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Preparation method of levofloxacin hydrochloride tablet

A technology for levofloxacin hydrochloride tablets and levofloxacin hydrochloride, which can be applied to medical preparations without active ingredients, medical preparations containing active ingredients, pharmaceutical formulas, etc., and can solve problems such as poor microbial limit test accuracy and unsatisfactory finished product content.

Pending Publication Date: 2021-04-20
DIAO GRP CHENGDU PHARMA
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0007] The purpose of the present invention is to provide a preparation method of levofloxacin hydrochloride tablets, which solves the problems that the existing levofloxacin hydrochloride preparation method has unsatisfactory finished product content and poor accuracy of microbial limit testing

Method used

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Embodiment Construction

[0038] The present invention will be further elaborated below in conjunction with embodiment.

[0039] The invention discloses a levofloxacin hydrochloride tablet. The levofloxacin hydrochloride tablet consists of the following ingredients per 1000 tablets by weight:

[0040] Raw material: levofloxacin hydrochloride 100g, calculated as levofloxacin;

[0041] Filling agent: pregelatinized starch 163.8g, carboxymethyl starch sodium 5g; pregelatinized starch viscosity 5-20cps;

[0042] Adhesive: Povidone K30 4.5g;

[0043] Disintegrant: sodium starch glycolate 5g;

[0044] Lubricants: stearic acid 3.7g, talcum powder 9g.

[0045] The preparation method of above-mentioned levofloxacin hydrochloride tablet is as follows:

[0046] (1) Povidone K30 is mixed with the adhesive solution that mass concentration is 9%, for subsequent use;

[0047] (2) Adopt high-efficiency wet granulator to prepare mixed wet granules, and its parameters are set as follows: stirring low speed setting ...

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Abstract

The invention discloses a preparation method of a levofloxacin hydrochloride tablet. The levofloxacin hydrochloride tablet is composed of levofloxacin hydrochloride, pregelatinized starch (viscosity is 5-20 cps), carboxymethyl starch sodium, povidone K30, stearic acid and talcum powder. The preparation method comprises the following steps of (1) burdening; (2) wet granulation; (3) drying; (4) granulating; (5) total mixing; (6) tabletting; and (7) coating. The levofloxacin hydrochloride tablet and the preparation method thereof have the advantages that the tablet forming effect is good, the prepared levofloxacin hydrochloride tablet has very high finished product content, it is ensured that the drug effect is brought into full play, the accuracy is good when the levofloxacin hydrochloride tablet is used for microbial limit inspection, and therefore good guarantee is provided for follow-up research and application of the levofloxacin hydrochloride tablet and preparation optimization. Therefore, the method is suitable for large-scale popularization and application.

Description

technical field [0001] The invention relates to the technical field of medicine production, in particular to a preparation method of levofloxacin hydrochloride tablets. 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 ratio of 1:1. 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...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K31/5383A61K47/36A61P31/04
Inventor 胡海波陈娟赵至东彭珊珊
Owner DIAO GRP CHENGDU PHARMA
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