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Levofloxacin oral administration solution and preparation method thereof

A technology of levofloxacin and oral solution, which is applied in the direction of pharmaceutical formulation, dispersion liquid delivery, and medical preparations of non-active ingredients, etc. It can solve the problems of photosensitivity reaction, inconvenience for patients with dysphagia, etc., and achieve the reduction of adverse reactions, good compliance, The effect of reducing bitterness

Inactive Publication Date: 2019-08-20
武汉兴华智慧医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Levofloxacin has good curative effect and safety in clinical treatment, but it is necessary to strictly control the dosage and frequency of the drug to avoid the occurrence of crystalluria and the impact on liver and kidney. At the same time, there is a risk of photosensitivity reaction when using levofloxacin
[0004] At present, there are tablets and capsules of levofloxacin preparations in China, which will cause inconvenience to patients with dysphagia, and it is not convenient for elderly patients or patients with liver and kidney diseases who need to adjust the dosage according to their conditions

Method used

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  • Levofloxacin oral administration solution and preparation method thereof
  • Levofloxacin oral administration solution and preparation method thereof
  • Levofloxacin oral administration solution and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] 1. Prescription composition:

[0035]

[0036]

[0037] 2. Preparation method:

[0038] (1) Measure 400mL of purified water and heat it to 75°C, then add sucrose, dissolve and cool to obtain a sucrose solution;

[0039] (2) Measure 150mL of purified water and add hydrochloric acid, mix well, then add levofloxacin and sodium saccharin, and stir at 400rpm at 30°C for 10min;

[0040] (3) Add glycerin, propylene glycol, alanine, taurine, β-carotene, grape essence and the sucrose solution obtained in step (1), add purified water to make up to 1000mL, mix well and fill to obtain Levofloxacin oral solution.

Embodiment 2

[0042] 1. Prescription composition:

[0043]

[0044]

[0045] 2. Preparation method:

[0046] (1) Measure 350mL of purified water and heat it to 80°C, then add sucrose, dissolve and cool to obtain a sucrose solution;

[0047] (2) Measure 200mL of purified water and add hydrochloric acid, mix well, then add levofloxacin and sodium saccharin, and stir at 300rpm at 25°C for 12min;

[0048] (3) Add glycerin, propylene glycol, alanine, taurine, β-carotene, grape essence and the sucrose solution obtained in step (1), add purified water to make up to 1000mL, mix well and fill to obtain Levofloxacin oral solution.

Embodiment 3

[0050] 1. Prescription composition:

[0051]

[0052]

[0053] 2. Preparation method:

[0054] (1) Measure 500mL of purified water and heat it to 70°C, then add sucrose, dissolve and cool to obtain a sucrose solution;

[0055] (2) Measure 200mL of purified water and add hydrochloric acid, mix well, then add levofloxacin and sodium saccharin, and stir at 20°C at 200rpm for 12min;

[0056] (3) Add glycerin, propylene glycol, alanine, taurine, β-carotene, grape essence and the sucrose solution obtained in step (1), add purified water to make up to 1000mL, mix well and fill to obtain Levofloxacin oral solution.

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Abstract

The invention provides a levofloxacin oral administration solution and a preparation method thereof. The levofloxacin oral administration solution is prepared from levofloxacin, corrigents, a pH regulating agent and a solvent, wherein the content of the levofloxacin is 2.5g / 100ml, the pH regulating agent is (5mL to 7mL) to 100mL of the using consumption of hydrochloric acid; the corrigent is a mixture of sucrose and saccharin sodium, the content of the sucrose is 48g / 100mL to 58g / 100mL, and the content of the saccharin sodium is 0.2g / 100mL to 0.6g / 100mL; and the solvent is a mixture of glycerol, propylene glycol and purified water. The levofloxacin oral administration solution disclosed by the invention adopts the corrigents including the sucrose and the saccharin sodium, and due to cooperation between the two corrigents, the bitter taste of the levofloxacin oral administration solution can be reduced; and because competitive combination of the contained flavor masking agents includingalanine and taurine and the bitter taste receptor in an oral cavity, the bitter taste of levofloxacin can be further reduced, so that the levofloxacin oral administration solution has a better taste;and due to the contained beta-carotene, the photosensitivity adverse effect caused by the levofloxacin can be reduced, and the safety of a preparation is improved.

Description

technical field [0001] The invention belongs to the technical field of levofloxacin medicines, and in particular relates to a levofloxacin oral solution and a preparation method thereof. Background technique [0002] Levofloxacin is the L-isomer of ofloxacin, its oral bioavailability is close to 100%, its urine concentration is high, and its half-life is 4-6 hours. Its antibacterial spectrum is similar to ofloxacin, and its antibacterial activity in vitro is 2 times that of ofloxacin. It is mainly used for various acute and chronic infections of the respiratory system, urinary system, digestive system, bones, joints and skin caused by sensitive bacteria. [0003] Levofloxacin is a fluoroquinolone antibacterial drug obtained by chemical resolution synthesis or stereoselective synthesis. In clinical application, levofloxacin acts on the lesion, inhibits the DNA helicase activity of pathogenic bacteria and prevents normal synthesis and replication, so as to achieve the effect ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/5383A61K47/06A61K47/10A61K47/18A61K47/20A61K47/22A61K47/26A61P31/04
CPCA61K9/0095A61K31/5383A61K47/06A61K47/10A61K47/183A61K47/20A61K47/22A61K47/26A61P31/04
Inventor 卢山王啸
Owner 武汉兴华智慧医药科技有限公司
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