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Levofloxacin tablet and preparation method thereof

A technology for levofloxacin and tablets, which is applied in the field of levofloxacin tablets and its preparation, can solve the problems of unfavorable industrial production, affecting drug efficacy, and high moisture absorption of tablets, and achieves the simple and easy operation of the preparation process, improving bioavailability, Suitable for industrial production

Pending Publication Date: 2022-05-06
ZHEJIANG POLY PHARMA +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] However, levofloxacin is stable in the solution environment below pH 6.5, and some turbidity occurs between pH 6.5 and pH 7.5, and crystals are easily precipitated above pH 7.5, and the environment of the small intestine is alkaline, so part of levofloxacin will precipitate and crystallize , cannot be absorbed by the body, affecting the efficacy of the drug
In response to this problem, CN103520124B discloses a levofloxacin hydrochloride tablet and a preparation method thereof, in which the drug-containing granules are mixed with citric acid enteric-coated granules and a lubricant and pressed into tablets to reduce the alkalinity of intestinal fluid and ensure that levofloxacin hydrochloride does not precipitate out. Thereby the bioavailability of medicine is improved, but this prior art technological process is quite complicated, has carried out two granulation processes, is unfavorable for industrialized production, and the tablet prepared by this method has high hygroscopicity, poor stability, is unfavorable for storage

Method used

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  • Levofloxacin tablet and preparation method thereof
  • Levofloxacin tablet and preparation method thereof
  • Levofloxacin tablet and preparation method thereof

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Experimental program
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Effect test

Embodiment 1-3

[0038] The preparation method of embodiment 1-3

[0039] (1) Levofloxacin hemihydrate, microcrystalline cellulose, crospovidone, and sodium stearyl fumarate are respectively passed through an 80-mesh sieve for subsequent use;

[0040] (2) Sodium dihydrogen phosphate, disodium hydrogen phosphate, and hypromellose of prescription quantity are dissolved in 180g purified water to make binder solution;

[0041] (3) Levofloxacin hemihydrate and microcrystalline cellulose that take recipe quantity are placed in fluidized bed granulator, carry out spray granulation with the binder solution that step (2) makes, dry, then add cross-linking Povidone and sodium stearyl fumarate are mixed evenly and compressed into tablets;

[0042] (4) Coating the base tablet obtained after tableting in step (3) with Opadry to obtain levofloxacin tablets.

Embodiment 4

[0043] The preparation method of embodiment 4

[0044] (1) Levofloxacin hemihydrate, microcrystalline cellulose, crospovidone, and sodium stearyl fumarate are respectively passed through an 80-mesh sieve for subsequent use;

[0045] (2) Sodium dihydrogen phosphate and hypromellose of prescription quantity are dissolved in 180g purified water to make binder solution;

[0046] (3) Levofloxacin hemihydrate and microcrystalline cellulose that take recipe quantity are placed in fluidized bed granulator, carry out spray granulation with the binder solution that step (2) makes, dry, then add cross-linking Povidone and sodium stearyl fumarate are mixed evenly and compressed into tablets;

[0047] (4) Coating the base tablet obtained after tableting in step (3) with Opadry to obtain levofloxacin tablets.

Embodiment 5

[0048] The preparation method of embodiment 5

[0049] (1) Levofloxacin hemihydrate, microcrystalline cellulose, crospovidone, and sodium stearyl fumarate are respectively passed through an 80-mesh sieve for subsequent use;

[0050] (2) Disodium hydrogen phosphate and hypromellose of prescription quantity are dissolved in 180g purified water to make binder solution;

[0051](3) Levofloxacin hemihydrate and microcrystalline cellulose that take recipe quantity are placed in fluidized bed granulator, carry out spray granulation with the binder solution that step (2) makes, dry, then add cross-linking Povidone and sodium stearyl fumarate are mixed evenly and compressed into tablets;

[0052] (4) Coating the base tablet obtained after tableting in step (3) with Opadry to obtain levofloxacin tablets.

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Abstract

The invention belongs to the technical field of medicine, and particularly relates to a levofloxacin tablet and a preparation method thereof, and the tablet is prepared by tabletting levofloxacin hemihydrate, sodium dihydrogen phosphate, disodium hydrogen phosphate and other pharmaceutically acceptable auxiliary materials. The levofloxacin tablet obtained by the invention cannot be separated out in slightly alkaline intestinal juice, the bioavailability is improved, the stability is high, and in addition, the preparation process provided by the invention is simple and efficient, and is more suitable for industrial production.

Description

technical field [0001] The invention belongs to the technical field of medicine, and specifically provides a levofloxacin tablet and a preparation method thereof. The tablet is compressed from levofloxacin hemihydrate, sodium dihydrogen phosphate, disodium hydrogen phosphate and other pharmaceutically acceptable auxiliary materials. made. Background technique [0002] The chemical name of levofloxacin is (S)-(-)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazine)-7-oxo-7H-pyridine [1,2,3-de]-[1,4]Benzoxazine-6-carboxylic acid, commercially used as its hemihydrate, formula C 18 h 20 FN 3 o 4 1 / 2H 2 O, the structural formula is as follows: [0003] [0004] 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 wit...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K31/5383A61K47/02A61K47/38A61P31/04
CPCA61K9/2009A61K9/2866A61K9/2054A61K31/5383A61P31/04
Inventor 朱逸凡范敏华张鹏袁方园刘葭
Owner ZHEJIANG POLY PHARMA
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