Single-dosage gatifloxacin eye drop and preparation method thereof

A technology of gatifloxacin and eye drops, applied in pharmaceutical formulations, drug delivery, sensory diseases, etc., can solve the problems of ophthalmic preparations judgment standards, waste of resources, narrow antibacterial spectrum, etc., to avoid toxic side effects and potential risk, avoid potential hazards, and save costs

Inactive Publication Date: 2014-01-15
QILU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In addition, the currently used preservatives or antibacterial agents have weak antibacterial ability and narrow antibacterial spectrum, and the antibacterial effect of preservatives is not ideal. See "Chinese Practical Medicine", 2010, 5 (24), P43-44
Although gatifloxacin itself has certain antibacterial efficacy, its antibacterial efficacy cannot be used as a criterion for judging whether to add antibacterial agents to ophthalmic preparations. Thoughts on Adding Bacteriostatic Agents, E-Journal September 12, 2008
[0006] At the same time, the irrationality of multi-dose packaging is becoming more and more prominent in the selection of ophthalmic medicines. The remaining ophthalmic medicines in the hands of patients will be discarded, which not only wastes resources, increases the pollution of medical waste, but also causes patients to suffer certain economic losses.
Multi-dose packaged eye drops are increasingly unable to meet the needs of long-term medication patients

Method used

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  • Single-dosage gatifloxacin eye drop and preparation method thereof
  • Single-dosage gatifloxacin eye drop and preparation method thereof
  • Single-dosage gatifloxacin eye drop and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0066] Example 1. Single-dose gatifloxacin eye drops, without bacteriostatic agent, for one-time use, the volume of the individually packaged medicine solution is 0.4mL / bottle, and the content of gatifloxacin is 0.5% (g / mL).

[0067] prescription:

[0068]

[0069]

[0070] A total of 2,500 pieces were made.

[0071] Preparation:

[0072] a. Accurately weigh 5.0g of gatifloxacin, add it to 200mL of 0.1mol / L hydrochloric acid to fully dissolve, add water for injection to 80% of the total volume; accurately weigh 8.0g of sodium chloride, and add it to the above solution; use 1N Adjust the pH value to 5.7 with hydrochloric acid or 1N sodium hydroxide solution, and make up the prescribed amount of water for injection to obtain a medicinal solution;

[0073] b. Filter the medicinal solution obtained in step a through a 0.22 μm microporous membrane for 2 times;

[0074] c. Fill 0.4mL of liquid medicine into a 1mL single-dose packaging container in a class A clean area, and ...

Embodiment 2

[0076] Example 2. Single-dose gatifloxacin eye drops, free of bacteriostatic agents, for one-time use, individually packaged with a volume of 0.6 mL / bottle and a content of 0.5% (g / mL).

[0077] prescription:

[0078]

[0079] A total of 1666 pieces were made.

[0080] Preparation:

[0081] a. Accurately weigh 5.0g of gatifloxacin, add it to 200mL of 0.1mol / L hydrochloric acid to fully dissolve, add water for injection to 80% of the total volume; accurately weigh 6.39g of sodium dihydrogen phosphate and 2.89g of disodium hydrogen phosphate 12.0 g of glycerol is added in the above-mentioned solution; the pH value is adjusted to 6.0 with 1N hydrochloric acid or 1N sodium hydroxide solution, and the water for injection of the prescribed amount is supplemented to obtain a medicinal solution;

[0082] b. Filter the medicinal solution obtained in step a through a 0.22 μm microporous membrane for 2 times;

[0083] c. Fill 0.6mL of liquid medicine into a 1mL single-dose packagin...

Embodiment 3

[0085] Example 3. Single-dose gatifloxacin eye drops, free of bacteriostatic agents, for one-time use, individually packaged with a volume of 0.8mL / bottle and a content of 0.5% (g / mL).

[0086] prescription:

[0087]

[0088] A total of 1250 pieces were made,

[0089] Preparation:

[0090] a. Accurately weigh 5.0g of gatifloxacin, and add it into 200mL of 0.1mol / L hydrochloric acid to fully dissolve; accurately weigh 12.0g of boric acid, 1.0g of borax, and 2.0g of sodium chloride, and add it into the above solution; or 1N sodium hydroxide solution to adjust the pH value to 8.0, and make up the prescribed amount of water for injection to obtain a medicinal solution;

[0091] b. Filter the medicinal solution obtained in step a through a 0.22 μm microporous membrane for 2 times;

[0092] c. Fill 0.8mL of liquid medicine into a 1mL single-dose packaging container in a class A clean area, seal the seal, and obtain the finished product.

[0093] Use the osmotic pressure detec...

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PUM

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Abstract

The invention relates to a single-dosage gatifloxacin eye drop and a preparation method thereof. The eye drop mainly contains gatifloxacin, a pH regulator, an osmotic pressure regulator and injection water, wherein the eye drop contains no bacteriostatic agents, has the pH value of 5.0-8.0, is independently packaged at single dosage and is disposable; the liquid medicine independently packaged at single dosage has the volume of 0.1-1.0mL, wherein the gatifloxacin has the mass content of 0.3-0.5% and the unit content of g / mL. The preparation method comprises the steps of carrying out sterile filtration, carrying out sterile operation and filling. In addition, the eye drop provided by the invention is independently packaged at single dosage and is disposable, so that the sterile performance of the eye drop is ensured, and the eye drop is safer as well as more reliable and convenient.

Description

technical field [0001] The invention belongs to the field of pharmacy, in particular to a single-dose gatifloxacin eye drop and a preparation method thereof. Background technique [0002] Gatifloxacin eye drops are used to treat bacterial conjunctivitis caused by the following sensitive strains: Oxygen gram-negative bacteria, Haemophilus influenzae. The gatifloxacin eye drops already 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 microorganisms in the air during use and storage, which will cause safety hazards. In order to prevent ophthalmic preparations from being contaminated by microorganisms during repeated use after opening, bacteriostatic agents are added to ophthalmic preparations, and bacteriostatic agents are used in almost all eye drop prescriptions in the "Chinese Hospital Preparation Standards" . The commonly used bacteriostatic agen...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/496A61P31/04A61P27/02
Inventor 王晶翼李红英张海杨清敏张明会
Owner QILU PHARMA
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