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Fusidic acid eye drop and preparation method thereof

A technology for fusidic acid and eye drops, applied in the field of fusidic acid eye drops and preparation thereof, can solve the problem of not seeing fusidic acid eye drops, etc., and achieves the guarantee of good patient compliance and sterility requirements , the effect of small particle size of drug particles

Inactive Publication Date: 2015-06-17
广州仁恒医药科技股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In the prior art, fusidic acid is almost insoluble in water. At present, its sodium salt is mostly used clinically, and its dosage form is freeze-dried powder for injection. However, there is no research on fusidic acid eye drops. of technology needs to fill gaps

Method used

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  • Fusidic acid eye drop and preparation method thereof
  • Fusidic acid eye drop and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] prescription

[0036] Element

[0037] Preparation method: Dissolve mannitol, benzalkonium chloride, and edetate disodium in 50% prescription water for injection, add carbomer while stirring to make it fully swell and disperse, and filter with a 0.45 μm filter membrane , to obtain solution I. Fusidic acid is mixed with 30% of the prescribed amount of water for injection, and micronized by a high-speed shear emulsifier or a high-pressure homogenizer to obtain solution II. Stir and mix solution I and solution II, add water for injection, adjust the pH value of the solution to 5.8 with sodium hydroxide, sterilize with moist heat at 121°C for 30 minutes, and aseptically subpackage to obtain fusidic acid eye drops.

Embodiment 2

[0039] prescription

[0040] Element

[0041] fusidic acid

[0042] According to the method used in Example 1, the eye drops of Example 2 were prepared.

Embodiment 3

[0044] prescription

[0045] Element

[0046] According to the method used in Example 1, the eye drops of Example 3 were prepared.

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Abstract

The invention discloses a fusidic acid eye drop. The fusidic acid eye drop comprises the following components in weight per volume: 0.5 to 2 percent of fusidic acid, 0.2 to 2 percent of a thickener, 0.5 to 8 percent of an osmotic pressure regulator, 0.01 to 0.05 percent of a preservative, 0.02 to 1.0 percent of a metal ion chelating agent, 0.05 to 0.3 percent of a PH regulator, and water for injection. Moreover, the invention further provides a preparation method of the fusidic acid eye drop. Compared with the prior art, the fusidic acid eye drop and the preparation method thereof have the advantages that the fusidic acid eye drop achieves high quality stability, small and uniformly distributed medicinal particles, elimination of eye irritation, and good patient compliance; the preparation method is simple in technique, is applicable for industrial production, and can better reduce the production cost and guarantee the product quality.

Description

technical field [0001] The invention relates to the field of eye drops, in particular to a fusidic acid eye drop and a preparation method thereof. Background technique [0002] Fusidic acid is the most antibiotic active compound among the fusidanes and is the only fusidane clinically used to treat infectious diseases. In 1962, it was first extracted from the fusidic acid coccus fungus in the fermentation broth by Leo Pharmaceutical Products of Denmark. It belongs to the fusidic acid antibiotics. [0003] Fusidic acid is a brand-new antibiotic, which is applied to various infections caused by various sensitive bacteria, especially Staphylococcus, such as osteomyelitis, sepsis, endocarditis, surgical and traumatic infections, etc. At the same time, it has good safety, and its toxicity is low, and allergic reactions are rare. Fusidic acid is used clinically in the treatment of severe staphylococcal infections, particularly of the bones and joints, in both the acute and intrac...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/56A61P31/04
Inventor 田元
Owner 广州仁恒医药科技股份有限公司
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