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A kind of Ulifloxacin eye drops and preparation method thereof

A technology of ulifloxacin and eye drops, which is applied in the direction of medical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve the problems of side effects and drug resistance, and achieve low toxic and side effects The effect of strong activity and low cost

Active Publication Date: 2016-01-20
GUANGZHOU PHARMACEUTICAL INDUSTRIAL RESEARCH INSTITUTE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0017] The purpose of the present invention is to develop ulifloxacin eye drops that meet the needs of large-scale production and clinical needs after the clinical application of current antibacterial eye drops.

Method used

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  • A kind of Ulifloxacin eye drops and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0063] Ulifloxacin eye drops contain 3mg of ulifloxacin, 40mg of polyvinylpyrrolidone, and 0.3mg of ethylparaben per milliliter.

[0064] prescription:

[0065] Ulifloxacin 30g

[0066] Polyvinylpyrrolidone (Povidone PVP) 400g

[0067] Ethylparaben 3g

[0068] Acetic acid 20mL

[0069] Appropriate amount of glycerin

[0070] Appropriate amount of acetic acid buffer

[0071] Add water for injection to 10L.

[0072] Preparation Process:

[0073] Dissolve 30g of ulifloxacin in 2L of water for injection containing 20mL of acetic acid; dissolve 400g of polyvinylpyrrolidone, 3g of ethylparaben, and 300ml of glycerin in 5L of water for injection, and dissolve the two liquids; Add acetic acid buffer solution, add water for injection to 10L, check the content of the semi-finished product, adjust the pH value to 5.0, sterilize by flowing steam at 100°C for 30 minutes, cool to room temperature, filter with 0.22um microporous membrane, aseptically dispense and package Instantly. ...

Embodiment 2

[0076] Ulifloxacin eye drops, the finished product contains 1mg of Ulifloxacin, 40mg of polyvinylpyrrolidone, and 0.4mg of ethylparaben per milliliter.

[0077] prescription:

[0078] Ulifloxacin 5g

[0079] Polyvinylpyrrolidone 200g

[0080] Ethylparaben 2g

[0081] Acetic acid 10mL

[0082] Appropriate amount of glycerin

[0083] Appropriate amount of acetate buffer

[0084] Add water for injection to 5L.

[0085] Preparation Process:

[0086] Dissolve 5 g of ulifloxacin in 1 L of water for injection containing 10 mL of acetic acid; dissolve 200 g of polyvinylpyrrolidone, 1.5 g of ethylparaben, and 150 ml of glycerin in 3 L of water for injection, and heat to dissolve; Add acetic acid buffer solution to the filter, add water for injection to about 5L, adjust the pH value to 6.5±0.5, the content of the semi-finished product is qualified, sterilize it by circulating steam at 100°C for 30 minutes, cool to room temperature, filter with a 0.22um microporous membrane, and m...

Embodiment 3

[0088] Ulifloxacin eye drops, the finished product contains 1mg of Ulifloxacin, 40mg of polyvinylpyrrolidone, and 0.3mg of ethylparaben per milliliter.

[0089] prescription:

[0090] Ulifloxacin 10g

[0091] Polyvinylpyrrolidone 400g

[0092] Ethylparaben 3g

[0093] Acetic acid 20mL

[0094] Appropriate amount of glycerin

[0095] Appropriate amount of acetic acid buffer

[0096] Add water for injection to 10L.

[0097] Preparation Process:

[0098] Dissolve 10g of ulifloxacin in 2L of water for injection containing 20mL of acetic acid; dissolve 400g of polyvinylpyrrolidone, 3g of ethylparaben, and 300ml of glycerin in 5L of water for injection, heat to dissolve; combine the two liquids, filter, and filter Add acetic acid buffer solution, add water for injection to make up to 10L, adjust the pH value to 5.5, sterilize by flowing steam at 100°C for 30 minutes, cool to room temperature, check the content of the semi-finished product, filter it with a 0.22um microporous ...

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Abstract

The invention provides an uliflourxacin eye drop and a preparation method thereof. The uliflourxacin eye drop is directly prepared from uliflourxacin as a raw material, and per ml of uliflourxacin contains 1-5mg and auxiliary materials suitable for an eye drop preparation or injection water. The uliflourxacin eye drop provided by the invention is capable of effectively preventing and treating eye infection of sensitive bacteria, especially infection of Gram-negative bacteria including pseudomonas aeruginosa with increasing drug resistance, is high in bioavailability, long in standing time in eyes, remarkable in post-antibiotic effect, beneficial to reduction of a single dose of a drug, good in treatment effect, and low in cost; the preparation method is simple and convenient, is short in period, meets the large-scale production need, and has a practical significance for treating eye infectious diseases increasingly resisting drug.

Description

technical field [0001] The invention relates to a ulifloxacin eye drop and a preparation method thereof, belonging to the technical field of pharmacy. The ulifloxacin eye drops of the invention can effectively prevent and treat eye sensitive bacteria infection. Background technique [0002] Infectious eye disease refers to a type of inflammatory disease of the eye and adnexa caused by pathogens such as bacteria, fungi, viruses, mycoplasma, rickettsia, spirochetes, and parasites. Different degrees of damage can seriously affect vision and even cause blindness. In recent years, due to environmental factors and other reasons, infectious eye diseases have been on the rise, and opportunistic pathogenic bacteria have increased, with more types and wider scope of pathogens. With the application of broad-spectrum antibacterial drugs, the drug resistance of bacteria continues to increase. [0003] The anatomical structure of the eye and its appendages is special. Once infection occ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/496A61K47/32A61K47/14A61K47/38A61K47/36A61P27/02A61P31/02
Inventor 罗成应军倪庆纯
Owner GUANGZHOU PHARMACEUTICAL INDUSTRIAL RESEARCH INSTITUTE
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