A kind of ophthalmic composition for improving the stability of chloramphenicol and preparation method thereof

A technology of ophthalmic composition and chloramphenicol, which is applied in the direction of non-active ingredient medical preparations, medical preparations containing active ingredients, drug combinations, etc., can solve the problem of improving the stability of preparations and improve treatment compliance stability, improving stability, and reducing the number of administrations

Active Publication Date: 2020-07-10
湖北远大天天明制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Although cyclodextrin and hyaluronic acid have improved some shortcomings of traditional eye drops, there are still deficiencies in improving the stability of the formulation.

Method used

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  • A kind of ophthalmic composition for improving the stability of chloramphenicol and preparation method thereof
  • A kind of ophthalmic composition for improving the stability of chloramphenicol and preparation method thereof
  • A kind of ophthalmic composition for improving the stability of chloramphenicol and preparation method thereof

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preparation example Construction

[0027] The embodiment of the present invention also proposes a preparation method of the ophthalmic composition for improving the stability of chloramphenicol, comprising the following steps:

[0028] Inject the prepared water for injection into the batching tank, add preservatives, pH regulators, osmotic pressure regulators and polyoxyethylene sorbitan monooleate into the batching tank according to the proportion, stir until completely dissolved, and boil; Dissolve chloramphenicol in castor oil, stir until dissolved, add into the batching tank; stir evenly, add the remaining amount of water for injection, sterilize and filter, fill, and the part amount of water for injection is 65% to 75% of the total amount.

[0029] It is generally believed that when the pH of chloramphenicol eye drops is below 7, the amide is hydrolyzed to generate amino and dichloroacetic acid. In the range of pH 2-7, pH has little effect on the rate of hydrolysis. It is most stable at pH 6, the hydrolys...

Embodiment 1

[0034] An ophthalmic composition for improving the stability of chloramphenicol, comprising the following components: 0.1% chloramphenicol, 0.7% pH regulator, 0.01% preservative, 0.3% osmotic pressure regulator, 1.2% castor oil and Polyoxyethylene sorbitan monooleate 0.5%, the balance is water for injection.

Embodiment 2

[0036]An ophthalmic composition for improving the stability of chloramphenicol, comprising the following components: 0.2% chloramphenicol, 1.0% pH regulator, 0.02% preservative, 0.4% osmotic pressure regulator, 1.8% castor oil and Polyoxyethylene sorbitan monooleate 0.6%, the balance is water for injection.

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Abstract

The invention discloses an eye composition capable of improving the stability of chloramphenicol as well as a preparation method thereof. The eye composition comprises the following components by weight percent: 0.1 to 0.4 percent of chloramphenicol, 0.7 to 1.5 percent of apH regulator, 0.01 to 0.04 percent of a preservative, 0.3 to 0.5 percent of an osmotic pressure regulator, 1.2 to 2.6 percentof castor oil as well as 0.5 to 0.8 percent of polyoxyethylene sorbitan monooleate, and the balance of injection water. By utilizing the castor oil and the polyoxyethylene sorbitan monooleate, the stability of the eye composition can be improved. A purpose of releasing the drug for a long time and reducing the administration times for a patient can be achieved, and the therapeutic compliance of the patient can be improved.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, and in particular to an ophthalmic composition for improving the stability of chloramphenicol and a preparation method thereof. Background technique [0002] Chloramphenicol eye drops is a commonly used drug for the eyes. It used to be used in the market as an OTC class A drug. Sodium hyaluronate and glycerin are added to the eye solution to enhance the viscosity and improve the retention time in the eyes. The usual period of validity or shelf life of medicines is 2 years, while the validity period of chloramphenicol eye drops can only reach 8-12 months. This is because chloramphenicol in chloramphenicol eye drops is easily decomposed into chloramphenicol glycol , p-nitrobenzaldehyde, chloramphenicol diol and p-nitrobenzaldehyde are highly irritating to the eyes and affect the use of patients. [0003] Through research, it is found that by adjusting the material components i...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/165A61K47/44A61K47/22A61P27/02
CPCA61K9/0048A61K9/08A61K31/165A61K47/22A61K47/44A61P27/02
Inventor 付欢王超尹传忠万利鹏延静
Owner 湖北远大天天明制药有限公司
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