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Disposable levofloxacin hydrochloride eye drops without bacteriostatic agent and preparation method thereof

A technology of ciprofloxacin hydrochloride and eye drops, which can be applied to medical preparations containing active ingredients, antibacterial drugs, pharmaceutical formulations, etc., can solve problems such as high risk, save costs and ensure sterility requirements , avoid potentially dangerous effects

Inactive Publication Date: 2009-06-24
HEBEI UNIVERSITY OF SCIENCE AND TECHNOLOGY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Especially for eye drops that need to be used frequently, the potential danger is greater

Method used

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  • Disposable levofloxacin hydrochloride eye drops without bacteriostatic agent and preparation method thereof
  • Disposable levofloxacin hydrochloride eye drops without bacteriostatic agent and preparation method thereof
  • Disposable levofloxacin hydrochloride eye drops without bacteriostatic agent and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] prescription:

[0046]

[0047] Its preparation method:

[0048] a. Accurately weigh 3.3g of ciprofloxacin hydrochloride, 11.8g of boric acid, and 5.0g of glycerin, add 200mL of water for injection to dissolve, stir evenly, and dilute to 1000mL with water for injection to obtain a medicinal solution.

[0049] b. The above medicinal solution is filtered once through a 0.45 μm microporous membrane, and then filtered twice through a 0.22 μm microporous membrane under a Class 100 environment.

[0050] 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.

Embodiment 2

[0052] prescription:

[0053]

[0054]

[0055] Its preparation method:

[0056]a. Accurately weigh 3.3g of ciprofloxacin hydrochloride, 11.2g of boric acid, 1.7g of sodium chloride, and 1.0g of sodium hyaluronate, add 200mL of water for injection to dissolve, stir evenly, and dilute to 1000mL with water for injection to obtain a medicinal solution .

[0057] b. Filter the medicinal solution prepared above through a 0.45 μm microporous membrane once, and then through a 0.22 μm microporous membrane once.

[0058] c. The filtered medicinal solution is sterilized at 121° C. for 8 minutes by autoclaving, and then cooled.

[0059] d. 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 3

[0061] prescription:

[0062]

[0063] Its preparation method:

[0064] a. Accurately weigh 3.3g of ciprofloxacin hydrochloride, 0.33g of sodium acetate, 0.42g of acetic acid, and 22.0g of glycerin, add 200mL of water for injection to dissolve, stir evenly, and dilute to 1000mL with water for injection to obtain a medicinal solution.

[0065] b. Filter the medicinal solution prepared above through a 0.45 μm microporous membrane once, and then through a 0.22 μm microporous membrane once.

[0066] c. The filtered medicinal solution is sterilized at 121° C. for 8 minutes by autoclaving, and then cooled.

[0067] d. After the medicinal liquid is tested and passed, fill 0.8mL 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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Abstract

The invention discloses bacteriostat-free ciprofloxacin hydrochloride eye drops and a preparation method thereof. The bacteriostat-free ciprofloxacin hydrochloride eye drops comprise ciprofloxacin hydrochloride, a pH regulator, an isotonic agent, a stabilizing agent, a thickening agent, and the like; and the preparation method adopts a bacteria-free bottling process or an autoclaving process. In addition, the eye drops are independently packaged in disposable single dose, thereby the sterility performance of products is guaranteed and the products are more safe, reliable, simple, convenient, and sanitary.

Description

technical field [0001] The invention belongs to the field of pharmacy, in particular to ciprofloxacin hydrochloride eye drops without bacteriostatic agent and a preparation method thereof. Background technique [0002] Ciprofloxacin hydrochloride eye drops are used to treat external eye infections caused by sensitive bacteria. The ciprofloxacin hydrochloride eye drops on the market all contain antibacterial agents, are packaged in multiple doses, and can be used repeatedly. 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, also known...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/496A61P31/04A61P27/02
Inventor 姚军
Owner HEBEI UNIVERSITY OF SCIENCE AND TECHNOLOGY
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