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Disposable levofloxacin lactate eye drops without bacteria inhibitor and preparation method thereof

A levofloxacin lactate, disposable technology, applied in the direction of medical preparations containing active ingredients, antibacterial drugs, pharmaceutical formulations, etc., can solve the problem that the antibacterial effect cannot be used as ophthalmic preparations, and has not yet been unanimously approved, so as to avoid toxicity Side effects, guaranteed sterility requirements, and cost-saving effects

Inactive Publication Date: 2009-06-17
HEBEI UNIVERSITY OF SCIENCE AND TECHNOLOGY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although levofloxacin lactate itself has a certain antibacterial effect, its antibacterial effect cannot be used as a criterion for judging whether to add bacteriostatic agents to ophthalmic preparations (References: Ning Lili, Zhao Deheng, "No addition of bacteriostatic agents to multi-dose ophthalmic preparations Thoughts on "Drug Evaluation and Application Center of the State Food and Drug Administration, Electronic Journal 2008-9-12)
Therefore, the safety of multi-dose ophthalmic formulations without bacteriostats remains highly controversial and has not yet been unanimously approved

Method used

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  • Disposable levofloxacin lactate eye drops without bacteria inhibitor and preparation method thereof
  • Disposable levofloxacin lactate eye drops without bacteria inhibitor and preparation method thereof
  • Disposable levofloxacin lactate eye drops without bacteria inhibitor and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] prescription:

[0047]

[0048]

[0049] Its preparation method:

[0050]a. Accurately weigh 3.75g of levofloxacin lactate, 7.24g of sodium dihydrogen phosphate, 0.94g of disodium hydrogen phosphate, 12.0g of glycerin, add 200mL of water for injection to dissolve, stir evenly, and dilute to 1000mL with water for injection to obtain a liquid medicine.

[0051] b. Filter the above medicinal solution once with a 0.45 μm microporous membrane, and then filter twice with a 0.22 μm microporous membrane under a Class 100 environment.

[0052] c. After the medicinal liquid is tested and passed, fill 0.5mL of the above medicinal liquid into a 1mL single-dose packaging plastic container in a class 100 environment, and seal it to obtain the finished product.

Embodiment 2

[0054] prescription:

[0055]

[0056] Its preparation method:

[0057] a. Accurately weigh 3.75g of levofloxacin lactate, 12.0g of boric acid, 0.6g of borax, 2.1g of sodium chloride, add 200mL of water for injection to dissolve, stir evenly, and dilute to 1000mL with water for injection to obtain a liquid medicine.

[0058] b. Filter the medicinal solution prepared above with a 0.45 μm microporous membrane for one time, and then with a 0.22 μm microporous membrane for one time.

[0059] c. The filtered medicinal solution is sterilized at 121° C. for 8 minutes by autoclaving, and then cooled.

[0060] d. After the medicinal liquid is tested and passed, fill 0.4mL of the above medicinal liquid into a 1mL single-dose packaging plastic container in a class 100 environment, and seal it to obtain the finished product.

Embodiment 3

[0062] prescription:

[0063]

[0064] Its preparation method:

[0065] a. Accurately weigh 3.75g levofloxacin lactate, 6.4g sodium dihydrogen phosphate, 1.9g disodium hydrogen phosphate, 4.6g sodium chloride, 1.0g sodium hyaluronate, add 200mL water for injection to dissolve, stir well, and dilute with water for injection. Make it up to 1000mL to get liquid medicine.

[0066] b. Filter the above medicinal solution once with a 0.45 μm microporous membrane, and then filter twice with a 0.22 μm microporous membrane under a Class 100 environment.

[0067] c. After the medicinal liquid is tested and passed, fill 0.4mL of the above medicinal liquid into a 1mL single-dose packaging plastic container in a class 100 environment, and seal it to obtain the finished product.

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PUM

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Abstract

The present invention discloses a disposable levofloxacin lactate eye drop and a preparing method thereof, wherein the disposable levofloxacin lactate eye drop comprises levofloxacin lactate, pH modifying agent, isoosmotic agent, stabilizing agent, thickening agent, etc. The preparing method adopts an aseptic manipulation filling technique or hot pressing sterilizing technique. Furthermore the eye drop according to the invention adopts single-dose independent packaging and disposable using. The sterilized performance of product is guaranteed. The product is safer, more reliable, easier and more sanitary.

Description

technical field [0001] The invention belongs to the field of pharmacy, in particular to a disposable levofloxacin lactate eye drop without bacteriostatic agent and a preparation method thereof. Background technique [0002] Levofloxacin Lactate Eye Drops is used to treat bacterial conjunctivitis, keratitis, corneal ulcer, dacryocystitis and other external eye infections. The levofloxacin lactate eye drops that have been on the market are all packaged in multiple doses for repeated use. Once the preparation is opened, it is easy to be contaminated by tears and microbes in the air during use and storage, thereby causing safety hazards. In order to prevent ophthalmic preparations from being contaminated by microorganisms during repeated use after opening, bacteriostatic agents (preservatives) are added to ophthalmic preparations, which are used in almost all eye drop prescriptions in the "Chinese Hospital Preparation Specifications" antibacterial agent. Bacteriostatic agents...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/5383A61P31/04A61P27/02
Inventor 姚军
Owner HEBEI UNIVERSITY OF SCIENCE AND TECHNOLOGY
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