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Levofloxacin sustained-release eye drop and preparation method thereof
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A technology of levofloxacin and sustained-release eye drops, which is applied to medical preparations with non-active ingredients, medical preparations containing active ingredients, organic active ingredients, etc., can solve the problem of damage to the corneal sebum layer, increase in product-related substances, and decline in quality etc. to achieve the effects of reducing dryness and irritation, stabilizing pH value and increasing viscosity
Inactive Publication Date: 2020-03-13
NANJING ZHIHE MEDICINE TECH CO LTD
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[0003] However, clinically used levofloxacin eye drops without thickeners cannot stay in the eye for a long time, and multiple eye drops are required to maintain an effective therapeutic concentration; The preservatives in the eye drops not only damage the epidermal layer of the cornea, but also lead to the increase of related substances in the product and the decline in quality.
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Embodiment 1
[0019] Embodiment 1: a kind of levofloxacin eye drops, its prescription is
[0020]
[0021] The preparation process comprises the following steps:
[0022] (1), first add 60% to 80% of the prescribed amount of water for injection;
[0040] (3), add levofloxacin again, stir until dissolving;
[0041] (4), add water for injection to the full amount.
[0042] (5), the rest of the preparation process is aseptic filtration, packaging and capping.
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Abstract
The invention discloses a levofloxacin sustained-release eye drop and a preparation process thereof. The levofloxacin sustained-release eye drop is prepared from the following components: levofloxacin20-25mg, sodium hyaluronate 10-15mg, sodiumchloride 10-15mg, citric acid 2.0-2.5 mg, sodium citrate 6.0-6.5 mg, and water for injection 5ml. The preparation process comprises the following steps: firstly adding 60%-80% of water for injection, sequentially adding sodium hyaluronate, sodium chloride, citric acid and sodium citrate, and stirring until dissolved; adding levofloxacin and stirring until dissolved; adding water for injection to the full amount; sterilizing, filtering, sub-packaging and capping. According to the invention, sodium hyaluronate is added to increase the viscosity of theeye drop, effectively prolong the residence time of the eye drop in the eyes and achieve the slow release effect; the influence of traditional preservatives on product quality, especially related substances is effectively avoided; in the process of stability investigation, the increase of related substances is smaller and the pH value is more stable.
Description
technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a levofloxacin sustained-release eye drop and a preparation process. Background technique [0002] A variety of bacteria can invade the surface of the human eye, causing eye bacterial infections, the most common being bacterial conjunctivitis and bacterial keratitis. Levofloxacin has a broad antibacterial spectrum, covering most of the Gram-positive bacteria, Gram-negative bacteria and propionibacterium, which are easy to induce ocular infectious diseases and other anaerobic bacteria. Therefore, levofloxacin eye drops can be developed to treat bacterial conjunctivitis and bacterial keratitis caused by sensitive bacteria. [0003] However, clinically used levofloxacin eye drops without thickeners cannot stay in the eye for a long time, and multiple eye drops are required to maintain an effective therapeutic concentration; The preservatives in the eye drops no...
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Application Information
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