Levofloxacin tablet composition and preparation method thereof

Abstract

The invention belongs to the technical field of medicines, and particularly relates to a levofloxacin tablet composition and a preparation method thereof. The pharmaceutical composition contains levofloxacin, a filling agent, a lubricating agent, a disintegrating agent, an adhesive and oleic acid. The product is high in stability, is dissolved completely, and has higher product quality. The product is easy and feasible to produce and operate, and is suitable for industrial production.

Description

technical field

[0001] The invention belongs to the technical field of medicine, and in particular relates to a levofloxacin tablet composition and a preparation method thereof. Background technique

[0002] Levofloxac (Levofloxac) is the left-handed optically active L-isomer of ofloxacin, its antibacterial activity is about twice that of ofloxacin, and it has the characteristics of broad antibacterial spectrum and strong antibacterial effect. For most Enterobacteriaceae, such as Escherichia coli, Klebsiella, Serratia, Proteus, Shigella, Salmonella, Citrobacter, Acinetobacter and Pseudomonas aeruginosa Gram-negative bacteria such as Monas, Haemophilus influenzae, and Neisseria gonorrhoeae have strong antibacterial activity. It also has a good antibacterial effect on Gram-positive bacteria such as methicillin-sensitive Staphylococcus, Streptococcus pneumoniae, Streptococcus pyogenes, and hemolytic streptococcus, as well as Legionella, Mycoplasma, and Chlamydia, but it has no...

Examples

Embodiment 1

[0074] prescription

[0075]

[0076] Preparation

[0077] (1) Levofloxacin, sorbitol, sodium stearyl fumarate, and croscarmellose sodium are respectively passed through an 80-mesh sieve for subsequent use;

[0078] (2) Dissolve hydroxypropyl cellulose in ethanol to make 5% (w / w) hydroxypropyl cellulose ethanol solution, add oleic acid to dissolve it;

[0079] (3) Levofloxacin, Sorbitol and Croscarmellose Sodium 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 sodium stearyl fumarate, mix evenly, and press into tablets to obtain levofloxacin tablets.

Embodiment 2

[0081] prescription

[0082]

[0083] Preparation

[0084] (1) Levofloxacin, microcrystalline cellulose, sodium stearyl fumarate, and sodium carboxymethyl starch are respectively passed through 80 mesh sieves, for subsequent use;

[0085] (2) Dissolve hydroxypropyl cellulose in ethanol to make 5% (w / w) hydroxypropyl cellulose ethanol solution, add oleic acid to dissolve it;

[0086] (3) Levofloxacin, microcrystalline cellulose and carboxymethyl starch sodium taking recipe quantity are placed in fluidized bed granulator, carry out spray granulation with the binding agent solution that step (2) makes, dry, then Add sodium stearyl fumarate, mix evenly, and press into tablets to obtain levofloxacin tablets.

Embodiment 3

[0088] prescription

[0089]

[0090]

[0091] Preparation

[0092] (1) Levofloxacin, microcrystalline cellulose, sodium stearyl fumarate, and croscarmellose sodium are respectively passed through an 80-mesh sieve for subsequent use;

[0093] (2) Dissolve hydroxypropyl cellulose in ethanol to make 5% (w / w) hydroxypropyl cellulose ethanol solution, add oleic acid to dissolve it;

[0094] (3) Levofloxacin, microcrystalline cellulose and croscarmellose sodium taking recipe quantity are placed in fluidized bed granulator, carry out spray granulation with the binding agent solution that step (2) makes, After drying, adding sodium stearyl fumarate, mixing evenly, and pressing into tablets to obtain levofloxacin tablets.

technical field

[0001] The invention belongs to the technical field of medicine, and in particular relates to a levofloxacin tablet composition and a preparation method thereof. Background technique

[0002] Levofloxac (Levofloxac) is the left-handed optically active L-isomer of ofloxacin, its antibacterial activity is about twice that of ofloxacin, and it has the characteristics of broad antibacterial spectrum and strong antibacterial effect. For most Enterobacteriaceae, such as Escherichia coli, Klebsiella, Serratia, Proteus, Shigella, Salmonella, Citrobacter, Acinetobacter and Pseudomonas aeruginosa Gram-negative bacteria such as Monas, Haemophilus influenzae, and Neisseria gonorrhoeae have strong antibacterial activity. It also has a good antibacterial effect on Gram-positive bacteria such as methicillin-sensitive Staphylococcus, Streptococcus pneumoniae, Streptococcus pyogenes, and hemolytic streptococcus, as well as Legionella, Mycoplasma, and Chlamydia, but it has no...

Examples

Embodiment 1

[0074] prescription

[0075]

[0076] Preparation

[0077] (1) Levofloxacin, sorbitol, sodium stearyl fumarate, and croscarmellose sodium are respectively passed through an 80-mesh sieve for subsequent use;

[0078] (2) Dissolve hydroxypropyl cellulose in ethanol to make 5% (w / w) hydroxypropyl cellulose ethanol solution, add oleic acid to dissolve it;

[0079] (3) Levofloxacin, Sorbitol and Croscarmellose Sodium 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 sodium stearyl fumarate, mix evenly, and press into tablets to obtain levofloxacin tablets.

Embodiment 2

[0081] prescription

[0082]

[0083] Preparation

[0084] (1) Levofloxacin, microcrystalline cellulose, sodium stearyl fumarate, and sodium carboxymethyl starch are respectively passed through 80 mesh sieves, for subsequent use;

[0085] (2) Dissolve hydroxypropyl cellulose in ethanol to make 5% (w / w) hydroxypropyl cellulose ethanol solution, add oleic acid to dissolve it;

[0086] (3) Levofloxacin, microcrystalline cellulose and carboxymethyl starch sodium taking recipe quantity are placed in fluidized bed granulator, carry out spray granulation with the binding agent solution that step (2) makes, dry, then Add sodium stearyl fumarate, mix evenly, and press into tablets to obtain levofloxacin tablets.

Embodiment 3

[0088] prescription

[0089]

[0090]

[0091] Preparation

[0092] (1) Levofloxacin, microcrystalline cellulose, sodium stearyl fumarate, and croscarmellose sodium are respectively passed through an 80-mesh sieve for subsequent use;

[0093] (2) Dissolve hydroxypropyl cellulose in ethanol to make 5% (w / w) hydroxypropyl cellulose ethanol solution, add oleic acid to dissolve it;

[0094] (3) Levofloxacin, microcrystalline cellulose and croscarmellose sodium taking recipe quantity are placed in fluidized bed granulator, carry out spray granulation with the binding agent solution that step (2) makes, After drying, adding sodium stearyl fumarate, mixing evenly, and pressing into tablets to obtain levofloxacin tablets.

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