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Timolol maleate eye drops without bacteriostatic agent and preparation method thereof

A technology of timolol maleate eye drops and timolol maleate, which is applied in the field of timolol maleate eye drops and its preparation, can solve problems such as high risk and achieve cost savings , avoid toxic and side effects, and ensure the effect of sterility requirements

Inactive Publication Date: 2009-07-08
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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  • Timolol maleate eye drops without bacteriostatic agent and preparation method thereof
  • Timolol maleate eye drops without bacteriostatic agent and preparation method thereof
  • Timolol maleate eye drops without bacteriostatic agent and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] prescription:

[0048]

[0049] Its preparation method:

[0050] a. Accurately weigh 3.42g of timolol maleate and 24.0g of glycerol, add 200mL of water for injection to dissolve, stir evenly, and dilute to 1000mL with water for injection to obtain a medicinal solution.

[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 0.4mL 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

[0054] prescription:

[0055]

[0056] Its preparation method:

[0057] a. Accurately weigh 3.42g timolol maleate, 3.2g sodium dihydrogen phosphate, 5.6g disodium hydrogen phosphate, 11.0g glycerin, add 200mL water for injection to dissolve, stir well, and dilute to 1000mL with water for injection , get 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 0.5mL 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

[0062] prescription:

[0063]

[0064]

[0065] Its preparation method:

[0066] a. Accurately weigh 6.8g timolol maleate, 11.5g boric acid, 1.1g borax, 1.8g sodium chloride, 0.6g 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.

[0067] 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.

[0068] c. The filtered medicinal solution is sterilized at 121° C. for 8 minutes by autoclaving, and then cooled.

[0069] 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 a timolol maleate eye drop which does not contain bacteriostat and a preparation method thereof. The timolol maleate eye drop contains timolol maleate, pH regulator, isotonic agent, stabilizing agent, thickening agent, freshener, etc. The preparation method adopts antiseptic technique filling technology or heat pressing sterilizing technique, and the eye drop uses one-off individual package with single dose, so that the aseptic performance of the product is ensured, and the product is safer, more reliable, simpler, more convenient and sanitary.

Description

technical field [0001] The invention belongs to the field of pharmacy, in particular to timolol maleate eye drops without bacteriostatic agent and a preparation method thereof. Background technique [0002] Timolol maleate eye drops are used for the prevention and treatment of glaucoma and ocular hypertension. The timolol maleate eye drops that have been on the market all 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 preservatives or p...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/5377A61P27/06
Inventor 姚军
Owner HEBEI UNIVERSITY OF SCIENCE AND TECHNOLOGY
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