Sodium hyaluronate eye drops without bacteriostatic agent and preparation method thereof

A technology of sodium hyaluronate and eye drops, which can be applied to medical preparations containing active ingredients, pharmaceutical formulations, organic active ingredients, etc., can solve problems such as high risk, save costs and avoid toxic and side 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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  • Sodium hyaluronate eye drops without bacteriostatic agent and preparation method thereof
  • Sodium hyaluronate eye drops without bacteriostatic agent and preparation method thereof
  • Sodium hyaluronate eye drops without bacteriostatic agent and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] prescription:

[0043]

[0044] Its preparation method:

[0045] a. Precisely weigh 1.0 g of sodium hyaluronate, 12.0 g of boric acid, 0.6 g of borax, and 6.3 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 medicinal solution.

[0046] 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.

[0047] 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

[0049] prescription:

[0050]

[0051] Its preparation method:

[0052] a. Accurately weigh 1.0g of sodium hyaluronate, add 300mL of water for injection to dissolve it, stir at a constant temperature of 50-70°C for 12 hours to achieve sufficient swelling, and cool to obtain solution 1 for later use; accurately weigh 4.82g of sodium dihydrogen phosphate , 3.78g disodium hydrogen phosphate, 4.5g sodium chloride, after adding 200mL water for injection to dissolve, it is stirred and mixed to obtain solution 2 for subsequent use; solution 1 and solution 2 are mixed, after stirring evenly, dilute to volume with water for injection to 1000mL to obtain liquid medicine.

[0053] 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.

[0054] c. After the medicinal liquid is tested and passed, fill 0.4mL of the above medicinal liquid into a 1mL single-dose packag...

Embodiment 3

[0056] prescription:

[0057]

[0058] Its preparation method:

[0059] a. Precisely weigh 1.0g sodium hyaluronate, 11.7g boric acid, 1.2g borax, 2.2g sodium chloride, 0.1g ethylenediaminetetraethylene disodium, add 200mL water for injection to dissolve, stir evenly, and dilute to volume with water for injection to 1000mL to obtain liquid medicine.

[0060] 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.

[0061] c. The filtered medicinal solution is sterilized at 121° C. for 8 minutes by autoclaving, and then cooled.

[0062] 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 sodium hyaluronate eye drops and a preparation method thereof. The bacteriostat-free sodium hyaluronate eye drops comprise sodium hyaluronate, a pH regulator, an isotonic agent, a stabilizing 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 sodium hyaluronate eye drops without bacteriostatic agent and a preparation method thereof. Background technique [0002] Sodium hyaluronate eye drops (also known as: sodium hyaluronate eye drops) is used to prevent and treat eye fatigue, dry eye and other diseases. Sodium hyaluronate 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. Bacteriostati...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/728A61P27/04A61P27/02
Inventor 姚军
Owner HEBEI UNIVERSITY OF SCIENCE AND TECHNOLOGY
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