Stable moxixacin tablet and its prepn process

A stable, tablet technology, used in pill delivery, respiratory diseases, antibacterial drugs, etc., can solve the problems of new impurities, harmless to the human body, etc., and achieve the effect of good hardness

Inactive Publication Date: 2005-09-28
深圳市天一时科技开发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] In addition, during the compression process of the above-mentioned three-prescription tablets, it was found that the edges of the tablets often showed obvious red color, indicating that new impurities were produced
[0012] At present, there are no reports on the pharmacological and toxicological effects of the moxifloxacin hydrochloride raw material or the red impurities produced during the tableting process, and it cannot be predicted that it is harmless to the human body

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Moxifloxacin Hydrochloride 218.4mg

[0024] Microcrystalline Cellulose 124.6mg

[0025] Pregelatinized starch 37.0mg

[0026] Sodium starch glycolate 7.0mg

[0027] Croscarmellose Sodium 7.0mg

[0028] Magnesium Stearate 4.7mg

[0029] HPMC (90SH 100) 1.3mg

[0030] 400.0mg

[0031] Get the raw and auxiliary materials in the above prescription (except magnesium stearate and HPMC) and mix well, use 1.0% HPMC aqueous solution to make granules, add magnesium stearate after drying, mix evenly, compress into tablets, and get final product.

[0032] The prepared tablet core can be coated, or it can be directly packaged in a light-proof and airtight package without coating.

Embodiment 2

[0034] Moxifloxacin Hydrochloride 436.8mg

[0035] Microcrystalline Cellulose 230.0mg

[0036] Pregelatinized starch 60.2mg

[0037] Sodium starch glycolate 13.0mg

[0038] Croscarmellose Sodium 9.0mg

[0039] Magnesium Stearate 6.0mg

[0040] HPMC (90SH 100) 4.5mg

[0041] Carbopol (934P) 0.5mg

[0042] 760.0mg

[0043] Get the raw and auxiliary materials in the above prescription (except magnesium stearate and HPMC, carbopol) and mix well, use the dilute alcohol solution of 2.0% HPMC and carbopol to make granules, add magnesium stearate after drying, mix well, press Slices, ready to serve.

[0044] The prepared tablet core can be coated, or it can be directly packaged in a light-proof and airtight package without coating.

Embodiment 3

[0046] Moxifloxacin Hydrochloride 218.4mg

[0047] Microcrystalline Cellulose 124.6mg

[0048] Pregelatinized starch 32.3mg

[0049] Sodium starch glycolate 7.0mg

[0050] Croscarmellose Sodium 7.0mg

[0051] Magnesium Stearate 4.7mg

[0052] Macrogol 6000 5.0mg

[0053] HPMC (90SH 100) 1.0mg

[0054] 400.0mg

[0055] Get the raw and auxiliary materials in the above prescription (except magnesium stearate and HPMC) and mix well, use 1.0% HPMC aqueous solution to make granules, add magnesium stearate after drying, mix evenly, compress into tablets, and get final product.

[0056] The prepared tablet core can be coated, or it can be directly packaged in a light-proof and airtight package without coating.

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PUM

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Abstract

The present invention relates to stable moxixacin tablet and its preparation process. The preparation contains moxixacin or its salt and/or hydrate and tablet supplementary material. The present invention features that during preparation, hypromellose or other filming material may be added to prepare granule before tabletting so that the medicine is stable without color change during pelletizing and tabletting.

Description

technical field [0001] The invention relates to a stable tablet of moxifloxacin or its salt and / or its hydrate and a preparation method thereof. Background technique [0002] Moxifloxacin is a new generation of fluoroquinolone antibacterial drugs, which are currently approved abroad 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 uncomplicated Treatment of 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 product has been sold in Germany, Spain, Italy, and Sweden , Switzerland, the United States, Canada, Australia, Argentina, Brazil, South Korea, Malaysia and other countries. [0004] Patent literature (Chine...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/4709A61P11/00A61P31/04
Inventor 傅雪琦赵邦爱赵冰奇
Owner 深圳市天一时科技开发有限公司
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