Gernebcin eye drops without bacteriostatic agent and preparation method thereof

A technology of tobramycin and eye drops, which is applied in the field of tobramycin eye drops and its preparation, can solve problems such as high risk, and achieve the effects of saving costs, avoiding potential risks, and ensuring sterility requirements

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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  • Gernebcin eye drops without bacteriostatic agent and preparation method thereof
  • Gernebcin eye drops without bacteriostatic agent and preparation method thereof
  • Gernebcin 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 3.0g tobramycin, 2.4g sodium dihydrogen phosphate, 6.6g disodium hydrogen phosphate, 4.2g sodium chloride, add 200mL water for injection to dissolve, stir well, and dilute to 1000mL with water for injection, Get the medicine.

[0049] b. Filter the above medicinal solution once through a 0.45 μm microporous membrane, and then filter 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. Precisely weigh 3.0 g of tobramycin, 11.7 g of boric acid, 1.2 g of borax, and 5.7 g of glycerin, add 200 mL of water for injection to dissolve, stir evenly, and dilute to 1000 mL with water for injection to obtain a liquid medicine.

[0057] b. Filter the above medicinal solution once through a 0.45 μm microporous membrane, and then filter twice through a 0.22 μm microporous membrane under a Class 100 environment.

[0058] 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 3

[0060] prescription:

[0061]

[0062] Its preparation method:

[0063] a. Accurately weigh 3.0g tobramycin, 1.6g sodium dihydrogen phosphate, 7.5g disodium hydrogen phosphate, 25g glucose, add 200mL water for injection to dissolve, stir well, and dilute to 1000mL with water for injection to obtain the medicinal solution .

[0064] 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.

[0065] c. The filtered medicinal solution is sterilized at 121° C. for 8 minutes by autoclaving, and then cooled.

[0066] 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.

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PUM

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Abstract

The invention discloses bacteriostat-free tobramycin eye drops and a preparation method thereof. The bacteriostat-free tobramycin eye drops comprise tobramycin, 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 tobramycin eye drops without bacteriostatic agent and a preparation method thereof. Background technique [0002] Tobramycin eye drops are used to prevent and treat infection before and after eye surgery, bacterial conjunctivitis, keratitis, dacryocystitis, etc. All tobramycin eye drops on the market contain antibacterial agents and are 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, also known as pre...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/702A61P31/04A61P27/02
Inventor 姚军
Owner HEBEI UNIVERSITY OF SCIENCE AND TECHNOLOGY
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