) of the above-mentioned components and mix well, use 4.5% HPMC aqueous solution to make granules, add magnesium stearate after drying, mix evenly, and compress into tablets. The punches and dies used for tableting are made of stainless steel.

[0096] The prepared tablet cores can be coated by conventional methods, or directly packed in a light-proof seal without coating.

[0097] The tablet quality was inspected immediately after the preparation was completed and two years later, and 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 a salt thereof and / or a hydrate thereof and a preparation method of the pharmaceutical preparation. Background technique [0002] Moxifloxacin is a new generation of fluoroquinolone antibacterial drugs. At present, moxifloxacin hydrochloride has been approved for upper and lower respiratory tract infections caused by sensitive microorganisms, such as acute exacerbation 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 listed in Germany in September 1999. The infusion solution was first listed in the United States and Germany in December 2001. At present, the produc...

Claims

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Application Information

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