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A kind of Ulifloxacin hydrochloride eye drops and preparation method thereof

A technology of ulifloxacin hydrochloride and eye drops, which is applied in directions such as pharmaceutical formulations, medical preparations containing active ingredients, and drug delivery, can solve problems such as side effects and drug resistance, achieve low toxic and side effects, a convenient and simple production process, Low cytotoxic effect

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

[0020] The purpose of the present invention is to develop ulifloxacin hydrochloride eye drops that meet the needs of large-scale production and clinical needs after many years of clinical application of current antibacterial eye drops.

Method used

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  • A kind of Ulifloxacin hydrochloride eye drops and preparation method thereof
  • A kind of Ulifloxacin hydrochloride eye drops and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0060] Ulifloxacin hydrochloride (prepared from sterile powder raw materials):

[0061] Add 5L of water and 1.5L of acetone into the reaction tank, add 1kg of Ulifloxacin powder at 10-15°C, add 1.5L of 2mol / L hydrochloric acid dropwise under stirring, stir for 1.5 hours, add 0.05kg of activated carbon, stir for 20 minutes, filter Decarburization; the filtrate is filtered through a 0.22um microporous membrane to a crystallization tank in a sterile room. Under stirring, 35 L of acetone was added dropwise until solid precipitated, and the addition was completed in 4 hours. Insulate at 0-5°C and stir for 5 hours, filter, wash twice with 6L of acetone, and dry under vacuum at 35°C to obtain 0.84 kg of raw material of sterile powder of ulifloxacin hydrochloride.

Embodiment 2

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

[0064] prescription:

[0065] Ulifloxacin Hydrochloride 30g

[0066] Polyvinylpyrrolidone (Povidone PVP) 400g

[0067] Ethylparaben 3g

[0068] Appropriate amount of glycerin

[0069] Appropriate amount of acetic acid-sodium acetate buffer (acetate buffer, pH5.5)

[0070] Add water for injection to 10L.

[0071] Preparation Process:

[0072] Take 30g of ulifloxacin hydrochloride and dissolve it in 2L of water for injection; take 400g of polyvinylpyrrolidone, 3g of ethylparaben, and 300ml of glycerin and dissolve it in 5L of water for injection, heat to dissolve; combine the two liquids, filter, and add acetic acid- Sodium acetate buffer solution, add water for injection to 10L, check the content of the semi-finished product to pass the test, adjust the pH value to 5.5, sterilize by steam at 100°C for 30 minutes,...

Embodiment 3

[0075] Ulifloxacin hydrochloride eye drops, the finished product contains 1mg of ulifloxacin hydrochloride, 40mg of polyvinylpyrrolidone, and 0.4mg of ethylparaben per milliliter.

[0076] prescription:

[0077] Ulifloxacin Hydrochloride 5g

[0078] Polyvinylpyrrolidone 200g

[0079] Ethylparaben 2g

[0080] Appropriate amount of glycerin

[0081] Appropriate amount of acetate buffer

[0082] Appropriate amount of 5% sodium hydroxide solution

[0083] Add water for injection to 5L.

[0084] Preparation Process:

[0085] Dissolve 5g of Ulifloxacin Hydrochloride in 1L of Water for Injection; Dissolve 200g of Polyvinylpyrrolidone, 1.5g of Ethylparaben, and 150ml of Glycerin in 3L of Water for Injection, heat to dissolve; combine the two liquids, filter, and add vinegar from the filter Salt buffer solution, add water for injection to about 5L, adjust the pH value to 6.5±0.5 with 5% sodium hydroxide solution, check the content of the semi-finished product to pass the test, s...

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Abstract

The invention provides a ulifloxacin hydrochloride eye drop and a preparation method thereof. The ulifloxacin hydrochloride eye drop is directly prepared by raw material ulifloxacin hydrochloride, every milliliter of the eye drop comprises 1-5 milligrams of ulifloxacin hydrochloride, and other components comprise suitable auxiliary materials for eye-drop preparation or water for injection. The ulifloxacin hydrochloride eye drop can effectively prevent and treat eye sensitive bacteria infection, especially Gram-negative bacterium including pseudomonas aeruginosa with growing drug resistance, has high bioavailability, can stay in eyes for long time, has prominent post-antibiotic effect, is beneficial to reducing single dose of medicine, has good curative effect and low cost, has simple and convenient production technology and short production cycle, meets the requirement of large scale production, and has practical significance for treating eye infectious diseases with growing drug resistance.

Description

technical field [0001] The invention relates to a ulifloxacin hydrochloride eye drop and a preparation method thereof, belonging to the technical field of pharmacy. The ulifloxacin hydrochloride 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 various reasons such as environmental pollution, infectious eye diseases are on the rise, and opportunistic pathogenic bacteria are increasing, 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 appendage...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/496A61P31/04A61P27/02
Inventor 罗成应军倪庆纯
Owner GUANGZHOU PHARMACEUTICAL INDUSTRIAL RESEARCH INSTITUTE
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