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Cromoglyn sodium eye drops without bacteria inhibitor and preparation method thereof

A technology for sodium cromoglycate and eye drops, applied in the field of sodium cromoglycate eye drops and preparation thereof, can solve problems such as high risk, achieve the effects of saving costs, avoiding toxic and side effects, and ensuring sterility requirements

Inactive Publication Date: 2009-06-17
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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  • Cromoglyn sodium eye drops without bacteria inhibitor and preparation method thereof
  • Cromoglyn sodium eye drops without bacteria inhibitor and preparation method thereof
  • Cromoglyn sodium eye drops without bacteria inhibitor and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] prescription:

[0048]

[0049] Its preparation method:

[0050] a. Precisely weigh 20.0 g of sodium cromoglycate and 4.0 g of sodium bisulfite, 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. 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.

[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 20.0g sodium cromoglycate, 7.24g sodium dihydrogen phosphate, 0.94g disodium hydrogen phosphate, 1.2g sodium bisulfite, add 200mL water for injection to dissolve, stir well, and dilute to 1000mL with water for injection, Get the medicine.

[0058] 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.

[0059] c. After the medicinal liquid is tested and passed, fill 2mL of the above medicinal liquid into a 3mL single-dose packaging plastic container under Class 100 environment, and seal it to obtain the finished product.

Embodiment 3

[0061] prescription:

[0062]

[0063] Its preparation method:

[0064] a. Accurately weigh 20.0 g of sodium cromolyn, 12.0 g of boric acid, 0.5 g of borax, and 1.0 g of sodium metabisulfite, 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.

[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 0.5mL 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.

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PUM

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Abstract

The present invention discloses sodium cromoglicate eye drops which do not contain bacteriostat and a preparing method thereof, wherein the sodium cromoglicate eye drops comprise sodium cromoglicate, pH modifying agent, isoosmotic agent, stabilizing agent, thickening agent, algefacient, etc. The preparing method adopts an aseptic manipulation filling technique or hot pressing sterilizing technique. Furthermore the eye drops of the invention adopt a disposable single-dose independent packaging. The sterilized performance of product is guaranteed. The product is safer, more reliable, easier and more sanitary.

Description

technical field [0001] The invention belongs to the field of pharmacy, in particular to sodium cromoglycate eye drops without bacteriostatic agents and a preparation method thereof. Background technique [0002] Sodium cromoglycate eye drops are used to treat ophthalmic diseases such as allergic conjunctivitis and vernal catarrhal conjunctivitis. The cromolyn sodium 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 age...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/352A61P27/02A61P27/14
Inventor 姚军
Owner HEBEI UNIVERSITY OF SCIENCE AND TECHNOLOGY
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