Tropicamide eye drops without bacteria inhibitor and the preparation method thereof

A technology for tropicamide and eye drops is applied in the field of tropicamide eye drops and preparation thereof, which can solve the problems of high risk and achieve the effects of saving cost and avoiding toxic and side effects

Inactive Publication Date: 2009-06-03
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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  • Tropicamide eye drops without bacteria inhibitor and the preparation method thereof
  • Tropicamide eye drops without bacteria inhibitor and the preparation method thereof
  • Tropicamide eye drops without bacteria inhibitor and the preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] prescription:

[0043]

[0044] Its preparation method:

[0045] a. Accurately weigh 2.50g of tropicamide and 8.00g of sodium chloride, add 200mL of water for injection to dissolve, adjust the pH to 5.0-7.0 with 5% hydrochloric acid, stir evenly, and dilute to 1000mL with water for injection to obtain the medicinal solution .

[0046] 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.

[0047] 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

[0049] prescription:

[0050]

[0051] Its preparation method:

[0052] a. Accurately weigh 2.50g tropicamide, 7.24g sodium dihydrogen phosphate, 0.94g disodium hydrogen phosphate, 13.0g glycerol, add 200mL water for injection to dissolve, stir well, and dilute to 1000mL with water for injection to obtain the drug liquid.

[0053] 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.

[0054] c. The filtered medicinal solution is sterilized at 121° C. for 8 minutes by autoclaving, and then cooled.

[0055] 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

[0057] prescription:

[0058]

[0059] Its preparation method:

[0060] a. Precisely weigh 5.0 g of tropicamide, 12.0 g of boric acid, 0.5 g of borax, and 2.1 g of sodium chloride, 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.

[0061] 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.

[0062] c. After the medicinal solution is qualified, fill 1.0mL of the above medicinal solution into a 2mL 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 disclose a tropicamide eye drops without bacteria inhibitor and the preparation method thereof, which comprises tropicamide, pH regulating agent, isotonic agent and stabiliser etc. sterile operation loading process or heat pressing sterilizing process is adopted in the preparation, and disposable single dose independent packaging is used in the eye drop through the present invention, so that sterilized performance is guaranteed to make product more secure, reliable, sanitary, simple and convenient.

Description

technical field [0001] The invention belongs to the field of pharmacy, in particular to tropicamide eye drops without bacteriostatic agent and a preparation method thereof. Background technique [0002] Tropicamide eye drops are used to dilate mydriasis and check fundus and diopter. The tropicamide eye drops 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 preservatives, refer to chemicals that inhibit t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/4409A61P27/06
Inventor 姚军
Owner HEBEI UNIVERSITY OF SCIENCE AND TECHNOLOGY
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