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Danofloxacin mesylate suspension and preparation method thereof

A technology of danfloxacin mesylate and suspension, which is applied in the directions of liquid delivery, emulsion delivery, antibacterial drugs, etc. Tension, enhanced stability, delayed release effects

Inactive Publication Date: 2012-07-25
烟台海研制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Described dafloxacin mesylate suspension has outstanding advantages such as long duration of drug effect, few times of medication, low cost and convenient administration, to solve the problem of adding a large amount of current dafloxacin mesylate suspension The problem that the drug effect is difficult to exert due to emulsifiers and excipients

Method used

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  • Danofloxacin mesylate suspension and preparation method thereof
  • Danofloxacin mesylate suspension and preparation method thereof
  • Danofloxacin mesylate suspension and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Embodiment 1: preparation 100ml mass volume ratio is 5% dafloxacin mesylate suspension

[0029] The actual dosage of the suspension is as follows:

[0030]

[0031] Preparation steps:

[0032] (1) Get 2g of aluminum monostearate, add it to 100ml of soybean oil for injection, stir while heating until the aluminum monostearate is completely dissolved, let stand and cool through No. 4 medicine sieve to obtain filtrate A;

[0033] (2) Put the dafloxacin mesylate raw material powder of the above quality in a beaker, add 50mg

[0034] Lecithin, 150mg Tween-80, 4mg antioxidant 2,6-di-tert-butyl-p-cresol, 4mg tert-butylhydroxyanisole and 10ml of the filtrate A obtained in the step were stirred evenly to obtain a mixture B;

[0035] (3) Place the mixture B obtained in step (2) in a disperser and add the remaining 90ml of filtrate A while dispersing; make the total volume to 100ml, wherein the dispersion speed is 8000r / min, and the dispersion time is 20min , to get mixture ...

Embodiment 2

[0039] Embodiment 2: prepare 100ml 1% dafloxacin mesylate suspension

[0040] The actual dosage of the suspension is as follows:

[0041]

[0042] The suspension was prepared according to the preparation steps of Example 1. Wherein the filtrate A added in the step (2) is 20ml; The dispersion speed described in the step (3) is 13000r / min, and the dispersion time is 8min;

[0043] The quality inspection of the above suspension was found to be a milky yellow, slightly viscous suspension liquid, which will be layered after standing for a long time. The upper layer is a yellow liquid, and the lower layer is a milky white suspension. After vigorous shaking, it becomes uniform. milky yellow suspension, the pH of the liquid is 4.0-5.0. The relative labeled amount of dafloxacin mesylate is 99.46%, and the appearance and properties have no obvious change after high temperature and light exposure, and the content change is within 0.2%. The sedimentation volume ratio is more than 0....

Embodiment 3

[0044] Embodiment 3: prepare 100ml 2.5% dafloxacin mesylate suspension

[0045]

[0046]

[0047] The suspension was prepared according to the preparation steps of Example 1. The quality inspection of the above suspension was found to be a milky yellow, slightly viscous suspension liquid, which will be layered after standing for a long time. The upper layer is a yellow liquid, and the lower layer is a milky white suspension. After vigorous shaking, it becomes uniform. milky yellow suspension, the pH of the liquid is 4.0-5.0. The relative labeling amount of dafloxacin mesylate is 99.39%, and the appearance properties have no obvious change during the high temperature and light test, and the content change is within 0.2%. The sedimentation volume ratio is more than 0.9, it can be re-dispersed after standing for several days or months, and it can be re-dispersed after vigorous shaking.

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Abstract

The invention discloses a danofloxacin mesylate suspension and a preparation method thereof. The danofloxacin mesylate suspension comprises the components of danofloxacin mesylate powder, aluminum monostearatre serving as a suspending agent, phosphatidylcholine serving as a dispersing agent, tween-80 serving as a wetting and emulsifying agent, 2,6-butylated hydroxytoluene and butylated hydroxyanisole serving as antioxidants. The invention also provides a preparation method of the suspension, which comprises the steps of: dissolving the aluminum monostearatre in oil, screening, adding the phosphatidylcholine, the tween-80, the 2,6-butylated hydroxytoluene and the butylated hydroxyanisole serving as the antioxidants, then placing in a dispersing machine for dispersing, then transferring to a colloid mill for circulating, and taking out to obtain the danofloxacin mesylate suspension. The danofloxacin mesylate suspension is a faint yellow and slightly-thick suspension. According to the danofloxacin mesylate suspension provided by the invention, effective components of medicines can be slowly released, bioavailability of the medicines can be improved, treatment effects of the medicines can be enhanced, and effective blood concentration time can maintain above 60h after once medication. The danofloxacin mesylate suspension is low in cost because no special solvent is needed during production, is simple in production process, and is easy to industrialize.

Description

Technical field: [0001] The invention belongs to the technical field of preparation of veterinary pharmaceutical compositions, and in particular relates to a dafloxacin mesylate suspension for treating respiratory diseases of livestock and poultry and a preparation method thereof. Background technique: [0002] Danofloxacin, also known as danofloxacin, is one of the fluoroquinolones with strong antibacterial effect. It has good water solubility (172-205g / L), can be administered in various ways, absorbs rapidly, and has high bioavailability , the drug concentration in the animal lung tissue is relatively high, and it has good antibacterial effect on the main pathogenic bacteria of the respiratory tract. It is an ideal drug for treating infectious diseases of the respiratory system of livestock and poultry. [0003] The chemical structural formula of dafloxacin is as follows [0004] [0005] The above structural formula shows dafloxacin mesylate (Danofloxacin Mesylate, DF...

Claims

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Application Information

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IPC IPC(8): A61K9/10A61K31/4709A61P31/04
Inventor 陶永侠梁宝玉毛瑞华杨永贵由佳李明举
Owner 烟台海研制药有限公司
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