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Levofloxacin hydrochloride micropill capsule and preparation method thereof

A technology of levofloxacin hydrochloride and pellet capsules is applied in the field of medicine to achieve the effects of improving drug stability, reducing irritation and high bioavailability

Active Publication Date: 2014-03-05
HAINAN PULIN PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The shortcoming is how to ensure the uniformity of mixing

Method used

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  • Levofloxacin hydrochloride micropill capsule and preparation method thereof
  • Levofloxacin hydrochloride micropill capsule and preparation method thereof
  • Levofloxacin hydrochloride micropill capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Embodiment 1: the present embodiment adopts following prescription:

[0033] Levofloxacin hydrochloride (calculated as ofloxacin) 200g

[0034] Sucrose core 153.4g

[0035] povidone k30 18.4g

[0036] Ethylcellulose 11.2g

[0037] Triethyl citrate 2.2g

[0038] Polyethylene glycol 6000 3.3g

[0039] Appropriate amount of talcum powder

[0040] Makes 1000 capsules

[0041] Preparation Process:

[0042] (1) Preparation of pill core:

[0043] First, 9.2g of povidone k30 is dissolved in the ethanol solution, 100g of levofloxacin hydrochloride is added in the povidone ethanol solution, and constantly stirred to make it into a uniform suspension; 153.4g of sucrose ball cores are placed in a fluidized bed In the granulator, the above-mentioned homogeneous suspension is sprayed on the surface of the blank sucrose pellet core to prepare pellets, and after all the suspension is added, the pellets are dried and screened;

[0044] (2) Sustained-release coating layer:

[0...

Embodiment 2

[0049] Embodiment 2: the present embodiment adopts following prescription:

[0050] Levofloxacin hydrochloride (calculated as ofloxacin) 400g

[0051] Sucrose core 300g

[0052] povidone k30 36g

[0053] Eudragit NE30D 122g

[0054] Talc powder 36.8g

[0055] Makes 1000 capsules

[0056] Preparation Process:

[0057] (1) Preparation of pill core:

[0058]First 21.6g of povidone k30 is dissolved in the ethanol solution, 240g of levofloxacin hydrochloride is added in the povidone ethanol solution, and constantly stirred to make it into a uniform suspension; 300g of sucrose ball cores are placed in a fluidized bed In the granulator, the above-mentioned uniform suspension is sprayed on the surface of the blank sucrose ball core to prepare micro-pills. After all the suspension is added, dry and screen to obtain micro-pills;

[0059] (2) Sustained-release coating layer:

[0060] Dissolve the Eudragit NE30D and talcum powder of the prescribed amount in water, and stir to obta...

Embodiment 3

[0064] Embodiment 3: the present embodiment adopts following prescription:

[0065] Levofloxacin hydrochloride (calculated as ofloxacin) 100g

[0066] Cane sugar core 80g

[0067] Hypromellose 20g

[0068] Ethylcellulose 8g

[0069] Triethyl citrate 1.6g

[0070] Macrogol 6000 2.4g

[0071] Appropriate amount of talcum powder

[0072] Makes 1000 capsules

[0073] Preparation Process:

[0074] (1) Preparation of pill core:

[0075] First, 8g of hydroxypropylmethylcellulose was dissolved in the ethanol solution, and 40g of levofloxacin hydrochloride was added to the povidone ethanol solution, and kept stirring to make it a uniform suspension; 80g of sucrose ball cores were placed in a fluidized bed In the granulator, the above-mentioned homogeneous suspension is sprayed on the surface of the blank sucrose pellet core to prepare pellets, and after all the suspension is added, the pellets are dried and screened;

[0076] (2) Sustained-release coating layer:

[0077] Diss...

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Abstract

The invention relates to a levofloxacin hydrochloride micropill capsule and a preparation method thereof. The levofloxacin hydrochloride micropill capsule comprises a pill core, a medicament-containing layer, a sustained-release coating layer and a quick-release layer, wherein levofloxacin hydrochloride is contained in the medicament-containing layer and the quick-release layer; and the sustained-release coating layer comprises the following materials in percentage by weight: 20 to 60 percent of levofloxacin hydrochloride, 30 to 55 percent of pill core, 10 to 25 percent of binding agent, 3 to 5 percent of sustained-release coating material, 0.3 to 3 percent of pore-forming agent and 0.1 to 1 percent of plasticizer. The levofloxacin hydrochloride micropill capsule has the advantages of high stability, small local stimulation of medicaments, high bioavailability and the like. Due to the adoption of a fluidized bed, the problems of large dust and low yield in a method of powder agglomerating in the background technology are solved.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a levofloxacin hydrochloride pellet capsule and a preparation method thereof. Background technique [0002] Levofloxacin hydrochloride is the left-handed body of ofloxacin S configuration, which is white or slightly yellow crystalline powder, odorless, bitter, and gradually changes color when exposed to light. It is a third-generation quinolone broad-spectrum antibacterial drug. Glucobacterium, Streptococcus, Streptococcus pneumoniae, Neisseria gonorrhoeae, Escherichia coli, Citrobacter, Shigella, Klebsiella pneumoniae, Enterobacter, Haemophilus influenzae, Acinetobacter, Helicobacter, etc. Good antibacterial effect. It has certain antibacterial activity against Pseudomonas aeruginosa, Chlamydia trachomatis and Mycobacterium tuberculosis. Moreover, the toxicity is low, and it is the least poisoning and side effect of quinolone drugs on the market, and the side effect rate is lower than ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/52A61K31/5383A61P31/04
Inventor 范敏华姜新东刘华
Owner HAINAN PULIN PHARMA
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