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

A levofloxacin hydrochloride, disposable technology, applied in levofloxacin hydrochloride eye drops without bacteriostatic agent and its preparation field, can solve the problem that the bacteriostatic effect cannot be used as an ophthalmic preparation, has not been unanimously approved, and avoids toxic and side effects , Guarantee sterility requirements, and save costs

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

Although levofloxacin hydrochloride itself has a certain antibacterial effect, its bacteriostatic 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

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

[0046] prescription:

[0047]

[0048]

[0049] Its preparation method:

[0050]a. Accurately weigh 3.3 g of levofloxacin hydrochloride, 7.24 g of sodium dihydrogen phosphate, 0.94 g of disodium hydrogen phosphate, and 12.0 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.

[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 3.3g of levofloxacin hydrochloride, 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 3.3g levofloxacin hydrochloride, 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 invention discloses disposable levofloxacin hydrochloride eye drops and a preparation method thereof. The disposable levofloxacin hydrochloride eye drops comprise levofloxacin 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 single dose for disposable use, 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 a disposable levofloxacin hydrochloride eye drop without bacteriostatic agent and a preparation method thereof. Background technique [0002] Levofloxacin hydrochloride eye drops are used to treat bacterial conjunctivitis and bacterial keratitis caused by sensitive bacteria. All the levofloxacin hydrochloride eye drops on the market 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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IPC IPC(8): A61K9/08A61K31/5383A61P31/04A61P27/02
Inventor 姚军
Owner HEBEI UNIVERSITY OF SCIENCE AND TECHNOLOGY
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