Levofloxacin hydrochloride tablets

A technology of levofloxacin hydrochloride and tablets, which is applied in the direction of pill delivery, medical preparations of non-active ingredients, antibacterial drugs, etc., and can solve problems such as interfering with gastrointestinal absorption and not affecting the antibacterial activity of levofloxacin hydrochloride

Inactive Publication Date: 2015-01-21
DIAO GRP CHENGDU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In view of the above situation, the present invention will provide a tablet that does not affect the antibacterial acti

Method used

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  • Levofloxacin hydrochloride tablets
  • Levofloxacin hydrochloride tablets
  • Levofloxacin hydrochloride tablets

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Experimental program
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Embodiment Construction

[0014] The present invention will be further described below by specific experimental scheme:

[0015] Evaluation indexes and detection methods such as hardness, compressibility, appearance in the experimental scheme of the present invention and the embodiment are as follows:

[0016] Hardness: Take the tablet and place it in a Monsanto hardness tester for testing, randomly select 20 tablets to measure the hardness respectively, and calculate the average value Y.

[0017] When Y is 30-50, it is recorded as "-", indicating that the hardness is good; when Y is lower than 30 or higher than 50, it is recorded as "+", indicating that the hardness is too low or too high.

[0018] Compressibility: Take the mixture of drug and excipients, put it in the tablet press machine, and observe the adhesion of the fine powder on the punch or die during the tablet compression process. "++" indicates that there is a lot of fine powder on the punch or die, and the sticking is serious; "+" indica...

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PUM

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Abstract

The invention discloses levofloxacin hydrochloride tablets which comprise an active ingredient levofloxacin hydrochloride and medicinal auxiliary materials, wherein the medicinal auxiliary materials comprise a filling agent, a disintegrating agent and a lubricating agent. In the large-scale production of tablets, magnesium stearate generally serves as the lubricating agent, however, because magnesium ion is extremely easily subjected to complexation with levofloxacin or salts thereof, the activity of the medicine is reduced, absorption of gastrointestinal tract on the medicine is interfered, and levofloxacin hydrochloride is unsuitable to be compatible with magnesium stearate. According to the research, when other conventional lubricating agents are used for large-scale preparation in the conventional technology, tests show that the conditions such as severe sticking, bonding, bouncing and low core friability occur in the process of tabletting levofloxacin hydrochloride exist. According to the research in the invention, the lubricating agent adopts talc powder and stearic acid which are added according to a specific compatibility ratio, the lubricating agent has excellent quality controllability in the large-scale production process of the levofloxacin hydrochloride tablets through tests, and the prepared levofloxacin hydrochloride tablets have high safety and effectiveness.

Description

technical field [0001] The invention relates to an oral solid preparation of broad-spectrum antibacterial drugs, in particular to a levofloxacin hydrochloride tablet. Background technique [0002] Levofloxacin is a new fluoroquinolone drug developed by Daiichi Pharmaceutical Co., Ltd. in 1986. It is the optically active L-isomer of ofloxacin, and it was first listed in Japan at the end of 1993. Ofloxacin is a racemic mixture composed of the L-isomer with high antibacterial activity and the D-isomer with low antibacterial activity in a 1:1 ratio. The in vitro activity of levofloxacin is twice that of the racemate and 8-128 times that of the dextro-form, with less toxic and side effects. Compared with fluoroquinolones such as ofloxacin and ciprofloxacin, levofloxacin has a wider antibacterial spectrum, and has stronger antibacterial activity against Gram-positive bacteria and Gram-negative bacteria including anaerobic bacteria. And side effects and adverse reactions are smal...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/12A61K47/04A61K31/5383A61P31/04
Inventor 简晓娜黄磊
Owner DIAO GRP CHENGDU PHARMA
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